The drug circuit is rebuilt after the storm

Over 200,000 copies sold, loaded with vitriolic attacks against the drug. In their “Guide to 4000 useful, useless or dangerous drugs”, Professors Bernard Debré and Philippe Even question the functioning of the molecule control system, considered opaque, lax, and above all at the service of the pharmaceutical industry. The Mediator case had, a few months earlier, highlighted the flaws in the health control system. But since then, several changes have been initiated.

The decree relating to the public declaration of interest, provided for by the Bertrand law of December 2011, has entered into force. It is now forbidden for experts to participate in the work without having previously carried out a public declaration of interests. It is also impossible for them to deal with a question in the event of a direct or indirect link with the file concerned. This transparency constraint also applies to pharmaceutical laboratories, even if the decree detailing the methods of publication of the links maintained with health stakeholders has not yet been published.

Listen to Professor Bernard Bégaud, professor of pharmacology at the University of Bordeaux and researcher at Inserm. “There is great difficulty in finding very competent experts who are not already consultants for laboratories. “

The drug circuit has also undergone changes. When a laboratory considers itself ready to launch its product, it comes knocking on the door of the National Medicines Safety Agency (Ansm), the new name of Afssaps since the Bertrand law. This law now requires companies to present, in their marketing authorization application (MA), comparative tests carried out with existing molecules, not only with placebos. “This illustrates a desire of the French legislator: to show that we do not accept reimbursement for a drug for which we do not know what it will bring new to existing therapeutic strategies,” said Catherine Lassale, director of scientific affairs at Leem. , the union of drug companies.

Once the file has been established, the scientific experts of the AMM committee assess several elements: quality, safety, efficacy and also benefit / risk ratio of the drug. The CEO of Ansm relies on this opinion to authorize or not the marketing.
An alternative exists: the European Medicines Agency, based in London. Also issuing an MA after examination of the file, it does not however require clinical trials carried out in comparison with existing drugs. It is used more and more by laboratories, wishing to distribute their products in all the Member States of the European Union.

When the laboratory wishes its drug to be registered on the list of products reimbursable by social security, it then turns to the Transparency Commission, a scientific body sitting within the High Authority for Health, made up of doctors, pharmacists and others. other specialists. She assesses the actual benefit (SMR) of the drug, taking into account the severity of the disease for which it is indicated, its efficacy, its adverse effects and its place in the therapeutic strategy. The SMR can thus be considered major, moderate, weak or insufficient, three categories which correspond to the coverage rates of 65%, 30%, 15% or 0%. The Transparency Committee then sends its opinion to the National Union of Health Insurance Funds (Uncam), which officially sets the reimbursement rate for the drug.

The Transparency Commission is also responsible for determining the Improvement in Service Provided (ASMR), rated from 1 to 5 depending on the progress that the drug is making compared to its competitors already on the market. Note on which the Economic Committee for Health Products (CEPS) will rely to set the price of the drug. The less the product provides benefits over existing drugs, the less expensive it is. Prices and reimbursement rates are finally officially published in the Official Journal by the Ministry of Health. And the boxes of tablets can start to line up on the shelves of pharmacies.

But the system does not stop there: the drug will be systematically re-evaluated after its marketing. The pharmacovigilance, which was previously only the spontaneous notification of undesirable effects by doctors, is more reactive: in the event of doubt about a product, the ANSM has access, via the health insurance funds, to all the data of city ​​medicine, computerized, that it can couple with hospital reports. Data sharing in the European Union is also being organized. “We are awaiting the French decree which transposes a European directive creating a common database,” explains Catherine Lassale du Leem. It will bring together all reports of adverse reactions from Member States. “

Listen to Professor Bernard Bégaud: “It’s great to regulate, but it’s even better to prevent and tackle problems. “

A new commission, specifically responsible for reassessing marketing authorizations, will soon be set up within the National Medicines Safety Agency. A prerogative that the AMM commission was already dealing with, but in a less systematic way. “This notion of permanent reassessment benefits and risks is new, says Prof. Jean-François Bergmann, vice-president of the marketing authorization commission at ANSM. Previously, one could only reassess if there was any data that raised major public health concerns. “