In a significant development for pharmaceutical laboratories holding or operating marketing authorisations in France, the Law Amending the Financing of Social Security for 2014 (2014-892) has modified the temporary recommendation for use framework.
A temporary recommendation for use is a special procedure by which a medicine can be authorised beyond its formal marketing authorisation indications and conditions of use (Article L5121-12-1 of the Public Health Code). It can be issued by the National Security Agency for Medicines and Health Products (ANSM) – as long as the benefit-risk balance of doing so is positive – and provides prescription criteria and monitoring procedures for patients whose treatment it covers (Articles R5121-76-1 and following of the Public Health Code).
The procedure was originally regarded as an exemption procedure for situations where no therapeutic alternative existed; Article L5121-12-1 of the Public Health Code states that the ANSM may establish a temporary recommendation of use only "in the absence of appropriate medication alternative with a marketing authorisation". This limit was justified because the temporary recommendation of use was not meant to be a substitute for marketing authorisation, the purpose of which is to guarantee a positive benefit-risk balance through approved clinical trials. If a therapeutic alternative with a marketing authorisation existed, it had to be chosen.
Nonetheless, in order to reduce expenditure on health insurance, for several months the government has tried to extend the temporary recommendation of use procedure to situations where although a therapeutic alternative with a marketing authorisation exists, a temporary recommendation of use would be less expensive.
The legislature had already made a first attempt by creating the 'economic temporary recommendation of use' which could be issued by the ANSM "in case of appropriate medication alternative with a marketing authorisation" in order to "avoid expenses with a significant impact on the health insurance finances" (Article L5121-12-1 of the Public Health Code, as amended by the Social Security Financial Law 2013). This measure never entered into force because an exemption to the principle of marketing authorisation for economic reasons would not comply with EU legislation (European Court of Justice, March 29 2012, C-185/10, Commission v Poland).
The August 8 2014 amendment modifies Article L5121-12-1 of the Public Health Code and allows the development of a temporary recommendation of use provided that no medicine with marketing authorisation exists that has the same trademarked active substance, the same dosage or the same pharmaceutical form. Essentially, a temporary recommendation of use is now possible even when a therapeutic alternative exists, provided that the medicines are not strictly identical.
This is a considerable extension of the temporary recommendation of use procedure. It remains to be seen whether the provisions conform with EU legislation, which strictly defines possible exemptions to the principle of marketing authorisation (Article 5 of EU Directive 2001/83/EC).
The following issues are important:
- In terms of competition and innovation, this measure penalises laboratories which incur the heavy expenses necessary to obtain marketing authorisation. It threatens research efforts because laboratories whose medicines with a marketing authorisation are forced into competition with cheaper medicines with a temporary recommendation of use will expose themselves to losses.
- In terms of liability, a temporary recommendation of use confers new obligations and increased responsibilities, both legal and financial, on laboratories. Laboratories must collect useful data about the medicine involved, inform practitioners and organise and finance the monitoring of patients. They are more likely to be sued by patients or prescribers insofar as it is easier to bring an action against a laboratory than the ANSM.
- In terms of regulatory and commercial strategy, the development of a temporary recommendation of use procedure helps to bypass any possible refusal by a laboratory to submit a request for a marketing authorisation.
- Further, a temporary recommendation of use constitutes a means to force laboratories to follow up with patients and to encourage them to organise necessary complementary trials – essentially to invest time and money where it was previously considered meaningless to do so.
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