ESC and European Affairs

December 2014 Newsletter update

Articles of interest:

 

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1. New European Commission appointed for 2014-2019

On 22 October, the European Parliament voted in favour of the new College of European Commissioners with 423 in favour, 209 against and 67 abstentions.
The Juncker Commission started its term of office on 1 November 2014.

With the new college of EU Commissioners voted in, Vytenis Andriukaitis, a former cardiosurgeon and Minister for Health for Lithuania, will be the new Commissioner for Health and Food Safety. He will be overseeing medtech and pharma policy.

Indeed, in occasion of the European Parliament vote, Mr Juncker announced officially that he had changed his mind about his earlier decision to shift responsibility of medical devices and drugs to the European Commission Industry Directorate (DG ENTR) after listening to the concerns of Parliament and other stakeholders, including the European Chronic Disease Alliance of which the European Society of Cardiology is a founding member.

Carlos Moedas from Portugal will be the new Commissioner for Research, Innovation and Science,responsible primarily for research - including EU research funding - and improving the conditions in the EU for researchers.

> More information in the “Background”  paragraph below + Juncker Commission page. 

Background:

A new team of 28 Commissioners (one from each EU country) is appointed every five years.
The European Council nominates a candidate to be president of the Commission, who must be approved by a majority of members of the European Parliament. If the MEPs reject the candidate, the Council has one month to put forward another. The president-elect chooses the commissioners (and their policy area) from candidates put forward by EU countries.

The list of commissioners is then submitted for approval (by qualified majority) first to the Council of Ministers, then to Parliament. If Parliament approves, the new Commission is officially appointed by the Council.

23 000 staff members work in the Commission in departments, known as directorates-general (DGs) or services, each responsible for a particular policy area and headed by a Director-General, who reports directly to the President.
The DGs draft laws, but their proposals become official only once the College of Commissioners adopts them during its weekly meeting.

The Commission also administers a number of executive agencies, such as the European Medicines Agency  (EMA).

2. Reshuffle @ DG SANCO

Ms Testori Coggi, Director General of the European Commission's health directorate (DG SANCO), tendered her resignation after a disciplinary procedure found that she had failed to respect the rules of procedure concerning a tender for a study on food-related issues:

A biologist by training, Ms Testori Coggi became Director General of DG Sanco in April 2010, having been deputy director general since August 2007. As head of the directorate, she was responsible for overseeing pharmaceutical and medical device policy, as well as relations with the European Medicines Agency.

Suggestions were made that Ms Testori Coggi's departure could have been accelerated by "internal disagreements" related to proposals by Jean-Claude Juncker to shift responsibility for pharmaceutical and medical device policy back to the industry directorate (DG ENTR).

She will be replaced by Ladislav Miko. Ladislav Miko is the more senior of DG SANCO’s two deputy DG’s, the other being Martin Seychell. Miko was Environment Minister in the Czech Republic in 2009.

3. Publication and Access to Clinical Data

The European Medicines Agency has developed a policy on the publication of clinical data for medicinal products for human use. The Agency took a considered approach to developing this policy based on respect for the views and concerns brought forward by a broad range of stakeholders and European bodies.

4. EMA's interaction with stakeholders

The European Medicines Agency just published the report outlining its interaction with patients, consumers, healthcare professionals and their representative organisations during 2013.

The ESC is a current member of EMA’s Healthcare Professionals Working Part (HCPW), formally established in June 2013 to provide recommendations to the EMA and its Human Scientific Committees on all matters of direct or indirect interest to healthcare professionals in relation to medicinal products and monitor the progress of interaction between the Agency and healthcare professionals.