Materia Medica Malaysiana

Banking on Biotechnology - A Disaster in the Making?

PENANG, Malaysia, Apr 26 (IPS) - 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 3.7 billion U.S. dollar Multimedia Super Corridor. Malaysian officials were hoping to attract 10 billion dollars in foreign and local investment in the biotechnology industry in 10 years - a tall order for a small domestic scientific community.
Four years later, the 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, the legal advisor for Third World Network - a coalition of NGOs 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,'' she told IPS.
In giving broad brush glimpses of the policy, Minister Jarjis said, ''We will discuss with the Ministry of Domestic Trade and Consumer Affairs for a complete review of IP (intellectual property) laws. Otherwise, the foreign biotechnology giants will not outsource their clinical trials in our country.''
It appears that Jamaludin may want to follow the footsteps of India where monitoring mechanisms and regulations for research are relaxed in order to encourage the setting up of contact research organisations (CROs) to take up the business of experimenting new drugs for pharmaceutical giants.
Clinical trials performed on humans, animals or cells are estimated to cost only one-tenth in Asia as compared to the United States and Europe.
A report by Sandhya Srinivasan of the India Resource Center indicated that in the case of India, the middleman and CROs, for instance, could collect up to two million dollars while spending only 20,000 dollars on initial research outlay. He said the huge profit margin was made using the poor and sick of India ''as raw materials''.
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.''
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 U.S.-based public interest group that looks into biosafety issues - cautioned that turning off the alarm bells, just to invite investment from multinational biotech companies, was tantamount to courting disaster.
''Bravo to Malaysia, if it takes the route of biosafety research!'' said Burrows.
''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 clean up and litigation costs.''
But Malaysia's neighbours could thwart the country's dreams by putting up strong competition for investment in a highly capital-intensive biotech industry.
Australia, Japan, South Korea and China have all introduced new legislation and provided funding to jumpstart their life-science industry. Singapore, for example, set aside two billion dollars 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-ranked U.S. institutions - something Malaysia is finding difficult to do.
''Many developing countries aspire towards 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 U.S. by the Brookings Institution revealed that it often takes a decade or more to develop biotechnology-based products and perhaps one in 1,000 patented biotech innovations produces a successful commercial product.
The study also shows 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 the accounting firm Ernst and Young, publicly traded biotechnology companies in the U.S. lost 41 billion dollars 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