October 19, 2021
Since 2021, the amount of public investment in research and development from which laboratories exploiting certain reimbursable medicines have benefited must be made available to the CEPS.
This new provision was introduced by Article L. 165-17-4-3 of the Social Security Code (SSC) created with the Social Security Financing Act for 2020 (LFSS n°2020-1576 of 14 Dec. 2020, Art. 79).
A decree published in the OJ on 17 October 2021 specifies the nature of the information to be transmitted by laboratories and the practical procedures for their transmission.
This concerns medicinal products registered on the list of specialities reimbursable to social insurance companies or on the list of medicinal products approved for use by public authorities, for which an application for registration on these same lists has been filed or for which the operating company plans to file such an application within a maximum period of five years from 31 January of the reporting year in question.
Article L. 162-17-4-3 of the SSC requires laboratories exploiting these reimbursable medicinal products to make available to the CEPS the amount of public investment in research and development from which they benefited for the development of these medicinal products.
From a simple provision, initially provided for by the law, the decree introduces the principle of a declaratory approach to the CEPS by the laboratory using this information.
So be careful not to forget this new declaration!
This information is transmitted to the CEPS for the previous calendar year by electronic means before 31 January of each year.
The amounts thus communicated will also be made public by CEPS, in its annual activity report published on its website.
.png)
