EuropaBio's Statement on French Substitution Policy
Brussels, 24/01/2014, In December 2013, the French Parliament passed into law the 2014 Social Security Bill (PFSS) which foresees substitution of biological medicines by a pharmacist at treatment initiation. This legislation has been misrepresented in terms of its scope and content in some reporting, and so for the benefit of EuropaBio members, and our stakeholders, we would like to clarify the developments of the legislation to date. The French law does not introduce general automatic substitution for biologics in France. On the contrary, it recognises that, unlike small molecule generic medicines, biosimilars are not interchangeable and sets strict limits for substitution of biologics. Such substitution would only be allowed at the initiation of a treatment.
EuropaBio recognises the fact thatseveral safeguards were introduced to the French law to ensure an appropriate “substitution” system which may not pose any risk for patient safety.In particular, the following measures are to protect patient safety and ensure best outcomes for patients:
- Treatment continuity has to be guaranteed by pharmacists: The law restricts any pharmacy-level substitution to patients who are commencing therapy only. The law is very clear that once a treatment has commenced, substitution shall not occur. Pharmacists are fully responsible for ensuring treatment continuity.
- Physician choice: Not only will physicians indicate whether a prescription is to initiate a treatment or whether it is to maintain an existing treatment, prescribers can also indicate that the medicine is “non-substitutable” even if the treatment is being initiated. This allows physicians to make choices which are best for the patient and it leaves the decision to substitute at the sole discretion of the treating physician.EuropaBio believes that any decision related to treatment with biologics, original, as well as biosimilars’ products should only be made under the close supervision of the physician, and with the consent of the patient.
For this law to become effective, a decree governing the implementation of the law will now need to be drafted. In the coming months, a working group will discuss the content of this decree to outline the exact conditions under which substitution is to be carried out. While the industry is looking forward to work closely with the French health authorities and other involved stakeholders, EuropaBio believes that in the interest of patient safety and treatment continuity, the following measures should be considered:
- Precautionary principle: in cases where the prescriber omits to indicate whether it is the initiation or the continuation of a treatment, the precautionary principle should apply and no substitution should be permitted.
- Brand name prescribing: to ensure treatment continuity, all prescriptions should be by brand name.