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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.
·
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. 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. |
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The European regulation relating to the marketing authorization (AMM) for the drugs of human use classifies the vaccines in the immunological drugs according to Council Directive 89/342/CEE of 3 May 1989 widening the field of application of directives 65/65/CEE and 75/319/CEE (OJ n° L142 of May 25, 1989).
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