Ethical Issues in Clinical Trials : Tenofovir and Beyond XVI International Aids Conference

1. Influencing legislative processes and policy development in order to improve research ethicsHugues Fischer, TRT-5 (French Cab), Act Up-Paris, Paris, France Ethical Issues in Clinical Trials : Tenofovir and Beyond XVI International Aids Conference Toronto Canada 13-18 August 2006

2. Influencing legislative processes and policy development in order to improve research ethics Issues • In many countries the HIV/AIDS movement is organised around Community Advisory Boards (CAB) to deal with issues such as protection of participants in clinical trials. • How can CABs influence legislative processes and policy development in order to improve research ethics for PLWHA ? • The presentation will show an important lobby work by the French CAB TRT-5 during the recent transposition of an European Union directive on biomedical research into the French Law.

3.  Influencing legislative processes and policy development in order to improve research ethics Summary of the presentation 1 – The TRT-5 and its work on clinical research 2 – The transposition of a European Union directive on biomedical research into the French Law : proposals and Lobby work 3 – Results  « Lessons learned » and conclusions

4. 1 – The TRT- 5 and its work on clinical research (1) What is TRT-5? The French Community Advisory Board (CAB) A coalition of 8 French HIV NGOs • With distinct and complementary skills and ways to take action Working since 1992 on • Access to the best standards of medical care • HIV & Aids clinical research

5. 1 – The TRT- 5 and its work on clinical research (2) Work on clinical Research To promote the needs of PLWHAs and to advocate for they rights • Work on the clinical development of new compounds and treatment strategies With three recurring claims: • Patients rights   • Enrollment consent form should be complete and understandable • Patients in need of vital treatments should get access to them • A better protection for participants • Ethic committees should integrate the point of view of the associations • Research openness • Access to research protocols has to be independent of the promoter’s willingness

6. 2 – Transposition of a European Union directive on biomedical research into the French Law (1) An opportunity European Union directive on biomedical research (2001) • Legislation on ethics and the organization of research • Inspired by the French « Huriet-Sérusclat » Law (1988) Its transposition into the French Public Health Law of August 2004 gives the opportunity to: • Perpetuate the practical experience acquired during 12 years by the TRT-5 • Promote the public discussion in order to gain new rights • Extend the benefit of what has been gained in the HIV field to other pathologies

7. 2 – Transposition of a European Union directive on biomedical research into the French Law (2) Modifications of the bill Amendments Proposals on • Patients rights   • e.g., to make compulsory the access to new treatments at the end of the clinical research and for patients excluded from the trial and whose survival request them • Participants protection • e.g., to make compulsory the participation of patients associations in the ethical committee • Research openness • e.g., to ensure that research protocols are sent to the associations when they ask for them Why should these proposals be submitted to the Parliament ? • Proposals were forwarded to the Health Ministry but not taken into account • The only choice left was to submit them to the members of the Parliament

8. 2 – Transposition of a European Union directive on biomedical research into the French Law (3) A year and a half of work Think-tank and writing of the amendments • Rallying together the various experts beyond the group : lawyers, … • Writing the amendments • keeping in mind to act in general interest, respecting the overall balance of Law • in a legal format and with appropriate practical examples • along with less demanding variations that are more likely to go through the Parliament • accompanied by a single synthetic lobbying document regrouping all the proposals Parliamentary Lobbying • Work with the usual partners : towards Ministry and Agencies • Establish contacts with new partners : members of Parliament • Lobbying art • systematic dispatching of the lobby document to all members of the Parliament • repeated meetings and phone contacts • follow-up of the text at every single step of the examination

9. Results (1) Progress has been achieved in terms of • Participants rights • The associations participate as an integral part of the ethical committee • Participants protection • The medical care after the clinical trial are described in the enrollment consent form • Research openness • The relevant items in the protocols will be provided to the associations However not everything is now settled ! • Work is on-going for writing the texts enabling the application of the law • The Law has been modified but • its enforcement can raise some issues • the monitoring of ethical issues must go on

10. Results (2) The most interesting progress may be elsewhere ! • The debate on ethical issues in medical research entered the Parliament and the civil arena, while they were usually addressed by specialists • The TRT-5 group is now recognized by new negotiating partners among administrators and politicians • New skills have been acquired: work on legislative and regulative texts • This enabled to intervene during the enforcement of the law to reform the Social Security (National Health Insurance) • The TRT-5 work practices changed • Working groups are now open to external experts

11. « Lessons learned » and recommandations « Lessons learned » • PLWHA associations can be a lobbying task force and can bring about changes in the law and the regulations • What they gain legally will not be achieved by anybody else • The knowledge accumulated by these associations in the HIV field is readily accessible for other pathologies • The work achieved bore fruit beyond the evolution of the legislation Recommendation • CABs should seize relevant legislative opportunities to engage in more formalized forms of advocacy on legislative and executive branches, for instance along the lines delineated in the model above

12. TO OUR NEGOTIATING PARTNERS : Parliament Martine Billard(députée des Verts), Guy Fischer(vice-président du Sénat)Ministry of Health Hélène Khoddos, Gérard Pelé ARNS Marie-Christine Simon, Michel Kazatchkine Ethic laboratory, Necker Hospital Ingrid Cailles TRT-5’s task force Veronique Collard, Anne-Sophie Giron, Emmanuel Trénado