EMA authorised Dr Luria's new activities with the following conditions: Dr Luria shall, for a period of two years: "refrain from holding any kind of managerial or executive role in pharmaceutical companies ... and also from providing guidance or advice with regard to any procedure concerning product development, assessment, supervision and evaluation, on any specific product with which he was previously involved directly or indirectly and which falls within the remit and the area of responsibilities assigned to EMA." (EMA Executive Director's Opinion dated 26 July 2012.)
Originally Dr Luria was also told to make EMA staff he comes into contact with aware of his new role(s). As more information was provided about Dr Luria's specific clients, this restriction was later tightened so that he could only contact EMA staff in writing. (EMA Executive Director's Opinion dated 26 July 2012.)
Dr Luria has told CEO "In preparation of my departure I had a number of internal meetings in order to get clarifications regarding what was considered to be seen as potential conflict of interest with respect to my professional activities after leaving the Agency. I ... reiterate now my full commitment in following the EMA’ rules... In particular, I have not accepted proposals to join the pharmaceutical industry and I have rejected to contribute to products and procedures which were directly or indirectly under my responsibility at the Agency."
He continued: "Since I left the EMA I have declared to the Agency all activities I have committed to and, as you have seen, all of them have been assessed and declared that are not in conflict with the interest of the service and are authorised subject to the restrictions outlined." You can read Mr Luria's full response to CEO here (published at his request).
Dr Luria's original request for authorisation for his post-EMA roles said he would be "providing consultancy services on drug development and drug regulation" including to governments, public institutions and biotech pharma companies. These companies were later clarified to include: Trial Form Support ("a Swedish company providing services to biopharmaceutical companies"); NDA Partners (A US company and "A Development Partner to the Pharmaceutical and Medical Device Industry"); Oryzon, "a biopharmaceutical company based in Barcelona"; and Kinesys Consulting UK ("providing regulatory affairs consultancy for the pharmaceutical, biotech and medtech industries").
A 10 June 2012 press release from Oryzon announced Dr Luria would be non-executive director of medical and regulatory affairs. It made clear that Dr Luria, the fomer Head of Safety and Efficacy of Medicines at EMA would be closely involved in the development of a new leukemia treatment and would "ensure a rapid and efficient transition of Oryzon’s antitumor candidate from preclinical development to clinical phases I and II."
The chair of the original review panel, which assessed Dr Luria's new activities was Vincenzo Salvatore, who would shortly go through the revolving door himself. The second review panel was chaired by Emer Cooke.
At the request of Mr Luria, CEO has also published all correspondance between himself and CEO regarding this case, in the interest of full information and transparency. You can download this correspondance here.
"With this case, EMA has once again been linked to the revolving door between the public and private sectors. It should come as no surprise that companies and consultants in the pharma, biotech, biopharma world wish to snap up former EMA staff. We believe that EMA should consider more use of cooling-off periods in order to avoid the risk of conflicts of interest arising from the revolving door."