15 Amendments of Daniel BUDA related to 2016/2057(INI)
Amendment 1 #
Draft opinion
Recital A
Recital A
A. whereas protection of health is a fundamental right recognised in Article 35 of the Charter of Fundamental Rights of the European Union and Article 168 of the Treaty on the Functioning of the European Union, and enshrined in the European Convention on Human Rights;
Amendment 5 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas, in accordance with Article 168 of the Treaty on the Functioning of the European Union concerning the protection of public health, a high level of human health protection should be guaranteed in the definition and implementation of all EU policies and activities; whereas, in this respect, the Union and Member States should foster cooperation with third countries and the competent international organisations in the sphere of public health;
Amendment 6 #
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas, under Article 35 of the Charter of Fundamental Rights of the European Union everyone is guaranteed the right to access1a preventive and curative healthcare and to benefit from medical treatment under the conditions established by national laws and practices; __________________ 1a access must correlate to the patient’s financial means, since otherwise the product may be available on the market, but its price will render it inaccessible.
Amendment 7 #
Draft opinion
Recital A c (new)
Recital A c (new)
Ac. whereas patients who are EU citizens should have access to innovative medicines that are safe in quality terms and sold on the market at an accessible price;
Amendment 8 #
Draft opinion
Recital A d (new)
Recital A d (new)
Ad. whereas there is a need for voluntary cooperation between Member States with a view to increasing the financial accessibility of medicinal products and ensuring EU citizens have suitable access to them;
Amendment 11 #
Draft opinion
Recital B
Recital B
B. whereas EU public budgets, including those covering health expenditure at national EU Member State level, are under significant constraints;
Amendment 17 #
Draft opinion
Recital D
Recital D
D. whereas competition can lower costs, reduce expenditure on medicines and improve access to affordable medicines, with higher quality standards being observed in the research and development process;
Amendment 23 #
Draft opinion
Recital D b (new)
Recital D b (new)
Db. whereas special consideration should be awarded to access to medicines for patients, particularly in the less developed Member States;
Amendment 24 #
Draft opinion
Recital D c (new)
Recital D c (new)
Dc. whereas it is important for medicines to be made available in a timely manner with a view to facilitating patients’ access to treatment and increasing the efficiency of national health systems;
Amendment 26 #
Draft opinion
Recital E a (new)
Recital E a (new)
Ea. whereas there is a need to devise a system of high-quality patents, granted through accessible and efficient procedures, which afford all stakeholders the requisite level of legal certainty;
Amendment 29 #
Draft opinion
Recital E d (new)
Recital E d (new)
Ed. whereas intellectual property protection is essential in the field of access to medicines and whereas there is a need to identify mechanisms that can help combat the phenomenon of counterfeit medicines;
Amendment 40 #
Draft opinion
Paragraph 2
Paragraph 2
2. Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms hinder competition, lead tomay help sustain research and development departments, but lead to a decrease in competition during those periods, with the higher prices and negatively impac for medicines, established on the basis of research costs, potentially having an adverse impact on their purchase by consumers, and even acting to limit access to needed medicines;
Amendment 51 #
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, while observing that generic medicines respect the requisite quality standards set to ensure effective treatment;
Amendment 66 #
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Calls on the Commission to identify the most effective mechanisms to help combat the phenomenon of counterfeit medicines, in order to ensure intellectual property protection and guarantee a high level of health protection;
Amendment 87 #
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. The following are prerequisites when it comes to establishing instruments that can lead to transparent assessment of the level of access to medicines: (a) analysis of the relationship between the benefits deriving from the original medicinal products with an impact on European health systems, with reference to the distribution point, and the price, which must be applied on the basis of the research and innovation costs; (b) analysis of whether patients’ access to generic medicines really is of a significantly higher level than for the original products, with a view to ensuring health protection and enhancing consumers’ quality of life; (c) analysis of the risk-benefit ratio for access to generic medicines; (d) assessment of the information communicated both to consumers and to healthcare professionals, and of the provisions attached to the generic medicines process versus that for original products.