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Reproduction is one of the primal instincts in any living organism, be it in animals, insects, birds, or humans. But the lifestyle that we, humans, are leading today, coupled with the environmental degradation caused by various pollutants, are leading to increasing cases of infertility. Thanks to the advancements in medical science, various techniques are now available to obtain pregnancy by means other than intercourse. Such techniques are called Assisted Reproductive Techniques (ARTs).
ARTs are of various kinds but two techniques that are most commonly used are:
In Vitro Fertilization and Embryo Transfer
The IVF technology has been in India since 1978 but has started gaining popularity only recently. IVF technology, if used properly following the prescribed procedures, is a boon for the modern society. But like any other medical procedure, reckless and irresponsible behaviors can lead to dire consequences. Hence, clearly laid down regulations and laws are required to govern various aspects of ARTs so as to ensure that no evil or malpractice occurs.
Code of Medical Ethics Regulations, 2002: The Medical Council of India, a statutory body set up by the government, in exercising its power to make regulations, published the Code of Medical Ethics Regulations, 2002, also called the Medical Council (Professional conduct, Etiquette, and Ethics) Regulations, 2002. It enumerates various responsibilities, duties, powers, and rights of a medical practitioner and holds them accountable for their actions. Codes under the regulation also apply to medical practitioners at IVF clinics.
Every medical practitioner is directed, under the code, to maintain a thorough record of every patient treated by them. In case of IVF treatment involving a donor, the identity of the donor is to be kept a secret by the clinic and the clinic is to obtain the reproductive material from a donor bank. The medical practitioner must share with the commissioning patients every detail about the donor, except those that can identify them.
Only a qualified medical professional is allowed to pursue modern medicine and practice medical science. All prescriptions, certificates, and money receipts given to patients must contain the registration number accorded to him/her by the State Medical Council/Medical Council of India. The registration number must also be displayed on the clinic.
For any medical procedure, the medical practitioner must make a full disclosure regarding the risks and benefits of the procedure, and only after obtaining an informed consent may the medical practitioner perform the procedure. Written consent of the patient commissioning IVF treatment is required before the procedure is conducted.
The Code enumerates a list of ‘Misconducts’ by medical practitioners, which attract penalty and disciplinary action. But the list is not exhaustive. The Medical Council of India, or the State Medical Council, are in no way precluded from dealing with any other manner of professional misconduct.
National Guidelines for Accreditation, Supervision, and Regulation of ART: Most countries have strict laws regulating this branch of medical science. But developing countries where such practices are still unpopular lack the required legislation. In India, there are currently no laws to govern ART. The Indian Council of Medical Research (ICMR) issued some nonbinding guidelines called the National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India, 2005 that define certain issues. The guidelines outline the physical requirements of an ART clinic, Qualifications and training of the ART team, procedure to screen patients, requirements for a surrogate mother, preservation and utilization of embryos, accreditation authority, the rights of children born through ART, legal issues involved, responsibilities of the clinics, and desirable practices, etc. The guidelines lay down the format for consent forms required for ART and provide for establishing a National Database for Human Fertility and a National Accreditation Committee and a National Advisory Committee.
Misuse of the Technology: The guidelines acknowledge the possibility of misuse of ART by selling embryos and stem cells. The guidelines suggest that sale or transfer of the embryo to any foreign party be prohibited. Even within the country, only bona fide researchers get access to embryos.
National Database: ART can pose great risks for future generations if apt tracking is not maintained. The guidelines recommend establishing a database to track the transmission of abnormal genes that would have been rejected through the natural process.
Legitimacy: According to the guidelines, a child conceived and hence born through ART is assumed to be legitimate if the husband consented to it. The donor does not have any claim over the child so born. The guidelines go beyond the Evidence Act, 1872 that holds that a child born posthumous or after divorce is only legitimate if he is born within 280 days of such death or divorce. The guidelines suggest that the law needs to expand its views and keep in mind the technological advancements because a child born to a woman through ART after the death of her husband must also be considered legitimate.
Draft Legislation: Lack of any binding and comprehensive legislation leads to numerous legal issues and exploitative behavior on the part of the clinics as well as the patients. A draft legislation regulating ART has been published but has not been passed by the parliament as yet. This legislation once passed is expected to bring some much-needed laws to protect surrogate mothers and patients, and regularize the practice of ART. Some of the proposals in the bill include:
An authority at the National as well as the State level for registration and regularization of ART clinics.
A forum to file complaints and register grievances relating to such clinics.
Regularize duties and responsibilities of ART clinics and rights and duties of surrogate and commissioning parents.
Procedures for sourcing, storing, and handling of embryos, gametes, and other human reproductive material. It also provides a procedure to keep records of the same.
Penalties for infringement.
International Standards: Many reputed IVF clinics in India follow the practices and standards laid down by the international committees, experts, and organizations. Since IVF is more common in western countries than it is in India, most countries already have standards laid down for ART are aptly regulating IVF. To uphold the international standard of service and to reliably cater to foreign as well as Indian clients, many IVF clinics in India follow these regulations and practice such standards.