BY Qaiser Lone
The sequencing of the human genome has ushered in a new scientific era in medicine which promises enormous benefits for humankind. Technology and resources developed by the ”Human Genome Project” and other genomic research are starting to have profound impacts on biomedical research and promise to revolutionize the wider spectrum of biological research and clinical medicine. Today, it seems a possibility that scientists in the near future will be able to identify all the genes contributing to a particular disease. This, in turn, will help in accurate diagnosis and consequently precise classification of the severity of the disease. People will also be able to know beforehand the disease for which they are at a risk, providing them with a chance to change their lifestyles and, if possible, to take preventive medication. This science also has the potential of devising novel therapeutic regimens based on new class of drugs, immunotherapy techniques, and possibly replacement of defective genes through gene therapy.
In spite of the potential benefits of genome research, many legal and social issues having global implications exist. As genetic information accumulates through genetic research, more and more people will find it virtually impossible to obtain health insurance or be stigmatized as a bad risk for employment. Genetic discrimination threatens to create an underclass of people who will be uninsurable and unemployable. Employers and insurers could save millions of rupees if they could use predictive genetics information in advance, then reject workers or policy Genetic discrimination threatens to create an underclass of people who will be uninsurable and unemployable. applicants who are predisposed to develop chronic disease. Thus, genetic discrimination could join the list of other forms of discrimination: racial, ethnic, age and sexual. Insurance companies can either deny insurance or charge higher premium from an individual who suffers from a genetic disorder. Perceived risk of discrimination can lead to refusal of genetic testing to safeguard employment and health insurance, sometimes with significant health consequences.
The legal contours with regard to the extension of ”Intellectual Property Rights” to There is a growing fear in the developing and the least developed countries that many of the world’s poor will be deprived of the benefits. genetic material are not well defined. Concerns have been expressed that patenting of the genome may inhibit genetic research and, further, allow the monopolization of this important new scientific knowledge. There is a growing fear in the developing and the least developed countries that many of the world’s poor will be deprived of the benefits of therapies which are based on the knowledge of the human genome, if it is allowed to be patented.
Although the international community has already rejected human cloning for reproductive purposes as an unacceptable instrumentalisation of the human being, questions remain regarding therapeutic cloning. Does accepting human cloning for therapeutic purposes imply running the risk of making reproductive human cloning possible? There is also a controversy about allowing human cloning for research because the human embryo has to be destroyed once it has served its research or therapeutic purpose.
At this point in time, there is an uncertainty with regard to the ownership of genetic information. Is the owner the person whose genetic material was used for research, the researcher who discovered it, or the organisation that paid for it? There is also a serious concern about the lack of regulatory norms throughout the world with regard to confidentiality of genetic records, informed consent procedures, protection of personal genetic information from misuse and unauthorised disclosures, manner in which genetic research can be conducted and genetic data collected and used. Further innovations in this field will affect virtually all policy areas, including privacy, health and economy.
The issues involved have global ramifications and would need global solutions because it concerns every nation on Earth, and the people of every nation. I propose a three-phase strategy. In the first phase there should be extensive public debates. In the second phase a ”Declaration on the Human Genome and Human Rights” (”Declaration”), ”Convention on Biological Diversity” (”Convention”), and other international instruments concerning the human genome should be reviewed and revised, because without international rules in genomic regulation, as with internet and e-commerce regulations, national laws can never be fully effective. In the last phase every signatory of the Declaration should be required to introduce municipal legislation to promote the principles set forth in the Declaration.
The public must be educated about the legal and social issues arising from the scientific developments in genetics. It is imperative that the general public has an adequate understanding of the newly discovered genetic information. Unless all the legal and social issues are debated before the public, it is probable that legal responses, when they come, will be peremptory, emotional and intuitive. Scientists, lawyers and politicians should engage in public debates and find answers to these issues by careful interdisciplinary dialogue.
International Instruments
The Declaration and the Convention need to be thoroughly reviewed and supplemented by a new international instrument, considering the nature of genetic research, the involvement of the private sector, increase in number of genetic databases and cross border implication of genetic research. The new instrument should spell out the principles under which genetic data can be collected, treated, stored and used. The Declaration, though the most thorough global initiative thus far to consider the human rights implications of the human genome, is toothless in absence of a procedural mechanism for international supervision of the implementation of the principles of the Declaration. The signatory states of the Declaration should give binding commitments to introduce municipal legislation A supervisory mechanism will go a long way in assisting legislators in addressing the legal, social and human rights implications. covering broad principles of the Declaration within a fixed time frame. UNESCO should take guidance from other international organizations to promote international consensus and national implementation of the Declaration by adopting an appropriate supervisory mechanism. UNESCO’s effective use of a supervisory mechanism will go a long way in assisting legislators in addressing the legal, social and human rights implications of genetic science. International protocols must be developed by the appropriate United Nations bodies for protecting the rights of individuals and groups from patent claims and unjust commercial exploitation.
There is a substantial risk of discordant legal regimes regarding human genome technology in the developed countries, and almost a legal vacuum on genomic matters in developing and the least developed nations. There is a need for every country in the world to have a harmonious and comprehensive legislation covering the human genome. The legislation should have the following broad features.
* The dignity, privacy, integrity, and basic human rights of the individual should be respected and no individual or group should be discriminated against on the basis of genetic characteristics.
* A Self-Regulating Organization (” SRO”) consisting of scientists, lawyers and sociologists should be established. The SRO should be responsible for formulating the regulatory norms for research of the human genome, including fixing standards for the collection and use of genetic information. Such standards are needed in many areas, including clinical research, medical care, adoption and social services, education, employment, insurance, and the criminal justice system (including DNA evidence). The SRO should have the power to hold healthcare delivery systems accountable. It should also be responsible for formulating a professional code of conduct which would set out the ethical parameters for professionals involved in genetic research.
* Employers should be prohibited from requiring genetic tests as a precondition to employment or any other employment-related benefit. Violators should be subjected to both civil and criminal consequences.
* Identifiable genetic information of a group or individual should be kept confidential.
* Insurance companies should be prohibited from using genetic information to deny or limit insurance coverage or establishing different rates or premium payments based on genetic information. The universal principles of uberrima fides, which requires the insured to disclose all known information to the insurer, should not be made applicable to information concerning genetic data.
* It should be mandatory to seek informed and free consent from the individuals or the groups who are subjected to genetic testing. Consent of the participant should be obtained in the language chosen best by him. The participant should also be made aware about the purpose, methods, risks, discomforts, and possible outcomes of the research. Where research pertains to a specific community or group, group consent should be obtained before obtaining individual consent.
* The human body and the simple discovery of one of its elements, including the sequence, should not constitute patentable inventions. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, should be patentable. The universal rule of 20 years patent protection should be reduced to 10 years. It should be made obligatory for companies or other entities which make profit from the patent protection of a sequence, or a partial sequence, of a gene to dedicate a percentage of the net profits for genetic research.
* Therapeutic and reproductive experiments with human bio-meterial should be prohibited.
* Individuals and groups should be given the right to bring suits in equity to require covered entities to comply with the provisions of the legislation.