CRYOPRESERVATION OF HUMAN EMBRYOS AND REPRODUCTIVE CELLS: The Legal Loopholes [EDITORIAL]

-by Ramsha Reyaz

Cryopreservation is the process of freezing biological specimens like cells, tissues, organelles etc. at very low temperatures for the purpose of preservation. Cryopreserved cells can remain viable for long periods of time and, therefore, the process is increasingly being used for preserving reproductive cells and fertilized embryos as part of in-vitro fertilization and other assisted reproductive techniques. Cryopreservation is an important aspect of Assisted Reproductive Technology (ART) and the use of ART treatments has grown immensely around the world, with an estimate of at least 8 million babies having been produced through such techniques worldwide. The process has also gained traction in India and ART is estimated to be a $30 billion industry, expected to grow to $45 billion by the year 2026. Complications in such processes creep in when a dispute arises between the parties of the cryopreservation process as India has no legislative or judicial precedents to deal such disputes. The article discusses the need for the adoption of a proper legal framework in India to deal with cryopreservation disputes, by taking into consideration the disputes that have come up in the USA and the legislative responses to dealing with this new concept.

Cryopreservation Disputes

The process of cryopreservation is usually preceded by the signing of a consent agreement or medical consent form by the parties for preservation of reproductive cells or embryos. The agreement should ideally specify what would be the fate of the cryopreserved cells in case of: separation of the biological parents, death of either or both of the parents and the situation in which the parties do not need the supernumerary frozen embryos after the procedure of IVF. However, the concept of cryopreservation is still quite new and agreements do not always consist of provisions to deal with these contingencies. Even in situations where such eventualities are covered by medical consent forms, disputes arise and the onus lies on the courts to decide on the matter.

There are a few judicial precedents from the USA on this issue. In Davis v. Davis, the Tennessee Supreme Court laid down a framework for deciding upon the custody of cryopreserved embryos in case of divorce proceedings. Firstly, the preferences of the parties should be considered. If the wishes cannot be ascertained or aligned, then the consent agreement about the disposition of the embryos, signed prior to the dispute, should be enforced. Lastly, if no such agreement exists, then the relative interests of the parties in using or not using the embryos must be weighed and analyzed. In this judgment, the interests of the two parties, undergoing a separation, could not be aligned as one wanted to go ahead with the implantation, and the other did not want a child anymore. The Court highlighted the importance of the constitutional right of procreational autonomy and the right to not have a child and eventually granted custody of the embryos to the fertility clinic. The right to procreational autonomy also exists in case of death of one of the parties to the cryopreservation agreement and for posthumous insemination, prior consent for the same must have been taken from the party. The issue further poses a moral dilemma as to the disposal of such embryos, as the Court, in Davis v. Davis, iterated that the embryo deserves a certain degree of respect, although it cannot be granted the status of a legal person.

Irrespective of the confusion and dilemma, usually, courts grant the rights over the disposition of embryos to the clinics, as in the case of Kass v. Kass and Litowitz v. Litowitz. In the latter case, the Washington Supreme Court allowed the embryos to be thawed and disposed of, as per the terms of the contract. Thus, the courts have, in most cases, simply enforced the cryopreservation agreements. Such precedents make the analysis of the situation harder for India.

Legal Framework in India

In India, the practice of signing agreements prior to cryopreservation is not warranted by any legislations or legal mandates. The Guidelines for ART Clinics in India by the Indian Council of Medical Research (ICMR) state that consent forms must be signed regarding the storage and use of embryos, including “for the use of stored embryos by other couples or for research, in the event of embryos not being used by (the parties) themselves”. However, these guidelines are neither legally binding nor do they specifically lay down the options in case of separation or death of the parents of the cryopreserved embryo.

The Assisted Reproductive Technology (Regulation) Bill was cleared by the Union Cabinet in February this year, although the draft had been prepared in 2017. The Bill provides that the process of cryopreservation must be necessarily preceded by the signing of a consent form by the parties and the form must specify what should be done with cryopreserved cells “in case of death or incapacity of any of the parties”. However, the Bill fails to address the issue of separation and lacks clarity as to the specific disposition of cryopreserved cells. Certain states in the USA, like California, have separate legislations stating the options available for the disposition of embryos in case of separation or death of either or both the parties, which removes the ambiguity from the considerably new concept and its repercussions.

Courts in the USA, have at times, refused to enforce cryopreservation agreements for the reason that agreements can be ambiguous and also because the situation of the parties can change over the course of the process of cryopreservation. A party could have previously consented to implantation of frozen embryos in case of a separation, but later exercise the right to procreational autonomy and refuse such an action, and the Courts would not enforce such an agreement as the right to procreational autonomy holds great value as a matter of public policy. The right to reproductive and procreative autonomy has also been recognized by the Supreme Court of India. The courts of the states that have such legislative precedents have faced problems in enforcing cryopreservation agreements and weighing them against the rights and autonomy of the parties. The issue is even more critical for India because the ART (Regulation) Bill doesn’t specifically mention what the contingencies and stipulations for the disposition of cryopreserved cells or embryos would be and what could be done in case of disputes.

Conclusion

Cryopreservation, being an essential part of ART, is being increasingly employed in India. However, the country lacks legal provisions regarding the procedure and this might lead to a number of varying decisions from the courts of the country in case of disputes. The country needs binding and legal provisions for the compulsory signing of cryopreservation agreements, along with clear and unambiguous options for the proper disposition of such cryopreserved cells in case of disputes. Further, there need to be clear provisions for the enforceability of such agreements and how the practice can be balanced against the procreational rights of individuals in case of conflict. There need to be coherent laws governing the process of cryopreservation, so that ART can continue helping and changing the lives of people around the country.

ABOUT THE AUTHOR

Ramsha Reyaz is a student of law at Maharashtra National Law University, Mumbai and a Senior Editor at ELS Review.

Leave a Reply