Open Medicine EU

In a previous post , I commented on the fact that the former Executive Director joined a number of industry-based groups immediately after leaving the European Medicines Agency.
On 21st March, the EMA board gave its approval to the former director’s activities, and imposed some limits for the next two years, including “prohibitions on taking managerial and executive positions in the pharmaceutical industry, and on providing product-related advice with regard to activities falling within the remit of the Agency. …. Mr Lönngren should neither have contacts with Agency staff or committee members in the context of his professional activities, nor represent or accompany third parties at meetings with the Agency.

The board’s decision can be read in full here. According to the board, the following appointments were OK:

“Contract with NDA to give strategic advice to the management of the company and to build up an advisory board on health technology assessment… (…. no involvement in the company’s product specific advice on the regulatory side)

Appointment as a non-executive board member of CBio Ltd, Australia… The company has no approved medicines, no applications under review and no clinical trials in Europe. My role in the board is to provide advice on the company’s corporate plans, budget and strategic management following the responsibilities of executive directors.

Essex Woodlands. Venture Capital Company investing in the wider health care sector. Mutual agreements with the company during a 6-month period to learn about investment practice and participate in evaluation of investments opportunity. My role is to give a strategic advice on business plan.”

We can take it from the CBio case that it is OK for the former director to be a non-executive board member of a pharmaceutical company – unless in this case the committee and board relied more on the fact that the company is based in Australia and has gone no further than phase II trials on a medicine in development.

The Board also cleared his membership of the following networks:

“CMR Institute for medicines research. Non-profit organization. Member since 2002. Participating in the institute’s board and workshops as chair or speaker. (See also JM)

The Athenaeum Group. A UK based think tank about drug development. Member since 2008.

Tapestry Network Network that bring together payers HTA and regulators for dialog. Have been members since 2009 in my role as Executive director at EMA. No contract just a informal agreement”.

The EMA and a number of national medicines agencies already participate in these industry-funded networks, and I think they could not reasonably have stopped the former director from doing so. (Whether or how medicines agencies should participate in networks of this kind is another question.)

So – no breach of the staff regulations and everything is OK? Well, no, not in my view. The whole episode raises questions, about the staff regulations which should be reviewed, but more about the agency itself. This has nothing to do with the integrity of the people involved, which I do not doubt, but rather with the capacity (or not) of the agency to stand back, to take a robust independent approach to the regulation of medicines, to review critically the nexus of relationships between the agency and the pharmaceutical industry, and to understand how science is made, used and marketed in an industry context. I accept that the agency should have multiple interactions with industry (and not only with industry) but there should be clear, open and binding guidelines governing these interactions, starting obviously with the maximum degree of transparency.

Until very recently, the agency’s view of “commercial interest” was (almost) identical to that of the industry – until the Ombudsman persuaded the agency to adopt a very much narrower definition. Under the old view, there was little or no transparency in relation to clinical trials; under the new view there is a promise (yet to be kept) of much greater transparency. The Ombudsman did not make up new law, he just cited existing case law, case law that the agency could have followed much earlier and changed its practices, if it had not been over influenced by the industry view.

Sadly, there is now a wider crisis of confidence in the agency, with the European Parliament having refused to discharge the 2009 accounts of the agency. This will be the subject of my next post.

I’ll close with a small salute to the EMA on one point, which is close to my heart. In setting up recently a new group on pharmacovigilance, the agency resisted intense pressure from some patient groups who were demanding the exclusion of consumer (BEUC) representation from the group. END

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