The Convention on Biological Diversity (CBD) was one of the important initiatives to come out of the Earth Summit in Rio in 1992. The convention is now ratified by more than 170 countries and provides an international legal framework for the conservation of biological diversity, including access to and exchange of genetic materials.

The convention has had a major impact on pharmaceutical and biotech companies making use of genetic resources. In order to comply, many companies have had to reconsider their means of obtaining access to these resources.

Novo Nordisk takes a proactive approach when it comes to biodiversity, and initial steps were already taken in 1992 to ensure compliance with the convention. In 1997, we were one of 30 companies to take part in a private sector study of biodiversity organized by the Royal Botanical Gardens in Kew, London, and the World Resources Institute, a policy research centre.

"In general, we see the convention as a good basis for international partnerships. Our aim is to comply with both the word and the spirit of the convention and to make it a win-win situation"
Hanne Gürtler, Head of Health care Bioethics and Environmental Management and spokesperson for Health Care and Lene Lange, Senior Principal Scientist and spokesperson for Enzyme Business.

In reality, many countries have not yet passed legislation to enable the convention to be implemented and many practical details remain to be resolved between the users and the providers of genetic material. This is the subject of the ongoing work of the Conferences of the Parties to the Convention (COP). We plan to participate and contribute our experience when the Danish authorities organize their COP preparatory meetings.

Even though the exact details are still being worked out, the intentions are clear. Novo Nordisk fully supports the convention and the following examples illustrate the efforts we are making to put the convention into practice.

Breaking new ground in Australia
Australia has a rich biodiversity. Some species and habitats are found nowhere else on Earth. This huge country also spans a variety of climatic zones. Novo Nordisk reasoned that if unique animals, birds and plants are to be found in Australia, there might be some unique microorganisms as well. We looked for a local collaborator and in 1995 signed an agreement with Flinders University in Adelaide. The biotechnology programme at the University receives research funds as well as equipment and material from Novo Nordisk. Royalty payments will be made if any of the microorganisms collected by the University leads to commercial pharmaceuticals. In addition, there are non-monetary benefits such as training of personnel and technology transfer.

To date, about 6,500 microorganisms have been isolated from samples collected in the desert and arid regions of South Australia, as well as in the tropical rain forest and other wet regions in Australia. Some unusual samples have been taken, for example fungi from the Jenolan Caves in New South Wales and from the salt pans of Lake Eyre.

One of the key requirements of the convention is prior informed consent. In other words, before Novo Nordisk's collaborators can prospect for microorganisms, permission must be obtained from the authorities.

Novo Nordisk has entered into discussion with a number of state governments with responsibility for the protection and management of biodiversity in their respective state. We are keen to ensure compliance with local regulations governing the ownership and handling of microorganisms. Several Australian government agencies have been visited together with our collaborators from Flinders University.

National legislation is currently under discussion. In late 1997, the Australian government released a discussion paper setting out options for managing Australia's biological resources under the Rio Convention.

Pharmaceutical lead compounds and enymyes can be isolated from microorganisms found in soil, water and plant samples from all regions of the globe, and for us it is therefore important that we have access to these biological resources. We are very aware of the importance of conserving biological diversity and we seek to work in full accordance with the objectives of the Convention on Biodiversity.

Investigating Thailand's microbial resources
An example from Enzyme Business is the new collaboration with BIOTEC in Thailand. BIOTEC is a research organization authorized by the Thai government to undertake international collaboration within the field of biodiversity.

The agreement will include transfer of knowledge from Novo Nordisk on fermentation, enzyme screening and gene technology. In return, Novo Nordisk has the option of evaluating some of the microbial strains isolated from Thailand, a country with a rich biodiversity. The work is based on a contract complying with the CBD.

The approach in Thailand follows similar arrangements made between Enzyme Business and institutes or universities in South America, Africa and Asia. The emphasis is on technology transfer. Novo Nordisk is able to gain access to interesting microorganisms, while scientists in developing countries become better qualified to screen the natural resources found in their own countries.

Home collections
Novo Nordisk has an in-house collection which is constantly being expanded to ensure a good taxonomical, ecological and geographical spread of the collection.

Where there is research collaboration such as those described above, each microorganism is stored both at Novo Nordisk and in a culture collection in the source country.

Studies like those in Australia and Thailand contribute to the characterization and recording of natural resources. The culture collections provide a kind of miniature zoo where potentially valuable microorganisms are preserved for posterity.

The Australian rain forest has a rich biodiversity and many unique species of animals and plants. Maybe it will be possible to find unique microorganisms from which we can isolate pharmaceutical lead compounds

The key to new products
Microorganisms are a source of new industrial enzymes as well as the starting point for developing new pharmaceuticals based on active biological compounds. Novo Nordisk is therefore aware of the importance of conserving biological diversity.

Nevertheless, natural microorganisms remain only one source of diversity for Novo Nordisk since our discovery programmes also make use of synthetic chemicals, combinatorial chemicals and new proteins made by protein engineering.

Getting down to work
The CBD helps to preserve species and conserve biological resources and protect ecological niches. All parties involved stand to gain by adhering to the convention - both users and providers of genetic material. We have been looking at the implications for our screening programmes based on the collection and use of natural microorganisms from around the world, and have developed guiding principles for our implementation of the convention.

Patent questions
Questions regarding intellectual property rights and patents are currently being raised by representatives of many countries with a broad biodiversity. We are aware that this is a concern and a subject for further discussion. We participate actively in these discussions and will report on their outcome.

New 1998 target: Develop a formal corporate policy on the use of and access to genetic resources in keeping with the Convention on Biological Diversity.

Read Novo Nordisk's position paper on biodiversity.

For a copy of Novo Nordisk Health Care Discovery's policy statement, "Acquisition of Natural Resources for the Development of New Pharmaceuticals", please contact Hanne Gürtler at: hg@novo.dk

In accordance with the Convention on Biological Diversity

• We acknowledge and respect the sovereign rights of states over their natural resources
• We acknowledge that the right to authorize access to genetic resources rests with the national governments and is subject to national legislation
• We acknowledge and respect that access to genetic resources requires prior informed consent
• We acknowledge that benefits arising from the utilization of genetic resources should be shared fairly and equitably with the country of origin, reflecting the contribution made

Gene technology