The drug is not a trivial product. It meets very strict regulations, and is part of a highly supervised circuit. It is one of the most supervised consumer products in the world. From its development in research to its placing on the market and the information given about it, including its manufacture, numerous regulations govern all stages of its life.
Preparing the drug (8-10 years) This is the first phase in the life of a drug. It is that of research which depends as much on the medical needs of the moment as on the strategy of a company. Then come the pre-clinical trials. They combine several approaches in order to select the right molecules that can be tested on humans. At this stage, they give rise to multiple tests on animals. If these are conclusive, it is the turn of clinical trials on humans which are strictly regulated by law. Three phases then intervene: the evaluation of the tolerance to the drug on a limited number of healthy volunteers, the evolution of the efficacy of the drug on the patients and finally the evaluation of the efficacy / tolerance ratio on a larger population.
Authorization and production (1-3 years) The marketing authorization file (AMM) must require two authorizations, the first is European and is issued by the EMA (European Medicines Agency). The second is national, it is issued by the ANSM (National Medicines Safety Agency). They sometimes lead to new indications and new expertise. Before validation of the AMM file, comes the transparency phase, where the file goes to the Transparency Commission of the Haute Autorité de Santé (HAS). The latter will therefore give its opinion on:e Medical Service Rendered (SMR) and Improvement of the Rendered Medical Service (AMSR). Last step to be taken for the drug, the setting of the price and its repayment rate. A price that is negotiated between the Economic Committee for Health Products (CEPS) and the pharmaceutical laboratory within a conventional framework. In the absence of agreement, the interministerial body that is the CEPS unilaterally fixes the price of reimbursable drugs. Once the AMM file has been fully validated, drug companies can then begin manufacturing on an industrial scale.
The life of the drug can then begin with its availability to the public in pharmacies, hospitals or doctors. It lasts 20 years, ie the lifetime of the patent which gives its holder temporary commercial exclusivity in return for the publication of the innovation. After the expiration of the latter, the life of the patented drug continues under its brand name or under the name of its generic. Subsequently, new indications can be found for the drug and will have to be the subject of a new Marketing Authorization. The cycle then resumes …
The follow-up. As a reminder, a drug is under control throughout its life and is reported to the French Medicines Agency by: taking into account the effects on patients, a pharmacovigilance network, and post-Marketing Authorization studies carried out by drug companies.
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