5.5. Medical Genetics Services, Policy Ethics and Pharmacogenomics:

An Indonesian View

pp. 61-62 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author: >M. K. Tadjudin (Faculty of Medicine, Universitas Indonesia)

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
The unprecedented growth in scientific knowledge, expansion in the availability and efficacy of biomedical technologies, a more equal relationship between patients and physicians, and new organizational arrangements in the provision of services, cause increased prominence of bioethics. At present virtually the entire sequence of the human genome is known. Many of the sequences are available in public databases. This knowledge will open a molecular window on the largely unexplored world of human biology. Many companies and universities throughout the world are seeking to file patents on gene sequences and proteins. Questions remain, however, over the moral implications of protecting rights to property in this kind of way and the implications for healthcare.

Research into DNA and proteins offers the possibility of many different kinds of developments in healthcare. New gene-based tests and drugs for a wide range of common diseases will be developed on the basis of knowledge about the human genome and the genomes of bacteria and viruses. What is the proper balance between public and private sectors in these developments? Will broad patents covering important disease genes such as the breast cancer genes restrict the development of affordable tests? What is the role of patent offices? Are they custodians of public good or servants of enterprise? Does the patent system actually encourage innovation in biomedical research?

The understanding of the molecular scripts that guide normal physiology and development as well as their alterations in disease and the knowledge of disease specific molecular and cellular targets will open opportunities to develop pharmaceutical compounds to be used against those targets. However because the technology required for research in this area is quite sophisticated and expensive, only the developed countries can take the greatest advantage of this knowledge. In reality, because of these constraints, a widening gap will develop in the development of biomedical technologies between the developed and the developing countries, hampering the access of the developing countries to the new technologies and services.

Medical genetics in Indonesia like the country is a "developing science". The area in which it is used is only in diagnostics and genetic counseling. There are less than 10 laboratories in the country (population 212 million) which are capable to deliver those services, as the costs of these services are very high. The priority for setting up better medical genetic services is also low as there are more pressing health problems and only limited resources available.

The future direction of ethics in the area of medical genetics and pharmacogenomics will be determined by the socio-cultural forces, medical technology revolution, growing concept of patient autonomy, and the litigious spirit of the time. A central concern to the biomedical research community is the extent to which claims on DNA or polynucleotide sequences are recognized within the patent system. Gene patenting has become an important aspect, since he US Patent and Trademark Office (PTO) treated DNA like a chemical (Steinberg, 2000). The potential stakes are enormous. The main issue is gene patentability. Some experts believe that genes should not be patentable because patent law requires inventions to be non-obvious to a person having ordinary skill in the arts, while with automated gene-hunting techniques it is quite easy to do and according to James Watson, co-discoverer of the structure of DNA, it could be done even by monkeys (Beardsley, 1998). Another reason for problems in gene patenting is that patent applications claiming hundreds of thousands of expressed sequence tags (ESTs) have been accumulating in PTO over the past decade. Rights to these DNA fragments may conflict with each other as well as with rights to the full-length genes from which the ESTs derive. The coverage of gene patents may shrink to accommodate competing patents. We do not believe that presumed theoretical function based on homology searches is sufficient to claim specific and substantial utility. Automated programs and databases frequently enable researchers to infer or "guess" the identity and function of a protein encoded by a gene based on the similarity of a fragment to known genes. Many genes have numerous functional domains and knowledge of one or a few can be misleading or incorrect as to the actual role of the gene in question. As such, gene sequences are merely research tools, which ultimately allow for determinations of actual function and thereby the invention to be made. However the tools are not themselves inventions. Unfortunately, thousands of patents are pending for sequences whose presumed function is based on little more than computer searches of homology. Such blind searches, lacking both creativity and scientific knowledge should not be patentable material. It is noteworthy that such "research" is no longer considered worthy of doctoral level dissertations, since there is virtually no novelty involved in such projects (letter from the president of the American College of Medical Genetics to the Commissioner of PTO, 22 March 2000).

US patent law also excludes "products of nature" from patentable subject matter (35 USC 112; Diamond v Chakrabarty 100 S. Ct 2204, 2206). One of the great advances of modern biology has been the recognition that the genetic material of an individual is inherited from previous generations. Our genes are derived from our parents, grandparents, and their progenitors through the germline. It is clear that human genes are products of nature and should not be considered as an invention in a gene patent claim. To be considered as an invention it should be proved that the sequence does not occur in any known organism.

A bio-patent law at present in the German parliament would bar patents on the human body, the discovery of genes or the isolation of genetic sequences. It would allow patents on genes or part of genes only in conjunction with specific functions, such as the creation of antibodies against a specific disease. It would also relieve researchers from the obligation to pay patent fees for new discoveries on already established gene sequences.

Patenting may also limit public access to important clinical services. We have difficulties understanding how or why patent law has been interpreted to permit naturally occurring sequences, which are uniquely fundamental information be patented. Such a view has led to the patenting of discoveries rather than inventions.

References

 Beardsley, T. "An express route to the genome ?", Scientific American, Aug. 1998, pp. 30-2.

Steinberg, D. "Will genomics spoil gene ownership ?", The Scientist, 4 September 2000.
Please send comments to Email < asianbioethics@yahoo.co.nz >.

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