Originally Published November/December 2000
Q & A: JACQUES DUMONT
SNITEM Optimistic about New French Reimbursement Scheme
France recently passed into law a decree reorganizing its reimbursement system. The revised system will fall under the aegis of the new agency for medical devices, AFSSaPS, and will provide for technology assessments similar to those now used in Germany and the UK. On the eve of the new system's adoption, EMDM spoke with Jacques Dumont, president of the French medical device trade association SNITEM.
Q: How does the new French reimbursement system differ from the previous one?
A: In the past, there was a nontransparent commission in charge of deciding the effectiveness of medical products and fixing reimbursement rates. This system was not viable in the long term, and we asked the Ministry of Health to review it. The new system makes two different bodies responsible for the technological assessment of medical devices and for the establishment of reimbursement rates, respectively. The first of these bodies is the French Health Products Safety Agency, or the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS). The second is an economic committee, the Comité Economique des Produits de Santé (CEPS). Both bodies formerly carried out their functions in the pharmaceutical industry.
Q: How do manufacturers submit their products for consideration under the new system?
A: Manufacturers submit a dossier to AFSSaPS. Within AFSSaPS, there is a transparency commission, the Commission de l'Evaluation des Dispositifs Médicaux (CEDM), which evaluates devices based on both clinical and economic data. The CEDM makes a recommendation to the economic committee, which then sets a maximum level of reimbursement to be applied to the device. This is actually another recommendation, because the Ministry of Health makes the final decision on the reimbursement level.
Q: The new system doesn't seem to provide much relief from the complex bureaucracy of the old reimbursement system. In fact, there seem to be more regulatory bodies involved.
A: It's true that there are more bodies involved, and it may look more complicated. But in the past, there was one commission, and it had no interaction with companies. Now, there is a more-transparent process and a clear time frame in which it functions. Company representatives are able to defend their dossiers and make an appeal to the transparency commission on the agency's decisions. And in any case, the agency will make its decision within 180 days. In the past, it could take 2 or 3 years--you never knew.
Q: So on the whole, you're optimistic that this new approach will benefit industry?
A: In terms of the efficacy and transparency of the process, yes. In the past, for example, industry never had any say in renegotiating prices. There was no discussion of short- or long-term changes in sales. On any given day, you could have a 1020% decrease in your price, but you never knew when it would happen. Now, you have a permanent discussion. So basically, I think the process is probably better.
Q: Do you foresee any problems with the new system?
A: There is an area that has the potential to be problematic. We recently discovered a specific article in the 2000 Financial Law stating that for implants--which represent a large part of French industry--private clinics will be able to negotiate a discount from the maximum reimbursement rate. This was not the case in the past, and it is significant, because it covers all of orthopaedics, as well as pacemakers, stents, and other cardiovascular implants. Why, if an economic committee negotiating on the national volume sets a reimbursement price, should a small, private clinic with 100 beds receive another discount off of this price? We tried to fight this article, but unfortunately, we did not receive enough support in the Parliament.
Q: What should manufacturers do to prepare their products for reimbursement in France?
A: Companies should have an excellent CE certification file, with strong clinical data. If your CE dossier is well done, I don't foresee any problem on the agency side. Of course, you also have to introduce your economic data, which is new. It's best to start [gathering economic and clinical data] at the same time, even if the approaches are very different.
SNITEM can be contacted at Paris-La-Défense Cedex F-92038, France; phone: +33 1 47176388; fax: +33 1 47176389; e-mail: info@snitem.fr.
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