In a publication outlining suggested principles and best practices for licensing of genetic innovations used in the health care industry, the OECD (Organization of Economic Co-operation and Development) makes several recommendations based on what appear to be three main objectives: 1) to ensure fair accessibility of new technologies, 2) Protect the inventor, and 3) Promote research and development.
Advances in genetic research have lead to a whole new industry of innovative products and services including diagnostic tests, therapeutics and medications utilizing nucleic acids, nucleotide sequences, expression products, transformed cell lines, and vectors, as well as methods and materials for making, using, and analyzing the above. When these inventions have commercial value and are to be exploited for profit, the IP is protected through patents, proprietary information agreements, trade secrets, trademarks, and copyrights.
There is potential for limited or unfair accessibility to these technologies, particularly for diagnostic genetic services in the healthcare industry. OECD aims to ensure that the handling of the IP related to these inventions is done fairly, at reasonable cost so as to serve the interests of society, stimulate genetic research, and maintain accessibility while still complying with competition law and protecting the rights and interests of researchers, investors, and other stakeholders.
OECD exists to assist governments in making policies and encourage appropriate behavior with respect to economic issues in our global marketplace. With 30 member (democratic) countries, the OECD takes an approach of dialogue, consensus, and peer-review, to publish reports and statistical analyses on topics encompassing economic and social issues such as trade, education, development, and technology (i.e. science and innovation).
These recommended guidelines for licensing of genetic inventions are presented to assist governments making policies. They call for rational, appropriate behavior with respect to the development and delivery of products and services to the health care sector while encouraging coordinated domestic and international policies.
Accessibility for all
The OECD recommendations are to make every effort to balance accessibility of IP by keeping licensing costs reasonable, while still protecting inventors’ rights to a return on their investments. By minimizing limitations on access for health care, the recommendations are to ensure that unmet and urgent health issues are more readily addressed, in both developed and, particularly, developing countries. This is a topic that OECD believes warrants further discussion.
Promoting Research and Development
Not all inventors fully exploit the technology to which they hold the rights. The recommendations of OECD are for licensing agreements that allow licensees to improve on a technology thereby preventing stagnation in the development of a process or product due to lack of interest on the part of the licensor.
License agreements should not be exclusive, but should also allow products or services to be combined as the licensee chooses, and tests licensed broadly so as to allow comprehensive and integrated diagnostic testing services.
An additional recommendation is for proprietary databases of genetic mutations, collected during clinical or other tests, to be available to other researchers.