2021/2013(INI) | [ParlTrack]

Margarita DE LA PISA CARRIÓN, Jessica STEGRUD

Draft opinion
Recital -A (new)

-A. whereas the problem of shortages of medicines in the EU is long-standing and the number of incidents relating to shortages of medicines has been growing in the EU Member States in recent years;

Amendment 10 #

Draft opinion
Recital A a (new)

A a. whereas over the last decades numerous peoples lives have been saved thanks to research; whereas this research can only be conducted in a innovation- friendly ecosystem, which has investor certainty and IP-right protection at the core;

Amendment 100 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 j (new)

1 j. Considers that future medicines and vaccine development needs to be steered towards delivering optimal health technologies for public health and global access, including through the design and use of mission-oriented innovation programmes; highlights the necessity of enhanced EU leadership in prioritising public health needs and steering future R&D of health technologies by selecting and pursuing promising potential products based solely on public health considerations;

Amendment 101 #

Draft opinion
Paragraph 1 j (new)

1j. Calls on the Commission to establish, as quickly as possible, a European strategic reserve of MPMTIs for which there are serious risks of shortages, which could constitute an emergency source of supply for the Member States;

Amendment 102 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 k (new)

1 k. Calls on the Commission and the Member States to examine the possibility of creating one or more European public or non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare, as part of its Industrial and Pharmaceutical Strategies, in order to complete and guarantee security of supply and prevent possible shortages of medicines in cases of emergency; recalls the essential role that new technologies, digitalisation and artificial intelligence can play in enabling researchers from European laboratories to work in a network and share their objectives and their results, while fully respecting the European Data Protection Framework;

Amendment 103 #

Draft opinion
Paragraph 1 k (new)

1k. Calls on the Commission and the Member States to work together with health professionals, patients’ associations and manufacturers to draw up an evolving list of MPMTIs for which there are serious risks of shortages, using monitoring indicators such as previous shortages and indicators relating to the fragility of the production chain;

Amendment 104 #

Draft opinion
Paragraph 1 l (new)

1l. Calls for public medicinal product hubs to be set up in all the Member States, and also at EU level; takes the view that these public hubs should be run democratically and transparently by management boards which bring together representatives of national health authorities and social security institutions, representatives of industry trade unions, associations of public health system users, scientists and parliamentarians;

Amendment 105 #

Draft opinion
Paragraph 1 m (new)

1m. Considers that these public medicinal product hubs should have the following priority tasks: (a) reshoring and providing for public production of medicines, active ingredients, reagents and diagnostics in accordance with a plan democratically agreed by the Member States; (b) guaranteeing supplies for a strategic reserve of essential medicines; (c) ensuring that national medicine stocks are sufficient to meet demand of any kind, and that public production units are sufficiently responsive to meet a sudden increase in demand; (d) making for transparency in the financing of research and development and the introduction of conditionality in the private sector which receives aid for research into medicines and vaccines; (e) monitoring prices of all health products, and communicating their real production costs.For imported active ingredients, information must be available on their origin; (f) expanding the use of diagnostics platforms; (g) taking decisions to export medicines and health products to provide health aid to third countries which are experiencing difficulties; (h) publishing all works and studies relating to their activities.

Amendment 106 #

Draft opinion
Paragraph 2

2. Calls on the Commission to pursue a public-driven model of R&D that ensures health innovations responding to real public health needs, to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines;

Amendment 107 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2

2. ~~Call~~Points onut th~~e Commission to keep the results of Union-funded R&D in the public domain; points out that the protection~~at a strong EU intellectual property regime is essential for the continued innovation of medicines and vaccines, acknowledges that policy which incentivises medical innovation is in the interest of patients ~~must not run~~and society at large, including by ensuring that Europe count~~er to the right to health~~inues tobe competitive and an attractive location for R&;D investment;

Amendment 108 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Aldo PATRICIELLO, Sara SKYTTEDAL, Tomas TOBÉ, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

2. ~~Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health~~Points out that the protection of the social contract between European pharmaceutical companies, patients and society as a whole rests on the EU intellectual property framework; points out that the intellectual property framework acts as a driver of investments in research and development, which is essential to innovation;

Amendment 109 #

Draft opinion
Paragraph 2

2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health; underlines that public interest and patient safety should be at the centre of all health policies, alongside investment and research;

Amendment 11 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Recital A a (new)

A a. whereas ensuring interoperability of HPC with AI is of the utmost importance, as major economic sectors relying on HPC include manufacturing, health and pharmaceuticals.

Amendment 110 #

Draft opinion
Paragraph 2

2. ~~Call~~Points onut th~~e Commission to keep the results of Union-funded R&D in the public domain; points out that the protection~~at a strong EU intellectual property regime is essential for the continued innovation of medicines and vaccines, and exist in the interest of patients ~~must not run~~and society at large, including by ensuring that Europe count~~er to the right to health~~inues to be an attractive location for R&;D investment and industrial development;

Amendment 111 #

Draft opinion
Paragraph 2

2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; ~~points out that the protection of patents must not run counter to the right to health;~~

Amendment 112 #

Draft opinion
Paragraph 2

2. Calls on the Commission to ~~keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run~~maintain simple public access to patenting and licensing conditions, information on clinical and pre-clinical trials and public and private count~~er to the right to health~~ributions;

Amendment 113 #

Draft opinion
Paragraph 2

2. Calls on the Commission to ~~keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health~~maintain a stable and predictable legislative framework for intellectual property in order to encourage pharmaceutical innovation in the EU;

Amendment 114 #

Draft opinion
Paragraph 2

2. Calls on the Commission to ~~keep~~ensure that the results of ~~Union-~~public funded R&D ~~in the public domain; points out that the protection of patents must not run counter to the right to~~(either on Union or Member State- level) shall benefit the public health;

Amendment 115 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 2 a (new)

2 a. Acknowledges that intellectual property rights, notably trade secrets, can hamper or delay future research by creating data silos; calls on the Commission to promote an innovation ecosystem better set up for using collective intelligence to accelerate advances; highlights the need to use collective intelligence to accelerate advances, making wider use of open science, patent pools and compulsory licensing ; Calls on the Commission to support measures favouring open science in order to accelerate the sharing of data and research results within the scientific community in Europe and beyond;

Amendment 116 #

Draft opinion
Paragraph 2 a (new)

2a. Notes that the implementation of Regulation (EC) No 141/2000 on orphan medicinal products and Regulation (EC) No 1901/2006 on medicinal products for paediatric use has led to an increase in the number of clinical trials and the number of treatments available for rare diseases; draws the Commission's attention to the fact that any proposal to revise these two regulations must maintain a stable and predictable incentive framework, with a particular focus on the prevalence threshold;

Amendment 117 #

Draft opinion
Paragraph 2 a (new)

2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, rare diseases and neurological diseases;

Amendment 118 #

Draft opinion
Paragraph 2 a (new)

2 a. Highlights the importance of a research-based pharmaceutical industry as an essential contributor to safeguarding quality manufacturing and supply of affordable medicines to reach all patients in need, strengthening the Union’s innovation, resilience, accessibility and responsiveness and helping address future challenges;

Amendment 119 #

Draft opinion
Paragraph 2 a (new)

2 a. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end products; calls on the Commission to adopt and implement a general policy on such conditionality under Horizon Europe;

Amendment 12 #

Draft opinion
Recital A a (new)

Aa. whereas, therefore, it is a matter of extreme urgency to reshore to Europe most parts of the production and distribution chain for medicines;

Amendment 120 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2 a (new)

2a. Condemns the practice employed by pharmaceutical laboratories of abandoning all medicines no longer considered profitable enough, even if they are essential, and only seeking to maximise profits by filing patents;

Amendment 121 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 2 a (new)

2a. Calls on the Commission to ensure that the results of research fully or partly financed by Union programmes or other public funds, including HERA, remain in the public domain and are subject to non- exclusive licences;

Amendment 122 #

Draft opinion
Paragraph 2 a (new)

2 a. Stresses that investment in research should deliver effective therapeutic treatments for patients with rare diseases, chronic diseases including cancer and paediatric cancers in particular;

Amendment 123 #

Draft opinion
Paragraph 2 b (new)

2b. Points out that patents are not synonymous with innovation; stresses that there are very high levels of public and charitable support for research, development and production and that the risks and the investment are therefore well and truly socialised, whereas the profits, stemming from unreasonable prices that are constantly rising, are privatised, going to the pharmaceutical laboratories; considers, therefore, that the system of patents on medicines is a fool’s game that works to the detriment of public authorities, social security institutions, citizens and patients; points out that, as a result, citizens are paying twice, and through the nose, for medicine, whether in the form of aid for research or through the reimbursement of the cost of medicines; considers that citizens are being dispossessed of the medicines that ought to belong to them;

Amendment 124 #

Draft opinion
Paragraph 2 b (new)

2 b. Urges the Commission to propose measures to promote green manufacturing of pharmaceutical products, to include assessment of environmental properties of the active substance and environmental standards in production in the marketing authorisation process and to review tendering systems in order to reward sustainable, ethical and quality manufacturing;

Amendment 125 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2 b (new)

2b. Takes the view that constant dialogue between pharmaceutical companies, health authorities and paying agencies is essential in order to match research and development priorities with those of health systems;

Amendment 126 #

Draft opinion
Paragraph 2 b (new)

2 b. Highlights the potential of AI- based solutions in reinforcing the resilience and sustainability of EU’s healthcare systems, while offering innovative therapies and better diagnosis using Real-World Data;

Amendment 127 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2 c (new)

2 c. Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems;

Amendment 128 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2 c (new)

2c. Calls on the health authorities and pharmaceutical companies to make determined efforts to address the persistent gender bias in this area and guarantee an equal focus on male and female physiology in research and development;

Amendment 129 #

Draft opinion
Paragraph 2 d (new)

2 d. Stresses the need to develop European federated data networks aiming to contribute to optimal research, development and healthcare delivery;

Amendment 13 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Recital A a (new)

Aa. having regard to the announcement made by the Commission on 11 November 2020 on the setting-up of the Health Emergency Preparedness and Response Authority (HERA);

Amendment 130 #

Draft opinion
Paragraph 2 e (new)

2 e. Underlines the importance of data sharing and data accessibility in deploying the full potential of AI in the field of healthcare, while putting in place robust ethical requirements;

Amendment 131 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 2 f (new)

2 f. Recalls that the processing of data for health research purposes should comply with the provisions of GDPR under Article 9 on the processing of special categories of data;

Amendment 132 #

Draft opinion
Paragraph 3

3. Calls on the Commission to develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment;deleted

Amendment 133 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Josianne CUTAJAR, Carlos ZORRINHO, Robert HAJŠEL

Draft opinion
Paragraph 3

3. Calls on the Commission to develop a new incentive model, make provision for marketing gestures geared on a pro rata basis to the aid received, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment;

Amendment 134 #

Draft opinion
Paragraph 3

Amendment 135 #

Draft opinion
Paragraph 3

3. Calls on the Commission to develop a new ~~incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment~~targeted incentives, in areas where the development of products would otherwise not be sustainable for companies, such as transferable market exclusivities to stimulate the development of new antimicrobials, based on decoupling mechanisms;

Amendment 136 #

Draft opinion
Paragraph 3

3. Calls on the Commission to develop a new ~~incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment~~targeted incentives in areas where the development of products would otherwise not be sustainable for companies such as transferable market exclusivities to stimulate the development of new antimicrobials, based on decoupling mechanisms;

Amendment 137 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Othmar KARAS, Aldo PATRICIELLO, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 3

3. Calls on the Commission to develop a new ~~incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment~~targeted incentives to ensure equitable access to medicines also in areas where the development of products would otherwise not be sustainable;

Amendment 138 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Aldo PATRICIELLO, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 3

3. Calls on the Commission to ~~develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds~~, attach strict conditions, including on pricing, transparency and availability, to public funds, incentives and rewards, in accordance with the principle of fair return on investment;

Amendment 139 #

Draft opinion
Paragraph 3 a (new)

3 a. Welcomes the impact of the Regulation on orphan medicinal products (EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006); notes however that scientific progress and investment in research have not been sufficient for the unmet needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases, to deal with antimicrobial resistance (AMR) or to prevent infectious diseases outbreaks; Calls on the Commission to support a regulatory framework which strengthens incentives for orphan medicines research and development in the EU to effectively address these shortcomings;

Amendment 14 #

Draft opinion
Recital A a (new)

Aa. whereas intellectual property rights contribute to the accessibility, innovation and competitiveness of the sector;

Amendment 140 #

Draft opinion
Paragraph 3 a (new)

3 a. Emphasises the value of the existing intellectual property (IP) framework as the key driver of medical innovation; calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU’s trade policy to promote European competitiveness, by ensuring a sound EU IP framework that protects investment in medical research and allows industry to remain an innovator and world leader in R&D and advanced manufacturing, integrating cutting edge technology and sustainable processes, and thus making the EU capable to compete with challenger regions such as the US and China;

Amendment 141 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Josianne CUTAJAR, Carlos ZORRINHO, Robert HAJŠEL

Draft opinion
Paragraph 3 a (new)

3 a. Emphasises the value of the existing intellectual property (IP) framework as the key driver of medical innovation and competitiveness; condemns any attempt to undermine the IP framework by public officials; calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU’s trade policy to promote European competitiveness in a global market, by ensuring a sound EU IP framework that protects investment in medical research and allows industry to remain an innovator and world leader in life saving cutting edge technologies;

Amendment 142 #

Draft opinion
Paragraph 3 a (new)

3 a. Highlights the latest evolution of pharmaceutical products towards disease and patient-specific therapeutics, involving scrupulous manufacturing steps and the need to take into account the high sensitivity to environmental and transport conditions and complicating supply chain logistics; invites the Commission to maximise synergies between European funds and other EU instruments and policies, to support the design and operation of robust manufacturing processes and distribution networks ensuring agile, responsive and reproducible manufacturing;

Amendment 143 #

Draft opinion
Paragraph 3 a (new)

3 a. Calls on the Commission to propose solutions that promote health systems fiscal sustainability, such as increasing the share of resources within healthcare budgets allocated for investments in prevention and strengthening primary care systems; and stresses the importance of promoting the sustainability of the pharmaceutical supply chain, including by adequately remunerating community pharmacists for the services they provide;

Amendment 144 #

Draft opinion
Paragraph 3 a (new)

3 a. Stresses the importance of continuous innovation, including the off- patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise these category of affordable innovation with appropriate incentives and its value for healthcare systems;

Amendment 145 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 3 a (new)

3 a. Is concerned, particularly in regard to the Innovative Health Initiative, that the Industry exercises exclusive control on the priorities of the Innovative Medicines Initiative (IMI2) Joint Undertaking, that the Industry alone draws up the strategic agendas and annual work plans and privatises the results and data of projects financed by public money;

Amendment 146 #

Draft opinion
Paragraph 3 a (new)

3a. Points out that a range of EU programmes can be used to fund pharmaceutical research projects, such as Horizon Europe, InvestEU, EU4Health, cohesion policy and the Digital Europe programme for projects focusing on the deployment of artificial intelligence;

Amendment 147 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 3 a (new)

3a. Calls for the introduction of a new incentive model, based on a study of decoupling mechanisms as an alternative to exclusive protection arrangements and subject to strict conditions governing the accessibility and availability of public funds for research and innovation;

Amendment 148 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 3 b (new)

3 b. Calls on the Commission to correct structural flaws in the design of Joint Undertakings, which give Industry a monopoly on strategic decision-making, allowing it to block the 2018 Commission proposal to integrate epidemiological preparation into the scope of the work of the IMI2 Joint Undertaking;

Amendment 149 #

Draft opinion
Paragraph 3 b (new)

3b. Calls for due consideration to be given to the further training and retraining of workers involved at all stages in the value chain and to broadening the range of training opportunities for STEM specialists;

Amendment 15 #

Draft opinion
Recital A a (new)

A a. whereas the right to health is one of the core principles of the European Pillar of Social Rights;

Amendment 150 #

Draft opinion
Paragraph 3 b (new)

3 b. Calls on Member States to encourage the uptake of generics and biosimilars in the EU by introducing financial incentives to healthcare professionals such as pharmacists to dispense these products to patients;

Amendment 151 #

Draft opinion
Paragraph 3 b (new)

3 b. Calls on the Commission to incentivise child specific and first-in-child innovation and to facilitate the repositioning of medicines failing in adults when there is scientific and preclinical rationale;

Amendment 152 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 3 c (new)

3 c. Notes that the Industry refuses to disclose crucial documents related to Joint Undertakings and public-private partnerships, such as project proposals, grants or project agreements; recalls, in that regard, that those documents concern projects funded by public money; regrets that these problems are partly a consequence of the structure and mechanisms of this public-private partnership; calls therefore on the Commission to introduce stringent transparency obligations in all current and future partnerships;

Amendment 153 #

Draft opinion
Paragraph 4

~~4. Calls on the Commission to develop a mandatory European licence in order to be able to respond rapidly to health crises;~~deleted

Amendment 154 #

Draft opinion
Paragraph 4

~~4. Calls on the Commission to develop a mandatory European licence in order to be able to respond rapidly to health crises;~~deleted

Amendment 155 #

Draft opinion
Paragraph 4

4. ~~Calls on the Commission to develop a mandatory European licence in order to be able to respond rapidly to health crises;~~ Takes the view that, in health emergencies involving shortages of medicines or vaccines, suspending patents is not a short-term solution to the problem; calls on the Commission to look into the development of exceptional mechanisms to make it possible to respond rapidly to health crises based on an impact analysis; takes the view that, in such crises, the Commission should work within a long-term framework and draw up a plan for the production of medicines or vaccines and, alternatively, identify solutions such as voluntary licensing by pharmaceutical companies to companies with production capacity, ensuring at all times that safety requirements are met;

Amendment 156 #

Draft opinion
Paragraph 4

4. ~~Calls on~~Welcomes the Commission ~~to develop a mandatory European licence in order to be able to respond rapidly to health~~'s proposal to foster production and investment in Europe as well as to simplify and streamline relevant procedures in order to be able to respond rapidly to health crises; points out that a regulatory framework which supports the open strategic autonomy of the EU will benefit patients also outside times of crises;

Amendment 157 #

Draft opinion
Paragraph 4

4. ~~Calls on~~Welcomes the Commission ~~to develop a mandatory European licence in order~~’s initiatives to strengthen European capacities to be able to re~~spond rapid~~act quickly to health crises;

Amendment 158 #

Draft opinion
Paragraph 4 a (new)

4 a. Calls on the Commission to consider proposing changes in the marketing authorisation framework that require the pharmaceutical industry to ensure that its supply chain is diversified, identifying alternatives for each component of the supply chain akin to the principle of N-1 redundancy in electrical grid operation and put in place a mandatory medicine shortage risk mitigation plan to manage any vulnerabilities in and risks to the supply chain; stresses the need to ensure that solid evidence, based on well-designed, well-powered comparative randomised clinical trials with meaningful endpoints are required for marketing authorisations;

Amendment 159 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 4 a (new)

4 a. Notes that the WTO TRIPS agreement provides flexibilities to patent rights, such as compulsory licensing, in order to be able to provide essential medicines at affordable prices under domestic public health programs and to protect and promote public health, which have effectively brought prices down; recognizes however that the use of these flexibilities can be cumbersome; Calls on the Commission to look for additional and sustainable solutions for knowledge governance for public health purposes, groups and health professionals;

Amendment 16 #

Draft opinion
Recital A b (new)

Ab. whereas the production chain for medicines, and therefore vaccines, is dependent on supplies of the raw materials needed not only for medicinal products, but also for the medical equipment used to manufacture medicines;

Amendment 160 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Josianne CUTAJAR, Carlos ZORRINHO, Robert HAJŠEL

Draft opinion
Paragraph 4 a (new)

4a. Calls for patents on pharmaceutical products, procedures or diagnostic methods to be made subject to an automatic licensing system as soon as appropriate in the public interest, for example when these products, or products manufactured using these procedures, or these methods are made available to the public in insufficient quantities, at inadequate quality levels or at abnormally high prices, or when the patent is being used in a manner at odds with the public interest;

Amendment 161 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 4 a (new)

4a. Emphasises that patent protection and enforcement should have due regard for the interests of society, namely the safeguarding of human rights and public health priorities; points out that patent protection should not interfere with the right to health, undermine the accessibility and availability of medicines or serve to widen social divides;

Amendment 162 #

Draft opinion
Paragraph 4 a (new)

4 a. Considers that the interconnection and interoperability of High Performance Computing infrastructures with the European Health Data Space would ensure the availability of large, high- quality health data sets which are critically important for research and treatment of pathologies, especially rare diseases and paediatric conditions;

Amendment 163 #

Draft opinion
Paragraph 4 a (new)

4 a. Calls on the Commission, in order to be able to react quickly to health crises, to develop mechanisms that promote and support the voluntary transfer of licenses and technological know-how to countries with scarce resources, up to a compulsory European license or to possible centralized emergential authorization

Amendment 164 #

Draft opinion
Paragraph 4 a (new)

4 a. Recommends that a key requirement for a Pharmaceutical Strategy for Europe should be that the flow of medicines meets patients demands and is not based on pure commercial interests; recommends the establishment of further EU guidance to Member States on the import and export of medicines across borders;

Amendment 165 #

Draft opinion
Paragraph 4 a (new)

4 a. Supports the Commission in its objective of designing a new EU industrial strategy in an effort to achieve a more competitive and resilient industry when contending with global shocks;

Amendment 166 #

Draft opinion
Paragraph 4 b (new)

4 b. Calls for increased funding for research on the potential negative impact of pharmaceuticals on the environment and the links between the presence of antimicrobials in the environment and the development and spread of AMR; stresses that the EU has a global responsibility in containing AMR; urges the Commission to propose the inclusion of environmental standards, especially on waste and wastewater management, in the Good Manufacturing Practice guidelines at the international level, also in order to create a level playing field;

Amendment 167 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 4 b (new)

4b. Calls on the Commission to consider introducing compulsory European licences for medicines and vaccines, as a means of making responses to future public health crises in Europe quicker and more effective; calls for the applicable data protection and market exclusivity periods provided for in Regulation (EC) No 816/20061 to be waived every time a Member State issues a compulsory licence or in case of need;

Amendment 168 #

Margarita DE LA PISA CARRIÓN, Jessica STEGRUD

Draft opinion
Paragraph 4 b (new)

4b. Calls for the immediate lifting of market exclusivity clauses and clinical data exclusivity clauses laid down in national and EU law; urges the Commission and the Member States to notify the World Trade Organisation (WTO) of its intention to declare member countries authorised importers within the meaning of Article 31a of the TRIPS Agreement;

Amendment 169 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 4 b (new)

4 b. Recalls that IP rights allow an extensive period of exclusivity that needs carefully and effectively to be regulated, monitored and implemented by the competent authorities so that IP rights do not limit accessibility and availability of medicines nor conflict with the fundamental human right to health;

Amendment 17 #

Draft opinion
Recital A b (new)

A b. whereas IP-rights are property rights; whereas property rights are fundamental rights and protected by Article 1 of protocol no 1. to the European Convention on Human Rights and article 17 of the EU Charter on fundamental rights;

Amendment 170 #

Draft opinion
Paragraph 4 c (new)

4c. Insists on a ban on patenting any research carried out on COVID-19 to develop tests, vaccines, medicines, masks, software, diagnostics or monitoring tools using artificial intelligence; calls for the immediate lifting of all existing patents on tests, vaccines, medicines, masks, software and AI-based diagnostic and monitoring tools developed as part of the fight against COVID-19;

Amendment 171 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 4 c (new)

4 c. Calls on the Commission to build on, extend and generalize the additional exploitation obligations, including an obligation to license on a non-exclusive basis and at fair and reasonable conditions included in the special Coronavirus calls under the Horizon 2020 Framework Programme;

Amendment 172 #

Draft opinion
Paragraph 5

~~5. Calls for public investment in R&D to be made transparent and for it to be ref~~delected ~~in product availability and pricing;~~

Amendment 173 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Josianne CUTAJAR, Carlos ZORRINHO, Robert HAJŠEL

Draft opinion
Paragraph 5

5. CStresses that public trust relies on full transparency; calls on the Commission to ensure that EMA has sufficient public funding and human capacity to sustainably cope with its transparency policy and obligations, both in normal times and in crisis situations; calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing;

Amendment 174 #

Draft opinion
Paragraph 5

5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing; Calls in this regard on the Commission to increase price transparency when it comes to the costs calculated in the prices, while also addressing the causes limiting affordability;

Amendment 175 #

Draft opinion
Paragraph 5

5. Calls for the inclusion of public investment in ~~R&D to be made transparent~~drug R&D, and for it to be reflected in product availability and pricing;

Amendment 176 #

Draft opinion
Paragraph 5

5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing when Member States issue marketing authorisations;

Amendment 177 #

Draft opinion
Paragraph 5

5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and ~~pricing~~affordability;

Amendment 178 #

Draft opinion
Paragraph 5 a (new)

5 a. Underlines that it is estimated that around 30 million citizens in Europe suffer from a rare condition; is of the opinion that the barriers hampering a robust and effective research on rare diseases should be overcome, including those linked to the lack of large amount of data; calls for additional public support to carry out research in this field;

Amendment 179 #

Draft opinion
Paragraph 5 a (new)

5a. Takes the view that any public funding that benefits European businesses in the pharmaceutical industry should be provided in exchange for transparency and traceability of investments, obligations to supply the European market and affordable prices for medicines;

Amendment 18 #

Angelika NIEBLER, Pernille WEISS

Draft opinion
Recital A b (new)

Ab. whereas the pharmaceutical sector is essential to the EU's strategic autonomy, in particular by virtue of its capacity to address health crises and provide biodefence;

Amendment 180 #

Draft opinion
Paragraph 5 a (new)

5 a. Stresses that R&D in drugs are very often not successfully completing clinical trials and thus are not resulting in final drug approval;

Amendment 181 #

Draft opinion
Paragraph 6

~~6. Calls on the Commission to support pricing models based on real production costs;~~deleted

Amendment 182 #

Draft opinion
Paragraph 6

6. Calls on the Commission to support pricing models based on real production costs, innovation and value to patients; calls also on the Commission to investigate novel pricing and payment models and their possible impact on patient access to innovative medicines;

Amendment 183 #

Draft opinion
Paragraph 6

6. Calls on the Commission to implement transparency obligations on research and development and production cost and to support pricing models based on ~~real production~~these costs;

Amendment 184 #

Draft opinion
Paragraph 6

6. Calls on the Commission to support novel pricing models based on real ~~production costs~~value to patients and wider society;

Amendment 185 #

Draft opinion
Paragraph 6

6. Calls on the Commission to support pricing models ~~based on~~which take account of real production costs;

Amendment 186 #

Draft opinion
Paragraph 6 – subparagraph 1 (new)

Calls on the Commission to promote the development of Research in the field of pain therapy drugs;

Amendment 187 #

Draft opinion
Paragraph 6 a (new)

6a. Calls on the Commission, in the context of Directive 2014/24/EU on public procurement, to draw up guidelines designed to support sustainable public procurement practices in the area of pharmaceuticals and bring about the inclusion in most economically advantageous tender (MEAT) criteria, in addition to price, of criteria concerning security and continuity of supply and environmentally sound production;

Amendment 188 #

Draft opinion
Paragraph 6 a (new)

6 a. Stresses that an outcomes-focused approach to pricing and payment will be essential to strengthen the sustainability and resilience of national health systems; calls on the Commission to support and promote wide implementation of novel pricing and payment models to improve patient access to innovative medicines, by facilitating best-practice sharing between Member States, ensuring an appropriate data infrastructure, and addressing legal barriers;

Amendment 189 #

Draft opinion
Paragraph 6 a (new)

6a. Notes that greater transparency in the Member States’ pricing negotiations could provide inspiration for best practices; calls on the Member States to share their best practices on a voluntary basis with a view to achieving greater agility in the process; emphasises that pricing is a national power that takes account of the free market and is based on free competition;

Amendment 19 #

Draft opinion
Recital A c (new)

Ac. whereas the COVID-19 pandemic has made the EU even more dependent on third countries for supplies of certain active ingredients, raw materials and other substances used in manufacturing medicines;

Amendment 190 #

Draft opinion
Paragraph 6 a (new)

6 a. Emphasises that an increased pressure on vaccine pricing and the threat of losing IP rights could discourage investment in the development of innovative technologies, treatments and production capacity in EU thereby undermining the health of Europeans, competitiveness and jobs; stresses that vaccine prices should be reflective of the comprehensive value of vaccination to the European citizens;

Amendment 191 #

Draft opinion
Paragraph 6 a (new)

6 a. Calls on the Commission and the Member States to develop new pricing and reimbursement models for patent expired drugs, including generics, aimed at ensuring full competition at the end of industrial property rights as well as to continue to ensure the marketing of even more consolidated drugs in clinical practice, essential for patients;

Amendment 192 #

Draft opinion
Paragraph 6 a (new)

6a. Calls on the Commission to keep the regulatory constraints on undertakings to a minimum, so that their operating costs are not excessive and so that ultimately prices can be set which are affordable for everyone, with no loss of medicine quality;

Amendment 193 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 6 a (new)

6 a. Stresses that the high level of public funds used for R&D is not reflected in the pricing due to a lack of traceability of the public funds in the patenting and licensing conditions, impeding a fair return on public investment;

Amendment 194 #

Draft opinion
Paragraph 6 a (new)

6a. Calls for the price of medicines to be fixed on the basis of specific criteria, such as origin, the price of raw materials and other intermediate costs, such as transport;

Amendment 195 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 6 b (new)

6 b. Considers that “value-based” and “willingness-to-pay” pricing models are at odds with the right to access to medicines, medical products and technologies as part of the right to health, as well as with sound fiscal policy, notably for new highly effective treatments for chronic diseases, life-saving medicines, orphan drug sand cures offering no proven benefit to research and development; therefore invites the Commission to support pricing models based on real production costs,including favouring grants, subsidies, and cash rewards to ensure robust funding for R&D, delinking the cost of R&D from the price of the products;

Amendment 196 #

Draft opinion
Paragraph 6 b (new)

6 b. Recognises that an increased pressure on vaccine pricing could discourage investment in the development of innovative technologies and production capacity in EU; stresses that vaccine prices should be reflective of the comprehensive value of vaccination to the European citizens;

Amendment 197 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 6 b (new)

6 b. Calls on the Commission to support innovative pharmaceutical pricing models, including based on real R&D costs, production costs, public sector participation and their value to the patient and society;

Amendment 198 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 6 c (new)

6 c. Notes that repurposing off-patent drugs has long been presented as a cost- effective and efficient way to develop new treatments; regrets however that a lack of publicly available data has limited its potential; insists that the repurposing of off-patent medicines not lead in any case to a decline in accessibility and that price increases would defeat the low cost of off- patent medications, a main point of interest of repurposing; highlights therefore the importance of public investment, coordination and initiative;

Amendment 199 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 6 d (new)

6 d. Calls on the Commission to urgently assess the impact of parallel trade on shortage of medicines in the Member States and to tackle problems adequately by taking all necessary action to ensure that medicines reach all patients in the EU in a timely manner; Calls to prioritize the right of access to healthcare to patients over the free movement of goods;

Amendment 2 #

Draft opinion
Recital A

A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicin~~es and vaccine~~al products, including vaccines; whereas ensuring the strategic autonomy in the field of medicines and diversifying pharmaceutical manufacturing and supply chains represents an essential step in effectively tackling future pandemics;

Amendment 20 #

Margarita DE LA PISA CARRIÓN, Robert ROOS

Draft opinion
Recital A c (new)

A c. whereas research on pharmaceuticals is often co-financed with public money; whereas public money shall serve the public interest;

Amendment 200 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Josianne CUTAJAR, Carlos ZORRINHO, Robert HAJŠEL

Draft opinion
Paragraph 7

7. Calls on the Commission to ~~promote joint procurement~~explore joint procurement only in exceptional circumstances and for extraordinary public cross-border health threats, such as the COVID-19 pandemic, if purchase of products cannot be ensured as efficiently by other means, and apply the most economically advantageous tender (MEAT) criteria more stringently; highlights that joint public procurement should have a clearly defined scope and be limited in time, and should not hinder patient access, medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, and should not jeopardise product choice, or create market distortion or any concentration of demand;

Amendment 201 #

Draft opinion
Paragraph 7

7. Calls on the Commission to promote joint procurement favourable to all member states and apply most economically advantageous tender (MEAT) criteria more stringently, while taking into account the need for more balance between public and private interests, including clear liability for manufacturers, as well as the need for sufficient flexibility for member states in line with national specificities; underlines the importance to improve security of supply and to enhance EU countries' preparedness to mitigate cross-border threats to health;

Amendment 202 #

Draft opinion
Paragraph 7

7. Calls on the Commission to promote joint procurement and apply most economically advantageous tender (MEAT) criteria more stringently with the same clinical value; it must be ensured that joint procurements comply with the conditions laid down by Directive 2014/24 / EU, in order to ensure long term sustainability, competition, security of supply and stimulating investments in manufacturing;

Amendment 203 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Aldo PATRICIELLO, Tomas TOBÉ, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 7

7. C~~alls on~~onsiders that the Commission ~~to promote~~and Member States could consider launching joint public procurement ~~and apply most economically advantageous tender (MEAT) criteria more stringently~~- procedures in times of health crises, as has been done during the COVID-19 crisis, with simplified and transparent procedures in the interest of improved response times; highlights that joint public procurement should not hinder patient access, medical innovation or competition;

Amendment 204 #

Draft opinion
Paragraph 7

7. Calls on the Commission to ~~promote jo~~conduct an audit of the 2020 vaccinte procurement ~~and apply most economically advantageous tender (MEAT) criteria more stringently~~fiasco with a view to preparing for a new stage in the process;

Amendment 205 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 7

7. Calls on the Commission to ~~promo~~facilitate joint procurement and make it standard practice and apply most economically advantageous tender (MEAT) criteria more stringently, in order to help push the price of medicines down; draws attention, in that connection, to the New Zealand Pharmac experiment or the Kiwi model;

Amendment 206 #

Draft opinion
Paragraph 7

7. Calls on the Commission to draw conclusions from the experience of joint negotiations gained during the pandemic, to promote joint procurement and apply most economically advantageous tender (MEAT) criteria more stringently;

Amendment 207 #

Draft opinion
Paragraph 7

7. ~~Calls on the Commission to promote joint procurement and apply~~Draws attention to the possibility for the Member States to engage in joint procurement whilst guaranteeing that most economically advantageous tender (MEAT) criteria moare ~~stringently~~applied;

Amendment 208 #

Draft opinion
Paragraph 7 a (new)

7 a. Welcomes the setting up of a structured dialogue on manufacturing and supply chain with and between the actors in the pharmaceuticals manufacturing value chain and public authorities to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances; in this context, urges the Commission, member states and parties involved to define as soon as possible a clear and ambitious policy roadmap through economic, regulatory and industrial reforms to secure and modernize existing manufacturing capabilities of medicines, technology and APIs in Europe, for example by rewarding investments in security of supply and manufacturing improvements;

Amendment 209 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Aldo PATRICIELLO, Tomas TOBÉ, Massimiliano SALINI, Christian EHLER

Draft opinion
Paragraph 7 a (new)

7 a. Urges the Commission, in the context of the EU Public Procurement Directive 2014/24/EU, to develop guidelines to support sustainable public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the criteria of the most economically advantageous tender (MEAT), aimed at ensuring long-term sustainability, competition and security of supply and stimulating investment in manufacturing; calls for remedies against single-winner, price-only tenders that can cause severe price erosion, reducing the number of suppliers on the market and often resulting in short lead times and penalties being applied to companies, which in turn increases the risk of shortages of medical products;

Amendment 21 #

Draft opinion
Recital B

B. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; whereas innovation and development and allocation of essential pharmaceuticals should be driven by medical and social needs, and governed by public mechanisms, particularly during health emergencies;

Amendment 210 #

Draft opinion
Paragraph 7 a (new)

7 a. Welcomes the Commission proposal on the European institutionalised partnerships that will enable research in the health sector; welcomes the collaboration between the private and the public sector in this domain; recalls that research and innovation on pharmaceutical products should aim to enhance their accessibility, availability and affordability;

Amendment 211 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

7 a. Calls for EU joint procurement to be used more systematically to avoid Member States competing against each other and to ensure equal and affordable access to important medicines and medical devices, in particular for new innovative antibiotics, new vaccines and curative medicines, and medicines for rare diseases;

Amendment 212 #

Draft opinion
Paragraph 7 a (new)

7 a. Calls for additional safeguards to ensure that pharmaceutical materials and ingredients entering the EU market are produced in accordance with adequate social and environmental standards;

Amendment 213 #

Draft opinion
Paragraph 7 a (new)

7 a. Calls the Commission and Member States to encourage cross- country cooperation to promote joint negotiations on the pricing of medicines and/or joint health technology assessments (HTAs);

Amendment 214 #

Draft opinion
Paragraph 7 a (new)

7a. Points out the need for better communication among the interested parties: industry, research groups, government bodies and health professionals;

Amendment 215 #

Draft opinion
Paragraph 7 b (new)

7 b. Calls for the strong involvement of patient and end-user associations as well as of representatives of health professionals in the design and the implementation of the Union’s initiatives enabling the Pharmaceutical Strategy for Europe;

Amendment 216 #

Draft opinion
Paragraph 7 b (new)

7b. Calls on the Member States to bear in mind, when pricing, the balance between the risks and the benefits of developing a medicine;

Amendment 217 #

Draft opinion
Paragraph 8

~~8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~deleted

Amendment 218 #

Draft opinion
Paragraph 8

~~8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~deleted

Amendment 219 #

Draft opinion
Paragraph 8

~~8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~deleted

Amendment 22 #

Draft opinion
Recital B

B. whereas universal access to medicines is a fundamental right, the full realiszation of which ~~is incompatible with a pharmaceutical model based primarily on the pursuit of profit~~can be achieved through policy ecosystem that fosters medical innovation, to the benefit of patients and society as a whole;

Amendment 220 #

Draft opinion
Paragraph 8

~~8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~deleted

Amendment 221 #

Draft opinion
Paragraph 8

~~8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~deleted

Amendment 222 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 8

8. ~~Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.~~Calls on the Commission to guarantee total transparency and democratic scrutiny of decisions, procedures and choices in this area; condemns the excessive influence of industry interest groups, which is exerted to the detriment of associations representing patients, consumers and health professionals, experts in clinical trials, public-health associations and trade unions representing workers in the industry; calls for transparent governance arrangements and decision-making procedures independent of the pharmaceutical industry to be established for all authorities, public agencies and joint undertakings in the health sector;

Amendment 223 #

Draft opinion
Paragraph 8

8. Regrets the excessive influence to public authorities of industry interest groups, which is detrimental to public- health, patient and consumer associations and to trade unions. ; calls the Commission and Member States for a wide, comprehensive and genuine involvement of all relevant stakeholders, including patient and consumer groups to ensure balance between the public and commercial interests;

Amendment 224 #

Draft opinion
Paragraph 8

8. ~~Regrets the excessive influenc~~Urges the Commission to broaden the scope of its industry ~~interest groups, which is detrimental to~~consultations to include all stakeholders in the medicines production and distribution chain, public- health, patient and consumer associations and to trade unions.

Amendment 225 #

Draft opinion
Paragraph 8

8. ~~Regrets the excessive influence of industry interest groups, which is detrimental to public-health~~Encourages the active involvement of public health organizations and societies, patient and consumer associations, a~~nd to~~s well as trade unions.;

Amendment 226 #

Draft opinion
Paragraph 8 – subparagraph 1 (new)

Calls the Commission, with regard to the structured dialogue on drug production and the implementation of the industrial strategy, to propose incentives and reforms - both market and regulatory - that stimulate investments in drug production to strengthen the production chain and to ensure a better adequate supply for cancer, rare disease needs;

Amendment 227 #

Draft opinion
Paragraph 8 a (new)

8 a. Calls on the Commission, on top of the structured dialogue on manufacturing and supply chain, to set up a focused, action oriented High Level Pharmaceutical Forum involving Ministers of Health and policy makers, regulators, payers, industry and other concerned stakeholders of the Healthcare supply chain. The key objective would be to share the learnings from the COVID19 situation and draw the conclusions to establish a pan European and effective policy framework to prevent shortages in the long term and ensuring a well- functioning, sustainable industry that continues to act as a catalyst to enable sustainable access to medicines for patients and innovation;

Amendment 228 #

Draft opinion
Paragraph 8 a (new)

8 a. Recognises that the pharmaceutical industry plays a crucial role in addressing underserved areas, during health crisis and beyond, and drives patient access to quality innovative medicines; recognises that the pharmaceutical industry is a strategic sector in Europe, which must be supported with adequate, strong industrial policies to ensure that Europe stays a globally leading hub for healthcare innovation; recognises the value of adequately involving the industry in the roll out of the Pharmaceutical Strategy for Europe, for it to successfully achieve its goals;

Amendment 229 #

Draft opinion
Paragraph 8 a (new)

8 a. Welcomes the recognition in the pharmaceutical strategy of the need to ensure fair access to medicines and to increase competition; therefore, urgently calls the Commission to ensure that competition, at the end of the protection of intellectual property, is timely and certain by removing all the barriers that limit it, such as the practices of IP evergreening and patent linkage that unjustifiably delay the access to medicines for patients;

Amendment 23 #

Draft opinion
Recital B

B. whereas ~~univers~~equal access toibility, affordability, and availability of medicines ~~is a fu~~anda me~~ntal right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit~~dicinal products is essential; whereas the EU can support this by applying a predictable policy framework that fosters public and private investments ensuring affordable patient access to medicines and benefit to society as a whole;

Amendment 230 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 8 a (new)

8 a. Stresses the importance of safe- guarding and creating quality jobs along the entire pharmaceutical value chain; calls on the Commission to promote equality employment in the pharmaceutical sector; considers that public funding, notably under Next Generation EU, requires employment safeguards; calls for a ban on collective redundancies in companies distributing shareholder dividends;

Amendment 231 #

Draft opinion
Paragraph 8 a (new)

8 a. Points out that small and medium sized enterprises (SMEs) and mid-caps play a crucial role in the pharmaceutical value chain, often as first-movers and drivers of innovation; calls on the Commission to maintain a comprehensive and predictable regulatory framework that fosters the investment and innovation of especially European pharmaceutical SMEs and mid-caps;

Amendment 232 #

Draft opinion
Paragraph 8 a (new)

8a. Welcomes the new European pharmaceutical strategy that is being presented as a fresh opportunity for the EU to enhance its competitiveness and consolidate the role of European industry, avoiding the relocation of companies; stresses that this is a unique opportunity for the EU to play a more prominent role at global level;

Amendment 233 #

Draft opinion
Paragraph 8 a (new)

8a. Urges the Commission to take all the steps needed to reshore most parts of the medicines production and distribution chain, in particular for medicines regarded as essential and/or critical by EU health institutions;

Amendment 234 #

Draft opinion
Paragraph 8 a (new)

8 a. Stresses the importance of ensuring the protection on personal data while harnessing the benefits of digital technologies in the pharmaceutical and health sector, stresses that electronic product information should complement, but not replace, the package information leaflet;

Amendment 235 #

Draft opinion
Paragraph 8 a (new)

8 a. Calls on the Commission to develop a digital platform or contact points between Member States to provide information, communication and advice to participate in innovation projects at European level;

Amendment 236 #

Draft opinion
Paragraph 8 a (new)

8a. Calls for long-term monitoring of medicines placed on the market in order to identify any harmful side effects and assess their cost-effectiveness as treatments;

Amendment 237 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 8 b (new)

8 b. Recalls the critical need both for global health and global supply chains to develop local capacities, including in developing countries, notably in terms of pharmaceutical research, development and production, in order to bridge the persisting gap in research and medicines production through product-development partnerships and the creation of open centres of research and production; Calls on the Commission to use the Industrial, IP and Pharmaceutical Strategies to facilitate this;

Amendment 238 #

Draft opinion
Paragraph 8 b (new)

8 b. Calls on the Commission to introduce a legal basis for a EU-wide early warning system for anticipated and verified shortages, involving all supply chain stakeholders, from manufacturers, full-service healthcare distributors, online and community pharmacists to prescribers, the national competent authorities and EMA for coordination at EU level; stresses that timely communication on shortages to affected stakeholders is crucial to ensure that patients’ needs are met;

Amendment 239 #

Draft opinion
Paragraph 8 b (new)

8 b. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA); believes that the final decision making should occur within maximum 7days of the final scientific opinion;

Amendment 24 #

Draft opinion
Recital B

B. whereas universal access to medicines is a fundamental right ~~the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit~~;

Amendment 240 #

Draft opinion
Paragraph 8 b (new)

8b. Emphasises that in order for the EU to be globally competitive it must overcome a series of challenges and create a long-term strategy that includes the simplification of the process of bringing new products to market; emphasises that changes need to be made to European legislation to provide an incentive for internal production – both of the finished product and of European active pharmaceutical ingredients – and to prevent industrial relocation;

Amendment 241 #

Draft opinion
Paragraph 8 b (new)

8b. Welcomes the Commission's intention, as part of the European Data Strategy, to establish a European health data area and to introduce interoperable tools for health data access in order to facilitate the secure and anonymous cross-border analysis of these data, which will be essential to the deployment of artificial intelligence;

Amendment 242 #

Draft opinion
Paragraph 8 b (new)

8 b. Underlines the importance for a rapid implementation of the digital transformation in the regulatory system which, while maintaining the same safety standards for patients, reduces administrative burdens and improves the European response to health crises and drug shortages;

Amendment 243 #

Draft opinion
Paragraph 8 b (new)

8 b. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls for initiatives to be proposed to develop mechanisms to ensure the competition and as a consequence, the equitable access to medicines;

Amendment 244 #

Draft opinion
Paragraph 8 b (new)

8 b. Calls on the Commission to address unjustified trade restrictions; points out that trade barriers can harm the accessibility and affordability of medicinal products;

Amendment 245 #

Draft opinion
Paragraph 8 c (new)

8c. Deplores the fact that researchers and pharmaceutical undertakings have thus far shown little interest in research into discharges of medical waste into the environment; points out that the result is a lack of knowledge about what happens to such waste in water and soil and their impact on human health, in particular as regards resistance to antimicrobials; calls on the Commission, when revising pharmaceutical legislation, to tighten up the requirements to be met by pharmaceutical undertakings as regards environmental risk assessment, and calls on HERA to make the study of antimicrobial resistance and research into and the development of new antimicrobials priorities;

Amendment 246 #

Draft opinion
Paragraph 8 c (new)

8 c. Calls on the Commission and Member States to fully implement the Clinical Trials Regulation; supports a new framework for the design of innovative trials, the simplification of the requirements for the conduct of clinical trials and additional support for the conduct of so-called pragmatic trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU-wide clinical trials network;

Amendment 247 #

Draft opinion
Paragraph 8 c (new)

8 c. Underlines that ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The adequate use of Information Technology systems will improve regulatory efficiency across Europe; therefore, the Commission should optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency;

Amendment 248 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 8 c (new)

8 c. Highlights that increasing manufacturing and ‘fill and finish’ capacities requires sharing the technological know-how and intellectual property and corresponding technology; invites the Commission to encourage the transfer of crucial health technologies to developing countries by granting open licenses for such technologies in line with obligations under Article 66.2 of the TRIPS Agreement;

Amendment 249 #

Draft opinion
Paragraph 8 c (new)

8 c. Urges the Commission to ensure the free flow of medicines within the EU Single Market and to implement a framework which only allows temporary restrictions to the free movement of medicines if they are in conformity with Treaty of the European Union;

Amendment 25 #

Draft opinion
Recital B

B. whereas universal, equitable access to medicines is a fundamental right ~~the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit~~;

Amendment 250 #

Draft opinion
Paragraph 8 c (new)

8 c. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;

Amendment 251 #

Draft opinion
Paragraph 8 c (new)

8c. Calls on the Commission to seek new synergies between the European industrial strategy, the European pharmaceutical strategy, the European recovery plan and the EU4Health programme;

Amendment 252 #

Draft opinion
Paragraph 8 d (new)

8 d. Urges to promote reforms and investments in drug production technologies (environmental, digital, technological process and automation) necessary to ensure safety, innovation and respect for the environment and also stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are important to enable EU industries to innovate their technology to compete and to meet society needs for security, value added innovation and sustainability;

Amendment 253 #

Draft opinion
Paragraph 8 d (new)

8d. Welcomes the publication by the Commission on 5 February 2021 of the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA Action Plan); calls on the Commission, when revising pharmaceutical legislation, to draw up a regulatory framework geared to the deployment of radiological and nuclear technologies for therapeutic, and not solely diagnostic, purposes;

Amendment 254 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 8 d (new)

8 d. Calls on the Commission to propose a strategy addressing the concentration of capacity production and support decentralisation with partners in multiple countries in order to distribute systemic risks, build systematic resilience in the manufacturing and supply of essential medicines and vaccines, and strengthen global health commons;

Amendment 255 #

Draft opinion
Paragraph 8 d (new)

8 d. Calls for the prudent implementation of the General Data Protection Regulation (GDPR) with regard to data minimisation, purpose limitation, the secondary use of data as well as on data transfer to third countries to avoid unnecessary restriction for health research and cross-border data sharing;

Amendment 256 #

Draft opinion
Paragraph 8 d (new)

8d. Calls on the Commission to develop a digital platform on which solutions are developed to create contact points between Member States to provide channels of information, communication and advice for the purposes of participating in innovation projects at European level;

Amendment 257 #

Draft opinion
Paragraph 8 d (new)

8 d. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of artificial intelligence (AI) technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 258 #

Draft opinion
Paragraph 8 d (new)

8 d. Calls for the need to reflect the diversity of society and gender-specific issues in physiology when conducting research on medicines, and stresses that legislation must ensure that these issues are properly reflected and taken into account when granting market authorisation;

Amendment 259 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 8 e (new)

8 e. Recalls that the Human Genome Project governed by the Bermuda Principles illustrated the potential of publicly funded initiatives committed to data sharing; calls for a coordinated, collaborative and open approach in the field of research and innovation, with a stronger role for the Commission and Member States in coordinating health and epidemiological research so as to avoid duplication and drive research towards outcomes including needed medicines, vaccines, medical devices and equipment;

Amendment 26 #

Draft opinion
Recital B

B. whereas universal access to medicines is a fundamental right the full realisation of which ~~is incompatible with a pharma~~can only be achieved through policy which inceunti~~cal model based primarily on the pursuit of profit~~vises medical innovation, to the benefit of patients and society as a whole;

Amendment 260 #

Draft opinion
Paragraph 8 e (new)

8 e. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;

Amendment 261 #

Draft opinion
Paragraph 8 e (new)

8 e. Urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;

Amendment 262 #

Draft opinion
Paragraph 8 e (new)

8e. Calls on the Commission to simplify bureaucracy and registration procedures so that they do not impede the marketing of medicines and so that medicines can be accessible to patients as early as possible;

Amendment 263 #

Draft opinion
Paragraph 8 e (new)

8e. Emphasises the strategic role played by the European pharmaceutical industry in guaranteeing the EU's autonomy in the event of a health crisis or a bioterrorist attack;

Amendment 264 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 8 f (new)

8 f. Notes that opacity of contracts and private-public partnerships generates information asymmetries that unduly benefit certain companies and limit public accountability of Commission and Member States; calls on the Commission and Member States to fully comply with WHO transparency resolution (WHA 72.8), and the specific transparency norms in the resolution, including in regard to transparency of net prices, patent landscapes, units sold, sales revenues, subsidies and incentives, registration status in countries, the costs of human subject clinical trials and the outcomes from trials;

Amendment 265 #

Draft opinion
Paragraph 8 f (new)

8 f. Calls on the Commission to develop new- and extend the scope of existing Mutual Recognition Agreements on Good manufacturing practice (GMP) certificates (most importantly on inspections and batch testing) with more countries who have high manufacturing standards; points out that this could make it easier to include sites in third countries in a production supply chain, without giving up European standards to allow for broadening the production capacity in times of crisis.

Amendment 266 #

Draft opinion
Paragraph 8 f (new)

8f. Welcomes the revised industrial strategy published by the Commission on 5 May 2021, which analyses the EU's strategic dependencies, including the production of active pharmaceutical ingredients, which is concentrated in a small number of factories in China and India;

Amendment 267 #

Draft opinion
Paragraph 8 f (new)

8 f. Underlines the importance to developed, adopted and implemented artificial intelligence (AI) technologies in healthcare systems ensuring inclusivity, capacity, trust and ethical principles.

Amendment 268 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 8 f (new)

8f. Calls for environmental objectives to be realistic and not to get in the way when it comes to consolidating a lively and dynamic pharmaceutical strategy;

Amendment 269 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 8 g (new)

8 g. Acknowledges the potential of health data to advance human rights, but calls on the Commission to ensure the full compliance with GDPR when working with it and that research collaborations with technology or other companies do not allow commercial actors to infringe on human rights, including the rights to privacy, science and health; refuses the commercialization of these data and notes the urgent need to act against the sale of these data to the amongst others the pharmaceutical industry, health insurance, technology companies and employers;

Amendment 27 #

Draft opinion
Recital B

B. whereas ~~universal~~equitable access to safe, effective and affordable medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit;

Amendment 270 #

Draft opinion
Paragraph 8 g (new)

8g. Calls for the introduction of reporting requirements vis-à-vis the competent public authorities for pharmaceutical undertakings, involving the drafting of a plan which guarantees continuity of supply so that they can cushion the impact of any event which disrupts the supply chain;

Amendment 271 #

Draft opinion
Paragraph 8 g (new)

8 g. Calls on the Commission and relevant authorities, to provide regulatory flexibility by allowing targeted measures such as more flexibility for multi- language packs, different pack size and e- leaflet, to ensure that patients are able to access high-quality and safe medicines faster;

Amendment 272 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Aldo PATRICIELLO, Sara SKYTTEDAL, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 8 g (new)

8 g. Calls on the Commission and the Member States to screen foreign direct investment in pharmaceutical manufacturing plants, which are part of Europe’s critical health infrastructure;

Amendment 273 #

Draft opinion
Paragraph 8 g (new)

8g. Calls on the Commission to design specific instruments to promote products produced in Europe over those produced in third countries;

Amendment 274 #

Draft opinion
Paragraph 8 h (new)

8h. Calls on the Commission to develop mechanisms to provide channels of information, communication and appropriate advice so as to make participation in innovation projects more accessible at European level, above all for SMEs and research centres;

Amendment 275 #

Draft opinion
Paragraph 8 h (new)

8 h. Calls on the Commission to implement a targeted dialogue between regulators, the industry and stakeholders to design an EU Roadmap aimed to define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;

Amendment 276 #

Draft opinion
Paragraph 8 h (new)

8 h. Calls on the Commission to increase its involvement in supporting critical health infrastructure protection in Member States and to start applying the European Programme for Critical Infrastructure Protection to the health infrastructure sector;

Amendment 277 #

Draft opinion
Paragraph 8 h (new)

8h. Calls for an Important Project of Common European Interest (IPCEI) to be launched in the pharmaceutical sector with a view to identifying targeted diseases or technologies in advance;

Amendment 278 #

Draft opinion
Paragraph 8 i (new)

8 i. Believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, bringing together policymakers, regulators, patient organizations, industry representatives and other relevant stakeholders in the healthcare supply chain in order to tackle other policy areas, such as prevent shortages, address pharmaceutical sustainability issues and ensure the competitiveness of the European pharmaceutical industry overall;

Amendment 279 #

Draft opinion
Paragraph 8 i (new)

8i. Calls on the Commission to include in the future Single Market Emergency Instrument on the free movement of goods and persons in the event of a crisis measures which ensure that borders are kept open for pharmaceutical undertakings and their workers, in particular through the establishment of green corridors, in order to guarantee the continuity of activities involving research into and the development, production and distribution of medicines;

Amendment 28 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Recital B

Amendment 280 #

Draft opinion
Paragraph 8 i (new)

8 i. Whereas the Horizon Europe programme provides essential support for research and innovation; whereas the programme is a key driver of job creation, industrial competitiveness, research and innovation also in the health and pharmaceutical sector;

Amendment 281 #

Draft opinion
Paragraph 8 i (new)

8i. Calls for there to be cooperation and communication among experts, scientists, industry and all interested parties with a view to exchanging views and information in order to achieve the objectives laid down in the pharmaceutical strategy;

Amendment 282 #

Draft opinion
Paragraph 8 j (new)

8 j. Welcomes the Strategy's objective to support the competitiveness of the pharmaceutical industry; acknowledges that the pharmaceutical industry is a strategic sector in Europe, which must be supported with adequate, strong industrial policies to ensure that Europe stays a globally leading hub for healthcare innovation, production and services;

Amendment 283 #

Draft opinion
Paragraph 8 j (new)

8 j. Calls on the Commission to propose as soon as possible a legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to brings new antibiotics to the market;

Amendment 284 #

Draft opinion
Paragraph 8 j (new)

8j. Emphasises that research into and the production and use of medicines should follow ethical principles that guarantee the right to life, dignity and the integrity of the person;

Amendment 285 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 8 k (new)

8 k. Underlines that the Pharmaceutical Strategy has to provide deeper and greater attention to all aspects of gender medicine and has to support specific Research in this regard;

Amendment 286 #

Draft opinion
Paragraph 8 k (new)

8 k. Stresses that the EU has to build a stronger European Health Union in particular by supporting closer EU cooperation in research and development and by sharing health data;

Amendment 287 #

Draft opinion
Paragraph 8 l (new)

8 l. Stresses that R&D is key for the development of innovative medicines, therapies and diagnosis;

Amendment 288 #

Draft opinion
Paragraph 8 m (new)

8 m. Highlights that supporting the competitiveness and innovative capacity of the EU’s pharmaceutical industry is crucial;

Amendment 289 #

Draft opinion
Paragraph 8 n (new)

8 n. Welcomes the Commission’s Action Plan on Intellectual Property which shall help companies, especially small and medium-sized companies (SMEs), to make the most of their inventions and creations and ensure they can benefit our economy and society and which aims at enabling the European innovative industry to remain a global leader;

Amendment 29 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO

Draft opinion
Recital B

B. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model ~~based primarily on the pursuit of profit~~that uses intellectual property rights in a monopolistic way;

Amendment 290 #

Draft opinion
Paragraph 8 o (new)

8 o. Fully supports the IP Action Plans proposal to upgrade a series of existing IP tools and make them fit for the digital age, including improving the supplementary protection certificates (SPC) for patented medicinal products among other;

Amendment 291 #

Draft opinion
Paragraph 8 p (new)

8 p. Recalls the Council conclusions ‘An EU Industrial Policy Strategy: a Vision for 2030’ of May 2019 recognising that a well-functioning and effective intellectual property rights regime is key to continued development and growth and recalling that it is essential to continue developing, improving and updating the European intellectual property frameworks, so as to ensure that ideas and inventions can be effectively developed and brought to the market, in particular by and for SMEs, to the benefit of the European economy and society at large;

Amendment 292 #

Draft opinion
Paragraph 8 q (new)

8 q. Recalls the Commission’s ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ of May 2021 which states that the EU is strategically dependent on third countries regarding pharmaceutical ingredients and other health related products, which could lead to vulnerabilities for the EU and affect the EU’s core interests, and refers to the pharmaceutical strategy to address these issues;

Amendment 293 #

Draft opinion
Paragraph 8 r (new)

8 r. Underlines the need to ensure a smart use of IP, and to better fight IP theft, as smart IP policies are essential to help companies to grow, to create jobs and to protect and develop what makes them unique and competitive;

Amendment 294 #

Draft opinion
Paragraph 8 s (new)

8 s. Urges to make the IP systemmore effective for SMEs, through actions to simplify IP registration procedures(e.g. reforming EU legislation on industrial designs), to improve access to strategic IP advice (e.g. by making such advice available in all EU-level R&D funding), and to facilitate the use of IP as a lever to gain access to finance;

Amendment 295 #

Draft opinion
Paragraph 8 t (new)

8 t. Stresses that investing in research and development is a costly, high-risk endeavour; underlines that patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public; repeats therefore that pharmaceutical companies need intellectual property (IP) rights and thus patents to achieve profits and keep innovating also in the interest of the consumers and patients;

Amendment 296 #

Draft opinion
Paragraph 8 u (new)

8 u. Underlines that the patent systems all over the world are drafted in a way that for a specific period of time, only for the duration of the patent, the inventor is allowed to commercially exploit its patent. Thereafter, the invention can be freely exploited by anyone;

Amendment 3 #

Draft opinion
Recital A

A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains ~~and accessibility to medicines and~~, in particular as a result of the newly globalised nature of the chain for the production and distribution of medicines, including vaccines;

Amendment 30 #

Draft opinion
Recital B

B. whereas ~~universal~~ access to medicines is a fundamental right the full realisation of which is inhardly compatible with a pharmaceutical model based primarily on the pursuit of profit;

Amendment 31 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B a (new)

B a. whereas the Commission’s final evaluation of the public-private IMI Joint Undertaking concluded that “no socio- economic benefits from IMI Joint Undertaking activities could be identified”, nor did it find any examples of it “bringing new, safer and more effective therapies or products to patients” or shortening development time; and that research topics “closer to the public interest than those identified by the industry” may be better identified under the wider research programme, and “at a lower cost for the public budget”;

Amendment 32 #

Draft opinion
Recital B a (new)

B a. whereas the covid19 experience also demonstrated how the European pharmaceutical industry and manufacturers have been resilient and had contingency plans in place avoiding any major disruption for critical products, notably on ICU medicines. This was also possible thanks to the bilateral dialogue and two-way communication established, demand visibility and close cooperation between governments/regulators and actors, a practice which should be maintained and continued on a regular basis;

Amendment 33 #

Draft opinion
Recital B a (new)

B a. whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector; whereas the EU's open strategic autonomy and security of supply should be ensured by diversification of supply chains for essential medicines and medicinal products, including European manufacturing sites, as well as by applying public procurement rules that should not consider price as the sole criterion;

Amendment 34 #

Ivo HRISTOV, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Recital B a (new)

B a. whereas the pharmaceutical strategy recognizes the fundamental role of expired patent medicines (including generics, biosimilars and value-added medicines) in ensuring that access for patients to drug therapies is equitable as well as in ensuring sustainability of health systems, recognizes that their entry into the market must not be delayed in anyway once the industrial property rights have expired;

Amendment 35 #

Draft opinion
Recital B a (new)

B a. whereas global events such as the COVID-19 pandemic have shown the importance of investing in digital health technologies such as artificial intelligence and computer modelling and simulation, which accelerate the identification of critical components for the pharmaceutical sector as well as the testing of safety, efficacy and performance of new treatments;

Amendment 36 #

Draft opinion
Recital B a (new)

Ba. whereas the COVID-19 crisis has shown that innovation in the development of medicines is a key factor in health, and therefore calls on the Commission to focus the pharmaceutical strategy on boosting efforts to promote medical research and innovation in the EU;

Amendment 37 #

Draft opinion
Recital B a (new)

B a. whereas the current R&D system is biased towards high revenue generating diseases, leading to an increasing gap between real unmet medical needs and investment; whereas transparency on R&D cost is urgently needed in order to ensure fair pricing for patients and social security systems;

Amendment 38 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B a (new)

Ba. whereas universal access to high- quality, effective and safe medicines is a fundamental right; whereas the full enjoyment of this right is incompatible with a pharmaceutical production system geared primarily to commercial interests and the pursuit of profit;

Amendment 39 #

Dominique RIQUET, Nicola DANTI

Draft opinion
Recital B a (new)

B a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs, and of strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Amendment 4 #

Draft opinion
Recital A

A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines; whereas access to medicines can be improved in particular by means of closer cooperation with third countries on regulatory standards;

Amendment 40 #

Draft opinion
Recital B a (new)

Ba. whereas it is clear that, because the cost of medicines is reimbursed under national health systems, pharmaceutical laboratories can to some extent be said to be performing a public-service task;

Amendment 41 #

Draft opinion
Recital B a (new)

Ba. whereas the EU pharmaceutical industry employs 800 000 people directly and in 2019 generated profits of EUR 109.4 billion;

Amendment 42 #

Draft opinion
Recital B b (new)

B b. whereas the Covid-19 pandemic left the other existing pathologies on standby for more than a year and therefore there was a lack of prevention and treatments for patients. It is necessary to ensure adequate financial tools for Research and production of oncological and non-oncological drugs as well as drugs for the treatment of all diseases of which the pandemic has slow down and reduced treatment, so as to be able to cope with the increase in diseases and the needs of patients;

Amendment 43 #

Draft opinion
Recital B b (new)

Bb. whereas research into and the development, production and distribution of medicines depends on an ecosystem of public and private actors which includes large pharmaceutical companies, SMEs, start-ups and other innovative newcomers, along with universities, public research centres, national paying agencies, wholesalers and pharmacies;

Amendment 44 #

Draft opinion
Recital B b (new)

B b. whereas residues of several pharmaceuticals found in surface and ground waters, soils and animal tissues across the Union pose risks because of their toxicity or other adverse properties and affect ecosystems; whereas growing antimicrobial resistance (AMR) through uncontrolled release of antibiotics in the environment poses a serious danger;

Amendment 45 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B b (new)

B b. whereas the practice of parallel exports to countries where medicine is more expensive can create disruptions in supply across Member States, whereas in its resolution of 2March 2017 Parliament called on the Commission and the Council to assess the impact of the parallel trade and supply quotas;

Amendment 46 #

Draft opinion
Recital B b (new)

B b. whereas during the covid19 pandemic, uncoordinated actions at national level, such as national hoarding and extreme stockpiling undermined industry’s ability to deliver equitable supply in all markets. This represents a lesson learned to avoid in any future crisis situations;

Amendment 47 #

Draft opinion
Recital B b (new)

B b. whereas Europe’s pharmaceutical sector is a major contributor to the EU economy in terms of creation of highly skilled jobs and investment in innovation; whereas the pharmaceutical sector is a significant driver of trade and economic growth in the EU;

Amendment 48 #

Draft opinion
Recital B b (new)

Bb. whereas at both EU level and in every Member State publicly funded research remains very limited, leaving private industry to shoulder most of the burden of funding the cost of R&D and their consequences;

Amendment 49 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B b (new)

Bb. whereas an effective pharmaceutical strategy should include measures designed to mitigate the impact of medicine shortages, but also to prevent them, by looking at their many root causes;

Amendment 5 #

Draft opinion
Recital A

A. whereas the pandemic has revealed a number of problems that already existed in the EU, such as shortages of essential medicines and the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;

Amendment 50 #

Bb. whereas there is a need to seek industry solutions for the development of medicines that are not covered or are for rare diseases, improvements in treatment and the production of reserve antibiotics;

Amendment 51 #

Draft opinion
Recital B c (new)

Bc. whereas significant advances in treatments have been achieved in the last 20 years by European pharmaceutical companies, in particular in the areas of biotechnological products for chronic diseases such as diabetes, anti-viral medicines, personalised treatments for cancer patients or cell or genetic therapy products; whereas Europe also recently scored a success by developing and producing the RNA messenger vaccine against COVID-19;

Amendment 52 #

Draft opinion
Recital B c (new)

B c. whereas data sharing is key to applying artificial intelligence and machine learning tools to research, to enable the digital transformation of healthcare and to tackle disparities in prevention, diagnosis and treatment in Europe; considers that AI-based solutions can help boost the resilience and sustainability of EU’s healthcare systems and offer new solutions to patients via a better diagnosis and the use of real-world data;

Amendment 53 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B c (new)

B c. whereas US Defense Advanced Research Projects Agency (DARPA)and the US Biomedical Advanced Research and Development Authority (BARDA) have pushed, supported and directed new technological trajectories in notably mRNA vaccine technologies; whereas certain Member States have experimented with similar programmes;

Amendment 54 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B c (new)

Bc. whereas public pharmaceutical research and innovation should be guided by, and intended solely to achieve, public health objectives, including unmet medical needs; whereas the effectiveness of the current innovation system has steadily declined;

Amendment 55 #

Draft opinion
Recital B c (new)

B c. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs, and of strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Amendment 56 #

Draft opinion
Recital B c (new)

Bc. whereas European medicine manufacturers invested EUR 37 billion in research in 2019, employ 800 000 people directly and generate profits of almost EUR 110 billion;

Amendment 57 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

B d. whereas the Declaration on the TRIPS Agreement and Public Health, adopted in Doha on14November 2001, states that the TRIPS agreement should be implemented and interpreted in a way that is good for public health – encouraging both access to existing medicines and the development of new ones; whereas the WTO TRIPS Council decided on 6 November 2015 to extend the drug patent exemption for the least developed countries (LDCs) until January 2033;

Amendment 58 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital B d (new)

Bd. whereas the problems of the lack of diversity in pharmaceutical supply chains and supply bottlenecks are being exacerbated by the emergence of monopolistic groupings, in particular in the biosurgery supplies industry; whereas this lack of diversity is being made worse by significant intellectual property barriers which are preventing actors from manufacturing the products needed;

Amendment 59 #

Draft opinion
Recital B d (new)

Bd. whereas the European Union is the world's second-largest market for pharmaceutical products, evidence of our continuing international importance, a status which must be safeguarded at all costs;

Amendment 6 #

Draft opinion
Recital A

A. whereas the pandemic has revealed the strengths and limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;

Amendment 60 #

Draft opinion
Recital B d (new)

Bd. whereas actors in the medicines industry have to reconcile incentives and rewards for innovation, guarantees regarding patient access to medicines and the viability of health systems;

Amendment 61 #

Draft opinion
Recital B e (new)

Be. whereas a European pharmaceutical industry which specialises in research into and the development and production of innovative medicines in areas where large population groups have glaring needs which are not being met is essential for public health and for the competitiveness of the industry itself;

Amendment 62 #

Draft opinion
Recital B e (new)

Be. whereas intellectual property, in addition to being an inalienable right of our modern industries, is the only short- and medium-term guarantee of high- quality research;

Amendment 63 #

Draft opinion
Recital B f (new)

Bf. whereas the setting-up of the future EU agency HERA is inseparable from the establishment of a defence Europe, and whereas the time scale for that process cannot be reconciled with the current health emergency;

Amendment 64 #

Draft opinion
Recital B f (new)

Bf. whereas health spending can be curbed by withdrawing from the market medicines whose therapeutic added value is zero or even negative;

Amendment 65 #

Draft opinion
Recital B g (new)

Bg. whereas a competitive pharmaceutical industry needs a skilled, specialist workforce;

Amendment 66 #

Draft opinion
Recital B h (new)

Bh. whereas too often pharmaceutical research is based on studies of male physiology, with most clinical trials still being conducted on men; whereas the result is a dangerous degree of ignorance about the effects of medicines on women;

Amendment 67 #

Draft opinion
Recital B i (new)

Bi. whereas research into and the development, manufacture and consumption of medicines are likely to lead to the discharge into bodies of water and the soil of medicine residues which, depending on their physical and chemical properties, have degraded naturally to a greater or lesser degree;

Amendment 68 #

Draft opinion
Recital B j (new)

Bj. whereas veterinary medicines are present in the food chain, and whereas animals are likely to ingest residues of medicines intended for human consumption which are present in water and the soil;

Amendment 69 #

Draft opinion
Recital B k (new)

Bk. whereas the excessive and inappropriate use of antimicrobials in veterinary and human medicine is giving rise to antimicrobial resistance which in turn is making it more difficult to treat infectious diseases and perform surgical operations;

Amendment 7 #

Draft opinion
Recital A

A. whereas the pandemic has re~~veal~~affirmed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;

Amendment 70 #

Draft opinion
Recital B l (new)

Bl. whereas radiological and nuclear technologies can contribute to the fight against cancer;

Amendment 71 #

Draft opinion
Paragraph 1

Amendment 72 #

Draft opinion
Paragraph 1

1. ~~Calls on the Commission to~~States that the current COVID-19 crisis shows the need for more European cooperation in the health sector, calls for more EU competences in the sector; calls on the Commission to take greater responsibility for investing in and shaping pharmaceutical innovation and work towards a European public biomedical infrastructure covering the entire medicines value chain and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA Incubator commit to sharing intellectual property and know- how to scale-up the production and availability of vaccines against new COVID-19 variants;

Amendment 73 #

Pernille WEISS, Angelika NIEBLER, Dennis RADTKE, Maria da Graça CARVALHO, Angelika WINZIG, Seán KELLY, Henna VIRKKUNEN, Othmar KARAS, Aldo PATRICIELLO, Sara SKYTTEDAL, Massimiliano SALINI, Christian EHLER, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI

Draft opinion
Paragraph 1

1. Calls on the Commission to work towards a European public biomedical infrastructure covering the entire medicines value chain and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; considers that HERA should closely collaborate with public and private entities to plan, coordinate and build an ecosystem of private and public capabilities which can provide suitable emergency frameworks for EU access to key raw materials in case of global supply chocks;

Amendment 74 #

Draft opinion
Paragraph 1

1. Calls on the Commission to work towards a European public biomedical infrastructure covering the entire ~~medicines~~ value chain of medicines, and to develop the prospective European Health Emergency Response Authority (HERA) ~~along those lines~~; recognises the importance of involving all stakeholders in the development and activities of HERA, building on the positive experiences of public-private partnerships throughout the COVID-19 pandemic;

Amendment 75 #

Draft opinion
Paragraph 1

1. Calls on the Commission to work towards a European public biomedical infrastructure covering the entire medicines value chain and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; recognises the importance of involving all stakeholders in the development and activities of HERA as the positive public- private partnerships throughout the COVID-19 pandemic;

Amendment 76 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Lina GÁLVEZ MUÑOZ, Maria-Manuel LEITÃO-MARQUES, Robert HAJŠEL, Josianne CUTAJAR, Carlos ZORRINHO

Draft opinion
Paragraph 1

Amendment 77 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 a (new)

1 a. Recalls the need of constant and sufficient availability of affordable medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to guarantee full transparency in production and supply chains, notably in its new industrial strategy; invites the Commission to develop synergies with horizon scanning and mapping processes already inexistence via EMA or existing voluntary inter-country cooperation schemes;

Amendment 78 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 a (new)

1a. Calls on the Commission and the Member States to establish a 'European public medicines hub' with a view to launching a genuinely public programme covering the whole of the value chain and life cycle of medicines, including research and development, production and distribution; calls, in that connection, for the development of European public biomedical infrastructure to foster public- public partnerships; emphasises the contribution which the European Medicines Agency, the European Centre for Disease Prevention and Control and the future European Health Emergency Preparedness and Response Authority (HERA) could make to this project;

Amendment 79 #

Draft opinion
Paragraph 1 a (new)

1 a. Highlights the need to prioritise R&D for innovative medicines and treatments that better address patients needs, as well as to create incentives for up-skilling, re-skilling and out-skilling of workers for health care careers in order to be better prepared for potential emergency and crisis situations;

Amendment 8 #

Draft opinion
Recital A a (new)

A a. whereas it is necessary to guarantee the resilience of the European health system by ensuring that the production of medicines and active ingredients on the European territory is maintained through support for productive investments that respond in particular to the objectives of the ecological, energy and digital transition;

Amendment 80 #

Draft opinion
Paragraph 1 a (new)

1a. Emphasises that health is a fundamental, inalienable and universal human right; regards medicines, therefore, as a shared resource for humankind which should not be treated marketable goods whose use is geared solely to the pursuit of profit;

Amendment 81 #

Draft opinion
Paragraph 1 a (new)

1a. Welcomes the launch on 17 February 2021 of the HERA incubator focusing on the fight against the variants of the COVID-19 virus;

Amendment 82 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 1 b (new)

1 b. Notes that uncompetitive medicine markets, including for generics, allow for easy market manipulation, causing rapid increases in prices of medicines and increase the risk of medicine shortages, leaving patients without critical treatments in times of need ; Calls on the Commission and Member States to increase public investment in generic and biosimilar medicines in order to save costs, stimulate innovation and increase market competition;

Amendment 83 #

Draft opinion
Paragraph 1 b (new)

1b. Calls on the Commission and the Member States, under the seven-year Multiannual Financial Framework, to endow HERA with an ambitious and predictable budget intended to support research and development and gear it towards addressing significant public health problems for which private funding is insufficient and, in the event of a health crisis, providing operational support to pharmaceutical companies;

Amendment 84 #

Draft opinion
Paragraph 1 b (new)

1b. Stresses that the COVID-19 pandemic has illustrated the disastrous consequences of de-industrialisation and the loss of major industrial sites of strategic importance in the production of medicines and health equipment; is concerned that the economic strategies followed by pharmaceutical laboratories are steadily weakening pharmaceutical production chains;

Amendment 85 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 b (new)

1b. Takes the view that the 'European public medecines hub' will be able to meet the Commission's calls for open strategic autonomy;

Amendment 86 #

Draft opinion
Paragraph 1 c (new)

1c. Condemns the fact that pharmaceutical laboratories' constant drive to cut costs has led to the subcontracting of production to third- party manufacturers and increasing recourse to countries with low labour costs for the supply of active ingredients; condemns the aims of this economic model, which is to keep as much profit as possible in the hands of the pharmaceutical laboratories and leave only a tiny fraction of it for the third-party manufacturers, which is often insufficient to ensure the sustainability of the industrial sites involved; is concerned that the increasing economic and industrial fragility of subcontractors is bound to increase the number of supply interruptions on the medicines market;

Amendment 87 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 1 c (new)

1 c. Considers that uncompetitive and monopolistic markets, as well as a lack of standardization, have contributed to supply chain shortages, notably for single use bioprocessing equipment, limiting the rapid scale-up of Covid-19 vaccine production; calls on the Commission to support intellectual property waivers and compulsory licensing of monopoly patents throughout the supply chain to address these bottlenecks;

Amendment 88 #

Draft opinion
Paragraph 1 d (new)

1d. Insists, with a view to mitigating the shortcomings and short-termism of private pharmaceutical laboratories, that a genuine industrial strategy be implemented to restore conditions conducive to local pharmaceutical production; considers that this European pharmaceutical industrial strategy should contribute to a genuine public health strategy focused on patients' interests;

Amendment 89 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 1 d (new)

1 d. Is concerned about the continuous decline in efficiency of the current innovation system due in part to data silos and the fragmentation of knowledge; calls on the Commission to promote and support open science partnerships as a mechanism to reverse declining efficiency and promote innovation, avoiding restrictive forms of intellectual property to facilitate use and sharing;

Amendment 9 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Recital A a (new)

Aa. whereas the COVID-19 pandemic has revealed the limits of the current set- up as regards the anticipation, coordination and strategic management of production, value and supply chains and the accessibility of key pharmaceuticals, including vaccines against COVID-19;

Amendment 90 #

Draft opinion
Paragraph 1 e (new)

1e. Stresses that public production, controlled not only by the Member States but also by health system users and industry employees, is a prerequisite for the effective implementation of a genuine public health strategy; urges that public production of this kind should cover all health products, including both medicines and essential raw materials;

Amendment 91 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 1 e (new)

1 e. Recognizes the shortcomings and limited returns of the usual economic models used by the industry to develop new antibiotics; calls on the Commission to urgently present its analysis and thorough review of the current R&I incentive models in this area and address antimicrobial resistance;

Amendment 92 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 f (new)

1 f. Recognizes that further analysis to examine the limits of the current pharmaceutical system in the EU and its Member States is needed, in particular in relation to the impact of certain incentives in EU pharmaceutical legislation, the use thereof by economic operators and the consequences for the innovation, availability, accessibility and affordability of medicinal products for the benefit of patients including as regards innovative treatment solutions to common diseases that cause a heavy burden for individuals and health systems;

Amendment 93 #

Draft opinion
Paragraph 1 f (new)

1f. Urges the Commission and the Member States to carry out a survey of all the most recent manufacturing locations of medicinal products of major therapeutic interest (MPMTIs) in the EU;

Amendment 94 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 g (new)

1 g. Welcomes the Commission's initiative to create a European Health Emergency Preparedness and Response Authority (HERA); Invites the Commission to set up an inclusive public health and public interest driven governance for HERA, ensuring transparent public control and a balanced representation of public health civil society organisations, patients, and consumers, while excluding industrial lobbies from its decision-making; Highlights the need for the new public agency to be financially sustainable in order to permit long-term planning;

Amendment 95 #

1g. Calls on the Commission and the Member States to adopt the following common definition of MPMTIs: medicines or classes of medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term, or which represents a significant loss of opportunity for patients with regard to the severity or potential evolution of the disease;

Amendment 96 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO

Draft opinion
Paragraph 1 h (new)

1 h. Invites the Commission to base HERA’s decisions on evidence-based and global health driven priorities defined in close collaboration with the World Health Organization; favours a broad mandate to address bottlenecks from the discovery phase all the way to production and distribution in order to guarantee public oversight and control and ensure equitable distribution and affordable access to end products; calls on the Commission to promote, through HERA, strategic public investment in research, development, manufacture, deployment, distribution and use of critical medicines and medical devices;

Amendment 97 #

Draft opinion
Paragraph 1 h (new)

1h. Urges the Commission and the Member States to introduce financial and administrative protection for MPMTIs at third-party manufacturing sites; calls on the Commission and the Member States to create immediately an environment conducive to security of supply of MPMTIs; calls on the Member States to restart the manufacture of those MPMTIs that are currently imported which are no longer being delivered regularly to patients or which are identified as being at risk of interruption of supply, prioritising third-party manufacturing sites that already have the required operational capacity;

Amendment 98 #

Marc BOTENGA, Marisa MATIAS, Giorgos GEORGIOU, Manuel BOMPARD, Sira REGO, Sandra PEREIRA

Draft opinion
Paragraph 1 i (new)

1 i. Highlights the importance of public R&D efforts in discovering new treatments; stresses that research priorities must address public health needs, and stresses that the regulatory framework must facilitate the best possible outcome for patients and public health; calls on the Commission and the Member States to foster R&D driven by public health and unmet medical needs, including by researching new antimicrobials;

Amendment 99 #

Draft opinion
Paragraph 1 i (new)

1i. Insists that the Commission and the Member States set up, as quickly as possible, one or more European non- profit pharmaceutical undertakings which operate in the public interest and have the capacity to produce certain MPMTIs for which there are serious risks of shortages;

source: 692.747

2021/06/03 JURI 93 amendments...

Amendment 1 #

Draft opinion
Paragraph -1 (new)

-1. Believes that the European Union's strategic autonomy has to be a key objective when addressing shortages of medicines, which has been a serious concern for many years currently amplified by the current COVID-19 pandemic;

Amendment 10 #

Draft opinion
Paragraph 1 a (new)

1a. Recalls that the European Union is aiming to ensure the well-being of European citizens by promoting healthy lifestyles, fair and equitable access to healthcare and the marketing of safe, effective and affordable medicines in the single market;

Amendment 11 #

Draft opinion
Paragraph 1 a (new)

1a. Stresses that R&D is key for the development of innovative medicines, therapies and diagnosis;

Amendment 12 #

Draft opinion
Paragraph 1 b (new)

1b. Whereas the European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19 (2020/2691(RSP)) has called on the Commission to assess the impact of intellectual property incentives on biomedical innovation and to explore credible and effective alternatives to exclusive protections for the financing of medical R&D, such as the numerous tools based on delinkage mechanisms;

Amendment 13 #

Emmanuel MAUREL

Draft opinion
Paragraph 1 b (new)

1b. Stresses that European industry has been severely affected by the COVID- 19 pandemic; underlines its strong dependence regarding supplies; calls for long-term measures to consolidate European industrial sovereignty, making it stronger, more integrated, more locally based and more robust, so as to avoid any disruptions in supply chains;

Amendment 14 #

Draft opinion
Paragraph 1 b (new)

1b. Calls on the Commission and the Member States to introduce tax and financial incentives, to authorise State aid and to supervise public funding as incentives for manufacturers to relocate to Europe the manufacture of the active ingredients and medicinal products of strategic importance for health care, in order to create a more crisis-resilient system;

Amendment 15 #

Draft opinion
Paragraph 1 b (new)

1b. Recalls that health falls within the remit of the Member States alone and that Union initiatives must remain within the framework laid down in Article 152 of the Treaty; points out in this regard that the EU must confine itself to complementing and facilitating measures by the Member States to achieve their objectives;

Amendment 16 #

Draft opinion
Paragraph 1 b (new)

1b. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by creating a proper regulatory framework;

Amendment 17 #

Draft opinion
Paragraph 1 b (new)

1b. Highlights that supporting the competitiveness and innovative capacity of the EU’s pharmaceutical industry is crucial;

Amendment 18 #

Draft opinion
Paragraph 1 c (new)

1c. Stresses that investment in research and development is crucial in order to create a thriving EU pharmaceutical sector; is concerned about the limited investment in a few therapeutical areas which generate the greatest profit; believes that it is important to increase investment also in new medicines for rare diseases, unmet needs, personalised medicines and individual therapies; urges the Commission to reform the current system of incentives for research and to prioritise research and innovation in areas, such as paediatric cancer;

Amendment 19 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 1 c (new)

1c. Underlines that the EU has to foster patients access to medicines, support the competitiveness of the EU’s pharmaceutical industry, develop the EU’s open strategic autonomy and ensure both robust supply chains and a strong EU voice on the global stage;

Amendment 2 #

Draft opinion
Paragraph 1

1. Stresses the importance of developing a new EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level, of paving the way for scientific progress and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; stresses the need to draw up future European framework provisions for regulatory approval, access and incentives for innovation, accompanied by vigorous industrial policies, with attractiveness and predictable rules being regarded as the key to innovation, and to facilitate patients’ access to medicines; notes that EU pharmaceutical strategy and legislative measures must support European developers and producers in guiding scientific progress and remaining globally competitive; draws attention to the need to develop production chains within Europe through the formulation of rational regulatory framework provisions that are compatible between the Member States, thereby ensuring the supply of medicines by safeguarding the entire production process;

Amendment 20 #

Draft opinion
Paragraph 1 d (new)

1d. Welcomes the Commission’s Action Plan on Intellectual Property which shall help companies, especially small and medium-sized companies (SMEs), to make the most of their inventions and creations and ensure they can benefit our economy and society and which aims at enabling the European innovative industry to remain a global leader;

Amendment 21 #

Draft opinion
Paragraph 1 d (new)

1d. Underlines the important role played by public investments in R&D, and calls on the Commission and the Member States to establish full transparency on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments;

Amendment 22 #

Draft opinion
Paragraph 1 e (new)

1e. Fully supports the IP Action Plan proposal to upgrade a series of existing IP tools and make them fit for the digital age, including improving the supplementary protection certificates (SPC) for patented medicinal products among other;

Amendment 23 #

Draft opinion
Paragraph 1 f (new)

1f. Recalls the Council conclusions ‘An EU Industrial Policy Strategy: a Vision for 2030’ of May 2019 recognising that a well-functioning and effective intellectual property rights regime is key to continued development and growth and recalling that it is essential to continue developing, improving and updating the European intellectual property frameworks, so as to ensure that ideas and inventions can be effectively developed and brought to the market, in particular by and for SMEs, to the benefit of the European economy and society at large;

Amendment 24 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 1 g (new)

1g. Recalls the European Commission’s ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ of May 2021 which states that the EU is strategically dependent on third countries regarding pharmaceutical ingredients and other health related products, which could lead to vulnerabilities for the EU and affect the EU’s core interests, and refers to the pharmaceutical strategy to address these issues;

Amendment 25 #

Draft opinion
Paragraph 2

2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic; stresses that compulsory licensing should only be possible in exceptional cases, where no other solution can be found and where it appears to be justified and necessary to increase production capacity effectively;

Amendment 26 #

Draft opinion
Paragraph 2

2. Emphasises the key importance of an adapted intellectual property protection regime in the EU~~, which is essential if the EU is not to be~~ in order to respond to urgent health needs in the EU and worldwide; Calls on the Commission to authorise State aid and to supervise public funding as an incentives for manufacturers to relocate the manufacture of the active ingredients of medicinal products to Europe, so that the EU is not dependent on third countries and ihas the means to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry, research and patient representatives, ands well as other civil society stakeholders, with a view to identifying shared approaches and best practices with short-term and long-term effect, in particular to the challenges posed by the COVID-19 pandemic;

Amendment 27 #

Draft opinion
Paragraph 2

2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic;

Amendment 28 #

Draft opinion
Paragraph 2

2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicinesNotes that patent protection is an incentive for companies to invest in innovation and produce new medicines; notes at the same time that the exclusionary effect of patents may lead to limited market supply and reduced access to medicines as well as pharmaceutical products; notes that a balance should be struck between intellectual property protection, encouraging innovation, ensuring access to medicines and protecting public health; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic;

Amendment 29 #

2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic, aimed at promoting innovation and the availability and affordability of medicines across the EU;

Amendment 3 #

Draft opinion
Paragraph 1

1. Stresses th~~e importance of developing a new~~at the EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more effective responses to future health emergenciess to build a stronger European Health Union in particular by supporting closer EU cooperation in research and development and by sharing health data;

Amendment 30 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 2

2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; ~~calls for a joint review process involving European, n~~stresses that intellectual property rights enhance the accessibility, innovation and competitiveness of the sector and improve the safety of medicines and of patients; calls for the role of the Member States to be enhanced by improving communicational and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemiccooperation between the European institutions, national authorities, health professionals, industry representatives and stakeholders;

Amendment 31 #

Draft opinion
Paragraph 2 a (new)

2a. Stresses that intellectual property plays a pivotal role in the expansion and growth of SMEs, which are penalised by a lack of knowledge of procedures and by inadequate or non-existent information regarding opportunities available to them;

Amendment 32 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 2 b (new)

2b. Stresses the need for the Commission, the Member States and the holders of marketing authorisations for medicines to work together in order to identify and address the root causes of the shortfall in medicines on EU markets and to find appropriate ways of addressing the remaining barriers to timely and effective patient access; stresses that affordability of medicines remains a challenge for national health systems;

Amendment 33 #

Luisa REGIMENTI

Draft opinion
Paragraph 2 c (new)

2c. Stresses the importance of building adequate legal and operational frameworks that give industry the necessary agility and flexibility to quickly rebuild stockpiles based on patients’ needs in each country and using regional supply strategies; underscores the need for regulatory solutions that encourage flexible and adaptable production and distribution strategies; highlights the need for dialogue with industry to find viable solutions that increase common capacity to prevent shortages;

Amendment 34 #

Draft opinion
Paragraph 2 a (new)

2a. Notes that the TRIPS Agreement lays down the rules applicable to compulsory licences, in particular the grounds on which they are granted, the requirements for limited scope and duration and for the payment of adequate remuneration to the rightholder; notes that the legislation of most Member States provides for compulsory licences, but not under the same conditions; notes, however, that compulsory licences for patents are not frequently used; notes that some Member States have already made use of compulsory licensing, in order to tackle the Covid-19 pandemic; calls on the Commission to encourage Member States to make use of compulsory license schemes to this effect;

Amendment 35 #

Draft opinion
Paragraph 2 a (new)

2a. Urges the Commission to take full account of and assess the effective implementation of the SPC manufacturing waiver in light of the several conditions and limitations posed to it.

Amendment 36 #

Draft opinion
Paragraph 2 a (new)

2a. Calls for the European Commission to carefully analyse which lessons have to be learned from the challenges posed by the Covid-19 pandemic for the pharmaceutical strategy;

Amendment 37 #

Draft opinion
Paragraph 2 b (new)

2b. Recalls that Regulation (EC) No 816/2006 harmonises the procedure for granting compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible importing countries in need of such products in order to address public health problems; calls on the Commission to consider the possibility for harmonised rules on granting compulsory licensing of medicinal products, such as vaccines, which would allow Member States to respond faster and more effectively to future public health crisis; stresses that the compulsory licensing system is insufficient to tackle the challenges of the COVID-19 pandemic; calls on the Commission to reconsider other solutions, including a waiver of TRIPS obligations;

Amendment 38 #

Draft opinion
Paragraph 2 b (new)

2b. Underlines the need to ensure a smart use of IP, and to better fight IP theft, as smart IP policies are essential to help companies to grow, to create jobs and to protect and develop what makes them unique and competitive;

Amendment 39 #

Draft opinion
Paragraph 2 c (new)

2c. Stresses that compulsory licensing schemes need to be part of wider EU action to address the issue of access to medicines; calls on the Commission to examine the legal and economic implications of voluntary and compulsory licences and their potential to address the shortage of medicines in the EU;

Amendment 4 #

Draft opinion
Paragraph 1

1. Stresses the need for and importance of ~~develop~~introducing a new EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more eff~~ective~~icient and rapid responses to future health emergencies;

Amendment 40 #

Draft opinion
Paragraph 2 d (new)

2d. Is concerned that access to medicines remains a question of price; urges the Commission to oblige Member States to ensure more transparency on price information and to tackle strategic pricings with the sole purpose of economic gain to the disadvantage of patients;

Amendment 41 #

Draft opinion
Paragraph 2 e (new)

2e. Supports greater generic and biosimilar competition combined with an appropriate market protection mechanism, further clarifying and possibly extending the research exemption for the production of generic drug manufacturers prior to the expiration of ordinary patent protection (so-called “Bolar exemption”), while guaranteeing legal certainty for investment;

Amendment 42 #

Draft opinion
Paragraph 2 f (new)

2f. Believes that secure and open access to interoperable health data must be increased while fully respecting EU data protection rules; further suggests establishing open platforms, creating synergies between databases on different types of health data and to extend the collaboration between private and public actors in this sector; encourages the development of platforms, which monitor and provide information on the safety and effectiveness of vaccines after the authorisation procedure;

Amendment 43 #

Draft opinion
Paragraph 2 g (new)

2g. Stresses the need for increased access to data for high performance computing, artificial intelligence and robotics, new technologies, which can help accelerate the identification of potential active substances, render animal testing obsolete and support the development of new medicines or therapies; stresses, however, the need for high ethical standards at EU level, notably in view of gender or other bias;

Amendment 44 #

Draft opinion
Paragraph 2 h (new)

2h. Welcomes a European Health Union, which foresees an enhanced role of the European Medical Agency (EMA), a strengthened mandate for the European Centre for Disease Prevention and Control as well as the establishment of a European Health Emergency Response Authority (HERA), in order to improve the cooperation of operations across the whole value chain and to generate strategic investment in research, development, manufacturing and distribution of medicines and medical devices within the European Union;

Amendment 45 #

Luisa REGIMENTI

3. Stresses the importance of investment and support~~ing~~ for research in the EU, not least in order to increase the number of patents filed in the Member States; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low, to be decided in close collaboration with interested parties, that is to say patients, consumers, healthcare professionals and not-for- profit researchers, and based on the added value to the patient, taking into account the severity of the disease, the costs and the alternative treatments possible; notes that public research should focus particularly on areas of low commercial interest; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;

Amendment 46 #

Draft opinion
Paragraph 3

3. Stresses the importance of supporting research in the EU~~, not least in order to increase the number of~~; further emphasises that public and private investment in research, including into and the development of innovative medicines and treatments, shall be driven by public health and unmet medical needs, with the involvement of regulators, academia, healthcare professionals and patients ~~filed in the Member Stat~~at early stages of R&D, to ensure research priorities respond to societal needs and enable as well as access to safe, effective and high-quality medicines; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low~~; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector~~, such as orphan and paediatric drugs; whereas high degree of transparency should apply in publicly funded medical research from decision-making to investment and open science;

Amendment 47 #

Draft opinion
Paragraph 3

3. Stresses the importance of supporting research in the EU, not least in order to increase the number of patents filed in the Member States; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low, such as orphan drugs, paediatric cancer therapies and antimicrobial resistance (AMR) drugs; calls for unmet needs and the concept of additional therapeutic value to be more closely defined; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;

Amendment 48 #

Draft opinion
Paragraph 3

3. Stresses the importance of facilitating and supporting research in the EU, ~~not least in order~~in order to be world market leader in improving existing and developing new medicines which could then lead to an increase of the number of patents filed in the Member States in this area; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;

Amendment 49 #

Draft opinion
Paragraph 3

3. Stresses the importance of supporting research in the EU~~, not least in order to increase the number of patents filed in the Member States~~; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;

Amendment 5 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 1 a (new)

1a. Whereas the preparation to next global health crisis urges decision and policy making to bring solutions allowing long-term resilience in society, and in particular to design an industrial ecosystem in the pharmaceutical sector where the balance between the different interests at stake is duly considered in the light of the circumstances, in order for the EU to be able to respond to health crisis;

Amendment 50 #

Draft opinion
Paragraph 3 a (new)

3a. Stresses that full realisation of the potential of new technologies also depends on the proper use of health data; stresses the importance of using the potential of digital technologies and health data to expedite access to innovative technologies and to help Member States develop the infrastructure necessary to better assess safety data, health benefits and outcomes; notes that the current COVID-19 crisis has already highlighted the usefulness of data sharing in expediting research, and stepping up public health surveillance systems across the EU with the intention of saving lives;

Amendment 51 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 3 b (new)

3b. Calls on the Commission to draw up guidelines to resolve problems relating to the interpretation of GDPR provisions on sharing health data for scientific purposes and a code of conduct for the processing of personal data in the health sector in accordance with Article 40 of the GDPR; recommends that appropriate consultations be carried out with the Member States and the scientific community in the implementation of these actions, so that the future health data space can truly fulfil its ambition to support scientific and medical research in Europe;

Amendment 52 #

Draft opinion
Paragraph 3 a (new)

3a. Stresses the importance of generic, biosimilar and value added medicines for consistently increasing equitable access for patients and making the healthcare systems sustainable in a European Union where access is still uneven; calls on the Commission to urgently ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;

Amendment 53 #

Draft opinion
Paragraph 3 a (new)

3a. Calls on the Commission and the Member States to incorporate collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for the exploitation of the final products, in all current and future calls for funding and investment;

Amendment 54 #

Draft opinion
Paragraph 3 a (new)

3a. Stresses that a revision of the system of legal incentives and obligations to support innovation, access and affordability of medicines across the EU has recognised the relationship with intellectual property rights;

Amendment 55 #

Draft opinion
Paragraph 3 b (new)

3b. Highlights the key role of European scientific research in developing new pharmaceutical products and treatments, and the importance to remove all unnecessary barriers, especially in case of health crisis, to enable researchers to find scientific solutions under exceptional time and efficiency constraints; supports all legal incentives to develop innovative R&D projects, such as ‘VACCELERATE’, and to make them sustainable on the long- term; encourages the Commission to assess the outcome of the COVID-19 Technology Access Pool (C-TAP), in terms of allowing maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data;

Amendment 56 #

Draft opinion
Paragraph 3 c (new)

3c. Prompts the Commission to proceed to an early evaluation of Regulation (EU) 2019/933 concerning the supplementary protection certificate (SPC) for medicinal products, so that the effectiveness of the SPC waiver can be reviewed in the light of the recent exceptional circumstances, and in the light of the aim to restore a global level playing field for makers of generics and biosimilars in the Union; such evaluation should also study the impact of the exception of SPC protection on research and production of innovative medicines in the Union by certificate holders and consider the balance between the different interests at stake, in particular as regards public health, public expenditure and, in this context, access to medicines within the Union;

Amendment 57 #

Draft opinion
Paragraph 3 d (new)

3d. Draws attention to the key role played by AI and, more generally, by data, and their potential as a driver of research and development in the health and pharmaceutical sector; nonetheless signals that health data should be subject of close legal scrutiny with respect to their interference with the GDPR and with the future Data Governance Act;

Amendment 58 #

Draft opinion
Paragraph 4

4. Stresses the importance of launching the unitary patent without delay, in order to create a one-stop shop for patent protection and enforcement across the EU and to do away with the fragmentation of the patent market and the obstacle that may pose to research and innovation;deleted

Amendment 59 #

Draft opinion
Paragraph 4

Amendment 6 #

Draft opinion
Paragraph 1 a (new)

1a. Is of the opinion that the diversification of production and supply chains as well as tactical stockpiling of essential medicines will help to achieve strategic autonomy; believes that the dependence of the EU on certain raw materials from third countries and the lack of such production technologies within the EU need to be addressed with priority within a new multi-year pharmaceutical strategy;

Amendment 60 #

Draft opinion
Paragraph 4

Amendment 61 #

Draft opinion
Paragraph 4

4. ~~Stresses~~Draws attention to differences in the validity of patents and supplementary protection certificates in the various Member States; stresses in this context the importance of launching the unitary patent without delay, in order to create a one-stop shop for patent protection and enforcement across the EU and to do away with the fragmentation of the patent market and the obstacle that may pose to research and innovation;

Amendment 62 #

Jean-Paul GARRAUD, Gunnar BECK, Gilles LEBRETON

Draft opinion
Paragraph 4 a (new)

4a. Recalls the importance that non- exclusive licensing can have in mitigating shortages and in stabilising prices of medicines, especially in times of health emergency; urges the Commission to call for a review of the legal provisions of the TRIPS Agreement regarding the implementation of compulsory licenses, in order to foster patent flexibilities, as stated in Resolution of 17 September 2020 (2020/2071(INI)); calls on the Commission to introduce waivers of patents, of data and of market exclusivity in exceptional circumstances, in order to enable global access to crucial health products to swiftly overcome health crisis in Europe and worldwide;

Amendment 63 #

Draft opinion
Paragraph 4 a (new)

4a. Calls on the Commission to revise the legal framework for the protection of the pharmaceuticals market or pharmaceutical data, so as to improve access to generic and biosimilar medicines, offering affordable treatments to a large number of patients, with better prices being charged by competitors as a result, thereby reducing health costs;

Amendment 64 #

Draft opinion
Paragraph 4 a (new)

4a. Urges to make the IP system more effective for SMEs, through actions to simplify IP registration procedures (e.g. reforming EU legislation on industrial designs), to improve access to strategic IP advice (e.g. by making such advice available in all EU-level R&D funding), and to facilitate the use of IP as a lever to gain access to finance;

Amendment 65 #

Draft opinion
Paragraph 4 a (new)

4a. Welcomes the initiative to launch the pilot project seeking to test the framework provisions regarding new indications for off-patent medicines and the basis for possible regulatory action; stresses in this regard the necessity and importance of input from industry and academia and their involvement;

Amendment 66 #

Draft opinion
Paragraph 4 a (new)

4a. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls on the Commission to carefully evaluate any actual impact that any proposal for a unitary or unified SPC would produce on generic and biosimilar medicines, and on equitable patient access to treatments;

Amendment 67 #

Draft opinion
Paragraph 4 b (new)

4b. Stresses that investing in research and development is a costly, high-risk endeavour; underlines that patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public; repeats therefore that pharmaceutical companies need intellectual property (IP) rights and thus patents to achieve profits and keep innovating also in the interest of the consumers and patients;

Amendment 68 #

Draft opinion
Paragraph 4 b (new)

4b. Call on the Commission to ensure a uniform and efficient application of the conditions for granting preliminary injunctions, including proportionality; recommends a consistent EU application of the IP Enforcement Directive on damages for competitor companies in cases of delayed off-patent competition;

Amendment 69 #

Draft opinion
Paragraph 4 c (new)

4c. Welcomes the Commission recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorization applications (so called Bolar provision); calls for urgent European harmonization and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day -1;

Amendment 7 #

Draft opinion
Paragraph 1 a (new)

1a. Notes the new European pharmaceutical strategy that is being presented as a fresh opportunity to enhance EU competitiveness and consolidate the role of European industry, thereby avoiding the relocation of companies outside the EU; stresses that this is also an opportunity for Member States to play a more prominent role at global level;

Amendment 70 #

Draft opinion
Paragraph 4 c (new)

4c. Stresses that R&D in drugs are very often not successfully completing clinical trials and thus are not resulting in final drug approval;

Amendment 71 #

Draft opinion
Paragraph 4 d (new)

4d. Underlines that the patent systems all over the world are drafted in a way that for a specific period of time, only for the duration of the patent, the inventor is allowed to commercially exploit its patent. Thereafter, the invention can be freely exploited by anyone;

Amendment 72 #

Luisa REGIMENTI, Gilles LEBRETON, Jean-Paul GARRAUD

Draft opinion
Paragraph 4 e (new)

4e. Stresses that a possible revision of the ‘Bolar’ exemption which is the provision for the conduct of trials on patented products to support generic and biosimilar marketing authorisation applications [Art. 10 (6) Community Code relating to medicinal products for human use [Directive (EC) 2001/83]] can only be undertaken after a thorough impact assessment;

Amendment 73 #

Draft opinion
Paragraph 5

5. Calls on the Commission to use all the means at its disposal to prevent counterfeit products from entering the market and so protect intellectual property rights holders and European citizens, as these products are often of low quality and pose a danger to health; notes that this is compounded by the heavy economic impact, estimated at a loss of at least EUR 10 billion for the European pharmaceutical industry and 37 000 jobs; notes that it is necessary to provide technical assistance to the Member States for the proper implementation of the EMVS;

Amendment 74 #

Jean-Paul GARRAUD, Gunnar BECK, Gilles LEBRETON

Draft opinion
Paragraph 5 a (new)

5a. Stresses that, in order to keep the Member States globally competitive, any EU action must be free of ideological prejudices and focused on the development of a long-term strategy based on technically sound and simplified processes and the easing of burdens, in order to encourage the entry of a raft of new products on the market; stresses that changes to EU legislation are necessary in order to avoid moves towards industrial relocation outside EU borders;

Amendment 75 #

Emmanuel MAUREL

Draft opinion
Paragraph 5 a (new)

5a. Calls for an EU health exemption to be notified to the WTO and incorporated into all past and future trade agreements, incorporating zero tariffs for pharmaceutical products, while allowing the parties to accord public funding to their national pharmaceuticals and health sectors; calls for a provision ruling out any future dispute arising from our FTA partners regarding health issues;

Amendment 76 #

Draft opinion
Paragraph 5 a (new)

5a. Notes that EU joint procurement agreements to address the COVID-19 crisis have not proven their effectiveness in the eyes of the Member States; stresses that such agreements fall within the competence of the Member States - and not the Commission - and help to mitigate the impact of cross-border health threats and guarantee increased security of supply;

Amendment 77 #

Jean-Paul GARRAUD, Gunnar BECK, Gilles LEBRETON, Luisa REGIMENTI

Draft opinion
Paragraph 5 b (new)

5b. Stresses the need to relocate the production of the most essential medicines into the EU; calls, therefore, on the Commission to prioritise the pharmaceutical production of vaccines in the EU, enabling Member States to conclude public contracts with the various European pharmaceutical laboratories producing vaccines in order to avoid a shortage of doses and ensure the safety of European citizens in the face of such a crisis;

Amendment 78 #

Draft opinion
Paragraph 5 b (new)

5b. Calls on the Commission to develop, at minimum cost, a digital platform to serve as a contact point between Member States, providing channels of information, communication and advice in order to involve Member States in innovation projects at national and European level; encourages Member States accordingly to pool information regarding their practices in order to foster innovation;

Amendment 79 #

Draft opinion
Paragraph 6

6. Stresses, lastly, the importance for European companies, in strategic sectors such as pharmaceuticals, of contractual freedom in the areas of licensing and the protection and effective enforcement of intellectual property rights, including in third countries where they operate; calls on the Commission to develop and implement new measures and tools for this purpose and to improve existing ones, such as the Intellectual Property Helpdesk for SMEs.deleted

Amendment 8 #

Draft opinion
Paragraph 1 a (new)

1a. Stresses that in order to reduce dependence on external suppliers, secure the drug safety of Europeans and make production in the EU competitive, it seems necessary to create appropriate conditions and financial incentives for the industry, which will be a key argument in the context of their investment decisions in the field of API production, intermediates and ready-made drugs;

Amendment 80 #

Draft opinion
Paragraph 6

6. Stresses, lastly, the importance for European companies, in strategic sectors such as pharmaceuticals, ~~of contractual freedom in the areas of licensing and the prot~~and of effectionve and ~~effective~~balanced enforcement of intellectual property rights, including in third countries where they operate; ~~calls on the Commission to develop and implement new measures and tools for this purpose and to improve existing ones, such as the Intellectual Property Helpdesk for SMEs.~~

Amendment 81 #

Draft opinion
Paragraph 6 a (new)

6a. Stresses that producers of generic drugs, as opposed to producers of innovative drugs, are usually regional enterprises with less resilience to supply problems and market turbulence; calls to the Commission to promote legal solutions that favour competitiveness in the field of generic production, while maintaining a proper legal balance between generic drugs and innovative drugs;

Amendment 82 #

Draft opinion
Paragraph 6 a (new)

6a. Calls on the Commission, to facilitate public access to information regarding patenting and licensing conditions, the findings of clinical and pre-clinical trials and public and private contributions;

Amendment 83 #

Draft opinion
Paragraph 6 a (new)

6a. Notes that most of the time, radical innovation in the pharmaceutical sector is driven by SMEs (“biotechs”);

Amendment 84 #

Draft opinion
Paragraph 6 b (new)

6b. Recalls that, in situations of crisis or health emergencies, changes to intellectual property rules are totally insufficient to meet short-term needs; calls on the Commission to endeavour to provide Member States with mechanisms and tools to ensure that, in exceptional situations and going beyond licensing policy, knowledge transfer is as effective as possible; calls on the Commission to consider the introduction of provisional regulatory mechanisms enabling Member States in exceptional circumstances to order and control the production of vaccines through the compulsory licensing of outside companies where they deem necessary;

Amendment 85 #

Draft opinion
Paragraph 6 b (new)

6b. Regrets that the EU is less attractive then other countries, such as the USA, in terms of pharmaceutical research and development which is mainly due to a financial environment which encourages more risk-taking by venture capital;

Amendment 86 #

Draft opinion
Paragraph 6 c (new)

6c. Underlines the importance of a strong, efficient, transparent and balanced system of IP and trade secrets protection and the need for a coherent overall strategy to ensure both protection of – and fair access to – innovation to ensure that all companies established in the EU, including small and medium- sized ones, can effectively capitalise on their IP and make use of new technologies;

Amendment 87 #

Draft opinion
Paragraph 6 c (new)

6c. Stresses the need for greater transparency in the price of medicines, especially in order to make consumers aware of indirect taxes on medicines and healthcare products; recalls that prices are set at national level;

Amendment 88 #

Draft opinion
Paragraph 6 d (new)

6d. Reminds the Commission that Member States are empowered to set their own priorities regarding innovative processes for the manufacture of new antibiotics; notes the need to facilitate access to new antibiotics while maintaining access to old ones;

Amendment 89 #

Draft opinion
Paragraph 6 d (new)

6d. Finally highlights that it is of outmost importance to speak with “a strong EU voice” on the global stage;

Amendment 9 #

Emmanuel MAUREL

Draft opinion
Paragraph 1 a (new)

1a. Stresses that the lack of strategic autonomy and the high level of EU dependence in a sector as essential as healthcare and pharmaceuticals is the concrete expression of free trade taken to extremes in line the policies encouraged for decades by the European Commission;

Amendment 90 #

Draft opinion
Paragraph 6 e (new)

6e. Calls for maximum transparency in the use of public research and development funding and for easy public access to information regarding patenting and licensing conditions, the findings of clinical trials and public/private contributions.

Amendment 91 #

Draft opinion
Paragraph 6 f (new)

6f. Stresses the need to devote more resources at European level to combat unfair and abusive market practices with regard to medicines; underlines, in this regard, the need for new funding lines to support the work of new start-ups and SMEs in the field of medical biotechnology;

Amendment 92 #

Draft opinion
Paragraph 6 g (new)

6g. Stresses that EU legislation frequently acts as a bottleneck, stifling many of the innovations that SMEs are seeking to market; calls on the EU to review its pharmaceutical policies with a view to becoming a global hub of medical innovation; points out that the EU should focus on developing adequate capacity for the production of active substances, raw materials and medicines, thereby reducing its dependence on external sources;

Amendment 93 #

Draft opinion
Paragraph 6 h (new)

6h. Notes that innovation is far outstripping legislation; calls on the Commission to introduce a degree of regulatory flexibility in order to be able to respond more rapidly and effectively to new market requirements and demand for products;

source: 693.696

2021/06/10 ENVI 723 amendments...

Amendment 1 #

Motion for a resolution
Citation 2 a (new)

— having regard to Article 6 TEU and Article 35 of the Charter of Fundamental Rights of the European Union on the right to preventive healthcare for all European citizens;

Amendment 10 #

Motion for a resolution
Citation 8 a (new)

— having regard to its resolution of 10 July 2020 on the EU’s public health strategy post-COVID- 19(2020/2691(RSP)), calling for an EU action plan on rare and neglected diseases,

Amendment 100 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Motion for a resolution
Recital C b (new)

C b. whereas the longstanding problem of shortages of medicines within the EU has worsened in recent years; whereas the increase in global demand, as well as the COVID-19 pandemic, have further aggravated shortages of medicines, undermining health services in the Member States and entailing considerable risks for the health and care of patients, including disease progression and/or worsening of symptoms, increased delays or interruption in care or therapy, longer hospitalisations, increased exposure to falsified medicines, medication errors or adverse events occurring when the missing medicine is substituted by another, avoidable transmission of infectious diseases, significant psychological distress, and increased expenditure for the healthcare system; whereas the Member States have a duty to find swift and effective solutions, including through common European coordination and action; whereas medicine shortages have multifactorial and complex root causes; whereas some decision-making by the pharmaceutical industry, such as discontinuations of products and withdrawals from less profitable Member States’ markets, is also often a reason for medicine shortages;

Amendment 101 #

Motion for a resolution
Recital C b (new)

C b. whereas there are variances and differences in health care systems, national regulation, implementation of EU-regulation, pricing and authorisation processes in the different Member States; whereas these differences are a result of Member States' legitimate competences on health; whereas the differences can lead to fragmentation and unpredictable circumstances for actors in the pharmaceutical sector that operate outside their own country;

Amendment 102 #

Motion for a resolution
Recital C b (new)

C b. Whereas for the Pharmaceutical Strategy to be fully effective it is necessary that it incorporates lessons learnt from the COVID-19 crisis and takes into consideration the resilience demonstrated by the off-patent medicines industry during the COVID-19 outbreak, so as to build on in the existing European manufacturing capacity;

Amendment 103 #

Motion for a resolution
Recital C b (new)

C b. whereas medicine producers made the biggest contribution to research investment in 2019, with over €37 billion; whereas the sector provides 800 000 direct jobs and a €109.4billion trade surplus; whereas the sector generates about three times more employment indirectly – upstream and downstream – than it does directly;

Amendment 104 #

Motion for a resolution
Recital C b (new)

C b. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;

Amendment 105 #

Motion for a resolution
Recital C b (new)

Cb. whereas the pandemic has brought to the fore a number of pre-existing problems, such as limited capacity to produce vaccines, lack of essential medicines and an unevenly functioning supply chain.

Amendment 106 #

Motion for a resolution
Recital C b (new)

C b. whereas the transfer of production to third countries tends to be motivated by an attempt to reduce production costs; whereas these savings are mainly due to more lax environmental, safety and labour law standards;

Amendment 107 #

Motion for a resolution
Recital Γ b (new)

Cb. whereas universal access to medicines, which is a basic right for all without discrimination, depends on their availability when needed and their affordability;

Amendment 108 #

Motion for a resolution
Recital C b (new)

C b. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;

Amendment 109 #

Motion for a resolution
Recital C b (new)

C b. whereas the entry of generic and biosimilar medicines play a key role in increasing equitable access for patients and hence market entry should not be unduly delayed;

Amendment 11 #

Motion for a resolution
Citation 8 a (new)

— having regard to its resolution of 14 February 2017 on EU options for improving access to medicines;

Amendment 110 #

C c. whereas the loss of European independence in the health sector is linked to the relocation of production, with 40 % of medicinal end products marketed in the EU now originating in third countries; whereas while Europe has a strong manufacturing footprint, the supply chain still relies heavily on subcontractors to produce pharmaceutical raw materials outside the EU, where labour costs and environmental standards are often lower, with the result that 60 % to 80 % of chemical active ingredients are manufactured outside the EU, mainly in China and India; whereas, to date, no label or labelling visible to patients and customers is required for medicinal products and active pharmaceutical ingredients (APIs) concerning their origin and country of manufacturing; whereas limited access to APIs required for the production of generic medicines poses a particular challenge; whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted even more the EU’s dependency on third countries in the health sector; whereas the novel coronavirus pandemic has also revealed shortages of medical devices, medical products and protective equipment;

Amendment 111 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Recital C c (new)

C c. whereas there is convincing evidence that pharmaceuticals leach into the environment, in particular into soil and water; whereas their presence can have adverse effects on wild animals such as fish, birds and insects and, as a result, broader impacts on the stability of individual ecosystems; whereas these medicines also appear in drinking water at lower concentrations;

Amendment 112 #

Motion for a resolution
Recital C c (new)

C c. whereas it is both in the interest of the individual patient and the society as such to have a competitive and resilient pharmaceutical industry with strong roots in research; whereas a thriving industry to a higher degree can identify and address patients' medical needs and contribute to advances in public health, economic growth, employment, trade relations and in science and technology;

Amendment 113 #

Motion for a resolution
Recital C c (new)

C c. whereas the Bolar exemption allows the development of generic and biosimilar medicinal products for regulatory approvals during the IP protection of the reference product in order to ensure market entry as soon as possible after the IP expiry, based on the basic rationale that free competition should be allowed as soon as protection expires;

Amendment 114 #

Motion for a resolution
Recital C c (new)

C c. whereas it is important to recognise that cooperation is required between the Commission and Member States so as to set out ambitious implementation agendas with clear timelines and the necessary long-term financing to implement concrete actions that follow from the Pharmaceutical Strategy for Europe;

Amendment 115 #

Motion for a resolution
Recital Γ c (new)

Cc. whereas, in many cases, the price of new innovative medicines is extremely high, to the point of being unaffordable for many European citizens and also threatening the sustainability of national health care systems;

Amendment 116 #

Motion for a resolution
Recital C c (new)

Cc. whereas there is a need to seek new synergies between the updated European industrial strategy, the pharmaceutical strategy, the EU4 health programme and the European recovery plan.

Amendment 117 #

Motion for a resolution
Recital C c (new)

C c. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;

Amendment 118 #

Motion for a resolution
Recital C d (new)

C d. whereas a patent linkage system is declared incompatible with the EU pharmaceutical legislation in the Commission’s Pharmaceutical Sector Inquiry Report of 2009; whereas in the fragmented system of national pharmaceutical policies patent linkages exist, causing disruptions in the functioning of the single market with undue delays to competition at IP expiry;

Amendment 119 #

Motion for a resolution
Recital C d (new)

Cd. whereas the European Green Deal must encourage rather than hinder the development of a vibrant and dynamic pharmaceutical industry within the EU.

Amendment 12 #

Motion for a resolution
Citation 8 b (new)

— having regard to its resolution of 13 September2018 entitled “A European One Health Action Plan against Antimicrobial Resistance”;

Amendment 120 #

Motion for a resolution
Recital C d (new)

C d. whereas the root causes of medicines shortage should be assessed and tackled in the context of a strategy on medicines shortage;

Amendment 121 #

Motion for a resolution
Recital C e (new)

C e. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;

Amendment 122 #

Motion for a resolution
Recital C f (new)

C f. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;

Amendment 123 #

Motion for a resolution
Recital C g (new)

C g. whereas patents have a significant impact on access to medicines and on sustainability of healthcare budgets; whereas the European Patent Office (EPO) plays a key role in the registration of European patents and it is fundamental to ensure the highest quality and efficiency of the patent granting process in the interest of patent applicants, consumers and the public;

Amendment 124 #

Motion for a resolution
Subheading 1

Putting patients a~~t the centre of all health policies~~nd public health at the centre of pharmaceutical research and decision-making

Amendment 125 #

Motion for a resolution
Paragraph -1 (new)

-1. Underlines that COVID-19 has brought challenges for health systems, their sustainability, but also had a dramatic impact on non-covid patients, including those suffering from chronic conditions, and their ability to access treatments and care; calls on the Commission and Member States to take seriously the impact for non-covid patients and to work collaboratively to ensure no patient is left behind and continuity of care is ensured even during emergency situations;

Amendment 126 #

Motion for a resolution
Paragraph -1 (new)

-1. Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and to prevent shortages thereof, prioritising the interest and safety of patients;

Amendment 127 #

Motion for a resolution
Paragraph -1 (new)

-1. Calls for national and European measures to guarantee the rights of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies; calls on Member States to guarantee the sustainability of public healthcare systems; stresses that patient access to medicines is a shared responsibility of all actors in the healthcare system;

Amendment 128 #

Motion for a resolution
Paragraph -1 (new)

-1 Stresses that the EU pharmaceutical strategy should be focusing on the interest of patients and that any support or public funding should be conditioned to the protection of public health and equitable access to healthcare services and treatments in the EU;

Amendment 129 #

Motion for a resolution
Paragraph -1 a (new)

-1 a Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and stresses the importance to decrease the EU’s reliance on third countries’ imports of key starting material of plasma for the manufacturing of plasma-derived medicinal products, and to prevent shortages thereof, prioritising the interest and safety of patients; stresses the importance of ensuring that all Member States have fair access to the supply chain; highlights, to that end, the need for the Union’s pharmaceutical industry to have a diversified supply chain and a medicine shortage risk mitigation plan to cope with any vulnerabilities and risks to their supply chain;

Amendment 13 #

Motion for a resolution
Citation 12 a (new)

— having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,

Amendment 130 #

Motion for a resolution
Paragraph -1 a (new)

-1a. Points out that while the Member States are responsible for the definition and organisation of their health policies, the Union is responsible for pharmaceutical legislation as well as various public health policies, and it is incumbent on the EU to coordinate and complement national measures to guarantee access to affordable and high- quality health services for all EU citizens and residents;

Amendment 131 #

Motion for a resolution
Paragraph 1

1. Stresses that investment in research into and the development of innovative medicines and treatments, as well as access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseasesfair and equitable access to safe, effective, high-quality and affordable healthcare services and treatments for all, as well as investment in research into and the development of innovative medicines and treatments, are essential for making progress in the prevention, diagnosis, treatment of diseases and quality of life of patients; regrets the disparities into the access to high quality healthcare services among member states and also between different regions within member states and asks the Commission to address those disparities with the appropriate legislative measures in order to ensure equal rights in the EU;

Amendment 132 #

Motion for a resolution
Paragraph 1

1. Stresses that public and private investment in research, in~~to and~~cluding the development of innovative ~~medicines and treatments, as well as~~treatments, shall be driven by public health and unmet medical needs, defined with the involvement of regulators, academia, healthcare professionals, patients and payers at early stages of R&D, to ensure research priorities respond to societal needs and enable access to safe, effective ~~and~~, high-quality ~~medicines, are essential for making progress in the prevention and treatment of diseas~~and affordable medicines, while ensuring collaboration and minimum duplication in ongoing studies;

Amendment 133 #

Simona BALDASSARRE, Silvia SARDONE, Gianantonio DA RE, Lucia VUOLO, Susanna CECCARDI

Motion for a resolution
Paragraph 1

1. Stresses that investment in research into and the development of innovative diagnostics and medicines and treatments, as well as access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseases; points out that embedding meaningful patient involvement throughout the entire life cycle of medicines and other therapies will be an indispensable requirement to achieve high-value innovation, patient benefit and patient safety; further underlines that EU Funding Programmes such as the future Framework Programme (Horizon Europe) must prioritize research on public health needs, especially those in the area neglected by the for-profit private sector, hence contributing to the development of medicines that bring actual added therapeutic value;

Amendment 134 #

Motion for a resolution
Paragraph 1

Amendment 135 #

Motion for a resolution
Paragraph 1

1. Stresses that investment in research into and the development of innovative medicines and treatments, as well as access to safe, effective and high-quality and affordable medicines, are essential for making progress in the prevention and treatment of diseases and for improving the quality of healthcare given to patients;

Amendment 136 #

Motion for a resolution
Paragraph 1

Amendment 137 #

Motion for a resolution
Paragraph 1

1. Stresses that public investment in research into and the development of innovative medicines and treatments, as well as ensuring access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseases;

Amendment 138 #

Motion for a resolution
Paragraph 1

1. Stresses that investment in research ~~into~~ and the development of innovative medicines and treatments, as well as equal access to safe, effective, affordable and high-quality medicines, are essential for making progress in the prevention and treatment of diseases;

Amendment 139 #

Motion for a resolution
Paragraph 1

Amendment 14 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Citation 12 a (new)

— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Amendment 140 #

Motion for a resolution
Paragraph 1

1. Stresses that investment in research into and the development of innovative medicines, diagnostics and treatments, as well as access to safe, effective and high- quality medicines, are essential for making progress in the prevention and treatment of diseases;

Amendment 141 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 1 – point 1 (new)

(1) Considers that equal access to medicines for all EU patients, in terms of affordability and accessibility should be one of the pillars of the revised Pharmaceutical Strategy, as the principles of putting patients at the centre of all health policies demands;

Amendment 142 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Notes with concern that most new medicines are launched earlier in the US than in the EU; notes that this delay is partly due to longer timelines for authorisation procedures in the EU; requests the Commission to assess how the EU’s procedures for authorisation can be made more efficient and timely, in order to allow EU patients to benefit from medicines that can improve their conditions sooner; invites the Commission to propose adequate resources for the EMA to achieve this objective;

Amendment 143 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Calls on the Commission and Member States to take the necessary measures so that non-covid patients do not suffer in terms of access to care and treatments during health crisis, as it has been the case during the COVID-19 emergency; underlines the importance of acting in terms of monitoring, access to diagnosis, screening and treatments, digital solutions and appropriate resources;

Amendment 144 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Stresses the importance of optimisation and efficient use of existing therapeutic options, including off-patent generic and biosimilar medicines use wherever they are available, in all policies in support of sustainable and equitable access and care, equity and affordability;

Amendment 145 #

Motion for a resolution
Paragraph 1 a (new)

1a. Points out that healthcare is a human right enshrined in the Universal Declaration of Human Rights; points out that equal access to medicines must be ensured in order to uphold this right;

Amendment 146 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Stresses that in order to develop effective treatments, the patient’s perspective must be taken into account in the research, development but also in regulatory, assessment and appraisal processes for rare diseases therapies;

Amendment 147 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Recognizes the role of off-patent generic and biosimilar medicines, wherever they are available, in contributing to the sustainable and equitable access, care and affordability for patients;

Amendment 148 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN

Motion for a resolution
Paragraph 1 a (new)

1 a. Calls for the strengthening of the European Medicines Market to speed up patient access to medicines, improve public health, make care more affordable and maximize savings in national health budgets;

Amendment 149 #

Motion for a resolution
Paragraph 1 a (new)

1 a. Stresses the importance of improving patients and healthcare professionals’ education on medicines by setting up a dedicated Europe-wide online resource centre;

Amendment 15 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Citation 12 b (new)

— having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

Amendment 150 #

Motion for a resolution
Paragraph 1 b (new)

1 b. Welcomes the upcoming creation of the European Health Emergency Preparedness and Response Authority (HERA) and calls for the allocation of sufficient resources and power autonomy to broadly address all the cross-borders threats to health that EU could face in the middle term and beyond the sole COVID- 19 pandemic, including resources for the development of new therapeutics against viral and bacterial pathogens;

Amendment 151 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 1 b (new)

1 b. Considers that Member States should converge on the evaluation of medical technologies; looks forward to a timely adoption of the Regulation on Health Technology Assessment (HTA) by the European Parliament and the Council to ensure rapid access to innovative treatments;

Amendment 152 #

Motion for a resolution
Paragraph 2

2. Considers that ~~investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases,~~research and scientific progress have so far not resulted in developing successful therapies for patients with rare diseases, chronic diseases including cancer and paediatric cancers, and neurodegenerative diseases, or in means to deal with the growing threat of antimicrobial resistance (AMR), concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted measures to effectively address these areas;

Amendment 153 #

Motion for a resolution
Paragraph 2

2. Considers that ~~investment in research~~research and scientific progress hasve not yet been sufficient ~~to meet the therapeutic needs of patients with~~for the underserved areas of rare diseases, paediatric cancers and neurodegenerative diseases, or to deal with antimicrobial resistance (AMR) concerning all AMR concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;

Amendment 154 #

Motion for a resolution
Paragraph 2

2. ~~Consider~~Underlines that investment in research ~~has not been sufficient to meet~~ should be further conditioned to public interest, recalls that public and private investments should be oriented with the necessary regulatory and legislative measures to meet the therapeutic needs of patients ~~with~~, including rare diseases, rare adult cancers and paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 155 #

Motion for a resolution
Paragraph 2

2. Considers that ~~investment in research~~research and scientific progress hasve not yet been sufficient ~~to meet the therapeutic needs of patients with~~for the underserved areas of rare diseases, paediatric cancers and neurodegenerative diseases or, to deal with antimicrobial resistance (AMR) concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;

Amendment 156 #

Motion for a resolution
Paragraph 2

2. Considers that ~~investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases,~~research and scientific progress has not yet produced sufficiently successful therapies for patients with rare diseases, chronic diseases, cancers, in particular paediatric cancers, and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 157 #

Motion for a resolution
Paragraph 2

2. ~~Consider~~Stresses that investments in research ~~has not been sufficient to meet the therapeutic~~should prioritise the needs of patients and health systems and focus on the greatest unmet needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 158 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); acknowledges the need to find innovative financing models for incentivizing research and development of novel medicine for diseases that are otherwise perceived as being unattractive to industry due to potentially low market value and revenue;

Amendment 159 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient in relation to quality of life and late effects of treatments, to meet the specific therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls for gender equality and additional research inpatient populations regularly excluded from clinical studies, such as children, pregnant women and the elderly;

Amendment 16 #

Motion for a resolution
Citation 12 b (new)

— having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’

Amendment 160 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls on the Commission to strengthen industrial policy in the pharmaceutical sector and stimulate investment in non-patented paediatric medicines;

Amendment 161 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls for unmet needs and the concept of additional therapeutic value too be more closely defined.

Amendment 162 #

Motion for a resolution
Paragraph 2

Amendment 163 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers ~~and~~, neurodegenerative diseases or chronic diseases, to deal with antimicrobial resistance (AMR) or to deal with prevent infectious diseases;

Amendment 164 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of many patients with chronic diseases – including those with rare diseases, paediatric cancers and neurodegenerative diseases, or to deal with antimicrobial resistance (AMR);

Amendment 165 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare ~~diseases,~~or chronic diseases such as paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 166 #

Motion for a resolution
Paragraph 2

2. Considers that public investment in research has not been sufficient to meet the therapeutic needs of patients, particularly patients with rare diseases, paediatric cancers and neurodegenerative diseases, or to deal with antimicrobial resistance (AMR);

Amendment 167 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research ~~has~~and scientific progress have not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 168 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 169 #

Motion for a resolution
Paragraph 2

2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers, obesity and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Amendment 17 #

Motion for a resolution
Citation 12 c (new)

— having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use,

Amendment 170 #

Motion for a resolution
Paragraph 2 a (new)

2 a. Calls for research results and data sets from all clinical trials submitted to the EMA for marketing authorisation to be publicly available, in order to build trust in the EU’s regulatory framework and foster further research concerning a products’ efficacy and safety; stresses that timely public disclosure of results from clinical trials increases value and efficiency in the use of funds and reduces reporting bias, which ultimately leads to better decision-making in health;

Amendment 171 #

Motion for a resolution
Paragraph 2 a (new)

2 a. Recalls its invitation to the Member States, in cooperation with the Commission, to consider the possibility of the establishment of a pooled public platform for R&D financed by all Member States via a minimum contribution of 0.01 % of their GDP; considers that this platform should also be able to directly produce life-saving medicines in the EU in the event of a market failure being identified1a; _________________ 1a P8_TA(2017)0061

Amendment 172 #

Motion for a resolution
Paragraph 2 a (new)

Amendment 173 #

Motion for a resolution
Paragraph 2 a (new)

Amendment 174 #

Motion for a resolution
Paragraph 2 a (new)

2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Amendment 175 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN

Motion for a resolution
Paragraph 2 a (new)

Amendment 176 #

Motion for a resolution
Paragraph 2 a (new)

2 a. Considers the serious and constantly increasing risks of AMR topublic health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Amendment 177 #

Motion for a resolution
Paragraph 2 a (new)

2 a. Calls on the Commission to support research into the treatment of major noncommunicable diseases, including obesity as a primary morbidity as well as where it exists as a gateway chronic disease to other noncommunicable diseases;

Amendment 178 #

Motion for a resolution
Paragraph 2 a (new)

2a. Considers it essential to establish a new dialogue with patients and to place their needs at the heart of R&D strategy and policy;

Amendment 179 #

Motion for a resolution
Paragraph 2 b (new)

2b. Highlights the valuable role of community pharmacies and recognises also their valuable contribution during the pandemic by continuously providing an essential and quality service; Stresses that pharmacists are an independent, reliable and trustworthy source of information; Suggests that pharmacists play a more active role in pharmacovigilance activities to assess and monitor the effectiveness of medicines and invites Member States to include them in their health, care and research programmes; Calls for greater recognition of pharmacies in rural areas, which enable such areas to retain their populations and ensure the well-being of citizens.

Amendment 18 #

Motion for a resolution
Citation 12 c (new)

— having regard to its resolution of 15 January 2020 on the European Green Deal

Amendment 180 #

Motion for a resolution
Paragraph 2 b (new)

2 b. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Amendment 181 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Paragraph 3

3. Considers it imperative that ~~a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated through a single calendar at EU level;~~ the ‘One Health’ approach guides reduction and use optimisation for antimicrobials, as well as the development of new medicines, including antimicrobial agents; stresses the importance of investment into the development of new non-animal methodologies, such as in silico and organoids, to shorten pre-clinical observation periods, increase efficiency in research and reduce unnecessary and often less reliable experiments on animals;

Amendment 182 #

Motion for a resolution
Paragraph 3

3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated t~~hrough a single calendar at EU level~~o create more awareness on antimicrobial resistance, its variants and its consequences at EU level; supports the Commission’s intentions of making the EU a ’best practice region’ and the introduction of interdisciplinary tools, as the future CAP, to tackle AMR;

Amendment 183 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 3

3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated through a single calendar at EU level; calls on the Commission and member states to address AMR with concrete and prompt measures, also with regulatory and legislative ones if needed;

Amendment 184 #

Motion for a resolution
Paragraph 3

3. Considers it imperative that a common EU therapeutic guide for antimicrobials be drafted in close cooperation with all relevant authorities; recommends that this guidance document be introduced and that communication campaigns on AMR be coordinated ~~through a single calendar~~more closely at EU level;

Amendment 185 #

Motion for a resolution
Paragraph 3

3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced, setting up traceable antimicrobial use reduction targets at EU level and that communication campaigns on AMR be coordinated through a single calendar at EU level;

Amendment 186 #

3a. Takes note of the increase in antimicrobial resistance and the threat it poses to public health and food safety; Notes that despite the lack of development of new antibiotics in Europe, it is essential to boost their production within the EU and reduce disparities in access across the Member States.

Amendment 187 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Calls on the Commission to further look into new delinked pull incentives models such as market exclusivity transfer and the subscription model for the development of new antibiotics; stresses that financial incentives are needed to re-creatre an investment friendly environment for research and innovation in this field and thus enable long-term investments into the AMR field;

Amendment 188 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Points out that antibiotic resistance is an urgent health challenge; Calls on the Commission to propose as soon as possible an effective legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to brings new antibiotics to the market;

Amendment 189 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Considers that while the public co- creates and is a major investor in health technologies, their exploitation is largely left to the discretion of industry driven by commercial interests alone, resulting in many of their promises not been fully translated into available and affordable clinical advances;

Amendment 19 #

Peter LIESE, Dolors MONTSERRAT, Radan KANEV, Cindy FRANSSEN, Christine SCHNEIDER

Motion for a resolution
Citation 12 d (new)

— having regard to the Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

Amendment 190 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Calls on the Commission to propose as soon as possible a legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to bring new antibiotics the market;

Amendment 191 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Highlights the importance of existing antibiotics in the fight against AMR and the need to continue to make these available for patients by developing targeted measures aimed at ensuring that economic conditions do not lead to market withdrawals;

Amendment 192 #

Motion for a resolution
Paragraph 3 b (new)

3 b. Considers that the current R&D system is biased towards high revenue generating diseases, leading to an increasing gap between real unmet medical needs and investment;

Amendment 193 #

Motion for a resolution
Paragraph 3 b (new)

3 b. Points out that it is essential to promote and/or maintain incentives in areas of low profitability such as rare diseases, paediatrics and AMR;

Amendment 194 #

Motion for a resolution
Paragraph 3 c (new)

3 c. Points out that science and research play a crucial role in the development of standards in the fight against AMR; asks the Commission to also look into alternative antibiotic therapies such as bacteriophage therapy, building up on the EU-funded Project Phagoburn; notes that so far no bacteriophage therapies have been authorized at EU Level and thus reiterates its call on the Commission to propose a Framework for bacteriophage therapy based on the latest scientific research;

Amendment 195 #

Motion for a resolution
Paragraph 3 c (new)

3 c. Calls on the Commission to play an active role in defining directions for health innovation to create a system that is aligned with medical and social needs, rather than leaving it to be driven by commercial interests alone;

Amendment 196 #

Motion for a resolution
Paragraph 3 d (new)

3 d. Calls on the Commission to reshape the system of incentives to foster the development of relevant health innovations and more actively explore alternative models for encouraging innovation which, instead of relying on the IPR system, decouple investment in innovation from medicine sales volumes and high prices; calls on the Commission to review thoroughly the Supplementary Protection Certificate(SPC) to assess its necessity to cover industry R&D costs and its impact on the medicines’ accessibility;

Amendment 197 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to ~~incorporate new criteria into the system of incentives for research into and the development of new~~build on the existing incentives regime, and improve it with additional incentives, such as transferable exclusivity extensions, for medicines for un~~met~~derserved therapeutic ~~needs, prioritising~~and prophylactic areas, where the development of projeducts ~~promoted by the pharmaceutical industry~~would otherwise not be sustainable for companies, prioritising projects combating rare diseases, paediatric cancers, ~~neurodegenerative diseases~~ and AMR, with the aim of finding more therapeutic and prophylactic options and meeting the needs of patients and health systems; calls on the Commission to target its framework programme funding into projects where there is insufficient basic science to develop treatments, such as neurodegenerative disease; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 198 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseasebuild on the existing incentives regime, and improve it with additional incentives, such as transferable exclusivity extensions, for underserved therapeutic and prophylactic areas where the development of products would otherwise not be sustainable for companies, prioritising projects and AMR, with the aim of finding more therapeutic and prophylactic options and meeting the needs of patients and health systems; calls on the Commission to target its framework programme funding into projects where there is insufficient basic science to develop treatments, such as neurodegenerative disease; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 199 #

Ondřej KNOTEK, Linea SØGAARD-LIDELL, Susana SOLÍS PÉREZ, Claudia GAMON, Billy KELLEHER

Motion for a resolution
Paragraph 4

4. ~~Calls on the Commission to inc~~Welcomes the intention to revise pharmaceutical legislation forp or~~ate new criteria into the syste~~phan and paediatric medicines and addressing AMR, with the aim of fincentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systemsding more affordable therapeutic options and meeting the needs of patients and health systems; calls on the Commission to provide public research funding to investigate the use of repurposed, off-label and off-patent products that can be used safely and effectively in patients; stresses that medicines resulting from publicly funded research must be equally available across the Union for a fair and affordable price; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 2 #

Motion for a resolution
Citation 3 a (new)

— having regard to the Commission communication of 5 May 2021 on Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe's recovery (COM(2021)350),

Amendment 20 #

Motion for a resolution
Citation 12 e (new)

— having regard to the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and the work of EUNetHTA Joint Actions,

Amendment 200 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 4

4. Calls on the Commission to revise the system of incentives and incorporate new criteria into ~~the system of incentives for~~promote public health driven research into and the development of new medicines for unmet therapeutic needs, ~~prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of~~as for example rare diseases, rare adult cancers and paediatric cancers, neurodegenerative diseases and AMR, with the objective of protecting public health, guaranteeing equitable rights and access to treatment for all, finding more therapeutic options at affordable prices and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 201 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission, together with the Member States, to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry to combat~~ing~~ rare diseases, cancer, including paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to ~~promote the creation of an EU framework to~~actively promote awareness and provide for guidance and ~~regularly evaluate~~support with the implementation of national plans to fight these diseases;

Amendment 202 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to ~~incorporate new~~strengthen the criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; ~~calls on~~emphasizes that EU funding should be steered towards projects where research is needed the most; invites the Commission to ~~promo~~evaluate the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 203 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Paragraph 4

4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative and mental diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases; and on the Member States to support research and development that focuses on the unmet medical needs of all citizens, and to guarantee non-exclusive licensing where R&;D is publicly funded and that access to medical advances in the European Union is non-discriminatory;

Amendment 204 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to further strengthen the current system of incentives for research and the development of new medicines for unmet therapeutic needs and to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet diagnostic and therapeutic needs, while maintaining the overall stability and predictability of the system, and prioritising projects promoted by the pharmaceutical industry combating rare ~~diseases,~~or chronic diseases such as paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 205 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to further strengthen the system of incentives for research and the development of new medicines for unmet therapeutic needs and incorporate new criteria into the system of incentives for research ~~into~~ and the development of ~~new~~advanced diagnostics and medicines for unmet therapeutic needs, while maintaining the overall stability and predictability of the system, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 206 #

Motion for a resolution
Paragraph 4

Amendment 207 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN

Motion for a resolution
Paragraph 4

Amendment 208 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry in order to combat~~ing~~ rare diseases, cancers, including paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 209 #

Motion for a resolution
Paragraph 4

Amendment 21 #

Motion for a resolution
Citation 12 f (new)

— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use,

Amendment 210 #

Motion for a resolution
Paragraph 4

4. Calls on the Commission to ~~incorporate new criteria into the system of incentives for~~promote public health driven research ~~into~~ and the development of new medicines for unmet therapeutic needs, ~~prioritising projects promoted by the pharmaceutical industry combating~~such as in the field of rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options at affordable prices and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Amendment 211 #

Motion for a resolution
Paragraph 4

Amendment 212 #

Motion for a resolution
Paragraph 4

Amendment 213 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Welcomes the very positive impact that the Regulation on orphan medicinal products EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006) have had on developing medicines; invites the Commission to maintain the philosophy of these Regulations, namely incentives and rewards, and appropriate disease thresholds to allow for investment in rare disease; recognises that more work is needed to enhance the lives of more patients and calls on the Commission to allow for measures targeting important underserved areas, such as transferable exclusivities, and streamlining and simplifying regulatory procedures.

Amendment 214 #

Motion for a resolution
Paragraph 4 a (new)

4a. Notes that there is a lack of instruments to combat antibiotic resistance and that there are no short- term solutions. Calls on the Commission to encourage R&D in the field of antimicrobial resistance; supports new legislative initiatives to ensure more effective R&D, with better planning as regards European research funding, making it possible to tackle the rise of antimicrobial resistance.

Amendment 215 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective for patients and intrinsically less harmful for the environment, given that ‘greener pharmaceuticals’ are not toxic for the environment, do not bioaccumulate, and degrade more readily, into harmless substances, in wastewater treatment plants and the environment;

Amendment 216 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise this category of affordable innovation with appropriate incentives and its value for healthcare systems;

Amendment 217 #

Peter LIESE, Christine SCHNEIDER, Cindy FRANSSEN

Motion for a resolution
Paragraph 4 a (new)

Amendment 218 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Calls on the Commission, where appropriate in dialogue with the Member States, to work on a framework for pharmaceutical legislation and a reimbursement system that favours real breakthrough innovations for patients and incentivizes less so-called ‘me too’ pharmaceuticals which do not have an added value or highly expensive pharmaceuticals that offer only minor improvements for patients;

Amendment 219 #

Motion for a resolution
Paragraph 4 a (new)

Amendment 22 #

Motion for a resolution
Citation 12 g (new)

— having regard to Directive 2010/63/EU of the European Parliament and of the Council of22 September 2010 on the protection of animals used in scientific procedures,

Amendment 220 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 4 a (new)

4 a. Calls on the European Commission and Member States to establish streamlined regulatory, pricing and reimbursement policies for therapies addressing rare diseases; stresses that these policies should encourage a continuum of evidence generation along the full life cycle of a product or technology as well as the patient journey from diagnosis to treatment access;

Amendment 221 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Calls on the Commission to strengthen the mechanism enforced by Regulation on orphan medicinal products (EC/141/2000)1a and Regulation on medicinal products for paediatric use (EC/1901/2006)1b through funding and public-private partnership projects, especially the relationship between local health authorities, universities and industry; _________________ 1a OJ L 18, 22.1.2000, p. 1–5 1b OJ L 378, 27.12.2006, p. 1–19

Amendment 222 #

Ondřej KNOTEK

Motion for a resolution
Paragraph 4 a (new)

4 a. Highlights the fact that therapies such as homeopathy, physiotherapy and acupuncture can bring benefits to the patients in relation to the parallel effects of several diseases and their treatments such as cancer; stresses the importance to develop a holistic, integrative and patient- centric approach and to encourage the complementary use of these therapies;

Amendment 223 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Calls on the Commission to start the process of defining unmet medical needs, under the coordination of EMA, in order to reach a commonly accepted definition that would help a better orientation of research needs and would avoid the use of various definitions of unmet medical needs for exorbitant pricing and marketing medicines at an early stage;

Amendment 224 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Underlines that continuous innovation, including in the off-patent segment, should strive to address patients’ unmet needs; in this regard, considers that a fit-for purpose regulatory framework could enable the development of value added medicines as well as recognise the category of affordable innovation;

Amendment 225 #

Motion for a resolution
Paragraph 4 a (new)

4a. Emphasises the need to support continuing innovation in the area of non- patented medicines as well, with a view to offering patients appropriate treatment; calls on the Commission to ensure that such medicines remain affordable for both health systems and patients;

Amendment 226 #

4 a. Calls on the Commission to consider setting research targets and milestone prizes as a complement to other research and development incentives, especially for developing medicines and therapies that are of low interest for industry due to market value;

Amendment 227 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Stresses that a common European understanding of key concepts such as "unmet needs" and "added therapeutic value" such as a definition or a set of common criteria is needed at Union level;

Amendment 228 #

Motion for a resolution
Paragraph 4 a (new)

4 a. Stresses that a common understanding of concepts such as innovation, value and added therapeutic value should be agreed in dialogue with patient organisations;

Amendment 229 #

Motion for a resolution
Paragraph 4 b (new)

4 b. Welcomes the very positive impact that the Regulation on orphan medicinal products (EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006) have had on developing medicines; invites the Commission to maintain the philosophy of these Regulations, namely incentives and rewards, and appropriate disease thresholds to allow for investment in rare disease; recognises that more work is needed to enhance the lives of more patients and calls on the Commission to allow for measures targeting important underserved areas, such as transferable exclusivities, and streamlining and simplifying regulatory procedures;

Amendment 23 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

— having regard to its resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)),

Amendment 230 #

Motion for a resolution
Paragraph 4 b (new)

4 b. Considers that antimicrobial resistance constitutes a serious threat to public health, whose cause should be found above all in the incorrect and superficial use of antibiotic drugs; calls on the Commission and Member States to fund projects aimed at improving diagnostics as well as suggesting a protocol for administrating antibiotics and an awareness campaign for health professionals to encourage more targeted treatment based on patients’ real needs;

Amendment 231 #

Motion for a resolution
Paragraph 4 b (new)

4b. Calls on the Commission to faciliate the Member States' ability to set their own priorities for innovation in the manufacturing process of new antibiotics; Notes the need to facilitate access to new antibiotics while maintaining access to old ones;

Amendment 232 #

Motion for a resolution
Paragraph 4 b (new)

4 b. Calls on the Commission to take the first steps to enhance transparency of research and development costs of medicines and to introduce new conditions for research funds so as to increase access for patients;

Amendment 233 #

Motion for a resolution
Paragraph 4 c (new)

4c. Supports the continuation of the Innovative Medicines Initiative and invites the European Investment Bank to play a more active role in financing innovative initiatives in the field of antimicrobial resistance; Stresses the importance of implementing the joint action plan on antimicrobial resistance and health infections.

Amendment 234 #

Motion for a resolution
Paragraph 4 d (new)

4d. Points out that the concept of unmet medical needs cannot exclude those areas where treatment is available but patients need better results; Stresses that in order to encourage this type of research, solutions are needed to encourage the achievement of these objectives; stresses that a system based solely on research incentives will not achieve the objectives in the fight against rare diseases; Proposes extending the EMA's PRIME scheme to orphan drugs.

Amendment 235 #

Motion for a resolution
Paragraph 4 e (new)

4e. Stresses the relevance of developing a new funding model for antimicrobial medicines that provides a return on R&D investment without relying on the sale of medicines.

Amendment 236 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether ~~the EU invest~~any type of public funding was used in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population and the wider patient community; stresses the need to promote discussion as well on what constitutes a socially acceptable profit margin for pharmaceutical products; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;

Amendment 237 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to ~~promot~~facilitate and enable dialogue ~~with~~among the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefitto steer cooperation in horizon scanning, pricing and reimbursement, including best practice and information exchange related to national pricing strategies, taking into account levels of public investment, cost of R&D, added therapeutic benefit and cost-effectiveness; such dialogue should further encourage cooperation in pricing negotiations and joint procurement and guidance on principles and costing methods for establishing R&D costs of medicines and their use at the national level; calls ofn the ~~medicine, and the primary and broader needs of the popul~~Commission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration;

Amendment 238 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote a high-level dialogue with the Member States and stakeholders ~~to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to~~, including patient and industry representatives, to assess how national pricing can incentivise R&D investment in the EU, including considerations such as high environmental manufacturing standards, capacity of supply and investment in innovation, and to promote novel pricing and payment models to foster sustainability in European health systems, strong patient outcomes, and rewards for innovation, and drive a harmonised transformation to an outcomes-focused approach considering the value of the therapeutic and prophylactic benefit of the medicine, and the primary and broader needs of the population;

Amendment 239 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote a dialogue ~~with the Member States and stakeholders~~ to assess new criteria for negotiating national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the ~~product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population~~research and development of the product, while promoting an analysis as well on what constitutes a socially acceptable profit margin for pharmaceutical products; recalls that national pricing should be based on transparency of factors such as public and private research, development costs and added therapeutic value; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;

Amendment 24 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Citation 12 i (new)

— having regard to the Council conclusions of 17 June2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,

Amendment 240 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote a well-structured and institutionalised dialogue with the Member States and stakeholders to assess ~~new criteria for~~how national pricing~~, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to~~ may encourage investment in R&D in the EU, and guide a harmonised transformation towards an approach based on results and on the basic and most extensive needs of the population, considering the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 241 #

Motion for a resolution
Paragraph 5

Amendment 242 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote the dialogue with ~~the~~ Member States and stakeholders to ~~assess new~~include procurement criteria ~~for~~in national ~~pricing~~tenders, such as ~~whether a product is ‘Made in Europe’, whether the EU invested in the product~~'Resilient and robust supply chain management,’ investments in manufacturing, investments made by the EU to support research, or ~~whether prices should be~~also adaptedation to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 243 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess ~~new~~additional criteria for national pricing, such as whether the supply chain management is sufficiently resilient and robust; whether there have been investments in innovation and/or high environmental manufacturing standards; whether a product is ‘Made in Europe’,; whether the EU invested in the product to support research, or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 244 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing~~, such as whether a product is ‘~~ and to include procurement criteria in national tenders such as "resilient and robust supply chains management", investment in research, development and manufacturing within the Union (Made in Europe’), whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 245 #

Motion for a resolution
Paragraph 5

5. Calls on the Commission to actively promote dialogue with the Member States and stakeholders to ~~assess~~provide for more guidance with existing and potentially new criteria for national pric~~ing~~es, such as whether a product is ‘Made in Europe’ represents a more effective and affordable treatment alternative, whether the EU has invested in the product to support research, or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 246 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote a high level dialogue with the Member States and stakeholders, including patients and representatives from the health sector to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population such as quality and capacity of supply;

Amendment 247 #

Motion for a resolution
Paragraph 5

Amendment 248 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Emma WIESNER

Motion for a resolution
Paragraph 5

5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess ~~new~~additional criteria for national pricing, such as whether a product is ‘~~Made~~Developed in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Amendment 249 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to build on the work of the Europe’s Beating Cancer Plan and ensure that Europe becomes the worldwide centre of excellence for R&D in emerging, innovative fields of medicine; underlines that State-of-the art technologies and treatment classes, such as nanomedicines, stand to provide solutions to current treatment challenges in areas such as cancer and cardiovascular diseases; Highlights that these innovative fields of medicine should be supported by fit-for- purpose regulatory frameworks, such as a centralised approval procedure for nanomedicines;

Amendment 25 #

Motion for a resolution
Citation 12 j (new)

— having regard to Articles 101 and 102 TFEU laying down rules on competition,

Amendment 250 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to implement the World Health Assembly Resolution of May 2019on Improving the transparency of markets for medicines, vaccines, and other health products, by requiring companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data, active pharmaceutical ingredient (API) sources and supply chains, number and status of patents and patent applications; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions;

Amendment 251 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to explore the possibility to establish a European fund, co-financed by the Member States, for negotiating and purchasing the orphan medicines and other new, personalised and experimental medication, as to guarantee equal access for patients from different Member States to effective therapeutics, treatments and prevent individual health care units from excessive and unreasonable costs when treating rare diseases;

Amendment 252 #

Motion for a resolution
Paragraph 5 a (new)

5a. Calls for greater price transparency and invites Member States to continue to share their best-pricing practices on a voluntary basis; Stresses that pricing should remain a national competence, taking account of diversity across the EU.

Amendment 253 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to develop fair pricing model for essential medicines that would reflect the real cost of research and production, limit the expenditure on sales and medical information and would reward medicines with an added therapeutic value, assuring fairness towards patients, industry and health systems;

Amendment 254 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to make all forms of public investment in the R&D process, incentives and rewards subject to concrete commitments (e.g. on pricing, transparency, or availability) to guarantee fair return on public investments;

Amendment 255 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 5 a (new)

5 a. Stresses that affordable medicines can be best guaranteed through public R&D coupled with public production of medicines, and urges Member States to invest accordingly;

Amendment 256 #

Motion for a resolution
Paragraph 5 a (new)

5 a. Calls on the Commission to apply public procurement rules that should not consider price as the sole and main selection criterion;

Amendment 257 #

Motion for a resolution
Paragraph 5 b (new)

5 b. Calls on the Commission and Member States to develop new pricing models for generic medicines aimed at ensuring healthy competition from day one whilst encouraging the continued marketing of mature products still therapeutically valuable;

Amendment 258 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to ~~review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainabl~~work with Member States and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines, and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability based on the fundamental pricing principle of solidarity across Member States and to increase price transparency via a revision of the Transparency Directive in order to include svolu~~tions that also promote competition~~ntary/secret agreements, public procurement and generic medicines;

Amendment 259 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competitionwork with Member States and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines, and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability, based on the fundamental pricing principle of solidarity across Member States, adequately rewarding the value of medicines across EU Member States and supporting the research-based industry as EU strategic, competitive and globally leading sector;

Amendment 26 #

— having regard to the Doha Declaration on the Agreement on Trade- Related Aspects of Intellectual Property Rights and Public Health (WTO/MIN(01/DEC/2) and to the implementation of Paragraph 6 of the Doha Declaration of 1 September 2003(WTO/L/540),

Amendment 260 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to ~~review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to~~work with Member States and relevant Union and Member State agencies to assess the root causes of shortages of pharmaceuticals and medicinal products, within the Union; and propose sustainable solutions that ~~also~~ promote competition and preserves and strengthens the Union's strong basis for innovation;

Amendment 261 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, also via a revision of the Transparency Directive in order to include voluntary/secret agreements, public procurement and generic medicines, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; recalls that all public funding must be made conditional on the full transparency and traceability of investments, on supply obligations on the EU market, to ensure accessibility and affordability of manufactured medicines in the EU and to guarantee fair return of public investments;

Amendment 262 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to periodically evaluate and review the incentive system and its criteria, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote ~~competition;~~ on and off-patent competition and the timely entry to market of generics and biosimilars; stresses the right balance between awarding incentives in medicines development, particularly where there exist no treatment alternatives, and preventing competition distortion and unintended effects on affordability and availability of medicinal products;

Amendment 263 #

Motion for a resolution
Paragraph 6

Amendment 264 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and ~~propose sustainable solutions that also~~to cooperate with relevant stakeholders and Member States to identify the root-causes of the unavailability of medicines and to find systematic, safe and sustainable solutions to address this long-standing issue of medicine shortages for patients while promoteing a competitive industrial market in the European Union;

Amendment 265 #

Motion for a resolution
Paragraph 6

Amendment 266 #

Motion for a resolution
Paragraph 6

Amendment 267 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Emma WIESNER

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; in this regard, calls on the Commission to submit a legislative proposal on transparency of decisions regulating the prices and the reimbursement of medicinal products in EU countries;

Amendment 268 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, ~~increase~~ensuring price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; further calls on the Commission, especially DG Competition, to be alert of anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry;

Amendment 269 #

Motion for a resolution
Paragraph 6

Amendment 27 #

Motion for a resolution
Citation 12 l (new)

— having regard to the 72nd World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products,

Amendment 270 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system so it contributes to innovation and medicine affordability, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition and the timely entry to market of generics and biosimilars;

Amendment 271 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, while taking into account the overall R&D efforts of the pharmaceutical industry and its implicit failure rate, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;

Amendment 272 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 6

6. Calls on the Commission to work with Member States to review the incentive system, increase price transparency when it comes to the costs calculated in the prices, highlight the causes for limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;

Amendment 273 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to review the incentive system, increase price transparency, ~~highlight~~conduct an assessment of the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;

Amendment 274 #

Motion for a resolution
Paragraph 6

Amendment 275 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Stresses the importance of generic, biosimilar and value added medicines for consistently increasing equitable access for patients and making the healthcare systems sustainable in a European Union where access is still uneven; calls urgently on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;

Amendment 276 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 6 a (new)

6 a. Underlines the importance of generic and biosimilar and value added medicines for increasing equitable access for patients and making the Unions healthcare systems sustainable where access is still uneven; Calls on the Commission to ensure healthy competition upon the expiry of intellectual property (IP) exclusivities by removing all barriers to access competitions such as patent linkage, IP evergreening and other misuse and abusive of IP related incentives and practices that unduly delay access to medicines;

Amendment 277 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Underlines that shortages and unavailability of medicines are multi- factorial issues; believes it is necessary to find solutions to address barriers to timely and effective patient access; calls on the Commission to work with Member States, medicine marketing authorisation holders and other relevant actors to identify and address the root-causes of unavailability of medicines while respecting Member States competences;

Amendment 278 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Considers it imperative to ensure broad and fact-based education and information about communicable and non-communicable diseases for adults as well as for children and adolescents, the treating and underlying causes thereof and healthy lifestyles in order to counteract misinformation and promote preventative actions; calls on the Commission to further support prevention measures and invest in research and promotion;

Amendment 279 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Considers that the European Union should encourage pharmaceutical companies to settle or return to European territory through state aids or via the Instrument for Important Projects of Common Interest (PIIEC); points out that incentives should be conditioned on companies' full compliance with the EU environmental and societal standards;

Amendment 28 #

Motion for a resolution
Citation 12 m (new)

— having regard to its resolution of 17 September 2020 on a strategic approach to pharmaceuticals in the environment,

Amendment 280 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Calls on the Commission to introduce measures to increase transparency into the research and development cost of medicinal products and to contribute to the development of a pricing mechanism in consultation with Member States which takes into account the actual cost of development and production;

Amendment 281 #

6 a. Calls on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage, as well as to limit IP evergreening practices that delay access to medicines;

Amendment 282 #

Motion for a resolution
Paragraph 6 a (new)

6 a. Calls on the Commission to evaluate the added value and if appropriate remove the supplementary protection certificate (SPC) mechanism in order to prevent delays in access to generic medicines and improve financial sustainability of healthcare systems;

Amendment 283 #

Motion for a resolution
Paragraph 6 a (new)

6a. Recalls that the administration must be proactive in reaching agreements to improve access to medicines for which public funds have been granted in their conception and development phase.

Amendment 284 #

Motion for a resolution
Paragraph 6 b (new)

6 b. Recalls that transparency on pricing should be enhanced, urges the Commission to take action in this sense particularly with regard to clearer information about list and net prices to be made publicly available, in order to mitigate asymmetry of information and disparities between Member States notably for products under market exclusivity; recalls its position on Directive 89/105/EC and calls on the Commission to revise the directive to ensure price transparency facilitating overall pricing and reimbursement;

Amendment 285 #

Motion for a resolution
Paragraph 6 b (new)

6 b. Insists on the need to ensure equal access to affordable drugs within the EU; promotes collective negotiation of the price of medicines with pharmaceutical industries such as the Beneluxa initiative and the Valetta Declaration; considers that pharmaceutical industries should respect a conditionality on the affordable price of medicines in the framework of publicly funded research;

Amendment 286 #

Motion for a resolution
Paragraph 6 b (new)

6 b. Recommends that political accountability of the European Patent Office (EPO) to the European Parliament be established in the interest of patent applicants, consumers and the public; calls on the Commission to address any abuses of EPO patent granting processes considered anticompetitive in its Pharmaceutical Sector Inquiry Report of 2009;

Amendment 287 #

Motion for a resolution
Paragraph 6 c (new)

6 c. Stresses that commercial withdrawals often have serious consequences in terms of availability of medicines and thus hamper the right of patients to timely and equitable access to high quality treatment; stresses that commercial withdrawals should be further regulated and only take place in exceptional cases, in a situation where substitute and equivalent treatment is already available for patients, duly taking into account health outcomes for patients and calls, before any actual commercial withdrawal begins, for extended early notification obligations to be required to MAHs and distributors to ensure that Member State authorities are able to make adequate plans and address the consequences in the interest of patients;

Amendment 288 #

Motion for a resolution
Paragraph 6 c (new)

6 c. Calls on the Commission to present a revision of Directive 89/105 /EEC on transparency in order to ensure effective controls and full transparency of the procedures used to determine the prices and reimbursement of medicines in the Member States;

Amendment 289 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments, allowing a broader competition and contributeing greatly to the budgetary sustainability of healthcare systems, thus helping to improve access to treatment for patients; calls on the Commission to introduce legislative and non-legislative measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the productionheir timely access to markets across the EU; regrets that generic and biosimilar alternatives are often not available in low and middle income member states where they might be needed most; deplores the litigation cases aimed at delaying generic entry and calls on the Commission to address any misuse of the IPR system to delay entry of generic and biosimilar medicines into the ~~EU and to propose EU protocols for the interchangeability of biosimilar medicines~~market; calls on the Commission to ensure that the end of the innovator’s period of commercial exclusivity is respected in order to make treatments available to patients as swiftly as possible;

Amendment 29 #

Motion for a resolution
Citation 12 n (new)

— having regard to Article 35 of the Charter of Fundamental Rights in the EU and Article 6(1) TEU on right to health protection for European citizens,

Amendment 290 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines andEmphasizes that competition leads to lower prices and greater affordability; calls on the Commission to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to ~~design rules for the industry~~take action that promotes research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, emphasizes that such proposals must respect the individual needs and preferences of patients and their clinicians;

Amendment 291 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 7

7. Stresses that ~~generic and biosimilar medicines are accessible and affordable treatments~~competition after loss of patent and exclusivity leads to price decreases, greater affordability and contributes greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturerharmonise at EU level the interpretation of the so-called Bolar provision with the broader scope of the Bolar exemption in force in the patent laws of most member states; further calls on the Commission to ~~design rules for the industry that~~ promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, in respect of individual patient needs and clinicians’ freedom to prescribe the best treatment choice for each patient;

Amendment 292 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to ~~the budgetary sustainability of healthcare system~~broadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by generating cost savings while maintaining equal quality of care, as well as freeing up resources for the development of new treatments; calls on the Commission to introduce the necessary and appropriate measures to support a greater market presence of these medicines and to harmonise and enlarge at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose ~~EU protocols for the inter~~common European guidelines for the implementation of physician-led switchaing~~eability of biosimilar medicine~~ of biologic medicine, including biosimilar medicines as defined by EMA; underlines that for the purposes of these guidelines, “physician” must signify exclusively medical doctors authorised to prescribe medical products;

Amendment 293 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines ~~are~~offer accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to ~~introduc~~provide measures to support a greater market presence of these medicines ~~and~~, to harmonise a~~t EU~~nd enlarge at European level the interpretation of the so-called “Bolar provision,” concerning possible exemptions ~~from the legal framework for the Unitary Patent system~~on patents regulatory framework for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and ~~the~~ production of generic and biosimilar medicines in ~~the EU~~Europe and to pro~~pose EU protocols for the inter~~mote harmonized European and Member States guidelines for the implementation of physician-led switchaing~~eability of biosimilar medicines~~ of biologic medicines, including biosimilar medicines as defined by the European Medicines Agency;

Amendment 294 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines ~~are~~offer accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to ~~introduc~~provide measures to support a greater market presence of these medicines ~~and~~, to harmonise a~~t EU~~nd enlarge at European level the interpretation of the so-called "Bolar provision," concerning possible exemptions ~~from the legal framework for the Unitary Patent system~~on patent regulatory framework for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and ~~the~~ production of generic and biosimilar medicines in ~~the EU~~Europe and to propomote harmonised E~~U protocols for the inter~~uropean Member State guidelines for the implementation of physician-led switchaing~~eability of biosimilar medicines~~ of biological medicines, including biosimilar medicines as defined by the European Medicines Agency;

Amendment 295 #

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to ~~the budgetary sustainability of healthcare system~~broadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages and by generating cost savings while maintaining equal quality of care, freeing up resources also for the development of new treatments; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines; keeping the patient always informed and at the centre of all decision-making;

Amendment 296 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU ~~and~~, to propose EU protocols for the interchangeability of biosimilar medicines, and to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;

Amendment 297 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce ~~meas~~changes to the legislation and a simplified approval procedures to support a greater market presence of these medicines ~~and~~in specific cases; calls to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; ~~further calls on the Commission to design rules for the industry~~calls for the revision of the Bolar provision to bring legal certainty to the sector and encourage investment in key areas; calls, furthermore, on the Commission and the Member States to design rules that are conducive to thate promoteion of research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 298 #

Motion for a resolution
Paragraph 7

7. Points out that generic and biosimilar medicines enable treatment efficacy and safety,increased competition, reduced prices and savings for healthcare systems, thus helping to improve access to medicines for patients ; Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 299 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines; calls for the removal of barriers to the production and distribution of generic medicines; calls on Member States to increase public production of generic and biosimilar medicines;

Amendment 3 #

Motion for a resolution
Citation 5 a (new)

— having regard to the Commission’s Strategic Agenda for Medical Ionising Applications(SAMIRA) Action Plan of 5 February 2021 in support of the European Beating Cancer Plan;

Amendment 30 #

Motion for a resolution
Recital A

A. whereas the~~alth is fundamental to the well-being of Europeans and~~ Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health, quality of life and medical treatment and public health systems are crucial to guaranteeing equitable access to health care ~~is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health po~~and safe, effective and affordable medicines; whereas patients should be at the centre of all health policies and involved throughout the medicines regulatory pathway; whereas access inequalities exist between and within Member States and special regard should be paid to people in vulnerable situation with specific health risks, including women, children, the elderly, pregnant women, persons with disabilicties, ~~alongside investment and research~~patients with chronic conditions and comorbidities, patients in intensive care units (ICU) and persons on long-term medication;

Amendment 300 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; calls on the Commission to address the misuse of the IPR (intellectual property rights) system to delay market entry of generic and biosimilar medicines; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 301 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 302 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise and widen at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, as defined by the European Medicines Agency;

Amendment 303 #

Motion for a resolution
Paragraph 7

7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU ~~and to propose EU protocols for the interchangeability of biosimilar medicines~~;

Amendment 304 #

Motion for a resolution
Paragraph 7

7. Stresses that timely access to generic and biosimilar medicines ais key to ensure accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 305 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Welcomes the Commission's recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorization applications (so called Bolar provision); calls for an urgent European harmonization and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1; urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;

Amendment 306 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Welcomes the Commission’s recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorisation applications (so called Bolar provision); calls for urgent European harmonisation and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1. Urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;

Amendment 307 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Stresses the need to take gender into account in the research, diagnosis, treatment and impact of medicines and therapeutics as women across the lifespan remain under-represented in biomedical and health research and data; underlines that consequently, the evidence base is weaker for women as well as for older people, leading to many conditions being underdiagnosed with women, such as cardiovascular disease; underlines that to reduce inequalities and health disparities, sex and gender must be balanced and incorporated in research throughout the process from stem cell testing to design of clinical trial protocols, data analysis, health technology assessment and access to care;

Amendment 308 #

Andrey SLABAKOV, Pietro FIOCCHI

Motion for a resolution
Paragraph 7 a (new)

7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the Commission to facilitate arrangements such as gainsharing programmes that allow savings from biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the Commission to launch a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on reinvestment of the freed-up budget;

Amendment 309 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Stresses that cost savings generated from the use of generics and biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to facilitate arrangements such as gainsharing programmes that allow savings from generic and biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the European Commission to launch and actively promote the awareness of a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on reinvestment of the freed-up budget;

Amendment 31 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN

Motion for a resolution
Recital A

A. whereas ensuring patient access to medicines is one of the core objectives of the EU and the WHO, and of Sustainable Development Goal 3; whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination; whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Amendment 310 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the European Commission to facilitate arrangements such as gainsharing programmes;

Amendment 311 #

Simona BALDASSARRE, Silvia SARDONE, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 7 a (new)

7 a. Underlines that biosimilars and generics can be an important component within the pharmaceutical strategy for Europe, however it underlines that there is no identity with the originator, therefore their interchangeability should not be automatic but subject to the evaluation of the physician; pharmacovigilance should be a key tool in the evaluation of biological drugs in terms of efficacy and safety, for which continuous monitoring can provide all the useful elements for decision-making in both clinical and regulatory contexts; highlights the need for an EMA- authorized reference platform for generics and biosimilars;

Amendment 312 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Calls on the Commission to harmonise at EU level the interpretation of the so called Bolar provision and extend its application for exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers in order to facilitate and speed up their entry to market; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Amendment 313 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU trade policy to promote European competitiveness by ensuring sound intellectual property frameworks that protect investment in medical research and allow industry to remain an innovator and world leader, making the EU capable to compete with challenger regions such as the US and China;

Amendment 314 #

Motion for a resolution
Paragraph 7 a (new)

7 a. Considers it important that the Commission addresses the issue of legal parallel trade in order to prevent shortages due to exports caused by high differences in terms of prices of a medicine between Member States and calls on starting to consider the possibility of declaring medicines public goods;

Amendment 315 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO

Motion for a resolution
Paragraph 7 a (new)

7 a. Stresses the need for the Commission to continue preventing anti- competitive practices and agreements by the pharmaceutical industry including pay-for-delay or abuse of dominant position to ensure a competitive market of generic and biosimilar;

Amendment 316 #

Motion for a resolution
Paragraph 7 b (new)

7 b. Highlights that the take-up of new and innovative treatments, as well as their successful delivery to patients, depends on the knowledge, preparedness of and technical base at the disposal of medical personnel; calls on the Commission and on Member States to further cooperate through sharing knowledge and best practices regarding emerging innovative medicines and treatments, to better prepare their medical professionals;

Amendment 317 #

Motion for a resolution
Paragraph 7 b (new)

7 b. Calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU trade policy to promote European competitiveness by ensuring sound intellectual property frameworks that protect investment in medical research and allow industry to remain an innovator and world leader, making the EU capable to compete with challenger regions such as the US and China;

Amendment 318 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 7 b (new)

7 b. Stresses the importance of improving education on biosimilars; calls on the European Commission to promote relevant educational and communication activities amongst healthcare professionals by setting up a dedicated Europe-wide online resource centre;

Amendment 319 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Inese VAIDERE, Roberta METSOLA

Motion for a resolution
Paragraph 7 b (new)

7 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;

Amendment 32 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas ~~saf~~the pandemic has demonstrated the weakness of European health care systems; whereas safe, innovative, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Amendment 320 #

Motion for a resolution
Paragraph 8

~~8. Welcom~~Notes the fact that the 8. Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; ~~further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce~~stresses the need for Member States to work towards making centrally authorised medicines a~~pproval times at national level and align them with~~vailable to patients at the time of European Medicines Agency (EMA) ~~times~~’s approval, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 321 #

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; ~~further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medic~~calls on the Commission to tackle the problem of diverging market launches of medicines by linking the centralised marketing authorisation to a commitment on the part of pharmaceutical companies, i.e., once authorised, medicinal products have to be launched ine a~~pproval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU~~ll EU countries in a timely manner and pharmaceutical companies should not be allowed to subsequently withdraw these products from particular markets for commercial reasons;

Amendment 322 #

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EUwelcomes and supports Commission action against abuses of dominant positions in the pharmaceutical sector;

Amendment 323 #

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market~~; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the nee~~ and also recalls the importance of addressing the issue of disparities in the availability of certain medicines due to discontinuation of products or withdrawals from less profitable markets of some Member States, where patients do not have access to treatments due to commercial decisions made by pharmaceutical companies and MAHs; calls on the Commission and Member States to implement the necessary measures in order to make centrally authorised medicines timely available to patients without any further delay and calls on the Commission to tackle the problem of diverging market launches by linking the centralised marketing authorization to commitments on the part of pharmaceutical companies to not delay the availability of the product in any Member State; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition and calls on the Commission to further develop capabilities to investigate potential anti-competitive practices; stresses the need address the reasons why the medicine approval time is so heterogeneous across the EU and to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, ~~in order to ensure~~when considered safe and beneficial for patients, in order to remove any obstacle to a rapid and equalitable access to medicines for ~~everyone in the EU;~~ all in the EU; emphasises that any revision of the regulatory procedures and approaches to the assessment of scientific evidence must be cautiously undertaken in order to adequately take patient benefit and safety aspects into consideration;

Amendment 324 #

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; calls on the Commission to look at the huge differences across EU of the average number of days between approval of a medicine and the moment it is available to the patients and to propose new ways to speed up the regulatory process;further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 325 #

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to ~~reduce~~devote more resources at European level to combat unfair and abusive market practices with regard to medicines; stresses the need to reduce and speed up medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 326 #

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; stresses the need of a complementary study looking into multi-factorial causes of access delays and inequality; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 327 #

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need ~~to reduce~~for Member States to work towards making centrally authorised medicines a~~pproval times at national level and align them wi~~vailable to patients as close to the European Medicines Agency (EMA) ~~times~~approval times as possible, in order to ensure rapid and equal access to medicines for everyone in the EU and avoid discrimination between EU citizens;

Amendment 328 #

Motion for a resolution
Paragraph 8

8. WStrongly welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; Calls on the Commission to implement innovative solutions to reduce medicine shortage; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 329 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines, diagnostic services and prevention measures for everyone in the EU;

Amendment 33 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU Member States’ national health policies; whereas safe, effective and affordable medicines are needed to combat all diseases; whereas p~~atients~~ublic interest and patient safety and well-being should be at the centre of all health policies, alongside investment and research;

Amendment 330 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Stelios KYMPOUROPOULOS, Cindy FRANSSEN

Motion for a resolution
Paragraph 8

8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times, setting a time limit for approval at national level, and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Amendment 331 #

Motion for a resolution
Paragraph 8 a (new)

8 a. Notes that only around 5% of shortages and non-availabilities are EU- wide, and that therefore issues such as non-launch and commercial withdrawals could be addressed via better use of the Internal Market and cross-border tools; Calls on the Commission to include this aspect in an upcoming revision of Directive 2001/83;

Amendment 332 #

Motion for a resolution
Paragraph 8 a (new)

8 a. Calls on the Commission to start an inquiry into the effects of parallel trade on medicine scarcity and market penetration of novel treatments into Member States with less developed economies;

Amendment 333 #

Motion for a resolution
Paragraph 9

~~9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines;~~deleted

Amendment 334 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 9

9. Highlights the ~~benefits~~role of public- private partnership ~~tenders for national health system~~s in funding research into and the production of innovative medicines; stresses that such collaboration must guarantee that research priorities are driven by patient and public health needs and public funds are invested in a transparent manner, ensuring availability and affordability of products resulting from these partnerships and other public funds; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Amendment 335 #

Motion for a resolution
Paragraph 9

9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; stresses that public-private partnership dialogues and academia-pharma cooperation are essential for the exchange of knowledge and information for the benefit of all patients across the Union;

Amendment 336 #

Motion for a resolution
Paragraph 9

9. Highlights the ~~benefits~~role of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; recalls that any PPPs must produce results in the interest of patients, maximise public return on public investment and respect the principles of transparency, traceability and affordability;

Amendment 337 #

Motion for a resolution
Paragraph 9

9. Highlights the ~~benefits of~~problems related to public- private partnership ~~tender~~s for national health systems in funding research into and the production of innovative medicines, such as concentration of research and development in profitable medicinal areas; underscores how this model has contributed to the neglect of rare diseases in particular;

Amendment 338 #

Motion for a resolution
Paragraph 9

9. Highlights the ~~benefits~~role of public- private partnership ~~tenders for national health system~~s in funding research into and the production of innovative medicines; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment;

Amendment 339 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Inese VAIDERE

Motion for a resolution
Paragraph 9

9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines, only if driven by public interest considerations;

Amendment 34 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research; whereas patients should be involved in every aspect of the medicine regulatory lifecycle;

Amendment 340 #

Motion for a resolution
Paragraph 9

9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines and medicines repurposing;

Amendment 341 #

Motion for a resolution
Paragraph 9

9. Highlights the benefits of public- private partnership tenders for national health systems in order to fund~~ing~~ research ~~into and the~~and production of innovative medicines and medicine repurposing;

Amendment 342 #

Motion for a resolution
Paragraph 9 a (new)

9 a. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing of intellectual property and know-how to scale-up the production and availability of COVID-19 products; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Amendment 343 #

Motion for a resolution
Paragraph 9 a (new)

9 a. Welcomes the Commission’s intention to adopt a legislative proposal to establish a Health Emergency Preparedness and Response Authority (HERA); considers that the Authority should identify health threats, initiate and support the development of innovation, establish at European level a list of medicinal products of major therapeutic interest, facilitate their production within the EU, promote the joint purchase and build up strategic stocks of those medicines;

Amendment 344 #

Motion for a resolution
Paragraph 9 a (new)

9 a. Calls on the Commission to draw conclusions from the experience of joint negotiations gained during the pandemic and to promote joint procurement of medicine; points out that a stronger position of different Member States speaking with one voice should be used in joint negotiation with industry to attain high transparency standards, equal and sustainable medicine procurement;

Amendment 345 #

Motion for a resolution
Paragraph 9 a (new)

9a. Underlines the need for new funding lines to support the work of new start-ups and SMEs in the field of medical biotechnology, while respecting criteria relating to safety and ethics.

Amendment 346 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to swiftly propose guidelines for the Member States, notably on how to best implement the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards; notes that procurement procedures with only one successful tenderer and/or only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to consider introducing procurement procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers;

Amendment 347 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States~~, especially for emergency medicines and unmet therapeutic needs~~; stresses that EU joint procurement should be used only in exceptional circumstances and for extraordinary public cross-border health threats, such as the COVID-19 pandemic, if purchase of products cannot be ensured as efficiently by other means, to ensure patient access to emergency medicines; highlights that joint public procurement should have a clearly defined scope and be limited in time, and should not hinder patient access, medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, and should not jeopardise product choice, or create market distortion or any concentration of demand;

Amendment 348 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for,but not limited to, emergency medicines and unmet therapeutic needs; calls for exploration of such practices in areas of high priced medicines, including for rare diseases and cancer with a clear outline of milestones, objectives and commitments undertaken by all parties involved; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 products;

Amendment 349 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for ~~emergency medicines and unmet therapeutic needs~~medicines during health crises, as well as unmet therapeutic needs, while taking into account the need for a better balance between public and private interests, including clear rules on liability for manufacturers, as well as the need for sufficient flexibility for Member States, as well as respect for the principle of subsidiarity, due to national specificities or divergent financial capacities across the EU;

Amendment 35 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research, and in every aspect of the medicine regulatory lifecycle;

Amendment 350 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN

Motion for a resolution
Paragraph 10

10. ~~Stresses the importance of new~~Highlights the potential of joint EU public procurement contracts by the Commission and the Member States~~, especially for emergency medicines and unmet therapeutic needs;~~; considers that the EU joint procurement has potential as a tool for extraordinary cross-border health threats; suggests that joint public procurement be clearly defined in scope, time, continues to be used on the mandate of Member States on a case-by-case basis and it should not create barriers for patient access, medical innovation or fair competition

Amendment 351 #

Simona BALDASSARRE, Silvia SARDONE, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States~~, especially for~~; stresses that joint EU procurement should be implemented only in exceptional circumstances and for extraordinary cross-border public health threats, such as the COVID-19 pandemic, if the purchase of products cannot be secured as efficiently by other means, to ensure patient’s access to emergency medicines and unmet therapeutic needs;

Amendment 352 #

Motion for a resolution
Paragraph 10

10. ~~Stress~~Notes the ~~importanc~~value of new joint EU public procurement contracts by the Commission and the Member States~~, especially~~ for emergency medicines and unmet therapeutic needs; stresses that such joint procurement initiatives should be undertaken only under exceptional circumstances and in situations where such action has a clear and demonstrable added value, such as serious cross-border health threats;

Amendment 353 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially ~~for~~, but not limited to, emergency medicines and unmet therapeutic needs; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 vaccines;

Amendment 354 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines ~~and unmet therapeutic needs~~such as extraordinary health threats like the COVID-19 pandemic; stresses that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU;

Amendment 355 #

Motion for a resolution
Paragraph 10

10. Stresses the ~~importance of new~~need for joint EU public procurement contracts by the Commission and the Member States, especially for, but not limited to, emergency medicines and unmet therapeutic needs; underlines the need to ensure high levels of transparency in these initiatives and apply lessons learned from joint procurement of COVID-19 vaccines;

Amendment 356 #

Motion for a resolution
Paragraph 10

10. ~~Stre~~Calls on the Commission to assess the imp~~ortance~~act of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; stresses that joint public procurement should not hinder patient access, medical innovation or competition;

Amendment 357 #

Motion for a resolution
Paragraph 10

10. Str~~esses the importance of new~~ongly supports the use of joint EU public procurement ~~contract~~procedures by the Commission and the Member States, especially for ~~emergency medicines and unmet therapeutic needs~~medicinal products of major therapeutic interest, emergency medicines and unmet therapeutic needs to improve their affordability and their access at EU level;

Amendment 358 #

Motion for a resolution
Paragraph 10

Amendment 359 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for, but not limited to, emergency medicines and unmet therapeutic needs;

Amendment 36 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable and innovative medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Amendment 360 #

Motion for a resolution
Paragraph 10

10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines, orphan medicines and unmet therapeutic needs;

Amendment 361 #

10 a. Calls on the Commission to make an assessment of the ICU joint procurement initiative and take the lesson learned to improve this tool by limiting it to serious cross-border threats to health; considers that it should not impact pre- existing contractual agreements with suppliers of medical countermeasures and should be carried out in accordance with the Directive 2014/24/EU in a transparent manner, while respecting the following conditions: the procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; a preliminary consultation phase involving potential participating manufacturers must take place; clear volume commitments irrespective of the selected supply modality must be ensured;

Amendment 362 #

Motion for a resolution
Paragraph 10 a (new)

10a. Emphasises that joint European procurement procedures can make it possible to counter shortages, especially in times of health crises, as was the case with the procedure launched following the onset of the COVID-19 epidemic, with simplified and transparent procedures in the interests of improved response times; calls, in particular, for the establishment of EU joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States;

Amendment 363 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 10 a (new)

10 a. Calls on the European Commission and Member States to strengthen European cooperation in pricing and negotiations, by exploring the feasibility of establishing a European Table of Negotiations, supported by joint procurement initiatives, specifically for rare and complex diseases, together with a functioning cooperation on Health Technology Assessment (HTA);

Amendment 364 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Believes it will be beneficial to have a common definition of unmet medical needs as the concept is a key criterion for medical prioritisation as well as a qualifier for adaptive and accelerated authorisation processes; therefore calls on the Commission to initiate talks to establish transparent criteria on how to define unmet needs;

Amendment 365 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Amendment 366 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Calls on the Commission and Member States to promote the creation of one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare;

Amendment 367 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Recognises the low healthcare budget allocations to immunisation programmes, including immunisation implementation and monitoring, across Member States, compared to the far- reaching health and economic benefits that vaccinations provide;

Amendment 368 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Considers that, in times of crisis, part of the Union joint procurement should, in the spirit of solidarity, be pre- allocated to low- and middle-income countries, in particular African countries.

Amendment 369 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Highlights the need to set a minimum level of public procurement produced within Europe for medical devices , personal protective equipment, medicines and such to be set at least 30%;

Amendment 37 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of ~~Europeans~~all and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, a~~longside~~nd investment and research should be patient-centred;

Amendment 370 #

Motion for a resolution
Paragraph 10 a (new)

10 a. Stresses the importance of securing joint medicine stocks to prevent the recurrence of essential medicine scarcity across Member States;

Amendment 371 #

Motion for a resolution
Paragraph 10 b (new)

10 b. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Amendment 372 #

Motion for a resolution
Paragraph 10 b (new)

10 b. Recognises that an increased pressure on vaccine pricing could discourage investment in the development of innovative technologies and production capacity in EU; stresses that vaccine prices should be reflective of the comprehensive value of vaccination to the European citizens;

Amendment 373 #

Motion for a resolution
Paragraph 10 b (new)

10 b. Recognises the low healthcare budget allocations to immunisation programmes, including immunisation implementation and monitoring, across Member States, compared to the far- reaching health and economic benefits that vaccinations provide;

Amendment 374 #

Motion for a resolution
Paragraph 10 c (new)

10 c. Recalls that the primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross- border health crisis only, ensuring equitable access for patients and increased visibility and predictability for the actors involved; believes that for multi-source markets, joint procurement is not the right solution to achieve its objective; however, if it is used, it shall be in the context of cross border threats to health only and shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure that all parties involved, both relevant authorities and manufacturers, can fulfil their contractual responsibilities,

Amendment 375 #

Motion for a resolution
Paragraph 10 c (new)

10 c. Stresses the importance of the World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products; calls on the Commission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions.

Amendment 376 #

Motion for a resolution
Paragraph 10 d (new)

10 d. Highlights the need to ensure that the revision of the general pharmaceutical legislation contributes to the strengthening of evidentiary requirements on medicine safety and efficacy; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment; stresses the importance of this type of evidence in health technology assessments and for clinical decisions on treatment;

Amendment 377 #

Motion for a resolution
Paragraph 10 e (new)

10 e. Calls on the Commission to ensure adequate consultation with consumer and patient representatives throughout the implementation of the Pharmaceutical Strategy;

Amendment 378 #

Motion for a resolution
Paragraph 11

11. Is concerned that ~~the~~accessibility and affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive or not even launched in certain Member States for commercial reasons; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust and fair competition and to ~~stabilise and balance national drug pricing systems;~~ promote fair national drug pricing systems; stresses the need to link any form of incentive to affordability clauses in order to ensure equal and fair pricing of pharmaceuticals, particularly innovative ones; calls for an increased transparency on research costs incurred for pharmaceutical development to better adjust the pricing mechanism to the actual costs; calls on the Commission and Member States in this regard to establish a framework for reporting research cost as regards pharmaceutical development;

Amendment 379 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; draws attention to the fact that national pricing policies in some Member States use different price levels to reduce expenditure on national health budgets by encouraging the links in the supply chain to buy medicines intended for patients in other Member States, thereby causing the secondary unavailability of those medicines for the patients for whom they were originally intended;

Amendment 38 #

Motion for a resolution
Recital A

A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat allnd prevent diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Amendment 380 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that ~~innovative medicines are expensive~~the ability to pay remains very different across EU Member States ; believes that the solution to this challenge lies in a transition towards an outcomes-based approach which recognizes the value of medicines to patients and the economic benefits brought to healthcare systems and society; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and ~~to stabilise and balance national drug pricing system~~improve access for patients across Member States;

Amendment 381 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a systemic challenge for national health systems, a key access barrier for patients and that innovative medicines are expensive; w~~elcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pr~~ith often uncertain added clinical benefit; stresses the need for solid evidence, based on well- designed comparative randomised clinical trials to meet health needs with meaningful endpoints and to evaluate medicine; stresses that the regulatory framework must facilitate the best possible outcomes for patients and public in~~g systems~~terest;

Amendment 382 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, ~~and~~ that innovative medicines are expensive, and that the ability to pay remains very divergent across EU Member States, leading to unequal access to medicines for EU citizens; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition ~~and~~, to stabilise and balance national drug pricing systems, and to ensure more equitable access for patients across Member States;

Amendment 383 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that equitable access to innovative medicines ~~are expensive~~is a challenge across Member States; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition ~~and to stabilise and balance national drug pricing system~~; highlights that decisions on the pricing and reimbursement of medicines are the purview of Member States;

Amendment 384 #

Motion for a resolution
Paragraph 11

Amendment 385 #

Motion for a resolution
Paragraph 11

Amendment 386 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomes the Commission’'s intention to review pharmaceutical legislation to promote robust and timely competition ands a key enabler for resilience and efficiency, as well as to stabilisze and balance the national drugs pricing systems;

Amendment 387 #

Motion for a resolution
Paragraph 11

Amendment 388 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; ~~welcomes~~takes note of the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;

Amendment 389 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Emma WIESNER

Motion for a resolution
Paragraph 11

Amendment 39 #

Motion for a resolution
Recital A

A. whereas health ~~is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU~~and equitable access to healthcare are fundamental to the well-being of Europeans; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Amendment 390 #

Motion for a resolution
Paragraph 11

11. Is concerned that the affordability of medicines remains a challenge for patients and national health systems, and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;

Amendment 391 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Calls the Commission to consider new processes for promoting the repurposing of medicinal products given that, as new research into certain medicinal products has proved, for example for anti-inflammatory and immunosuppressant Rheumatic and Musculoskeletal Disease (RMD), they can be adopted quickly to provide more effective and lower cost treatments for many burdensome inflammation-linked diseases including COVID-19, cancer, cardiovascular disease and diabetes; calls on the Commission to analyse the existing situation concerning off-label use of medicines, including less expensive medicines and medicines used for rare cancers among others, and underlines the need to address this issue in order to facilitate the use of those medicines when beneficial for the patient;

Amendment 392 #

Motion for a resolution
Paragraph 11 a (new)

11a. Calls on the Commission to develop European health strategies on the basis of a common basket of medicines for the treatment of cancer, infections, rare diseases and other areas particularly affected by shortages; calls on the Commission to consider the option of harmonised pricing criteria to make such medicines affordable;

Amendment 393 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Points out that medicines are often pulled form markets due to company low commercial interest in them; Calls on the Commission to look into policy options that help secure that centrally authorized medicines are marketed in all EU Member States and not just in those that are commercially interesting;

Amendment 394 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Calls on the Commission to support and promote wide implementation of novel pricing and payment models to improve patient access to innovative medicines, by facilitating best-practice sharing between Member States, ensuring an appropriate data infrastructure, and addressing legal barriers;

Amendment 395 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 11 a (new)

Amendment 396 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Believes that facilitating faster access would be especially beneficial for patients with severe chronical diseases; suggests accordingly to allow patients to take part in the decisions on risk-benefit from early access to new and innovative medicines and treatment;

Amendment 397 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN

Motion for a resolution
Paragraph 11 a (new)

11 a. Considers that unjustified import and export restrictions and/or bans exacerbate shortages and reduce competition in the Internal Market decreasing affordability; calls on the Commission to tackle such unjustified restrictions and/or bans;

Amendment 398 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Calls on the Commission to create a High-Level Forum on Better Access to Medicines to identify multi-stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;

Amendment 399 #

Motion for a resolution
Paragraph 11 a (new)

11 a. Calls on the Commission to start a dialogue to exchange on better access to health innovation and technologies and to reduce delays and mitigate the impact of shortage of medicines within the Union;

Amendment 4 #

Motion for a resolution
Citation 5 a (new)

— having regard to the Commission communication of 10 March 2020 entitled ‘A New Industrial Strategy for Europe’ COM (2020) 102 final

Amendment 40 #

Motion for a resolution
Recital A a (new)

A a. whereas the Treaties and the Charter of Fundamental Rights of the European Union state that everyone shall have access to preventive healthcare and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the economically disadvantaged or smaller Member States and in the most peripheral areas of the Union; whereas shortage of medicines is a growing public health threat with a serious impact on healthcare systems and the right of every patient in the EU to access appropriate medical treatment;

Amendment 400 #

Motion for a resolution
Paragraph 11 b (new)

11 b. Welcomes the creation of the new EU agency HERA and underlines its key role to address the needs of patients when health emergencies occur, thus filling gaps in foresight, stockpiling essential medicines and medical devices, and coordinating the EU's Response to cross- border health threats;

Amendment 401 #

Motion for a resolution
Paragraph 11 b (new)

11 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Amendment 402 #

Motion for a resolution
Paragraph 11 b (new)

11b. Calls on the Commission consider creating a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages;

Amendment 403 #

Motion for a resolution
Paragraph 11 b (new)

11 b. Calls on the Commission to create a High-Level Forum on Better Access to Health Innovation to identify multi- stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;

Amendment 404 #

Motion for a resolution
Paragraph 11 b (new)

Amendment 405 #

Motion for a resolution
Paragraph 11 c (new)

11 c. Points out that new health technologies should demonstrate their clinical added-value and cost- effectiveness compared to what is already available on the market; emphasizes that health technology assessment is a tool to support this analysis and inform national pricing and reimbursement decisions and that currently such assessment is highly fragmented within the Union, although it can enable cooperation on clinical evidence requirements and clinical trial design and therefore support Member States’ timely and evidence-based decision making on patient access to new medicines; once again stresses the need for more cooperation on HTA on Union level;

Amendment 406 #

Motion for a resolution
Paragraph 11 c (new)

11 c. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Amendment 407 #

Motion for a resolution
Paragraph 11 d (new)

11 d. Encourages the inclusion of disease-based communities in the European Medicines Agency’s Scientific Advice processes, for rare cancers and diseases, to provide regulators with their expertise of the disease and factor in its rarity and unmet needs;

Amendment 408 #

Motion for a resolution
Subheading 2

Supporting a transparent competitive and innovative EU pharmaceutical industry to respond to public health needs

Amendment 409 #

Motion for a resolution
Subheading 2

Supporting a ~~competitive and innovative~~n EU pharmaceutical industry that meets peoples' needs

Amendment 41 #

Motion for a resolution
Recital A a (new)

A a. whereas the increasing burden of chronic diseases and health needs of aging populations combined with high and rising prices of medicinal products and an increase in the societal cost of providing care cause budgetary and affordability constraints and serious threats to the sustainability of European health systems; whereas the adoption of integrated models of care for chronic and other long term conditions, underpinned by a person-centred and multi- disciplinary approach to health care is essential to deliver high quality health services;

Amendment 410 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 11 c (new)

11c. Urges the Commission and the Member States to introduce financial incentives, in line with State aid rules, to preserve and expand the EU’s pharmaceutical industrial base, from the production of active pharmaceutical ingredients to medicine manufacturing, packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies in order to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of entire production lines; recalls that all public funding must be made conditional on the transparency and traceability of investments, on supply obligations on the European market, and on facilitating the best outcome for patients, including in terms of accessibility of manufactured medicines;

Amendment 411 #

Motion for a resolution
Paragraph 12

12. ~~Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’~~Welcomes the Commission's objective of improving the innovation capacity and competitiveness in the pharmaceutical industry; insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs and that it is in the interest of patients that the industry is in the strongest possible position to meet their diagnostic and therapeutic needs; points out that the industry needs a stable, flexible and agile regulatory environment; ~~believes that it can~~ underlines that the marketing authori~~ve globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space~~sation system should build on the existing legislative framework and prevent duplication and additional administrative burdens, believes that it can thrive globally with a clear, robust and efficient intellectual property system;

Amendment 412 #

Motion for a resolution
Paragraph 12

12. Insists that ~~a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexi~~public responsibilities fall upon the EU pharmaceutical industry and that its competitiveness is strategic for functioning and effective healthcare systems in the EU and for public authorities to be more responsive to patients’ needs and protect public health; points out a predictable and agile regulatory environment~~; believ~~ is beneficial to address th~~at it c~~e needs of patients and t~~hrive globally with a clear, robust and efficient intellectual property system~~o create a better environment for innovation and drugs development; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; underlines that a harmonised interpretation of the General Data Protection Regulation (GDPR) in all EU Member States is the foundation for such initiatives;

Amendment 413 #

Motion for a resolution
Paragraph 12

12. Insists that a focus on competitiveness for the EU pharmaceutical industry is ~~strategic and more responsive to~~contrary to meeting patients’ needs; points out that the industry needs ~~a stable, flexible and agile regulatory environ~~to be regulated to ensure patients' needs are ment; believes that ~~it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Spac~~the industry can provide an essential public good by providing medicines to people in need rather than profits to patent-holders; recalls the contribution to global public health from the act of avoiding the intellectual properly system, such as with the development of the highly-successful polio vaccine;

Amendment 414 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable~~, flexible and agi~~ and predictable regulatory environment; bwel~~iev~~comes th~~at it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative~~e initiative to support real world evidence generation and to build interoperable digital infrastructure ~~for~~within the European Health Data Space, while ensuring privacy and security of health data;

Amendment 415 #

Andrey SLABAKOV, Pietro FIOCCHI

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that ~~it can thrive globally with a clear, robust and efficient intellectual property system~~the current intellectual property system should be reviewed in order to ensure that it incentives innovation, while ensuring a universal and equitable access to medicinal products, especially in emergency situations; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 416 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment, which at the same time sustains a robust and responsible framework of requirements, safeguarding the principle of prevention and the availably of safe, effective and quality medicines on the EU market; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 417 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ, Claudia GAMON

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment and that should build on the existing framework and prevent duplication and additional bureaucratic burdens; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space to leverage the full potential of real-world-date and access to rare therapies;

Amendment 418 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; calls on the Commission to develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe;

Amendment 419 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; calls on the Commission to establish a unified supplementary protection certificate (SPCs) for the internal market, following the excellent results achieved on national basis; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 42 #

Motion for a resolution
Recital A a (new)

A a. A. whereas over time, trust in the pharmaceutical sector and its ability to promote the development of medical innovations while ensuring sustainable access has been eroded, and confidence in how this system works needs to be restored;

Amendment 420 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can only thrive globally with a clear, robust and efficient intellectual property system and that the framework for intellectual property must therefore be protected and preserved; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 421 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU research-based pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it ~~can~~the European research-based pharmaceutical industry can only thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 422 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space, which will integrate data from real-world evidence;

Amendment 423 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive, self- sufficient and sustainable EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build the European Health Data Space and interoperable digital infrastructur~~e for the European Health Data Spac~~e;

Amendment 424 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry is strategic, fosters innovation and is more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 425 #

Motion for a resolution
Paragraph 12

12. Insists that a competitive EU pharmaceutical industry based on research is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Amendment 426 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Notes that patent protection is a key incentive for companies to invest in innovation and produce new medicines; notes, at the same time, that the exclusionary effect of patents may lead to limited market supply and reduced access to medicines as well as pharmaceutical products; stresses that a balance should be struck between encouraging innovation through the exclusionary effect of patents and ensuring access to medicines and protecting public health; recalls that a company that markets a medicine can enjoy data exclusivity for a period of eight years as of the first marketing authorisation pursuant to Article 14(11) of Regulation (EC) No 726/2004; calls on the Commission to propose a revision of that regulation to provide for the possibility to temporarily authorise the granting of compulsory licenses in the event of a health crisis in order to allow the production of generic versions of life-saving medicines; recalls that this is one of the public health flexibilities in the field of patent protection already included in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as further reaffirmed by the 2001 Doha Declaration; calls on the Commission to ensure that the implementation of the EU free trade agreements (FTAs) does not interfere with the possibilities of invoking flexibilities provided by the TRIPS Agreement and to provide guidance to Member States in order to encourage voluntary licencing over immediate compulsory licencing;

Amendment 427 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimize and modernize the existing regulatory framework, such as the revision of the variations legislation, more digitalised and efficient regulatory processes, the implementation of the Electronic product information (ePI), streamlining API assessment, and better GMP/ Manufacturing management and resources; urges the Commission to advance fast on this agenda making the best use of existing digital tools at EU level (telematics) and enhancing regulatory cost efficiency and fit-for- purpose regulatory measures and processes, supporting this way both security of supply, tackling medicines shortage, as well as manufacturing resilience in Europe;

Amendment 428 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 12 a (new)

12 a. Recalls that priority should be given to the continuous optimisation of regulatory processes while maintaining high scientific standards, in order to keep up with scientific and technological progress, ensure fit-for-purpose requirements, enable simplified administrative tasks associated with maintaining medicinal products on the market by amending the existing Variations Regulation, ensure continuous access to information for patients and healthcare professionals, and simplified flow of medicines from one Member State to another in case of a shortage. Encourages the Commission to make the best use of information technology for regulatory processes, including digital and telematics tools, in order to improve regulatory efficiency;

Amendment 429 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; highlights the need to promote both primary and secondary use of aggregated health data and the need in this regard for a clearer definition of secondary data use vs. primary data collection; believes that awareness on fragmentation regarding the implementation of GDPR should be raised; further believes that it is of outmost importance to enable and promote trust and data innovation in digital health, which will be possible through education and capability building for regulators, industry and patients;

Amendment 43 #

Motion for a resolution
Recital A a (new)

A a. whereas a competitive and innovative pharmaceutical industry is of vital importance for the Union's public health, economic growth, science base and ability to create jobs and drive technological progress;

Amendment 430 #

Motion for a resolution
Paragraph 12 a (new)

12a. Expresses concern that certain groups at particular risk of social exclusion and particularly affected by the COVID-19 pandemic have difficulty in accessing treatment and other services aimed at eradicating infectious diseases such as HIV/AIDS, hepatitis C and B and tuberculosis; calls on the Commission and the ECDC, working to a single timetable with an agreed set of guidelines/ good practices, to invite Member States to draw up integrated action plans to improve access, focusing on cooperation between state and non-state actors in reaching out to those concerned;

Amendment 431 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Notes that there is significant public demand for the adoption and implementation of a new legislative framework to eliminate animal testing; calls on the Commission to stimulate research for the development of alternative non-animal testing methods applicable to pharmaceuticals; notes that the EU should intensify its international cooperation on alternative testing methods under EPAA, ICRR and ICATM; stresses that the objective of these efforts must be a complete phase-out of animal testing in the EU;

Amendment 432 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting amore expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA); believes that the final decision-making should occur within maximum 7 days of the final scientific opinion;

Amendment 433 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Asks the Commission to assess the need for a supportive legislative framework which goes beyond the scope of the GDPR when it comes to the uses of real-world data or artificial intelligence in medicines development; underlines in this regards that all information systems where health data is generated, used or stored must be designed to meet the highest quality and safety standards;

Amendment 434 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls on the Commission to expand the role of EMA in the assessment of drug-device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise-driven scientific assessment on marketing authorisations within the European Medicines Agency(EMA);

Amendment 435 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA);

Amendment 436 #

Motion for a resolution
Paragraph 12 a (new)

12a. Stresses that EU legislation frequently acts as a bottleneck, stifling many of the innovations that SMEs are seeking to market; calls on the EU to review its pharmaceutical policies and become a hub for global medical innovation;

Amendment 437 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Stresses that Intellectual Property Rights incentivise research, development and innovation and ensure that European patients receive the latest and best scientific advances to address unmet medical needs; acknowledges, that market exclusivity for orphan drugs is a specific incentive for the development of new drugs for rare diseases;

Amendment 438 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls for relocation back to the European Union of some of the plants producing active ingredients and medicinal end products of strategic importance for health care, given that breaks in supply put at immediate risk patients with serious conditions who are more often unable to obtain recommended alternative treatments;

Amendment 439 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Recalls the importance of close collaboration between the Commission and Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Amendment 44 #

Motion for a resolution
Recital A a (new)

A a. whereas the right to health is a fundamental right enshrined in article 35 of the Charter of Fundamental Rights of the European Union;

Amendment 440 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 12 a (new)

12 a. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 441 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Underlines the key role of medical gases, such as oxygen, in treating patients; calls on the Commission to simplify the procedures for production and distribution of medical gases as part of the revision of Directive 2001/83/EC1c; _________________ 1c OJ L 311, 28.11.2001, p. 67–128

Amendment 442 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls on the Commission to include in the EU Statistics on Income and Living Conditions (EU-SILC) data on self-reported lack of access to medicines, as so far access to medicines in not measured in the EU-SILC;

Amendment 443 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Encourages European federated data networks to improve research, development and healthcare delivery; highlights the importance of defining more clearly Secondary data use vs. Primary data collection;

Amendment 444 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Supports the conclusion of industrial agreements between actors of the EU pharmaceutical industry to ensure a stronger EU production of medicines and improve the constant access to affordable medicines;

Amendment 445 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Stresses that the intellectual property framework acts as an essential driver of investments in research and development, which is key to innovation to the benefit of patients and society as a whole;

Amendment 446 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ, Claudia GAMON

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls on the Commission and the Member States to ensure full and harmonised application of the General Data Protection Regulation in regards to conducting clinical research across the EU;

Amendment 447 #

Motion for a resolution
Paragraph 12 a (new)

12 a. Calls for the Commission and Member States to use real-world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials;

Amendment 448 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Recalls that Regulation (EC) No 816/2006 harmonises the procedure for granting compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products; Calls on the Commission to update and harmonise the rules on granting compulsory licensing of medicinal products and to introduce waivers for data and market exclusivity to allow effective compulsory licensing as an important public health safeguard for EU Member States allowing them to respond faster and more effectively to future European public health crises;

Amendment 449 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Welcomes the fact that the strategy recognises that the better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;

Amendment 45 #

Motion for a resolution
Recital B

B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European integration is necessary; whereas a European Health Union, which contributes to an increasingly social Union, is key in this processdevelopment, production and delivery of accessible, affordable, and available medicines can be supported by applying a predictable EU policy framework that fosters public and private investments benefitting both patients and society as a whole;

Amendment 450 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Underlines that in times of crisis, other mechanisms should be used to enable a global response and crises mitigation, including a Union export control mechanism, enhanced cooperation agreements on the production of medical countermeasures, pre- allocating part of the Union joint procurement, and both voluntary and compulsory technology know-how pools and licensing agreements between companies, which should guarantee access to counter-measures to low- and middle-income countries, in particular the African countries;

Amendment 451 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 12 b (new)

12 b. Calls for the continuous optimisation and digitalisation of regulatory processes in order to keep up with scientific and technological progress, while maintaining high scientific standards; calls to ensure fit-for-purpose requirements and continuous access to information for patients and healthcare professionals; stresses that the Commission and the Member States should make the best use of information technology for regulatory processes, including digital and telematics tools;

Amendment 452 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust, while adhering to the high EU standards for personal data protection; reiterates that with all AI-based technologies, human oversight must at all times be guaranteed;

Amendment 453 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Calls on the Commission and relevant authorities to provide regulatory flexibility to mitigate medicines shortages when they occur, by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high-quality and safe medicines faster;

Amendment 454 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Invites the Commission to initiate the creation of a “European Fund” to support the generation of additional real- world evidence data in the years following marketing authorisation for selected, innovative and transformative medicines for complex and low prevalence diseases, with true cross-border value;

Amendment 455 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Calls for the prudent implementation of the General Data Protection Regulation (GDPR) with regard to data minimisation, purpose limitation, the secondary use of data as well as on data transfer to third countries to avoid unnecessary restriction for health research and cross-border data sharing;

Amendment 456 #

Motion for a resolution
Paragraph 12 b (new)

12b. Stresses that innovation is far outstripping legislation; calls on the Commission to introduce a degree of regulatory flexibility in order to be able to respond more rapidly and effectively to new requirements and products, while respecting safety and ethical criteria.

Amendment 457 #

Motion for a resolution
Paragraph 12 b (new)

12 b. Supports adapting existing frameworks to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 458 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Paragraph 12 b (new)

12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

Amendment 459 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN

Motion for a resolution
Paragraph 12 b (new)

12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

Amendment 46 #

B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European integration is necessary; whereas a European Health Union~~, which~~ should contributes to an ~~increasingly social Union, is key in this proces~~d foster closer cooperation, coordination and knowledge sharing on health between Member States and relevant stakeholders;

Amendment 460 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Emphasises that patent protection and enforcement should have due regard for the interests of society, namely the safeguarding of human rights and public health priorities; recalls, in the same vein, that patent protection should not interfere with the right to health and should not serve to widen the gap between wealthier and poorer citizens when it comes to access to medicines; considers that the Union’s approach to this question should ensure harmonisation and coherence among the different measures at the disposal of the Member States;

Amendment 461 #

Motion for a resolution
Paragraph 12 c (new)

12c. Stresses that innovation must focus on those areas of greatest need in order to create a true health and innovation strategy that does not currently exist; calls on the Commission to create an innovation ecosystem that facilitates the exchange of experience and access for SMEs; suggests giving greater weight to scientific research so that it can identify medical priorities independently of commercial interests.

Amendment 462 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting amore expertise- driven scientific assessment on marketing authorisations with in the European Medicines Agency (EMA); believes that the final decision making should occur within maximum 7 days of the final scientific opinion;

Amendment 463 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 12 c (new)

12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment;

Amendment 464 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Calls on the Commission and Member States to intensify work towards the implementation of the electronic product information (ePI), as it could support the better delivery of information to patients and a wider availability of medicines, especially in critical situations;

Amendment 465 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which would facilitate the conducting of clinical research in Europe;

Amendment 466 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Calls on the Commission to ensure that the regulatory system is adequately resourced to share advice given across the system, and to rapidly embrace new technologies via regulatory alignment;

Amendment 467 #

Motion for a resolution
Paragraph 12 c (new)

12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;

Amendment 468 #

Motion for a resolution
Paragraph 12 d (new)

12 d. Stresses the need for a harmonised implementation of the General Data Protection Regulation (GDPR), especially by Data Protection Authorities and its interaction with the Clinical Trials Regulation (CTR) once applicable; requests the European Data Protection Board to ensure its guidelines concerning health research are updated with the aim of fostering research;

Amendment 469 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 12 d (new)

12 d. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 47 #

Motion for a resolution
Recital B

B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European ~~integ~~cooperation is necessary as well as a greater sharing of epidemiological and health data at European level; whereas a European Health Union, which contributes to an increasingly social Union, is key in this process;

Amendment 470 #

Motion for a resolution
Paragraph 12 d (new)

12d. Points out that the Pharmaceutical Strategy should contribute to improved interaction with regulators, the development of non-legislative initiatives, flexibility in labelling and the adaptation of clinical trials to new needs.

Amendment 471 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 12 d (new)

12 d. Requests the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Amendment 472 #

Motion for a resolution
Paragraph 12 d (new)

12 d. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;

Amendment 473 #

Motion for a resolution
Paragraph 12 d (new)

12 d. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

Amendment 474 #

Motion for a resolution
Paragraph 12 e (new)

12e. Invites the Commission and Member States to provide information, communication and advice to enable SMEs to participate more effectively and in a coordinated manner in innovation projects; Notes that the Commission should seek new advisory strategies to facilitate access to innovation funds for smaller companies; Points out that bureaucratic hurdles and complexity make it difficult for SMEs or public research centres to take full advantage of European innovation programmes.

Amendment 475 #

Motion for a resolution
Paragraph 12 e (new)

12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognise and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasises the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;

Amendment 476 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 12 e (new)

12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognize and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasizes the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;

Amendment 477 #

Motion for a resolution
Paragraph 12 e (new)

12 e. Calls on the Commission to ensure that the regulatory system is adequately resourced to share advice given across the system, and to rapidly embrace new technologies via regulatory alignment;

Amendment 478 #

Motion for a resolution
Paragraph 12 f (new)

12 f. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;

Amendment 479 #

Motion for a resolution
Paragraph 12 f (new)

12f. Underlines that the current intellectual property model has proven its effectiveness but needs to develop further to respond to new challenges in the pharmaceutical sector;

Amendment 48 #

Motion for a resolution
Recital B

B. whereas COVID-19 has had an huge impact on people’s health, physical and mental, and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, ~~more European integration is necessary; whereas a European Health Union, which contributes to an increasingly social Un~~a certain level of European integration, is ~~key in this pro~~necessary;

Amendment 480 #

Motion for a resolution
Paragraph 12 f (new)

12 f. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;

Amendment 481 #

Motion for a resolution
Paragraph 12 g (new)

12 g. Supports the adaptation of existing frame works for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 482 #

Motion for a resolution
Paragraph 12 g (new)

12g. Invites the Commission and the Member States to consider the possibility of introducing exceptional and temporary mechanisms to be able to react rapidly to crises and shortages.

Amendment 483 #

Motion for a resolution
Paragraph 12 g (new)

12 g. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Amendment 484 #

Motion for a resolution
Paragraph 12 h (new)

12 h. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognise and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasises the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;

Amendment 485 #

Motion for a resolution
Paragraph 12 h (new)

12h. Points out that the EU should focus on developing adequate capacity for the sustainable production of active substances, raw materials and medicines which reduce dependence on external sources; Advocates providing greater legal certainty for drug developers.

Amendment 486 #

Motion for a resolution
Paragraph 12 h (new)

12 h. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Amendment 487 #

Motion for a resolution
Paragraph 12 i (new)

12 i. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;

Amendment 488 #

Motion for a resolution
Paragraph 12 i (new)

12i. Suggests promoting clinical data registries to improve the ability to assess the outcome of a given medicine.

Amendment 489 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 12 j (new)

12 j. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Amendment 49 #

Motion for a resolution
Recital B

B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience and integrity of our national health systems to cross-border health threats, more European ~~integ~~cooperation is necessary; whereas a European Health Union~~, which contributes to an increasingly social Union, is key~~ plays an important role in this process;

Amendment 490 #

Motion for a resolution
Paragraph 13

Amendment 491 #

Motion for a resolution
Paragraph 13

Amendment 492 #

Motion for a resolution
Paragraph 13

13. Calls on the Commission to ~~revise the use~~address the fragmented implementation of supplementary protection certificates ~~based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU~~(SPCs) across Member States by introducing a unified SPC grant mechanism and/or create a unitary SPC title;

Amendment 493 #

Motion for a resolution
Paragraph 13

13. Calls on the Commission to revise the use of supplementary protection certificates based on technological and scientific advances to ~~prevent~~allow generic and biosimilar medicines ~~from~~to becom~~ing less~~e more competitive inside and outside the EU; Recalls that supplementary protection certificates (SPCs), by extending the patent term up to 5 years, delay access to more affordable generic and biosimilar products thereby placing a major financial burden on national healthcare systems and hampering patients access to treatment; underlines therefore that the use of SPCs should be allowed only for exceptional and justified cases;

Amendment 494 #

Motion for a resolution
Paragraph 13

13. Calls on the Commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU; Stresses that this revision should be accompanied by an impact assessment and take account of horizontal regulation in the area of intellectual property.

Amendment 495 #

Motion for a resolution
Paragraph 13

13. Calls on the Commission to revise the use of supplementary protection certificates ~~based on technological and scientific advances~~ to prevent generic and biosimilar medicines from becoming ~~less~~ competitive inside and outside the EU;

Amendment 496 #

Christian DOLESCHAL, Marlene MORTLER, Markus FERBER

Motion for a resolution
Paragraph 13 a (new)

13 a. Calls on the Commission to thoroughly evaluate the actual impact that a proposal for a unitary SPC would have on the generic and biosimilar medicines market entry, and on equitable patient access to treatments; at the same time calls on the Commission to take full account of and assess the effective implementation of the SPC Manufacturing Waiver in light of the conditions and limitations to it, especially in regards to stockpiling;

Amendment 497 #

Motion for a resolution
Paragraph 13 a (new)

13a. Emphasises that reliable and robust protection of intellectual property is vital for the development of new medicines and, in particular, for the promotion of research and development in Europe; takes the view that any restrictions on the protection of intellectual property will hamper the development of new medicines and undermine Europe's economic standing;

Amendment 498 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 13 a (new)

13 a. Encourages Member States to establish regional business hubs to promote biosolutions and green technology in the production of biosimilar medicines as well as other sustainable and innovative pharmaceutical products; underlines the importance of improving education on biosimilars for health care professionals on Member State level;

Amendment 499 #

Motion for a resolution
Paragraph 13 a (new)

13 a. Urges the Commission to take full account of, and assess the effective implementation of, the SPC manufacturing waiver in light of the several conditions and limitations posed to it;

Amendment 5 #

Motion for a resolution
Citation 6 a (new)

— having regard to the ongoing Commission revision of the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;

Amendment 50 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Recital B

Amendment 500 #

Motion for a resolution
Paragraph 13 b (new)

13 b. Calls on the Commission to develop a separate European Life Science strategy drawing on the lessons from the Industrial Strategy, Pharmaceutical strategy and a European Health Union; suggests that the new strategy should be horizontal and include a strategic approach including areas such as industry, research, health union, crisis preparedness and trade;

Amendment 501 #

Motion for a resolution
Paragraph 13 b (new)

13 b. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls on the Commission to carefully evaluate the actual impact that any proposal for a unitary or unified SPC would have on generic and biosimilar medicines, and on equitable patients’ access to treatments;

Amendment 502 #

Motion for a resolution
Paragraph 14

14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level; recalls that any form of fund or support must be conditioned to clauses on traceability, transparency, accessibility and affordability of manufactured medicines and supply obligations;

Amendment 503 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 14

14. Underlines that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation; Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the Next Generation EU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level;

Amendment 504 #

Motion for a resolution
Paragraph 14

14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector~~, facilitating talent retention and mobility at EU level~~ in all EU Member States, facilitating geographical balance, talent retention and employment opportunities across the whole EU;

Amendment 505 #

Motion for a resolution
Paragraph 14

14. Stresses the importance of recognition and creating quality jobs in the EU along the entire pharmaceutical value chain and the medical field, including the health workforce, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the ~~pharmaceut~~medical sector, facilitating talent retention and mobility at EU level;

Amendment 506 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 14

14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, in all Member States, ensuring geographical balance and facilitating talent retention and mobility at EU level;

Amendment 507 #

Motion for a resolution
Paragraph 14

Amendment 508 #

Motion for a resolution
Paragraph 15

Amendment 509 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 15

~~15.~~ Highlights the fact that gene and ~~15.~~ cell therapies, personalised medicine, nanomedicines, nanotechnology, next- generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring ~~enormous~~substantial benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases~~; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;~~ if they prove their added value compared to existing health technologies before and after the marketing authorisation phase; highlights as well that the increasing number of advanced medicinal products entering the market with high prices and so far limited information on their added therapeutic value and safety issues poses a great challenge for the sustainability of health budgets and may hamper doctors’ and patients’ ability to choose the adequate treatment; underlines the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from chronic management and care to one-time treatment, thereby contributing to reduce costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to develop appropriate regulatory frameworks and to run information campaigns to raise awareness and encourage the use of these innovations when beneficial for patients and once their risk-benefit balance is proved to be positive assessment and improve overall the quality of life of patients; reminds that any decision on the authorization of these innovative products and treatments should be conditioned to the maximum level of patient safety and that fast track approval should be limited to exceptional cases and if needed for urgent public health needs;

Amendment 51 #

Motion for a resolution
Recital B a (new)

Amendment 510 #

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; ~~urges the Commission to develop appropriate regulatory frameworks, to guide new business models~~stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing unmet medical needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 511 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; ~~urges the Commission to develop appropriate regulatory frameworks, to guide new business models~~stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing other unmet medical needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 512 #

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, radionuclide therapy, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring ~~enormous~~significant benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; ~~urges the Commission to develop appropriate regulatory frameworks, to guide new business model~~stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission, in close cooperation with Member States, to develop appropriate regulatory frameworks, to guide new business models without compromising the high level of safety, quality and effectiveness of medicines, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 513 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ, Claudia GAMON

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative have a transformative potential and can bring enormous benefits to patients and societies in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to ensure sufficient regulatory expertise to support dialogue with developers, to develop appropriate regulatory frameworks, to guide new business models without compromising safety standards and product efficacy, and to run information campaigns to raise awareness and encourage the use of these innovations; calls on Member States to authorize the use of these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement process for cross-border treatment of patients;

Amendment 514 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and ~~the ‘Million plus genomes’ initiative~~gene sequencing can bring enormous benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations; calls on the Commission to encourage enhanced data generation on these new products through improved cooperation among regulatory agencies, HTA bodies and patients organizations, healthcare professionals and pharmaceutical companies;

Amendment 515 #

Motion for a resolution
Paragraph 15

Amendment 516 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS

Motion for a resolution
Paragraph 15

Amendment 517 #

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative ~~can bring enormous benefits in relation to~~for the prevention, diagnosis, treatment and post-treatment of all diseases are potentially hazardous and should therefore be used only with great care and in accordance with the precautionary principle; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness ~~and encourage the use~~ of these innovations;

Amendment 518 #

Motion for a resolution
Paragraph 15

Amendment 519 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanomedicines and nanotechnology, next- generation vaccines, including the m-RNA derivatives, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 52 #

Motion for a resolution
Recital B a (new)

B a. whereas the increasing levels of medicine shortages across Europe pose severe threats to patient safety and adversely impact patient outcomes and the patient care continuum; whereas the COVID-19 pandemic further highlighted the fragility of supply chains of medicinal products; whereas the understanding of root causes of medicine shortages are crucial for constructing an appropriate European response to this long-standing challenge;

Amendment 520 #

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, medicine repurposing, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 521 #

Motion for a resolution
Paragraph 15

15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, nanomedicines, next- generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;

Amendment 522 #

Motion for a resolution
Paragraph 15

15. Highlights ~~the fact~~ that gene and cell therapies, personalised medicine, nanotechnology, next- generation vaccines, e-health, medicines repurposing and the ‘'Million plus genomes’' initiative can bring enormous benefits in ~~relation to~~ the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to ~~run~~promote information campaigns to raise awareness and encourage the ~~use~~application of these innovations;

Amendment 523 #

Motion for a resolution
Paragraph 15

Amendment 524 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN

Motion for a resolution
Paragraph 15 a (new)

15 a. Recognises that ATMPs are fundamentally different from traditional pharmaceuticals as they address the root causes of disease and that their fundamental durability and potential curative nature can allow them to be the future of medicine; acknowledges that regulatory bodies such as the EMA are set to review and approve dozens of ATMPs over the coming years, underlining the need for the Commission to establish in addition to its ATMP Action Plan a robust regulatory landscape that facilitates access for all the eligible European patients, and to continue to build on Europe’s position as a major player in ATMPs in order for Europe to remain globally competitive in ATMP development;

Amendment 525 #

Motion for a resolution
Paragraph 15 a (new)

15 a. Urges the European Commission and EMA to consider the full life-cycle of all innovative medicines and therapies including gene and cell therapies, personalised medicine, nanotechnology, next generation vaccines, and ensure a fit-for-purpose framework for off-patent competition at the time of loss of exclusivity;

Amendment 526 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Paragraph 15 a (new)

Amendment 527 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Cindy FRANSSEN, Inese VAIDERE

Motion for a resolution
Paragraph 15 b (new)

15 b. Calls on the Commission to establish a coordinating body to facilitate cross-border treatments and to ensure that patients across Europe enjoy equitable access to innovative therapies; urges the Commission to work with the EMA to create a one-stop-shop for ATMP developers to seek guidance and communication on their applications;

Amendment 528 #

Motion for a resolution
Paragraph 15 c (new)

15 c. Calls on the Commission to establish a regulatory framework for nanomedicines and nanosimilars, and calls for these products to be approved through a compulsory centralised procedure;

Amendment 529 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 to facilitate the launch of large clinical trials carried out in a harmonized and coordinated manner at European level; stresses that patient associations should be more involved in defining research strategies for public and private clinical trials, in order to ensure that they meet the unmet needs of European patients; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 53 #

Motion for a resolution
Recital B a (new)

B a. Whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the European pharmaceutical industry;

Amendment 530 #

Motion for a resolution
Paragraph 16

16. 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation ~~to adapt it to cutting-edge products, scientific advances and technological transformation~~, including for blood, tissues and cells products; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the re~~use~~-purposing of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; stresses the need for more comparative and collaborative, multi-centre platform trials; stresses that comparative randomised double-blind well-designed clinical trials with relevant endpoints are necessary to meet the health needs and respond to questions or regulators, health technology assessment and health payers; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 531 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety; _________________ 9Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 532 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the creation of a data monitoring committee exclusively for emergency clinical trials to ensure the human dignity of patients involved in research and to avoid duplication of emergency trials; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 533 #

Andrey SLABAKOV, Pietro FIOCCHI

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety;

Amendment 534 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation and re- examine the need for exemptions in light of these advances, while safeguarding the interest of public health and of patients for safe, effective and quality medicines on the EU market; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 535 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 , actively monitor its implementation on Member States Level and enforce trial sponsors' compliance with transparency provisions; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 536 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ, Claudia GAMON

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; Calls on the Commission to establish continuous dialogue between ECDC, EMA, and vaccines developers; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 537 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports clinical trials that are more patient- centred as well as a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 538 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to reduce the red tape and adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Amendment 539 #

Motion for a resolution
Paragraph 16 a (new)

16 a. Urges the Commission, having regard to the European Strategy for Data and the digital transformation of healthcare and considering the vast potential that health data has for improving healthcare quality and patient outcomes, to encourage implementation of interoperable technologies in the Member States’ health sectors which will facilitate delivery of innovative health solutions to patients; welcomes the planned creation of a fully cooperative and operational European Health Data Space with a governance framework which fosters the creation of an innovative data-driven ecosystem, based on a secured and controlled exchange of information and critical data, among Member States; asks the Commission to promote next-generation standards, tools and infrastructure in order to store and process data suitable for research and the development of innovative products and services; underlines that personal health data may only be collected and processed on the legal grounds provided for in Article 6(1) of the GDPR, coupled with the conditions provided for in Article 9 of the GDPR; considers that in this context further processing of personal health data should be prohibited; urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe; recalls the need of finding a balance between data protection and the condition for a productive research collaboration at EU and international level and to ensure access to large, high quality health data sets to researchers and clinicians, which could be fundamental for developing innovative treatments;

Amendment 54 #

Motion for a resolution
Recital B a (new)

B a. whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling, undermined the delivery of equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation

Amendment 540 #

Motion for a resolution
Paragraph 16 a (new)

16 a. Urges the Commission to ensure more transparency in clinical trial results, with pharmaceutical companies sharing participant-level data, both positive and negative results (avoiding bias derived from lack of public access to negative trials that weakens the conclusions of systematic reviews and provides a false sense of reassurance on the efficacy or safety of medicinal products), protocols and other trial documents, in a timely manner (urgently in case of emergency);

Amendment 541 #

Motion for a resolution
Paragraph 16 a (new)

16a. Calls for an in-depth review of the rules governing clinical trials in order to consolidate a clear and proportionate set of rules to ensure legal certainty for operators; Notes that many European companies conduct their clinical trials outside the EU because of the many bureaucratic hurdles imposed by EU law in areas such as data protection.

Amendment 542 #

Motion for a resolution
Paragraph 16 b (new)

16b. Calls on the Commission to improve the participation of public researchers in clinical trials, to provide new guidelines on clinical trials, to encourage European networking for better use of public funds, to facilitate cooperation with the UK, to relax regulations to allow clinical trials in several countries simultaneously, and to develop specific provisions in relation to cancer or personalised medicines where long-term research is essential.

Amendment 543 #

Motion for a resolution
Paragraph 16 b (new)

16 b. Recalls the importance of adapting existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems in the interest of patients;

Amendment 544 #

Motion for a resolution
Paragraph 16 c (new)

16 c. Calls on the Commission to require pharmaceutical companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data and active pharmaceutical ingredient sources, number and status of patents and patent applications, and supply chains as a condition for market approval;

Amendment 545 #

Motion for a resolution
Paragraph 17

Amendment 546 #

Motion for a resolution
Paragraph 17

Amendment 547 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls onfor the ~~Commission to work with the EMA to develop the use of~~paper information notice to be supplemented by an electronic product information leaflet notice, to be drawn up in all languages for all the countries where the medicine is marketed in order to facilitate the moving and sales of medicines within the single market and thus mitigate shortages; stresses that electronic product information ~~for all medicines in the EU~~could complement, but never replace, the package information leaflet;

Amendment 548 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU; Points to the urgent need to move forward with the creation of a European health data space to improve the scope and added value of clinical studies and research, thereby facilitating the digital transformation of our health systems.

Amendment 549 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines and evaluate how further regulatory flexibilities, including for GMO medicinal products, could contribute to a more efficient authorisation system; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU, including a shift towards electronic labelling and package leaflets;

Amendment 55 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ

Motion for a resolution
Recital B a (new)

B a. whereas healthcare is a national competence and thus an area over which Member States have ultimate responsibility;

Amendment 550 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews ~~to other emergency medicine~~and to incorporate lessons learned from the extraordinary and accelerated authorisation process where it is relevant, safe and beneficial for patients and for innovative medicinal products for underserved areas; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;

Amendment 551 #

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA, t~~o develop the use of electronic product information for all medicines in the EU~~he industry and all relevant stakeholders accelerate the development and adoption of electronic product information for all medicines in the EU by defining timelines and harmonised standards within a common European interoperable information exchange network;

Amendment 552 #

Motion for a resolution
Paragraph 17

Amendment 553 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews ~~to other emergency medicine~~and further regulatory flexibilities to other emergency medicines and innovative medicinal products for underserved areas; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU and allow electronic patients information instead of paper insert;

Amendment 554 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 17

Amendment 555 #

Motion for a resolution
Paragraph 17

17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work in close cooperation with the EMA to consider extending the application of rolling reviews to other emergency medicines, while safeguarding high level of safety, quality and effectiveness; further calls on the Commission to work with the EMA to ~~develop~~further accelerate the use of electronic product information for all medicines in the EU;

Amendment 556 #

Motion for a resolution
Paragraph 17

Amendment 557 #

Motion for a resolution
Paragraph 17

Amendment 558 #

Motion for a resolution
Paragraph 17

Amendment 559 #

Motion for a resolution
Paragraph 17

Amendment 56 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO

Motion for a resolution
Recital B b (new)

B b. Whereas the COVID-19 experience also demonstrated how the European pharmaceutical industry and manufacturers have been resilient and had contingency plans in place avoiding any major disruption for critical products, notably on ICU medicines; whereas this was also possible thanks to the bilateral dialogue and two-way communication established, demand visibility and close cooperation between governments/regulators and actors, a practice which should be maintained and continued on a regular basis;

Amendment 560 #

Motion for a resolution
Paragraph 17 a (new)

17 a. Welcomes the Commission’s acknowledgement of the difficulties faced by SMEs during the regulatory approval, licensing and product launch processes; highlights that the heavy administrative burden may hinder SMEs’ ability to develop and bring to patients innovative medical products, including for unmet medical needs and rare diseases; reiterates that the administrative burden often forces SMEs into buyouts by larger pharmaceutical companies or into leaving the EU altogether; calls on the Commission and Member States to take SMEs under special consideration when ensuring a level playing field in the process for simplifying and streamlining procedures, due to the fact that, unlike large pharmaceutical companies, SMEs cannot easily absorb administrative costs; calls on the Commission to bring up to date the capabilities of EMA for providing information and assistance to SMEs during the authorisation process; calls on the Member States to establish One-Stop- Shop contact points for SMEs, providing all necessary information, as well as expert help and assistance, to facilitate compliance with national standards and procedures;

Amendment 561 #

Motion for a resolution
Paragraph 17 a (new)

17 a. Welcomes the fact that the strategy recognises that the better use of electronic product information (ePI) will support the better delivery of information to patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU Roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;

Amendment 562 #

Motion for a resolution
Paragraph 17 a (new)

17 a. Calls for a review of the incentives put in place to encourage research in orphan medicines to evaluate their effects and consider appropriate actions to this end; calls for Regulation (EC) No 141/2000 on orphan medicinal products to be revised in order to reverse the burden of proof for the 10-year market exclusivity clause so that the holder of the market authorisation has to prove that the product is not sufficiently profitable to cover R&D costs;

Amendment 563 #

Motion for a resolution
Paragraph 17 a (new)

17a. Emphasises that research into and the production and use of medicines should follow ethical principles that guarantee the right to life, dignity and the integrity of the person.

Amendment 564 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 17 b (new)

17 b. Calls on the Commission to address the negative impacts of parallel trade with regards to shortage of medicines in the Member States and to tackle problems adequately by taking the necessary action to ensure that medicines reach all patients in the EU in a timely manner;

Amendment 565 #

Motion for a resolution
Paragraph 18

18. Calls on the Commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; encourages the Commission in cooperation with the EMA to consider how already established tools like accelerated authorisation, early dialogue, expanded guidance and the PRIME scheme can be used to make medicine available to patients at a faster pace, especially medicine that has potential to address an urgent public health threat or an unmet medical need;

Amendment 566 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 18

18. Calls on the Commission to assess how the conditional marketing authorisation approach has been used by regulators and industry to speed up the availability of innovative medicines to patients, with a view to making better use of conditional marketing authorisation in the future; reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; ~~asks for the time before the final evaluation to be reduced from five to three years;~~

Amendment 567 #

Motion for a resolution
Paragraph 18

Amendment 568 #

Peter LIESE, Christine SCHNEIDER, Cindy FRANSSEN

18 a. Underlines – especially in view of the experiences of the COVID-19 crisis – the importance of drug repurposing as a faster way to new treatment options and therefore demands five years of data protection for valuable innovation on known substance; in addition, underlines that a framework which supports the marketing and use of the drug with the approved new label claim - instead of off- label use - should be urgently considered to make drug repurposing attractive in the EU;

Amendment 569 #

Simona BALDASSARRE, Susanna CECCARDI, Marco CAMPOMENOSI, Luisa REGIMENTI, Danilo Oscar LANCINI

Motion for a resolution
Paragraph 18 a (new)

18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;

Amendment 57 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Recital B b (new)

B b. whereas there exists a large duplication in medical research which predominantly focuses on limited therapeutic areas; whereas public investment should be driven by public health and unmet medical needs; whereas a high degree of transparency should apply in publicly funded medical research from decision-making, investment to open science;

Amendment 570 #

Motion for a resolution
Paragraph 18 a (new)

18 a. Welcomes the Commission’s SAMIRA Action Plan and calls on the Commission to evaluate whether the current pharmaceutical legislation remains appropriately aligned with scientific progress in the development of therapeutic applications of nuclear medicine, recognising that the current legislative framework is largely tailored to diagnostic applications of radiopharmaceuticals;

Amendment 571 #

Motion for a resolution
Paragraph 18 a (new)

18a. Calls on the Commission, the EMA and the competent authorities to capitalise on all the pragmatic efforts made during the COVID-19 crisis, in particular as regards regulatory flexibility with a view to tackling medicine shortages more effectively;

Amendment 572 #

Motion for a resolution
Paragraph 18 a (new)

18 a. Calls on the Commission to extend the mandate of the EMA further, to allow it to monitor medicines shortages even outside health crises and to ensure it has the necessary resources;

Amendment 573 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 18 a (new)

18 a. Calls on the Commission to extend the mandate of the EMA further, to allow it to monitor medicines shortages even outside health crises and to ensure it has the necessary resources;

Amendment 574 #

Motion for a resolution
Paragraph 18 b (new)

18 b. Calls on the Commission to reinforce the role and capacities of EMA with regards to novel medicines; recalls that new treatment modalities, such as radionuclide therapies and nanotechnologies, may require the development of specific clinical development guidelines to support manufacturers with the development of new medicines in innovative fields; reiterates that ensuring sufficient experience and capacity in relation to new treatment modalities is fundamental for the EMA to efficiently guide companies and assess new medicines;

Amendment 575 #

Motion for a resolution
Subheading 3

Increasing resilience: prevention of medicine shortages, secure supply chains, sustainable medicines, crisis preparedness and response mechanisms

Amendment 576 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; recalls that medicines shortages have a direct impact on patients' health, safety and the continuation of their treatment; stresses that for patients, the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment, avoidable transmission of infectious diseases, increased risk of exposure to falsified medicines and significant psychological distress for patients and their families; notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU); calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 577 #

Motion for a resolution
Paragraph 19

19. ~~Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient~~Calls on the Commission to heed the recommendations of the European Parliament stated in resolution of 17 September 2020 on the shortage of medicines; Recalls that the EU’s open strategic autonomy, particularly focused on production of critical products, contributes to the availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on atransparency of medicines' stocks and on a centralised European information network on ~~supply problem~~medicine shortages, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability and stocks of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains and impose dissuasive sanctions in the event of ~~emergencies;~~ non-compliance;

Amendment 578 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; ~~calls on the Commission to develop an early~~recognises the multiple drivers of shortages and therefore the importance of ensuring the involvement of manufacturers and other supply chain stakeholders to prevent and manage medicines’ shortages; calls on the Commission to build on existing systems such as the European Medicines Verification System (EMVS), to develop a warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry and all supply chain stakeholders to provide early and transparent information on the ~~availability of medicines~~demand of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while ensuring that reporting burdens do not increase, become ineffective or unjustified; stresses that confidentiality should be safeguarded; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls for systematic regulatory measures of flexibility to mitigate shortages when they occur;

Amendment 579 #

Motion for a resolution
Paragraph 19

19. 19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; considers it imperative to increase the EU’s manufacturing production and ensure sustainable, diversified and robust supply chains; calls on the Commission to define a robust supply chain, conduct an assessment of causes and drivers of vulnerabilities and dependencies of the supply chain and of cost implications of increasing the robustness of the supply chains, conduct a mapping of the EU manufacturing capacity, and identify the products critical from the public health view; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; stresses in this regard the importance of monitoring and fighting against counterfeit pharmaceuticals;

Amendment 58 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ, Claudia GAMON

Motion for a resolution
Recital B c (new)

B c. whereas pharmaceutical companies receive public financial support at both national and EU level for the development and production of medicines; whereas these grants and subsidies are currently not conditioned by obligations to supply the market with subsidised products for affordable prices;

Amendment 580 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; recognises the multiple drivers of shortages; stresses the importance to involve all stakeholders including manufacturers, wholesalers and pharmacists to prevent and manage medicines’ shortages; recommends, when shortages of medicine occur, to inform healthcare professionals and patients about available alternatives; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while limiting the administrative burdens on stakeholders and safeguarding confidentiality; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 581 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission, Member States and the European Medicines Agency to develop an early warning system for ~~drug~~medicine shortages, based on a ~~European information network on supply problems,~~ n electronic platform capable of determining the volume of stock existing at any given moment, as well as the actual level of demand, providing data capable of detecting, predicting and preventing shortages of medicinal products; calls also to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;

Amendment 582 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to ~~develop~~explore an early warning system for drug shortages based on existing structures, based on a European information network on supply problems, to increase public- private collaboration and to monitor the obligation on the part of ~~industry~~all relevant supply chain stakeholders to provide early and transparent information on ~~the availability of medicines~~relevant factors, including but not limited to the availability of medicines, demand for medicines, parallell trade activities and market distortions without undue regulatory burden; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 583 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission ~~to develop an early warning system for drug shortages, based on a European information network on supply problems,~~, the Member States and the European Medicines Agency to develop an electronic platform capable of determining the volume of stock existing at any given moment, as well as the actual level of demand, providing data capable of detecting, predicting and preventing shortages of medicinal products; calls also to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 584 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on ~~a European information network on supply problems,~~ the improved collection of digital information linked to telematics and digital shortages reporting, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 585 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’'s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on ~~a European information network on supply problems, to increase~~the improved collection of digital information linked to telematics and digital shortages reporting, and greater public-private collaboration ~~and~~, to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 586 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on ~~a European information network on supply problems, to~~improved collection of digital information and digital shortages reporting, and an increased public-private collaboration ~~and to~~while monitoring the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 587 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; and create an emergency preparedness plan to fast track an increase in the production capacity so that it is sufficient to fulfil Union needs for the medicinal products in times of crisis and unexpected demand;

Amendment 588 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; underlines that shortages are a critical public health problem that can seriously harm patients' health and safety, quality of care, professionals' ability to deliver care and health system functioning; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 589 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls on the Commission for measures of flexibility to mitigate shortages when they occur;

Amendment 59 #

Motion for a resolution
Recital B c (new)

B c. Whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling undermined the industry’s ability to deliver equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation;

Amendment 590 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to take steps in this direction leading to the strengthening of cooperation between Member States, in order to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public- private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 591 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s odepen ~~strategic autonomy is linked to~~dence on the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, ~~to increase public-private collaboration~~ and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 592 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines in all Member States; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 593 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;

Amendment 594 #

Motion for a resolution
Paragraph 19

19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information exchange network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Amendment 595 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Underlines that the EP in its recent resolution on shortage of medicines has recalled the obligations for the supply of medicinal products by marketing authorisation holders (MAHs) and distributors, as well as a notification obligation in the event of a temporary or permanent supply interruption, as provided by Directive 2001/83/EC; regrets once more the disparities observed in the transposition of these obligations into national legislations for which the Commission and member states must react promptly and with binding measures; calls on the Commission and the Member States to ensure that MAHs and wholesale distributors comply with the requirements of Directive 2001/83/EC in order to ensure appropriate and continued supplies of medicines; calls on the Commission to further clarify the obligations for MAHs under Directive 2001/83/EC and highlights the need to ensure that they report medicine shortages within the established timeframes; stresses the need to apply dissuasive and proportionate sanctions in the event of non-compliance with these legal obligations in line with the existing legislative framework;

Amendment 596 #

Christine SCHNEIDER

Motion for a resolution
Paragraph 19 a (new)

19a. Points out that the EU’s open strategic autonomy is linked to the availability of sufficient medicines in all Member States at all times; calls on the Commission, therefore, to diversify and thereby strengthen medicine supply chains and to further develop and expand European production sites for essential medicines, in particular those operated by SMEs and MidCaps; calls on the Commission to develop an early-warning system for medicine shortages which draws on a European information network focusing on supply problems; calls on the Commission to enhance cooperation between the public and private sectors and to monitor industry compliance with the requirement to provide timely and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in emergencies;

Amendment 597 #

Motion for a resolution
Paragraph 19 a (new)

19a. Emphasises that security of supply is an essential factor and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to act swiftly in proposing guidelines for the Member States, to look beyond the lowest price criterion, and to ensure that investments in the manufacture of active ingredients and medicinal end products in the EU are also retained as an essential criterion;

Amendment 598 #

Motion for a resolution
Paragraph 19 a (new)

19a. Calls on the Commission to draw up a new definition of 'supply shortages' and to implement an early warning system; invites the Commission to take into consideration the information exchange systems in place in some Member States, based on communication between distribution and pharmacies, which have so far been effective in detecting supply shortages and which may inspire future initiatives without creating new structures, building rather on the experience gained in the Member States and the capacity of national medicines agencies.

Amendment 599 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Recalls the importance to look at the root causes of medicines shortage and to implement systemic sustainable policies, before applying any disproportionate regulatory requirements, obligation to supply, penalties or ill- conceived stockpiling fragmenting the single market or threatening products’ economic sustainability, which may lead to further shortages; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;

Amendment 6 #

Motion for a resolution
Citation 6 a (new)

— having regard to the Council conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,

Amendment 60 #

Motion for a resolution
Recital B d (new)

B d. whereas gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring benefits in relation to the prevention, diagnosis, treatment and care of all diseases, provided they are effective, safe, affordable and accessible to all patients who need them;

Amendment 600 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Recalls that the root causes of medicines shortage should be assessed and tackled and systemic sustainable reforms put in place, before imposing any disproportionate, quick-fix and punitive measures, such as penalties and uncoordinated and extreme stockpiling requirements; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;

Amendment 601 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Insists that the Public Service Obligation (PSO) as established in Article 81 of Directive 2001/83 is not sufficient to ensure that the EU as a whole is sufficiently supplied; calls on the Commission to put in place an obligation for MAH’s to report to EMA the total quantities supplied to the Internal Market and to ensure the right to be supplied for wholesalers in order to meet patient demand and to ensure a competitive internal market;

Amendment 602 #

Motion for a resolution
Paragraph 19 a (new)

19a. Points out that the underlying causes of medicine shortages should be tackled and assessed in the light of the lack of a European industrial policy and that the links between the supply chain and production challenges should be addressed as a matter of urgency with a view to guaranteeing the independence of European pharmaceutical production;

Amendment 603 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Urges the Commission to address transparency in the entire pharmaceutical system, including transparency of the costs of developing new therapies, transparency of clinical trials, and transparency of the decision-making process and criteria to patients and citizens;

Amendment 604 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Invites the Commission to evaluate which medicinal products have to go through a mandatory centralized approval at EMA in order to ensure a safe and efficient approval procedure for the most innovative and complex medicinal products, including nanomedicines;

Amendment 605 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Calls on the Commission to ensure a reliable and independent supply of medicines for European citizens and urges to strengthen the production of medicines and medical products within the EU;

Amendment 606 #

Motion for a resolution
Paragraph 19 a (new)

19 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages;

Amendment 607 #

Motion for a resolution
Paragraph 19 b (new)

19 b. Stresses the need for the publication of concrete and legally binding shortage management and prevention plans as part of the medicine supply obligations of marketing authorisation holders based on an analysis of the manufacturing and distribution risks, including minimum stock levels, measures allowing for the diversification of raw materials supply sources, and the development of other manufacturing sites when necessary;

Amendment 608 #

Motion for a resolution
Paragraph 19 b (new)

19b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; takes the view that the EMA is the body best suited to be designated as the regulatory authority tasked with preventing shortages of medicines at EU level during emergencies and beyond;

Amendment 609 #

Motion for a resolution
Paragraph 19 c (new)

19 c. Urges the Commission to address medicine shortages specifically aimed at women such as female hormonal medicines used for contraception and hormone replacement therapy (HRT); stresses the importance to take into account the threats posed by such shortages to women’s and girls’ sexual and reproductive health and rights, particularly among those most vulnerable such as older women or transgender women; highlights the importance of enhancing the control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability;

Amendment 61 #

Motion for a resolution
Recital B e (new)

B e. whereas accelerated approvals of medicinal products granted by the European Medicines Agency (EMA) should not compromise safety and efficacy of new treatments coming the EU market, not even in the times of public health crises; whereas all new treatments should demonstrate added clinical benefit and cost-effectiveness compared to existing products;

Amendment 610 #

Motion for a resolution
Paragraph 19 c (new)

19c. Calls on the Commission to set up an innovative, user-friendly, transparent and centralised digital platform for reporting and notifying information provided by national agencies and all stakeholders regarding available stocks and shortages of medicines and medical equipment; calls for existing information systems to be evaluated and improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State to prevent overstocking;

Amendment 611 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; stresses the need to discuss key health policies directly with representatives of patient organisations, health service providers, industry, regulators and other key stakeholders, on the basis of the High-Level Forum format, which has proven successful in coordinating joint action against COVID- 19;

Amendment 612 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, including the involvement of policymakers, regulators, payers, industry representatives and patients organizations, among others;

Amendment 613 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 20

20. SConsiders it essential to improve early communication with healthcare professionals and patients on the availability of medicines; supports the Commission in its efforts to conduct a transparent and inclusive structured dialogue with players in the pharmaceutical value chain, public authorities, healthcare professionals, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;

Amendment 614 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to ~~conduct~~achieve a public disclosure, in accordance to Good Clinical Practices, through a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community, with the aim of protecting the dignity of human beings involved in clinical trials and to address weaknesses in the global medicines manufacturing and supply chain;

Amendment 615 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; emphasises that actions such as dual sourcing and safety stocks mitigate upcoming risks, increase resilience and the security of supply;

Amendment 616 #

Motion for a resolution
Paragraph 20

20. ~~Supp~~Notes the efforts of the Commission ~~in its efforts~~ to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non- governmental patient and health organisations and the research community ~~to address weaknesses in the global medicines manufacturing and supply chain~~as one of the tool to explore weaknesses and deficiencies in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;

Amendment 617 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Paragraph 20

Amendment 618 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Inese VAIDERE, Roberta METSOLA

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address the root causes of shortages of medicines and the weaknesses in the global medicines manufacturing and supply chain;

Amendment 619 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address weaknesses and identify opportunities for innovation in the global medicines manufacturing and supply chain;

Amendment 62 #

Motion for a resolution
Recital B f (new)

B f. whereas access to generics and biosimilars can generate substantial savings that can be reinvested in improved healthcare provision, as the EU annually spends 274billion USD (224 billion EUR) on pharmaceuticals, of which 76% (or 170 billion EUR)on patented medicinal products, compared to an annual expenditure of 24% (54billion EUR) on generic products; whereas robust competition rules and scrutiny is needed to enable entry of generics onto the market, reducing prices and ensuring the sustainability of healthcare systems and improving timely access for patients to affordable medicines;

Amendment 620 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 20

Amendment 621 #

Motion for a resolution
Paragraph 20

20. Supports the Commission in its efforts to conduct a structured dialogue with ~~playe~~relevant actors in the pharmaceutical value chain, public authorities, non- governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain;

Amendment 622 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improving the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;

Amendment 623 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improve the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;

Amendment 624 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Welcomes the reference in the strategy to the fact that actions in the area of public procurement can foster competition and improve access. In this context, urges the Commission to consider the importance of diversified supplies and sustainable procurement practices for pharmaceuticals, notably with multi- winners tender, and, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tenders practices for pharmaceuticals, where tender practices are used, notably on how to best implement the MEAT (Most Economic Advantageous Criteria) criteria, looking beyond the lowest price criteria only and rewarding quality and security of supply, as well as environmental and social investments in manufacturing;

Amendment 625 #

Motion for a resolution
Paragraph 20 a (new)

20a. Welcomes the establishment of structured dialogue on production and the supply chain with the actors in the pharmaceutical value chain and the public authorities with a view to identifying the weak points in the global supply chain for critical medicines, raw materials and active ingredients; in that connection, urges the Commission, the Member States and stakeholders to draw up a clear and ambitious political roadmap of economic, legislative and industrial measures designed to safeguard and modernise medicine production capacity and stimulate investment in security of supply and improved production;

Amendment 626 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks of medicinal products of major therapeutic interest , diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production; underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;

Amendment 627 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimise and modernise the existing regulatory framework; urges the Commission to make the best use of existing digital tools at EU level; stresses the need to prioritise a structured dialogue on the manufacturing, the supply chain and the security of supply of Active Pharmaceutical Ingredients (APIs), raw pharmaceutical materials and intermediates; underlines the need to bring all relevant stakeholders together to define a policy roadmap to tackle medicine shortages by enhancing the manufacturing resilience within the European Union;

Amendment 628 #

Motion for a resolution
Paragraph 20 a (new)

20a. Welcomes the introduction of a structured dialogue with all stakeholders to identify weak links in the global supply chain for critical medicines, pharmaceutical raw materials, intermediate products and active pharmaceutical ingredients; with that in mind, urges the Commission, the Member States and stakeholders to draw up, as soon as possible, a clear and ambitious policy roadmap to secure and modernise Europe’s existing manufacturing capacity for medicines, technology and active pharmaceutical ingredients;

Amendment 629 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Calls on the Commission to recognise patients as the end-users of medicines and thus an essential stakeholder group in the assessment of the value of new medicines; calls for investment in frameworks, structures and methodologies for meaningfully incorporating patients in setting research priorities, regulatory and Health Technology Assessment, and pricing and reimbursement decision-making;

Amendment 63 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Recital B g (new)

B g. whereas supplementary protection certificate (SPC) extends patent protection up to 5additional years, after the 20 years of patent expiry, with no proven direct link to innovation, by which it delays access to more affordable generic and biosimilar products, placing an unnecessary financial burden on national healthcare systems and hampering patients access to needed medicines;

Amendment 630 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Considers it important that the Internal Market for medicines is safeguarded and that unjustified import and export restrictions, that can cause harm to the internal market and decrease affordability, should be avoided and addressed by the Commission if they occur;

Amendment 631 #

Motion for a resolution
Paragraph 20 a (new)

20a. Stresses that flexibility in pharmaceutical regulations to meet the challenges of COVID-19 should be extended to unmet needs through more streamlined and less bureaucratic procedures, while maintaining all guarantees of safety and quality.

Amendment 632 #

Motion for a resolution
Paragraph 20 a (new)

20 a. Recalls that localization policies may have adverse effects on the access to medicines; stresses that global networks and supply chains lower the dependency on one specific country or continent, which acts as an additional resilience factor;

Amendment 633 #

Motion for a resolution
Paragraph 20 b (new)

20 b. The EU should aim to create a framework for fair and equitable access that can maximise societal benefit and patient access whilst avoiding unacceptable impact on healthcare budgets, encompassing at least the following elements: - closer collaboration by Member States on price negotiations and scaling-up of pilots on early dialogues; - closer collaboration by Member States on price negotiations and scaling-up of pilots on early dialogues; - adoption of common principles and mechanisms for encouraging and rewarding innovation in order to encourage continued investment in R&D, based on the evaluation of the current EU IP and incentives legal framework; - exploration of innovative models for incentivising research & development especially in areas of high unmet need; - exploration of the potential of optimal use of mechanisms such as adaptive pathways, managed entry agreements and others for optimising access and determination of value; - exploration of differential pricing mechanisms, barriers and potential solutions to dealing with practical issues such as parallel trade; - common EU principles for calculating a fair price, taking into account the specifics of each Member State;

Amendment 634 #

Motion for a resolution
Paragraph 20 b (new)

20 b. Recalls the role of sustainable procurement practices in preventing medicines shortages and that, as recognised in the EU industrial strategy, public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing; considers that these targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;

Amendment 635 #

Motion for a resolution
Paragraph 20 b (new)

20 b. W Welcomes the reference in the pharmaceutical strategy that actions in the area of public procurement can foster competition and improve access; emphasises the importance of diversified supplies and sustainable procurement practices for pharmaceuticals; urges the Commission, in the context of Directive2014/24/EU, to swiftly propose guidelines for the Member States on the implementation of the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacturing of Active Pharmaceutical Ingredients (APIs) and medicinal end products in the EU should be considered, as well as the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;

Amendment 636 #

Motion for a resolution
Paragraph 20 b (new)

20b. Urges the Commission, in the context of Directive 2014/24/EU on public procurement, to put forward guidelines for the Member States which are designed in particular to steer contracting authorities towards applying the award criterion of the most economically advantageous tender rather than that of the lowest price; takes the view that investment in the production of active ingredients and medicinal products in the European Union, security of supply, the reinvestment of profits in research and development and the application of social, environmental, ethical and quality standards should be taken into account in assessing bids;

Amendment 637 #

Motion for a resolution
Paragraph 20 b (new)

20 b. Calls on the Commission to draft a harmonized definition of “shortages” and to standardize reporting requirements across Member States in order to enable closer cooperation and enhanced data exchange across Europe;

Amendment 638 #

Motion for a resolution
Paragraph 20 c (new)

20 c. Calls on the Commission to audit the level of prevention, preparedness and response planning within the Member States; considers it imperative to consult with relevant stakeholders from the pharmaceutical and health sectors;

Amendment 639 #

Motion for a resolution
Paragraph 20 d (new)

20 d. Considers it imperative to ensure a joint approach and procurement for safety stocks in each Member State; stresses that national stockpiles and capacities of critical medical products as well as of diagnostic services and tools and safety equipment contribute to the security of supply on Union level;

Amendment 64 #

Motion for a resolution
Recital B h (new)

B h. whereas the aim of intellectual property and regulatory incentives to benefit society and promote innovation in areas of public health and unmet medical needs should not be misused/abused nor pose threats to affordability and patient access to pharmaceuticals; whereas awarding such incentives and public funds should be conditioned by transparency of public funding, research data, R&D and other associated costs, and product prices, to ensure affordability and fair return on public investment;

Amendment 640 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and contribute to an effective response in the event of a health emergency; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines and to support that Member States can import medicines produced under a compulsory license by reversing their opt-out of Article 31bis of the TRIPs agreement;

Amendment 641 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 21

Amendment 642 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them, while adhering to the high EU standards for personal data protection; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and to ensure the creation of minimum necessary stocks for both raw materials and medical equipment, and contribute to an effective response in the event of a health emergency;

Amendment 643 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, while developing a strategic autonomy in Europe for certain essential raw materials, and contribute to an effective response in the event of a health emergency;

Amendment 644 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them, in full respect of the highest EU standards for personal data protection; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and contribute to an effective response in the event of a health emergency;

Amendment 645 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 21 a (new)

21 a. Recalls the role of sustainable procurement practices in preventing medicines shortage and that, as recognised in the EU industrial strategy public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing; considers that these targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;

Amendment 646 #

Motion for a resolution
Paragraph 21 a (new)

21 a. Welcomes HERA as a permanent structure that should help facilitate agile and quick decision-making, response and action for future European health crises; stresses that public-private partnerships are a key element in this regard; calls on HERA to facilitate a structured dialogue with industry with the aim of identifying vulnerabilities in the global supply chain of critical medicines and raw materials;

Amendment 647 #

Motion for a resolution
Paragraph 21 a (new)

21 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply chains; calls for obliging medicine manufacturers to submit shortage prevention and management plans to the EMA and national authorities;

Amendment 648 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 21 a (new)

21 a. Supports the broadened mandate of the EMA and its new responsibilities; calls for the centralisation of scientific advice procedures, thereby strengthening the EMA's capacity in the field of medical technologies; reiterates that the approval process must respond in an appropriate and timely manner to the needs of patients and the pharmaceutical industry.

Amendment 649 #

Motion for a resolution
Paragraph 21 a (new)

21 a. Insists that the quality of raw material imports for the pharmaceutical industry from outside the EU must be ensured at all times; calls on the Commission and on Member States to improve quality control and introduce penalties for repeat offenders;

Amendment 65 #

Motion for a resolution
Recital B i (new)

B i. whereas, during a health emergency, the EU should support the introduction of waivers of patents, data and market exclusivity to enable global access to crucial health products to swiftly overcome the crisis;

Amendment 650 #

Motion for a resolution
Paragraph 21 a (new)

21 a. Calls on the Commission to evaluate the TRIPS+ commitments in EU trade agreements in light of the lessons learned from the covid-19 pandemic, and to increase the effective use of intellectual property rights flexibilities;

Amendment 651 #

Motion for a resolution
Paragraph 21 b (new)

21 b. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply chains; calls for the implementation of binding shortage prevention and management risk plans address to EMA and national authorities to be made mandatory for MAHs and wholesale distributors;

Amendment 652 #

Motion for a resolution
Paragraph 21 c (new)

21 c. Calls on the Commission to take stock of the lessons learnt with the negotiations around COVID-19 vaccines and facilitate clear contracts between the EMA and industry on preventing and managing pharmaceutical supply chain disruptions; stresses that contracts should come with conditionalities and sanctions should a stakeholder not fulfil its commitments;

Amendment 653 #

Motion for a resolution
Paragraph 22

22. Stresses the need for ~~the pharmaceutical industry to be~~an environmentally -friendly and climate- neutral pharmaceutical industry throughout the life cycles of the medicinal product~~s; calls on the Commission to strengthen inspection and auditing throughout the~~ and ensure that no action taken jeopardises access to safe and effective pharmaceutical treatments for human patients; calls on the Commission to develop with industry global manufacturing frameworks for environmental produtection ~~cha~~in medicines manufacturing; urges the Commission to ensure quality and environmental sustainability ~~standards~~framework for active pharmaceutical ingredients imported from ~~non-EU~~third countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with ~~measures to reduc~~incentives to optimise packaging, a~~nd the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;~~ s well as to facilitate medicines movement to mitigate shortages if they occur; Call on the Commission to take into account existing and self- regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, which shall be proportionate and based on scientific evidence;

Amendment 654 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 22

22. Stresses the need for ~~the pharmaceutical industry to be~~an environmentally -friendly and climate- neutral pharmaceutical industry throughout the life cycles of the medicinal product~~s; calls on the Commission to strengthen inspection and auditing throughout the~~ and to ensure that no action taken jeopardises access to safe and effective pharmaceutical treatments for human patients; calls on the Commission to develop, with industry, global manufacturing frameworks for environmental produtection ~~cha~~in medicines manufacturing; urges the Commission to ensure a quality and environmental sustainab~~ility standards~~le framework for active pharmaceutical ingredients imported from ~~non-EU~~third countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with ~~measures to reduc~~incentives to optimise packaging, a~~nd the size of conta~~lso to facilitate mediciners ~~to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs~~movement to mitigate shortages if they occur; calls on the Commission to take into account existing and self- regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, as well as to be based on scientific evidence;

Amendment 655 #

Motion for a resolution
Paragraph 22

Amendment 656 #

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products~~; calls on the Commission to strengthen inspection and auditing throughout the production chain~~ and the insurance of access to safe and effective pharmaceutical treatments for patients; calls on the Commission to develop a framework for environmental protection while manufacturing medicines; urges the Commission to ensure high-quality, safe and environmental sustainab~~ility~~le standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Amendment 657 #

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; welcomes the intention to revise the pharmaceuticals legislation; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; commends the Commission's intention to consider advertising, marketing and prescription of pharmaceuticals having negative environmental impact; calls on the Commission to include an ERA that assesses the impact of pharmaceutical substances, their degradation products and metabolites on the quality of surface and ground water bodies, including drinking water resources, in the risk- benefit analysis; urges the Commission to speed up the catch-up procedure for ERA of pharmaceuticals authorised before 2006;

Amendment 658 #

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to heed the calls of the European Parliament in its resolution of 17September 2020 on a strategic approach to pharmaceuticals in the environment, in particular to revise the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of approval and use for medicines by including the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines; calls on the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Amendment 659 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Cindy FRANSSEN

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, particularly outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like, for example, the Eco-Pharmaco- Stewardship initiative;

Amendment 66 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Susana SOLÍS PÉREZ

Motion for a resolution
Recital B j (new)

B j. whereas rising prices of medicines and growing uncertainty on their real-life effectiveness pose challenges to health decision-making; whereas collaboration on horizon scanning, health technology assessment (HTA), joint price negotiations and joint procurement is crucial to achieve high quality evaluation, affordability and equal access to medicines throughout the EU;

Amendment 660 #

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles and value chain of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain; encourages the Commission to consider the potential of e-leaflets to reduce use of paper in packaging while also maintaining equal access to important information; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, while ensuring convenient and safe handling for patients or consumers with limited mobility, and to bring medical prescriptions into line with real therapeutic needs;

Amendment 661 #

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, particularly outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of e-leaflets would be an effective way to reduce packaging; acknowledges steps taken already by the pharmaceutical industry to adopt and strengthen green practices, including for example the Eco-Pharmaco- Stewardship initiative;

Amendment 662 #

Motion for a resolution
Paragraph 22

22. Considers that the European Green Deal constitutes a major opportunity to encourage pharmaceutical manufacturers to participate to the green recovery plan by producing in compliance with environmental and ecological standards; Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Amendment 663 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 22

Amendment 664 #

Motion for a resolution
Paragraph 22

Amendment 665 #

Motion for a resolution
Paragraph 22

22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout ~~the production chain~~especially the part of the production chain located outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Amendment 666 #

Motion for a resolution
Paragraph 22 – point c (new)

(c) Highlights the importance of faster, more ambitious and targeted action to eliminate the environmental risks posed by pharmaceuticals, including and based on research providing a better understanding of the impact of pharmaceuticals on human health, animal health and the environment;

Amendment 667 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 22 – point a (new)

(a) Recalls that information such as the impact of pharmaceuticals on water, environmental behaviour, degradability and potential cocktail effects, plays a key role in risk management and that this type of information should be transparant and made available to all relevant stakeholders; calls on the Commission and the relevant authorities to set up a secure, centralised database enabling all stakeholders concerned to have access to the results of environmental risk assessment;

Amendment 668 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Welcomes the fact that the strategy recognises that better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines; calls on the Commission to release an EU Implementation Roadmap for ePI with a defined timeline and suggested measures at EU and Member State level; urges the Commission to review the requirement of the pharmaceutical legislation(Article 58 of Directive 2001/83/EC1) to include a package leaflet (PL) in the packaging of all medicines or directly convey all information required (by Articles 59 and 62 of the Directive) on the outer or immediate packaging with a goal to completely replace PL with ePI;

Amendment 669 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Calls on the Commission, on top of the structured dialogue on manufacturing and supply chain, to set up a focused, action oriented High Level Pharmaceutical Forum involving Ministers of Health and policy makers, regulators, payers, industry and other concerned stakeholders of the Healthcare supply chain; underlines that the key objective would be to share the learnings from the COVID19 situation and draw the conclusions to establish a pan European and effective policy framework to prevent shortages in the long term and ensuring a well-functioning, sustainable industry that continues to act as a catalyst to enable sustainable access to medicines for patients and innovation;

Amendment 67 #

Motion for a resolution
Recital B k (new)

B k. whereas the ‘One Health’ approach in restricting and optimising the use of antibiotics is needed to address antimicrobial resistance;

Amendment 670 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Welcomes the Commission’s efforts to address the problem of pharmaceuticals in the environment; draws attention, in this connection, to the need to continue and to step up these efforts, in particular as regards investments in technologies providing more effective solutions for the removal of pharmaceuticals from waste water, the assessment of the environmental impact of veterinary medicines, the development of continuous monitoring and data sharing on potential significant sources of this type of pollution, and the improvement of the management of animal by-products containing pharmaceutical residues, such as antibiotics;

Amendment 671 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Motion for a resolution
Paragraph 22 a (new)

22 a. Believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, bringing together policymakers, regulators, payers, patient organizations, industry representatives and other relevant stakeholders in the healthcare supply chain in order to tackle other policy areas, such as prevent shortages, address pharmaceutical sustainability issues and ensure the competitiveness of the European pharmaceutical industry overall;

Amendment 672 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Stresses that for pharmaceutical waste should be handled in a safe and hygienic matter with regard to the objections and targets of the circular economy and to protect the environment; believes that the pharmaceutical industry should have the same requirements and standards on packaging and waste management as other sectors; calls on the Commission to create a uniform framework for packaging that takes into account user-friendliness and the circumstances for industry;

Amendment 673 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Is of the opinion that environmental sustainability of medicinal products cannot be achieved without proper assessment of environmental effects associated with their production and use; asks the Commission to ensure that negative environmental effects of medicinal products, both existing and new, are duly assessed and taken into account during the authorisation procedure or post-authorisation monitoring;

Amendment 674 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Points out that residue of production, use and disposal of medicines can negatively affect ecosystems and water quality; calls on the Commission to assess the sufficiency of current requirements for environmental risk assessment and conditions of uses of medicines; urges the Commission to explore innovative digital solutions for monitoring and improving the efficiency of medicines consumption and quality;

Amendment 675 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Calls on the Commission to include the environmental impact of pharmaceuticals in the benefit-risk assessment of human medicines, as it is already the case for veterinary medicines, provided that marketing authorisation are not delayed nor refused solely on the grounds of adverse environmental impact;

Amendment 676 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Calls on the Commission to include the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines, as is already the case for veterinary medicines, provided that marketing authorisations are not delayed nor refused solely on the grounds of adverse environmental impacts;

Amendment 677 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Urges the Commission, without further delays, to implement the electronic product information leaflet notice (ePi), made available in all languages for all the member states where the medicine is marketed in order to mitigate shortages and to attain a swifter implementation of the e-leaflet;

Amendment 678 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorized before 2006 where they are not available;

Amendment 679 #

Motion for a resolution
Paragraph 22 a (new)

22 a. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Amendment 68 #

Motion for a resolution
Recital B l (new)

B l. whereas action is required throughout the lifecycle of medicines to reduce resource use, emissions and levels of pharmaceutical waste and residues in the environment;

Amendment 680 #

Motion for a resolution
Paragraph 22 b (new)

22 b. stresses that rational use of medicines and prevention of wastage are crucial in minimization of their negative environmental effects and can help to ensure that medicines are affordable and available for people who need them, especially from disadvantaged and vulnerable groups; asks the Commission to pay attention to the promotion of rational use of medicines, including by responsible prescribing, consumer awareness and technical measures such as reduction of pack sizes and their alignment to real use;

Amendment 681 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Calls on the Commission to set up a focused and action-oriented High Level Pharmaceutical Forum on Better Access to Health Innovation by bringing together multi-stakeholder solutions; Asks the Commission to share via this Forum lessons learned from the COVID-19 emergency situation and to establish an effective policy framework to prevent shortages in the long-term and enable access to medicines for patients and innovation;

Amendment 682 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 22 – point b (new)

(b) Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective for patients as well as harmless to animal health and the environment, given that green pharmaceuticals are not toxic for the environment, do not bioaccumulate and degrade into harmless substances, particularly in wastewater treatment plants and the environment;

Amendment 683 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Highlights the fact that currently 40% of medicines marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; stresses the urgent need to bring the pharmaceutical industry back to Europe and to stimulate new job growth inside the EU by establishing a minimal required percentage of the value chain to remain within the EU;

Amendment 684 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Calls on the Commission to update environmental risk assessment requirements of human medicine waste to ensure a proper assessment of persistent, bio-accumulative and toxic substances and of mixture effects, and to take into account the risk of antimicrobial resistance developing in the environment.

Amendment 685 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Insists that the pharmaceutical strategy for Europe should consider the objectives of the Zero Pollution Action Plan for water, air and soil;

Amendment 686 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;

Amendment 687 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Amendment 688 #

Motion for a resolution
Paragraph 22 b (new)

22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Amendment 689 #

Motion for a resolution
Paragraph 22 c (new)

22 c. Calls on the Commission to speed up the catch-up procedure for environmental risk assessment of human medicines that were authorized before 2006 where they are not available;

Amendment 69 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality; whereas the strategy offers the opportunity to restore balance in the pharmaceutical sector between public and private interests in order to fulfil the Union’s primary mission in the pharmaceutical sector, which is to ensure patients’ access to affordable medicines that bring additional therapeutic benefits;

Amendment 690 #

Motion for a resolution
Paragraph 22 c (new)

22 c. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorised before 2006 where they are not available;

Amendment 691 #

Motion for a resolution
Paragraph 22 c (new)

22 c. Calls on the Commission to include environmental criteria in the Good Manufacturing Practice (GMP) framework;

Amendment 692 #

Motion for a resolution
Paragraph 22 – point a (new)

(a) Calls on the Commission to propose a targeted approach in a bid to drastically reduce the concentration of antibiotics and other plant treatment products in the soil; calls on the Commission to submit a programme for the monitoring of both pharmaceuticals and antibiotics in the soil;

Amendment 693 #

Motion for a resolution
Paragraph 22 d (new)

22 d. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;

Amendment 694 #

Motion for a resolution
Paragraph 22 d (new)

22 d. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing practice (GMP) Framework;

Amendment 695 #

22 e. Supports the "polluter pays principle" to improve the responsibility of the Pharmaceutical industry;

Amendment 696 #

Motion for a resolution
Subheading 4

~~The EU is leading the world in healthcare~~Needs-driven and sustainable healthcare in the EU and the world

Amendment 697 #

Motion for a resolution
Paragraph 22 – point d (new)

(d) Calls on the Commission to include pharmaceuticals that pose a risk to the environment in the list of priority substances under the Water Framework Directive and to set strict environmental quality standards and concentration limits under the Environmental Quality Standards (EOS) Directive;

Amendment 698 #

Christine SCHNEIDER

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission to secure supply chains and Europe's open strategic autonomy by diversifying supply chains for essential medicines and critical product components, focusing also on European production sites for the European pharmaceutical industry, which consists mostly of SMEs and MidCaps, by ensuring that public procurement rules take greater account of this objective and are more conducive to efforts to achieve it;

Amendment 699 #

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission to examine the contribution of the pharmaceutical sector to climate change through greenhouse gas emissions; calls for special attention to be paid to emission hot spots, such as hospitals, pharmaceutical plants and intensive stockbreeding areas;

Amendment 7 #

Motion for a resolution
Citation 6 b (new)

— having regard to the ongoing Commission revision of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;

Amendment 70 #

Motion for a resolution
Recital C

C. whereas, in the spirit of the ‘One Health’ approach, the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality; whereas animal welfare should be ensured by meeting the goal of Directive 2010/63/EU for full replacement of all animals that are used for scientific purposes;

Amendment 700 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to seek a better enabling environment for innovation through stronger protection of intellectual property in the EU and in foreign markets; encourages the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium- sized enterprises, through a level playing field and a regulatory framework promoting the highest standards on quality and safety at international level, facilitating trade agreements that ~~priz~~value innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; highlights the importance of removing trade barriers and red tape in third countries, and ensuring fair access to international markets for companies operating in the EU;

Amendment 701 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EUuropean pharmaceutical industry, including ~~small and medium-sized enterprises, throug~~SMEs, with a level playing field and a regulatory framework, facilitating trade agreements that prize ~~innovation-based~~manufacturing and technological know-how competitiveness, ~~in order~~ to make the pharmaceutical sector a strategic pillar of the EU;

Amendment 702 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that ~~prize innovation-based competitivenes~~are based on peoples' needs, in order to make the pharmaceutical sector a strategic ~~pilla~~and public sector of the EU;

Amendment 703 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.

Amendment 704 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries;

Amendment 705 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.

Amendment 706 #

Andrey SLABAKOV, Joanna KOPCIŃSKA, Pietro FIOCCHI, Ryszard Antoni LEGUTKO, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework promoting the highest standards on quality and safety at international level, facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;

Amendment 707 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a robust and clear regulatory framework facilitating trade agreements that prize innovation- based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;

Amendment 708 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to ~~mak~~preserve the pharmaceutical sector as a strategic pillar of the EU;

Amendment 709 #

Motion for a resolution
Paragraph 23 a (new)

23 a. Emphasises that the implementation of an open, free, fair, transparent and enforceable rules-based multilateral trading system is fundamental to ensure global availability of medical products and limiting vulnerabilities in the future; calls on the Commission to develop a medicines trade agenda that ensures that EU Free Trade Agreements should not focus exclusively on enforcing Intellectual Property standards in third countries, but they should take into account the impact on generic and biosimilar medicines in the EU and in third countries, as well as include coordination on regulatory standards; calls on the Commission to implement the single development programmes with third parties on generic medicines, complex generic medicines and biosimilar medicines to avoid unnecessary and unethical studies;

Amendment 71 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full life cycle of medicines, including ~~research, test~~collection and production of starting material, research, testing, manufacturing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the Europe’s Beating Cancer Plan, the digital transformation and climate neutrality;

Amendment 710 #

Motion for a resolution
Paragraph 23 a (new)

23a. Stresses that the WTO TRIPS Agreement offers flexibility with regard to patent rights, for example through compulsory licensing, thereby bringing down prices substantially; points out that this flexibility can be effectively turned to account to address public health concerns in exceptional circumstances, enabling the necessary medicines to be supplied at affordable prices as part of domestic policy aimed at promoting public health;

Amendment 711 #

Motion for a resolution
Paragraph 23 a (new)

23 a. Urges the Commission to issue a proposal in the framework of paragraph 9 of Article218 TFEU to update the EU position regarding ongoing WTO TRIPS flexibilities so as in times of health emergency, to allow for use of TRIPS waiver, as well as lifting data and market exclusivity, to enable use of compulsory licensing by the Member States and third countries as an important public health safeguard, and to evaluate the TRIPS+ commitments in EU trade agreements;

Amendment 712 #

Motion for a resolution
Paragraph 23 a (new)

23 a. Points out that small and medium sized enterprises (SMEs) and mid-caps play a crucial role in the pharmaceutical value chain, often as first-movers and drivers of innovation; urges the Commission to maintain a comprehensive and predictable regulatory framework that fosters the investment and innovation of especially European pharmaceutical SMEs and mid-caps;

Amendment 713 #

Motion for a resolution
Paragraph 23 a (new)

23 a. Believes the EU Member States have a responsibility to ensure equitable access to medicines and therapeutics worldwide; calls on the EU to advocate access to medicines globally, and to commit to ensuring that none of its actions block access to medicines and therapeutic care, including in the WTO;

Amendment 714 #

Motion for a resolution
Paragraph 23 b (new)

23 b. Calls on the Commission to ensure due diligence, transparency, ethical and responsible behaviour throughout the pharmaceutical sector to promote trust in health decision-making and protect the environment and societal welfare;

Amendment 715 #

Motion for a resolution
Paragraph 23 b (new)

23b. Calls for EU initiatives to provide patients with equal access to medicines at global level;

Amendment 716 #

Motion for a resolution
Paragraph 23 c (new)

23 c. Calls on the Commission to ensure adequate consultation with stakeholders, in particular consumer, patient and healthcare professionals and non-profit research organisations throughout the implementation of the Pharmaceutical Strategy;

Amendment 717 #

Motion for a resolution
Paragraph 24

24. Reiterates its commitment to continue working with the Commission and the World Health Organization to ~~standardise effective, safe and sustainable regulatory frameworks for medicinal product~~improve access to safe, effective and affordable medicines;

Amendment 718 #

Motion for a resolution
Paragraph 24

Amendment 719 #

Simona BALDASSARRE, Silvia SARDONE, Joëlle MÉLIN, Aurélia BEIGNEUX, Gianantonio DA RE, Lucia VUOLO, Danilo Oscar LANCINI, Susanna CECCARDI

Motion for a resolution
Paragraph 24

24. Reiterates its commitment to continue working with the Commission and the World Health Organization and the International Council for Harmonisation to standardise effective, safe and sustainable regulatory frameworks for medicinal products;

Amendment 72 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, pre-and post-marketing pharmacovigilance, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;

Amendment 720 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 24 a (new)

24 a. Highlights that according to the WHO, an increasing number of counterfeit drugs are also being sold in developing countries in connection with COVID-19, and continue to be distributed in Europe as well; calls on the Commission and on Member States to improve control of medical products and equipment entering the EU; calls further for the introduction of more stringent penalties for producers and distributors of counterfeit medicines;

Amendment 721 #

Motion for a resolution
Paragraph 24 a (new)

24 a. Stresses the need to ensure that Brexit does not adversely affect our capacity for innovation in the medical field.

Amendment 722 #

Motion for a resolution
Paragraph 24 b (new)

24 b. Recalls that, in situations of crisis or health emergencies, changes to intellectual property rules are not useful to meet short-term needs; invites the Commission to seek solutions, for example in the area of licensing, to address new needs for the production of vaccines or medicines.

Amendment 723 #

Andrey SLABAKOV, Pietro FIOCCHI, Margarita DE LA PISA CARRIÓN, Hermann TERTSCH

Motion for a resolution
Paragraph 25 a (new)

25 a. Calls on the Commission to address the systemic problems embedded in the global pharmaceutical sector to ensure that the development and allocation of essential pharmaceuticals is driven by medical and social needs, not profit, and governed by public mechanisms instead of being left to the discretion of private interests, particularly during health emergencies;

Amendment 73 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, ~~and contributes to meeting the objectives of the European Green Deal,~~ the digital transformation and climate neutrality;

Amendment 74 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Recital C

Amendment 75 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, assessment, testing, authorisation, production, access, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;

Amendment 76 #

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines and medical devices, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;

Amendment 77 #

Peter LIESE, Christine SCHNEIDER, Cindy FRANSSEN

Motion for a resolution
Recital C

C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, manufacturing, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;

Amendment 78 #

Motion for a resolution
Recital C a (new)

C a. Whereas many innovations of the pharmaceutical industry are not really offering breakthrough improvements for the patients but are either so-called ‘me- too’ pharmaceuticals, which are just another substance for the same indication without major benefits or offer only minor improvements with significantly higher costs; whereas it would be beneficial for patients if the framework for the pharmaceutical industry in Europe would better incentivize real breakthrough innovations;

Amendment 79 #

Christine SCHNEIDER

Motion for a resolution
Recital C a (new)

Ca. whereas the strategy must focus more on the innovative potential of European pharmaceutical research, in particular that conducted by SMEs and MidCaps, in order to strengthen Europe for the future; whereas close links must therefore be established with current and future EU strategies, whilst steps are taken to ensure that no additional administrative burdens are imposed on the undertakings in question;

Amendment 8 #

Motion for a resolution
Citation 6 b (new)

— having regard to the Council’s conclusions on innovation for the benefit of patients of 1 December 2014;

Amendment 80 #

Motion for a resolution
Recital C a (new)

C a. whereas 40% of medicinal end products marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; whereas this delocalisation of part of the production of essential components of medicines, vaccines and medical devices has direct consequences on the follow-up of treatments for patients;

Amendment 81 #

Linea SØGAARD-LIDELL, Jan HUITEMA, Asger CHRISTENSEN, Nils TORVALDS, Nicolae ŞTEFĂNUȚĂ, Frédérique RIES, Susana SOLÍS PÉREZ, Emma WIESNER

Motion for a resolution
Recital C a (new)

C a. whereas the overall consumption of pharmaceuticals continues to grow both globally and in the EU; whereas an important part of pharmaceuticals is prescribed, dispensed, sold or used inappropriately; whereas such misuse of pharmaceuticals means a waste of precious resources and can lead to health and environmental hazards;

Amendment 82 #

Motion for a resolution
Recital C a (new)

C a. whereas, to secure the Union's lead position in the pharmaceutical development, the strategy must focus on strengthening the innovative potential of European pharmaceutical research as well as acknowledging and reinforcing the link with the EU industrial strategy, the SME strategy and the European Health Data Space;

Amendment 83 #

Motion for a resolution
Recital C a (new)

C a. Whereas the pandemic has revealed the Union’s neglect of the EU pharmaceutical sector’s capacity to combat cross-border health threats by underfunding biomedical innovation and entrusting R&D necessary to meet public health needs to private companies operating for the purpose of making profit;

Amendment 84 #

Motion for a resolution
Recital C a (new)

C a. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;

Amendment 85 #

Motion for a resolution
Recital C a (new)

C a. Whereas, to make Europe fit for the future, the strategy must focus on strengthening the innovative potential of European pharmaceutical research; whereas this requires a close link with the EU industrial strategy and the European Health Data Space;

Amendment 86 #

Motion for a resolution
Recital C a (new)

C a. whereas to make Europe fit for the future, the strategy must focus on strengthening the innovative potential of European pharmaceutical research; whereas this requires a close link with the EU industrial strategy and the European Health Data Space

Amendment 87 #

Motion for a resolution
Recital C a (new)

C a. whereas the shortage of medicines in the European Union has worsened, in particular as a result of increased global demand; whereas the European Union has lost pharmaceutical independence and self-sufficiency as a result of the relocation of production to third countries;

Amendment 88 #

Motion for a resolution
Recital C a (new)

C a. whereas a competitiveand resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Amendment 89 #

Motion for a resolution
Recital C a (new)

C a. whereas one of the 20 principles of the European Pillar of Social Rights, reinforced by the Porto declaration, establishes that everyone has the right to timely access to affordable, preventive and curative health care of good quality;

Amendment 9 #

Motion for a resolution
Citation 7 a (new)

— having regards to its resolution of 13 September 2018 on a European One Health Action Plan against Antimicrobial Resistance

Amendment 90 #

Dolors MONTSERRAT, Lídia PEREIRA, Radan KANEV, Bartosz ARŁUKOWICZ, Pernille WEISS, Stelios KYMPOUROPOULOS, Cindy FRANSSEN, Roberta METSOLA

Motion for a resolution
Recital C a (new)

Ca. whereas the new pharmaceutical strategy must be implemented taking into account the lessons learned from the COVID-19 crisis, especially the need to reduce the EU's dependence in sectors of a strategic nature.

Amendment 91 #

Motion for a resolution
Recital C a (new)

C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Amendment 92 #

Motion for a resolution
Recital C a (new)

C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Amendment 93 #

Motion for a resolution
Recital Γ a (new)

Ca. whereas ensuring that patients have access to affordable essential medicines is one of the core objectives of the EU, the WHO and UN Sustainable Development Goal 3;

Amendment 94 #

Motion for a resolution
Recital C a (new)

C a. whereas the entry of generics and biosimilars into the market is an important tool for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;

Amendment 95 #

Motion for a resolution
Recital C a (new)

Ca. whereas intensive animal husbandry, with large numbers of animals crowded together, leads to excessive use of veterinary pharmaceuticals, including antibiotics, as well as outbreaks of zoonotic diseases;

Amendment 96 #

Motion for a resolution
Recital C a (new)

C a. whereas a molecule can be repurposed, reformulated and combined with new digital technologies (complex combination) to address unmet patient needs and contribute to healthcare system sustainability;

Amendment 97 #

Motion for a resolution
Recital C a (new)

C a. whereas there is a need for coordination and interlinkage between the Pharmaceutical Strategy, the Beating Cancer plan, the Industrial Strategy for Europe and the Health Data Space;

Amendment 98 #

Motion for a resolution
Recital C a (new)

C a. Whereas the strategy highlights the importance of removing barriers to access for generic and biosimilar medicines and the encouragement of their rapid uptake;

Amendment 99 #