On 22 December 2017, the National Agency for Medicines and Health Products Safety (ANSM) published guidelines to assist pharmaceutical companies when reporting intentional non-compliant prescribing or use of medicinal products. Non-compliance can in particular relate to the indication, patient characteristics, administration route or posology of the products.
French law requires pharmaceutical companies to report to the ANSM any use of their medicinal products that does not conform to their marketing authorisation, temporary authorisation for use or recommendation for temporary use. The guidelines clarify that they must report as soon as the risk analysis is concluded and the proposed safety measures (where appropriate) are available. Reporting is most important where non-compliance is widespread, exposes patients to relevant risks, or concerns patients that are vulnerable or suffer from a rare disease. In contrast, unintentional non-compliant use (for example, medical error), intentional non-compliant use without medical purpose (such as abuse), and risk of non-compliant use that has been signalled in a risk management plan and addressed through specific measures, is not subject to the guidelines but to other reporting obligations.
The guidelines clarify the information that companies must send to the ANSM, including:
- Administrative information (company’s data, active substance and product concerned, regulatory status).
- A description of the non-compliant use (in particular, nature, clinical context, data of patients and healthcare professionals concerned, modalities of use of the product and possible justification).
- A risk analysis (in particular, estimate of patients concerned in France, summary of data on the benefit-risk ratio of the non-compliant use, impact on public health, possible safety measures, possible pharmacovigilance signalling (on the basis of patients’ health risks) and the assessment as to whether the non-compliant use is potentially suitable in line with current scientific knowledge).
- Corrective measures taken or foreseen to restrict or validate non-compliance (including, through modification of the authorisation).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2018 issue (Thomson Reuters).