Thu, Dec 23, 2010 - Page 8 News List

Losing health checks and balances

By Lai Chung-chiang Wang Chan-hsi 賴中強,王占璽

Association for Relations Across the Taiwan Strait (ARATS) Chairman Chen Yunlin (陳雲林) came to Taipei for talks with Straits Exchange Foundation (SEF) Chairman Chiang Pin-kung (江丙坤) to sign an agreement on medical and health cooperation. The Department of Health (DOH) said the pact would bring standards and norms for medical products on both sides of the Taiwan Strait — including drugs, medical devices, health foods and cosmetics — into line with each other and facilitate cooperation on clinical trials for new drugs.

In other words, China and Taiwan will eventually have identical standards and norms governing medicines, and the human clinical trial stage for at least some of the drugs that find their way onto the market in Taiwan will have been carried out in China.

This news has put a smile on the faces of businesspeople on either side of the Taiwan Strait, as stocks of biotech firms shot up in value. For the rest of us, it means being extra vigilant about the safety of medicines, about the rights of people involved in clinical trials and the concomitant public health risks in the two countries.

The first issue is China’s ability to supervise and control health and medical affairs. During the SARS epidemic in 2003, the Chinese government resorted to a forced and belated mobilization of resources, a classic case of shutting the stable door after the horse had bolted. There was no consolidated epidemic prevention system in place. In 2008, in the middle of the toxic milk powder scandal, China’s food safety regulatory system was once again found sorely wanting.

Corruption in China’s drug supervision bodies has led to many drug safety incidents and scandals. In China, government departments compete with each other, and the position of Taiwan’s DOH there has always been weak. Powerful groups with vested interests often brush aside troublesome supervisory regulations, and in such cases there is little the DOH can do.

These problems are proving to be stubborn despite all the assistance the WHO has given to China to help it rebuild its health system. Put it like this: Are you going to sleep well at night knowing that new drugs appearing on the market, and in your own medicine cabinet, had their human clinical trials conducted in China, where the supervision of drugs development is in the hands of the powerful few?

The second question is Taiwan’s own record when it comes to public health. Department of Health Minister Yaung Chih-liang (楊志良), who is always mentioning how “professional” he is, denied all knowledge of the existence of a man who apparently suffered from the brain-wasting disease new variant Creutzfeldt-Jakob disease years after his return to Taiwan from the UK. That should be warning enough about the reliability of Taiwan’s public health system.

The Ministry of Economic Affairs allows the import of blood serum and plasma from China, with Yaung saying that these products are for exclusive use in external reagents and applications, and not to be used in injections.

Who is going to stand up and guarantee that? Is the health department really up to monitoring how all imported blood products are eventually used?

The third problem is that once the pact is signed, the problems with China’s health system will become Taiwan’s health risks. Even if things are done in line with international standards, who’s to say that these norms and standards are going to be thoroughly implemented in China? Let’s assume we send officials over there to carry out inspections. These will, at best, only be random checks. What about the parts not included in these random checks? DOH officials readily admit that all we can do is “hope” that their counterparts will implement adequate supervision.

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