EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

By Gareth Macdonald

- Last updated on GMT

European Parliament in Strasbourg, France
European Parliament in Strasbourg, France

Related tags European commission European union

DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

Juncker, who was addressing the European Parliament in Strasbourg, France this morning​, said: “Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other.

He added that: “The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska​, who showed her incredible talents in her hearing​.”

Andriukaitis, who is a former surgeon, will be Commissioner for Health and Food Safety. Elżbieta Bieńkowska will head up DG Enterprise.

An EMA spokeswoman told in-Pharmatechnologist.com that: "We look forward to continuing our close relationship with DG SANCO, working in cooperation with DG ENTR, under the new Juncker Commission.

"We have worked successfully with both DGs for many years, with both DG SANCO and DG ENTR represented on our Management Board since the creation of the Agency in 1994​" she added.

U-turn

News of Juncker's decision was also welcomed on twitter.

twitter

(This twitterfeed has been disabled since the article was published)

The plan​ to hand the EMA to DG Enterprise prompted protests​ from European parliamentarians and Non-Governmental Organisations (NGOs) worried commercial interests would be put before public health​.

Some suggested DG Enterprise would not be able to operate the EMA effectively in a flu pandemic – which was cited as a reason for the agency’s move to DG SANCO in 2009 – while others like MEP Glenis Willmott and HAI director Tim Reed were concerned about the impact on trial transparency.

In September, Reed told us “We’re particularly concerned about the impact that the move of the EMA will have on clinical trial data transparency in the European Union​,” citing management of the EMA's planned trial results database​ by DG Enterprise as a major worry.

Industry pressure

Another common criticism of the abandoned plan was that it was a result of pressure from drug industry groups like European Federation of Pharmaceutical Industries and Associations (EFPIA).

At the time EFPIA told us it  "welcomes the new EC structure with vice-presidents that oversee several Commission DGs, aiming to bring down silos. EFPIA has consistently called for much greater coherence within the Commission on health and life science policy issues. One cannot work without the other." 

EFPIA has not commented on Juncker's change of plan.

Commission elected

MEPs elected Juncker's commission earlier today 423 votes to 209 with 67 abstentions. The yes vote means the Commission will take office next month

Note: DG Health is officially the Directorate-General for Health and Consumers of the European Commission. The body was previosuly known as the Directorate-General for Health and Consumer Protection or DG-SANCO for the French words Santé [Health] & Consommateurs [Consumers].

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