Requirements for disclosure of conflicts of interest by experts participating in drug approval were discussed when the Council of Ministers considered a draft medicines bill on 1 August.
Their decisions will be incorporated into the bill, which is due to be considered by the National Assembly when it reconvenes in September.
New legislation will aim to enhance drug safety and prevent another Mediator scandal.
Mediator, also known as benfluorex, was marketed in France as a diabetic medicine by a French drug company, Servier Laboratories, but often prescribed off-label as a weight-loss remedy. It was withdrawn from the French market in 2009, following safety concerns. There have been claims of serious adverse reactions, including potentially fatal heart valve problems, possibly affecting hundreds of patients.
OLAF, the European anti-fraud office, is investigating possible conflicts of interest during the European approval of benfluorex.
Press reports and politicians’ comments indicate that a draft bill would require directors and experts at regulatory agencies to disclose any conflict of interest. This information would be published in a public database. Failure to disclose relevant information would incur sanctions.
Legislation would probably make it compulsory for pharmaceutical companies to publicly declare benefits and incentives that they provide to doctors, students, associations, hospitals, learned societies and specialist press.
In this respect, it would be draw on the US Sunshine Act, designed to increase transparency in government.
It would also seek to ensure that patients’ safety would always influence final decisions about the comparative risks and benefits of a new drug.
In an interview with Le Monde on 23 June, the minister for health, Xavier Bertrand, suggested that restrictions would be imposed on off-label use of drugs. Prescriptions would have to specify when a drug could be used off-label and such use would be closely monitored. Off-label use would be limited in time and would have to be followed by marketing authorisation.
These suggestions triggered criticism from the pharmaceutical trade body, Leem, which accused the government of trying to prevent patients’ access to drugs they needed and of attempting covertly to clamp down on health expenditure.
The planned legislation is expected to re-name the regulatory authority National Agency for Medicine Safety—ANSM, formerly known as Afssaps. The authority’s drug approval committees would be smaller, experts’ involvement limited to 4 or 5 years, and decisions more transparent.
The bill might seek to expand the role of ANSM, so that it became responsible for informing doctors about new medicines.
The nature of the information provided by pharmaceutical companies to doctors would probably be more tightly regulated, with advertising to doctors having to be vetted in advance. Another suggestion is that medical representatives would be able to speak only to groups of doctors in hospitals, and not to individual doctors.
The law is likely to reinforce pharmacovigilance requirements. The ANSM would have the authority to request additional post-marketing surveillance studies and impose sanctions for failing to fulfil such requirements.