Separate guidelines for ART and gynaecologic clinics needed:Experts

Shardul Nautiyal - Mumbai

Infertility specialists across the country have suggested that separate guidelines should be laid down differentiating Assisted Reproductive Technology (ART) clinics from general gynaecologic clinics conducting basic infertility treatments. Experts argue that norms related to ART clinics cannot be implemented on general infertility clinics, as it would entail unnecessary expense on the infrastructure and qualification of the professionals running the set-up.

ART group, a consortium of 43 infertility specialists under the chairmanship of Dr Sadhana Desai, have suggested this amendment in the draft proposal of “The National Guidelines for Accreditation, Supervision and Regulation of ART clinics in India” of the Indian Council of Medical Research (ICMR), New Delhi.

According to Dr Mandakini Parihar, infertility specialist and member of the ART group, “The ART guidelines should certify a lab which would conduct advanced infertility treatments and not a general gynaecologic clinic because different treatment protocols are followed in advanced infertility treatment, which would require high-end equipment, not required in basic infertility treatments.”

A gynaecologic clinic requires one sonography machine run by a gynaecologist and a team of nurses.

An ART set-up comprises equipment like oocyte retrieval pump costing around 1.5 lakh, hiracell incubator and binder incubator costing Rs four lakh, stereozoom microscope costing one lakh twenty five thousand, ICSI unit costing 15 Lakh, cryofreezer costing Rs 3.5 lakh, laminar flows or sterile benches costing Rs one lakh and OT equipment costing Rs one lakh, stage warmer, test tube warmer and centrifuge costing around Rs 60,000 and a computer system comprising a digital camera, a computer and an imported software costing around Rs one lakh and an ultrasound unit costing another one lakh.

A fully equipped ART centre in a rural area costs around Rs 20 lakh as against Rs 40 lakh to 50 lakh in cities depending on the cost of the premises.

Other suggestions made in the draft dated December 3, 2003 relate to the minimal physical requirements for an ART clinic(sec.1.3), qualification of the embryologist in the ART clinic (1.5.3), protection of the personal identity of the donor(3.4.8), (3.12.3), maintenance of records(3.3.7), commercial donation of sperms/eggs(3.5.13), oocyte(egg) sharing(3.9.3), surrogacy(3.10.6),(3.10.1), reimbursement of infertility treatment or insurance(3.14.3), human cloning(3.14.11), stem cell cloning and research(3.14.12). The draft also specifies in sec. 9 that there would be a National Accreditation Committee of 15 professionals to monitor and regularise ART clinics, which should have representation of professionals from the medical fraternity, NGOs, government with a representative of patient and a medico-legal expert.(See box for details)

“The suggestions made have been agreed in principle by the ICMR and approval to the same is likely to be expected in the month of August this year,” informed Dr Parihar.

Experts opine that section (3.9.3) relating to egg sharing should be encouraged as it helps in monetary compensation of an ART procedure. According to Dr Duru Shah, infertility specialist, “Section 3.9.3 would be a boon for the poor people as ART treatment is very expensive.”

Experts have also greeted section 3.14.3, which implies that infertility treatment should be covered under medical insurance to make the treatment affordable to the poor people.

Experts have welcomed section (3.12.3) relating to the protection of donor’s identity as revealing donor’s identity can have serious legal and social implications.

“Section (3.2.9), which states that no human embryo can be placed in a non-human animal and that all research projects must be approved by the institutional ethics committee before submission to the accreditation authority, proposed by ICMR has also been welcomed by the ART group,” informed Dr Parihar.

However, there has been difference of opinion about the formation of a national accreditation committee as suggested by ICMR to regulate ART clinics in the country.

“The committee should have representation from all walks of life: infertility specialists, law professionals, representatives from government and non-government organisations,” avers Dr Shah. While Dr Parihar points out that the “committee requires more clinical people than social.”

Meanwhile, infertility specialists have raised objection to section 3.3.7, which implies keeping and maintaining the records of all donor oocytes, sperm or embryos for 40 years. The experts have also raised objection to section 3.5.13, which states use of sperm donated by a relative or a known friend of either the wife or the husband shall not be permitted and which allows for commercial donation of eggs. “Donation of eggs has built in complication rate. Exposure to various hormonal injections, anaesthesia and surgical procedures can lead to ovarian hyperstimulatiion or infection. Young girls from low economic strata of the society are the most vulnerable as they might for donation of eggs for financial reasons,” points out Dr Shah. ICMR has not complied to these suggestions, yet.

Suggestions accepted by ICMR for ART clinics in India

Section (3.14.11) states that human cloning for delivering replicas must be banned and section 3.14.12, which states that stem cell cloning and research on embryos (less than 15 days old) needs to be encouraged.

Section (3.12.3) specifies that children born through the use of donor gametes shall not have any right whatsoever to know the identity (such as name, address, parentage, etc.) of their genetic parent(s). A child thus born will, however, be provided all other information about the donor as and when desired by the child, when the child becomes an adult.

Section 3.10.1 specifies that a child born through surrogacy will be considered as the child of the genetic (biological) parents on establishing through genetic (DNA) fingerprinting (of which the records will be maintained in the clinic) that the child is theirs. In case DNA fingerprinting is not available, then the child can be adopted by the genetic parents.

Section 3.14.3 specifies “Keeping in mind the societal pressures, there is an urgent need to have infertility treated like any other disease, the expense of dealing with which by authorised ART clinics should be reimbursable, e.g. by the government or other employee or by the health insurance company, but for one child only.”

Section(1.3) states that non-sterile area should consist of a reception and waiting room for patients to ensure privacy, a general purpose clinical laboratory, store room, record room, auto-clave room, steps for vermin proofing, semen collection room, semen processing lab and a clean room for IUI and the sterile area comprising of OT, room for intra-uterine transfer of embryo and the embryology lab.

ICMR have considered that the qualification of an embryologist should not necessarily be an MBBS or an MSc/PhD and it is agreed upon that a person who holds a BSc degree with experience in embryology then, he/she can also be qualified to be an embryologist as specified under section 1.5.3). There would be an assessment test that the ICMR will administer for all these embryologist.

Section 1.3, which relates to minimal physical requirements for ART clinic like non-sterile area and sterile area proposed by ICMR is also welcomed by the medical fraternity. IUI sample should cumpulsorily be processed and recorded by a certified lab while general gynaecologists can do insemination is also a significant guideline welcomed by infertility specialists.