Materia Medica Malaysiana

Bio-piracy and law of jungle

HAVE you heard the story about the pharmaceutical giant and the delicate flowering plant? It is an oft-quoted tale but one worth repeating.

In the early 1950s, following clues from indigenous medicine men in Madagascar, researchers at Eli Lilly pharmaceuticals extracted two powerful cancer-fighting alkaloids from the rosy periwinkle: vinblastine and vincristine. Global sales of the two substances, patented by Eli Lilly, earned it hundreds of millions of dollars, but not a sen went to Madagascar or the medicine men.

A notorious example in a long history of such incidences, the rosy periwinkle case would today be termed bio-piracy. It put tropical countries, home to much of the world's biodiversity, on high alert and cleanly divided them from the developed countries, which had the capital and capability to turn resources like plants, into life-saving, money-making medicines. The divide has also marked India's long war to rescue extracts of neem and tumeric from being patented by biotechnology powerhouses who know it as a medicinal plant, not a part of life. Years after the end of Eli Lilly's patent, the rosy periwinkle story and others like it serve as cautionary tales for resource-rich countries competing for biotech dollars — countries like Malaysia. Earlier this month, Science, Technology and Innovation Minister Datuk Dr Jamaludin Jarjis met industry players at Bio 2004, the biotech industry's annual conference and exhibition.

He was part of the Malaysian delegation to San Francisco, looking to attract possible partnerships in the field and investments in Malaysia.

The companies that did show an interest were the world's biggest biotech group, Amgen, another pharmaceutical giant, Chiron, and Novartis, which ranked seventh on the US Top 10 Sellers of Prescription Drugs in 2003.

Among resources on offer to investors were excellent facilities at competitive rates, support agencies, a strong information-technology base and our tropical rainforest.

The offer of such a precious and depleting resource seemed the sort of thing that should make us dizzy with paranoia but apparently not, says Forest Research Institute Malaysia director-general Datuk Dr Abdul Razak Mohd Ali.

Taking a practical view to things he says, we are already losing such resources to thieves masquerading as tourists, who pick up a leaf or shoot and take it home for testing. "That's all they need. They don't need a kilo." Furthermore, FRIM has long been receiving requests for samples, from institutions with offers of payment, but FRIM has refused. "If they (the institutions) discover something and patent it, we would stand to lose a lot.

"It is better to bring them here in an organised manner, sign good agreements and have our researchers participate in the project." Technology Park Malaysia's chief executive officer Datuk Salleh Ismail thinks along the same lines. He believes setting up a biodiversity centre in Raub to bio prospect and conduct research, is just about being systematic and organised.

Located within minutes of a tropical forest reserve, the centre will have a resource centre, herbarium, offices for research and development activities and on-site laboratories for analysing and processing samples.

Research here will be focused on rare medicinal plants, particularly those reputed for their anti-cancer properties. About 12 have been identified and research will soon begin, says TPM.

In the near future, the centre could be opened to expeditionary scientists, both local and foreign, to utilise it as a base out in the fields, while they conduct key research. Are we declaring open season on our genetic resources? Salleh was asked, and he said "no".

"Drug discovery no longer means going down the jungle track. For big research institutions, it is all about work in laboratories.

"Malaysia though, must also not miss the opportunity to explore the treasures for ourselves." Salleh concedes that things could go wrong but says that not all scientists are thieves.

TPM will require institutions carrying out research at Raub to sign agreements and register each sample they take out of the forest. He adds that TPM, already big on biotech research, will carry on with its programmes whether foreign researchers come or not, he says.

At the Raub centre, TPM researchers will have help from indigenous people. A storehouse of information on the healing power of herbs, the history of drug discovery is replete with stories of their knowledge being sought but rarely compensated.

This traditional knowledge system is not recognised by existing laws, says University of Malaya law lecturer Gurdial Singh Nijar. Co-editor of Indigenous People's Knowledge Systems and Protecting Biodiversity, Gurdial says allowing corporations to use this knowledge and own it with intellectual property rights means marginalising alternative knowledge systems.

The knowledge, he points out, is as essential as the plants and herbs are. One is useless without the other. Recognising it in law, ensures it is preserved.

Another concern raised following Malaysia's offer to foreign biotech firms, was that Malaysia is without a national biotechnology policy.

In an exclusive interview with New Straits Times last week, Jamaludin assured that one such policy was in the works. However, pulling in investors before setting down goals and strategies, raises the question of whether we know where we are headed and how we want to handle problematic issues.

"We need this policy," says Third World Network's Chee Yoke Ling, "and the public should have a chance to comment on it." Have we considered how we want to deal with issues of bio prospecting, safeguarding of traditional knowledge and possible mishaps from the use of biotechnology? Chee asks.

She also expresses concern about a lack of key legislation like a Biosafety Act and an Access and Benefit Sharing Act that would address environmental and health problems as well as economic loss that could arise from venturing into biotechnology.

Even the Convention on Biological Diversity stresses the importance of domestic legislation. Enacting laws to govern resources is one way host countries can control foreign access to their genetic resources.

This is especially so when it comes to working with US-based firms, because the country is not a signatory to the convention.

But the greatest doubts raised thus far is whether we are operating on the wrong assumption — that everything we touch in the forest will instantly turn to gold.

On making money out of biotech, an Associated Press report on Bio 2004 quoted economist Joseph Cortright as saying that luring biotech in the hope of saving a community's economy, is a laughable notion.

He explained that San Francisco, host to the conference and the centre for biotech in the US, finds industries concentrated there because of the built-in venture capital community, vibrant academic institutions and highly educated workforce. They cluster around universities and each other, so they could easily swap technology and scientists, making it difficult for other regions to launch such industries from scratch.

But for all its promise, said the report, the biotech industry has lost a combined US$40 billion (RM152 billion) since its inception in 1976. Last year, it lost US$5.4 billion, said an Ernst and Young study.

Combined annual revenues of the biotech companies were about US$30 billion. That's the same amount a single pharmaceutical giant — Pfizer Inc — took in last year.

The performance of our own Bio Valley has also been less than spectacular. Reports in April showed that only three companies had signed up to establish plants there thus far. "There is a lot of disquiet about the biotechnology industry among consumers and business," says Gurdial.

He wonders if we are not going down the same road as we did with rubber and tin: inviting big corporations, which will use up the resource and leave or like many other industries, fall because a cheaper production centre has opened elsewhere.

"Are we using the tried and failed formula of competing with every other Third World country for the limited amount of foreign direct investments available? We must be cautious not to be seduced by promises," he cautions.

It is obvious that Malaysia is pinning its hopes on biotechnology. The sector was identified as the new wealth-generating technology under the Eighth Malaysia Plan.

Chee asks if anyone has done an economic viability study on the biotech industry and this is a valid question, considering that on a global scale, all is not well for biotech.

The landmark 1991 bio prospecting between pharmaceutical giant Merk and Costa Rica's National Institute of Biodiversity ended in 1999 after the failure to produce a single commercially viable drug, The Scientist reported last year.

Painful proof that not every herb and tree turns into a money-spinner.

The term "stiff competition" is an understatement in this industry. It has to be when authorities offer to change adjust parking requirements to suit the needs of biotech investors.

Governors and mayors from across the US were offering this in addition to tax breaks, government grants and help in securing permits at the same convention in which Malaysia was wooing investors.

In a battle like this, says Chee, it may come down to a race of who can give away more, namely give up rights over valuable resources.

Already, Razak warns against Malaysia being too strict with regulations. Investors can go elsewhere. Intellectual property lawyer Teoh Bong Kwang also feels legislating access and benefit-sharing may inhibit the growth of the industry. It should be in the form of agreements.

So, will we be left doing the ground work and simply facilitating things for the big firms? Will the greatest draw end up with these firms having being access to our genetic resources? Salleh says, this will not happen. He is confident that if we can create a more efficient system, consolidate research facilities and invest in bright minds, we have every chance of making inroads into the admittedly tough arena.

But both Salleh and Razak say that Malaysia does need to look into the nuts and bolts of the system, look beyond building facilities. We need a centralised mechanism for permits, a one-stop application processing centre, patent lawyers who understand both science and the law in order to ensure we get a fair deal in research agreements.

More importantly, we need to boost funding, manpower and equipment of agencies that are already doing good work; agencies like FRIM, Mardi, the Institute for Medical Research and scientists in all our universities, says Razak.The Government has also got to start dealing with the difficult issues and public concerns regarding biotechnology, says Chee.

As society advances, they will be confronting administrators and legislators with ethical questions about biotechnology, questions about genetically modified foods, privacy issues with regards to personal genetic data, clinical trials and cloning.

They have to be able to discuss these issues with a citizenry that is growing more informed by the day and yet remains deeply religious and traditional in many ways.

By all means, let's get onto the biotechnology bandwagon, but let's us do so with a well-thought-out plan and our eyes wide open.Considering all we know, it would be tragic if Malaysia ends up as the next unfortunate example everybody cites.