#dnaEdit: Patients’ privacy

It does not seem to be clear whether the decision of the Directorate General of Foreign Trade (DGFT) that no prior permission is required to import or export human biological samples for commercial purposes, has been taken after due consultation. It can be argued that this will help in many ways. Doctors and patients can now access facilities for testing  — including tissue culture — abroad. It can even work in favour of test centres in India because many abroad may want to get the tests done in India because of cost efficiencies. This could work to everybody’s advantage. At another level, medical centres and researchers would now be in a position to access valuable human biological samples for their work without too many hassles. This is in stark contrast to the earlier system where the Indian Council of Medical Research (ICMR) had to clear every request backed by complicated paperwork.

The move from total control to total freedom might be termed a much needed change. But there is need for some kind of monitoring system that could track the movement of the human biological blood samples going out and getting into the country. There is scope for foul play because there are mischievous and criminal elements in hospitals, pharmaceutical companies and universities who could misuse the facility. It would be futile to sit up after something goes wrong at a later date.

The necessary safeguards can only be evolved if there is an open discussion on the many aspects of the issue. At the moment the only safeguard that is in place is an undertaking that all the ethical rules and norms are being adhered to. It is good that a culture of trust is being sought to be created. There is also complication that when the human biological samples that are being carted across the borders are blood, sputum, tissue, the question of medical confidentiality assumes great importance. Patients would want the information to remain strictly private. It becomes necessary that procedures and norms should be in place to protect information. There should be a legal framework, a policy, which will help the patient to protect her privacy, and which he or she can use to defend the right if there is a violation.

It will be necessary, on the other hand, that doctors, pathological laboratories, research institutes must maintain meticulous records so that the movement of the human biological samples are not misused. This involves questions of ethics and norms on the one hand, and legal obligations and liabilities on the other. There has to be, then, a general framework which would incorporate these different aspects. This can be done only by a group of practising physicians, pathologists, biological laboratory researchers as well as legal experts. There is need for someone to represent the patients so that their concerns get reflected in the rule-book.

The debate has to remain in the public domain and as far as possible the debate has to remain non-partisan and rational. It would be inevitable that some non-governmental organisations, claiming to represent the concerns of ordinary people, will most likely jump on to the bandwagon. The troublemakers cannot be kept out but they can be shown to be good-for-nothing ignoramuses if the experts play their role in an honest-to-God fashion. This is a matter that is too important to be left to the representatives of the special interest groups though the representatives of these groups cannot be kept out. The DGFT seems to have acted in good faith but it is quite clear that it has not understood the complicated questions involved in this.