It is estimated that 15 per cent2 of couples around the world are infertile. This implies that infertility is one of the most highly prevalent medical problems. The magnitude of the infertility problem also has enormous social implications as infertility widely carries with it a social stigma.
Artificial Reproduction Technologies (ART) includes those technologies that allow couples to have children in ways other than natural conception. These range from artificial insemination to IVF techniques. In some cases, a surrogate mother is engaged, who is not the genetic mother of the child but bears the child for other couples.
Different possibilities of ART
Head – Pharma & Life Sciences, Nishith Desai Associates |
The chart titled, Different possibilities of ART, depicts various possibilities of ART that people may resort to.
All the possibilities mentioned are performed at ART clinics and involve various stakeholders who are responsible for their performance.
Laws and regulations
Partner, Nishith Desai Associates |
Since there is no Indian law that regulates ART, any medically qualified person can establish infertility or ART clinic in India, without any specific permission. This has led to an exponential growth of infertility clinics (that use techniques requiring handling of spermatozoa or the oocyte outside the body, or the use of a surrogate mother) throughout the country.
In view of this, it has become important to regulate the functioning of such clinics to ensure that the services provided are ethical and that the medical, social and legal rights of all those concerned are protected.
Therefore, the Government of Health and Family Welfare has proposed Assisted Reproductive Technologies (Regulation), Bill in the year 2010. The bill details procedures for accreditation and supervision of infertility clinics (and related organisations such as semen banks) handling spermatozoa or oocytes outside of the body, or dealing with gamete donors and surrogacy, ensuring that the legitimate rights of all concerned are protected, with maximum benefit to the infertile couples/individuals within a recognised framework of ethics and good medical practice.3 Unfortunately, the ART Bill is still in draft form and only regulation that governs ART currently are the ART Guidelines (“ART Guidelines”) proposed by the Indian Council of Medical Research (“ICMR”). Pending the adoption of the ART Bill, the ART Guidelines are the only framework available to regulate ART. While the ART guidelines undoubtedly are necessary for preventing possible misuse of such technologies and for ensuring safe and ethical practice of ART, currently they do not have any legal enforceability. It is very important to adhere to the provisions of the ART guidelines by ART clinics in India; especially for surrogacy.
Unknown sperm donor
Associate, Nishith Desai Associates |
Prime matters of concern are the donor’s health and necessity to avoid donors who are infected with venereal diseases, hepatitis B or C, hypertension, sexually transmitted diseases or HIV. Hence, under the ART guidelines and ART Bill, every male willing to donate semen must undergo thorough clinical investigations to rule out various infections including syphilis, HBV, HCV and HIV and their appropriate management. The donor should be of the age between 21 and 45 years and must undergo detailed semen analysis as per the WHO method for semen analysis. Further, the sperm donor is obligated to relinquish in writing all parental rights concerning the offspring. He would have no parental rights or duties in relation to the child. It is observed that recently there has been significant increase in the number of donors who have come forward to donate semen mainly as a revenue stream. It is very important to have a robust regulation to avoid donations from unqualified donors.
Unknown egg donor
Female egg donor too has to qualify as described above in case of male sperm donor. However; the age limit in case of female egg donor is 35 years.
Single male father
The ART guidelines and ART Bill are silent on whether single male can opt for surrogacy technology for having children. However, there are examples of such cases4. It has been claimed on some websites that “individuals from many countries fly to India” for this purpose5.
Single female mother
A single woman is also permitted to take benefit of surrogacy technologies6 and a child so born may be treated as her own legitimate child.
In India, the laws of adoption and succession are religion driven. i.e. each religion have their separate adoption and succession laws; hence, each case will have to be examined in the light of relevant facts and circumstances to ascertain, the rights of the child born out of ART.
| Different possibilities of ART |
Surrogacy
The incidence of children born through the practice of surrogacy is on rapid rise in India and it is fast becoming a hub for the same. Commercial surrogacy is legal in India but safeguards are provided under the ART guidelines against exploitation by ART clinics.
The guidelines provide for the need for a surrogacy agreement between the couple and the surrogate mother. Once the agreement is entered in to the agreement is binding between the parties and can be enforced. Under the agreement, the couple must undertake to bear all the expenses related to the pregnancy of the surrogate mother including post-delivery expenses and insurance.
Under the provisions of the ART guidelines, a woman acting as a surrogate mother, who is not above the age of 45 years, is required to obtain the consent of her husband, in case she is married, and is to relinquish all parental rights concerning the child. This is required even if the sperm or egg doesn’t belong to the adopting couple.
There is a requirement of adoption of the child by the couple unless they can prove that the child is genetically theirs, i.e. the egg and sperm are that of the couple, in which no formal adoption is necessary. It is also provided in the ART guidelines that no woman may act as surrogate more than thrice in her lifetime. As stated earlier, the religion of the couple will also determine what process needs to be followed so that the child is treated as the child of the couple and is granted the inheritance rights. The couple may have to carefully draft their will in case there is a lack of clarity on the succession rights.
The ART Bill
The ART Bill is still in draft form. The important features of ART Bill are as follows:-
General Provisions:
1. Lays down infra-structural requirements such as space, standards of sterilisation etc.
2. Lays down number of people to be employed along with their basic qualifications and the roles to be played by them.
3. Lays down circumstances and conditions in which different ART procedures are to be used.
4. Lays down cautions and precautions to be taken- ovarian hyper stimulation, indiscriminate use of ICSI, prevent sale and misuse of embryonic stem cells.
5. Lays down the parameters of patient selection— the protocol to be followed in infertility management.
6. Lays down three types of infertility clinics—primary, secondary and tertiary. The primary clinics can undertake preliminary investigation, history taking and correcting minor defects. Secondary clinics carry out in-depth investigation and treatment, except treatment of oocytes outside the body. The tertiary clinics engage in the highest level of diagnostic and therapeutic specialisation.
7. Lays down a code of practice for physicians dealing with the issues of sex selection, pre implantation genetic diagnosis, DNA fingerprinting, payment to surrogate mother, choosing whom to give ART procedures, provisions for detailed consent forms etc.
8. Setting up a National Accreditation Committee to monitor such clinics.
9. Since ART is not part of any medical curriculum, separate training institutes to be set up.
10. Research to be done in this area to make ART accessible to the economically weaker sections of the society.
11. The ART clinic must not be a party to any commercial element in donor programs or in gestational surrogacy
12. No ART procedure shall be done without the consent of the spouse
13. Sex selection at any stage of embryos of any particular sex should not be permitted, except to avoid the risk of transmission of a genetic abnormality.
14. Use of sperm donated by a relative or a known friend of either the wife or the husband should not be permitted. It will be the responsibility of the ART clinic to obtain sperm from appropriate banks.
15. No relative or a person known to the couple may act as surrogate.
16. Surrogacy by assisted conception should normally be considered only for patients for whom it would be physically or medically impossible/ undesirable to carry a baby to term.
17. The genetic (biological) parents must adopt a child born through surrogacy.
18. After a specific consent, the embryos may be stored for five years and stored embryos may be used either for another couple or for research after taking the consent of the couple to whom the embryos belong.
19. The sale or transfer of human embryos or any part thereof, or of gametes in any form and in any way to any party outside the country must be prohibited.
The government may also consider amendments to the personal laws to give the children born out ART the same rights as that of the naturally born children.
ART Facility
The ART clinics are categorised as Primary (Level 1), Secondary (Level 2), and tertiary (Level 3) infertility / ART clinics. They are specified in Schedule I, part 1 of “Draft The Assisted Reproductive Technologies (Regulation) Rules – 2010”7. An institute, hospital, nursing home or any other place providing infertility/ART services should also conform to these requirements. The physical infrastructure for the aforementioned infertility/ ART clinics should conform to the requirement as specified in Schedule I, Part-3 of ART rules.
The appointment of staff and their qualification for various types of infertility clinics should conform to the requirement as specified in Schedule I, Part-2 of the ART rules. The employees should consist of gynecologists, andrologists, clinical embryologists, counselor and a programme co-ordinator/director, among others.
One of the primary concerns of all ART treatments is the safety of the patients and of their gametes and embryos which constitute the very beginning of a new individual’s life. The basic tenets of any medical treatment mentioned in the Helsinki Declaration of 19648 as received from time to time, clearly spell out the ethical concerns of treating patients. These basic tenets are also applicable to ART. The clinic must ensure that a particular ART being offered has been appropriately tested according to the norms of scientific practice, or—if experimental has a sound scientific basis as adjudged by peers, and is fully in consonance with the diagnosis made of the cause of infertility. More particularly, the clinic must make sure that patients are well informed about the treatment being offered to them, the reasons of suggesting a particular form of treatment, and alternative therapies available if any.9
Every potential patient of an ART clinic must undergo clinical investigations10 to check whether they are physically capable of having a child naturally. Based on the results of these investigations, couples or singles should be selected for treatment at different levels of infertility care units.
The ART clinic is also required to sign a confidentiality agreement, which prevents it from revealing the identity of the parents to the surrogate or vice-versa unless asked explicitly by a court of law. Most importantly, the ART guidelines also specify that ART clinics are not to provide a couple with a child of desired sex.11
Conclusion
Given the facts, it is clear that ART are being utilised by a large number of people in India. In fact, a multinational study carried out by WHO12 places the incidence of infertility between 10 and 15 per cent. Out of the population of 1020 million Indians, an estimated 25 per cent (about 250 million individuals) may be conservatively estimated to be attempting parenthood at any given time. By extrapolating the WHO estimates, approximately 13 to 19 million couples are likely to be infertile in India at any given time. This is a large number of people that are likely to approach ART clinics.
Thus, due to the sheer potential size of the industry and the chances of possible foul play being of a high risk, and commercial angle it is extremely important that laws and regulations be formulated at the earliest to ensure that everybody can have their little bundle of joy.
References
1. Assisted Reproductive Technology (Regulation) Act (Bill), 2010 of India hereinafter referred to as ART Bill
2. ibid.
3. ibid.
4. First surrogate child of single father to evolve ethics debate. <rediff.com> Oct 03, 2005.
5. http://www.surrogacyclinics.com/tag/surrogacy-single-father-india/>
6. Supra
7. hereinafter referred to as ART Guidelines
8. http://www.wma.net/ en/30publications/ 10policies/b3/
9. ART Guidelines
10. Infra
11. ART Guidelines
12. Diagnosis and Treatment of Infertility, ed. P. Rowe and E.N. Vikhlyaeva, 1988