In the second of this two part series, Dr Ames Dhai tackles the highly topical subject of patenting in biotechnology. In part one, she addressed the threats posed by patenting DNA. This month she shows how research on malaria can show the way forward.
Prof. Ames Dhai
Scientific and economic progress may be retarded by the current situation regarding DNA patenting and hence, public interest is being undermined. This will obviously have significant implications for the health of developing countries. The contribution of the global research community to the creation and application of medical technologies for these countries is weakened.
Two eminent bodies have published reports recently undermining the assertion that patents on genes are good for innovation. The Nuffield Council on Bioethics published its report "The Ethics of Patenting DNA" in July 2002, and in September 2002, the Commission on Intellectual Property Rights (CIPR) set up by the British Government's Department for International Development, published its report, "Integrating Intellectual Property Rights and Development Policy".
The Nuffield Council recommended that gene patents extending to gene therapy should seldom be awarded. Where an abnormal gene is associated with a disease the process of inserting a normal gene, or correcting or replacing a faulty one is obvious. They recommend that patents covering the difficult problems of getting gene therapy to work are of greater value. They suggest that protection should be concentrated on developing safe and effective methods of appropriate gene delivery.
Patenting and the developing world
The CIPR in its report concluded that an expansion of intellectual property rights was unlikely to result in significant benefits for most developing countries. Should developing countries be coerced into to accepting developed world practices in patenting the likelihood of higher priced medicines and seeds would be the outcome. Consequently, poverty reduction and alleviation would be even more difficult to achieve. Developing world countries are already suffering to an even greater extent from the pressures to allow patents on medicines, plants and seeds. Developed world interests with regards to patents, interferes with and the ability of developing countries to build their own industries, and feed and treat their people. Hence, the developing world is prevented from being empowered towards self-sustainability.
The CIPR recommends that the World Trade Organisation's TRIPS agreement make provision to allow countries to exclude genes, plants and seeds from patentability, for developing countries to pass compulsory licensing laws, which ensure that affordable drugs can be made locally, and to use differential pricing when necessary. The CIPR concluded that the intellectual property laws of the developed world do not encourage research on the diseases resulting from poverty which effect the developing countries.
There is growing support that for the fact that a better knowledge of the genomics of pathogens and their vectors will play a major role in the prevention and treatment of infectious disease. There is also evidence that when this knowledge is freely shared, immediate opportunities are provided for combating health care problems of the developing world and when this knowledge is patented, considerable time and resources are utilized before even research into these areas can be commenced. The studies into the combating of malaria is an appropriate example.
The Malaria debacle
The Malaria Vaccine Initiative (MVI), part of the Programme for Appropriate Technology (PATH), an international charitable organization dedicated to improving health in developing countries, aims to develop vaccines for malaria. Before PATH could invest in the development of a vaccine based on the MSP-1 protein, it was necessary to establish whether patents were granted or pending on the specific protein and what the scopes of these patents could be. PATH had to outlay considerable resources to negotiate with individual owners to obtain the necessary agreements before proceeding with research. There was also a substantial delay before any work could commence on this important public health research.
On the other hand, the Malaria Genome Project has analysed the sequence data of the malaria parasite Plasmodium falciparum and has released information freely into public databases as it is produced.
Through computational analysis of this data it was discovered by researchers that the parasite utilized an enzymatic pathway absent in humans. They also discovered that a drug developed, but never marketed for the treatment of recurrent urinary tract infections in the 1970s targeted this very pathway.
Immediate testing on mouse models of malaria found it to be a highly effective antimalarial agent. Clinical trials are presently well under way testing the efficacy of this drug against malaria. It is remarkable to note that the trajectory between laboratory investigations and initial clinical trials in this case has been less than two years, due to in the main, fundamental genomic knowledge being freely available in the public domain.
Disease gene patents have generated a new phenomenon in clinical laboratory medicine, research and therapy: that of monopolization of services, which is diametrically in conflict with the principles espoused by good medical practice. This is something that poor countries cannot afford.
The practice of medicine should not be limited in any way. Public interest, especially where developing world countries are concerned should be prioritized. Rigorous application of the basic tests for patentability is requisite and the issue of whether the human genome is the common heritage of mankind and hence not patentable needs to be resolved.
Prof Ames Dhai is the Head, Bioethics, Medical Law and Research Ethics at the University of KwaZulu Natal, South Africa.