Lobby groups call for closure of “revolving door” between drug regulators and industry

The European Commission has been urged to review procedures at the European Medicines Agency (EMA) and the staff regulations that govern the conduct of EU officials, after claims that a former executive director of EMA arranged to become a consultant to the drug industry while still employed by the agency.

Thomas Lönngren, who ran Europe’s drug regulatory agency for 10 years before stepping down at the end of 2010, has already been told by the EMA that he should not provide product related advice to drug companies nor take managerial, executive, or consultative positions in the industry for a period of two years.

But three European activist groups say the agency has done too little to close the “revolving door” through which former regulators become industry advisers paid for their expertise. The Alliance for Lobbying Transparency and Ethics Regulation, Formindep, and Health Action International wrote an open letter last month to John Dalli, the European Commissioner for Health and Consumer Policy, saying that the evidence about Mr Lönngren’s activities demands revisions and tightening of the regulations.

The evidence consists of documents from Companies House showing that a new company, Pharma Executive Consulting Ltd, was established on 2 November 2010 and that Mr Lönngren became a director of it on 10 November, while still employed by EMA. In a letter to EMA dated 28 December 2010 Mr Lönngren first disclosed his intention to become a consultant to the drug industry and in later disclosures, made in response to questions raised by EMA, he said this would include a contract with NDA, a consultancy group based in Germany, Sweden, and the UK that describes itself as Europe’s leading regulatory affairs consultancy.

An EMA inquiry into Mr Lönngren’s activities reported in March 2011 that they did not represent a conflict of interest so long as he did not take management, executive, or consultative positions in the industry and that his consultancy services did not include advising on matters that fell “within the remit and the area of responsibilities” of the EMA.

In a letter to the committee from his lawyers, Mr Lönngren said that he would be advising NDA on heath technology assessment and would not be involved in regulatory issues.

The activist groups are far from satisfied by these assurances. “The possibility that a former regulator may use his insider knowledge to advise pharmaceutical companies is worrying,” the letter stated. The letter calls on Mr Dalli to revise and strengthen the “revolving door” rules within the regulations that govern European Commission employees.

Anne Chailleu from Formindep, a French group that campaigns for independent information and education in healthcare, said: “Revolving doors, where the regulated become confused with the regulators, are at the core of NDA’s business model.

“Six out of the ten members of NDA’s advisory board are former regulators at EMA and other regulatory agencies. Industry is exploiting its links to the European regulatory framework. This is damaging the trust that European citizens should place in officials appointed to protect public health.”

The EMA told the BMJ that it was preparing a response to the open letter.