A December 16 2014 circular clarified the new powers of the National Agency for Medicines and Health Products (ANSM).

The Act of December 29 2011 empowered the ANSM to guarantee the safety of healthcare products for human use. In particular:

  • it assesses the safety, efficiency and quality of products;
  • it provides information on the benefits and risks of products; and
  • it performs surveillance and laboratory testing of products and inspects manufacturing sites.

This last role was further defined in decrees – notably in the Ordinance of December 19 2013 and the Decree of January 30 2014, which gave the ANSM:

  • injunctive powers;
  • the authority to impose financial and administrative penalties; and
  • new investigative powers.

These powers were further clarified by the latest circular.

The powers of the ANSM's inspectors have been increased. Inspectors can conduct investigations to conclude that a laboratory does not comply with the Public Health Code. In such case the laboratory can take part in adversarial proceedings and discuss the alleged infringement. The ANSM determines the corrective actions to be taken and the timeframe within which to remedy non-compliance. Inspectors have also been given new powers – for example, they now have powers in line with inspectors of the competition authority. Under Order 2012-1427, which regulates the online sale of drugs, they can can monitor online drug purchases in order to investigate this market. Injunctions issued by the ANSM are published on its website until the relevant corrective measures have been taken to remedy the situation.

The inspectors can also impose financial penalties. The amount of these penalties depends on the turnover and the nature of the infringement. Such penalties and any additional discharges are to paid to the Treasury. Notably, the regulations set out in the circular have reorganised and increased the applicable penalties. Among other things, they provide that criminal penalties are incurred when the infringement of the Public Health Code creates a serious risk for public health. For instance, Article L5421-4 of the Public Health Code now states that failure to communicate information which would lead to reassessment of the risk-benefit balance is punishable by a two-year prison sentence and a €150,000 fine. Before the reform, this infringement was punishable by a fine of only €3,750. If the infringement creates no serious risk to public health, only a financial penalty is incurred. This will be the case under Article L5421-8 1 of the Public Health Code, which provides that the failure to set up a pharmacovigilance system is punishable by a fine. In other words, a laboratory which infringes the law can incur criminal and financial penalties simultaneously.

The new regulations demonstrate that pharmaceutical practices will be monitored more tightly. In terms of liability, they increase the financial and legal responsibilities of laboratories.

For further information on this topic please contact Claire Picard at Dentons by telephone (+33 1 4268 4800) or email (claire.picard@dentons.com). The Dentons website can be accessed at www.dentons.com.

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