Healthy Skepticism Library item: 19282

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Publication type: Media Release

European drug regulator challenged over revolving door case involving former Director
ALTER-EU, HAI, ISDB 2011 Feb 25

Notes:

Notes:
Link to the joint open letter sent to Commissioner John Dalli
http://haieurope.org/wp-content/uploads/2011/02/25-Feb-2011-Joint-Open-Letter-to-European-Commission.pdf

Link to correspondence between EMA and Mr. Thomas Lönngren
http://www.alter-eu.org/documents/2011/02/25/access-to-documents-request-l%C3%B6nngren

For more information, please contact: – Alliance for Lobby Transparency & Ethics Regulation (Olivier corporateeurope.org, +32474486545) - Health Action International Europe (Katrina haieurope.org, +31 20 683 3684) – International Society of Drug Bulletins (President @ isdbweb.org)

Full text:

Public health and transparency campaigners have sent a joint letter to the European Commission challenging the European Medicines Agency’s (EMA) decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector just weeks after leaving his position with the regulatory agency.

In the joint letter, sent to European Commissioner for Health and Consumer Policy, John Dalli on 25 February, the Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and other public health advocates express their concern that the EMA did not adequately follow the procedures outlined in the EU Staff Regulations designed to prevent undue influence in the medical regulatory process.

Lönngren stepped down as Executive Director of the EMA at the end of December 2010. In a letter dated 28 December 2010, Lönngren told the EMA’s management board of his intention to take up a consultant role within the private pharmaceutical sectior as of 1 January 2011. Ten days later, the Chairman of the EMA management board, Pat O’Mahony, responded that the agency retained no objections vis-à-vis Lönngren’s new position. Prior to approving of his future ambitions, the EMA board did not request any further details from Lönngren concerning his activities, or impose any form of restriction to prevent a conflict of interest arising.

The signatories of the joint letter question the lack of “cooling-off” period between Lönngren’s change of employment, as they are concerned that this may result in a conflict of interest in the field of medical regulations at the EU level.

“There are currently several high profile dossiers on pharmaceutical policies under discussion, including the revision of the Clinical Trial Directive, where we have concerns that a conflict of interest may arise involving Mr. Lönngren’s past and current employment,” the letter states.

The letter continues to explain: “It goes without saying, that a former head of the EU drug regulatory agency has an extensive network and knowledge in the field, and this opens up the potential to influence the outcome of these dossier discussions. We question whether this is appropriate, and suggest that this damages public trust in the regulatory agency.”

To this day, Lönngren’s consultancy posts have included working for NDA Advisory Services, an agency that specializes in helping pharmaceutical companies obtain regulatory approval to sell their products in Europe.

“The European Medicines Agency appears to have failed to adequately check the potential for a conflict of interest arising from Thomas Lönngren’s decision to establish his own consultancy and other new jobs,” said Katrina Perehudoff from HAI Europe.

Jörg Schaaber from ISDB is aghast about the failure to protect EMA from undue commercial influence, stating: “Given the very clear overlap between Mr Lönngren’s previous activities and his proposed new roles, surely further questions should have been asked – and some form of restriction imposed.”

Speaking on behalf of the ALTER-EU Alliance, Olivier Hoedeman, added: “When former EU Commission officials pass through the revolving door – as happens frequently – it is essential that clear checks are made to ensure they are not exploiting their knowledge and contacts to benefit the private sector. All too often such conflicts of interest appear to be overlooked, showing that tougher rules and more rigorous enforcement are required.”