49 Amendments of Margrete AUKEN related to 2016/2057(INI)
Amendment 15 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to the Report of the United Nations Secretary-General's High Level Panel on access to medicines – Promoting innovation and access to health technologies – published in September 2016;
Amendment 35 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Recalls that in its reply to Petition No 2128/2014 where the petitioner demands the EU to adopt a directive allowing governments to impose compulsory licences and royalty levels on pharmaceutical patents when the general or public interest is at stake, the Commission states that it "has no plans to harmonise this field, given that many Member States, including Spain, already have provisions in national law for compulsory licensing";
Amendment 37 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Recognises the current market failure to produce medicines patients need, as pointed out in Petition No 2128/2014 where "the petitioner regrets that the medicine Reandron, used by transgenders and patients that were operated for testicular cancer to increase their testosterone levels, was withdrawn from the Spanish market by its exclusive producer, Bayer. Indeed, following the order of the Ministry of Health to decrease its price by 35% to be reimbursed, Bayer estimated it was not profitable anymore. Even though the Ministry assured there are alternatives to this medicine, these alternative are less efficient and require more numerous injections (whereas the Reandron only needs to be injected every three or four months). Thus, it forces the patients to be more dependent on the healthcare, and creates a new burden on the social security system."
Amendment 39 #
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Recalls the detrimentally high level of public dependency on the will of the private companies to develop life- saving products, as highlighted in Petition n° 0791/2009, where the Commission recalls in its reply that "the pharmaceutical legislation of the EU foresees specific instruments as incentives for the development of innovative medicines, in particular data exclusivity for specific studies, or market exclusivity for certain medicinal products for rare diseases. Within this legal framework, pharmaceutical companies are free to choose which medicinal products they want to develop."
Amendment 48 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Deplores that while the European Semester thematic analysis on health and health systems 2016 1a identifies that "the most common barriers for access to healthcare resulted from patients' inability and/or unwillingness to pay medical goods and services, while in some countries waiting times or travelling distance were an issue healthcare could also be constrained by insufficient availability of healthcare infrastructure and health workforce", it does not include any explicit recommendation on lowering the prices of medicines and strengthening the budgets for staff and infrastructure; __________________ 1a http://ec.europa.eu/europe2020/pdf/theme s/2016/health_health_systems_201605.pdf
Amendment 50 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the third Sustainable Development Goal of the United Nations is to ensure healthy lives and promote well-being for all at all ages;
Amendment 56 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination;
Amendment 57 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
Amendment 58 #
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas trade and investment agreements regularly contain TRIPS-plus provisions that increase levels of intellectual property protection and enforcement that impede the ability of parties to use laws and policies promoting their human rights obligations to the fullest extent possible;
Amendment 64 #
Motion for a resolution
Recital C
Recital C
C. whereas the prices of new medicines, following the expiry of the patents on blockbuster medicines, the pharmaceutical sector changed its business model towards acquisitions of niche market pharmaceutical assets; whereas the prices of new medicines, directly linked to the need for pharmaceutical companies to propose an attractive return on investments for their shareholders, have increased during the past few decades to the point of being unaffordable for many European health care systems and citizens;
Amendment 74 #
Motion for a resolution
Recital D
Recital D
D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, rigid patent rules and budget restrictions owing in particular to the economic crisis that has hit the European Union and austerity policies;
Amendment 85 #
Draft opinion
Paragraph 10
Paragraph 10
10. Calls on the Member StatesCommission to establish a pooled public platform for R&D financed by all sMember States via a contribution of 0.01 % of their GDP. Considers that this platform should also be able to directly produce life-saving medicines in the EU in case a market failure has been identified.
Amendment 89 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and whereas there is concernaccessibility of the knowledge contained in patent applications, whereas the WTO Doha declaration on the TRIPS agreement and Public Health raised concerns about its effects on prices and whereas the Commission raised concerns in its sector inquiry about the abuse/misuse thereof;
Amendment 97 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the WTO TRIPS agreement provides since 1995 for patent flexibilities, such as compulsory licensing, i.e. when a government allows someone else than the patent owner to produce the patented product or process without the consent of the patent owner, for the domestic market only, and where the patent owner still has to be paid royalties;
Amendment 101 #
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the private sector currently holds a monopoly on the production facilities and whereas the EU has to face a widely recognised market failure leading to a lack of private investment in R&D in combating non- competitive segments for which the market does not provide sufficient financial return, such as antimicrobial resistance, rare diseases or poverty-related diseases;
Amendment 102 #
Motion for a resolution
Recital E c (new)
Recital E c (new)
Ec. whereas the number of new medicines put on the market has continuously been decreasing in last years and whereas among the new medicines, only 1% were seen as innovative or a real therapeutic advance by Prescrire, an independent critical drug information journal in France;
Amendment 103 #
Motion for a resolution
Recital E d (new)
Recital E d (new)
Ed. whereas the sector inquiry led by the Commission has shown that from 2000 – 2007 originator companies spent on average 17% of their turnover from prescription medicines on R&D worldwide (approximately 1.5% of turnover was spent on basic research to identify potential new medicines and 15.5% of turnover was spent on developing the identified potential medicines through trials into products sufficiently safe and efficacious to be marketed), while expenditure on marketing and promotional activities accounted for 23% of their turnover during the period;
Amendment 104 #
Motion for a resolution
Recital E e (new)
Recital E e (new)
Ee. whereas on 31st August 2016, on the basis of urgent public interest, the German Federal Patent Court issued a compulsory licence for an HIV drug as requested by the company Merck, after the patent holding company Shionogi had rejected Merck's offer for a voluntary worldwide license on the patent; whereas the NGO Médecins du Monde successfully filed a patent opposition to sofosbuvir, the active substance of a new drug against Hepatitis C owned by the company Gilead that was added to the WHO list of essential medicines in 2014, the EPO deciding on 5th October 2016 that Gilead's patent extended beyond the content of the patent application as filed;
Amendment 112 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas there are currently no tools that prevent the public from paying medicines twice, via reimbursement guaranteed by the national public health systems and substantial contributions to financing R&D in the pharmaceutical sector through: - public subsidies to research programmes such as Horizon 2020 and Innovative medicines initiatives (IMI) where attribution of funds is not yet subject to any condition regarding local employment and unpatentability of the results - tax credits
Amendment 118 #
Motion for a resolution
Recital G
Recital G
G. whereas the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States and whereas strong asymmetry in negotiation powers is to deplore between globalised multinational pharmaceutical companies and individual Member States that are subject to fiscal and social competition among themselves and with third countries in an attempt to foster attractiveness of their labour market, fight against unemployment and resistance to offshoring blackmailing by the private sector;
Amendment 127 #
Motion for a resolution
Recital H
Recital H
H. whereas, in the absence of EU fiscal and social integrated policy, the majority of Member States have their own health care assessment agencies with their own standards;
Amendment 129 #
Motion for a resolution
Recital I
Recital I
I. whereas the entry of generics onto the market is an important mechanism to reduce prices, and whereas there areremedy distorted competition, reduce expenditure on medicines and improve universal access to affordable medicines, and whereas the Commission expressed clear concerns about the strategies to delay this entry;
Amendment 158 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that the EU pharmaceutical industry is one of the most competitive industries in Europe and that quality, safety and efficacy of innovation isare key to improving its competitiveness;
Amendment 172 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Regrets that as long as medicines are considered to be regular consumer goods, unresolved policy incoherencies between trade and intellectual property rules, public health objectives and international human rights lead to a situation where the research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented;
Amendment 202 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that the interests of the pharmaceutical industry, as trade and intellectual property rules were not developed with the goal of protecting the right to health, the interests of private patent holders favour short trials and fast access to the market;
Amendment 227 #
5a. To this effect, asks the Commission to commit itself to carrying out an analysis of the patent system for medicines, in particular to check whether patents for medicines obstruct innovation and the movement of products in delicate and non-competitive sectors, such as the treatment of rare diseases;
Amendment 246 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that the high level of public funds used for R&D is not reflected in the pricing due to the lack of traceability of the public funds in the patenting and licensing conditions, impeding a fair public return on public investment;
Amendment 254 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Recalls that the WTO TRIPS Agreement provides for flexibilities to patent rights, such as compulsory licensing, which have proven to be a major tool to introduce competition and bring prices to reasonable levels;
Amendment 255 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission to set up an EU easily searchable and regularly updated database on the flexibilities to patent rights requested/used in Member States and on filed patent oppositions and the outcome thereof;
Amendment 287 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of assessing the real therapeutic evidence- based added value of new medicines compared to the best available alternative; therefore calls on the Commission to extend the definition of added therapeutic value used for paediatric medicines to all medicines, as follows: "Added therapeutic value could be based on one or more of the following: - reasonable expectation of safety and efficacy for an authorised or new medicinal product to treat a condition, where no authorised medicinal product is on the market; - expected improvement in efficacy, as compared with the current standard of care for the treatment, diagnosis or prevention of the condition concerned; - expected improvement in safety, as regards adverse reactions or potential medication errors as compared with the current standard of care; - improved dosing scheme or method of administration (e.g. number of doses per day, oral compared with intravenous administration, reduced treatment duration) leading to improved safety, efficacy or compliance; - availability of a new clinically relevant formulation or pharmaceutical form; - different mechanism of action, with a scientific explanation of the potential advantage in terms of improved efficacy or safety; - unsatisfactory nature of existing treatments and need for alternative methods expected to involve an - improved benefit-risk balance; and - expected improvement in the quality of life;"
Amendment 308 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profit; the failure of the market to systematically invest in needed innovation demonstrates the inefficacy of policies linking the price to the costs of R&D and that a fair price should cover the cost of the drug production, plus a reasonable margin of profit; therefore calls on to the Commission and Member States to explore the implementation of delinkage mechanisms, characterized by the uncoupling of R&D costs and the end prices of health products, to finance research and development as mentioned in the report of the United Nations Secretary General's high level Panel on access to medicines - Promoting innovation and access to health technologies;
Amendment 319 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Commission to set up, in cooperation with Member States, a public and regularly updated database with the different prices across the EU of patented and generic medicines and biosimilars, also indicating the geographical distribution of purchase and sales volumes thereof;
Amendment 326 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Calls on the Commission to enhance detailed control of use of R&D public funding for medicines, and to make sure that research funds are not invested in marketing;
Amendment 334 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few ofe low level of public return on public investment in them are entirely publicbsence of access conditionalities to EU public funding;
Amendment 346 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recalls that transparency in all EU and national institutions and agencies is crucial to the well functioning of democracy, and that experts involved in the authorisation process should have no conflicts of interest;
Amendment 368 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for EU-wideon the Commission to ensure the implementation of measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;
Amendment 381 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide measures on the pharmaceutical marketon the Member States, in cooperation with the Commission, to join forces to reinforce the negotiation capacities of Member States in order to achieve availability and fair prices ofor medicines all across the EU;
Amendment 392 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to promote transparency on the costs of R&D and to promote R&D driven by patients’' needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Daiming at defining EU public health needs in a democratic and inclusive way based on: - analysis of the sales volumes for each medicine and for each therapeutic indication, to the extent possible including off-label use - analysis of the burden of each disease, taking social and geographical distribution into account - analysis of national registries for diseases and syndromes - consultations with the Council, the Parliament, EMA and ECDC - consultations with all stakeholders in a public and transparent way, including first and foremost patients, carers and doctors, including those who work with alternative treatments to chemical ones;
Amendment 415 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to analyse the overall impact of IP in promotingdelaying access to innovation, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;
Amendment 432 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to promote open data in private research, especially where public funding is involvedresearch on public health, and to establish conditions such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020 and IMI;
Amendment 437 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission, when engaged in bilateral trade and investment partnerships to ensure that these agreements do not include provisions that interfere with the obligations of Member States to fulfil the right to health;
Amendment 461 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to only allow fast-track approval in exceptional and duly justified urgencies, to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness;
Amendment 490 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a Europeanduce a report analysing the current different national systems for classification on the added value level of medicines in the EU and beyond;
Amendment 529 #
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Calls on the EPO and the Member States to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability; a mere discovery of a new form of a known substance that does not improve efficacy should not be patentable;
Amendment 537 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Calls on the Member States, where the private sector fails to deliver on availability and/or affordability of medicines listed on the WHO list of essential medicines, to cooperate in setting up public facilities for medicines production, while those medicines should be produced and sold in the EU at a price not exceeding the cost of production;
Amendment 563 #
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission to propose a new directive on transparency of price-setting procedures, of real costs of R&D and marketing and reimbursement systems, taking into account the challenges of public budgets and of the market;
Amendment 567 #
Motion for a resolution
Paragraph 32
Paragraph 32
32. Calls on the Commission and the Court of Justice of the European Union to clarify, in accordance with Article 102 of the TFEU, what constitutes an abuse of a dominant position due to high prices in the case of the Peyona orphan drug;
Amendment 572 #
Motion for a resolution
Paragraph 33
Paragraph 33
33. Calls on the Commission and the Member States to make use of the flexibilities under the WTO TRIPS Agreement and to coordinate and clarify their use when necessary; recalls that no undue political and economic pressures should be used to dissuade governments from using the flexibilities that could protect public health;
Amendment 585 #
Motion for a resolution
Paragraph 35
Paragraph 35