- Email: [email protected]
What you Need to Know about the New Regulations for Biomedical Research in France
R EGULATORY SYSTEM
Thérapie 2006 Novembre-Décembre; 61 (6): 467–470 DOI: 10.2515/therapie:2006084 c 2007 Société Française de Pharmacologie et de Thérapeutique
What you Need to Know about the New Regulations for Biomedical Research in France Yves Tillet1 and Aurélie Lebrun2 1 White-Tillet, Consultants & Experts, Chelles, France 2 Appamed, Clichy, France
Keywords: biomedical research; regulations; procedures; safety; vigilance; traceability; clinical trials
Abstract – The EC 2001/20 directive relating to the clinical trials of medicinal products was transposed into French law in 2004 by means of a public health law. But this transposition actually came into effect on 27 August 2006 by the implementation of decree no. 2006-477 of 26 April 2006 which has been followed subsequently by numerous statutory orders. A reading of these regulatory texts shows that the new provisions go far beyond the framework of the directive as they have been notably extended by the French legislator to encompass all the health products within the competence of the French Agency for Sanitary Safety in Health Products (Afssaps) as well as to other studies that do not involve health products. In addition, all research undertaken is from now subject to the prior, and jointly favourable, reasoned opinion of a CPP (Ethic Committee) and authorisation by Afssaps. These new regulations for biomedical research in France substantially modify and reinforce the previous provisions defined by the Huriet law of 1988, for safety, vigilance and traceability.
1. Delayed transposition but widened scope of application Implementation decree no. 2006-477 of 26 April 2006 and the numerous subsequent statutory orders, rendered public health law no. 2004-806 effective on 27 August 2006 transposing into French law the directive 2001/20/CE relating to the clinical trials of medicinal products.[1, 2] This decree was framed in consultation with the representatives of the principal players in biomedical research (industrial and institutional developers, committees of protection of persons – hereafter referred to as CPP –, and patients’ groups).[3] As for the delay in transposition, it can be explained by the difficulties the French legislator had in reconciling the provisions set out in the directive, with a view to European harmonisation with the spirit and letter of the previous national regulations of the Huriet Law of 1988 and the subsequent texts. In this way the scope of the new biomedical research regulations in France has been extended to all healthcare products within the competence of the French Agency for Sanitary Safety in Health Products (Afssaps) as well as to other studies that do not involve health products (for example, physiopathology studies). Moreover, the concept of research with or without direct individual benefit disappears. From now on, the new body of regulations encompasses what is termed interventional research,
with authorisation based on a risk/benefit analysis.[4–7] In fact, two types of research are excluded from the new field of application: i) non-interventional research, for which the medical strategy is not fixed in advance by protocol and which arises from current practice; and, except for medicinal products; ii) a new category of research relating to current care, the objective of which is to evaluate actions, the combination of actions, and medical strategies for prevention, diagnosis and treatment, which are the subject of professional consensus, and in keeping with their indications. Research into current care must, however, gain favorable approval from a CPP, which has the obligation to ensure within Afssaps that the products used in research are used in conformity with their indications and their destination.[6,7] Biomedical research is defined by the law of 2004 as “research organized and practised on human beings with a view to developing biomedical or medical knowledge”.[4, 6, 7] Biomedical research into medicinal products has been extended, as with all clinical trials, to one or more medicinal products aimed at determining or confirming their clinical, pharmacological and other pharmacodynamic effects, or to highlight their undesirable effects, or to study their absorption, distribution, metabolism and elimination, with the aim of ensuring their innocuousness and effectiveness. Biomedical research relating to a medical device has been extended, as with all clinical trials and clinical investigations of one or more medical devices aimed at
Article published by EDP Sciences and available at http://www.journal-therapie.org or http://dx.doi.org/10.2515/therapie:2006084
468
Tillet and Lebrun
determining or confirming their performance or highlighting their undesirable effects and evaluating whether these constitute a risk regarding the performance assigned to the device.[3, 6, 7] All research practised on human beings must maintain a satisfactory balance between the estimated benefit, both short and long-term, and the risks encountered.[6, 7]
2. New and regulated procedures From a consultative advisory regime with CCPPRB and a simple declaration with Afssaps, which existed since the Huriet Law of 1988, we now pass to a regime of positive advice justified by a CPP and of authorization by Afssaps.[2, 7] The composition of the CPPs is defined and their powers are extended to the evaluation of the medical and methodological validity of the research.[2, 5–7] In all cases, the promoter must first: i) register its research (obtain a number from the European database EUDRACT for the medicinal products or provided by Afssaps for the medical devices and cosmetic products); and ii) pay a tax (e 3000–4000, reduced to 1/10th for institutional requestors).[2–7] In the absence of which, no trial can be initiated. The research must be carried out in material conditions that guarantee its scientific and health integrity. When the research is the subject of a prior authorization, the request must be addressed to the regional Prefect (or the Minister of Defense if it falls under his authority). Agreement, given after investigation by a medical inspector and, where appropriate (sterile products), a pharmacist inspector of public health, cannot exceed five years. Note that if any research is not implemented within a year following authorization, the initially granted authorization becomes null and void.[2, 7, 8] Research into medicinal products must be pursued in keeping with current good clinical practices (cGCPs) and, if the research includes pharmaceutical operations (notably, preparation, secondary packaging or labelling/re-labelling of medicinal products), it must conform to current good manufacturing practices (cGMPs - under the responsibility of an experienced pharmacist).[7, 8] Moreover, the legislator has planned the publication, by decree, of good practices recommendations for the research relating to medicinal devices (voluntary, not regulated as previously, but constituting without doubt the state of the art).[7] Subjects and patients lending themselves to the research benefit from the free use of all the products used but cannot receive any financial benefit for participating in that research, except for compensation to a maximum of 4500 euros/year per person.[2, 7, 8] Each participation in a trial is subject, if necessary, to an exclusion period, the length of which depends on the nature of the research. Certain subjects or patients, depending on their situation or their condition (healthy volunteers for example) vis-à-vis the aim of the research in which they participate, c 2007 Société Française de Pharmacologie et de Thérapeutique
must be entered in a national register.[2, 7] In all cases, the conditions for informing the patients and obtaining their free, informed and express consent are defined in the regulations, with particular provisions for protected persons.[2, 7] Are also set out by the new regulations all informations intended for the directors and pharmacists of health establishments where, as the case may be, the research is carried out.[2, 7] Furthermore, orders set out the procedures for requesting opinion from the CPPs and authorisation from Afssaps as well as the format and content of the principal documents necessary for any biomedical research. The format and content differs according to the category of the product concerned (Table I).[2, 7] Procedural time limits are also set by orders. According to this, from the time of the initial request, the CPP has a maximum of 35 days to give its opinion. Beyond that, its silence means an unfavourable opinion. For its part, Afssaps has a maximum of 60 days, but its silence beyond this time, in contrast, means authorisation (however, the research relating to high-risk products:organs, tissues, cell and gene therapy, labile blood products. . . requires the express authorisation of Afssaps).[2, 7] CPP and Afssaps can formulate objections or demands for modifications from the promoter. The time limit for responding to this has a suspensory effect with the CPP, but not with Afssaps, which fixes the time limit.[7, 8] Similarly, the procedures governing appeal against a negative opinion from the CPP, substantial modifications to the research requested by the promoter, as well as the “terms & conditions” for completing the research, are set out by the new regulations.[7, 8] On this subject, the end of the research, interrupted or not, must be declared to Afssaps and CPP, at the latest after 90 days, and the final report must be placed at the disposal of Afssaps, while a summary must be sent to it within a maximum of one year after the completion of the research.
3. Increased safety through regulations for vigilance and traceability Vigilance and traceability have also been strengthened by the legislator, which introduced the notion of the suspicion of an undesirable effect, which it defines. The suspicion of an undesirable effect relates to all undesirable effects for which the investigator or the promoter thinks a causal relationship can be envisaged to the experimental medicinal product.[2, 6, 7] A reference document enables the expected or unexpected nature of a suspicion of serious undesirable effects to be determined. For medicinal products authorised to be placed on the market, this document is a summary of the product’s characteristics (SPC); failing that, it’s the brochure intended for the investigator. For a medical device which has an EC label, it’s the package leaflet; there too, if not, it’s the investigator’s brochure. The modes of transmission to Afssaps and CPP, Thérapie 2006 Novembre-Décembre; 61 (6)
New Regulations for Biomedical Research in France
469
Table I. The main types of documents necessary for research relating to medicinal products and medical devices and references to the statutory orders setting out their format and content. Type of document to present with format/content to required*
Legal reference Medicinal products
Medical devices
Dossier to be submitted to Afssaps
SANP0622223A SANP0623844A**
SANP0623370A
Dossier to be submitted to CPP
SANP0622225A SANP0623689A**
SANP0623371A
Protocol
SANP0622226A
SANP0623372A
Investigator’s brochure
SANP0622120A
SANP0623373A
Request for substantial modification(s)
SANP0622121A SANP0623688A**
SANP0623514A
Declaration of end of research, final report and summary of final report
SANP0622180A
SANP0623516A
Safety report
SANP0622181A
SANP0623515A
Declaration of undesirable effects and new facts
SANP0622224A
SANP0623374A
Labelling of experimental medicinal products
SANP0622121A
NA***
* Non-exhaustive list (there are also regulations for other products’ categories); ** Modifying the previous statutory orders; *** Not applicable.
the different types of undesirable effects (serious, unexpected or expected), for each category of healthcare products, are fixed by law. However, whatever the product type (medicinal product or medical device), the investigator must notify without delay any undesirable serious event or effect – notably but not exclusively defined as death or danger to life –, in writing to the promoter, who, in turn, must make a declaration to Afssaps and the CPP, within a maximum of 7 days if the undesirable serious effect is unexpected, or within a maximum 15 days if it has been previously listed as expected.[2, 7, 8] Previously, all serious adverse effects, expected or not, had to be communicated only to Afssaps.[8] Moreover, if a new fact concerning the research or the product which is the subject of the research is potentially able to adversely affect human safety, the promoter and the investigator must take appropriate urgent safety measures, and the promoter must immediately inform Afssaps and CPP of this. [2, 6, 7] In addition, the promoter must transmit to Afssaps a six-monthly declaration of events and incidents encountered in all research, and – an annual safety report, the content of which is fixed by product category.[2, 3, 6–8] Finally, the provisions relating to viral safety are retained and made explicit for experimental medicinal products of biological origin and medical devices in development (not CE marked), which are invasive or intended to be in contact with injured skin, and which contain or are manufactured with the aid of tissues of animal origin. In these two above cases viral safety data, relating to conventional viruses or non-conventional transmittable agents responsible for spongiform encephalopathy, must be addressed to Afssaps. The “Viral Safety” group of Afssaps has a 60 day time period within which to give its opinion.[2, 7] To complete the c 2007 Société Française de Pharmacologie et de Thérapeutique
safety measures, the notion of presumed fault of the promoter is extended to encompass all biomedical research. This thus will assume a priori liability for consequential damages from research to the people who lend themselves to that research (accordingly the promoter must take out specific professional insurance), the only successful defence being proof of absence of fault on its part.[2, 7]
4. Conclusion On reading the above, it seems clear that France, by these new regulatory provisions developed in favour of the transposition into French law of the EC directive 2001/20, has wished to strengthen its instruments for safety, vigilance and traceability, in biomedical research which has been extended by the French legislator to all healthcare products within the competence of Afssaps as well as to other studies that do not involve health products; that is well beyond the scope of the directive relating to clinical trials of medicinal products. In doing so, and notably through the new decree and numerous statutory orders, the legislator has introduced more transparency, strengthened the role of the competent authorities and enhanced safety while basing the evaluation of risk on comparison with expected benefits. Lastly, the large and complex regulatory arsenal put in place,[2, 7] demonstrates the French legislator’s intention to indicate precisely, to the promoter as well as the investigator, how broadly it understands the high level of protection of persons who participate in biomedical research in France.
References 1. JOCE. Directive 2001/20/CE
Thérapie 2006 Novembre-Décembre; 61 (6)
470
2. JORF. Loi, décret, arrêtés, décisions, et circulaires relatifs à la nouvelle réglementation de la recherche biomédicale en France http://www.recherche-biomedicale.sante.gouv.fr/pro/ ppprofesionel 3. Durand R B. Editorial. Droit & Dispositifs Médicaux Actualités. 2006 (Juin):1-4 4. Lahami C. Le nouveau décret relatif aux recherches biomédicales. Observations juridiques. La Gazette de l’AFAR, 2006; 52: 4-15 5. Tillet Y, Lebrun A. La nouvelle réglementation de la recherche biomédicale en France : de nouvelles procédures pour un renforcement de la protection des personnes. La lettre de l’ARTEB. Juillet-août-septembre 2006 6. Tillet Y, Lebrun A. The New Regulations for Biomedical Research in France. Regulatory Rapporteur 2006; 3(12): 34-5
c 2007 Société Française de Pharmacologie et de Thérapeutique
Tillet and Lebrun
7. White-Tillet. La Nouvelle Réglementation de la Recherche Biomédicale : Nouvelles Bases Réglementaires et Modalités Pratiques. 5ème édition actualisée, novembre 2006, 137 pages. Rédaction par Aurélie Lebrun, coordination et révision par Yves Tillet. www.white-tillet.com 8. Boyer Ph. Recherche biomédicale sur les médicaments : du décret aux arrêtés. La Gazette de l’AFAR, 2006; 53: 8-17
Correspondence and offprints: Yves Tillet, Cabinet White-Tillet, 35 rue Franck Hémon, 77500 Chelles, France. E-mail: [email protected]
Thérapie 2006 Novembre-Décembre; 61 (6)
Thérapie 2006 Novembre-Décembre; 61 (6): 467–470 DOI: 10.2515/therapie:2006084 c 2007 Société Française de Pharmacologie et de Thérapeutique
What you Need to Know about the New Regulations for Biomedical Research in France Yves Tillet1 and Aurélie Lebrun2 1 White-Tillet, Consultants & Experts, Chelles, France 2 Appamed, Clichy, France
Keywords: biomedical research; regulations; procedures; safety; vigilance; traceability; clinical trials
Abstract – The EC 2001/20 directive relating to the clinical trials of medicinal products was transposed into French law in 2004 by means of a public health law. But this transposition actually came into effect on 27 August 2006 by the implementation of decree no. 2006-477 of 26 April 2006 which has been followed subsequently by numerous statutory orders. A reading of these regulatory texts shows that the new provisions go far beyond the framework of the directive as they have been notably extended by the French legislator to encompass all the health products within the competence of the French Agency for Sanitary Safety in Health Products (Afssaps) as well as to other studies that do not involve health products. In addition, all research undertaken is from now subject to the prior, and jointly favourable, reasoned opinion of a CPP (Ethic Committee) and authorisation by Afssaps. These new regulations for biomedical research in France substantially modify and reinforce the previous provisions defined by the Huriet law of 1988, for safety, vigilance and traceability.
1. Delayed transposition but widened scope of application Implementation decree no. 2006-477 of 26 April 2006 and the numerous subsequent statutory orders, rendered public health law no. 2004-806 effective on 27 August 2006 transposing into French law the directive 2001/20/CE relating to the clinical trials of medicinal products.[1, 2] This decree was framed in consultation with the representatives of the principal players in biomedical research (industrial and institutional developers, committees of protection of persons – hereafter referred to as CPP –, and patients’ groups).[3] As for the delay in transposition, it can be explained by the difficulties the French legislator had in reconciling the provisions set out in the directive, with a view to European harmonisation with the spirit and letter of the previous national regulations of the Huriet Law of 1988 and the subsequent texts. In this way the scope of the new biomedical research regulations in France has been extended to all healthcare products within the competence of the French Agency for Sanitary Safety in Health Products (Afssaps) as well as to other studies that do not involve health products (for example, physiopathology studies). Moreover, the concept of research with or without direct individual benefit disappears. From now on, the new body of regulations encompasses what is termed interventional research,
with authorisation based on a risk/benefit analysis.[4–7] In fact, two types of research are excluded from the new field of application: i) non-interventional research, for which the medical strategy is not fixed in advance by protocol and which arises from current practice; and, except for medicinal products; ii) a new category of research relating to current care, the objective of which is to evaluate actions, the combination of actions, and medical strategies for prevention, diagnosis and treatment, which are the subject of professional consensus, and in keeping with their indications. Research into current care must, however, gain favorable approval from a CPP, which has the obligation to ensure within Afssaps that the products used in research are used in conformity with their indications and their destination.[6,7] Biomedical research is defined by the law of 2004 as “research organized and practised on human beings with a view to developing biomedical or medical knowledge”.[4, 6, 7] Biomedical research into medicinal products has been extended, as with all clinical trials, to one or more medicinal products aimed at determining or confirming their clinical, pharmacological and other pharmacodynamic effects, or to highlight their undesirable effects, or to study their absorption, distribution, metabolism and elimination, with the aim of ensuring their innocuousness and effectiveness. Biomedical research relating to a medical device has been extended, as with all clinical trials and clinical investigations of one or more medical devices aimed at
Article published by EDP Sciences and available at http://www.journal-therapie.org or http://dx.doi.org/10.2515/therapie:2006084
468
Tillet and Lebrun
determining or confirming their performance or highlighting their undesirable effects and evaluating whether these constitute a risk regarding the performance assigned to the device.[3, 6, 7] All research practised on human beings must maintain a satisfactory balance between the estimated benefit, both short and long-term, and the risks encountered.[6, 7]
2. New and regulated procedures From a consultative advisory regime with CCPPRB and a simple declaration with Afssaps, which existed since the Huriet Law of 1988, we now pass to a regime of positive advice justified by a CPP and of authorization by Afssaps.[2, 7] The composition of the CPPs is defined and their powers are extended to the evaluation of the medical and methodological validity of the research.[2, 5–7] In all cases, the promoter must first: i) register its research (obtain a number from the European database EUDRACT for the medicinal products or provided by Afssaps for the medical devices and cosmetic products); and ii) pay a tax (e 3000–4000, reduced to 1/10th for institutional requestors).[2–7] In the absence of which, no trial can be initiated. The research must be carried out in material conditions that guarantee its scientific and health integrity. When the research is the subject of a prior authorization, the request must be addressed to the regional Prefect (or the Minister of Defense if it falls under his authority). Agreement, given after investigation by a medical inspector and, where appropriate (sterile products), a pharmacist inspector of public health, cannot exceed five years. Note that if any research is not implemented within a year following authorization, the initially granted authorization becomes null and void.[2, 7, 8] Research into medicinal products must be pursued in keeping with current good clinical practices (cGCPs) and, if the research includes pharmaceutical operations (notably, preparation, secondary packaging or labelling/re-labelling of medicinal products), it must conform to current good manufacturing practices (cGMPs - under the responsibility of an experienced pharmacist).[7, 8] Moreover, the legislator has planned the publication, by decree, of good practices recommendations for the research relating to medicinal devices (voluntary, not regulated as previously, but constituting without doubt the state of the art).[7] Subjects and patients lending themselves to the research benefit from the free use of all the products used but cannot receive any financial benefit for participating in that research, except for compensation to a maximum of 4500 euros/year per person.[2, 7, 8] Each participation in a trial is subject, if necessary, to an exclusion period, the length of which depends on the nature of the research. Certain subjects or patients, depending on their situation or their condition (healthy volunteers for example) vis-à-vis the aim of the research in which they participate, c 2007 Société Française de Pharmacologie et de Thérapeutique
must be entered in a national register.[2, 7] In all cases, the conditions for informing the patients and obtaining their free, informed and express consent are defined in the regulations, with particular provisions for protected persons.[2, 7] Are also set out by the new regulations all informations intended for the directors and pharmacists of health establishments where, as the case may be, the research is carried out.[2, 7] Furthermore, orders set out the procedures for requesting opinion from the CPPs and authorisation from Afssaps as well as the format and content of the principal documents necessary for any biomedical research. The format and content differs according to the category of the product concerned (Table I).[2, 7] Procedural time limits are also set by orders. According to this, from the time of the initial request, the CPP has a maximum of 35 days to give its opinion. Beyond that, its silence means an unfavourable opinion. For its part, Afssaps has a maximum of 60 days, but its silence beyond this time, in contrast, means authorisation (however, the research relating to high-risk products:organs, tissues, cell and gene therapy, labile blood products. . . requires the express authorisation of Afssaps).[2, 7] CPP and Afssaps can formulate objections or demands for modifications from the promoter. The time limit for responding to this has a suspensory effect with the CPP, but not with Afssaps, which fixes the time limit.[7, 8] Similarly, the procedures governing appeal against a negative opinion from the CPP, substantial modifications to the research requested by the promoter, as well as the “terms & conditions” for completing the research, are set out by the new regulations.[7, 8] On this subject, the end of the research, interrupted or not, must be declared to Afssaps and CPP, at the latest after 90 days, and the final report must be placed at the disposal of Afssaps, while a summary must be sent to it within a maximum of one year after the completion of the research.
3. Increased safety through regulations for vigilance and traceability Vigilance and traceability have also been strengthened by the legislator, which introduced the notion of the suspicion of an undesirable effect, which it defines. The suspicion of an undesirable effect relates to all undesirable effects for which the investigator or the promoter thinks a causal relationship can be envisaged to the experimental medicinal product.[2, 6, 7] A reference document enables the expected or unexpected nature of a suspicion of serious undesirable effects to be determined. For medicinal products authorised to be placed on the market, this document is a summary of the product’s characteristics (SPC); failing that, it’s the brochure intended for the investigator. For a medical device which has an EC label, it’s the package leaflet; there too, if not, it’s the investigator’s brochure. The modes of transmission to Afssaps and CPP, Thérapie 2006 Novembre-Décembre; 61 (6)
New Regulations for Biomedical Research in France
469
Table I. The main types of documents necessary for research relating to medicinal products and medical devices and references to the statutory orders setting out their format and content. Type of document to present with format/content to required*
Legal reference Medicinal products
Medical devices
Dossier to be submitted to Afssaps
SANP0622223A SANP0623844A**
SANP0623370A
Dossier to be submitted to CPP
SANP0622225A SANP0623689A**
SANP0623371A
Protocol
SANP0622226A
SANP0623372A
Investigator’s brochure
SANP0622120A
SANP0623373A
Request for substantial modification(s)
SANP0622121A SANP0623688A**
SANP0623514A
Declaration of end of research, final report and summary of final report
SANP0622180A
SANP0623516A
Safety report
SANP0622181A
SANP0623515A
Declaration of undesirable effects and new facts
SANP0622224A
SANP0623374A
Labelling of experimental medicinal products
SANP0622121A
NA***
* Non-exhaustive list (there are also regulations for other products’ categories); ** Modifying the previous statutory orders; *** Not applicable.
the different types of undesirable effects (serious, unexpected or expected), for each category of healthcare products, are fixed by law. However, whatever the product type (medicinal product or medical device), the investigator must notify without delay any undesirable serious event or effect – notably but not exclusively defined as death or danger to life –, in writing to the promoter, who, in turn, must make a declaration to Afssaps and the CPP, within a maximum of 7 days if the undesirable serious effect is unexpected, or within a maximum 15 days if it has been previously listed as expected.[2, 7, 8] Previously, all serious adverse effects, expected or not, had to be communicated only to Afssaps.[8] Moreover, if a new fact concerning the research or the product which is the subject of the research is potentially able to adversely affect human safety, the promoter and the investigator must take appropriate urgent safety measures, and the promoter must immediately inform Afssaps and CPP of this. [2, 6, 7] In addition, the promoter must transmit to Afssaps a six-monthly declaration of events and incidents encountered in all research, and – an annual safety report, the content of which is fixed by product category.[2, 3, 6–8] Finally, the provisions relating to viral safety are retained and made explicit for experimental medicinal products of biological origin and medical devices in development (not CE marked), which are invasive or intended to be in contact with injured skin, and which contain or are manufactured with the aid of tissues of animal origin. In these two above cases viral safety data, relating to conventional viruses or non-conventional transmittable agents responsible for spongiform encephalopathy, must be addressed to Afssaps. The “Viral Safety” group of Afssaps has a 60 day time period within which to give its opinion.[2, 7] To complete the c 2007 Société Française de Pharmacologie et de Thérapeutique
safety measures, the notion of presumed fault of the promoter is extended to encompass all biomedical research. This thus will assume a priori liability for consequential damages from research to the people who lend themselves to that research (accordingly the promoter must take out specific professional insurance), the only successful defence being proof of absence of fault on its part.[2, 7]
4. Conclusion On reading the above, it seems clear that France, by these new regulatory provisions developed in favour of the transposition into French law of the EC directive 2001/20, has wished to strengthen its instruments for safety, vigilance and traceability, in biomedical research which has been extended by the French legislator to all healthcare products within the competence of Afssaps as well as to other studies that do not involve health products; that is well beyond the scope of the directive relating to clinical trials of medicinal products. In doing so, and notably through the new decree and numerous statutory orders, the legislator has introduced more transparency, strengthened the role of the competent authorities and enhanced safety while basing the evaluation of risk on comparison with expected benefits. Lastly, the large and complex regulatory arsenal put in place,[2, 7] demonstrates the French legislator’s intention to indicate precisely, to the promoter as well as the investigator, how broadly it understands the high level of protection of persons who participate in biomedical research in France.
References 1. JOCE. Directive 2001/20/CE
Thérapie 2006 Novembre-Décembre; 61 (6)
470
2. JORF. Loi, décret, arrêtés, décisions, et circulaires relatifs à la nouvelle réglementation de la recherche biomédicale en France http://www.recherche-biomedicale.sante.gouv.fr/pro/ ppprofesionel 3. Durand R B. Editorial. Droit & Dispositifs Médicaux Actualités. 2006 (Juin):1-4 4. Lahami C. Le nouveau décret relatif aux recherches biomédicales. Observations juridiques. La Gazette de l’AFAR, 2006; 52: 4-15 5. Tillet Y, Lebrun A. La nouvelle réglementation de la recherche biomédicale en France : de nouvelles procédures pour un renforcement de la protection des personnes. La lettre de l’ARTEB. Juillet-août-septembre 2006 6. Tillet Y, Lebrun A. The New Regulations for Biomedical Research in France. Regulatory Rapporteur 2006; 3(12): 34-5
c 2007 Société Française de Pharmacologie et de Thérapeutique
Tillet and Lebrun
7. White-Tillet. La Nouvelle Réglementation de la Recherche Biomédicale : Nouvelles Bases Réglementaires et Modalités Pratiques. 5ème édition actualisée, novembre 2006, 137 pages. Rédaction par Aurélie Lebrun, coordination et révision par Yves Tillet. www.white-tillet.com 8. Boyer Ph. Recherche biomédicale sur les médicaments : du décret aux arrêtés. La Gazette de l’AFAR, 2006; 53: 8-17
Correspondence and offprints: Yves Tillet, Cabinet White-Tillet, 35 rue Franck Hémon, 77500 Chelles, France. E-mail: [email protected]
Thérapie 2006 Novembre-Décembre; 61 (6)