Activities of Enrico GASBARRA related to 2016/2057(INI)
Shadow opinions (1)
OPINION on EU options for improving access to medicines
Amendments (24)
Amendment 2 #
Draft opinion
Recital A
Recital A
A. whereas protection of health is a fundamental right enshrined in the European Convention on Human Rights; whereas also the promotion of health is referred to in Articles 6 and 168 of the Treaty on the Functioning of the European Union;
Amendment 5 #
Draft opinion
Recital A
Recital A
A. whereas guaranteeing universal access to medicines presents a myriad of pressing challenges which must have priority;
Amendment 9 #
Draft opinion
Recital B
Recital B
B. whereas EU public budgets, including those covering health expenditure, are under significant constraints, also as a result of the economic crisis and austerity policies, European public budgets, in particular for the sectors covering health expenditure, are under significant pressure because of sovereign debts and the requirements to contain spending;
Amendment 11 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises its concern at the burgeoning increase in the price of medicines, for example for Hepatitis C, which is taxing countries’ ability to maintain healthcare spending in the long term and ensure access to treatment for their citizens;
Amendment 16 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points to the conclusions of the informal Council meeting of healthcare ministers held in Milan on 22 and 23 September 2014 during the Italian Council Presidency, at which many Member States agreed on the need to make joint efforts to facilitate the sharing of best practices and enable swifter access for patients;
Amendment 21 #
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses thehow importance of observingt it is that, in keeping with the principle of subsidiarity, as each Member State mustshould address any shortcomings on the basis of its own particular requirements, by optimising the targeting and use of the instruments at its disposal and seeking - above all as regards drugs used to treat rare diseases - to reduce the current substantial differences in cost;
Amendment 27 #
Draft opinion
Recital E b (new)
Recital E b (new)
Eb. having regard to the strong political commitment of the European Parliament, especially since the beginning of the current parliamentary term, in favour of a more open policy on access to medicines;
Amendment 30 #
Draft opinion
Paragraph 1
Paragraph 1
1. Highlights the fact that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which have proved to be a major tool in bringing prices to reasonable levels; hopes that the mechanism for granting and issuing compulsory licences is freed from discretionary judgement and bureaucratic constraints in order to encourage those less developed countries which possess suitable capacities to start production of medicines locally, thereby helping to avoid difficulties in accessing medicines to treat the most vulnerable sectors of the population;
Amendment 32 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls for support for the research carried out and the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;
Amendment 42 #
Draft opinion
Paragraph 5
Paragraph 5
5. Highlights the negative impact of Member States’ austerity policies and stresses that budgetary cuts should not prevent any EU citizen from being able to access medicines; calls particularly on the Council to consider adopting extraordinary measures and joint cooperation initiatives to remove the differences that exist between countries in terms of purchasing power when accessing medicines;
Amendment 45 #
Draft opinion
Paragraph 3
Paragraph 3
3. Recommends that each Member State should be free to invest and set its own innovation policy in the field of cutting- edge technologies, possibly for disease prevention and public health and well- being, in part with the aid of EU funding;
Amendment 50 #
Draft opinion
Paragraph 3
Paragraph 3
3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 showed that manufacturers of medicines have developed abusive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided; Asks the Commission to act responsibility and in particular to introduce tougher checks on possible cases of infringements of internal market and competition rules;
Amendment 51 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls urgently for fresh political impetus for the adoption of the Directive on Transparency in the Prices of Medicinal Products, which is still blocked pending a decision in the Council;
Amendment 52 #
Draft opinion
Paragraph 4
Paragraph 4
4. Recommends that information sharing and, the training of medical professionals be made an immediate priorityand exchanges of best practice be made an immediate priority with a view to bringing about a gradual but decisive improvement in the provision of healthcare, and emphasises that the development of the instruments which new technologies are now making available in the areas of research, ease of access to patients, also in their own homes, and the sharing of information could play a key role in facilitating the provision of healthcare;
Amendment 53 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on the Commission to consider resolving the difficulties regarding access to medicines by adopting a uniform price in Europe, in order to avoid disparities being created between the various markets;
Amendment 55 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Calls on the EU institutions and Member States to take the utmost care to prevent the parallel trade in pharmaceutical products in the most profitable markets, which is causing quotas to be established and a consequent shortage of many medicines, and thus creates extreme risks for the health of citizens, who in some cases are even forced to discontinue treatment;
Amendment 59 #
Draft opinion
Paragraph 5
Paragraph 5
5. UrgesPoints out that prevention, health and well-being are fundamental rights and key principles underpinning a social Europe; urges, therefore, that there should be no inequality or discrimination as regards innovation and the provision of healthcare and that universal access to medicines should not be contingent on price, which should reflect a fair balance between the cost of research, industry growth and the need for sustainable welfare systems;
Amendment 64 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to explore the implementation of delinkage mechanisms, characterized by the uncoupling of R&D costs and the end prices of health products, to finance research and development as mentioned in the report of the United Nations Secretary General's high level Panel on access to medicines - Promoting innovation and access to health technologies; 1a __________________ 1a https://static1.squarespace.com/static/562 094dee4b0d00c1a3ef761/t/57d9c6ebf5e23 1b2f02cd3d4/1473890031320/UNSG+HL P+Report+FINAL+12+Sept+2016.pdf
Amendment 65 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Commission to implement a coherent policy at EU level that favours the principle of access to medicines in all the various aspects of EU legislation, starting with international trade and a revision of the laws on patents and infringements of copyright;
Amendment 76 #
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to encourage Member States to fully implement existing patent limitations and flexibilities when confronted with excessive pricing or abuse of monopoly rights; calls in this respect on the Commission to undertake to carry out an analysis of the patent system for medicinal products within the internal market, in particular to check whether patents for drugs facilitate the movement of products in fragile, non-competitive sectors, such as the treatment of rare diseases;
Amendment 81 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to establish full transparency on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments and reflect the structure of R&D funding; Calls on the Commission to introduce best practices so as to encourage a positive conditionality with the aim of promoting forms of sharing and a greater circulation of patents.
Amendment 88 #
Draft opinion
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Calls again on the Commission to give political impetus to the proposal to amend Directive 89/105 in order to obtain more transparent and thus more reasonable prices; asks the Commission to step up efforts, as provided by the law in force, to ensure public access to appropriate information on the safety and effectiveness of medicines;
Amendment 92 #
Draft opinion
Paragraph 7 h (new)
Paragraph 7 h (new)
7h. Asks the Commission to pay particular attention to 'evergreening', i.e. the practice whereby slight modifications of existing products are patented as new inventions in order to perpetuate the patent and the privileges arising therefrom;
Amendment 340 #
Motion for a resolution
Paragraph 14a (new)
Paragraph 14a (new)
14a. Calls on the Commission to give renewed political impetus to the proposal to amend Directive 89/105, with a view to making prices more transparent and thus more affordable; calls on the Commission to increase efforts, in accordance with legislation currently in force, to guarantee public access to suitable information on the safety and effectiveness of medicines;