As part of a draft bill reforming the drugs approval and safety system, France may soon require that conflicts of interests between physicians/researchers and industry are publicly disclosed by directors and experts at regulatory agencies and made available publicly. Failure to do so would now incur sanctions including fines of up to €30,000 ($43,000).
The proposal seems very similar to the Physician Payment Sunshine Act contained in the Affordable Care Act.
If this bill is to pass, it will have significant implications for Foreign Corrupt Practices Act issues with respect to any companies that do business in France.
Etienne Caniard, president of Mutualité Française, a federation of most of France's nonprofit private health insurers, contends that the new rules will have a positive effect. “This proposal will help uncover the sectors where the state has given free rein to the pharmaceutical industry and where it should take its responsibility and regain control, such as continuous medical education,” he says.
The draft law should be presented to the French Parliament at the end of September with the objective to have it adopted by the end of the year.
The law was developed as a response to one of the biggest French medical scandals of recent years about the Mediator, a drug developed for treating overweight diabetics, and which side effects allegedly contributed to deaths of between 500 and 2,000 people before it was taken off the market in November 2009.
In addition, it is worth noting that the political climate is heavily affected by the up-coming presidential elections in 2012. The government therefore attempts to move this law forward through the accelerated legislative procedure. Implementation decrees will however be required before specific items can come into force.
Specifically regarding the transparency requirements, in order to prevent conflicts of interest, the draft law provides on one hand a public conflict of interest declaration by all senior managers and experts working for health related public agencies, when they take office. These declarations are already an obligation for some officials.
On the other hand, industry, drug and devices companies, will have to make public all [direct and indirect] benefits they provide to healthcare professionals, patient associations, hospitals, students, scientific societies and specialized media.
Implementation details will be published in the follow up "implementation decree."
As far as the scope is concerned, it seems that the transparency requirements will apply to:
- French healthcare professionals,
- French patient associations,
- French hospitals,
- French students,
- French scientific societies and
- French specialized media as well as French companies.
Open questions at this point are the following:
- Disclosure requirements will apply as of a certain threshold. For the moment, 100 Euros are considered for such a threshold.
- Moreover, "normal working relationships" (relations normales de travail) should fall out of the scope of the law. Industry is lobbying in order to have a practical framework, where "normal working relationships" would be excluded.
- It is unclear at this point where the disclosed data will have to be published. The Ministry of Health informally mentioned that company’s website was a reasonable approach but following press articles seem to indicate that a central website/database is considered.
The French are not known for such drastic measures, it is almost certain that whatever they adopt will be changed to a form that works best in the French system. They should not throw away a medical system that has produced breaktrough medications just to placate critics.
Thanks to Marc Eigner at Polaris drawing our attention to this issue.