29 Amendments of Peter LIESE 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 35 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to European Parliament resolution of 16 September 2015 on the Commission Work Programme 2016 (2015/2729(RSP))
Amendment 37 #
Motion for a resolution
Citation 7 b (new)
Citation 7 b (new)
- having regard to European Parliament resolution of 11 September 2012 on voluntary and unpaid donation of tissues and cells (2011/2193(INI))
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 95 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas significant progress has been made in recent decades as regards treating previously incurable diseases, meaning, for example, that no more patients die of HIV/AIDS in the EU today; however, there are still many diseases against which there is no optimal treatment (including cancer, which kills almost 1.3 million individuals in the EU every year);
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 145 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas the Regulation on advanced therapy medicinal products was introduced to promote EU-wide innovation in this area while ensuring safety, but only eight novel therapies have been approved to date;
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 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 303 #
Motion for a resolution
Paragraph 13
Paragraph 13
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 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 436 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls for the framework conditions in the areas of research and medicine policy to be established in a way that promotes innovation, particularly against diseases such as cancer, which cannot yet be treated to a satisfactory degree;
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 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 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 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 583 #
Motion for a resolution
Paragraph 35
Paragraph 35
Amendment 589 #
Motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Calls on the Commission to recommend measures to improve the rate of approval of novel therapies and their supply to patients;