The European Medicines Agency has placed tough restrictions on any business activities carried out by its former executive director, Thomas Lonngren, over the next two years.
Mr Lonngren stepped down from his post at end-December 2010, and told the EMA Management Board on December 28 that he planned to take up a consultant role within the private pharmaceutical sector as of January 1, 2011. The Board replied to him shortly after, stating that it 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."
However, in February a group of public health and transparency campaigners wrote to John Dalli, the European Commissioner for Health and Consumer Policy, warning that, in approving Mr Lonngren's new activities, the Board had not adequately followed the procedures outlined in the European Union (EU) Staff Regulations which are designed to prevent undue influence in the medical regulatory process. Two Members of the European Parliament (MEPs) had also expressed similar concerns to the EMA Board.
The Agency Board said yesterday that its members were satisfied that none of the activities currently being undertaken by Mr Lonngren, "as communicated" by him, presented any conflict of interest, in terms of risking either the misuse of confidential or privileged information gained during his leadership of the Agency or improper influence on decisions taken by the EMA. The Board members did however add that they "regretted the late notification by Mr Lonngren of details of his activities," which he did not supply until February 10.
Nevertheless, the Board also said it was placing serious restrictions on the current and any future activities of its former executive director for a period of two years. During this period, it says, he may not hold any kind of managerial, executive or consultative role in pharmaceutical companies or industry associations, "whether gainful or not," nor may he provide any kind of product-related guidance or advice to pharmaceutical or other companies "with regard to any matter related to activities that fall within the remit and the area of responsibilities assigned to" the EMA.
Also during the two years, Mr Lonngren must have no contract with members of EMA staff or its scientific committees in the context of his professional activities, nor represent or accompany any private company, consultancy group or state authority in meetings with the Agency. Nor may he take part as a potential beneficiary in calls for tender for activities to be financed by the Agency's budget, says the Board.
In his letter of February 10, Mr Lonngren told the Board members that he was undertaking a number of new business activities, including - providing strategic advice to consultancy company NDA on management of the firm and building up an advisory board on Health Technology Assessment (HTA), but with no involvement in the company's product-specific advice on the regulatory side; - appointment as a non-executive board member of CBio Ltd Australia; and - "mutual agreements" to provide strategic advice for a six-month period with venture capital company Essex Woodlands.
Announcing Mr Lonngren's appointment to its board in January, CBio had also reported that he had accepted an invitation to join the scientific advisory board of H Lundbeck and that he would also be acting in an advisory role to Novo Nordisk. In his letter to the EMA Board, Mr Lonngren described these two announcements as "premature."