Govt Plans Ethical Policies For Human Genome

The department of company affairs (DCA) is preparing a note for the committee of secretaries (CoS) that seeks to make it obligatory for national and international companies to disclose the annual net profits arising from knowledge derived by the use of human genetic material separately in their profit and loss accounts, while dedicating 1-3 per cent of the profits for community welfare.

The proposal also allows intellectual property based on human genome to be patented with companies required to value them for mandatory disclosure in balance sheets as assets. At present, patents are not disclosed in balance sheets of companies.

The proposal has already been vetted by the law ministry and the department of science and technology and was discussed by the CoS on October 4.

The DCA was asked to submit the proposal at the CoS meeting held to discuss a notification on the ethical policies for human genome, genetic research and services proposed by the department of biotechnology (DBT).

Explaining the rationale behind the proposals a senior official in the department of science and technology (DST) said that the government does not want the commercial benefits arising from clinical trials based on pharmacogenic studies in a given population to be exploited by foreign and domestic companies, so the CoS has set a process in motion.

The proposals, however, would be notified and enforced at a later date. It is premature to make the proposed policies enforceable, he said.

The proposal requiring profits to be divulged separately in profit and loss accounts under Schedule VI of the Companies Act, 1956, would also require an amendment to the Act by notification, top DCA officials told Business Standard, when contacted.

The CoS did not ask for the proposal from the DBT to be taken to cabinet since the health ministry has said that the matter is outside DBT's purview and that the Indian Council of Medical Research (ICMR) guidelines already exist, the DST official said.

DBT has, however, said that it is the nodal department since proposal is about implementable policies and not guidelines and involves testing on human beings. The two departments have now been directed to settle the differences, he added.