32 Amendments of Eleonora EVI related to 2016/2057(INI)

Draft opinion
Paragraph 2 b (new)

2b. Stresses that without full transparency of research and development costs to originator companies and information on the actual prices paid for medicines across EU Member States, any discussion on fair medicine prices remains highly problematic;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 2 c (new)

2c. Underlines that Directive 89/105/EC on the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems no longer reflects the increased complexity of pricing and reimbursement procedures in the EU Member States;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 2 d (new)

2d. Calls on the Commission to propose a new Directive to replace the Directive 89/105/EC on the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems with the aim of ensuring full transparency and effective controls of all procedures used to determine the prices and the reimbursement of medicinal products in the EU Member States;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 2 e (new)

2e. Believes that a strategic breakthrough is needed in the area of disease prevention as it can be considered a key factor to reduce the use of medicines and guarantee at the same time a high level of human health protection; calls on the EU and Member States to reinforce legislation aimed at supporting a sustainable food production and to undertake all necessary initiatives to promote healthy and safe habits such as healthy nutrition;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 3 a (new)

3a. Calls on the Commission to effectively monitor and assess the implementation of the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare in the EU Member States and to plan and carry out a formal evaluation of it that includes complaints, infringements and all transposition measures;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 3 b (new)

3b. Calls on the EU Member States to fairly implement the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare avoiding limitations to the application of the rules on reimbursement of cross-border healthcare, including the reimbursement of medicines, that could constitute a means of arbitrary discrimination or an unjustified obstacle to free movement;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 4 a (new)

4a. Calls on the Commission and Member States to adequately tackle all problems related to parallel trade in medicines in the EU adopting measures based on the highest human rights standards in order to guarantee full availability and accessibility for all medicines, with particular attention to those needed for serious diseases such as, inter alia, hepatitis C;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 4 b (new)

4b. Urges the Commission to improve the collection of readily and standardised data and statistics concerning access to medicines for EU citizens, in particular focusing on all issues encountered by the most vulnerable and disadvantaged social groups;

2016/07/25
Committee: PETI

Draft opinion
Paragraph 4 c (new)

4c. Stresses that some Member States should cut the unnecessary red tape with the purpose to reduce the existing differences in the waiting times for the availability of medicines in the EU, making sure in any case that the highest level of human health protection is safeguarded;

2016/07/25
Committee: PETI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Draft opinion
Paragraph 7 a (new)

7a. Notes that Member States should enhance measures aimed at avoiding any conflicts of interest between producers and prescribers of medicines;

2016/07/25
Committee: PETI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Draft opinion
Paragraph 10 a (new)

10a. Recognizes the value of citizens' initiatives such as the European Charter of Patients' Rights, based on the Charter of Fundamental Rights of the European Union, and the European Patients' Rights Day celebrated every year on 18 April at local and national level in the EU Member States; invites the Commission to institutionalise the European Patients' Rights Day at EU level;

2016/07/25
Committee: PETI

Motion for a resolution
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 drug~~of infections caused by resistant bacteria while only one novel class of antibiotics has been developed in the past 40 years;

2016/10/21
Committee: ENVI

Motion for a resolution
Recital F a (new)

Fa. whereas public investments in Research and Development play a key role in the development of innovative medicines;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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 ~~effectivenes~~clinical trial data that demonstrate an advance over existing treatment options for patients and clinically-relevant outcomes;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23 a (new)

23a. Calls on the Commission to guarantee the independence of drug regulatory agencies from corporate influence and funding;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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 monitor~~ing~~ unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
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 market~~containing 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;

2016/10/21
Committee: ENVI

Motion for a resolution
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;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 33

33. ~~Calls on the Commission and the~~ Strongly supports Member States t~~o make~~hat intend to use of the safeguard and flexibilitiy clauses under the WTO TRIPS Agreement ~~and to coordinate and clarify their use when necessary~~to 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’;

2016/10/21
Committee: ENVI