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European Medicines Agency: A look at its activities and the way ahead

10-07-2017

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the ...

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the decision-making process for selecting the new location were announced on 22 June 2017. Interested Member States have until 31 July 2017 to submit their offers. A decision is expected to be taken in November 2017. The EMA is governed by a management board and employs 897 staff (December 2016 figures). Its executive director is Guido Rasi. Around 89 % of the agency's budget comes from fees and charges levied for services rendered. Its scientific work is conducted in its scientific committees, working parties and other groups. Its main activities include: facilitating the development of and patient access to medicines; evaluating applications for marketing authorisations; monitoring the safety of medicines throughout their use in healthcare practice; and providing information to healthcare professionals, patients and the public.

Links between Pharmaceutical R&D Models and Access to Affordable Medicines

14-10-2016

Each patient in the European Union has a right of access to care. National governments face the challenge to balance resources against healthcare demand to ensure that populations enjoy equitable access to effective, affordable and sustainable healthcare. This study describes the main challenges with regard to access to affordable medicines, including Research & Development, pricing and reimbursement of medicines and the influence of the economic crisis. Potential policy options to tackle these challenges ...

Each patient in the European Union has a right of access to care. National governments face the challenge to balance resources against healthcare demand to ensure that populations enjoy equitable access to effective, affordable and sustainable healthcare. This study describes the main challenges with regard to access to affordable medicines, including Research & Development, pricing and reimbursement of medicines and the influence of the economic crisis. Potential policy options to tackle these challenges are presented, drawing on best practices and a review of specific measures implemented in different European countries. This document was provided by Policy Department A for the Committee on the Environment, Public Health and Food Safety.

Autorzy zewnętrzni

Brian GODMAN, Wija OORTWIJN, Chiara DE WAURE, Ilaria MOSCA, Anna PUGGINA, Maria Lucia SPECCHIA, Paolo CAMPANELLA and Jeroen VAN DER TUIN

Workshop on the Impact of the Economic Crisis on Access to Healthcare and Medicines

30-09-2016

A Workshop organised by the Policy Department C was held on the impact of economic crisis on access to healthcare and medicines. The speakers addressed issues such as budget cuts in health care, high price of medicines, inequalities in access to various treatments as a direct result of those cuts, addressed medicines as a financial products with their share on stock market which creates an artificial incentive to keep the high value for medicines, etc. Better coordinated procurement for medicines ...

A Workshop organised by the Policy Department C was held on the impact of economic crisis on access to healthcare and medicines. The speakers addressed issues such as budget cuts in health care, high price of medicines, inequalities in access to various treatments as a direct result of those cuts, addressed medicines as a financial products with their share on stock market which creates an artificial incentive to keep the high value for medicines, etc. Better coordinated procurement for medicines, as practiced by the Benelux countries, was given as an example. Further recommendations on how to improve access to healthcare were suggested by the experts and by the representative of the Commission.

EU Options for Improving Access to Medicines

12-09-2016

This document summarises the presentations and discussions of the workshop on access to medicines, held at the European Parliament in Brussels on Thursday 14 July 2016. The purpose of the workshop was to discuss the latest trends and the current situation as regards the availability of affordable medicines in Europe, to present a range of EU initiatives, and to raise awareness on prices, accessibility, acceptability, affordability and availability of medicines in the EU. During the first part of ...

This document summarises the presentations and discussions of the workshop on access to medicines, held at the European Parliament in Brussels on Thursday 14 July 2016. The purpose of the workshop was to discuss the latest trends and the current situation as regards the availability of affordable medicines in Europe, to present a range of EU initiatives, and to raise awareness on prices, accessibility, acceptability, affordability and availability of medicines in the EU. During the first part of the workshop, the current situation on access to medicines was analysed by different stakeholder groups. The second part of the workshop analysed pharmaceutical systems in the EU, covering topics such as intellectual property, pricing and reimbursement systems, and competition enforcement laws. The third part of the workshop concerned authorisation procedures and systems for pricing and reimbursement. Here, an overview of the role of the EMA, the benefits of health technology assessment and improving affordability were presented. Proposals to improve access to medicines were discussed in the final workshop session. This workshop and the respective document were prepared by the Policy Department A at the request of the Committee on Environment, Public Health and Food Safety.

Autorzy zewnętrzni

Paola Banfi, Rachel DEMPSEY, Manon EMONTS and Hana SPANIKOVA

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