Paris, 02 Feb 2005
Biotechnology and genetics research have been the subject of extensive investment by both the public and private sectors, with the products and processes emerging from these efforts making a significant and increasing contribution to human health and health care. The science and health ministers of the OECD member countries concluded in the first part of 2004 that biotechnology will be a key driver for sustainable growth and development in the OECD member countries and beyond.
Biotechnological, including genetic, innovations have been the subject of intellectual property rights for decades. Over the last decade, as the number of such innovations has increased their use in and importance for the human health care field has also grown. Recently, some countries have expressed concerns with how certain genetic inventions have, in certain circumstances, been licensed and exploited, particularly for diagnostic genetic services in the human health care field.
In response, the OECD held a workshop in Berlin in 2002 to investigate the impact on access to information, products and services for researchers, clinicians and patients resulting from an increase in patent applications filed and patents granted for genetic inventions used in human health care as well as the associated licensing practices for such inventions. The workshop report, entitled Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies, concluded that the intellectual property system, as applied to genetic inventions used for human health care purposes, functions largely as intended – stimulating innovation and the disclosure of information, and that there is no evidence to suggest a systemic breakdown in the licensing of such inventions. Nevertheless, some specific concerns were identified, and in particular with respect to access to diagnostic genetic tests.
At the November 2002 meeting of the Working Party on Biotechnology (WPB), the senior intergovernmental body dealing with biotechnology in the OECD, member countries agreed that the development of guidelines for the licensing of genetic inventions was a priority. The WPB established a Steering Group who determined that the guidelines would best be developed through a series of experts meetings. Expert meetings were held in 2003 and 2004 to develop the Draft Guidelines for the Licensing of Genetic Inventions ("Guidelines"), on which comments are now being invited.
These draft Guidelines offer principles and best practices for the licensing of genetic inventions used for the purpose of human health care. They are targeted at those involved with innovation and the provision of services in health, and particularly at those involved in the licensing of such inventions. Overall, the draft Guidelines seek to foster the objectives of stimulating genetic research and innovation while maintaining appropriate access to health products and services.
Once the consultation period has ended, it is intended that the draft Guidelines will be revised, in light of the comments received, and will be submitted to further experts meetings with a view to presenting them for endorsement by the OECD in late 2005/early 2006.
The development of these draft Guidelines was endorsed by OECD's Committee for Scientific and Technological Policy meeting at ministerial level in January 2004 as well as by OECD health ministers at their meeting in May 2004.