History and Organisation

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Chapter: Pharmacovigilance: Spontaneous Reporting - France

To understand the way it functions, and some of the differences with other countries’ pharmacovigilance systems, a little history is necessary.


To understand the way it functions, and some of the differences with other countries’ pharmacovigilance systems, a little history is necessary. After the thalidomide tragedy, and the other early drug safety scandals or scares, a number of clinical toxicologists and pharmacologists, usually associated with Poison Control Centres (Paris, Lyon, Marseille), decided to set up units to inform their physicians of the risks of drugs, and provide for a local place to report ADRs. In 1973, a national centre was set up by the French Medical Association in collaboration with the French Pharmaceutical Manufacturers Associa-tion. The same year, six experimental pharmacovigi-lance centres were created in France. Over the years, more pharmacologists joined the first ones, and a network of centres appeared. The heads of these centres, at the time without any official remit, met regularly during meetings of the French Associa-tion of Pharmacologists. As this network evolved, they had to work out common methodologies. From the mid-1970s the centres were officially recog-nised, the regular meetings started taking place at the Ministry of Health, and a unit was set up there to co-ordinate activities. In 1979 a decentralised system was put in place with a network of 15 centres, which was thereafter extended to 29 in 1984 and 31 in 1994. Since 1984, prescribers (physicians, dental surgeons and midwives) and marketing authorization holders (MAHs) have been required to report ADRs. The national database was rejuvenated in 1985 so that online input became possible, and it could be accessed from all centres. In 1994 the Pharmacovig-ilance Unit was transferred to the French Medicines Agency (now French Agency for the Safety of Health Products, AFSSAPS). Good Pharmacovigilance Prac-tices were evolved and sent to every prescriber in the country. To implement the European legisla-tion, two decrees came into force which extended the mandatory reporting of ADRs to pharmacists and defined the current general organisation of the French pharmacovigilance system: the decree of March 1995 on general principles and the decree of May 1995 that especially related to human blood products.

At the present time, the 31 Regional Centres have a duty to collect, record and evaluate ADR reports, and input them into the common database, after causal-ity assessment. The Heads of the Regional Pharma-covigilance Centres meet monthly at the AFSSAPS in the Technical Committee, a working group set up to prepare the work of the National Pharmacovig-ilance Commission (Advisory Board). The Techni-cal Committee is responsible for co-ordinating the collection and evaluation of information on ADRs, conducting surveys and providing recommendations that are forwarded to the National Pharmacovigi-lance Commission, which recommends action to the General Director of the Agency, to prevent or elimi-nate drug-related accidents (Figure 16.1).

The AFSSAPS is responsible for implementing the national pharmacovigilance system. It defines the pharmacovigilance trends and co-ordinates the actions of the various partners involved. The Phar-macovigilance Unit of AFSSAPS centralises all the data collected on the territory by the regional phar-macovigilance centres (via the national database) and the pharmaceutical companies (who report directly ADRs to the Unit). This Unit is in charge of the co-ordination of the Regional Centres’ activities, the organisation of meetings held by the Technical Committee and the National Pharmacovigilance Commission, and the exchange of information with other competent authorities: the European Medicines Agency (EMEA), other Member States, the World Health Organisation (WHO), competent authorities in third countries (Food and Drug Administration (FDA), etc.). It also monitors compliance with pharmacovigilance regulatory obligations of each partner involved, especially to ensure that the report-ing requirements are fulfilled. The AFSSAPS takes appropriate measures to ensure the safe use of medic-inal products after marketing with the same objective: to protect public health. 

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