Price setting and regulation for pharmaceutical products in France
Prices of reimbursed pharmaceutical products are fixed and regulated by the inter ministerial Economic Committee of Health Products after negotiations with the manufacturer. 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.
Reimbursement price is negotiated and fixed on the basis of HAS opinion regarding the medical value and the added medical value, price of available and reimbursed reference products (comparators) and reimbursement prices in main four European countries (Germany, UK, Italy, Spain). The framework agreement between the Economic Committee and French Association of Pharmaceutical Products Manufacturers (LEEM) fixes the general principles of reimbursed price administration.
Conditional pricing strategies have seen a substantial development in France over the last decade. Most of the pricing contracts include specific clauses such as non-transparent rebates, price-volume agreements, revenue caps, discounts, planned reimbursement price cuts etc. Prices of innovative products are increasingly conditioned by real-world evidence data to be collected by the manufacturer within a specified timeframe. The face price agreed during the negotiations is published in the Official Journal whereas the terms and specific clauses of the price contracts remain confidential.
Updated on December 15th, 2016