2021/2013(INI) A Pharmaceutical Strategy for Europe
Lead committee dossier:
Progress: Awaiting committee decision
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | MONTSERRAT Dolors ( EPP) | MORETTI Alessandra ( S&D), SØGAARD-LIDELL Linea ( Renew), METZ Tilly ( Verts/ALE), BALDASSARRE Simona ( ID), SLABAKOV Andrey ( ECR), KONEČNÁ Kateřina ( GUE/NGL) |
Committee Opinion | ITRE | BOTENGA Marc ( GUE/NGL) | Joëlle MÉLIN ( ID), Dominique RIQUET ( RE), Jutta PAULUS ( Verts/ALE), Ivo HRISTOV ( S&D), Pernille WEISS ( PPE), Margarita DE LA PISA CARRIÓN ( ECR) |
Committee Opinion | TRAN | ||
Committee Opinion | IMCO | ||
Committee Opinion | JURI | REGIMENTI Luisa ( ID) | Emmanuel MAUREL ( GUE/NGL), Angelika NIEBLER ( PPE), Jana TOOM ( RE), Tiemo WÖLKEN ( S&D), Kosma ZŁOTOWSKI ( ECR), Marie TOUSSAINT ( Verts/ALE) |
Lead committee dossier:
Legal Basis:
RoP 54, RoP 57
Legal Basis:
RoP 54, RoP 57Events
2021/05/03
EP - Committee draft report
Documents
2021/03/18
EP - REGIMENTI Luisa (ID) appointed as rapporteur in JURI
2021/03/11
EP - Committee referral announced in Parliament
2021/03/11
EP - Referral to associated committees announced in Parliament
2021/02/17
EP - MONTSERRAT Dolors (EPP) appointed as rapporteur in ENVI
2021/02/08
EP - BOTENGA Marc (GUE/NGL) appointed as rapporteur in ITRE
Activities
- Lívia JÁRÓKA
Plenary Speeches (0)
- Kateřina KONEČNÁ
Plenary Speeches (0)
- Marisa MATIAS
Plenary Speeches (0)
- Tilly METZ
Plenary Speeches (0)
- Alessandra MORETTI
Plenary Speeches (0)
- Angelika NIEBLER
Plenary Speeches (0)
- João PIMENTA LOPES
Plenary Speeches (0)
- Clare DALY
Plenary Speeches (0)
- Juozas OLEKAS
Plenary Speeches (0)
- Marc BOTENGA
Plenary Speeches (0)
- Mislav KOLAKUŠIĆ
Plenary Speeches (0)
- Stelios KYMPOUROPOULOS
Plenary Speeches (0)
- Dolors MONTSERRAT
Plenary Speeches (0)
- Jutta PAULUS
Plenary Speeches (0)
- Susana SOLÍS PÉREZ
Plenary Speeches (0)
- Simona BALDASSARRE
Plenary Speeches (0)
- Joanna KOPCIŃSKA
Plenary Speeches (0)
- César LUENA
Plenary Speeches (0)
- Edina TÓTH
Plenary Speeches (0)
- Eugen JURZYCA
Plenary Speeches (0)
- Sara CERDAS
Plenary Speeches (0)
- Luisa REGIMENTI
Plenary Speeches (0)
- Tomislav SOKOL
Plenary Speeches (0)
- Véronique TRILLET-LENOIR
Plenary Speeches (0)
- Klára DOBREV
Plenary Speeches (0)
- Mathilde ANDROUËT
Plenary Speeches (0)
- Pernille WEISS
Plenary Speeches (0)
- Sunčana GLAVAK
Plenary Speeches (0)
- Ladislav ILČIĆ
Plenary Speeches (0)
Amendments | Dossier |
389 |
2021/2013(INI)
2021/06/02
ITRE
296 amendments...
Amendment 1 #
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 #
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 #
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 #
Draft opinion Paragraph 2 2.
Amendment 108 #
2.
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 #
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.
Amendment 111 #
Draft opinion Paragraph 2 2. Calls on the Commission to keep the results of Union-funded R&D in the public domain;
Amendment 112 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 113 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 114 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 115 #
Draft opinion Paragraph 2 a (new) 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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 Amendment 133 #
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 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 and prioritisation of public interest;
Amendment 135 #
Draft opinion Paragraph 3 3. Calls on the Commission to develop
Amendment 136 #
Draft opinion Paragraph 3 3. Calls on the Commission to develop a new
Amendment 137 #
Draft opinion Paragraph 3 3. Calls on the Commission to develop
Amendment 138 #
Draft opinion Paragraph 3 3. Calls on the Commission to
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 #
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 #
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 #
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 #
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 #
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 Amendment 154 #
Draft opinion Paragraph 4 Amendment 155 #
Draft opinion Paragraph 4 4.
Amendment 156 #
Draft opinion Paragraph 4 4.
Amendment 157 #
Draft opinion Paragraph 4 4.
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 #
Draft opinion Paragraph 4 a (new) 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 #
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 #
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 #
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 #
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 #
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) Amendment 171 #
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 Amendment 173 #
Draft opinion Paragraph 5 5.
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
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
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 #
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 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
Amendment 184 #
Draft opinion Paragraph 6 6. Calls on the Commission to support novel pricing models based on real
Amendment 185 #
Draft opinion Paragraph 6 6. Calls on the Commission to support pricing models
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) 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 #
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 #
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 #
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 #
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 #
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
Amendment 20 #
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 #
Draft opinion Paragraph 7 7. Calls on the Commission to
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 #
Draft opinion Paragraph 7 7. C
Amendment 204 #
Draft opinion Paragraph 7 7. Calls on the Commission to
Amendment 205 #
Draft opinion Paragraph 7 7. Calls on the Commission to
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.
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 #
Draft opinion Paragraph 7 a (new) 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 #
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) 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 Amendment 218 #
Draft opinion Paragraph 8 Amendment 219 #
Draft opinion Paragraph 8 Amendment 22 #
Draft opinion Recital B B. whereas universal access to medicines is a fundamental right, the full reali
Amendment 220 #
Draft opinion Paragraph 8 Amendment 221 #
Draft opinion Paragraph 8 Amendment 222 #
Draft opinion Paragraph 8 8.
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
Amendment 224 #
Draft opinion Paragraph 8 8.
Amendment 225 #
Draft opinion Paragraph 8 8.
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
Amendment 230 #
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 #
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
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) 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 #
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
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) 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 #
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 #
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
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 #
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 #
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 #
Draft opinion Paragraph 8 g (new) Amendment 27 #
Draft opinion Recital B B. whereas
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 #
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 #
Draft opinion Recital B B. whereas universal access to medicines is a fundamental right, the full reali
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) 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 #
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 #
Draft opinion Recital B B. whereas universal access to medicines is a fundamental right the full
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
Amendment 30 #
Draft opinion Recital B B. whereas
Amendment 31 #
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) Amendment 34 #
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 #
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 #
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) 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 #
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 #
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) Amendment 53 #
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 #
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 #
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 #
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) 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) 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
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.
Amendment 73 #
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
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 #
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 Preparedness and Response Authority (HERA) along those lines;
Amendment 77 #
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 #
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 #
Draft opinion Paragraph 1 b (new) 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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 #
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 #
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
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
Amendment 28 #
Draft opinion Paragraph 2 2.
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
Amendment 30 #
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;
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 #
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 #
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
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 #
3. Stresses the importance of investment and support
Amendment 46 #
Draft opinion Paragraph 3 3. Stresses the importance of supporting research in the EU
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,
Amendment 49 #
Draft opinion Paragraph 3 3. Stresses the importance of supporting research in the EU
Amendment 5 #
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 #
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 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.
Amendment 62 #
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) 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 #
Draft opinion Paragraph 4 e (new) 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 #
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 #
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 #
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 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,
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 #
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
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