I strongly believe that the initial test for any international ABS regime should be ‘benefit generation’ — that is, the practical impact that a proposed ABS IR element would have in the encouragement of access to genetic resources and the equitable sharing of the benefits relating to their commercialization. It is because industry plays a pivotal role in generating those benefits that it is a vital stakeholder in the ABS IR process.

Positive incentives
Many stakeholders have focused much more on user measures and enforcement, crowding out positive incentives needed to ensure benefit generation. To that end, it is critical that any international regime recognize the on-the-ground realities by which businesses operate and include appropriate positive incentives to balance the expected user measures and enforcement provisions that will be needed to ensure compliance by all Parties. Such a balanced approach will ensure that the regime will benefit all stake-holders.

The regime should include measures that demonstrably generate benefits and provide positive incentives that will encourage access to genetic resources, on a sustainable basis, and the equitable sharing of benefits relating to their commercialization. It should be based on the actual experiences of stakeholders either at the local, regional or national level, including the actual experiences of countries, indigenous communities, NGOs, and business.

In other words, the regime should be based on reality and experience.

Patent disclosure
Our member companies strongly take exception to the utility and benefit of any additional, new patent disclosure obligations of source and origin as a condition of patentability. For three reasons. First, a system based on GR patent disclosure is purely a defensive measure that does not generate meaningful benefits to provider countries and their indigenous peoples. Second, any regime based on mandatory patent disclosure will lack positive incentives to promote the commercialization of genetic resources. Third, experience on the ground shows the disutility of mandatory patent disclosure.

In short, a mandatory patent disclosure regime would be self-defeating, and only extend failed national policies across borders. The relevant national experiences of Brazil, India, the Philippines and other countries that have adopted mandatory patent disclosure regimes since 1996 demonstrate that such regimes have led to reduced ethnographic work, conservation and other commercial and non-commercial activities relating to genetic resources and traditional knowledge. In addition, because the patent disclosure schemes resulted in reduced commercial activity, the expected generation of benefits from the increased commercial activities failed to materialize.

Likewise, ABIA Members remain concerned that some stakeholders are proposing the development of an international certificate of source, origin, and/or legal provenance to serve as an additional formality for either patent protection or regulatory approval for new products. We cannot support the establishment of a certificate system on this basis. We are, like others, concerned about the feasibility and costs involved. We also would like to see broader participation by all stakeholders in future expert-level discussions on certificates.

There is a growing consensus on the practical benefit of positive front-loaded incentives for access and benefit-sharing. There is a critical need, for example, for ABS-related scientific and technical assistance and capacity building programmes. Scientific research, science exchange and other capacity building programmes have a proven positive track-record at the national level — in countries as varied as Australia, China, Costa Rica, and Thailand.

In addition, Parties across the development spectrum, including India, Malaysia, Venezuela, China and others, have already implemented online databases of genetic resources and/or traditional knowledge. Traditional Knowledge Digital Libraries (TKDL) provide a greater degree of transparency than is currently available and provide a valuable point of contact to the holders of traditional knowledge and sovereign rights over genetic resources.

Our members have, from the outset, supported Model Material Transfer Agreements and other mutually beneficial agreements that have been demonstrated to bring benefits to ABS stakeholders. These agreements can include assignment of intellectual property rights, benchmarks and/or other royalty payments. We support the continuing use of patents, trademarks and trade secrets, and expanded capacity building directed at promoting the ability of all stakeholders to benefit from intellectual property rights.

We seek to provide useful input in focusing the discussions in Geneva at WG-ABS-6 and beyond on the positive elements of an international regime that will be based on the actual experiences of all stakeholders. These positive elements, some of which I have just described, will go a long way in elaborating an international ABS regime that will provide proven benefits for all stakeholders while protecting their individual interests in the negotiating process itself.

To contact Jaques Gorlin at The American BioIndustry Alliance (ABIA): jgorlin@abialliance.com

The American BioIndustry Alliance (ABIA) was founded in 2005 to provide focused advocacy on behalf of the American biotechnology industry in support of the development and implementation of equitable, sustainable, and mutually beneficial ABS policies.