Regulatory System of Research on New Infectious Diseases

1
Regulatory System of Research on New Infectious
Diseases

• the Thai Perspective

Soraj Hongladarom, Center for Ethics of Science
and Technology Chulalongkorn University
Workshop on Globalization and the New
Epidemics Ethics, Security and Policy Making,
Brussels, 22-23 May 2006
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Overview

• Regulation of Research Ethics in Thailand
• How are the New Epidemics being Handled?
• Ethical Issues

3
Research Ethics in Thailand

• Currently there is no national law on research
  ethics, though one is being drafted at the
  Ministry of Public Health.
• Ethics on human subjects conducted by medical
  doctors or in hospitals have to be approved by an
  appropriate ethical review committee. This is
  required by the Medical Council.
• Other health care professionals also have their
  own guidelines.

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• There are some problems regarding the different
  standards of various ethical review committees.
• Also problems with compliance with international
  norms.
• Since the regulation is currently part of
  professional code, those outside of the
  profession are not regulated (though the new law
  is designed to change this.)
• As for the new infectious diseases, there has
  been some research on the virology and the
  infection mechanisms, but not much on the social
  and ethical implications.

5
Coping with the New Epidemics

• Thailand has received recognition for its
  efficiency in fighting the new diseases.
• Various government agencies are concerned Public
  Health, Agriculture.
• Many factors dedicated personnel, timely
  responses, openness, funding.

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• However, there are currently no regulations
  concerning research on the new epidemics. Most
  effort has been concentrated on monitoring,
  prevention and providing awareness to the public.
• There is very little research on how
  globalization as a social and economic phenomenon
  is related with the new epidemics either.
• Problems with reporting - at first there was a
  reluctance to report, but after international and
  domestic pressure the authorities have been very
  open. Still there are conflicts between poultry
  industry and the govt. - especially those in
  traditional farms.

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Ethical Issues

• Global justice
• Since this is a global phenomenon, what should
  the richer countries be doing to help? Call for
  more interaction, collaboration, funding,
  expertise support.
• The diseases usually spread from the poorer
  countries to the richer ones. It seems that only
  when the diseases threaten the richer countries
  that is there a concerted effort and substantial
  funding and other resources toward combatting
  them.

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Ethical Issues

• Protection of participants vs. Protection of
  public goods.
• There is a need to find a balance between the
  individual rights and protection of public goods.
  But the former should be taken as a default, and
  any infringements of them need to be clearly
  justified.

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Ethical Issues

• Antiviral Drugs
• Currently the availability of Tamiflu is strictly
  regulated by the Public Health Ministry. This
  creates the problem of who should get the drug
  should the epidemic breaks out. Many fear chaos
  and violent conflicts. Is it ethical for the
  pharmaceutical companies to hold on to their
  patents and keep the price high?

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Globalization

• What we need now is tighter involvement of
  countries, not more isolation. But the
  involvement should not result in exploitation or
  injustice.

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Thank you!
See you at the 8th Asian Bioethics Conference,
March 19-23, 2007, Chulalongkorn University,
Bangkok, Thailand. http//www.stc.arts.chula.ac.t
h/ABC2007/