45 Amendments of Andrey KOVATCHEV related to 2016/2057(INI)
Amendment 1 #
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection should be ensured in the definition and implementation of all Union policies and activities,
Amendment 4 #
Motion for a resolution
Citation 1 b (new)
Citation 1 b (new)
- having regard to the Commission’s Inception Impact Assessment1a on the strengthening of EU cooperation on Health Technology Assessment (HTA), __________________ 1ahttp://ec.europa.eu/smart- regulation/roadmaps/docs/2016_sante_14 4_health_technology_assessments_en.pdf
Amendment 5 #
Motion for a resolution
Citation 1 c (new)
Citation 1 c (new)
Amendment 17 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to the Council’s conclusions on innovation for the benefit of patients of 1 December 2014 1c, __________________ 1c http://www.consilium.europa.eu/uedocs/c ms_data/docs/pressdata/en/lsa/145978.pdf
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 65 #
Motion for a resolution
Recital C
Recital C
C. whereas, in some cases, the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizenthreatening the sustainability of national healthcare systems;
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 105 #
Motion for a resolution
Recital C
Recital C
F. whereas the Commission has had to introduced 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 113 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the gap between the growing resistance to antimicrobial agents and the development of new antimicrobial agents is widening, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial agents;
Amendment 139 #
Motion for a resolution
Recital J
Recital J
J. whereas under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Parliament and the Council can, in order to meet common safety concerns, adopt measures setting high standards of quality and safety for medicinal products, and whereas, in accordance with Article 114(3) of the TFEU, legislative proposals in the health sector shall take as a base a high level of protection;
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 168 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. RegretNotes that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orientedemployees of pharmaceutical companies are primarily interested in medical progress and the well-being of patients, but that pharmaceutical companies ultimately want to make a profit , which means that the political framework has to create the best possible outcome for patients and the general public;
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 261 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Deplores the large number of litigation cases aiming to delay generic entry;
Amendment 278 #
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 assessevaluate new drugs in termorder to support their decisions ofn pricing and reimbursement;
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 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 331 #
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 publicwhich aim to develop new medicines that address the unmet medical needs of patients, e.g. new antimicrobial agents;
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 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 370 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for national and, if necessary, 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;
Amendment 387 #
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, including by strengthening collaborations in health technology assessment (HTA) and evaluating its relative effectiveness at EU level;
Amendment 416 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to analyse the overall impact of IP in promoting innovation with a neutral, fact-based and comprehensive approach, 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 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 439 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to reviewanalyse the implementation of the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess and subsequently decide whether impact of incentives to develop effective, safe and affordable drugs compared to the best available alternativet needs to be revised, 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 453 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to clearly define the concept of unmet medical needs;
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 483 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Stresses that health technology assessments (HTA) are an important and effective instrument that contributes to the sustainability of national healthcare systems and creates incentives for innovations by rewarding them with high added value;
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 495 #
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,promote early dialogue with companies that develop new health technologies, introduce compulsory relative effectiveness assessments at EU level as a first step for new medicines, ensure that joint HTA information at national level can be reused to harmonise processes and methods to prevent unnecessary overlaps, and address any financing and organisational issues with regard to this new system; also calls on the Commission to take into account the degree of innovation and to put in place a European classification on the added value level of medicines;
Amendment 525 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council to increase coopermprove communication 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 536 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Stresses that antimicrobial resistance has become a serious problem that needs to be urgently tackled; therefore calls on the Commission and the Member States to tackle the key scientific, regulatory and economic challenges facing the development of antimicrobial agents, particularly by creating incentives for investments in research and development as well as new financing models to address the most urgent needs of the public healthcare sector and at the same time safeguard the sustainability of public healthcare systems in order to improve and ensure future access to suitable antimicrobial agents;
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 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 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 583 #
Motion for a resolution
Paragraph 35
Paragraph 35
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 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;