The elsi implications of gene therapy under the unesco declaration a taiwan s perspective
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The ELSI Implications of Gene Therapy under the UNESCO Declaration -a Taiwan’s Perspective. Panelist : Lin, Jui-Chu & Wang, Triumph. The Meaning of Gene Therapy The Development trend of Gene Therapy Regulation The Status of Regulations of Gene Therapy Clinical Trial

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

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The elsi implications of gene therapy under the unesco declaration a taiwan s perspective

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

Panelist:Lin, Jui-Chu & Wang, Triumph


The elsi implications of gene therapy under the unesco declaration a taiwan s perspective

  • 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


The meaning of gene therapy

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.


Gene therapy development

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


The development trend of gene therapy regulation

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


Unesco declaration

UNESCO Declaration

  • Universal Declaration on Bioethics and Human Rights

  • International Declaration on Human Genetic Data


The status of regulations of gene therapy clinical trial

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


The basic principles of clinical trial

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


The application procedure of clinical trial

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


The censorship procedure of clinical trial

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


The protection of the interests of tested persons

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


The suggestions on the regulations

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


Conclusion

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


The elsi implications of gene therapy under the unesco declaration a taiwan s perspective

  • 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


The elsi implications of gene therapy under the unesco declaration a taiwan s perspective

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


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