Economic Committee for Health Products (CEPS)

The Economic Committee for Health Products is the interministerial body responsible for setting the prices of reimbursable medicinal products and the tariffs of medical devices covered by the national health insurance system. Attached to the ministers responsible for health, social security and the economy, it brings together representatives of the State and of the health insurance system. It sets the price by agreement with the company or, failing that, by decision, in accordance with Article L. 162-16-4 of the French Social Security Code.

Contractual policy

The Committee’s action rests on a multi-year framework agreement concluded with the trade association representing pharmaceutical companies, which sets the general rules of negotiation, and then on agreements concluded with each company. These agreements determine the price, but also volume commitments, price-volume clauses, performance-based contracts and rebates. The Committee also contributes to the expenditure control provided for by the Social Security Financing Act, in particular through its interplay with the safeguard clause.

Patent expiry and the life of the price

Loss of exclusivity is a key moment in the contractual life of a medicinal product. When generic medicinal products arrive, the Committee sets their price at a discount to the originator and generally lowers the price of the reference medicinal product. It may also introduce a reference price for the generic group. These reductions, which are difficult to reverse afterwards, explain the importance of the actual date of generic entry and of the litigation surrounding it.

Remedies

Unilateral decisions of the Committee are administrative acts that may be challenged before the administrative courts. The agreed price, by contrast, results from an agreement, which in practice limits the scope for challenge by the signatory company. Exchanges with the Committee are confidential, and its annual activity report provides an overall picture.

Key points

The Economic Committee for Health Products is the company’s counterpart on price and expenditure control. The negotiation should be anticipated as soon as the Transparency Committee’s opinion is issued, and any patent enforcement strategy should measure the effect of generic entry on the originator’s price. A price reduction following a premature launch is a head of loss to be documented without delay.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation