Activities of Mireille D'ORNANO related to 2016/2057(INI)
Plenary speeches (1)
Options for improving access to medicines (debate) FR
Shadow reports (1)
REPORT on EU options for improving access to medicines PDF (447 KB) DOC (95 KB)
Amendments (28)
Amendment 41 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas Article 168 of the Treaty on the Functioning of the European Union stipulates that decisions on their health systems fall within the competence of the Member States;
Amendment 46 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas, however, every Member State has its own national legislation and tax policy, including VAT rates and mechanisms to negotiate pharmaceutical product prices;
Amendment 55 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas Member States have sovereignty, in particular, over decisions on whether their national health systems should provide reimbursement for pharmaceutical products;
Amendment 121 #
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 and whereas every Member State has their own price negotiation system;
Amendment 126 #
Motion for a resolution
Recital H
Recital H
Amendment 137 #
Motion for a resolution
Recital I a (new)
Recital I a (new)
Amendment 138 #
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. stresses that the generic medicines share should be even higher, but the production of new generic medicines is dependent on the formulation of innovative active ingredients;
Amendment 140 #
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, without forgetting that under the terms of the same article, the Member States’ responsibilities include managing health and medical care services, and allocating resources to those services;
Amendment 164 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 165 #
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Stresses, however, that almost 80% of the European pharmaceutical industry’s ingredients for new active substances are imported, above all, from India and China, and that its dependence on imports threatens the self-sufficiency of the European Union and its Member States and, in the long term, European consumers’ health;
Amendment 173 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Regrets that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented; points out that public health as a domain can sometimes be irrational; some general and expensive screenings are passing fads, rather than proper, effective screenings, and screenings targeted according to risk and followed up with more comprehensive examinations would be more appropriate;
Amendment 181 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that the costs of research and development activities are difficult to assess because of the experimental nature inherent in scientific research;
Amendment 190 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that transparency of the cost of development and clinical trials is crucial in order to set a fair price, as indicated in Directive 89/105;
Amendment 247 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that the high level of public funds used for R&D is not always reflected in the pricingfinal price of medicines;
Amendment 266 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Stresses, nevertheless, that with regard to the free movement of goods and, in the case in point, of pharmaceutical products, among the Member States, pharmaceutical products imported from another Member State now represent some 30% of sales of pharmaceutical products in the European Union;
Amendment 268 #
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Stresses that this significant share of pharmaceutical products moved between Member States on the European pharmaceutical product markets (hereafter ‘parallel trade’) does not lower or level the costs of pharmaceutical products in the European Union and that, on the other hand, the consequence of this parallel trade has been a rise in the number of counterfeit pharmaceutical products recorded in the European Union, and it therefore poses a significant health risk to consumers;
Amendment 271 #
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Stresses that for the reasons outlined in paragraphs 9a and 9b of this text, it is important to regulate the parallel trade of pharmaceutical products;
Amendment 279 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Stresses, however, that every Member State has its own evaluation criteria and methods for negotiating tariffs with the pharmaceutical industry, and that the pharmaceutical product tariff differentials between Member State amount to around 25%, and sometimes range from 1 to 16 for generic medicines;
Amendment 374 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for EU-widMember States to take 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 377 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Stresses that as a result of austerity and its consequences on health systems (including frequent pharmaceutical product reimbursement reversals), Europeans are increasingly often obliged to give up medical care and/or pharmaceutical treatments which they need;
Amendment 385 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wideevery Member State to adopt measures on the pharmaceutical market to; stresses that they must reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines;
Amendment 481 #
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 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 493 #
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, and to put in placeess for the added value of medicines to be factored in when they are compared with the best available alternative; also calls on the Commission to support a European classification on the added value level of medicines;
Amendment 510 #
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;
Amendment 517 #
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 administrativ; emphasises that the European Medicines Agency would benefit from developing the assessment of the ‘medical service delivered’ by medicines on the basis of several satisfaction levels and the ‘improvement of the medical service delivered’ with a view to comparing the latter with the trequireatments and delaythat already existed, as the French Health Authority already does;
Amendment 532 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines across the EU, including by limiting wastage through excessive use of medicines or prescriptions which are inappropriate to patients’ illnesses; in fact, this challenge amounts to several millions of euros which could be put to better use elsewhere;
Amendment 565 #
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission to propose a new directive onsupport transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market;
Amendment 600 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission, by way of independent studies, 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, and to promote the supply of generics;