Development, marketing and assumption of responsibility of the vaccines in France

The responsibilities taken by the health insurance

Two joint and complementary procedures lead to the refunding of the vaccines by the sickness insurance:

·         The decree which determines  vaccinations  taken of load by the health insurance under the terms of the article L.321-1 7° of the social Error correcting code, which lays out that "the health insurance covers expenses related with vaccinations whose list is fixed by decree of the minister in charge of the social security and the minister in charge of health". This list fixed by the decree of April 10, 1995 determines the list of the vaccinations dealt with by the sickness insurance (by monovalent vaccines or associated vaccines) against certain affections limitativement enumerated. This catch of load is done within the framework of the recommendations, made by the higher Council of public health of France on the basis of opinion of the technical Committee of the vaccinations, registered in the vaccine calendar. This decree must be subjected for opinion with the CNAMTS.
Any convergent vaccine to protect from these affections has thus vocation to be refunded, within the framework of the recommendations of the technical Committee of vaccinations. 

·         The inscription of  the vaccine  on the list of the refundable specialities to the social policy-holders under the terms of the article L 162-17 of the social Error correcting code.
After opinion of the commission of the transparency, the vaccine is registered on the list of the refundable specialities to the social policy-holders by decree of the ministers in charge of health and of the social security Its price is fixed by convention between the Economic Committee of the Products of Health and the company which exploits the drug or, failing this, by decree of the Ministers for Health, the Social security and the Economy.
The commission of the transparency is an advisory authority in particular made up of medical and scientific experts. The commission of the transparency delivers an opinion on:
1. Rendered medical department.
2. The improvement of the medical department rendered of the drug by comparison with the drugs of the pharmaco-therapeutic class of reference the opinion of the commission on this point is carried out compared to a scale which goes from the absence of improvement to the major improvement.
3. The revaluation of the medical department rendered during the renewal of the inscription of the drugs on the list
4. The rate of participation of the policy-holder.
5. Posologies, durations of treatment, conditioning
6. The epidemiology of the drug: the number of patients concerned with the therapeutic indications selected.
7. Appropriateness of refunding by the organizations of sickness insurance. 

The economic committee of the Products of Health is an advisory interdepartmental authority gathering the representatives of the ministers signatories of the decrees of inscription of price and rate as well as ministry for Industry. It proposes to the ministers the prices refundable drugs downtown on the basis of opinion of the commission of the transparency. This proposal is made within sight of the prices charged for the comparable drugs, when they exist on the market.

The inscription on the list of the refundable specialities to the social policy-holders is matched price, rate of refunding and and therapeutic indications opening right to refunding of the vaccine which can be, if necessary, more restrictive than those of the AMM.

Control vaccines

The French Agency of medical safety of the products of health has laboratories of control which evaluate the biological activity, quality, the harmlessness of the batches of vaccines in comparison with the data provided by the file of AMM. For the majority of the vaccines, the standards of control and manufacture are those of the European pharmacopeia which make it possible to have common quality standards in the European union, thus facilitating freedom of movement of the vaccines pursuant to the European directives.
The specific controls practised for the vaccines relate to the identity, the activity, microbiological safety and stability. Controls of activity, according to the type of vaccines, can be carried out either by in vitro  proportionings  (content of antigen, cellular activity indirect) or by proportionings  in vivo  in the animal (tests of challenge or tests of immunogenicity). Recently methods of molecular biology applied to and the viral safety quality controls of the vaccines were introduced in supplement of controls of routine.
The batches of vaccines are the object, before their marketing in the European union, of a control by the French Agency of medical safety of the products of health or by another authority of European health according to the principle of mutual recognition of controls. These controls lead to the delivery, by the authority of health selected, of a certificate of release allowing the circulation of the batch in Europe. The French Agency of medical safety of the products of health can also carry out controls of vaccines intended for other countries or within the framework of the programs of the agencies of the United Nations.

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