45 Amendments of Jasenko SELIMOVIC related to 2016/2057(INI)
Amendment 9 #
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the Report of the United Nations Secretary-General's High- Level Panel on Access to Medicines
Amendment 11 #
Motion for a resolution
Citation 4
Citation 4
— having regard to the antitrust procedure, Case AT.39612 – Perindopril (Servier), and to paragraphs 249 and 250 of the judgment of the Court of Justice of 14 February 1978 in Case 27/76 on excessive prices,;
Amendment 47 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the high prices of innovative medicines conflicts with the patients' and national health systems' ability to pay for pharmaceutical expenditure and hinders the fundamental right of citizens to health and medical treatment;
Amendment 84 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the growing expenditure in the pharmaceutical sector prompts European cooperation and new policy measures at both EU and national level to enable selective investment in efficient and effective healthcare;
Amendment 91 #
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 concern about the abuse/misuse thereofto diffuse knowledge;
Amendment 92 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing incentivise investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof;
Amendment 111 #
Motion for a resolution
Recital F
Recital F
F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs;
Amendment 122 #
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, following rules set out in national reimbursement and pricing legislation;
Amendment 131 #
Motion for a resolution
Recital I
Recital I
I. whereas the entry of generics and biosimilars onto the market is an important mechanism to increase competition, reduce prices, and whereas there are clear concerns about the strategies to delay this entry;
Amendment 159 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that the EU pharmaceutical industry is one of the most competitive and strategic industries in Europe and that quality innovation is key to improving its competitiveness;
Amendment 167 #
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 177 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes that over 7000 innovate medicines are in the development pipeline with much expected therapeutic benefit for patients; considers that some current pricing strategies for innovative medicines and their combined budgetary impact pose a threat to the sustainability of health care systems and therefore might not be accessible for those who need it;
Amendment 185 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Notes with concern the recent scientific trends that lead to investments being steered to low volume, high priced medicines, leaving other important areas neglected;
Amendment 187 #
Motion for a resolution
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Calls on Member States to build on the example of existing initiatives in Europe to place negative incentives on the marketing expenditure by the pharmaceutical industry such as a contribution system towards an innovation fund aimed at promoting independent research in areas of interest for the National Health Services that are insufficiently addressed by commercial research, (e. g. antimicrobial resistance), and for patient populations normally excluded by clinical studies such as children, pregnant women and the elderly;
Amendment 188 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that more transparency ofin the cost of development and clinical trials is crucial in order to set a fair price; proportion of publicly funded research is needed, and that when assessing the total cost of a drug, it is necessary to take into account the costs for research and development, including research failures and clinical trials, and the whole pharmaceutical value chain;
Amendment 198 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that robust clinical trials are necessary to assess the efficacy and safety of medicines;
Amendment 204 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that it is in the interests of the pharmaceutical industry favour short trials andand patients to ensure fast access to the market for innovative medicines both in-patent and off-patent;
Amendment 210 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes the fragmentation of the pharmaceutical market in the EU and acknowledges the increased administrative burdens and the higher costs that it implies for industry; Highlights that this is an obstacle to the sector's competitiveness and to the expansion of spin-off and young companies seeking to enter the market, pulling away from Europe investment in this innovative sector; Stresses that such barriers bring important delays to patients' access to new medicines;
Amendment 215 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on Member States to develop closer collaboration to fight such market fragmentation, namely to develop shared Health Technology Assessment processes and results, and to work on shared criteria to instruct price and reimbursement decisions at national level;
Amendment 221 #
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Considers innovation in the pharmaceutical sector to be crucial in order to address unmet medical needs;
Amendment 230 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recognises that a balanced and strong, functioning and effective intellectual property environment, that is line with international commitments of the European Union, is important for supporting and promoting access to innovative, safe, effective and quality medicinal products in the European Union;
Amendment 234 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergRecalls that incremental innovation for patented molecules such as repurposing, reformulation and the development of new medicines for the same indication ("me-too" substances) may offer incremening’ products, whictal value to patients, to patients sub-groups and to health care permitted notably by complementary patent extensionsystems; believes that the added value of such medicines should be carefully assessed and measurable benefits should be demonstrated prior to price and reimbursement decisions; warns against the potential misuse of IP protection rules allowing for the "evergreening" of patent rights;
Amendment 240 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recognises that medical innovation is also coming from known off-patent molecules through finding new indications, drug reformulations or new innovative combinations and stresses the importance to deliver to patients more customized treatments delivering better efficacy, less side effects, better adherence and better quality of life, to avoid disease exacerbations and costly therapeutic escalations;
Amendment 243 #
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 263 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that better regulation will promote competitiveness; also recognises the importance and effectiveness of antitrust tools against anti-competitive behaviours such as the abuse or misuse of patent systems and of the system for authorisation of medicines, in violation of Articles 101 and/or 102 of the TFEU; calls on the Commission to carry out an in- depth analysis of the existing Intellectual Property legislation in the pharmaceutical sector with a focus on divergent interpretation and litigation cases and, where necessary, to bring forward a legislative review to ascertain legal clarity and the correct implementation and use of legal provisions in order to safeguard legitimate intellectual property and patent rights, as well as public interest;
Amendment 264 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission to revise the Transparency Directive with a focus on guaranteeing timely entry into the market for generic and biosimilar medicines, ending patent linkage according to Commission's guidelines, accelerating pricing and reimbursement decisions for generics and precluding the multiple reassessment of the elements supporting marketing authorisation; Believes that this will maximise savings for national health budgets, improve affordability, accelerate patient access and prevent administrative burdens for generic and biosimilar companies;
Amendment 269 #
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Calls on the Commission to monitor regularly patent settlement agreements that may restrict generic market entry into the market in exchange for benefits transferred from the originator to the generic company;
Amendment 270 #
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Calls on the Commission to introduce a Supplementary Protection Certificate (SPC) manufacturing waiver to Regulation 469/2009 allowing the production of generic and biosimilar medicines in Europe, with the purpose of exporting them to countries without SPCs or where these have expired earlier, without undermining the exclusivity granted under the SPC regime in protected markets; believes that such provisions could have a positive impact on access to high quality medicines in developing and least developed countries and on increasing manufacturing and R&D in Europe, creating new jobs and stimulating economic growth;
Amendment 273 #
Motion for a resolution
Paragraph 9 e (new)
Paragraph 9 e (new)
9e. Highlights that value-based pricing of medicines can be misused as a profit- maximization economic strategy, which in that case leads to the setting of prices that are disproportionate to its cost structure, regardless of an optimal distribution of social welfare
Amendment 283 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Considers that independent and good quality evidence is crucial to determine the cost-effectiveness of new medicines;
Amendment 288 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Highlights the technical nature of Relative Efficacy and Effectiveness Assessment (REA) and of Therapeutic Added Value (ATV) procedures; Notes that differences in methodological approaches and quality of evidence required at Member State level contribute to unnecessary fragmentation and increased burden for industry;
Amendment 291 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls on Member States and the Commission to pursue efforts to develop shared capacities, data and methodologies; Calls on the Commission to put forward a proposal for a common framework for REA and ATV to be carried out at European level, with the participation of expert representatives from Member States; Believes this should be done within the existing institutional context and in respect of national competences concerning social and economic considerations within pricing and reimbursement decisions;
Amendment 321 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Stresses the importance of transparency, including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels, to improve access to medicines with relevant additional benefits for patient and health systems;
Amendment 348 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages Members States to make full use of this tool;
Amendment 350 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccineal countermeasures for serious cross border health threats in accordance with Decision No 1082/2013/EU;
Amendment 446 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to review aluate the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 460 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectivenessensure that such approvals are admissible in exceptional circumstances where a high unmet medical need has been identified;
Amendment 480 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;
Amendment 519 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council toand the Commission to promote increased cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays;
Amendment 521 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, ensuring faster patient access to innovative medicines;
Amendment 534 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines across the EU, such as avoiding overconsumption of medicines, in particular antibiotics;
Amendment 540 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Calls on the Commission and on Member States to ensure full implementation of the pharmacovigilance legislation;
Amendment 551 #
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Calls on the Member States to enter into dialogue with all the relevant stakeholders, such as patient organisations, paying agencies, healthcare professionals and industry, with the aim of establishing short-, medium- and long term holistic strategies for access to medicines, ensuring the sustainability of healthcare systems and a competitive pharmaceutical industry, leading to faster access for patients and affordable prices;
Amendment 578 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the actual prices of medicines in the EU and to present an annual report to the Council and to the European Parliament in this regard;
Amendment 592 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, to explore mechanisms to address the withdrawal of effective medicines from the market purely for commercial reasons, such as remarketing for new indications, and to promote the supply of generics;