Biomedical ethics legislation needs rethinking

Mentally-ill individuals and children are the most vulnerable lot in our society. While there are laws to protect them and punish the guilty when they are abused sexually or otherwise, the legislative protection against their use in medical research/practice is still nascent in India and the clinical trials conducted in Indore during January 2008 and October 2010 is a testimony to it. Out of 233 patients who were subjected to drug trials, 42 were tested for efficacy of Dapoxetine, a drug used to cure premature ejaculation. The trials were conducted at private clinics by doctors of the mental hospital attached to the Mahatma Gandhi Medical College (MGMC). The regulatory mechanisms for private clinics in India are unfortunately inadequate. Consequently, insufficient information on clinics is available regarding their functioning, expertise, financing, standards of patient care, lack of transparency, cuts and commissions for referrals and other such activities. As public health is a state subject, most of the states have failed to enact any legislation to regulate private clinics. Out of 29 states, 16 have no legislation that makes it mandatory to register a private clinic. The existing legislation in the 13 states is inadequate, outdated and poorly implemented. The Clinical Establishments (Registration and Regulation) Act 2010 is applicable only to Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and Union Territories. In such a situation, unethical practices are bound flourish. This being the case in Madhya Pradesh, Indore trials would never have come to the public knowledge had it not been the whistle-blower junior doctor in the MGMC and the media that exposed the scam.

The inadequacy of law is seen in a recent judgment of the Bombay High Court where a reputed local hospital has been directed to transplant kidney from a mentally-ill Adivasi girl Sonia to her younger brother notwithstanding that the hospital committee held that the person can’t be accepted as a donor because her verbal IQ was 56, performance IQ was 50 and full scale IQ was 50 whereas the average ought to be between 80 and 100. The court observed: “It is submitted that this court had already questioned Petitioner No.1 on 23 December 2011 and this court had already recorded the reasons for prima facie taking a view that the petitioner is aware that she is donating one of her kidneys to her younger brother. It is submitted that Petitioner No.1 is a tribal from Chhattisgarh and that considering her education and social background she would not be in a position to answer the questions put by the hospital committee or the authorization committee in the manner in which the committee members residing in Mumbai would expect a lady of her age to answer. It is submitted that merely on that ground Petitioner No.1 could not be considered as mentally retarded person.”

The ICMR guidelines 2006 under clause 80 deal with organ donation from live donors and prescribe that children and mentally incompetent adults and also persons with restricted autonomy should not be considered as donors; that the donor should be informed of all possible risks in a manner easily understood by the participant who should have sufficient knowledge to be able to make a decision with full understanding of the consequences. His/her voluntary consent is absolutely necessary. It is true that the high court is not bound by the guidelines but the Bill based on these guidelines is pending. It is to be believed that the court has adequately explained to the donor in her language all about the important functions of kidneys and the implications of its removal. Whether the girl has agreed to donate her kidney with the understanding no better than giving her doll or the toy to her younger sibling on coercion and persuasion by elders? Should it also not be considered a factor that her parents have Adivasi culture and poor educational background with prejudice against their daughter whose mental condition would be an additional burden to them?

Last December, a Massachusetts Court ordered a mentally-ill girl with two months pregnancy to be placed under the co-guardianship of her parents who had prayed for her abortion. The court ordered them to do whatever was necessary, including having their daughter “coaxed, bribed, or even enticed... by ruse” into a hospital for abortion. The judge added that the girl should be sterilised thereafter so that the same situation did not come up again. On being challenged, the appellate court has overturned this lower court order. The Bombay High Court order on kidney donation has not yet been challenged. Present legislation on biomedical ethics is nascent the world over and needs serious rethinking.

(The opinions expressed in this column are the author’s own.

Singh is a scientist-cum-lawyer and a member of several bioethics committees)