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Outlook for the European Council meeting on 19-20 October 2017 and the European Council (Article 50) meeting on 20 October 2017

27-10-2017

At their meeting on 19-20 October 2017, EU leaders will focus on migration, in particular assessing the progress made in stemming illegal flows on all migration routes, and digital Europe, following up on the Digital Summit held in Tallinn on 29 September. Heads of State or Government will also discuss defence, in particular the preparations for permanent structured cooperation (PESCO) as well as external relations, including relations with Turkey. The President of the European Council, Donald Tusk ...

At their meeting on 19-20 October 2017, EU leaders will focus on migration, in particular assessing the progress made in stemming illegal flows on all migration routes, and digital Europe, following up on the Digital Summit held in Tallinn on 29 September. Heads of State or Government will also discuss defence, in particular the preparations for permanent structured cooperation (PESCO) as well as external relations, including relations with Turkey. The President of the European Council, Donald Tusk, is expected to present the new 'Leaders' Agenda 2017-2018', outlining the decisions that need to be taken at the level of the European Council in the coming year. Finally, EU-27 leaders will meet on 20 October in a separate formal European Council (Article 50), without the United Kingdom, to discuss the latest developments in the latter’s withdrawal negotiations. It is expected that the European Council (Article 50) will postpone the decision on starting the second phase of negotiations on the EU's future relations with the UK until the December 2017 European Council, due to insufficient progress having been made to date.

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.

Outcome of European Council meeting of 22-23 June 2017

29-06-2017

The main results of the European Council meeting of 22-23 June 2017 include the ‘historic step’ of agreeing to set up ‘permanent structured cooperation’ in European defence, the commitment to implement the Paris Agreement on climate change in all its aspects, and the extension of sanctions against Russia. The EU Heads of State or Government also reviewed progress in deepening the single market, endorsed the country-specific recommendations on economic policy, pledged to increase cooperation on counter-terrorism ...

The main results of the European Council meeting of 22-23 June 2017 include the ‘historic step’ of agreeing to set up ‘permanent structured cooperation’ in European defence, the commitment to implement the Paris Agreement on climate change in all its aspects, and the extension of sanctions against Russia. The EU Heads of State or Government also reviewed progress in deepening the single market, endorsed the country-specific recommendations on economic policy, pledged to increase cooperation on counter-terrorism, and called for reinforced cooperation with countries of origin and transit to tackle migration issues. EU-27 leaders endorsed the procedural arrangements for the relocation of the EU agencies currently sited in the UK.

Outcome of the special European Council (Article 50) meeting of 29 April 2017

09-05-2017

At their first formal meeting as the European Council of the EU-27 on 29 April 2017, EU leaders took a united stance on the main priorities of the EU-27 for the Article 50 negotiations, namely to guarantee EU and UK citizens' rights, settle the UK's financial obligations to the EU, and avoid a hard border between Ireland and Northern Ireland. They also agreed on a phased approach for the negotiations, i.e. the negotiations on the future relationship with the UK can only start once sufficient progress ...

At their first formal meeting as the European Council of the EU-27 on 29 April 2017, EU leaders took a united stance on the main priorities of the EU-27 for the Article 50 negotiations, namely to guarantee EU and UK citizens' rights, settle the UK's financial obligations to the EU, and avoid a hard border between Ireland and Northern Ireland. They also agreed on a phased approach for the negotiations, i.e. the negotiations on the future relationship with the UK can only start once sufficient progress has been made on the three priority issues. EU leaders were also informally updated on the process for the relocation of EU agencies, which should be decided upon in the autumn of 2017.

Medicinal products in the European Union: The legal framework for medicines for human use

01-04-2015

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute ...

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute to increasing medicines' safety. An emerging approach to granting early access to medicines – adaptive pathways – could prove its future merits for patients with a medical condition not adequately addressed by an existing therapy.

Partially Self-Financed EU Agencies and the Principle of Fee Setting

14-03-2014

This study examines the budget structure and cost allocation, fee determination as well as treatment of surpluses/deficits and potential financial reserves of the partially selffinanced EU agencies (i.e. the agencies which carry out public tasks for the EU and provide services to clients from industry and are not co-financed by national public authorities), namely the European Aviation Safety Agency (EASA), the European Chemicals Agency (ECHA) and the European Medicines Agency (EMA). The study identifies ...

This study examines the budget structure and cost allocation, fee determination as well as treatment of surpluses/deficits and potential financial reserves of the partially selffinanced EU agencies (i.e. the agencies which carry out public tasks for the EU and provide services to clients from industry and are not co-financed by national public authorities), namely the European Aviation Safety Agency (EASA), the European Chemicals Agency (ECHA) and the European Medicines Agency (EMA). The study identifies and analyses the characteristics of the two mutually exclusive approaches – the “assigned revenue model” (case of EASA) and the “universal budgeting model” (case of ECHA and EMA) – as well as the consequences of each model. Furthermore, the study discusses the potential for extending self-financing of EU agencies.

External author

Lionel KAPFF, Mathieu SAUNIER and Thierry VAN SCHOUBROECK (Deloitte Consulting CVBA, Belgium)

Proceedings of the Workshop on "Effectiveness of Medicines and Therapies"

12-12-2013

This report summarises the presentations and discussions at the Workshop on “Effectiveness of Medicines and Therapies”, held at the European Parliament in Brussels, on Wednesday 18 September 2013. The aim of the workshop was to exchange views on the latest developments and main challenges healthcare systems have to address while assessing risks and benefits of new drugs and therapies. The workshop was hosted by MEP Mr Alojz PETERLE (EPP, SL), Co-chair of the Health Working Group within the ENVI Committee ...

This report summarises the presentations and discussions at the Workshop on “Effectiveness of Medicines and Therapies”, held at the European Parliament in Brussels, on Wednesday 18 September 2013. The aim of the workshop was to exchange views on the latest developments and main challenges healthcare systems have to address while assessing risks and benefits of new drugs and therapies. The workshop was hosted by MEP Mr Alojz PETERLE (EPP, SL), Co-chair of the Health Working Group within the ENVI Committee.

External author

Tapani PIHA (DG SANCO, European Commission), Francesco PIGNATTI (Haematology and Diagnostics at European Medicines Agency - EMA), Jonathan CYLUS (European Observatory on Health Systems and Policies, London, the UK), Erik BAARS (University of Applied Sciences, Leiden, the Netherlands), Lidija GAJSKI (Croatian Association for Patients' Rights, Zagreb, Croatia)

Disease Mongering (Pseudo-Disease Promotion)

15-11-2012

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern ...

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern, and policy makers should be aware of its perils and consequences.

The Impact on the EU and National Budgets of EU Agencies - Case Studies

16-07-2012

The study looked into the impact - on both EU and national budgets - of transferring responsibilities/tasks from the national to the European level following the creation of EU agencies and also examined possible synergies and duplications between them. The study focused on two growing EU agencies - the European Aviation Safety Agency and the European Medicines Agency - which cooperate with the national agencies in different ways. The study covers all 27 Member States and provides an analysis of ...

The study looked into the impact - on both EU and national budgets - of transferring responsibilities/tasks from the national to the European level following the creation of EU agencies and also examined possible synergies and duplications between them. The study focused on two growing EU agencies - the European Aviation Safety Agency and the European Medicines Agency - which cooperate with the national agencies in different ways. The study covers all 27 Member States and provides an analysis of available financial figures and qualitative assessments in order to evaluate the impact at national and EU level.

External author

PricewaterhouseCoopers SARL, Luxembourg

"Evaluation of the management of H1N1 influenza in 2009-2010 in the EU"

15-10-2010

This report summarises the presentations and discussions at a Workshop- Hearing on the response of Member States and EU institutions to the H1N1 influenza pandemic in 2009-2010 in the EU, held at the European Parliament in Brussels on Tuesday 5th October 2010. The aim of the workshop was to assess the response and to draw lessons from H1N1 for the EU response to future pandemics.

This report summarises the presentations and discussions at a Workshop- Hearing on the response of Member States and EU institutions to the H1N1 influenza pandemic in 2009-2010 in the EU, held at the European Parliament in Brussels on Tuesday 5th October 2010. The aim of the workshop was to assess the response and to draw lessons from H1N1 for the EU response to future pandemics.

External author

Mr Gavin McBride, Mr Tony Zamparutti - Milieu Ltd, Brussels (Belgium)

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