In French its full name is the “Loi du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé” but it is generally known as the « Loi Bertrand ».
After consulting the ANSM (French Agency for the Safety of Health Products), CNOM (French Professional Association of Physicians), LEEM (French Association of Pharmaceutical Manufacturers) and SNITEM (French Association of Medical Device Manufacturers), various statutory instruments, and notably Decree n° 2013-414 of 21 May 2013, subsequently set out the practical detail of the provisions which the new law brought into force.
The stated aim of the provisions is to bring about much greater transparency in the relationship between health care practitioners (HCPs) and the pharmaceutical and medical device manufacturing sectors.
In particular it covers not only the giving and receiving of gifts but also financial or other incentives of any sort, whether directly or indirectly.
The ultimate aim of this legislation is to underscore transparency in the interaction between HCPs and life sciences entities in order to prevent any conflict of interest, notably to the detriment of the public, in the decision-making process.
The Loi Bertrand is applicable to all companies operating on the French market, regardless of whether the company is based in France or working from outside France.
The law covers fieldwork commissioned to take place with healthcare professionals in France irrespective of where the individual, team or company that is paying for, designed or is undertaking the work is based.
Thus, for example, an agency company based outside France, for instance in London, which does all the recruitment and interviewing independently of any support from France would have to declare the project.
Since 2014-2015 there have been discussions to include veterinary products although in practice this is yet to be implemented.
Accordingly currently the Loi Bertrand and transparency requirements only apply to the products referred to at article L 5113-1 of the law (notably medicines and medical devices for human use).