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Malaysia's biotech
folly
By Sabrina Ooi
PENANG, Malaysia - There are fears that the
Malaysian government is attempting another bad
swing in the biotechnology game by welcoming
clinical trials outsourced by pharmaceutical
giants, where monitoring mechanisms and
regulations for research could be relaxed to spawn
domestic biotech ventures.
On Thursday,
the government is due to unveil a national policy
that will earmark biotechnology - which harnesses
the science of genetics to develop medicines - as
the next engine of growth for the country. This
national biotech policy comes after the
disappointing Bio Valley project venture, which
started in 2001 inside Malaysia's US$3.7 billion
Multimedia Super Corridor. Malaysian officials
were hoping to attract $10 billion in foreign and
local investment in the biotechnology industry in
10 years - a tall order for a small domestic
scientific community.
Four years later,
indications are that Bio Valley has been a dismal
failure, with only three companies signing up to
establish plants. Now there is much speculation as
to what the government has in mind. "We understand
it [the draft policy] was essentially farmed out
to a private consultant and even among government
ministries and agencies, the consultation has been
unsatisfactory," said Chee Yoke Ling, legal
adviser for Third World Network - a coalition of
non-governmental organizations in the developing
world. "From the public statements made by
Malaysia's minister of science, technology and
innovation, Dr Jamaludin Jarjis, it is not clear
exactly which part of the biotech world he is
aspiring to."
In giving broad-brush
glimpses of the policy, Jarjis had said, "We will
discuss with the Ministry of Domestic Trade and
Consumer Affairs for a complete review of IP
[intellectual property] laws. Otherwise, foreign
biotechnology giants will not outsource their
clinical trials in our country."
It appears that Jarjis may want to follow
in the footsteps of India, where
monitoring mechanisms and regulations for research are relaxed
to encourage the setting up of contact research
organizations (CROs) to take up the business of
experimenting with new drugs for pharmaceutical
giants. Clinical trials performed on humans,
animals or cells are estimated to cost only
one-tenth in Asia what they do in the United
States and Europe.
A report by Sandhya
Srinivasan of the India Resource Center indicates
that in the case of India, the middleman and CROs,
for instance, could collect up to $2 million while
spending only $20,000 on initial research outlay.
He said the huge profit margin was made using the
poor and sick of India "as raw material". The
report goes on to add that unethical practices by
drug companies and CROs are common, and the ones
bearing the brunt are usually the unsuspecting
Indian people in areas where the clinical trials
are conducted. "Mostly, patients do not know that
they are on experimental drugs," the report
claims.
The 1964 Helsinki Declaration on
ethical principles for medical research involving
human subjects, in an updated note added last
year, states clearly that "at the conclusion of
the study, every patient entered into the study
should be assured of access to the best proven
prophylactic, diagnostic and therapeutic methods
identified by the study".
But the Indian
Resource Center report explicitly points out that
most of the time these patients are shortchanged.
"There is no guarantee that the drug will be made
available post-trial," it states. Critics are
concerned that the same thing could happen in
Malaysia should the country take this biotech
route.
Jamaludin's promise to have
a one-stop agency to cut the red tape for
foreign biotech companies has also created fear
among certain quarters. Beth Burrows, president of
the Edmonds Institute - a US-based public-interest
group that looks into biosafety issues - cautioned
that turning off the alarm bells just to invite
investment from multinational biotech companies is
tantamount to courting disaster. "Bravo Malaysia,
if it takes the route of biosafety research. Good
regulation is efficiency in the long run - it can
help a country to have safe, dependable products
on the market, build trust with consumers
worldwide and thereby sustainable markets, and
avoid human health and environmental disasters as
well as long-term cleanup and litigation costs."
But Malaysia's neighbors could thwart the
country's dreams by putting up strong competition
for investment in the highly capital-intensive
biotech industry. Australia, Japan, South Korea
and China have all introduced new legislation and
provided funding to jump start their life-science
industry. Singapore, for example, set aside $2
billion to offer as incentive to attract leading
research corporations and to invest in local and
foreign biotech start-ups. To bolster its
universities' research capabilities, Singapore is
also offering competitive salaries to attract
professors from top-ranking US institutions -
something Malaysia is finding difficult to do.
"Many developing countries aspire toward
this goal [of having a lucrative biotech
industry]. Nonetheless, they go about this without
very clear specific understanding of the various
aspects of the industry," said Third World
Network's Chee. "It's a very risky venture,
especially since public funds will be spent."
A study of 51 biotech centers in the US by
the Brookings Institution revealed that it often
takes a decade or more to develop
biotechnology-based products, and perhaps only one
in 1,000 patented biotech innovations produces a
successful commercial product. The study also
showed that most biotechnology firms are quite
small and typically contract with global
pharmaceutical firms to produce, market, and
distribute successful products rather than
attempting to create their own capacity to do so.
The losses, too, have been tremendous.
According to accounting firm Ernst and Young,
publicly traded biotechnology companies in the US
lost $41 billion from 1990 to 2003. As the saying
goes, the road to hell is paved with good
intentions gone astray, and Malaysia's national
biotechnology policy might be another headstone in
a graveyard of investors' dreams.
(Inter
Press Service) |
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