Under a planned reshuffle announced by Commission president elect Jean-Claude Juncker, the EMA, which is the agency responsible for assessing pharmaceutical products, will be managed by business promotion organisation, DG Enterprise and Industry.
Few reasons for the reorganisation were given, although the EC does explain that as a result of the move the EMA will be part of a new “internal market, industry, entrepreneurship and SME” portfolio overseen by commission nominee, Elžbieta Bieńkowska.
The move would reverse a reshuffle by then Commission President José Manuel Barrosso in 2009 when DG Sanco took on management of the EMA on the basis that it was better positioned to run the agency in the event of an influenza pandemic than DG Enterprise and Industry.
EMA spokesman Martin Harvey told in-Pharmatechnologist.com that the proposed changes will not impact how the agency works.
"We have worked with various different DGs for the past 20 years," Harvey said, adding that "the move to DG Enterprise and Industry is not going to change our role."
He explained that representatives for both DG Sanco and DG Enterprise and Industry have always sat on the EMA's management board, which is an arrangement that is unlikely to change.
Harvey declined to comment on suggestions by organisations like Health Action International (HAI) that the move threatens the EMA's independance, explaining that such concerns are better addressed by the Commission.
The European Public Health Alliance was also critical of the reshuffle.
The organisation, a Belgium-based health advocacy NGO, said it cannot support this decision which threatens Europe’s ability to prepare for major health crises such as outbreaks of infectious diseases and health threats arising from climate change, whilst putting the public interest behind the drive for profits in drug authorisation procedures.
EPHA president Peggy Maguire said: “This is a potential disaster. President Barroso took the decision to strengthen Europe’s ability to respond to pandemics, and to bring the European Commission in line with national governments. It is disappointing that President-elect Juncker believes these objectives fall a pale second place to appeasing big business.
She added that: “It sends a terrible message during times when criticism is being levelled at Europe: the College of Commissioners should work for the interest of citizens and not anonymous corporate masters."