Practicalities of regulating cryogenic preservation in the UK

In the recent “cryonics case”, JS (Disposal of Body), Re [2016] EWCH (Fam) (10 November 2016), which was reported here and here, Peter Jackson J observed that the Human Tissue Authority (HTA) had provided advice to the NHS Hospital Trust concerned, but under the terms of the Human Tissue Act 2004 it currently has no formal remit in this area [15]. This post gives an overview of  the issues to be addressed should legislation be introduced for the regulation of cryonics and similar technologies; and considers whether the 2004 Act would be an appropriate vehicle for doing so.

Basis for regulation

Peter Jackson J concluded his judgment with the statement [69]:

“It may be thought that the events in this case suggest the need for proper regulation of cryonic preservation in this country if it is to happen in future”.

If such regulation were to be introduced, it would first be necessary to determine on what basis cryonic preservation would be regulated. In some countries such as France, whilst it is not a legal mode of body disposal, shipment to other countries for cryonic freezing is permitted; others prohibit prohibits the sale of arrangements for body preservation based on cryonics, as in British Columbia, Canada. There are thus three basic legal scenarios:

• an absolute prohibition on the use or prospective use of cryonic preservation; through the specification of territorial limitations, legislation could be drawn up to define the scope of any such prohibition, domestically and internationally;

• a prohibition on the operation of cryogenic preservation facilities within specified countries within the United Kingdom, but the introduction of legislation specific to the preparation, transport, storage and export of bodies for their cryogenic preservation in other countries; and

• the formal acceptance of cryonic preservation within specified countries of the United Kingdom with concomitant regulation of the processes and actors involved.

As a preliminary, however, it is necessary to give some consideration to the underlying premise upon which cryonic preservation is undertaken; this has been expressed by the Cryonics Institute as:

“death is a process that isn’t inevitable or irreversible if it can be stopped in time and the patient stabilized at cryonic temperatures until science can revive them”.

Whilst this might be an acceptable “mission statement” for organizations operating in this area, it has no basis in present-day law or medical science. Ironically, the preparation of JS’s body for cryonic preservation could not have taken place had Peter Jackson J, in the words of Professor Hoppe,  “thought that her death was, on the balance of probabilities, reversible at a future point in time”. Hoppe further noted:

“The Court was required to work on the basis of what is scientifically possible at this point in time, and be agnostic as to any future developments…The theoretical question of what becomes of all those cryopreserved in facilities across the world if technology advances to the point where they can effectively be resuscitated remains for another time.”

Current position

Possession of the body

In England and Wales, the person with the right to take possession of the body has the right to do so as soon as death happens; the coroner has the superior right, if he/she chooses to take temporary possession in order to ascertain the cause of death; next, a hospital has the right to detain the body of anyone who has died of a notifiable disease. Then the executor named in the will of the deceased, whether a family member or not, has the immediate right to act as personal representative and take possession of the body. If the person died intestate, a hierarchy of rightful personal representatives is defined in the Non-Contentious Probate Rules, rule 22.

In the case of JS, Peter Jackson J made a “prospective order under s.116 of the Senior Courts Act 1981, alternatively under the inherent jurisdiction of the High Court, to take effect upon JS’s death, appointing the mother as the sole administrator of her estate in place of the mother and father jointly, and specifying that the mother shall thereby have the right to make arrangements for the disposal of the body, and to decide who should be permitted to view it ” [41(3)].

Preparation for cryonics preservation

As JS (Disposal of Body) has demonstrated, within England and Wales there is at present “acceptance by default” in relation to the preparation of a body for cryonic preservation in another country.  Nevertheless, there is extant, generally-applicable legislation of relevance to the preparation, transport, storage and export of bodies. Whether all the legal niceties were observed in the case of JS is not recorded; unless cryonic preservation was the focus of the competent authorities at that time, such observance was dependent to a substantial degree on the non-profit organisation and its non-medically trained “cryonics enthusiasts” which provided the bridging arrangements in the UK,  [12]. However, the judgment notes:  “funeral directors are willing to attend at the hospital to ensure that the transportation of JS’s body is appropriately supervised”, [15];

The initial preparation required a significant degree of cooperation of, and coordination with the NHS hospital in which JS was a patient. The judge observed: [t]he body must be prepared within a very short time of death, ideally within minutes and at most within a few hours. Arrangements then have to be made for it to be transported by a registered funeral director to the premises in the United States where it is to be stored'”.

Perhaps significantly, the meeting on 5 October, between a representative of the voluntary organisation and the doctors, nurses and other representatives of the hospital trust,  was at the request of the judge. Consideration was given at to all the practical aspects of the plan at a senior level within the Trust, but a deep unease was expressed by the professionals involved [13]. This was borne out in the detailed note from the solicitors for the hospital trust which described the unsatisfactory nature of the events surrounding JS’s death from the point of view of the hospital, infra [68 (2)].

Regardless of other considerations, it is evident that the present situation  is unsatisfactory; this is clearly an area that would benefit from additional regulation (or more rigorous enforcement of existing measures) in order to ensure a better interface between medical and non-medical staff and the necessary degree of professionalism and training.

Time constraints

Major internal organs deteriorate rapidly at body temperature if they are not continually perfused with oxygenated blood; when organ donation is undertaken, these must be removed whilst the heart is still beating and an adequate circulation is being maintained. Similarly with cryonics: the Cryonics Institute’s  advice to hospitals includes cooling of the head, injection of an anticoagulant and:

“after pronouncement of death, use prompt CPR-like [i.e. Cardiopulmonary resuscitation-like] compressions  to maintain heart ad lung function. Vigorous compressions for 5 to 15 minutes helps to delay deterioration, improves heat transfer and helps to circulate heparin [an anti-coagulant] throughout the body”.

It is then important for the body to transferred to the Cryonics Institute in Detroit as quickly as possible for the completion of the process. In the case of JS, now designated as ‘patient 143’, it is reported that the transfer was completed 8 days after her death, unlike domestic US patients who can arrive within a couple of hours. This may have been a consequence practical or legal requirement, or both, and highlights the potential benefit of domestically-based facilities.

In addressing “the common myth” that “cryonics conflicts with religion”, the Cryonics Institute (CI) states:

“CI has members from many religious faiths all over the world, pointing out the life-affirming nature of cryonics. We view cryonics as simply another life-saving medical procedure, which is consistent with pro-life principles espoused by both medicine and religion. Our goal is not to “bring the dead back to life”… it is to preserve people in what we consider to be a critical condition until medical technology can cure them…Cryonics seeks to extend that window of time indefinitely to insure our patients can eventually receive the care and attention they need no matter how long it takes science to “catch up.”

Aside the more profound theological considerations, some of which are considered here and here, the practicalities involved in preparing a body cryonic preservation precludes the normal end-of-life requirements of many religions, from the laying out of the body to those of an “ecclesiastical funeral” for Roman Catholics, Can.1176 – 1185 (CIC).

Lawful control of the body

As noted above, as soon as death has occurred, the body may be released to the to the personal representative of the deceased, unless this is precluded by requirements of the coroner or hospital. The law does not require the personal representative to furnish the hospital with specific documentation when seeking the release of a body. However, a Westminster Hall debate highlighted this as a “grey area” which had arisen from a number of test cases [Commons Hansard 30 Oct 2013 Vol 569(66) Col 302WH]; a case in 1974 established that a person claiming lawful control does not need to provide any paperwork at to justify their claim over a body.

The debate was followed by a Consultation in January 2015 which stated:

“There is no legal requirement for hospitals to see the registrar’s Certificate for Burial and Cremation (the ‘Green Form’) before agreeing to release a body. Having this requirement can lead to delays with funeral arrangements and can cause unnecessary distress to the bereaved”.

Views were sought on a Draft Release form developed by the Department of Health “to help hospitals have a more consistent, quality-controlled, and timely process to release bodies”. There is no formal response to this consultation. In the debate, the Minister stated [col. 330] the lawful disposal may occur once a registrar has received a satisfactory medical certificate of cause of death and subsequently issued a certificate of disposal, commonly known as the green form, or the coroner issues a certificate of disposal where a death has been referred [by the hospital] for a coroner’s investigation.

If a body is to be moved out of England or Wales, under  Removal of Bodies Regulations 1954 SI 448 (as amended) the coroner must be notified by the personal representative of the deceased. This notification must be accompanied by the certificate of death from the registrar. Although S6 of the 1954 Act states that the body may not be moved until four clear days have elapsed after the notification to the coroner,

“Provided that, where the coroner states in his acknowledgment of receipt of the notice that after making due enquiry he is satisfied that no further enquiries by him are necessary concerning the death, the body may be removed out of England at any time after the acknowledgment has been received by the person to whom it is addressed, notwithstanding that the said period of four days has not expired.”

The current status of JS

In JS (Disposal of Body), the court’s primary concern was JS’s desire for cryonic preservation, for which the judge noted:

 “the law in relation to the disposition of a dead body emanates from the decision of Kay J in Williams v Williams [1882] LR 20 ChD 659, which establishes that a dead body is not property and therefore cannot be disposed of by will. The administrator or executor of the estate has the right to possession of (but no property in) the body and the duty to arrange for its proper disposal.”

However, in certain circumstances human remains may be regarded as ‘property’, as in Doodeward v Spence (1908 6 CLR 406), Australia High Court, or be subject to a human rights claim Re Crawley Green Road Cemetery Re Crawley Green Road Cemetery, Luton, (St Alban’s Consistory Court: Bursell Ch, [2001] 2 WLR 1175. Furthermore, Professor Hoppe has observed that “unless the law is changed ex ante, cryopreservation companies will suddenly have custody of hundreds of comatose patients, rather than dead bodies – with all of the entailing legal and moral obligations”.

Comment

Peter Jackson J stated [emphasis added] :

“…The HTA would be likely to make representations that activities of the present kind should be brought within the regulatory framework if they showed signs of increasing.  It also raises questions about the standing of the voluntary organisation and draws attention to possible public health concerns and the position of the coroner”, [15];

and

“[i]t may be thought that the events in this case suggest the need for proper regulation of cryonic preservation in this country if it is to happen in future”, [69].

However, in her post Corporeal freedom after death? Rosalind English comments:

“It is difficult to see why the Human Tissue Authority should be involved in what is essentially a privately-funded decision to make arrangements for a body that has no environmental or public health consequences. The question of standing is equally straightforward, since the deceased cannot speak for him or herself. Happily the HTA has no traction yet. In short, what the fourteen year old cancer patient wanted was not illegal.”

This is certainly true when one views preparation for cryonic preservation from the point of view of the rights associated with JS. However, in this case, the processes involved in the preparation of the body for subsequent “freezing” had a significant impact on third parties [emphasis added]:

“Cryonic preservation, whether or not it is scientifically valid, requires complex arrangements involving the participation of third parties”, [12];

“The voluntary organisation [which provided the bridging arrangement referred to in paragraph 12] is said to have been under-equipped and disorganised, resulting in pressure being placed on the hospital to allow procedures that had not been agreed.  Although the preparation of JS’s body for cryogenic preservation was completed, the way in which the process was handled caused real concern to the medical and mortuary staff, [68 (2)].

This raises two related issues: what form of regulation should be introduced to prevent the recurrence of such a situation? and, to what extent should hospital staff be involved with procedures with a scientifically uncertain outcome; which involve a privately-funded initiative; and relate to someone certified as being dead, i.e. how does this conflict with their normal duties and the application of clinically-proven medical treatment to their other patients?

With regard to the future demand for cryonic preservation (and therefore the need for specific legislation), this will depend in part upon the extent to which the publicity associated with the case of JS prompts others to seek out this route, in addition to those already “signed up” for this procedure. However, as Rosalind English observed “what the fourteen year old cancer patient wanted was not illegal”, the corollary of which is that had there not been a dispute between the parents of JS, the case would not have come before the court.

Whilst the Human Tissue Act 2004 provides a framework within which cryonics preservation could be regulated, in the short term it seems likely that hospital trusts will rely upon internal procedures to place more rigorous constraints on those involved in the preparation of a body for cryogenic preservation.