Ex-head of Europe’s drug regulator set up consultancy while still in office

Thomas Lönngren. Following correspondence with Dr Lönngren, the ALTER-EU press statement of 19 December 2011 has now been amended and the revised statement is available below.

Brussels, published 19 December 2011, updated 27 January 2012 – New evidence shows that the former head of the European Medicines Agency (EMA), Thomas Lönngren, set up his own consultancy business to advise pharmaceutical industry clients while he was still employed as the head of EMA. EMA is the agency responsible for the evaluation of medicines used throughout Europe. [This paragraph has been clarified following information provided by Dr Lönngren].

Mr Lönngren set up his own consultancy firm, Pharma Executive Consulting Ltd, within the headquarters of NDA Regulatory Science Ltd. two months before he left EMA. [Dr Lönngren has now informed us that although the address was shared by Pharma Executive Consulting Ltd, NDA and other companies, it was not NDA's headquarters.] NDA Regulatory Science Ltd advises nine out of 10 pharmaceutical companies seeking regulatory approval for their products [1].

The Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Formindep and HAI Europe have appealed to the Commissioner for Health and Consumer Policy John Dalli, to Commissioner Maroš Šefčovič, who is responsible for the revolving door rules, and to the new head of EMA, Guido Rasi, to look into the issue [2].

According to the European Ombudsman, officials who arrange future jobs while still working for the EU institutions can provoke a serious conflict of interest. In reference to a similar case at the European Food Safety Authority, the Ombudsman recently ruled that officials should declare such job negotiations, which should then be evaluated under the Staff Regulations [3]. Correspondence between Mr Lönngren and EMA suggests that his relationship with NDA was only disclosed after he left EMA [4]. [This correspondence was secured through access to documents requests. Dr Lönngren has subsequently told us that he did seek advice from EMA before setting up his consultancy and that the consultancy only became operational after he left the Agency.]

Mr Lönngren’s move to NDA was approved by EMA but was subject to some restrictions. Yet campaigners consider that these conditions may not be sufficient to prevent the risk of conflicts of interest from arising.

Katrina Perehudoff speaking on behalf of HAI Europe and the Steering Committee of ALTER-EU said: “The potential for NDA’s clients in the pharmaceutical industry to benefit, however indirectly, from Mr Lönngren’s extensive network and knowledge of the European regulatory system as a result of his position at EMA is in conflict with the core mandate of EMA as a regulatory agency. It is hard to see how such a job move does not provoke a risk of conflicts of interest with his former responsibilities as an Executive Director of an organisation which oversaw the evaluation of medicines.”

“This new evidence in such a high-profile revolving door case highlights the substantial loopholes that still exist in the EU’s Staff Regulations and how they are implemented by EMA. We urge the Commission, specifically Commissioner John Dalli and particularly Commissioner Maroš Šefčovič who is responsible for revolving door rules across the EU institutions, to recognise this problem and to urgently strengthen the current rules and procedures.”

Anne Chailleu from Formindep added: “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.”

[Dr Lönngren has stated that he will not participate in any product specific business that is related to applications to the Agency or any business where it directly or indirectly gives advice to companies about ongoing activities related to the Agency or European Commission.]

Additional note: In the open letters to Commissioner Dalli and Mr Guido Rasi, it was stated that Dr Lönngren had spoken publicly as a representative of his former employer, specifically that in March 2011, he was listed as a Strategic Advisor to EMA when speaking at The World Life Science Forum. Dr Lönngren has since told us that the organisers made an error in the programme, he notified the organisers of this, and that they subsequently rectified it. Furthermore, Dr Lönngren has confirmed to us that he has not accepted posts with H Lundbeck A/S or Novo Nordisk.

Contact

Vicky Cann, Alliance for Lobbying Transparency & Ethics Regulation (Alter-EU), Vicky@corporateeurope.org, Tel: + 32 2893 0930 Mobile: + 32 489 596 478

Anne Chailleu, Formindep, a.chailleu@formindep.org

Katrina Perehudoff, Health Action International (HAI) Europe, Katrina@haieurope.org Tel: +31 20 683 3684

Notes

1 See http://www.ndareg.com/index.php and http://www.ndareg.com/index.php?nda-group-champion-topra-awards

2 Letter to Mr Dalli. http://haieurope.org/wp-content/uploads/2011/12/19-Dec-2011-Open-Letter-to-Mr-Dalli-concerning-new-evidence-in-Lonngren-case.pdf

3 European Ombudsman ruling no. 775/2010/ANA, 7 December 2011.

4 Letter from Lönngren to EMA http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/03/WC500103924.pdf

This revolving door case and others can be found in ALTER-EU’s report Block the Revolving Door: Why we need to stop EU officials becoming lobbyists (Nov 2011)