Organ Donation – The Essential Guide - G.G Balmforth Solicitor, Head of Clinical Law, www.law-med.co.uk
How is Organ Donation Regulated?
It is the Human Tissue Authority (HTA) that regulates all living and deceased organ and tissue donation and transplantation as well as human tissue storage across the UK, there are no separate devolved organisations with similar or overlapping regulatory authority and the HTA is therefore one of the few British regulators outside of the devolved NHS structure. The HTA is the subsequent creation of The Human Tissue Act 2004. This act, among other things, provides a substantive legal framework for living organ donation in England, Wales and Northern Ireland. It is worth noting that the regulatory framework in Scotland is out within the Human Tissue (Scotland) Act 2006 although the regulatory authority remains with the HTA. Also of note is the Human Transplantation (Wales) Act 2015 which sets out a “opt out” position.
How is Organ Donation Organised?
The demand for organ donation increases every year and currently the level of demand is in the region of 7500 outstanding entries awaiting transplant. The list is regrettably and intolerably eroded by death at the current rate of 3 deaths per day while transplants remain outstanding. The issue with deceased donation and transplantation is that organ death follows very rapidly from brain death or circulatory death and so organ donation can only really be considered feasible if the donor dies in the circumstances of Hospital admission and frequently therefore, while supported on ventilation. Outside of these circumstances the possibility of successful donation and transplantation of deceased organs is practically nil. By that same token, issues of consent are very difficult for clinicians to raise and for the deceased’s kin to adequately comprehend at the time of death. Prior consent obtained during the donors fit lifetime is therefore essential for increasing instances of successful deceased donation. The administration of the process of donation is relatively straightforward. A national register of organ donors has been created. It is a computerised database that hold the details of more than 18 million people who have given consent for donation of their organs after death. Each registrant has the option to consent to partial donation, full donation or even nil organ donation but tissue donation instead (see below). There is also the possibility for an individual to nominate someone to give consent or otherwise in situations where consent cannot be given by the donor. Everyone can join the NHS Organ Donor Register regardless of age as long as they are legally capable of making the decision to donate and they live in the UK. Medical conditions and illnesses are not necessarily a bar to registration or donation. Ultimately the decision on whether an organ is suitable for transplant is made by a clinician who has had proper access to the donors medical history.
There are however, two situations in which transplantation can be ruled out completely.
a) Where the donor is HIV positiveb)
b) Where the donor has or suspected of having variant CJD (Creutzfeldt Jakub Disease)
In every other case registration is encouraged. Actually joining the register can be achieved online at www.organdonation.nhs.uk or by calling 0300 123 23 23, or even texting SAVE to 84118. Removal from the register is equally easy by again calling 0300 123 23 23 or visit www.organdonation.nhs.uk and fill in the form asking for your name to be removed. In both cases, registration and deregistration is crucial that family and close friends are aware of the situation regarding your intent. It is likely to be they who interpret and communicate your wishes to the Hospital team. It is certainly worth noting at this point that if you registered on the Organ Donor Register to be an organ donor and donation is a possibility when you die, then a dedicated nurse specialising in organ donation will support your family, let them know of your decision, and help to honour it. If you have not made a decision or nominated a representative, the law allows family members to make this decision on your behalf. The actual process of deceased donation and transplant is likely to be achieved by a specialist team of donation surgeons, they will not likely be the same surgeons involved in care and these specialist services are usually called on very quickly by the various emergency and surgical teams in situations where consent is given.
Is the Law on Organ Donation Changing?
At this point in time, its hard for any self respecting lawyer to be certain about anything that requires large scale legislation to be put in place and supported by an administrative network. Our Government is certainly “challenged” by the position it has made for itself over the last 10+ years of unchallenged Euroscepticism and we subjects are now reaping the whirlwind of this devastating situation. Here is a quick skip around the Home Countries. WalesThere is certainly strong movement towards a universal “opt out” arrangement generally but in Wales, as previously mentioned and as of 1 December 2015, there is a new system for organ and tissue donation as part of the Human Transplantation (Wales) Act 2013. This new system creates a legal consent in Wales called deemed consent. This means that unless you registered or expressed a decision not to donate your organs after your death, you will be regarded as having no objection to donation. Your consent will be deemed to have been given, unless you fall into one of the exemptions or if your family and friends can show that you did not want to be a donor. You can register your decision to donate using the NHS Organ Donor Register link above and by telling your family or friends. If you do not want to donate, and do not register your objection, your relatives will be given the opportunity to show evidence that you didn’t want to donate. You can also appoint a representative to make your decision on your behalf. If you have registered your decision to donate, there is absolutely no legal entitlement for your family to override that consent; however, families will still be involved in discussions about organ donation.
The situation in England is currently that an “opt in” or “express consent” has to be in place. However, in summer 2018, the Government published a response to its consultation into the organ donation system in England. This was widely welcomed by the Medical Profession and within it the Government confirmed that under the proposed new system (commonly known as ‘deemed consent’ or ‘opt out’) everybody would be considered a potential organ donor unless they have added their details to the NHS Organ Donor Register to say that they do not wish to donate their organs or are in one of the excluded groups. They have provisionally indicated that the system may be in place in April 2020. I consider (at this time January 2019) that the prospects of this system actually being in place and working effectively by April 2020 are less than the chances of our current Prime Ministerial Cabinet Officers all being made saints by the Church of Rome. The situation of express consent is certainly one that is attractive to all but unless the changes are rolled out and recorded by someone such as a GP I anticipate that the potential litigation surrounding such a system could be a real headache for the DOH. Instead, I expect some sort of hybrid system to be introduced and eventually phasing to “opt out – deemed consent” by say 2030. Mark my words!
This same position with express and deemed consent, also applies to the situation in the rest of the British Isles but with the proviso that Scotland, who in my view, is a world leader in Healthcare has issued with great confidence, the Human Tissue (Authorisation) (Scotland) Bill, which includes provision for a 'deemed authorisation system'. This was published by the Scottish Government on 11 June 2018 for consideration by the Scottish Parliament. The date for the change to legislation is not known but could be spring 2020. Now, I have no doubt the canny Scots could pull this off but for the chaos that will likely be imposed on them by what they charmingly refer to as “the Westminster Parliament” over the Brexit fiasco. Also of note is the situation in the Channel Isles and the Isle of Man, both of whom have their own parliamentary bills not yet read through all stages and both aiming at a 2020 deemed consent deadline.
Ever a hotbed for contentious issues with quasi-religious overtones, the Irish of Northern Ireland have had a good look at the proposed changes back in 2016 and firmly decided (one of the few issues uniting them) not to proceed with anything that moves the situation to a deemed consent system whatsoever. In a compromise worthy of them however, they did apportion budgetary measures to promote opt in systems. They are required to confirm that position every five years. Now, the observant of you will have noticed that the NI Assembly is currently not sitting and there appears little hope of that situation changing in the immediate future. This does not seem to be a priority for the “Westminster Parliament” and therefore, the actual position is currently threatened by the situation of Britain, taking back devolved power should the Assembly not get back into gear.
Are there any Penalties for Non Authorised Organ removal?
Here’s what is clear: it is a criminal offence to carry out a transplant operation between two living people if the conditions of the HT Act are not met with regard to consent. This means valid consent must have been given. The penalty for conducting a transplant is a prison sentence of up to three years, a fine, or both. That is a hefty position for a surgeon and in a era where consent and its presence or otherwise is subject to considerable judicial fluidity, you can see why medico legal defence organisations are live to the issue. Unfortunately nobody else seems interested in listening to this and potential for legal challenge by an aggrieved estate remains a real possibility.
The Scottish Independent Review Group on the Retention of Organs at Post Mortem 2001 (not cited) proposed that, rather than speaking of consent in the context of organ retention, we should speak of authorisation. They are, it has to be said, very persuasive in reasoning for abandonment of the term. They offer two reasoning's;1. That the families remaining to be consented often feel precluded from consent as they are not the “owners” of the tissue and have no access to the wishes of the deceased. 2. With reference to children, the Review Group argue that parental powers to consent on behalf of young children are limited to consenting to procedures in the best interests of the child. The mutilation of a child after death does not fit into the framework of parental consent as it is applied in life. I have to say that I find this reasoning very hard to argue with. In fact to do so would be to take a view of the “property” of the human tissue that precludes the humanity of approach that is activated by death also it engages an objectivity that is otherwise alien to most humans.
However, as things stand at the moment consent must be express, it must be demonstrably obtained by fair means and hopefully supported by friends and family as a decision previously expressed. In the presence of such a situation hopefully the intermediary period before deemed consent is the norm will be uneventful for patients and surgeons alike. What about Living Donation are there any rights once the organ is Donated?
As far as I can see there have been no cases of any donor actually looking toward re-possession, however, you can of course, never rule anything out. What I am interested in is the inevitable situation where a mismatched donor supplies a kidney and that operation for transplant is a consequential failure through immune system rejection. In such a situation both donor and recipient may well join issue over the negligence. Now that’s an action I want to be in the room for.
As the situation develops with organ donation I will keep this blog updated. If you have any remarks, particularly if you have access to case law on donation or transplant and or you are representing clients in such cases – by all means drop me a line at email@example.com .
…………………………………………………………………………Graham G Balmforth, Medical Negligence Solicitor and Higher Court Advocate, Civil Proceedings. Clinical Law Law-Med, Jan 2019.