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Losing health checks and balances
By Lai Chung-chiang Wang Chan-hsi ¿à¤¤±j¡A¤ý¥eâ
Association for Relations Across the Taiwan Strait (ARATS) Chairman Chen Yunlin
(³¯¶³ªL) came to Taipei for talks with Straits Exchange Foundation (SEF) Chairman
Chiang Pin-kung (¦¿¤þ©[) 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 ¡X including drugs, medical
devices, health foods and cosmetics ¡X 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 (·¨§Ó¨}), 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.
Yaung and Chinese Health Minister Chen Zhu (³¯ªÇ) discussed food and drug
regulation at a World Health Assembly conference in May, with Chen saying it was
an opportunity that would benefit the consolidation of China¡¦s health system.
Yaung was quite proud of this, saying that Taiwan had applied pressure on China
this time round. Which is fine, but if you look at it from the other side, it
tells us that the people we are dealing still have a health system they freely
admit is uncoordinated.
If the WHO couldn¡¦t get China to reform its health system, what is the
likelihood that pressure exerted from Taiwan is going to do any good?
Lai Chung-chiang is a lawyer and a member of the Alliance of
Supervising Cross-Strait Agreements. Wang Chan-hsi is a postdoctoral fellow.
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