40 Amendments of Frédérique RIES related to 2016/2057(INI)
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 76 #
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 betweendifficulty with always reconciling research and clinical needs and research, unjustified administrative procedures, rigid patent rules and budget restrictions and delays to marketing authorisation, patent rules which are sometimes too rigid and budget choices with regard to reimbursement;
Amendment 85 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
E. whereas the aim ofsystem for protecting intellectual property is to benefit society, guaall too often used to generanteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof economic benefits for pharmaceutical companies beyond lawful profit margins instead of according to the needs of patients, resulting in an irreconcilable conflict with the fundamental right to health;
Amendment 87 #
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 thereofparticularly considering that patent law contributes to the innovation cycle of medicines, even if there is concern about the granting of unoriginal or excessively broad patents;
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 130 #
Motion for a resolution
Recital I
Recital I
I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and whereas there are clear concerns about the strategies to delay this entrycontributes to ensuring the sustainability of healthcare systems, and whereas market entry of generics and biosimilars should not be delayed;
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 163 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that in a European Union which is suffering deindustrialisation, the pharmaceutical sector remains an important industrial pillar and a driving force for job creation;
Amendment 167 #
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 175 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. RegretNotes that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orientedencompass ensuring better treatment for patients and generating financial returns;
Amendment 206 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that, in case of unmet medical needs, the interests of the patients and the pharmaceutical industry favourmay require short trials and fast access to the market;
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 212 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Welcomes the adaptive pathways pilot project and the PRIME scheme by the European Medicines Agency as a way to ensure timely access to medicines for patients with unmet medical needs, without compromising on patient safety;
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 224 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recalls that IP rights allow a legal monopoly, which needs to be carefully regulatedprovide a limited period of exclusivity, which is carefully regulated and monitored by the authorities to avoid conflict with the right to health protection and to promote quality of innovation and competitiveness;
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 233 #
Motion for a resolution
Paragraph 6
Paragraph 6
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 257 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Deplores the large number of litigation cases aimingStresses the importance of having generic medicines and biosimilar medicines in good time in order to dhelay generic entry;p patients to access pharmaceutical therapies,
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 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 300 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses that in the framework of pricing and reimbursement decisions, Member States should not re-assess the elements on which the European marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product leading to delayed access for patients;
Amendment 324 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Encourages Members States to engage in early dialogue and horizon scanning with industry, patients and payers and to anticipatorily incorporate in their determination of the cost- effectiveness of new medicines the forecasted evolution in the pharmaceutical innovation pipeline while giving due regard to budgetary impact considerations;
Amendment 332 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; which bring together the private and public sectors in order to stimulate research and accelerate patients' access to innovative therapies;
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 389 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines, such as the initiative of the Benelux countries and Austria on rare diseases;
Amendment 395 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission 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 theby setting up an EU public fund to finance R&D oriented towards unmet medical needs, in pharmaceutical industry through sales to public health systemticular in the field of rare diseases and paediatric diseases; calls for more transparency onregarding the costs of R&D;
Amendment 406 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission toNotes the Council Conclusions of 17 June 2016 inviting the Commission to conduct a fact- and evidence-based analyseis on the overall impact of IP in promoting 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 onwhere necessary, to regulate these practices;
Amendment 420 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Acknowledges that the incentives put forward by the Paediatric Regulation have not proved effective to drive innovation in medicines for children, namely in the fields of oncology and neonatology; calls on the Commission to examine existing obstacles and propose measures to promote advancement in this area;
Amendment 431 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to promote open data in private research, especially whereas far as possible open data where a significant amount of public funding is involved, and to establishncourage conditions such as affordable pricing and non- exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020;
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 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;