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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The National Agency for Medicines and Health Products Safety is vested with the power to inspect and monitor pharmaceutical companies’ activity, as part of its mission is to guarantee the safety of health products during the entirety of their lifespan – from trial to market surveillance (Article L5412-1 and following of the Public Health Code).
In addition, various fines can be imposed on companies that fail to comply with the applicable rules (Article L5421-1 and following of the Public Health Code). Other penalties can also be imposed on companies, such as a temporary or definitive prohibition against undertaking an activity relating to the infringement or debarment from public tenders.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
Concerning falsified medicinal products, the European Union has strengthened patient and consumer protection by adopting the Directive on the Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products (2011/62/EU).
Further, France adopted the Bribery Act (Law 2016/1691) on December 9 2016, which broadly applies to all industries, including the pharmaceutical industry.
In practice, the new law established the National Anti-corruption Agency, which will have various responsibilities, including monitoring the implementation of specific compliance programmes that are newly imposed on companies that have at least 500 employees and an annual turnover of more than €100 million.
Failure to implement such a compliance programme could result in the National Anti-corruption Agency imposing penalties, including a fine of up to €1 million for legal persons.
In addition to the transparency requirements resulting from the French Sunshine Act, which sets forth disclosing obligations of the so-called ‘links of interest’ between life sciences companies and healthcare practitioners, the new Bribery Act now imposes the disclosure of links of interest with lobbyists. An implementing decree was published on May 9 2017 regarding the register of lobbyists. Since July 1 2017 lobbyists have been required to register on an online State Portal. From January 1 2018 to April 30 2018, lobbyists must disclose their identity and the scope of their lobbying activities for 2017.
However, there is still uncertainty with regard to the precise scope of public officials falling under the scope of the law, as well as the question as to whether contacts with the National Agency for Medicines and Health Products Safety, National Authority for Health and the Economic Committee for Health Products within the framework of mandatory administrative procedures would be covered by the law.
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