On 12 December 2018, seven representative pharmacy organisations (ANEPF, USPO, FSPF, APR, Federgy, le Collectif and UDGPO) addressed a joint letter to the French Health Ministry to call for the implementation of biosimilar substitution in France. While the principle of biosimilar substitution at the initiation of treatment has been established in French law since 2014, the required implementing decree to apply such substitution in practice is still pending.
The letter is a response to the recent adoption of the 2019 Social Security Financing Law which focuses on reducing the deficit of the French national health insurance system. The representative organisations state that pharmacists play an important role in the reduction of health insurance costs by means of generic substitution, but that they are limited in doing so with respect to biologic medicines in the absence of an implementing decree and given the narrow scope of the law, which reduces biosimilar substitution to the point of treatment initiation (see our previous updates, Long-awaited biosimilar register created; French Parliament approves expanding substitution of biosimilars, France one step closer to biosimilar substitution: ANSM introduces first similar biologic groups).
The representative organisations have requested a meeting with the Health Ministry to:
- Envisage the adoption of the implementing decree in the near future.
- Broaden the scope of biosimilar substitution (by not limiting it to the initiation of treatment).