What is an ART Bank?
Assisted Reproductive Technology Bank defined by ART Law 2021; ART Bank “means an organisation which shall be responsible for collection of gametes, storage of gametes and supply of gametes to the assisted reproductive technology clinics or their patients”.
But the latest gazette published on 7th June ,2022 has restricted the role of ART bank to dealing with Donated gametes instead of patient gametes which was being implied in ART law 2021.
Regulation for ART Banks as per new ART law 2021
The ART Act 2021 has been enacted to provide a legal framework for the regulation and supervision of ART banks in the country. The Act sets out clear rules and guidelines for the establishment and operation of ART banks. It mandates that all ART banks must be registered with the National
Registry of ART Banks (NRAB) and obtain a license from the National ART Authority (NAA) before commencing operations.
As per Ministry of Health and Family Welfare ART banks will be responsible for the collection, monitoring and registration of donors whether it is a sperm donor or egg donors.
They must maintain proper records of all the donors and any changes should be informed to the National
ART banks should adhere to strict quality standards. They must meet the standards set by the Indian Council of Medical Research (ICMR) and the NAA. They must have adequate infrastructure and facilities, equipment, and trained personnel to ensure the safety and quality of their services.
The Act also prohibits certain practices such as commercial surrogacy, sex selection, and the use of donor eggs or sperm without the consent of the donor. It also places restrictions on the number of embryos that can be transferred during IVF procedures.
What are the roles and responsibilities of an ART Bank?
The duties of an ART Bank defined by ART LAW 2021 are as follows:
1. Shall be solely responsible for Screening, collection and registration of Semen Donor & egg donor as well as cryopreservation of sperms.
2. Shall ensure the eligibility of gamete donors for donation. The eligibility criteria are:
a. Age Limits:
- Male Donor/Semen Donor : 21 – 55 years of age
- Female Donor/Egg Donor : 23 – 35 years of age
b. Donors should be medically tested negative for 4 diseases as listed below:
3. Shall not supply the sperm or oocyte of a single donor to more than one couple.
4. Ensure that the information regarding the Donor shall be kept confidential and information about treatment shall not be disclosed to anyone except to the database to be maintained by the National Registry or by an order of a court of competent jurisdiction.
5. Every Bank shall maintain a grievance cell for making a complaint.
6. ART Bank shall provide all information periodically to national Registry related to :
a. Enrolment of gamete donors
b. Procedure being under taken
c. Outcome of the procedures and complications if any
** Within 1 month of enrolment of Gamete Donor, the information should be submitted to National Registry.
7. ART Bank shall cryo-preserve any human gametes with specific instructions and consent in writing from all the parties seeking ART Bank services.
8. Ensure to maintain detailed record of all donor oocytes or sperms used or unused, screened and supplied.
9. Shall ensure that all the above said records are maintained for at least a period of 10 years and upon expiry, the ART Bank shall transfer the records to central database of the National Registry.
10. Donor gametes could be stored for a duration maximum of 10 years and on expiry of the duration, the gametes shall be allowed to perish or donated to a research organization with consent of the individual.
11. Consents must be signed and collected by the ART clinics and banks to begin the procedures and collect semen and embryos. The government has introduced designated forms for each of the processes from collection to retrieval and the ART clinics must get them filled before and maintain them properly.
12. A new rule has been made for oocyte donors. The ministry has made it compulsory for the ART banks to make sure that the couple buys general health insurance coverage in favor of the donor for a period of at least one year and from a company or an agent recognized by the Insurance Regulatory and Development Authority. The amount should be sufficient enough to cover all the expenses which might be needed in case of any complications while egg retrieval. Also, the couple needs to sign an affidavit which must be sworn before a Metropolitan Magistrate ora Judicial Magistrate giving a guarantee.
Why do we need ART Banks?
1. ART Banks are boon to couples who otherwise cannot conceive using their own gametes either due to complete absence of gametes or due to lack of healthy gametes.
2. ART Bank ensures that the Donors selected or screened for donation are free from communicable diseases
3. They assist in prevention of misuse or over use of single donor gamete for multiple couples.
4. They also aid to restrict over exploitation of oocyte donors by restricting donation to one time alone by strict monitoring and record maintenance through National Registry
At a glance process flow of ART BANK