France: Greenlight for PrEP

In a historic move, France has become the first country outside the USA, and the first country with a centrally-organised, reimbursable health system, to approve no-expense pre-exposure prophylaxis for people who need it. The French Minister of Health, Marisol Touraine, announced that PrEP would be available from mid-December, and reimbursable through the French health system from the beginning of January.

The positive recommendation for Truvada comes via a uniquely French health measure called a Recommendation of Temporary Use (Recommandation Temporaire d'Utilisation – RTU). This provides for drugs to be made available to people in urgent need on an ‘off-label’ basis, i.e. without a full Marketing Authorisation. RTUs are used for drugs that already have Marketing Authorisation for other uses – in this case, for HIV treatment.

Mme. Touraine said: "Given the level of efficacy of this approach, which has been recognised by all national and international scientific experts in the battle against HIV/AIDS, I take the financial responsibility for this treatment, which can contribute to complete our global strategy against HIV and AIDS, so it can be available without financial restriction.”

She added, however: "We can never say often enough that condoms are the best protection against HIV and other STIs…PrEP does not stop other STIs and, as a medicine, is not without adverse events.”  Read more via AIDSmap