Key Benefits:
The Prime Minister,
On the report of the Minister of National Education, Higher Education and Research, the Minister of Health and Social Welfare and the Minister for Research,
Considering the public health code, including articles L. 1243-2 and L. 1243-5;
Considering the Customs Code, and in particular its article 38;
Having regard to Act No. 2004-800 of 6 August 2004 on bioethics, including article 37;
In light of the amended Decree No. 90-437 of 28 May 1990, setting out the conditions and procedures for the payment of costs caused by the displacement of civilian personnel in the metropolitan territory of France when they are responsible for the budgets of the State, national administrative institutions and certain subsidized bodies,
Decrete:
The provisions of this Decree apply to import for the purpose of researching embryonic stem cells, to study and research protocols relating to these imported embryonic stem cells and to the conservation of these imported embryonic stem cells.
Any institution or organization that imports embryonic stem cells for research purposes or that which conducts studies or research on imported cells ensures that they have been taken from embryos designed in vitro in the context of medical reproductive assistance and no longer being the subject of a parental project.
It also verifies that the couple whose embryos are derived or the surviving member of that couple has consented to the embryos being investigated. He must be able to justify that he made sure of it.
Any establishment or organization that holds embryonic stem cells shall not disclose any information that would identify the couple or surviving member of the couple who donated these cells.
Only individuals may obtain authorization to import embryonic stem cells for research purposes, or authorization to conduct studies or research on these cells, establishments or organizations that hold the authorization for the conservation of embryonic stem cells for scientific purposes or those that have entered into a convention with an institution or body that owns such authorization.
These authorizations may be requested simultaneously by the same institution or agency. In this case, the import authorization or authorization of the study or research protocol only takes effect from the date on which the establishment or body is authorized to retain embryonic stem cells.
The application for authorization with a record shall be sent in twenty copies to the Minister responsible for research and in two copies to the Minister responsible for health under recommended fold with a request for notice of receipt or shall be filed against receipt with these two departments under the same conditions.
This application can only be considered if it is accompanied by a supporting file, the model of which is set by joint decree of ministers responsible for research and health.
This record must include, in all cases, any document certifying compliance with the conditions laid down in Article 2 of this Decree.
Depending on the nature of the application, it includes, among other things, the information mentioned in 1°, 2° and 3° below:
1° For import authorization for research purposes:
- a copy of the conservation authorization obtained by the applicant or of the agreement entered into with the establishment or organization holding that authorization or, if not, of the document certifying the filing of that application by the applicant himself or by the institution or agency with which the applicant has entered into the agreement;
- the precise designation of the embryonic stem cells concerned;
- the name, status and contact information of the foreign agency supplier;
- processes for the removal and retention of cells used by the supplier organism;
- the description of the means in place to ensure the traceability of the cells as well as their conservation and transport modalities;
- the results of the analyses of bio-logical markers of infection.
2° For the authorization of a study or research protocol:
- the description of the study or envisaged research, including in particular the evidence that it is likely to permit major therapeutic progress and that it cannot be pursued by an alternative method of comparable effectiveness in the state of scientific knowledge;
- a copy of the authorization to import embryonic stem cells obtained by the applicant or the document certifying the filing of the application for authorization or, if not, a copy of the authorization to import the establishment or agency with which the applicant has entered into a convention or document certifying the filing of the application for authorization by that institution or agency;
- a copy of the conservation authorization obtained by the applicant or of the agreement entered into with the establishment or organization holding that authorization, or, if not, of the document certifying the filing of that application by the applicant himself or by the institution or organization with which the applicant has entered into the agreement;
- the list and qualification of the members of the research team and the name of the person responsible for the study or research.
3° For conservation authorization for scientific purposes:
- a copy of the authorization to import embryonic stem cells obtained by the applicant or the document certifying the filing of the application for authorization or, if not, a copy of the authorization to import the establishment or agency with which the applicant has entered into a convention or document certifying the filing of the application for authorization by that institution or agency;
- the layout of the premises and their organization, specifying, where appropriate, the distribution of the various activities;
- the list and qualification of personnel responsible for the conservation activity and the nature of the missions entrusted to it;
- a precise description of equipment and materials, including those relating to cell transport, as well as of the conservation processes used;
- where applicable, the indication of the existence on the same site of activities authorized under articles L. 1243-2 and L. 1243-5 of the Public Health Code.
The file is deemed to be complete if, within eight days of its receipt, the Minister for Research did not disclose to the applicant any missing or incomplete information by registered letter with a request for a notice of receipt, indicating the time limit to provide it. The applicant's response time is not counted within the eight-day period mentioned above.
The Minister for Research shall forward the deemed complete record to the chair of the ad hoc committee for notice.
The committee shall render its notice to the Minister for Research and the Minister for Health within thirty days of the date of receipt by the chair of the committee of the file transmitted by the Minister for Research.
The absence of notice within the 30-day period is unfavourable notice.
For all authorizations, it is up to the ad hoc committee to verify compliance with ethical principles.
For study and research authorizations, the ad hoc committee's opinion includes an assessment of the scientific relevance of the protocol and its interest in public health. In particular, it takes into account the qualifications, diplomas, experience and scientific work of staff.
In addition, for study and research authorizations and for conservation authorizations, the advice of the ad hoc committee shall take into account the premises, materials, equipment and processes and techniques implemented by the applicant. As such, it checks the existence of alarm and security devices and means to ensure the quality and traceability of cells.
When establishments and organizations seeking a conservation authorization simultaneously operate on the same site activities referred to in sections L. 1243-2 and L. 1243-5 of the Public Health Code, the committee ensures that they have provided procedures to ensure compliance with the rules of hygiene and separate circuits in order to avoid any risk of contamination.
The joint decision of the Ministers responsible for research and health shall take place within two months of the date of receipt of the complete file.
Ministers responsible for research and health as well as the chair of the ad hoc committee may request, by registered letter with a request for notice of receipt, any additional information they consider necessary. This information may include financial and accounting data relating to the applicant institution or agency.
In the event of a request for further information, the deadlines referred to in Article 6 and the first paragraph of this Article shall be suspended until further information is provided.
The absence of a decision within the period referred to in this section is an implicit decision to reject.
The person responsible for the study or research shall address to the Ministers responsible for research and health an annual activity report on the study or research undertaken. It sends them the final report of the study or research as soon as it is completed. This report contains, in particular, information relating to the destination of embryonic stem cells that have been the subject of the protocol, including their destruction.
Upon request from the Ministers responsible for research or health, the person responsible for the study or research shall report on the status of the work.
Authorizations for study and research protocols and conservation permits are issued for a maximum of five years. Import authorizations are requested for each planned operation.
Authorities mention the type of activity involved, namely import, study or research, or conservation.
Any changes to the elements in the application for authorization file are brought to the attention of the Ministers responsible for research and health. They may request additional information in order to ensure that the amendment in question does not affect compliance with the legislative and regulatory provisions relating to the conditions for the issuance of authorizations or those established by the authorization.
If the amendments reported affect compliance with the legislative and regulatory provisions referred to in the first paragraph of this section or the purpose of the study or research, a new application for authorization is required for the continuation of the activity.
With respect to conservation authorization, the holder of the authorization shall, in particular, inform the ministers responsible for research and health prior to any transfer or further detention of embryonic stem cells. In the event of a transfer, it must justify that cells are assigned to an institution or organization that holds a protocol of study or research on these cells or a retention authorization. In the event of the detention of embryonic stem cells not designated in the original application for authorization, the holder of the retention authorization must file a copy of his import authorization or of the establishment or organization with which he or she has entered into a convention.
The Minister for Research maintains the list of authorized institutions and agencies and communicates it to the Minister for Health. It transmits the list of institutions or bodies authorized to import embryonic stem cells to the Minister responsible for Customs.
The French Health Products Safety Agency is informed by the Minister responsible for the research of embryonic stem cell conservation activities conducted on the same site as the activities authorized by the Minister pursuant to sections L. 1243-2 and L. 1243-5 of the Public Health Code.
The institutions and bodies authorized under this Decree shall maintain a register of embryonic stem cells that they hold.
The register states:
- the origin of stem cells;
- the results of analyses of biological markers of infection;
- the number of cell lines held;
- the place of conservation;
- the destination of embryonic stem cells: research, disposal or destruction.
In the event of a violation of the legislative or regulatory provisions or those established by the authorization, authorizations relating to study or research protocols and conservation authorizations may be suspended or withdrawn at any time by joint decision of the Minister for Research and the Minister for Health, after notice of the ad hoc committee.
Prior to any decision on suspension or withdrawal of authorization, the holder of the authorization shall, by the Minister for Research, terminate his or her failures within the time limit set for him or her to present his or her observations.
If the comments made by the licensee or the measures taken by the licensee are not likely to put an end to the deficiencies noted, the Minister for Research and the Minister for Health shall notify the licensee of their decision to suspend or withdraw the authorization, after the advice of the ad hoc committee.
The suspension decision refers to the period for the licensee to terminate the deficiencies found.
The members of the ad hoc committee are appointed by joint decree of the Ministers responsible for research and health.
The committee shall appoint a Vice-Chair to be the chair.
The mandate of the members of the ad hoc committee ends on the date of publication of the decree appointing the Director General of the Biomedicine Agency and the decree provided for in Article L. 2151-8 of the Public Health Code.
In the event of death, resignation or termination of office for any other cause of a member of the committee in the course of his or her term, his or her replacement shall be carried out in the same conditions as his or her appointment.
The committee may only deliberate in the presence of ten members, of whom at least three belong to the category referred to in c of II of section 37 of the above-mentioned Act of 6 August 2004. If the quorum is not reached, the committee is reconvened within fifteen days with the same agenda. It then deliberates validly whatever the number of members present.
The notices are rendered by a simple majority of the members present on the report of one of the members of the committee designated by the chair.
In the event of a vote with equal sharing of votes, the President's voice is preponderant.
The committee may hear any person from whom it considers the relevant hearing to its information.
Committee meetings are not public.
The committee shall notify the Minister for Research and the Minister for Health. The committee's notice includes the names of persons who deliberated on the application.
A committee member who would have a direct or indirect personal interest in a matter before the committee must make a statement to the Minister for Research and the Minister for Health. The Minister for Research shall inform the President of this matter. He cannot be appointed as a rapporteur and may not participate in the debate or vote on this case.
Members of the committee as well as persons who have to know information they hold are held in professional secrecy. They must exercise professional discretion for all facts, information or documents that they are aware of when participating in the work of the committee.
In the event of a breach of the provisions of this Article by a member of the ad hoc committee, the ministers responsible for research and health may terminate their duties as a member of the committee after having previously put it in a position to present its observations.
The committee secretariat is provided by the research minister's services in conjunction with the health minister's services. A representative of the French Registry Institution attends, as necessary, this secretariat.
Records, deliberations and notices are retained by the committee secretariat.
The functions of a member of the ad hoc committee are exercised free of charge. The travel and residence expenses of the members of this committee may be covered under the conditions established by the regulations applicable to State officials.
The Minister of State, Minister of Economy, Finance and Industry, the Minister of National Education, Higher Education and Research, the Minister of Health and Social Welfare, the Minister of Research and the Secretary of State for Budget and Budgetary Reform are responsible, each in this regard, for the execution of this decree, which will be published in the Official Journal of the French Republic.
Done in Paris, September 28, 2004.
Jean-Pierre Raffarin
By the Prime Minister:
Minister of National Education,
higher education
and research,
François Fillon
Minister of State, Minister of Economy,
finance and industry,
Nicolas Sarkozy
Minister of Health
and Social Welfare
Philippe Douste-Blazy
Minister Delegate for Research,
François d'Aubert
Secretary of State in the budget
and budgetary reform,
Dominic Bussereau
