Activities of Alessandra MORETTI related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Shadow reports (1)
REPORT on a pharmaceutical strategy for Europe
Amendments (54)
Amendment 1 #
Motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
— having regard to Article 6 TEU and Article 35 of the Charter of Fundamental Rights of the European Union on the right to preventive healthcare for all European citizens;
Amendment 5 #
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to the ongoing Commission revision of the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;
Amendment 7 #
Motion for a resolution
Citation 6 b (new)
Citation 6 b (new)
— having regard to the ongoing Commission revision of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;
Amendment 40 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas the Treaties and the Charter of Fundamental Rights of the European Union state that everyone shall have access to preventive healthcare and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the economically disadvantaged or smaller Member States and in the most peripheral areas of the Union; whereas shortage of medicines is a growing public health threat with a serious impact on healthcare systems and the right of every patient in the EU to access appropriate medical treatment;
Amendment 71 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full life cycle of medicines, including research, testcollection and production of starting material, research, testing, manufacturing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the Europe’s Beating Cancer Plan, the digital transformation and climate neutrality;
Amendment 94 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas the entry of generics and biosimilars into the market is an important tool for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;
Amendment 100 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
Amendment 110 #
C c. whereas the loss of European independence in the health sector is linked to the relocation of production, with 40 % of medicinal end products marketed in the EU now originating in third countries; whereas while Europe has a strong manufacturing footprint, the supply chain still relies heavily on subcontractors to produce pharmaceutical raw materials outside the EU, where labour costs and environmental standards are often lower, with the result that 60 % to 80 % of chemical active ingredients are manufactured outside the EU, mainly in China and India; whereas, to date, no label or labelling visible to patients and customers is required for medicinal products and active pharmaceutical ingredients (APIs) concerning their origin and country of manufacturing; whereas limited access to APIs required for the production of generic medicines poses a particular challenge; whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted even more the EU’s dependency on third countries in the health sector; whereas the novel coronavirus pandemic has also revealed shortages of medical devices, medical products and protective equipment;
Amendment 128 #
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1 Stresses that the EU pharmaceutical strategy should be focusing on the interest of patients and that any support or public funding should be conditioned to the protection of public health and equitable access to healthcare services and treatments in the EU;
Amendment 129 #
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1 a Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and stresses the importance to decrease the EU’s reliance on third countries’ imports of key starting material of plasma for the manufacturing of plasma-derived medicinal products, and to prevent shortages thereof, prioritising the interest and safety of patients; stresses the importance of ensuring that all Member States have fair access to the supply chain; highlights, to that end, the need for the Union’s pharmaceutical industry to have a diversified supply chain and a medicine shortage risk mitigation plan to cope with any vulnerabilities and risks to their supply chain;
Amendment 131 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative medicines and treatments, as well as access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseasesfair and equitable access to safe, effective, high-quality and affordable healthcare services and treatments for all, as well as investment in research into and the development of innovative medicines and treatments, are essential for making progress in the prevention, diagnosis, treatment of diseases and quality of life of patients; regrets the disparities into the access to high quality healthcare services among member states and also between different regions within member states and asks the Commission to address those disparities with the appropriate legislative measures in order to ensure equal rights in the EU;
Amendment 154 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. ConsiderUnderlines that investment in research has not been sufficient to meet should be further conditioned to public interest, recalls that public and private investments should be oriented with the necessary regulatory and legislative measures to meet the therapeutic needs of patients with, including rare diseases, rare adult cancers and paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 183 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated through a single calendar at EU level; calls on the Commission and member states to address AMR with concrete and prompt measures, also with regulatory and legislative ones if needed;
Amendment 200 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to revise the system of incentives and incorporate new criteria into the system of incentives forpromote public health driven research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim ofas for example rare diseases, rare adult cancers and paediatric cancers, neurodegenerative diseases and AMR, with the objective of protecting public health, guaranteeing equitable rights and access to treatment for all, finding more therapeutic options at affordable prices and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 239 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote a dialogue with the Member States and stakeholders to assess new criteria for negotiating national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the populationresearch and development of the product, while promoting an analysis as well on what constitutes a socially acceptable profit margin for pharmaceutical products; recalls that national pricing should be based on transparency of factors such as public and private research, development costs and added therapeutic value; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;
Amendment 261 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, also via a revision of the Transparency Directive in order to include voluntary/secret agreements, public procurement and generic medicines, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; recalls that all public funding must be made conditional on the full transparency and traceability of investments, on supply obligations on the EU market, to ensure accessibility and affordability of manufactured medicines in the EU and to guarantee fair return of public investments;
Amendment 280 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on the Commission to introduce measures to increase transparency into the research and development cost of medicinal products and to contribute to the development of a pricing mechanism in consultation with Member States which takes into account the actual cost of development and production;
Amendment 284 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Recalls that transparency on pricing should be enhanced, urges the Commission to take action in this sense particularly with regard to clearer information about list and net prices to be made publicly available, in order to mitigate asymmetry of information and disparities between Member States notably for products under market exclusivity; recalls its position on Directive 89/105/EC and calls on the Commission to revise the directive to ensure price transparency facilitating overall pricing and reimbursement;
Amendment 287 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
Amendment 289 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments, allowing a broader competition and contributeing greatly to the budgetary sustainability of healthcare systems, thus helping to improve access to treatment for patients; calls on the Commission to introduce legislative and non-legislative measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the productionheir timely access to markets across the EU; regrets that generic and biosimilar alternatives are often not available in low and middle income member states where they might be needed most; deplores the litigation cases aimed at delaying generic entry and calls on the Commission to address any misuse of the IPR system to delay entry of generic and biosimilar medicines into the EU and to propose EU protocols for the interchangeability of biosimilar medicinesmarket; calls on the Commission to ensure that the end of the innovator’s period of commercial exclusivity is respected in order to make treatments available to patients as swiftly as possible;
Amendment 312 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Calls on the Commission to harmonise at EU level the interpretation of the so called Bolar provision and extend its application for exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers in order to facilitate and speed up their entry to market; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;
Amendment 323 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the nee and also recalls the importance of addressing the issue of disparities in the availability of certain medicines due to discontinuation of products or withdrawals from less profitable markets of some Member States, where patients do not have access to treatments due to commercial decisions made by pharmaceutical companies and MAHs; calls on the Commission and Member States to implement the necessary measures in order to make centrally authorised medicines timely available to patients without any further delay and calls on the Commission to tackle the problem of diverging market launches by linking the centralised marketing authorization to commitments on the part of pharmaceutical companies to not delay the availability of the product in any Member State; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition and calls on the Commission to further develop capabilities to investigate potential anti-competitive practices; stresses the need address the reasons why the medicine approval time is so heterogeneous across the EU and to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensurewhen considered safe and beneficial for patients, in order to remove any obstacle to a rapid and equalitable access to medicines for everyone in the EU; all in the EU; emphasises that any revision of the regulatory procedures and approaches to the assessment of scientific evidence must be cautiously undertaken in order to adequately take patient benefit and safety aspects into consideration;
Amendment 336 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefitsrole of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; recalls that any PPPs must produce results in the interest of patients, maximise public return on public investment and respect the principles of transparency, traceability and affordability;
Amendment 346 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to swiftly propose guidelines for the Member States, notably on how to best implement the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards; notes that procurement procedures with only one successful tenderer and/or only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to consider introducing procurement procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers;
Amendment 355 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of newneed for joint EU public procurement contracts by the Commission and the Member States, especially for, but not limited to, emergency medicines and unmet therapeutic needs; underlines the need to ensure high levels of transparency in these initiatives and apply lessons learned from joint procurement of COVID-19 vaccines;
Amendment 366 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Calls on the Commission and Member States to promote the creation of one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare;
Amendment 378 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that theaccessibility and affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive or not even launched in certain Member States for commercial reasons; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust and fair competition and to stabilise and balance national drug pricing systems; promote fair national drug pricing systems; stresses the need to link any form of incentive to affordability clauses in order to ensure equal and fair pricing of pharmaceuticals, particularly innovative ones; calls for an increased transparency on research costs incurred for pharmaceutical development to better adjust the pricing mechanism to the actual costs; calls on the Commission and Member States in this regard to establish a framework for reporting research cost as regards pharmaceutical development;
Amendment 391 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls the Commission to consider new processes for promoting the repurposing of medicinal products given that, as new research into certain medicinal products has proved, for example for anti-inflammatory and immunosuppressant Rheumatic and Musculoskeletal Disease (RMD), they can be adopted quickly to provide more effective and lower cost treatments for many burdensome inflammation-linked diseases including COVID-19, cancer, cardiovascular disease and diabetes; calls on the Commission to analyse the existing situation concerning off-label use of medicines, including less expensive medicines and medicines used for rare cancers among others, and underlines the need to address this issue in order to facilitate the use of those medicines when beneficial for the patient;
Amendment 401 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;
Amendment 406 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11 c. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;
Amendment 407 #
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11 d. Encourages the inclusion of disease-based communities in the European Medicines Agency’s Scientific Advice processes, for rare cancers and diseases, to provide regulators with their expertise of the disease and factor in its rarity and unmet needs;
Amendment 412 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexipublic responsibilities fall upon the EU pharmaceutical industry and that its competitiveness is strategic for functioning and effective healthcare systems in the EU and for public authorities to be more responsive to patients’ needs and protect public health; points out a predictable and agile regulatory environment; believ is beneficial to address that it ce needs of patients and thrive globally with a clear, robust and efficient intellectual property systemo create a better environment for innovation and drugs development; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; underlines that a harmonised interpretation of the General Data Protection Regulation (GDPR) in all EU Member States is the foundation for such initiatives;
Amendment 426 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Notes that patent protection is a key incentive for companies to invest in innovation and produce new medicines; notes, at the same time, that the exclusionary effect of patents may lead to limited market supply and reduced access to medicines as well as pharmaceutical products; stresses that a balance should be struck between encouraging innovation through the exclusionary effect of patents and ensuring access to medicines and protecting public health; recalls that a company that markets a medicine can enjoy data exclusivity for a period of eight years as of the first marketing authorisation pursuant to Article 14(11) of Regulation (EC) No 726/2004; calls on the Commission to propose a revision of that regulation to provide for the possibility to temporarily authorise the granting of compulsory licenses in the event of a health crisis in order to allow the production of generic versions of life-saving medicines; recalls that this is one of the public health flexibilities in the field of patent protection already included in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as further reaffirmed by the 2001 Doha Declaration; calls on the Commission to ensure that the implementation of the EU free trade agreements (FTAs) does not interfere with the possibilities of invoking flexibilities provided by the TRIPS Agreement and to provide guidance to Member States in order to encourage voluntary licencing over immediate compulsory licencing;
Amendment 448 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Recalls that Regulation (EC) No 816/2006 harmonises the procedure for granting compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products; Calls on the Commission to update and harmonise the rules on granting compulsory licensing of medicinal products and to introduce waivers for data and market exclusivity to allow effective compulsory licensing as an important public health safeguard for EU Member States allowing them to respond faster and more effectively to future European public health crises;
Amendment 460 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Emphasises that patent protection and enforcement should have due regard for the interests of society, namely the safeguarding of human rights and public health priorities; recalls, in the same vein, that patent protection should not interfere with the right to health and should not serve to widen the gap between wealthier and poorer citizens when it comes to access to medicines; considers that the Union’s approach to this question should ensure harmonisation and coherence among the different measures at the disposal of the Member States;
Amendment 468 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Stresses the need for a harmonised implementation of the General Data Protection Regulation (GDPR), especially by Data Protection Authorities and its interaction with the Clinical Trials Regulation (CTR) once applicable; requests the European Data Protection Board to ensure its guidelines concerning health research are updated with the aim of fostering research;
Amendment 493 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to revise the use of supplementary protection certificates based on technological and scientific advances to preventallow generic and biosimilar medicines fromto becoming lesse more competitive inside and outside the EU; Recalls that supplementary protection certificates (SPCs), by extending the patent term up to 5 years, delay access to more affordable generic and biosimilar products thereby placing a major financial burden on national healthcare systems and hampering patients access to treatment; underlines therefore that the use of SPCs should be allowed only for exceptional and justified cases;
Amendment 502 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level; recalls that any form of fund or support must be conditioned to clauses on traceability, transparency, accessibility and affordability of manufactured medicines and supply obligations;
Amendment 509 #
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 539 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. Urges the Commission, having regard to the European Strategy for Data and the digital transformation of healthcare and considering the vast potential that health data has for improving healthcare quality and patient outcomes, to encourage implementation of interoperable technologies in the Member States’ health sectors which will facilitate delivery of innovative health solutions to patients; welcomes the planned creation of a fully cooperative and operational European Health Data Space with a governance framework which fosters the creation of an innovative data-driven ecosystem, based on a secured and controlled exchange of information and critical data, among Member States; asks the Commission to promote next-generation standards, tools and infrastructure in order to store and process data suitable for research and the development of innovative products and services; underlines that personal health data may only be collected and processed on the legal grounds provided for in Article 6(1) of the GDPR, coupled with the conditions provided for in Article 9 of the GDPR; considers that in this context further processing of personal health data should be prohibited; urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe; recalls the need of finding a balance between data protection and the condition for a productive research collaboration at EU and international level and to ensure access to large, high quality health data sets to researchers and clinicians, which could be fundamental for developing innovative treatments;
Amendment 543 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16 b. Recalls the importance of adapting existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems in the interest of patients;
Amendment 544 #
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
16 c. Calls on the Commission to require pharmaceutical companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data and active pharmaceutical ingredient sources, number and status of patents and patent applications, and supply chains as a condition for market approval;
Amendment 547 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls onfor the Commission to work with the EMA to develop the use ofpaper information notice to be supplemented by an electronic product information leaflet notice, to be drawn up in all languages for all the countries where the medicine is marketed in order to facilitate the moving and sales of medicines within the single market and thus mitigate shortages; stresses that electronic product information for all medicines in the EUcould complement, but never replace, the package information leaflet;
Amendment 562 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Calls for a review of the incentives put in place to encourage research in orphan medicines to evaluate their effects and consider appropriate actions to this end; calls for Regulation (EC) No 141/2000 on orphan medicinal products to be revised in order to reverse the burden of proof for the 10-year market exclusivity clause so that the holder of the market authorisation has to prove that the product is not sufficiently profitable to cover R&D costs;
Amendment 564 #
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17 b. Calls on the Commission to address the negative impacts of parallel trade with regards to shortage of medicines in the Member States and to tackle problems adequately by taking the necessary action to ensure that medicines reach all patients in the EU in a timely manner;
Amendment 581 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission, Member States and the European Medicines Agency to develop an early warning system for drugmedicine shortages, based on a European information network on supply problems, n electronic platform capable of determining the volume of stock existing at any given moment, as well as the actual level of demand, providing data capable of detecting, predicting and preventing shortages of medicinal products; calls also to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;
Amendment 595 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Underlines that the EP in its recent resolution on shortage of medicines has recalled the obligations for the supply of medicinal products by marketing authorisation holders (MAHs) and distributors, as well as a notification obligation in the event of a temporary or permanent supply interruption, as provided by Directive 2001/83/EC; regrets once more the disparities observed in the transposition of these obligations into national legislations for which the Commission and member states must react promptly and with binding measures; calls on the Commission and the Member States to ensure that MAHs and wholesale distributors comply with the requirements of Directive 2001/83/EC in order to ensure appropriate and continued supplies of medicines; calls on the Commission to further clarify the obligations for MAHs under Directive 2001/83/EC and highlights the need to ensure that they report medicine shortages within the established timeframes; stresses the need to apply dissuasive and proportionate sanctions in the event of non-compliance with these legal obligations in line with the existing legislative framework;
Amendment 616 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. SuppNotes the efforts of the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non- governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chainas one of the tool to explore weaknesses and deficiencies in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;
Amendment 641 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and contribute to an effective response in the event of a health emergency; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines and to support that Member States can import medicines produced under a compulsory license by reversing their opt-out of Article 31bis of the TRIPs agreement;
Amendment 650 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Calls on the Commission to evaluate the TRIPS+ commitments in EU trade agreements in light of the lessons learned from the covid-19 pandemic, and to increase the effective use of intellectual property rights flexibilities;
Amendment 651 #
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21 b. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply chains; calls for the implementation of binding shortage prevention and management risk plans address to EMA and national authorities to be made mandatory for MAHs and wholesale distributors;
Amendment 652 #
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21 c. Calls on the Commission to take stock of the lessons learnt with the negotiations around COVID-19 vaccines and facilitate clear contracts between the EMA and industry on preventing and managing pharmaceutical supply chain disruptions; stresses that contracts should come with conditionalities and sanctions should a stakeholder not fulfil its commitments;
Amendment 703 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.
Amendment 718 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Reiterates its commitment to continue working with the Commission and the World Health Organization to standardise effective, safe and sustainable regulatory frameworks for medicinal productimprove access to safe, effective and affordable medicines;