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(Jan 31, 2012) On December 29, 2011, the French Parliament adopted Law No. 2011-2012, on reinforcing drug safety, aimed at restoring public trust in the drug regulatory system following the scandal that erupted in France in connection with the drug Mediator (Loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé, LEGIFRANCE). Mediator, originally licensed as a diabetes drug, was prescribed as a diet aid to increase sales and may have killed up to 2,000 patients (Scott Sayare, Scandal over Mediator, a French Weight-Loss Drug, Prompts Calls for Wide Changes, THE NEW YORK TIMES (Dec. 11, 2011)).
The new Law strengthens the rules governing disclosure of conflicts of interest with pharmaceutical companies by directors and experts involved in the drug approval process at the competent regulatory agencies. Failure to disclose such conflicts may result in a €30,000 fine (about US$39,000) (Law No. 2011-2012, arts. 1 to 4). Companies manufacturing or marketing drugs must make public the existence of agreements they conclude with anyone involved in health care, including medical professionals, associations, charities, institutions, and students, as well as the trade press and learned societies (id. art. 2). Failure to make these agreements public is punishable by a maximum fine of €45,000 (about US$58,000) (id. art. 3).
The former French Health Products Safety Agency, which was under fire for not recalling Mediator earlier, has become the National Safety Agency for Drug and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM). The new agency has been granted the power to impose administrative sanctions and is to play a central role in the new pharmacovigilance system (id. art. 5).
Drugs will be monitored periodically after their marketing authorizations have been issued (id. art. 9). The Law also regulates the advertising of drugs and medical devices. It prohibits, for example, the advertisement of an authorized drug that is subject to reevaluation following discovery of a risk posed to human heath. Healthcare professionals must be notified of the fact that a drug is being reassessed (id. art. 29). The advertising of medicines and medical devices to healthcare professionals is now subject to a priori control by ANSM (id. art. 30).
Finally, the Law transposes into French law Directive 2010/84/EU of the European Parliament and of the Council of December 15, 2010, amending, in Regard to Pharmacovigilance, Directive 2001/83/EC, on the Community Code Relating to Medicinal Products for Human Use (Directive 2010/84/EU, OFFICIAL JOURNAL OF THE EUROPEAN UNION (L 348) 74 (Dec. 30, 2010)). The new provisions on pharmacovigilance introduce, among other measures, the mandatory reporting of adverse drug reactions by health professionals or enterprises exploiting a drug. Failure to report is punishable by a maximum penalty of three years of imprisonment and a fine of €45,000 (id. art. 28).
- Author: Nicole Atwill More by this author
- Topic: Health and safety More on this topic
- Jurisdiction: France More about this jurisdiction
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Last updated: 01/31/2012