61 Amendments of Cristian-Silviu BUŞOI related to 2016/2057(INI)
Amendment 12 #
Motion for a resolution
Citation 4
Citation 4
Amendment 32 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the report approved by the Committee on the Environment, Public Health and Food Safety and by the European Parliament on the amendment of the Regulation 726/2004;
Amendment 33 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the obligations contained in Article 81 of European Directive 2001/83/EC, for the maintenance of an appropriate and continued supply of medicinal products;
Amendment 51 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas pharmaceuticals are one of the main pillars of healthcare rather than mere objects of trade;
Amendment 62 #
Motion for a resolution
Recital C
Recital C
C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizenpharmaceutical expenditure has remained constant, Member States are concerned with financing healthcare expenditures going forward given lower than expected economic growth, an ageing population and the high costs associated with treating patients with chronic diseases;
Amendment 83 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas a stable and predictable intellectual property and regulatory framework, as well as the proper and timely implementation thereof are essential to create an innovation-friendly environment, supporting patient access to innovative and effective treatments;
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 88 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to and promote innovation, and whereas there is concern about the abuse/misuse thereof; notes the Council Conclusions of 17 June 2016 inviting the Commission to conduct an evidence-based analysis on the overall impact of IP in promoting innovation;
Amendment 94 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas research on rare diseases is more challenging due to their complexity and difficulties in recruitment for clinical trials due to a limited number of patients, therefore requiring incentives for manufacturers to take the risk of investing in this area;
Amendment 119 #
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 Stateset in accordance with criteria laid out in national pricing and reimbursement regulations;
Amendment 162 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses the importance of medicines in improving public health enabling patients to live longer and better lives, thereby supporting the productivity of our societies and economic growth.
Amendment 174 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. RegretNotes that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orientedreflect a balance between patient medical needs and the likelihood of generating the return on investment necessary to continue investing in future innovation;
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 189 #
Motion for a resolution
Paragraph 3
Paragraph 3
Amendment 196 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses that patients' organisations should be better involved in the definition of private and public clinical trials research strategies, to ensure that they meet the true unmet needs of European patients;
Amendment 200 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that the interests ofshort trials that allow the pharmaceutical industry favour short trialsst access to the market must always be the exception and not the rule for authorising new medicines, must not be motivated by commercial considerations, and famust accessnever sacrifice the rights guaranteed to the mparketticipants of clinical trials;
Amendment 203 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market, especially in case of unmet needs, the interests of patients favour more efficient trials and fast access to safe and effective medicines;
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 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 231 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses that research and development is essential to address unmet medical needs, and should be thus incentivized accordingly, to ensure best treatments for patients, and to enhance socio-economic value through job creation and knowledge clusters.
Amendment 236 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that mostnew medicines are not examples of genubringineg innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extenssufficient added clinical value do not provide genuine innovations;
Amendment 245 #
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 276 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement and stresses the importance of increasing collaboration among Member States in the field of pricing and reimbursement of medicinal products to ensure sustainability of healthcare systems and preserve the rights of European citizens to access quality healthcare;
Amendment 282 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Recognises that pricing and reimbursement of medicinal products are competences of Member States;
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 301 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Draws attention to the fact that several obstacles still exist to capture the full potential of incremental innovation notably related to known non-patented molecules, due to the lack of pricing and market access pathways to enable the recognition of the benefits of these medicines;
Amendment 314 #
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 profitprices of medicines should be adequate to the specific economic situation of the country where they are marketed;
Amendment 316 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should cover the cost of the drug developmentthe price of a medicine should provide an incentive for manufacturers to invest in developing new therapies and improduction, plus a margin of profitving existing ones, while ensuring best outcomes for patients, healthcare professionals and payers;
Amendment 323 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. points out that patient access to innovative therapies within the European Union would be better supported through a differential pricing policy, which could take into account the varying levels of affordability, disease prevalence and healthcare priorities between EU Member States; calls on the Council and the Commission to build on the reflection started by the Belgian Presidency of the EU in 2010, with a view to identifying practical ways to implement differential pricing within the existing legal framework of the TFEU.
Amendment 327 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. stresses that the wide use of International Reference Pricing by EU Member States and parallel trade acts as a deterrent to differential pricing and may have a detrimental effect on patient access in low- and middle-income EU countries; calls on the Commission and Member States to explore alternatives to International Reference Pricing or, as a minimum, a more rational use of this mechanism based on reference baskets representing clusters of countries with a similar socio-economic profile.
Amendment 328 #
Motion for a resolution
Paragraph 13 c (new)
Paragraph 13 c (new)
13c. highlights that International Reference Pricing is one of the main obstacles to the increased transparency of pharmaceutical prices; points out that confidential contractual agreements with pharmaceutical companies have proven to be a useful tool to address affordability concerns and to improve patient access to innovative therapies, mitigating the undesired effects of International Reference Pricing to some extent.
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 347 #
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 the possible use of the procedure in case of shortages of infant vaccines;
Amendment 351 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. recalls the importance of the digital health agenda and the need to prioritise the development and the implementation of eHealth and mHealth related solutions to ensure safe, reliable, accessible, modern and sustainable new health care models to patients, care givers, healthcare professionals and payers;
Amendment 356 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester, and welcomes the production of country-specific recommendations in the field of healthcare sustainability;
Amendment 366 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Ccalls for EU-wide 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 and to ensure future investment in pharmaceutical innovation;
Amendment 369 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for EU-wide 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, and to ensure future investment in pharmaceutical innovation;
Amendment 383 #
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 forensure fast and equitable access to innovative medicines;
Amendment 393 #
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 the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Dinvolve patients and their organisations in the definition of research priorities of all its programmes related to health, to promote R&D driven by patients' need;
Amendment 418 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Recalls that maintaining incentives is important to attract R&D in Europe and deliver quality innovative treatments to patients, therefore encourages the Commission not to revise incentive frameworks that have proven successful in delivering the intended results, such as the Regulation on orphan medicinal products, and calls on the Commission to perform, when the case, evidence-based analysis of the impact of incentives provided by the EU legislative framework based on an objective, balanced and scientifically sound methodology;
Amendment 419 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to adopt a targeted SPC manufacturing waiver for export purposes to allow EU-based manufacturers of generic and biosimilar medicines to compete on equal footing with competitors from non-EU countries, thus avoiding the outsourcing of production and helping to maintain and create additional jobs and growth in the EU;
Amendment 442 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to reviewupdate 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 drugsprovide guidance on priority unmet medical needs, and to review existing incentives schemes to facilitate the development of effective, safe and affordable drugs for rare diseases, including rare cancers, compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 450 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to analyse the adequacy of the legislative framework to the current situation with the parallel export and re-export of medicines, and underlines the need to strike the right balance between public health and economic considerations;
Amendment 457 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in anypromote fast- track approval process and to introduce the concept of conditional authorisation based ones for unmet medical needs, and to introduce transparent and accountable process to monitor safety and effectiveness;
Amendment 465 #
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 made possible only in exceptional circumstances where a clear unmet medical need has been identified;
Amendment 485 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Reiterates that European collaboration on HTA allows Member States to pool their expertise and use their resources more effectively, thus helping them to better meet the increasing demand for assessments;
Amendment 486 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. calls on the Commission and encourages Member States to develop a strategy to stimulate new use of old drugs with the objective to ultimately fight against suboptimal use of current treatments and to tackle related inefficiencies impacting patient's life and the sustainability of the healthcare systems;
Amendment 489 #
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 tocontinue supporting cooperation between MS on HTA through the HTA Network and EUnetHTA and to continue to investigate the feasibility and added value of further streamlining national health technology assessments, takeing into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a European classification on the added value level of medicinespecificities of national pricing and reimbursement systems;
Amendment 513 #
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on medical needs, and to introduce conditional funding based on affordable end pricing and non-exclusive licencing; further encourages Member States to ensure that their pricing and reimbursement frameworks guide private investment towards those innovations which they expect to deliver the desired benefits and patient outcomes;
Amendment 514 #
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on Member States to ensure that their pricing and reimbursement systems and pharmaceutical policies effectively convey a long term policy vision, therefore creating a more predictable operating environment for all actors of the healthcare system, including pharmaceutical companies, ultimately supporting patient access to medicines throughout the whole lifecycle of molecules and incentivizing innovation;
Amendment 542 #
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission and the Council to explore new measures to control prices, such as horizontal scanningdevelop a framework for ensuring "fair access" that maximises patient access and societal benefit whilst avoiding unacceptable impact on healthcare budgets; including exploration of different measures, such as horizon scanning, early dialogue, innovative pricing models, mechanisms for systematic collection of real-world data, and coordinating joint procurements;
Amendment 550 #
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. calls on the Commission to define with all relevant stakeholders how best the most advantageous economic tender (MEAT) criterion, as described in the Public Procurement Directive, and which does not imply only the lower cost criteria, could apply to medicines tenders in hospitals at national level, in order to enable sustainable and responsible supply of medicines; encourages Member States to best transpose the most economic advantageous tender criterion for medicinal products in their national legislation;
Amendment 570 #
Motion for a resolution
Paragraph 32 a (new)
Paragraph 32 a (new)
32a. Calls on the Commission to take note of the scale of the problem with parallel export of pharmaceuticals within the EU, as well as of the margin of discretion of the Member States when justifying measures on public health grounds;
Amendment 577 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the priaccess tof medicines in the EU and to present an annual report to Parliament in this regard;
Amendment 582 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the prices ofaccess to medicines in the EU and to present an annual report to Parliament in this regard;
Amendment 588 #
Motion for a resolution
Paragraph 35
Paragraph 35
35. Calls for the creation of a European Parliament task force to monitor the priaccess tof medicines;
Amendment 597 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, particularly the specific impact of parallel trade of medicines, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;
Amendment 605 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Ccalls on the Commission to analyse the causes of shortages, toespecially due the impact of parallel trade, to address effectively parallel trade consequences by establishing a list of essential medicines and a mechanism to enable stable supply of these medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;
Amendment 612 #
Motion for a resolution
Paragraph 36 a (new)
Paragraph 36 a (new)
36a. Calls on the Commission and Member States to develop a single eHealth and mHealth road map including notably the development and valorisation of pilots projects at national level, the modernisation of the reimbursement models stimulating a shift towards health outcomes driven healthcare systems, the definition of incentives to stimulate the healthcare community to engage in this digital revolution, and to enhance education of healthcare professionals, patients, and all relevant stakeholders to enable their empowerment;
Amendment 614 #
Motion for a resolution
Paragraph 36 b (new)
Paragraph 36 b (new)
36b. Calls on the Commission and Council to establish a mechanism whereby medicine shortages across the EU can be reported upon on an annual basis;
Amendment 615 #
Motion for a resolution
Paragraph 36 c (new)
Paragraph 36 c (new)
36c. Calls on the Commission and Council to review the statutory basis of the European Medicines Agency, and give consideration to enhancing its remit to coordinate pan-European activity aiming at tackling medicines shortages in EU Member States;