TWN Info Service on Health Issues (Apr11/05)
Dear friends and colleagues,
One of the most contentious issues in the Nagoya Protocol on Access and Benefit Sharing, that was adopted in November 2010 by the Conference of Parties to the Convention on Biological Diversity, was the issue of microorganisms that are pathogenic.
Most developed countries, at the behest of their pharmaceutical/vaccine industries, aggressively tried to exclude pathogens from the legally binding benefit sharing treaty. They were unsuccessful.
Meanwhile, the issue of the sharing of influenza viruses with pandemic potential and the sharing of the benefits derived from those viruses (vaccines, diagnostic kits etc) has also been the subject of intense negotiations at the World Health Organisation. Developing countries have pushed for the WHO framework to be in accordance with the CBD's third objective of fair and equitable benefit sharing. On 16 April 2011 the Pandemic Influenza Preparedness Framework was finally agreed upon. While the agreement is a milestone as it obliges the pharmaceutical industry and other entities (that benefit from the WHO virus sharing scheme) to engage in sharing of benefits, the Framework does not go far enough to secure from the industry and other entities a reasonable level of benefits nor are there mandatory commitments to share knowledge, technology and know-how with developing countries on the production of vaccines, and other products. [Please see TWN Info Service on Intellectual Property Issues (Apr11/02) and (Apr11/03) for details.]
Thus it is important for developing countries to examine the Nagoya Protocol closely, and exercise their full rights to enact and implement national ABS laws that cover all microorganisms including pathogens. In this way the full range of benefits that are due to developing countries can be ensured.
We are pleased to share with you a Policy Brief that has just been released by South Centre, an inter-governmental think tank of developing countries, entitled "The Nagoya ABS Protocol and Pathogens" by Professor Gurdial Nijar, Director of the Centre of Excellence for Biodiversity Law (University of Malaya, Malaysia) and one of the lead ABS negotiators of developing countries. The summary is below, and the full document is attached. The link is: http://www.southcentre.org/index.php?option=com_content&view=article&id=1557%3Athe-nagoya-abs-protocol-and-pathogens&catid=154%3Aintellectual-property-and-biological-diversity&Itemid=364&lang=en
With best wishes,
by Professor Gurdial Nijar
South Centre Policy Brief, April 2011
Pathogens are clearly within the scope of the Nagoya Protocol (NP). Preamble 16 of the NP makes clear that pathogens are within the scope of the NP. Further the preamble does not exclude the application of the benefit sharing provisions of the NP. Indeed it cannot do so in the face of the express objective of the NP for the sharing of benefits. Also there is nothing in paragraphs 3 and 4 of Article 4 that makes the NP inapplicable to pathogens. Article 8(b) also does not establish a special benefit sharing regime for pathogens.
The upshot is that :
1. A Party to the Protocol can develop a national law that deals with pathogens as a genetic resource and subject it to the ABS requirements.
2. A Party to the Protocol may also collectively enter into any obligation - including a material transfer agreement in international fora such as the World Health Organisation - that reflects the ABS objective of the Protocol. The Agreement must therefore include fair and equitable sharing of benefits arising from the utilisation of the viruses (which should be expeditious if access to the viruses is expeditious), access and transfer of relevant technologies in relation to developing vaccines for pathogens. The vaccines must be made available to developing countries at affordable prices.
3. A Party to the Protocol in developing its national law or administrative or policy measures is not bound to take into account any ongoing work or practice in the WHO relating to pathogens. It needs only to consider taking into account any such work or practice.