Indian Council of Medical Research and Ministry of Health and Family Welfare proposed modification of guidelines regulating Assisted Reproductive Technologies in 2008. Here are our comments, criticism and suggestions submitted to the Ministry in December 2008.



General Comments

The Assisted Reproductive Technology (Regulation) Bill & Rules, 2008 (hereinafter referred to as Bill) attempts to incorporate issues related to gender inequality, but still falls short on many fronts as detailed later. The Bill should go beyond technicalities and build effective safeguards so that the unequal power relationship between the providers of new technology and users of ART is minimised. The Bill must incorporate concerns about the unequal gender balance, and ensure that the rights of women users of these technologies are not compromised in any manner.

Alongside, legislation on ART must foresee future developments that could prove contentious when applied to human beings. For instance, scientific developments such as stem cell research have a direct impact on ART. The ethical dilemmas involved in commercial transfer of embryonic material, stem cells etc are deep, and have yet to be played out in the arena of individual lives, the medical establishment and the market. It is still too early to visualise all the knotty and complex situations that could emerge. However, a Bill on ART needs to be broad and flexible in order to accommodate these future scenarios, but stringent enough to prevent violation of individual rights in the current context. Thus, scope should be left in the Bill to consider introduction of new technologies and the debates ensuing from their potential use, since it is not desirable to amend legislation time and again. This is also true for anticipating future modifications and advances in diagnostic techniques. To quote one example, laboratory tests which should be carried out for ensuring sperms are from a healthy, uninfected donor should include ruling out HIV, HBV, HCV, syphilis and other known sexually transmitted diseases, but not restrict itself only to these infections. A basic minimum should be mentioned in the clause relating to such cases, leaving scope to add more in the future.

The field of Assisted Reproduction is a rapidly developing one. Newer techniques, modifications of existing ones and new approaches characterise this specialisation. In this context, particular care needs to be taken to ensure that the rights of women subjects of research as well as consumers of these techniques are articulated. For instance, infertile women, due to social pressure to reproduce, as well as their own intense desire to conceive are particularly vulnerable to commercial interests. Likewise, surrogate mothers who are generally from a weaker socio-economic background. A law on ART must safeguard their interests, and protect their health and well-being.

Specific Comments

Chapter 1

p3. Clause 2r. Nowhere is the semen bank being defined and list of facilities required to set it up and maintain listed. This is a major omission. Semen bank is not the same as ART clinic and hence separate infrastructural requirements etc. need to be specified before giving them permission as an approved laboratory/clinic.

Chapter 2

p7. Clause (5)(1)(e). Though ICMR is expected to maintain all the data for ART clinics, semen banks etc. how ICMR will do it needs to be detailed. What infrastructure and personnel will be required, how will confidentiality will be maintained, and how frequently will the data get uploaded; how ICMR will obtain data if permission to run ART clinic is suspended - none of these issues are defined anywhere. They need to be spelt out in the Rules.

p10. Clause (9)(7). It needs to be clarified whether the Chairman of the State Board is an ex-officio appointment or will someone be appointed from IAS cadre for a period of 3 years? If ex-officio person, will this be additional duty? This seems unviable at the State level.

p11. Clause (12). This clause that State boards will have a major function to do as a deemed civil court is an unnecessary and potentially dangerous proposition. Disputes must be referred to the usual courts of the land.

Chapter 3

p14. Clause (19)(2). Appeal against the state registration authority’s decision can be made to the State Board. Who has the authority to deal with such complaints? Is the Board meeting necessary for the decision making? If so a 3 month period for decision making is too short. The State Board may meet only once in 4 months as per stipulated guidelines. The 3 month period needs to be extended at least up to 4 months.

Chapter 4

p16. Clause (20)(9). A clear mandate has been given under this clause to ICMR for nationwide record-keeping of ART procedures, patients etc. However, there are no guidelines provided as to how this should be carried out. As mentioned earlier, details of what information to be stored, how to store, how to retrieve, how to get information from ART clinics and semen banks which have been denied permission to continue functioning etc. need to be outlined. In the present document these guidelines are missing.

p16. Clause (20)(4). What information pertaining to the semen and oocyte donors can be released to the prospective users of ART? Information on religion of donors, even if retained in the database, should not be disclosed. The genetic diversity in India is such that religion is unlikely to be an indicator of as-yet-unidentified genetic defect.

p16. Clause (20)(12). If a female relative is willing to be a surrogate mother for a couple, how would this clause be interpreted? Can the man and the woman provide their own gametes for developing embryo which can be implanted in this surrogate mother? Conflicting clauses are present here and need to be clarified.

p17. Clause (21) (3): According to this clause, "No assisted reproductive technology clinic shall use any human reproductive material to create an embryo or use an in vitro embryo for any purpose without the specific consent in writing of all the parties to whom the assisted reproductive technology relates."

However, there should be general Guidelines, and not only dependent on the consent of the parties. These Guidelines must also incorporate notions of social good and public interest.

p17. Clause (22)(1). DNA fingerprinting of individuals participating in ART procedures is expected to be done. What are the anticipated number of people who will opt for ARTs? What is today’s capability of doing DNA fingerprinting and keeping the record? A realistic estimate is needed. It seems that in today’s date this does not look feasible. More infrastructural investment to set up fingerprinting labs in each state might be needed. Else following the law will not be possible.

Chapter 5

p21. Clause (26)(12). The law will permit disclosure of the religion of the semen and egg donor. This is inappropriate. There is so much genetic overlap between people of various castes and religion in India that disclosure of religion for the sake of genetic diseases seems unjustified. The way caste is not supposed to be disclosed, religion should also not be disclosed.

p21. Clause (27)(3). The fee for storage of embryos should be high enough to cover the costs of storage, but should not be so high that the couples would consider the expense exorbitant. Because non-payment would make it easy for semen banks to provide embryos for research. In fact, the couple should be asked to make a judgement about storage or discard of the embryos soon after the delivery of their child. The broad nature of the intended research must also be specified, to the extent possible.

The Bill must also clarify the owners of spare embryos when some are used for implantation in surrogate mother. What is the fate of them? How long can they be stored? Are biological owners of gametes expected to pay? Clarity is needed.

Chapter 7

p25. Clause (32)(1). In the definition of who is eligible, single people must also be mentioned as eligible for ART, as later clauses mention that individuals are eligible.

p25. Clause (32)(4), (33)(1) and (33)(2). Disclosing information of donors to patients. As mentioned earlier, religion must not be disclosed.

Conversely, there must also be confidentiality regarding the recipients i.e information about recipients must not be disclosed to the donor.

p25. Clause (33)(4). Husband needs permission from wife for sperm donation and wife needs permission for egg donation from husband. In what form is this permission sought? Though there is a column asking for spousal permission in consent form, the details of how the spousal consent is obtained are missing. Men may donate without wife’s consent as the procedure of semen donation is non-invasive. The same is not the case with women. Both sexes as married partners should be treated equally as far as consent and information is concerned, differences in biology notwithstanding.

p26. Clause 34 (2): Besides expenses, medical insurance, and life insurance to the heirs of the surrogate must also be added. At present, the law seems to be skewed in favour of the persons wanting a child, and not adequately protecting the surrogate mother's rights.

Most women who go in for surrogacy will be from an economically and socially weaker stratum, and therefore need protection through law (for example, what happens if the people wanting the baby change their minds even though the pregnancy is half way through, or even once the child has appeared? Also, the law must provide for insurance in case of illness, accident or medical negligence. Further, post-delivery health complications/medical issues must also be covered, and insurance provided.

p26. Clause 34 (4): It is not clear if the spouse (if present) also has to sign away rights over the child?

p26. Clause (34)(6). Does a potential surrogate mother get debarred if she has received blood transfusion ever in her life? Or is there a limitation of period - say should not have received in the last 5 years? Also blood component transfusion will be as much of a potential hazard and needs to be included.

p27. Clause (34)(9). Total number of attempts to become a surrogate mother are not mentioned. Not more than 3 attempts for a given couple, how many such couples? If surrogate delivers a child, how many more pregnancies can she undergo as a surrogate for the same or different couple? This must be specified.

p29. Clause (36)(3). In case of medical emergency the parents/donors of the ART child cannot be traced, is it permissible to release the DNA finger print? There is a mention to have it as data but no guidelines about whether to make it available as information to all, to certain people, and under what conditions.

Chapter 8

Who will be the responsible authority if an ART clinic is a part of the government hospital? Will that person be liable for punishment if there is mismanagement of any kind?

Chapter 9

p34. Clause (47)(b). Can gametes and embryos be sold to the research institutions? If so guidelines need to be specified about cost, if embryos stored for 5-years can be sold or donated (since they do not have use for ART), if embryos not required by owners/parents can be sold or donated.



p40. Rule (6). While established procedures are listed in the proposed law a clear outline about how newer techniques would be tested and introduced is missing. They should be treated along the lines of phase I to phase III clinical trials guidelines notified by ICMR. Since a majority of the ART clinics are run by private practioners for strictly commercial purposes, it is recommended that suitability or otherwise of newer techniques should not be tested by commercial establishments but by clinics in the government hospitals. The data of such trials should be seen by the National Board and the next appropriate steps to be initiated.

p42. Rule (14)(4). The review of appeal by the State Board cannot happen reliably in 90 days as the State Boards do not mandatorily meet more than 3 times a year. The limit of 60 days may be extended to 120 days.

p42. Rule (15)(1). Artificial insemination (AID) should be accessible to single women (including widows) as well. The consent form F needs appropriate modification to allow single women to use this facility.

p44 to p47. Nowhere in these descriptions in Schedule 1, part I is there a description for semen bank. It is not clear whether it is a level 1A, 1B, 2 or 3 level facility. This is a serious omission and needs to be rectified.

p48. Schedule 1, Part 2. (2)(2.1). While describing responsibilities of a gynaecologist there is no mention of record-keeping as his/her duty. S/he should be held responsible for record-keeping as a major information is collected by him/her.

Also not all gynaecologists can be considered as fertility experts. A special training and refresher programme should be available and possibly approved by MCI, before gynaecologists are treated as experts in ARTs. How many ART clinics can a gynaecologist be associated with? Needs specification, else junior untrained people will be conducting investigations with gynaecologist only as a signing authority.

p48-50. Schedule 1, Part 2. (2)(2.2) and (2.3). Neither andrology nor clinical embryology are specialisations in medical or science stream in this country. If an andrologists or a clinical embryologist is to be treated as a legally responsible person, a special course and/or training has to be offered and qualification obtained before the person can be appointed. Either the MCI or some other professional body needs to set up courses and do quality control. This has been recommended for a clinical embryologist (2.3) but also needs to be applied to andrologist.

Additionally, the number of clinics serviced by an andrologist also need to be specified for the same reason as mentioned above for gynaecologist.

p57 & p60. Schedule 1, Part 4. (4.1) and (4.8.1). Whether for AIH or AID is cryopreserved semen the only way to use it? Whether it is a husband or a donor HIV screening procedure and 6-month waiting period need not be different. There is no clarity about whether fresh or frozen semen is used for AIH and AID. Thus even for AIH and AID semen cryopreserved and screened for HIV should be the way. If there is no clarity the provision is likely to be more misused and HIV can spread.

p64. Schedule 1, Part 5. (5.4) ‘... leading to the use of ART- failing which, adoption may be the only alternative’. This is sounding like a canvassing on behalf of commercial ART clinics. Why should adoption be the last choice only after everything else fails. The government rules should not make priority statements favouring ART.



p77. Form-A(2). In declaration ‘semen bank’ should be changed to ‘research centre’.

p83. Form-F. Consent for AID - single women excluded because ‘we’ are required to authorise!

p85. Form-G. Throughout the proposed law and rules maximum period over which embryos could be frozen is mentioned as 5 years, after which they should not be used. Is this recommendation of time limit based on technical viability and success data or convenience of semen bank? If former, a clause in this form to extend the period of embryo storage beyond 5 years is invalid. A reconciliation of discrepancy is needed.

p91. Form-J. Even a widow with proven fertility can think of commercial surrogacy as a means of income. In the present form she is not permitted to be a surrogate as ‘husband’s consent’ is needed for surrogacy!

p95. Form-J. Will the potential surrogate mother be permanently debarred if she had blood or blood products transfused into her ever in her life? A 5-year ban period for transfusion appears sufficient.

p95 & p97. Form-K and Form-L. For donation of gametes spousal consent is required. However, no proof of spousal consent is asked, the donor himself or herself can tick on spousal behalf. More stringent procedure needed, or else only women will have to provide spousal consent as the procedure of egg retrieval is invasive.

p98. Form-M. If caste is not an item of basic information why is religion an item? This information is meant for the user of the semen or egg, and this question is not needed, in any case need not be disclosed.

p101. Form-M(1). Religion of the egg donor should not be disclosed to the end users.

p104. Form-M(2). Religion of the surrogate need not be disclosed to the end users.

p116. Form-R. Semen is not donated by women, so ‘Ms’ is not relevant here. A blank should be left to write the year, 2008 written there should be deleted.

p117. Form-R. Point 2 - ‘accept’ in line 5 to be replaced by ‘except’.

p117 and p120. Form-R and R(1). How does the semen or oocyte donor provide proof of the consent given by the spouse to donate semen or oocyte? If this is needed then procedural details are lacking, need to be formulated.

Also if the couple is unmarried couple, are these kinds of consents necessary? What should be followed as a procedure?

p120. Form-R(1). Point 2. Oocyte donor cannot be a man, under point 2 ‘himself’ should be changed to ‘herself’

p122. Form-R(2). Does the surrogate have a contract with semen bank or the ART clinic in addition to a separate contract with the desirous parents?

p129. Form-T. Point 6 under section ‘Now this indenture....’ - as mentioned earlier religion of the gamete donors need not be disclosed to the potential users of the gametes.