20 Amendments of Marco AFFRONTE related to 2016/2057(INI)
Amendment 45 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas there are policy incoherencies between public health objectives, trade and intellectual property rules, and international human rights; whereas, nonetheless, State obligations include duties not only to respect, but to protect and fulfil the right to health;
Amendment 54 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas access to innovative healthcare is to be conceived not only as access to new medicines containing an active substance or combination of active substances that has not been authorised before, but also as access to new tools, standards and approaches to therapies that bring a meaningful improvement over existing treatment with respect to outcomes that matter to patients;
Amendment 73 #
Motion for a resolution
Recital D
Recital D
D. whereas in addition to high prices and unaffordability, other barriers to access to medicines include austerity policies and linear cuts to healthcare spending, shortages of essential medicines and inappropriate use, the poor connection between clinical needs and research, unjustified administrative procedures, rigid patent rules and budget restriction, lack of sufficiently qualified and skilled healthcare workers;
Amendment 106 #
Motion for a resolution
Recital F
Recital F
F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and wher; whereas it is estimated that every year in the EU at least 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugof infections caused by resistant bacteria while only one novel class of antibiotics has been developed in the past 40 years;
Amendment 116 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas public investments in Research and Development play a key role in the development of innovative medicines;
Amendment 376 #
Motion for a resolution
Paragraph 17a (new)
Paragraph 17a (new)
17a. Calls on the Commission to launch a public consultation open to all stakeholders aimed at considering the creation of a European Public Pharmaceutical Company, with the main minimum objective of remedying the absence of the private sector of the pharmaceuticals industry when it comes to conditions for which the market does not offer a sufficient economic return;
Amendment 380 #
Motion for a resolution
Paragraph 14b (new)
Paragraph 14b (new)
17b. Calls on the Commission and the Member States to take the first step towards creating a European Public Pharmaceutical Company, by creating a central European facility from which to buy medicines, starting with life-saving medicines, price differences for which cannot be tolerated within the EU;
Amendment 434 #
Motion for a resolution
Paragraph 21a (new)
Paragraph 21a (new)
21a. Urges the Commission to adopt a strategic plan aimed at preventing the spread of HCV and eradicating the Hepatitis C epidemic through the use of new and old medicines, to be administered to all patients diagnosed with hepatic fibroses caused by Hepatitis C starting from at least stage F2, when damage to the fibrocicatricial tissue can be considered significant, up to stage F3 when sclerocicatricial damage is severe, and stage F4 when the patient is considered cirrhotic or pre-cirrhotic;
Amendment 441 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the principle of simultaneous introduction of orphan medicines in all Member States, as well as the European register of rare diseases and reference centres;
Amendment 462 #
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 effectivenesclinical trial data that demonstrate an advance over existing treatment options for patients and clinically-relevant outcomes;
Amendment 468 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls on the Commission to guarantee the independence of drug regulatory agencies from corporate influence and funding;
Amendment 470 #
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Calls on the Commission to ensure rigorous and proactive pharmacovigilance requirements, including the application of dissuasive sanctions if post-marketing requirements are not complied with;
Amendment 475 #
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 and biosimilar medicines, guaranteeing their faster entry onto the market and sustainable conditions, and to monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;
Amendment 511 #
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, and results yielded by biomedical research in the form of suitable and affordable medicines;
Amendment 539 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Calls on the Commission, the Council and the Member States to operationalize funding for R&D through delinkage innovation models with a view to addressing antimicrobial resistance and the related challenges;
Amendment 555 #
Motion for a resolution
Paragraph 30a (new)
Paragraph 30a (new)
30a. Calls on the Commission and national antitrust authorities to monitor unfair practices to protect consumers from artificially high prices of medicines;
Amendment 557 #
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the marketcontaining measures to regulate the setting of prices of speciality medicines for human consumption and their inclusion in national health insurance regimes, to guarantee full transparency and effective controls over all procedures used to establish prices and the reimbursement of medicines in the Member States of the EU;
Amendment 569 #
Motion for a resolution
Paragraph 32a (new)
Paragraph 32a (new)
32a. Calls on the Commission and the Member States to stop concluding free- trade agreements that could seriously damage health systems and compromise the principle of universal access to medicines, along with the principle of universal access to health services;
Amendment 571 #
Motion for a resolution
Paragraph 33
Paragraph 33
33. Calls on the Commission and the Strongly supports Member States to makehat intend to use of the safeguard and flexibilitiy clauses under the WTO TRIPS Agreement and to coordinate and clarify their use when necessaryto protect and promote public health, and calls on the Commission to coordinate efforts in this regard; calls on the EU to stop discriminating against countries such as India that have implemented progressive IP policies that promote access to medicines in the interest of the health of their citizens, through its watch-list of ‘priority countries’;
Amendment 604 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission 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 generic and biosimilar medicines;