Drugs: Bertrand wants transparency
Posted by adminThe text provides for the implementation of financial sanctions in case of conflict of interest.
LE FIGARO. – What are the main points of this text?
Xavier BERTRAND. – I said I want there to be a before and an after-Mediator. That's why I wanted an ambitious reform and concerted based on three pillars. The first is transparency in conflicts of interest. For it is clear that it is essentially this question that has caused confusion in public opinion after the Mediator by creating a climate of suspicion unbearable. Another important point when there will be questions about a drug, the doubt should benefit patients and not laboratories. Finally, better information for patients is necessary, as well as better information and training for health professionals.
Only sanctions can overcome the conflicts of interest.What are your plans?
The law sets up financial and criminal penalties for violators. Any decision of a proceeding in which a conflict of interest is identified will be void. For laboratories, the penalties can go as far as the marketing ban. All this is particularly chilling.
You know a law can not do everything. How do you proceed?
The law will not be the only element of this overhaul of the system. We must prepare decrees, including the training of health professionals. Thus, the continuing education of physicians should no longer give the feeling of being entirely in the hands of medical representatives. That is why I want this new system is evaluated in two to three years.I do not want to do in half-measures but in radical reform.
The General Inspectorate of Social Affairs called to abolish the profession of pharmaceutical sales. You do not accept this proposal, why?
There is a distinction between promotion and information. It is clear that the existence of the medical as we knew it is over. It is even prohibited individual to the hospital. Physicians will face several health visitor. Funding for the training of doctors must be watertight. Certainly, the pharmaceutical industry will contribute, but not directly as is the case today. It will do so through taxes and royalties, which go through the state and Medicare before being paid back. I want there to be far fewer links between laboratories and physicians in training low fee payday loans.Finally, the Minister of Health should be aware of all the training modules for sales representatives and all the documents they will present to health professionals. This is the French Agency for Safety of Health Products, renamed the "National Security Agency of Medicines and Health Products" (ANSM), who will have control.
The text also plans to make public all contracts with the press, learned societies and patient organizations. This means he the death of the medical press?
This is not to stop there advertising in the newspapers, but we can require that the amounts of payments to be made public.
While France has decided to prohibit the marketing of the Actos diabetes, the European Medicines Agency wants to leave it on the market.What do you do?
We will maintain the suspension of Actos. This medicine will not be back in French pharmacies. With Germany, we call an approach at European level so that our position is respected. If the European Commission sided with the European Medicines Agency and forced us to return the Actos on the market, there will be a showdown. Also, I am convinced that it is necessary to reform the drug in Europe, because I want that one gives more power to national agencies. Laboratories must understand that things have changed.
The Constitutional Council has just approved the text on the compensation fund for victims of the Mediator.To the laboratory Servier is it always the first charge before the health authorities?
Yes! We should not be mistaken about the primary responsibility in this matter: it is the responsibility of laboratory Servier. The compensation requested by the National Compensation Medical (ONIAM) for victims of the Mediator will be increased to a 30% penalty if the laboratory Servier refuses to comply. We were told that with this 30% penalty (in the body of law, the penalty is 15%, Ed) it was an emergency law, the Constitutional Council has given us reason. In addition, I ask Servier to cooperate fully to compensate the victims.
ALSO READ:
"The Mediator makes doctors uncomfortable
"Everything about the business of the Mediator