This article is written by Paridhi Goel, from Amity Law School, Noida. This is an exhaustive article which deals with the explanation of laws that regulate the donation of eggs and sperm in our country along with a discussion on whether the current guidelines cover the process of donation in an efficient manner. 

Introduction

If you follow the news daily, you must have come across the headlines reading “young girls donating their eggs for money without informing parents”. Or if you are into movies, one cannot miss Ayushman Khurana’s ‘Vicky Donor’ which popularised sperm donation in India. It is indeed legal for a woman to donate her eggs and for a guy to donate sperm. It indeed brings good money too. For example, a female might earn money starting from Rs. 25,000 to 75,000 for a one-time donation of her eggs. 

However, there are certain requisites one must meet to donate at the fertility clinics or sperm banks. Unfortunately, at present, there is a lack of a proper law or legislation to guide the donation of eggs and sperm but the Indian Council of Medical Research (ICMR) has come up with guidelines to ensure that the ART (Assisted Reproductive Technologies) clinics in our country are accredited, regulated and supervised keeping in mind that there are no health risks to donors.  

According to the World Health Organisation (WHO), out of a population of 1000 million Indians, approximately 13 to 19 million couples are currently trying their chance at parenthood as either one of the partners or both are infertile. Most of these couples take the help of advanced ART procedures such as In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) in which donation of eggs by a female and sperm donation by males constitutes an essential part of the whole process. Thus, a donation made by a person can not only bring a new life to this world but will also end the mental trauma that many infertile couples go through. However, there are legal rules that every donor must follow to prevent certain health hazards like girls donating eggs at a young age. Legal awareness on this topic is important so that no one can take advantage of the donor and the donation process goes smoothly. 

What is egg donation

Egg donation is a method where a female donates her eggs (oocytes) to help another woman to get a baby. It is a part of assisted reproduction and is a great family-building option for couples in which the woman either has a premature ovarian failure or responds poorly to the traditional ovarian stimulation and the male suffers from severe disturbances in gamete production. Egg donation can also be done for couples who are carriers of hereditary diseases and do not want to cause their child any significant morbidity due to their disease. According to the Indian Council of Medical Research, egg donation should be an anonymous process and the donor should be properly screened before her eggs are used further. 

Who is an egg donor

An egg donor is a woman who consensually contributes her genetic material that is oocytes to help in the reproduction process of another woman. The egg donors must be healthy women, usually having at least one child of their own. They undergo a complete medical and psychological evaluation which includes being screened for infectious diseases like HIV and Hepatitis. The guidelines given by the ICMR are adhered to and accordingly all the tests are performed before choosing a donor. An egg donation only takes place after the screening process and legal paperwork is complete. 

Ways through which donor eggs can be obtained:

1. Anonymous donors- Women who are not known to the recipient(s) or wish to keep their identity hidden. Such donors can be found through egg donation programs, agencies, or fertility clinic records. In India, the legal framework proposes the donor be anonymous and not someone known to the recipient. 
2. Known donors- Women who are known to the couple or the recipient. Such a donor can generally be a close relative or friend. In some instances, couples or recipients advertise directly for donors in newspapers or on the internet. In these circumstances, the recipient(s) and the donor know each other from before and meet without an intermediary program or agency. Recipients, however, should take caution when recruiting donors directly without having an intermediary program or agency to screen donors or without seeking legal counsel.
3. IVF programs- Women who are undergoing IVF may agree to donate their excess eggs to infertile patients. This way of donation is limited because it can be seen as coercive, particularly if the donors are offered a financial discount on their IVF cycle.

Requirements for being an egg donor

Willingness to donate eggs is the first essential step taken by an oocyte donor. Further, there are certain requirements and tests that the donor has to fulfill to become an eligible egg donor. They are as follows-

• The individual must be free of HIV and Hepatitis B and C infections, hypertension, diabetes, sexually transmitted diseases, and any kind of identifiable or common genetic disorders for example thalassemia. 
• The donor is tested for other infections like gonorrhea, chlamydia, and syphilis. The donor must be tested to be sure that she does not carry the cystic fibrosis gene. 
• Another genetic testing should be performed based on the donor’s history and ethnic background. Some programs perform chromosome analysis and tests for Fragile X syndrome, which are not always required. Psychometric testing is often done as part of mental health screening.
• The blood group and the Rh status of the donor must be determined and recorded.
• Information concerning the donor such as height, weight, age, educational qualification, profession. The Colour of the skin and eyes, family background, and history of any family disorder must be recorded appropriately.
• The age of the donor must not be less than 21 years or more than 35 years. It is preferred to have a female donor who has at least one child. 

While these requirements are a must for the egg donor to fulfill, due to the lack of proper legislation in India, many fertility clinics do not tend to follow all the conditions. Mostly the requisite of age is neglected by the clinics when young girls of 18 years of age walk in to donate eggs to earn some money. India witnessed death in 2010 when a 17-year-old Sushma Pandey died two days after she had donated eggs at a leading infertility clinic in Mumbai. This incident is still shrouded in mystery. Thus, it is important to adhere to the guidelines laid down for safe donation. 

Who should be considered an egg donor

Infertility is the basic reason for any individual to ask another woman to donate her eggs. There can be various other reasons to ask for an egg donation. These are-

• Gonadal dysgenesis which are defective developmental issues of female gonads (ovary or egg sac) which usually occurs due to a congenital defect.
• Premature ovarian failure is the loss of normal ovarian functioning before 40 years of age.
• Iatrogenic ovarian failure due to surgical intervention in the ovary or chemical castration, even any kind of radiation exposure.
• Development of resistance against ovary syndrome, or female has a poor response to ovulation induction.
• Women who are carriers of recessive autosomal disorders.
• Women who reach menopause should consider IVF and ask for egg donation. 

Advantages

Certain advantages of egg donation which can be considered are as follows-

1. The female will be able to give the gift of parenthood to a couple who wanted to start a family and could not do so on their own due to medical or personal reasons. 
2. It allows the female egg donor to receive free medical testing as, before donation, the donors undergo a series of tests to detect any genetic or infectious diseases in the individuals. 
3. Egg donation is not just a kind act but also comes with financial benefits. 
4. It informs the female about her fertility potential. Moreover, the clinics encourage females for egg freezing as well which could be helpful in the future. 
5. It may allow the female to become a part of the child’s life whose birth was made possible by her decision of donating eggs. 

Disadvantages

There are certain disadvantages of egg donation that one might want to consider before making any decisions. They are as follows-

1. The whole process of egg donation takes time and patience which may cause stress and sometimes anxiety to the female donor. 
2. It may cause irreversible physical changes to the ovulation cycle. Like some women experience the onset of early menopause due to egg donation. 
3. It is usually an anonymous process and it is made known to the donor that no details of her will be shared with the child she helped to create nor can the donor have any contact with such a child. It can be hard sometimes to deal with this anonymity and leaves the woman donor wondering about this child’s well-being.
4. It takes a lot of time and effort as retrieving eggs requires minor surgery. The donor may face complications for the day. The whole process cannot be taken lightly. 

Other ICMR guidelines 

There are certain guidelines issued by ICMR regarding egg donation that should be followed along with fulfilling other requirements. They are as follows-

• All such clinics that are involved in infertility treatment promoting the use and creation of embryos outside the body and conducting research on embryos, must be legally registered.
• A code of practice lays down the qualifications for personnel in these clinics.
• Any kind of treatment should begin with the written consent of the patient. Along with this, the patients must receive information and counselling beforehand.
• No human embryo should be placed in a non-­human animal for experiments and all research projects must get approval by the Institutional Ethics Committee.

What is sperm donation?

Sperm donation is a process in which a male referred to as the sperm donor, donates his semen with the intention that it can be used to achieve a pregnancy and produce a baby in a woman who is not the donor’s sexual partner and with whom the male is not involved physically. Various attempts are made to impregnate a woman with the sperm of the donor using third-party reproduction techniques mostly through artificial insemination. Sperm donation can either take place by directly donating the semen to the woman recipient at a clinic known as the sperm bank or can be done through a third party that brokers arrangements between sperm donors and those who need it in a ‘sperm agency’. 

Sperm donor

A sperm donor is a male who donates semen, which contains sperm, to a woman or a couple who is trying to get pregnant. The donor should give his consent before any kind of donation is accepted at a clinic. The donor has to be anonymous to the woman or couple the sperm is being handed over to; however, the clinic should keep a record of the donor’s details. The donor has no parental rights over the offspring that is produced with the help of such a donation. According to the ICMR, a sperm donor in India should only be approached through a sperm bank.

Requirements for being a sperm donor

A sperm donor goes through a screening process before becoming eligible as a donor. The requirements are as follows- 

• Donors also have to be screened for communicable diseases such as HIV, hepatitis, gonorrhea, and syphilis. 
• Sperm from anonymous donors must remain quarantined for at least six months until the donor is rescreened for these diseases and the results of such tests come negative.
• A donor’s semen quality must be evaluated, which can take some time. This is why some banks continue to analyze sperm for infectious diseases for at least six months.
• Sperm donors must compile a complete family and medical history to check for any genetic disorders.
• The clinic at which the sperm donation takes place shall have the donor’s entire information like height, weight, skin, colour, educational qualification, ethnicity, profession, etc. The sperm is usually inseminated using various artificial reproduction techniques.
• The age of the sperm donor must not be below 21 years of age or above 45 years. 
• The blood group and the Rh status of the donor must be determined and placed in the records of the sperm bank.
• Following the guidelines of ICMR, the donor can donate sperm only at a sperm bank and the identity of the donor stays anonymous for the one using such sperm for producing a baby. 

When is a sperm donor needed?

An individual or a couple usually needs a sperm donor under the following situations-

• When the male partner has Azoospermia, in simple terms absence of sperm can be due to a blockage such as the congenital bilateral absence of the vas deferens (CBAVD) or previously performed vasectomy. Alternatively, azoospermia can be due to testicular failure resulting from exposure to toxins like pesticides, radiation treatment, or chemotherapy.
• When the male partner suffers from severe oligozoospermia that is a decrease in the sperm count or other significant sperm or seminal fluid abnormalities.
• When the male partner is facing Ejaculatory dysfunction, such as the inability to achieve or maintain an erection or to ejaculate.
• When the male partner has some genetic disorders which he does not want to pass on to his child. 
• When there is no male partner, such as single women who wish to become mothers or lesbian couples who desire pregnancy. Using donated sperm allows them to start a family of their own. 

Advantages

There are certain advantages to donating sperm. They are as follows-

1. The greatest advantage of sperm donation is being able to help a couple to conceive, ending their lifelong misery and giving them the gift of parenthood. The contribution of the donor can lead to bringing a new life to the world.
2. The sperm donors will be happy to know that they have good health as, before the donation, they undergo a series of tests for examining any genetic disorders or infectious diseases.
3. The sperm donors are compensated financially for their contribution.

Disadvantages

There are certain problems that a donor might face while deciding to donate sperm. They are as follows-

1. The donor will be asked to abstain from ejaculating for at least two to three days before donating his sperm.
2. You will not get to meet or even know your biological child as the identity of you and the person using your sperm has to remain anonymous. 
3. You may get concerned about the fact that your child is somewhere out there in the world yet you do not have any knowledge. 

Other ICMR guidelines

There are some basic guidelines that need to be followed along with fulfilling the requisites of a sperm donor. They are as follows-

• A relative, friend of the female partner, or the actual male partner is not permitted to donate the sperm in India. 
• The donor has to be anonymous. Neither the clinic nor the couple using the sperm has the right to know the identity of the donor. 
• It will be the responsibility of the ART clinic to obtain sperm from appropriate sperm banks
• The clinic and the couple have the right to get as much information as possible on the donor such as height, weight, skin colour, profession, family background, freedom from diseases, ethnic origin, and the DNA fingerprint.
• The ART clinic will be authorized to ask for appropriate charges from the couple for the semen provided and the tests done on the donor semen.
• The age limit must be strictly followed. 

Rights and duties of donors

The donors are assured of certain rights and in return, it is expected that they fulfill the duties of being a donor. The following are their rights and duties-

• All information about the donors shall be kept confidential. Any details of oocyte or sperm donation cannot be disclosed to anyone else other than the central database of the Indian Council of Medical Research, except with the consent of the person or persons to whom the information relates, or by an order of a court of competent jurisdiction.
• The donor will be given the right to decide what information related to him/her can be passed and to whom, except in the case of an order of a court of competent jurisdiction.
• A donor is informed beforehand to relinquish all parental rights over the child which may be conceived from his or her donation.
• No assisted reproductive technology procedure shall be conducted on or concerning anyone donating sperm or egg unless their consent is taken in writing for such a procedure. 

The child’s right to information about the donor 

• A child, who was born due to the possible donation of a parent who then is referred to as the genetic parent, may, upon reaching the age of 18, apply for any information, excluding personal identification, relating to his/her genetic parent.
• The legal guardian of a minor child may apply for any information, excluding personal identification, about his/her genetic parent or parents when required, and to the extent necessary, for the welfare of the child. 
• Personal identification of the genetic parent or parents may be released only in cases of life-threatening medical conditions which require physical testing or samples of the genetic parent.
• Provided that such personal identification will not be released without the prior informed consent of the genetic parent.

Duties of the clinics regarding egg and sperm donation

A female usually approaches a fertility clinic for egg or oocyte donation. Similarly, a male is required to approach a sperm bank/semen clinic to donate his sperm to assist another in reproduction. Such Assisted Reproductive Technologies (ART) clinics have a duty towards these donors and they are expected by law to perform such duties. They are as follows-

• To ensure that the donors of eggs and sperm are eligible to make such a donation. They need to adapt the screening process recommended by the ICMR and check for any diseases that are sexually transmitted or otherwise so that the donation procedure does not endanger the health of the donor. 
• It is the duty of the ART clinics to obtain relevant information from the sperm banks or fertility clinic records to assist the couple in choosing the right donor. However, such information must not include details that reveal the identity of the donor. 
• The ART clinic has to obtain the consent of the bank from which they are taking the donated sperm from and also from where they obtain the oocytes. Such consent has to be in writing. Disclosure of any kind of information to the couple in need or anyone else is an offence punishable by the law. 
• The clinics have the duty to give all the possible information about the procedure of the donation to the donors including the possible health risks, how they might feel, the payment details, and anonymity clauses.
• The clinics have to make sure that the age limits specified for the donors are followed. 
• They should assist the donors in case any donor feels uncomfortable or faces any difficulty. 
• They should acknowledge any kind of egg/sperm contribution made by a female or male by keeping proper records of such donations. 

ART Regulation Bill, 2020

Assisted Reproductive Technology Regulation Bill, 2020 was introduced in Lok Sabha on September 14, 2020, by the Minister of Health and Family Welfare. The Union Cabinet has approved the Assisted Reproductive Technology (ART) Regulation Bill, 2020 to monitor medical procedures used to assist people to achieve pregnancy. The Bill will regulate the Assisted Reproductive Technology services in the country. Consequently, infertile couples will be more confident of the ethical practices followed by ARTs. 

The bill highlights that ARTs refer to techniques that seek to obtain a pregnancy by handling a gamete (sperm or egg) that has been donated and transferring the gamete or fertilized embryo into the woman’s uterus. These arrangements include in-vitro fertilization that is a process of fertilizing an egg in the lab, gamete donation, and surrogacy.  

The Bill allows married infertile couples and women up to a certain age to commission ART procedures. It also specifies age ranges for gamete donors. It places conditions such as egg donors must be married with a child who is at least three years old, which are a little different from the guidelines of ICMR. Commissioning parties must ensure egg donors against risks.  It also states that National and State Boards will be set up for regulating ART services. 

Further, a National Registry with information on all ART clinics and banks will be formed. ART clinics and banks will be required to share periodic information about donors and commissioning parties with the Registry, which may share this with the National Board. However, the identity would not be shared with anyone else. Under offences and penalties, the bill suggests that the sale or purchase of gametes will attract a fine between Rs 5-10 lakhs. A subsequent offence will attract imprisonment of 8-12 years with a fine.

Features of the Bill with regard to donors

The key features of the ART Bill, 2020 include a lot about clinics, registration of couples, eligibility, etc. It also has rules that need to be followed with respect to the donation of sperm and eggs. They are as follows-

• Eligibility criteria for donors- A bank can obtain semen from males between 21 and 55 years of age, and eggs from females between 23 and 35 years of age. An egg donor should be an ever-married woman with at least one alive child of her own who is a minimum of three years of age. The woman can donate eggs only once in her life and not more than seven eggs can be retrieved from her. A bank cannot supply the gamete of a single donor to more than one commissioning party that is to couples or single women seeking services.
• Conditions for offering services- ART procedures may only be carried out with the written consent of the commissioning parties and the donor. The commissioning party will be required to provide insurance coverage in favour of the egg donor in case of any loss, damage, or death. Clinics are strictly required to check for genetic diseases before any donation is made by an individual and are prohibited from providing any sex-selective services like sex determination.
• Rights of a child born through ART- A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple. A donor will not have any parental rights over the child.
• Duties of ART Clinics and Sperm Banks- ART clinics and the bank must share information with the National Registry related to: 
  1. Enrolment of the couple interested or the commissioning parties and donors. 
  2. All the procedures being undertaken.
  3. The outcome of the procedure.

Further, they must maintain records of all donations made for at least 10 years, after which the records must be transferred to the National Registry. 

• Offences and penalties- Offences under the Bill include: 
  1. abandoning, or exploiting children who are born through ART.
  2. selling, purchasing, trading, or importing the collected human embryos, or gametes.
  3. The exploitation of the commissioning couple, woman, or the gamete donor in any form.

These offences will be punishable with a fine between five and ten lakh rupees for the first contravention. For subsequent contraventions, these offences will be punishable with imprisonment between eight and twelve years, and a fine between 10 and 20 lakh rupees. A court will take cognizance of an offence only on a complaint that is made either by the National or State Board.

Conclusion

There is a famous saying by Winston Churchill that “We make a living out of what we get, but we make a life by what we give”. Donation of eggs and sperm is something a donor should be proud of as it is done to help another person or a couple, in starting a family of their own. The ART Bill Regulation, 2020 works as a guide for the medical practitioners, patients, donors, and parties interested in ART services. It protects their rights and reminds them of their duties that they are bound to perform while being a part of ART. The laws on sperm and egg donation so far are quite basic and straightforward. The only problem that India is still facing is the implementation of these laws. Even though many guidelines and rules have been laid down, strong legislation is the need of the hour because it is not worth risking a donor’s life only to bring another life to this world. 

References

• https://www.whattoexpect.com/getting-pregnant/fertility-tests-and-treatments/sperm-donor/
• https://www.slideshare.net/ovary2009/guidelines-for-art-clinics-in-india
• https://www.drishtiias.com/daily-updates/daily-news-analysis/assisted-reproductive-technology-regulation-bill-2020
• https://www.prsindia.org/uploads/media/vikas_doc/docs/1241500084~~DraftARTBill.pdf

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