A Bill of Law entitled « Recherches sur la personne » (« Researches on person ») was filed with the French Parliament (« Assemblée Nationale ») on 6 January 2009. The French Parliament adopted the Bill on 22 January 2009.

The Bill of Law notably aims at harmonizing the regime of interventional and non-interventional clinical trials. Currently, non-interventional studies are not considered as clinical trials and are not regulated by the provisions of the French Public Health Code on clinical trials.

According to the Bill of Law, non-interventional studies will now require the information of the patients which can refuse to participate in a non-interventional study.  Moreover, the

sponsor will have to obtain the prior approval of the non-interventional clinical trial by the competent Ethic Committee. Finally, Good Clinical Practices for non-interventional clinical trials will be adopted.

Since 29 October 2009, the Bill of Law has been under discussion before the French Senate.

The new Bill of law modified by the French Senate in a second lecture was filed on 20 December 2010 and is now available (in French) since 5 January 2011.

A commission between members of the French Parliament and of the French Senate is now in charge of making proposals regarding what is still under discussion.

Acknowledgements: Paule Drouault-Gardrat, PDG Avocats, Paris

• Clinical Trials
• Post-Authorization Studies
• Market Research Studies

• 2010 Farmaindustria COP
• Implementation Guide for the 2010 Farmaindustria COP
• Rules of Procedure for the Control Bodies of the Spanish Pharmaceutical Industry Self-Regulation System (2010)
   
• NIS Considerations (Feb 2010) - Spain: Draft Guidelines Finalised
   

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centres and other research organisations.

The purpose of the E-Register is to increase the availability of information on the utilisation, safety and effectiveness of medicines used in clinical practice through a readily accessible database resource.

It will also contribute to reducing publication bias by handling both positive and negative study results in the same manner and promote exchange of information, thereby facilitating collaboration within the scientific community and preventing unnecessary duplication of research.

Registration of studies in the register is voluntary, except for those studies wishing to apply for the status of 'ENCePP Studies', a seal awarded to wholly or partially EU-based, benefit/risk studies that are carried out in compliance with the ENCePP Code of Conduct for independence and transparency and the ENCePP Checklist of Methodological Research Standards. Studies that potentially qualify for this seal must be entered into the E-Register before they commence.

The E-Register of studies can be accessed through the ENCePP website.

For all studies included in the E-Register, investigators are required to regularly update the information that is available in the register.

The launch of the E-Register of Studies is the latest milestone achieved by ENCePP, following the adoption of the ENCePP Code of Conduct, the launch for public consultation of the Guide on Methodological Standards for pharmacoepidemiological studies and the launch of an inventory of resources. The ENCePP project, which is led by the European Medicines Agency, is intended to enhance the way medicines are monitored once they have been approved for use in the European Union by facilitating the conduct of high quality, multi-centre, independent, post-authorisation studies.

Source: EMA Press Release (25/11/2010)  

Acknowledgements: Professor David Hutchinson of Canary Ltd and Brookwood Academy 

1. All persons participating in a clinical trial must respect the ethical and professional principles and guidelines such as the Helsinki Declaration and the ICH guidelines for Good Clinical Practice
2. The purpose of the trial must always be the improvement of therapeutic, diagnostic methods and / or medical knowledge to the best interest of patients.
3. A trial must not be performed in view of increasing sales or prescribing.
4. The purpose of the trial must be declared in advance. The trial protocols must be compiled in such a way as to ensure success of the aim of the trial and that valid conclusions are drawn.
5. All kinds of clinical trials are carried out only upon approval by the competent authorities (Drugs' Council) or / and the BIO Ethics Committee.
6. The sponsor must be known to patients participating in the trial.
7. The physician must not receive any remuneration or compensation for the mere inclusion of patients in clinical trials.
8. The physician may receive remuneration for his / her work in the trial. Remuneration must be given in connection with the work provided and must be declared to the National BIO Ethics Committee the management of the organisation that he or she belongs and the Drugs' Council, who supervise the trial. Remuneration must not be connected with the expected outcome of the trial.
9. i) Remuneration shall be effected in accordance with the applicable law.
10. j) All data on safety and efficacy with respect to marketed products must be truthfully published on the internet irrespective of the outcome of the trial, at least in summary, within the year following the grant of the marketing authorisation. Furthermore, other important clinical results must be published in the same way.
11. In publications, lectures and other presentations, the identity of the sponsor must be known.
12. The physician may receive remuneration for lectures relating to the clinical trial and the results thereof.
13. When presenting clinical trials, the physician must make known his connections with all the companies of the therapeutic area covered by his lecture.

• AIFD Code of Good Promotional Practice, Third Edition Version 3.1 (2010)
   

• 2010 Code of Conduct of Pharmaceutical Industry in Switzerland (Pharma Code)

• Text only entry: £75
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