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COVER STORY:Biodiversity is life. Biodiversity is our life.

Biological Resources: Sharing the Wealth

Japanese

Access to genetic resources and the sharing of benefits arising from their use will be an important item on the agenda at COP10. The Japan Journal’s Osamu Sawaji reports.



The human race has always used microorganisms and other biological resources in a number of different ways. Even in Japanese cuisine, miso, soy sauce, sake and other basic ingredients are fermented and made from microorganisms. Drugs such as the antibacterial agent penicillin, which saved the lives of many of those wounded during World War II, and streptomycin, which is used in chemotherapy for tuberculosis, were also developed using microorganisms.

At the same time, there are countless examples f products made from biological resources, such as pharmaceuticals and food products, going on to make huge profits. In the past, the profits that companies made as a result of discovering such living organisms in other countries and developing them into products used to go straight into the relevant company’s pockets. With resource-providing countries increasingly demanding a share of the profits however, the Convention on Biological Diversity which came into effect in 1993 set out regulations stipulating “access to genetic resources and the fair and equitable sharing of the benefits arising out of their utilization,” or “access and benefit-sharing” (ABS) for short. How to establish an international framework for ABS will be one of the key topics debated at COP10, the tenth meeting of the Conference of the Parties.

NITE and the BiologicalResource Center


NITE’s Japanese researchers collected biological samples near Mongolia’s saline Lake Uvs in a joint project with Mongolian researchers.
Credit: COURTESY OF NITE
Since the adoption of the Convention on Biological Diversity, all negotiations regarding access to biological genetic resources are required to go through a government agency. If a company were to enter into such negotiations independently however, it would have to invest a massive amount of time and money. That is where the National Institute of Technology and Evaluation (NITE) comes in, to act in a bridging capacity between resource-providing countries and companies. NITE is an independent body that runs the NITE Biological Resource Center, one of the largest facilities of its kind in Japan, and collects and preserves various kinds of microorganisms, which it then makes available to the likes of companies and researchers.

“Of all the microorganisms on Earth, we are only thought to have identified around 10% at present. That means that we still know nothing about around 90% of the planet’s microorganisms. There must be some useful microorganisms amongst all those,” suggests Dr. Katsuhiko Ando from the Department of Biotechnology at NITE. “Most of the planet’s rainforests, where many of these unknown microorganisms are thought to live, are located in developing countries. Unfortunately, there is a real possibility that microorganisms could be wiped out as a result of issues such as the destruction of the rainforests. Developing countries lack the resources they need to preserve such areas. That is why we need a mechanism in place to enable resource-users to access biological resources and give a share of the proceeds to resource-providing countries, so that they can use that money for preservation.””

Since 2003, NITE has concluded a Memorandum of Understanding (MOU) regarding the preservation and sustainable use of microbiological resources and a Project Agreement (PA) outlining joint research with some East Asian countries. It continues to carry out surveys for microbiological resources in each country and conduct joint research into potential uses, whilst ensuring compliance with the Convention on Biological Diversity.

So far, NITE has concluded MOU and PA and entered into cooperative relationships with Indonesia in 2003, Vietnam and Myanmar in 2004, Mongolia in 2006 and Brunei in 2009.

Working in partnership with researchers from the resource-providing country, NITE researchers start by collecting samples of soil or fallen leaves from areas of rainforest, or water from saltwater habitats, and then screen samples for biological resources. Once microorganisms have been isolated from the samples at research facilities in the resource-providing country, they are preserved by the researchers of both the country and NITE. They are then made available to Japanese companies by NITE under the agreement from the provider country.

Companies benefit massively from the ability to instantly access microorganisms from other countries. NITE provided companies with approximately 10,000 isolates of microorganisms in total during fiscal 2009. Companies pay a fee for using those microorganisms, a portion of which is given back to the resource-providing country. The system is set up so that the resource-providing country would also receive a share of the profits if a company were to obtain a patent or release a commercial product using microorganisms provided by NITE, although that still hasn’t happened as yet.

There are other benefits from the standpoint of resource-providing countries, in addition to financial benefits. By cooperating with NITE, countries also get involved in exchange with Japanese researchers and receive technical guidance in areas such as the collection, isolation and identification (biological classification and naming) of biological resources. The opportunity to interact with Japanese researchers and learn about cutting-edge microbiological research and development is another major attraction. As well as sending its own researchers out to other countries, NITE also invites overseas researchers to Japan for training.

“It is crucial that we continue to work together at all times. That is the way that we can share technology with developing countries,” explains Dr. Ando. “Building stronger trusting relationships also helps to further research.”

Participation from Companies


An employee of Chugai Pharmaceutical collected biological samples in Vietnam on a joint project with local researchers in 2005.
Credit: COURTESY OF CHUGAI PHARMACEUTICAL
Japanese companies are getting directly involved in joint research with NITE and resource providing countries in some cases. Companies participating in research to date have included pharmaceutical, oil and food companies.

A prime example is Chugai Pharmaceutical. In addition to collecting samples of microorganisms in Japan, Chugai Pharmaceutical also uses microorganisms from other countries via NITE in an effort to expand the possibilities of drug discovery. The company also sent researchers to engage in joint research in Vietnam in 2005 and Mongolia in 2007.

“As there are agreements in place between NITE, as a public body, and governments in resource-providing countries in accordance with the Convention on Biological Diversity, everything from benefit-sharing to technical cooperation is precisely mapped out. The fact that this gives us access to microorganisms and enables us to engage in joint research means that we are able to focus on the development of new drugs,” explains Dr. Masahiro Aoki from Chugai Pharmaceutical’s Research Division.

It is extremely important for companies to use as many microorganisms as possible for research. As the technology used to facilitate drug discovery becomes more and more advanced with every passing year, there are cases in which new discoveries are made using the same microorganisms but different methods.

“We have come to understand that the microorganisms made available through joint research with NITE can be used to make different substances to Japanese microorganisms,” explains Dr. Aoki. “There’s no denying that joint research is producing solid results.”

A Win-Win Relationship


Astellas Pharma offers equipment and training to Malaysian researchers as well as remuneration for its use of Malaysian biological resources.
Credit: COURTESY OF ASTELLAS PHARMA
Astellas Pharma is another company that has participated in joint research with NITE. Having focused extensively on drug discovery using biological resources, drugs made from such resources currently account for 34% of the company’s sales. Astellas Pharma has already developed an immunosuppressant Prograf designed to minimize adverse reactions after organ transplants, using microorganisms extracted from soil in Japan. Initially launched in 1993, worldwide sales of Prograf reached the 200 billion yen mark in fiscal 2008.

In addition to joint research with NITE, since 2001 Astellas Pharma has also been independently involved in joint research relating to overseas biological resources in conjunction with SIRIM, a 100% government-funded industrial technology research body that plays a central role in research in Malaysia.

The company sends out researchers from Japan to collect soil, fallen leaves and other samples from the Malay peninsular in partnership with Malaysian researchers. Microorganisms are then isolated locally and taken back to Japan for culture screening (the process of identifying microorganisms with the potential to be used as drugs).

“As a company, it’s not easy to negotiate agreements independently. Even so, concluding an agreement with SIRIM has enabled us to carry out direct screening and research in line with the direction of our drug discovery activities,” explains Dr. Yuji Watanabe from Astellas Pharma’s Intellectual Property Division. “Eight years after we started joint research, we are now identifying substances that have real potential in terms of drug discovery.”

The agreement between Astellas Pharma and SIRIM also stipulates that any profits be shared with Malaysia. Specific requirements include the payment of compensation when using resources at the research stages, or royalties if releasing a commercial product, the transfer of screening technology to Malaysian researchers and the provision of testing equipment, reagents and other such resources to local institutions.

“As the drug discovery process takes at least ten years, resource-providing countries won’t receive any profits from the provision of resources right away,” explains Dr. Watanabe. “That is why we try to keep both sides happy.”

Discussions regarding ABS at COP10 are attracting attention from companies the world over, not just those in Japan.

“If access to biological resources is too tightly regulated, resources will go unused and resource-providing countries won’t receive a share of any profits. That would mean that both resource-using or resource-providing countries would lose out,” explains Dr. Watanabe.

“At COP10, we are hoping to see some decisions that will help build a win-win relationship between resource-using and r e sour c e-providing countries.”

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