Activities of Jana TOOM related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (16)
Amendment 1 #
Draft opinion
Paragraph -1 (new)
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 6 #
Draft opinion
Paragraph 1 a (new)
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 14 #
Draft opinion
Paragraph 1 b (new)
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 18 #
Draft opinion
Paragraph 1 c (new)
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 21 #
Draft opinion
Paragraph 1 d (new)
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 28 #
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicinesNotes that patent protection is an incentive for companies to invest in innovation and produce new medicines; notes at the same time that the exclusionary effect of patents may lead to limited market supply and reduced access to medicines as well as pharmaceutical products; notes that a balance should be struck between intellectual property protection, encouraging innovation, ensuring access to medicines and protecting public health; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic;
Amendment 34 #
Draft opinion
Paragraph 2 a (new)
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 37 #
Draft opinion
Paragraph 2 b (new)
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 39 #
Draft opinion
Paragraph 2 c (new)
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 40 #
Draft opinion
Paragraph 2 d (new)
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)
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)
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)
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)
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 49 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of supporting research in the EU, not least in order to increase the number of patents filed in the Member States; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;
Amendment 79 #
Draft opinion
Paragraph 6
Paragraph 6