Price setting and regulation for medical device in France
Price setting and regulation process depends on the reimbursement scheme applicable to each medical device.
Per-product reimbursement
Prices of reimbursed medical devices are fixed and regulated by the inter ministerial Economic Committee of Health Products (CEPS) after negotiations with the manufacturer for brand-specific products or with the associations of medical device manufacturers for generic categories, and the representatives of different distributors associations.
For brand-specific registrations, reimbursement price is negotiated on the basis of the HAS opinion regarding the added medical value and prices of comparable reference products used in the same indication. Manufacturers have to provide the Economic Committee with reimbursement prices in other European countries, however, this information has little impact on negotiations outcome, given the disparities of medical device reimbursement systems within Europe.
In case of positive negotiations outcome, a price contract is signed between the Economic Committee and the manufacturer. If no agreement is reached during the negotiations, the Economic Committee can fix the price unilaterally; the manufacturer is free to market or not the product in France at the proposed price.
The final official price is the public reimbursement tariff including VAT. In addition to the reimbursement tariff, the Pricing Committee can fix the Maximum Sale Price (MSP, Prix Limite de Vente in French) that cannot be exceeded by any end distributor supplying hospitals or patients in community. In most cases, the MSP is equivalent to the reimbursement tariff so that patients have nothing to pay from their pockets. However, for some not expensive and not irreplaceable products, the MSP may be fixed at a higher level than the reimbursement tariff; in that case, patient’s out-of-pocket expenses are not completely avoided but limited to a reasonable amount. MSP includes VAT, distribution margin(s) and manufacturer’s price.
Distribution margins for medical device are not regulated. However, for some products, the Economic Committee fixes the price to end distributor (PED, prix de cession in French). PED is fixed without VAT and represents the maximum that can be charged to the end distributor, e.g. by wholesaler to retail pharmacist or by manufacturer to home care provider. This mechanism guarantees the minimal margin for end distributor.
Manufacturer’s price is neither regulated nor protected. However, for products sold directly to hospitals or other health care organisations, it can never exceed MSP. For products dispensed in the retail setting, manufacturer’s price must leave a reasonable margin for distribution channel (e.g., wholesaler and retail pharmacist) and can never exceed the PED when it is fixed.
The VAT applied to medical device depends on its indication and intended use. Basically, implantable and disability-compensation medical devices benefit from a reduced 5.5% VAT. Their lists are fixed by decrees. Other products are subject to the standard VAT of 20%.
Fee-for-service (FFS) reimbursement FFS are fixed and regulated by the inter ministerial Economic Committee of Health Products (CEPS) after negotiations with the home care providers associations, and secondarily, with manufacturer’s associations. The FFS tariff is intended to cover all product- and service-associated costs. There is no per product reimbursement under FFS scheme, therefore the manufacture’s price in not regulated in any way. In general rule, the home care provider is free to choose the brand of medical device to use within FFS; therefore, the home care provider negotiates the purchase price directly with the manufacturer.
The FFS price including VAT agreed during the negotiations (or decided by the Economic Committee unilaterally) is published in the Official Journal.
The classification, technical specifications and reimbursement tariffs of products and FFS registered on the LPPR list are regularly reviewed. The official LPPR version is updated every 2 to 3 months.
Updated on December 15th, 2016