Interview by Léa Teissonnier (BEO BERLIN) with EUMMAN Partner Marie Glori Pasquet (GloriMed Consulting) on the French medical device market and reimbursement procedures.
Which authorities should you know in order to better understand the French medical device market?
Among the existing institutions in France, there are two important organizations that medical device manufacturers should keep an eye on:
- ANSM – Agence Nationale de Securité du Médicament et des Produits de Santé
The National Agency for the Safety of Medicines and Health Products is the competent authority for the market surveillance of medical devices. Its various tasks include assessing the benefits and risks associated with the use of the medical device. The agency acts on behalf of the French government to ensure patient safety, carries out expert evaluations and acts as a decision-making body in the field of health product regulation - HAS – Haute Autorité de Santé
The French National Health Authority is an independent public scientific authority whose general mission is to contribute to the regulation of the healthcare system by improving the quality and efficiency of healthcare.
The HAS evaluates medical devices from a clinical and medico-economic point of view. It evaluates their progress in relation to existing therapeutic strategies. The HAS statements to the authorities enable them to clarify their decisions with regard to the coverage of these products by health insurance. It also evaluates public health measures and programs.
What is required of a medical device to be placed on the French market?
To be placed on the European market, a Medical Device must meet the general safety and performance requirements that apply to it. If the product meets these requirements, which depends on various criteria, it is given the CE marking marking.
Once CE conformity has been established, the medical device can be sold on the European market.
n the context of reimbursement by the French health insurance funds, additional procedures must be followed, for example for inclusion in the list of reimbursable products and services (LPPR).
Who checks the application for inclusion in the LPPR?
The validity of the application for inclusion in the LPPR (Liste des Produits et Prestations Remboursables) is checked by the CNEDIMTS (Committee for the Evaluation of Medical Devices and Health Technology of the HAS ).
What are the procedures for LPPR?
In general, the LPPRs done under a generic description, which is the default option for registration. If a product does not match an existing generic description or if it is an innovative product compared to the existing generic product line, registration under the brand name is also possible.
There are two procedures for registration in the LPPR :
1) Inclusion in the generic description
If a product corresponds to the wording and technical specifications of one of the existing generic descriptions in the LPPR , manufacturers can take steps to register their product.
Similar medical devices correspond to the same generic description and thus the same specifications required in the LPPR .
The following applies when using this procedure:
- Neither the brand name of the product nor the company name is mentioned.
- Common and identical intended use, technical specifications (etc.) must be proven
- Identical refund rate
- An individual code is required
The steps for the generic approach include:
- Determining whether a generic LPPRdescription exists
- Verification of the conformity of the product
- Conformity with the definition and technical characteristics of the existing generic LPPRdescription/line/code
In some cases, however, registration under the generic product line is not possible (e.g. if there is no generic product description). The alternative is to register under the trade name.
2) Procedure: Application for registration under the brand name
The LPPRregistration is valid for a maximum of 5 years and can be renewed.
This procedure is applied:
- For products with an innovative character
- For a product that is unique and/or does not allow a general description
- If the impact on health insurance, public health requirements, control and/or the difficulty of defining minimum technical specifications require special monitoring of the product
To summarize, registration in the LPPR is under a generic description, which is the default choice for registration. On the other hand, if there is no generic description, or it is an innovative product compared to the existing generic line, registration under the brand name is a second option.
Company profile
Marie Glori Pasquet is the Managing Director of GloriMed Consulting.
After completing her studies in international trade, she quickly joined American and French pharmaceutical companies. She was involved in the commercial strategy and the launch of new products on the export market. As Area Sales Manager, she was also involved in the registration of medical devices in Germany and coordinated sales development in Europe in close cooperation with distributors.
GloriMed Consulting is a member of EUMMAN (EUropean Medical Market Access Network), a network of European consulting companies that focus on small and medium-sized companies in the medical technology industry. Regulatory affairs, development, marketing, communication - thanks to a multidisciplinary team, GloriMed Consulting supports manufacturers in all phases of their medical device's life cycle.
(1 Rating(s), average: 5.00 out of 5)
Loading...
