France is a highly attractive market for pharma, biotech and medtech Market Access with one of the largest populations in Europe (68 million people) and around 96% of the total population covered by health insurance. France represents one of the biggest healthcare markets in terms of value in the EU. The French healthcare system offers strong incentives for market access, such as attractive reimbursed Early Access Programmes. Our agency Justin Stindt Consultants is specialized in Market Access in France and can help you navigate the French Market Access.
Market Access France – Essential to access one of the largest EU markets for pharma, biotech and medtech
With a population of 68 million, the country’s health spending accounted for 12.2% of its GDP in 2020. In 2020, the country ranked fourth among OECD countries in terms of health spending as a percentage of GDP. France’s reimbursed Early Access Programs make it a very attractive market to enter in the early stages of new medicines as it allows for fully reimbursed usage.
Exploring France’s Early Access Programs: Navigating AAP and AAC for Medicinal Products and Medical Devices
Early access authorization enables the early access, availability and reimbursement of a medicinal product indicated for a severe, rare or incapacitating disease. There are two early access programs in France known as the Early Access Authorization or AAP (Autorisation d’accès précoce) and Compassionate Access Authorization or AAC (autorisation d’accès compassionel). AAP allows the reimbursed use of an innovative medicine before marketing authorization (MA) has been granted and between MA and reimbursement decision. The AAC (or CPC cadre de prescription compassionnel) is intended for non-innovative medicines or for medicines that are not initially intended for marketing authorization that allows the use in a small number of cases but this can also apply to innovative medicines, especially prior to approval of an AAP. While the ANSM is responsible of granting compassionate access authorizations (AAC), both ANSM and HAS hold the responsibility of granting early access authorizations (AAP). The ‘Forfait innovation’ also allows for early access to health technologies other than medicines such as medical devices in the early phase of clinical development. For more information visit our French reimbursed early access programs page.
Decoding the French P&R Dossiers: The Roles of the Transparency Commission and CEESP in Medicine Assessment and Pricing
For regular Pricing & Reimbursement decisions, the assessment of medicines and the determination of their added value are entrusted to the Transparency Commission (TC) of the Haute Autorité de Santé (HAS). Medicines meeting certain conditions also undergo a health economic assessment by the CEESP, another commission within the HAS. Following this assessment, manufacturers engage in price negotiations with the Economic Committee (CEPS). For more information visit our French P&R dossiers page.
Understanding France’s P&R Pathways: Differentiating Pricing Strategies for Hospital-Only Drugs and Retail Medicines
Unlike hospital-only drugs, medicines in a retail setting do not have free pricing. While hospital-only drugs can be priced freely, the cost of medicines must be covered within the scope of the Diagnosis-Related Group (DRG) system, which emphasizes price sensitivity in a hospital setting. However, for expensive but innovative medicines there are pathways for extra funding such as the liste en sus and the retrocession list.
France also offers reimbursement pathways for medical devices and eHealth products. The CNEDiMTS is the commission within the HAS appraising medical devices. For more information visit our French P&R Pathways page.
Justin Stindt Consultants is your agency to support you with Market Access in France
Justin Stindt Consultants is your consulting agency with experts who have extensive experience in Market Access in France.
As a service provider, our consultancy has helped many clients by engaging the HAS for scientific advice meetings and develop benefit assessment TC dossiers and early access dossiers. Our consultants also support price negotiations for pharma, biotech and medtech companies. For medical devices and digital health apps, our agency supports dossiers and negotiations. Many of our consulting firm’s clients have found France the place to start for Market Access in Europe due to attractive reimbursed early access opportunities and decided to enlist our agency as partner of choice given our footprint and experience in the French market.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in France.
Market access services for pharmaceutical and biotech products in France
CASE STUDIES FOR French MARKET
- Support entire French Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
