Genetics, genomics and the patenting of DNA
Title: Genetics, genomics and the patenting of DNA: Review of the potential implications for health in developing countries.
Goal of the report: The report reviews major ethical, legal, social and health issues raised by the patenting of DNA, and proposes areas of further exploration that could provide a foundation for the establishment of informed policies that protect public health interest without unduly compromising advance in genomics.
THEMES & KEY ISSUES
The debate surrounding DNA patenting is characterized by three main themes.
- The first is the nature of DNA (deoxyribonucleic acid) itself: DNA patents can be problematic because DNA can be simultaneously viewed as (a) a biochemical molecule; (b) information about an individual; (c) an element of common human heritage; (d) a scientific tool.
- The second theme is the duality in the role of DNA patents as (a) an incentive to drive research and development in genomics and (b) a barrier to accessing research tools, and the products generated by research.
- The third theme is the balance between (a) private ownership of the products of genomic research; and (b) public access to the benefits of these products.
These themes and tensions underlie many of the specific issues discussed in the report, which include:
- The special ethical, legal, research and medical challenges raised by DNA patents, with particular reference to genomic industries.
- The response of different countries, legislative and otherwise, to the question of DNA patents, and the consequences of these actions for access to genetic diagnostics.
- The flexibilities in international frameworks, particularly the TRIPS Agreement, for national policymaking relating to DNA patents.
- The particular needs, both health and technological, of developing countries in relation to genetics, and what this suggests in terms of how they should structure their patent regimes.
The report draws the following conclusions:
Developing countries stand to benefit from genomics
There is a body of epidemiological data that attests to the considerable burden of debilitating genetic diseases, particularly blood disorders, in developing countries. Moreover, other chronic diseases with a significant genetic component, including heart disease, cancer and diabetes, contribute to the health burden in all countries. DNA-based diagnostics, which can be used to diagnosis infectious and noncommunicable diseases, are generally inexpensive to manufacture. Building on the Genomics and World Health report, WHO and its partners can work to build a global strategy on how innovation in genomics can better serve the health needs of the world’s poor. This would include considering how developing countries at the leading edge of technological development in genomics and biotechnology, such as Brazil, China, India and South Africa, could provide leadership by sharing experiences and expertise relating to the development of local research capacity, as well as the development of infrastructure and capacity for appropriately evaluating, processing and enforcing patents.
Ongoing ethical, legal and social controversy regarding the patentability of human DNA
The controversy about the patenting of DNA remains unabated. Objections to DNA patents operate on a number of different levels from moral and legal claims, to consequentialist arguments about social benefit. Questions of benefit sharing arise in relation to human genetics research, particularly regarding the obligations of inventors or researchers towards those who provide genetic samples. Agencies might make a useful contribution in suggesting how policy-making around ethically thorny subject matter, such as DNA, might take better account of the legitimate concerns of the public.
Ambiguity in TRIPS regarding whether DNA may be excluded from patentability
National legislation is constrained by provisions within international agreements. TRIPS, in particular, requires that its members states adopt minimal standards of intellectual property protection, though countries may take advantage of certain flexibilities to protect the health and safety of their populations. In relation to DNA patents specifically, however, there is ambiguity as to whether TRIPS requires countries to grant patents on DNA sequences. DNA patents have been widely permitted in Europe and the United States, but not all countries have responded in like manner. Some proposals are made about avenues of study that could suggest a way forward.