Key Benefits:
Publics concerned: manufacturers and distributors of individual medical devices and associated health insurance benefits; representative trade unions or organizations comprising manufacturers or distributors of these products and services; public and private health institutions engaged in medical, surgical and obstetric activities.
Purpose: Procedures for the evaluation of medical devices used in health care facilities, funded by the rates of hospitalization benefits and a homogeneous category for which this evaluation is required.
Entry into force: the text comes into force on the day after its publication.
Notice: This decree first specifies the procedure for determining, by order, homogeneous categories of health products subject to assessment and the manner in which these products are registered on the list allowing their use by health institutions and their care by health insurance.
This registration may involve "general description" common to a comparable product category or by specific registration of a product under its commercial name. Registration is made for a period of five years, renewable, and may be subject to prescription and use conditions or to the production by the operator of additional studies on its product.
The text also defines the modalities for scientific evaluation of products by the commission of experts known as the National Commission for the Assessment of Medical Devices and Health Technologies. The final notices of the commission are made public and are previously the subject of a conflicting exchange with the company concerned.
Finally, the order specifies the rules, deadlines and formal requirements applicable to the application procedure for registration on the list, the renewal or modification of the registration and the delisting of the products of the list.
References: the Social Security Code in its writing resulting from the provisions introduced by this decree can be found on the website Légifrance (http://www.legifrance.gouv.fr). The decree is taken for the application of thesection 37 of Act No. 2011-2012 of December 29, 2011 on strengthening the health safety of the drug and health products.
The Prime Minister,
On the report of the Minister of Social Affairs and Health,
Vu le Public Health Code ;
Vu le Social Security Codeincluding article L. 165-11;
Vu la Act No. 2000-321 of 12 April 2000 the rights of citizens in their relations with administrations;
Considering the opinion of the Central Board of Directors of the Agricultural Social Mutuality of 5 April 2012;
Having regard to the advice of the Board of the National Health Insurance Fund for Employees dated 10 April 2012;
Having regard to the advice of the Council of the National Health Insurance Union dated 12 April 2012;
The State Council (Social Section) heard,
Decrete:
In chapter V of title VI of Book I of the Social Security Code (Part Two: Decrees in the Council of State), it is added a section 12 as follows:
“Section 12
" Provisions relating to the assessment and care of certain health products financed from the rates of hospitalization benefits provided for in section L. 165-11
"Art. R. 165-49. - The homogeneous categories of health products defined in the II of Article L. 165-11 shall be determined by order of Ministers responsible for health and social security, taking into account, inter alia, the indications provided by the National Agency for the Safety of Medicine and Health Products, the High Health Authority, regional health agencies or health professionals operating in health facilities referred to in Article L. 162-22-6.
"The Ministers also set for each of these homogeneous categories:
« 1° The period in which health care facilities can continue to purchase, provide, support and use health products already funded under hospital benefits referred to in section L. 162-22-6. This deadline is set within four years, taking into account the invasive nature of the products concerned, the risks they may pose to public health and the commission's capacity referred to in Article L. 165-1 to assess them;
« 2° The terms and conditions of registration retained within the meaning of section R. 165-50.
"Art. R. 165-50. - The products are listed in the I list of Article L. 165-11 by decree of ministers responsible for health and social security. This registration is made in one of the following terms:
« 1° By the generic description of the product listing the main characteristics of the product;
« 2° In the form of brand name or trade name for products with an innovative character or when the impact on health insurance expenses, public health requirements or the control of minimum technical specifications warrant a nominal specific follow-up.
"The order referred to in the first paragraph specifies the duration of registration of the product, within a five-year renewable period, as well as, where applicable, the therapeutic or diagnostic indications and the specific conditions for the prescription or use of the product that is entitled to its purchase, supply, care and use, and the additional studies that must be carried out before the end of the registration period.
"A code is assigned to each generic product or description listed.
"Art. R. 165-51. - cannot be registered or renewed on the list provided for in Article L. 165-11:
« 1° Products for which advertising rules have not been complied with;
« 2° Products whose expected or rendered service is insufficient;
« 3° Products that do not meet market-based marketing requirements Public Health Code ;
« 4° Products that may result in unwarranted spending on health insurance.
"Art. R. 165-52. - For products belonging to the homogeneous categories defined in the II of Article L. 165-11, the inscription on the list provided for in Article L. 165-1 shall be on the list referred to in Article L. 165-11.
"Art. R. 165-53. - With a view to the registration or modification of the conditions for the registration of their product on the list provided for in I of Article L. 165-11, manufacturers, or their agents, or distributors, or, if any, their representatives in the case of a registration in the form of a generic description, file an application with the commission referred to in Article L. 165-1, which acknowledges receipt. A copy is sent simultaneously to Ministers responsible for health and social security. The application is accompanied by a file containing the information necessary to assess the relevance of an entry to the list or to amend the registration conditions.
"If the evidence provided is insufficient, the commission provided for in Article L. 165-1 or the ministers responsible for health and social security shall inform the applicant of the necessary additional information. A copy of this request for additional information is simultaneously addressed to the Ministers responsible for health and social security and to the commission mentioned above. In this case, the period referred to in R. 165-55 is suspended from the date of receipt of this information request and until the date of receipt of the requested information.
"The Commission's opinion referred to in Article L. 165-1 concerns the elements provided for in Articles R. 165-2 and R. 165-11, with the exception of 3° of the latter Article.
"Art. R. 165-54. - When the initiative of registration or modification of the conditions of registration of a product is taken by the ministers responsible for health and social security, the manufacturers, or their agents, or the distributors concerned are informed by an individual notification or, when the registration is considered as a generic description, by a notice published in the Official Gazette. They may make written submissions or request to be heard by the commission referred to in Article L. 165-1 within 30 days of receipt of notification or publication of the notice.
"Art. R. 165-55. - Decisions relating to the registration or modification of the conditions for the registration of a product on the list provided for in I of Article L. 165-11 are published in the Official Gazette. They are taken and communicated within one hundred and eighty days of receipt of the application.
"Art. R. 165-56. - The application for the renewal of the registration of a product on the list referred to in I of section L. 165-11 is submitted by the manufacturers, their agents, or their distributors, or, if any, their representatives in the case of a registration in the form of a generic description, not later than one hundred and eighty days before the expiry of the registration period. It is addressed to the commission referred to in Article L. 165-1, which acknowledges its receipt. A copy is sent simultaneously to Ministers responsible for health and social security. The application is accompanied by a file containing the information necessary to assess the conditions for renewal of the registration.
"If the evidence provided is insufficient, the commission provided for in Article L. 165-1 or the ministers responsible for health and social security shall inform the applicant of the necessary additional information. A copy of this request for additional information is simultaneously addressed to the Ministers responsible for health and social security and to the commission mentioned above. In this case, the registration period is extended for a period equal to the period between the date of receipt of this information request and the date of receipt of the requested information, within three months.
"The Panel's opinion referred to in Article L. 165-1 concerns the elements referred to in Article R. 165-11-1, with the exception of its 2°.
"Art. R. 165-57. - Decisions relating to the renewal of registration are issued by order of Ministers responsible for health and social security and published in the Official Gazette before the expiry of the registration period. They are communicated to applicants.
"On the expiry of the registration period, in the absence of a publication of the renewal decision and if a file containing all the necessary elements has been filed no later than one hundred and eighty days previously, the renewal of the registration is granted tacitly under the same conditions and for the same period. Where a request for additional information has been made pursuant to the second paragraph of section R. 165-56, this tacit renewal shall be granted on the expiry of the registration period as extended under that same paragraph and subject to the submission of the requested information within three months of the application. A notice mentioning this renewal is communicated to the person who has filed the file and published in the Official Gazette.
"Art. R. 165-58. - may be removed from the list provided for in I of Article L. 165-11, after notice of the commission referred to in Article L. 165-1, the products that cease to meet the criteria for registration or renewal of registration on this list referred to in Article R. 165-51 or whose terms of limitation and use do not comply with those referred to in Article L. 165-11.
"Deletion is pronounced by decree of ministers responsible for health and social security. Ministers inform the manufacturer or its agent, or the distributor of the radiation project. In the case of a generic description, this information is effected by the publication of a notice in the Official Journal.
"The manufacturer, or its agent, or the distributor may make written submissions within 30 days of receipt or publication of the information, or may request within the same time limit to be heard by the commission referred to above.
"Art. R. 165-59. - Products that are subject to a ban on marketing, use, prescription, issuance or administration are removed from the list provided for in I of Article L. 165-11 without the application of the provisions of Article R. 165-58.
"Can be disposed of, under the conditions set out in the first paragraph, products whose marketing is suspended or interrupted.
"Art. R. 165-60. - The Commission's draft notice referred to in section L. 165-1 under sections R. 165-53, R. 165-56 and R. 165-58 shall be communicated to the manufacturer, or its agent, or to the distributor or a representative when the notice has been made at the initiative of one of them or when a product is concerned in the form of a trademark or trade name. These persons have a period of eight days following receipt of this notice to make written submissions or request to be heard by the Commission.
"The final notice is communicated to the manufacturer, its agent, the distributor or their representative and simultaneously transmitted to the ministers responsible for health and social security. He's made public.
"Art. R. 165-61. - The commission referred to in Article L. 165-1 may, at its initiative or at the request of Ministers responsible for health and social security, re-evaluate the service expected or rendered of the products listed in the list provided for in Article L. 165-11, in particular when issuing a notice favourable to the listing of a product likely to substantially alter the therapeutic, diagnostic or compensation strategies of the previous disability.
"Art. R. 165-62. - Decisions denying registration on the list set out in I of Article L. 165-11, refusal to amend the terms of registration, refusal to renew the registration or delisting of the list are notified to the manufacturer, its agent, or to the distributor, or to their representative. These decisions are motivated and refer to the remedies and deadlines applicable to them. »
The same code is amended:
1° The 9th of Article R. 165-11 is repealed;
2° The 9th of section R. 165-11-1 is repealed.
The Minister of Economy and Finance, the Minister of Social Affairs and Health and the Minister Delegate to the Minister of Economy and Finance, responsible for the budget, are responsible, each with respect to it, for the execution of this Order, which will be published in the Official Journal of the French Republic.
Done on 13 September 2012.
Jean-Marc Ayrault
By the Prime Minister:
Minister of Social Affairs
and Health,
Marisol Touraine
Minister of Economy and Finance,
Pierre Moscovici
Minister Delegate
to the Minister of Economy and Finance,
Budget Officer
Jérôme Cahuzac
