Revealed: how bosses of French medicines regulators secretly advised drugs companies

By and Pascale Pascariello

The French prosecution services have been asked to launch a probe after an investigation by Mediapart revealed that medical experts in charge of key medicines regulation bodies were secretly moonlighting as consultants for pharmaceutical firms. France’s health minister Marisol Touraine has also ordered an inquiry. The investigation by this website shows how this tight-knit network of friends, all senior medical personnel, sat on committees that approved medicines as safe and, crucially, recommended which new medicines should have their costs refunded by the state-backed health insurance system. At the same time they were receiving cash payments or gifts for secretly advising pharmaceutical firms on how to present those very same new products to the authorities. These clandestine meetings cost the drugs companies up to 60,000 euros a time. Some of the medical officials have admitted their involvement but say there was no conflict of interest, others have denied the claims. There are also allegations that some medical experts even solicited large sums in return for agreeing to favour a drug's application. Michaël Hajdenberg and Pascale Pascariello report on an affair that raises serious questions about the moral integrity of the French health system.

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Senior figures in the French medical sector sat on regulatory bodies that approved the use of new medicines while secretly advising the drugs companies who made them on how best to present their products, Mediapart can reveal. The affair involves a tight-knot circle of friends who, for 20 years, presided over key committees that advised not just on the safety of medicines but, crucially, also on whether their use should be subsidised by France's state-backed health insurance system. For the drugs companies the financial stakes were huge, and Mediapart has learnt that the senior officials were paid in cash for their secret consultancy role. The pharmaceutical firms are said to have paid out up to 60,000 euros for each clandestine meeting. The affair raises serious issues about the ethics of the senior medical personnel involved and their potential conflicts of interest. It also raises wider questions about the financial probity of France's health system itself.

After details of Mediapart's investigation emerged, France's health minister Marisol Touraine ordered an immediate inquiry. “If the facts as reported are correct, they are unacceptable and even of extreme gravity,” said the minister, adding that “transparency is an essential condition for trust in our health system”. The National Security Agency for Medicines and Health Products (ANSM) and the French National Authority for Health (HAS) have been instructed to look into the claims.

The HAS has now referred the issue to France's prosecution services, asking them to carry out the “investigations necessary to establish the truth of the reported facts, some of which pre-date the creation of the HAS in 2005”. The authority has also launched an internal audit into the procedures used to evaluate the products cited in Mediapart's article, in particular Seroplex, made by Danish pharmaceutical firm Lundbeck, and Cymbalta, produced by American company Lilly.

After months of investigation Mediapart has established the names of some of the medical experts who effectively operated as paid consultants to drugs companies without ever declaring their work. They include Gilles Bouvenot, who from 2003 to 2014 was president of the Commission de la Transparence or transparency committee, a key commission of France's state health authority which evaluates the usefulness of each new medicine brought to the market. Other figures involved include Bernard Avouac, president of the Commission de la Transparence from 1989 to 1998, Jean-Pierre Reynier, vice-president of the French committee that approves medicines for use, the Commission d’Autorisation de Mise sur le Marché (AMM), from 1994 to 2002 and a member of the management board of the European Medicines Agency (EMA), Christian Jacquot, a member of the AMM from 1996 to 2012, and Renée-Liliane Dreiser, a former expert advisor on the transparency committee.

Several members of the group have admitted the facts behind the claims, which are based on the statements of numerous officials plus former executives at drugs companies, though they dispute that there was a conflict of interest. Others have sought to play down the details or claim that there are mistakes in the dates cited in the allegations.

There is no dispute, however, about the importance of the watchdog bodies on which these senior figures have sat. Approval by the Commission d’Autorisation de Mise sur le Marché (AMM) means a medicine can be sold on French territory, even if since 1998 most such authorisations have been made at European level.

The Commission de la Transparence or transparency committee, meanwhile, plays a crucial role on behalf of the French National Authority for Health (HAS). This committee evaluates the usefulness of a new medicine – known in the jargon as a drug's 'service médical rendu' (SMR) – as well as assessing the new benefits that this drug will bring in relation to medicines that are already available, known as a drug's 'amélioration du service médical rendu' (ASMR). Importantly, the committee gives its opinion – nearly always accepted by the ministry of health – on whether the cost of the new drug to patients should be picked up by the state health and social security system, the Sécurité Sociale. And if so, just how much of that cost should be refunded to the patient. Its official advice has a direct impact on the medicine's future price.

For the French public the advice handed down by these committees has two major effects. One is on health safety. The other, which has an even more direct impact, is on the Sécurité Sociale's budget deficit, which could reach 15 billion euros in 2015. The more the system pays back to patients the greater, potentially, its deficit.

As far as the drugs firms are concerned, hundreds of millions of euros can hinge on the committee's official advice. For if the committee deems that the cost of a particular drug should not be reimbursed by the state then it has no commercial future in France.

Taking these factors into account, the 'system' uncovered by Mediapart is an ingenious one. The close-knit group of friends and colleagues involved – who often met pharmaceutical company representatives in Marseille - could use their positions on key committees for their own personal benefit without, on the face of it, putting public health in danger. For simply paying this group of consultants did not guarantee that the drugs firms would get a favourable verdict on their medicine. And the drugs companies knew this. The laboratories simply hoped that the transparency committee might look on them more favourably, with no guarantee as to the outcome.

Contacted by Mediapart, Christian Jacquot played down the importance of what this group of experts did. A former specialist in pharmaceutical toxicology, he does not dispute either the existence or the nature of consultancy meetings with drugs firms, in which he often took part. These gatherings were frequently held in Marseille where Gilles Bouvenot and Jean-Pierre Reynier live. But, he explains, “...above all I went to these meetings for a bite to eat. I was there more than anything as 'Mr Common Sense' because of my experience. I no longer remember the payment exactly. It was very modest.”

But if these meetings were so routine, why did they take place discreetly in Marseille, and not in the official setting of the French National Authority for Health (HAS)? “It's better to go to Marseille than to Saint-Denis [editor's note, a town just north of Paris which has a bad reputation in France for its crime levels, and where the HAS is based] where you risk your car getting damaged,” says Christian Jacquot, who is now retired. He does not see how the advice he gave to drugs laboratories on different products while carrying out his own responsibilities on the AMM committee could have posed any problems. “You know, for me the AMM took up 2 hours or 2 hours 30 minutes a week. No more.”

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Another member of this discreet consultancy 'group', who sat on the transparency committee in the 2000s, agreed to speak to Mediapart about how the system operated on condition that he could remain anonymous. This doctor told Mediapart: “There were two types of meetings. One at a very early stage when a laboratory wanted to know how to develop a product to get an SMR or an ASMR five or six years down the line. And another type, which would take place just before an application was made to the transparency committee. We met in Marseille, at the Sofitel [hotel] or at the pharmaceutical faculty. And sometimes in Paris at hotels such as the Méridien Montparnasse [editor’s note, now the Pullman Paris Montparnasse Hotel]. On the laboratories' side there was often someone in charge of market access, a medical director and possibly a head scientist.”

The doctor continued: “I wasn't called to all the meetings. There were some regulars and then the invitations depended on the nature of the product and the competences of the various people. I was asked to come perhaps once a quarter. We advised on what should be highlighted, on how to present things.”

The doctor cited many French and foreign drugs firms who were advised in this way. But while numerous executives from the firms themselves told Mediapart that sums of around 60,000 euros were spent on such consultancy services at one go, the doctor said that he received 'only' 1,000 euros to 1,500 euros per meeting. “It was always in cash,” he said. “I would either find an envelope in the dossier that was sent to me or an envelope in my hotel room, on my bed.” He said he never declared these payments to anyone. The medical expert said that as soon as he left the transparency commission he stopped being invited to the meetings – which he thought was quite understandable.

When contacted by Mediapart, Jean-Pierre Reynier, the former vice-president of the AMM, former member of the management board at the European Medicines Agency and, in common with Gilles Bouvenot, Bernard Avouac and Christian Jacquot, recipient of the Légion d'honneur, was much more embarrassed and more cautious in his responses. Did he take part in meetings with Gilles Bouvenot, Bernard Avouac, Renée-Liliane Dreiser and Christian Jacquot? “It's possible,” he said at first. Then he noted: “Most of these meetings on the strategy for developing a product were held in hotels but there was nothing clandestine about it.” When asked about the details of the meetings Reynier responded: “It's all very hazy.” His payments? “I asked for the money to be paid as an apprenticeship tax [editor's note, in France companies, including drugs firms, pay an apprenticeship tax, which can be allocated directly to particular training or educational bodies] to the faculties,” he said. When questioned, the university faculty at Marseille declined to respond directly to Mediapart's questions. Instead it merely stated the obvious: “The faculty has received payments in the form of apprenticeship taxes from pharmaceutical laboratories.”

As for Renée-Liliane Dreiser, her role as part of the 'group' was said to have been to canvass likely pharmaceutical firms and send them offers. She has not responded to Mediapart's various requests for a comment.

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This article was updated on the evening of Thursday March 26th to reflect the decision of the French National Authority for Health (HAS) to refer the claims made in the article to the prosecution services.