PharmaGossip: EMA warned of potential “conflicts of interest” involving former exec director

Lynne Taylor

The European Medicines Agency (EMA)’s decision to allow its former executive director, Thomas Lonngren, to take up an advisory role within the private pharmaceutical sector - just weeks after leaving his position at EMA - risks conflicts of interest, campaigners have claimed.

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In a joint letter sent to John Dalli, the European Commissioner for Health and Consumer Policy, a group of public health and transparency campaigners express concern that the EMA did not adequately follow the procedures outlined in the European Union (EU) Staff Regulations which are designed to prevent undue influence in the medical regulatory process.

Mr Lonngren stepped down as EMA executive director at end-December 2010 and, in a letter dated December 28, he told the chairman of the Agency’s management board, Pat O’Mahony, of his intention to take up a consultant role within the private pharmaceutical sector as of January 1, 2011.

“I am very conscious of my obligations and commitments to the EMA, and can assure you that in my new role there will be no conflict of interest, breach of code of conduct or any of my other legal contractual obligations, as a departing employee of the EMA,” Mr Lonngren tells Mr O’Mahony.

“It is my intention to uphold the reputation of the EMA and myself in a highly professional manner. I hope to support the EMA as much as possible in everything I do,” he writes.

10 days later, Mr O’Mahony wrote back to Mr Lonngren, telling him that the Agency had “no objections to these activities, having regard to your assurances that they do not cause a conflict of interest nor breach the code of conduct or any other aspects of Staff Regulations.”

But prior to approving his future ambitions, the EMA board did not request any further details from Mr Lonngren concerning his activities, or impose any form of restriction to prevent a conflict of interest arising, says the letter to Commissioner Dalli, which is signed by the Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), the European Consumers’ Organization (BEUC) and the European Public Health Alliance (EPHA).

The groups question the lack of “cooling-off” period between Mr Lonngren’s change of employment, and express concern 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 Lonngren's past and current employment,” they tell Commissioner Dalli, adding: “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 date, Mr Lonngren’s consultancy posts have included working for NDA Advisory Services, an agency that specialises in helping pharmaceutical companies obtain regulatory approval to sell their products in Europe, the signatories note.

According to Katrina Perehudoff of HAI Europe, the EMA “appears to have failed to adequately check the potential for a conflict of interest arising from Thomas Lonngren’s decision to establish his own consultancy and other new jobs,” while Jorg Schaaber of ISDB adds that: “given the very clear overlap between Mr Lonngren’s previous activities and his proposed new roles, surely further questions should have been asked - and some form of restriction imposed.”

“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,” says ALTER-EU Alliance spokesman Olivier Hoedeman.