"Mr Marino’s involvement in the activities of the Agency is determined by the job description of the Head of the Legal Service/Department. He is not involved in any legal or other issues that may involve the EMA and his former employer Sigma-Tau. In addition, Mr Marino left Sigma-Tau in March 2013. His new job at the Agency started mid-June 2013.”
Stefano Marino has had a long career working within the pharmaceutical industry before he joined the European medicines agency (EMA) in June 2013. The EMA press release which announced Marino's employment said: “He is an expert in pharmaceutical and corporate law with a long career as legal counsel and member of senior management committees, most recently as Director of Corporate Legal and Intellectual Property at Sigma-Tau, a position that he held from 1997. He was also Chairman of the Trademark Committee at the European Federation of Pharmaceutical Industries and Associations (EFPIA) from 2005.”
Sigma-Tau is a pharmaceutical company and one of Italy's largest companies. Information from Marino's Linked-in profile (viewed 21 May 2014) indicates that prior to joining Sigma-Tau in 1997, he worked at Menarini Pharmaceuticals Industries giving him a total career history of over 23 years history spent within the pharmaceutical industry.
Marino's declaration of interests is available on the EMA website. It mentions his previous employment with Sigma-Tau (although not his role at EFPIA) and that has led to him being assigned a level 3 risk as he has “declared direct interests”, which is EMA's highest level of risk. According to information provided by EMA to CEO this means that “he cannot participate to any discussion/decision-making process concerning any interests of his former employer, Sigma-Tau of Italy”. EMA's conflicts of interest policies have been substantially revised in recent years and can be found here.
For many months, EMA has been working on the 'publication and access to clinical-trial data' policy which is of great importance to medical researchers and academics. Yet in recent weeks, some academics, researchers and NGOs have become concerned that initial “agency plans to make such data available contains small print that may severely limit access and that constitutes a turnaround from earlier promises for openness”.
EMA has told CEO that the clinical-trial data policy has been coordinated by its chief policy adviser, Noel Wathion. However, it is clear that Marino, as the head of EMA's legal department, has been closely involved. Marino's role has been to: “to review the draft policy from a legal perspective, also in light of some indications coming from the European Court of Justice … concerning transparency and access to documents in the European Union. He participated, together with several other colleagues, to various meetings with the stakeholders aimed at presenting the draft policy and receiving suggestions from them.”
In May 2014, the European ombudsman wrote a strongly-worded letter to EMA criticising draft guidelines on the use of and access to clinical trial data. The ombudsman wrote that her office had previously welcomed an EMA commitment to “pro-actively publish clinical trial data and enable access to full data sets to interested parties” and that she was now concerned that EMA was reneging on this commitment. She expressed concerns that EMA's new proposed policy might not be in line with the EU's access to documents policy (regulation 1049/2001) and she said “I am now concerned about what appears to be a significant change in EMA's policy, which could undermine the fundamental right of public access to documents established by EU law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse."
EMA has now replied to the ombudsman stressing that it wishes to boost transparency in this area. The issue will be voted on by EMA's board on 12 June 2014.
EMA has a history of recent revolving door cases, including Vincenzo Salvatore, Marino's predecessor as EMA's head of legal department who joined Sidley Austin LLP in 2012 as a senior counsel in their European life sciences regulatory practice; Xavier Luria who was EMA's head of sector safety and efficacy of medicines before he became a freelance consultant for a range of public and private sector organisations, including in the pharmaceutical sector in 2012; and EMA's ex-director Thomas Lönngren who set up Pharma Executive Consulting Ltd.
EMA's executive director Guido Rasi has put up a strong defence of its recruitment from the pharmaceutical industry, telling CEO that “excluding experienced managers from the selections for vacant positions at the Agency, or refusing to hire them solely because they have been working for industry for a long time would be a highly discriminatory and disproportionate decision.” Indeed he argues that “In this case, Mr Marino’s professional conduct and absolute personal integrity reinforces my belief that, for once, the revolving doors have worked in favour of the EMA”.
You can read Mr Marino's full response to CEO's questions here; you can read the full response of Guido Rasi (executive director of EMA) here.
For more information on this issue read CEO's comment piece.
"In the case of Stefano Marino at the European medicines agency, CEO questions whether the assessment of Mr Marino's interests has been performed adequately, and whether restrictions in place are enough to prevent undue influence over the agency's decision-making process. This case dealing with the position of head of legal affairs for EMA shows that EMA's current independence policy which consists of managing conflicts of interest rather than avoiding them is too weak and should be urgently revised in order for public trust in the agency's work to be preserved."