France has adopted a new law, dated 29 December 2011 and effective 31 December 2011, reinforcing the safety of health products (Law n. 2011-2012). This law was adopted in large part in an effort to restore public trust in the French pharmaceutical and medical device regulatory system, a confidence which has been shaken by such events as the Mediator® scandal. Originally licensed as a diabetes drug, Mediator was also prescribed as a weight loss aid over many years and is blamed for the deaths of thousands of patients. French regulators have been heavily criticized for failing to recall Mediator® earlier, allegedly due in part to conflicts of interests among government agencies, healthcare professionals and the pharmaceutical industry.
As a general matter, the new law can be divided into three main areas of focus: (i) creation of a new pharmaceutical regulatory body, ANSM, replacing AFSSAPS; (ii) transparency in respect of conflicts of interest; and (iii) reinforcement of pharmacovigilance. There are also new rules with respect to the promotion of pharmaceuticals. It is important to point out that most provisions of the new law are awaiting implementation by a series of decrees, which will detail the concepts, obligations and procedures contemplated by the new law. AFSSAPS has indicated that it is anticipated that the implementing decrees will be issued in late March / early April 2012.
Creation of a new regulatory body: ANSM
The former French Agency for Safety of Health Products (Agence Nationale de Sécurité Sanitaire des Produits de Santé - AFSSAPS) will be replaced with a newly created National Agency for Health Products Safety (Agence Nationale de Sécurité du Médicament et des Produits de Santé - ANSM). The new agency will be subject to institutional rules designed to favour transparency and independence, such as making public minutes of meetings of certain regulatory bodies. The new agency will also have an expanded role, on an on-going basis, as to the monitoring and evaluation of risks posed by products. Significantly, the ANSM will have the authority to impose administrative penalties against individuals or entities who produce or market a product in violation of their obligations (e.g., failure to impose a pharmacovigilance system).
Transparency in respect of conflicts of interest - A "Sunshine Act à la française"
In an attempt to remediate situations involving conflicts of interest such as those that were highlighted by the Mediator® scandal, the new law strengthens and unifies disclosure rules and obligations between authority directors and medical experts, among others, and the pharmaceutical and medical devices industry. Reinforcing current obligations in respect of "anti-gift" measures, pharmaceutical and medical devices companies must now publicly disclose agreements with healthcare professionals, associations of healthcare professionals, medical students and trade press. The failure to comply with such disclosures is punishable by a fine, as well as other additional penalties.
The new law also transposes a number of the provisions of Directive 2010/84/EU of 15 December 2010 (amending, as regards pharmacovigilance, Directive 2001/83/EC). Among these changes, ANSM will have an increased role in pharmacovigilance, undertaking an on-going monitoring role in respect of risks posed by pharmaceuticals. In this regard, for example, ANSM will have the authority to order marketing authorization holders to conduct post-authorization studies as to the safety or efficiency of a product. Moreover, ANSM will have the authority to withdraw marketing authorizations in respect of any product, for example, that is harmful or in the event that an authorization holder fails to comply with the conditions applicable to the authorization (e.g., obligation to conduct safety studies).
In addition, the new law broadens the scope of parties subject to an obligation to report adverse drug reactions to include a wider range of health professionals and entities marketing pharmaceuticals. The new law also provides that patients and patient groups may now also report such reactions. Failure to comply with this obligation is punishable by a penalty of imprisonment and a fine. Drawing from the Mediator® scandal, marketing authorization holders will be obligated to immediately notify the ANSM of any prohibition or restriction imposed by a foreign regulatory body in respect of an authorized pharmaceutical. In addition, the new law imposes additional restrictions and obligations on health professionals in respect of prescribing pharmaceutical for purposes outside the scope of the drug's marketing authorization (off-label prescriptions).
The new law also further regulates the advertisement of pharmaceuticals, which is largely limited to health professionals. Under the new law, all advertising in respect of pharmaceuticals is subject to prior review of ANSM. Furthermore, the new law prohibits the advertisement of an authorized pharmaceutical that is subject to a risk / benefit re-evaluation subsequent to a notice of adverse drug reactions. In addition, pharmaceutical companies must inform health professionals in the event of such re-evaluation.
For more information, please contact Carol A.F.Umhoefer in Paris.
You may also be interested in our blog covering the latest legal developments in the health care sector, Health Care Law Matters.