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, May 2006

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

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.

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.

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. Coping with the New Epidemics

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.

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.

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.

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?

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

Thank you! See you at the 8th Asian Bioethics Conference, March 19-23, 2007, Chulalongkorn University, Bangkok, Thailand.