The ELSI Implications of Gene Therapy under the UNESCO Declaration -a Taiwan’s Perspective

1. The ELSI Implications of Gene Therapy under the UNESCO Declaration-a Taiwan’s Perspective Panelist：Lin, Jui-Chu & Wang, Triumph

2. The Meaning of Gene Therapy • The Development trend of Gene Therapy Regulation • The Status of Regulations of Gene Therapy Clinical Trial • The Suggestions on the Regulations

3. The Meaning of Gene Therapy • It is through the way of importing gene or cell containing gene into the human body to treat disease or recover one’s health.

4. Gene Therapy Development • 1260 clinical trials of gene therapy from 1989 to January, 2007 in the whole world • 5.5 billion dollars market in 2008 (estimate) • “Vascular endothelial growth factor for the treatment of chronic critical lower limb ischemia”-The first clinical trial of gene therapy in Taiwan, 1995-2004

5. The Development trend of Gene Therapy Regulation • Austria Gene Therapy Technology Act had passed in 1995 • Gene Therapy regulations in Medicines law or Medical Care Law (most countries) • In Taiwan, involved in civil law, criminal law, medical care law, consumer protection law, etc. and administrative ordinances

6. UNESCO Declaration • Universal Declaration on Bioethics and Human Rights • International Declaration on Human Genetic Data

7. The Status of Regulations of Gene Therapy Clinical Trial • The basic principles of clinical trial • The application procedure of clinical trial • The censorship procedure of clinical trial • The protection of the interests of tested persons

8. The Basic Principles of Clinical Trial • In Taiwan, Article 1 of The applications and Operating Standards of Gene Therapy Clinical Trial • Life threatened • Scientific basis, predictable effect and safe • More excellent than present treatment • Benefits outweigh maladies • Confined to somatic cell

9. The application procedure of clinical trial • The application entity • The entity applying for clinical trial • Te establishment of the laboratory standard regulations • The application Process

10. The censorship procedure of clinical trial • The prior censorship by the Clinical Trial Committee in the hospital • The censorship by the Department of Health Censorship Committee • The preliminary censorship and re-censorship by exports • Article 4 of The applications and Operating Standards of Gene Therapy of Clinical Trials • Article 1 of The Procedure of the Application and Censorship of New Medical Technology Clinical Trial

11. The protection of the interests of tested persons • The system of approval after information • The establishment of Human Trial Censorship Committee • The prior censorship • The supervision after the trial

12. The Suggestions on the Regulations • Central Bio-security Committee • Guidelines of the regulation • Integrate the related excellent operating regulations • Collect the safety information of tested persons after receiving the gene therapy clinical trial

13. Conclusion • The legislative idea we need is rapid response but not hurry to intervene • Focus on the establishment of standard, the education of professional and the implementation of the certification, rather than the establishment of broad principled rules; unless there is a consensus in society

14. The Applications and Operating Standards of Gene Therapy Trial on Human Body§3 • Medical Care Law§§7，78 Application for Gene Therapy (Main body) • Medical Care Law§78 • Detailed Rules for Medical Care Law§50 • The Applications and Operating Standards of Gene Therapy Trial on Human Body§4 • The Procedure of The Application and Censorship of New Medical Technology Human Trial§1 • UNESCO Universal Declaration on Bioethics and Human Rights §19 Application for Gene Therapy （Flow of operation） • Medical Care Law§79 • The Applications and Operating Standards of Gene Therapy Trial on Human Body§6 • The Provisions of The Applications and Operating Standards of Somatic Cell Therapy on Human Body§3Ⅲ（1） • Helsinki Declaration • International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prior Censorship of Gene Therapy Supervision after Trial of Gene Therapy • The Applications and Operating Standards of Gene Therapy Trial on Human Body§1Ⅰ（3） • Organization and Operating Standards of Medical Institutions of Human Trial Committee§30

15. Mechanism of Application and Censorship Supervision after Trial Prior Censorship Human Trial Censorship Committee in the Hospital General Procedure Emergency Procedure Measure of Supervision Effect of Supervision Measure of Supervision Effect of Supervision Refuted Medical Censorship Committee of Department of Health External Supervision: Department of Health Department of Health Has Discretionary Power to Order Hospital Stop the Trial Mechanism of Implementer’s repots Refuted Internal Supervision: Hospital No Relevant Provision Preliminary Censorship and Re-Censorship by Exports Refuted