Mr. J. P. McDowell:

I apologise for not circulating them in advance.

I listened carefully to the medical practitioners who have given evidence to the committee and I am grateful for the opportunity to address the committee. Listening to the evidence that has been given, it seems that the concern and focus of the medical community at the very least is possibly not around the issue of opt-in or opt-out and presumed consent, but more around the issue of what legislation can bring in terms of infrastructure and resources.

When preparing for this, I was struck by what the CEO of the Spanish transplant authority stated recently about the early years of opt-in in Spain. He made the point that in the first ten years of the presumed consent or opt-out structure in Spain during the period leading up to 1979, the opt-out structure introduced by legislation there did not increase rates of donation significantly.

He was making the point that increased rates of donation represented the introduction of expert liaison personnel or transplant coordinators throughout the intensive care units around the hospital network, and that the opt-out or presumed consent system, in itself, was not necessarily contributing to increased rates of donation. That possibly touches on some of the issues highlighted by the medical practitioners who have already given evidence. Regulation 22, within the recent statutory instrument, is the current legal background. That follows the directive. The directive itself does not compel member states to introduce one system or another but it compels them to address the issue of consent. That is exactly what this member state has done. It has issued a statutory instrument in which the issue of consent has been addressed. Consent is required from the next of kin of the deceased at present.

As I understand it, there is a framework to be introduced by the HSE. We are awaiting its publication. This committee is now interested in considering whether presumed consent is ethically and legally robust and whether it is potentially challengeable. Throughout the 30 years in which presumed consent has been introduced in various member states, there has been no challenge to it or an opt-out system. I refer to a challenge on the basis of the convention. The committee may be aware that the European convention provides for a number of rights that might provide the basis of a challenge to a presumed consent system. One is Article 8, which establishes the right to a private and family life, and another is Article 9, which pertains to the freedom of conscience and religion. We also have constitutional rights, which would have to be observed in any legislative structure. We have Article 40.3.1°, the right to bodily integrity, Article 44, the right to freedom of conscience and religion, and Article 41, which recognises the family as a fundamental unit. These rights are all relevant in this territory.

I am not quite certain from a legal perspective whether there is a significant difference between an opt-in system and an opt-out system in terms of whether the underpinning legislation is legally fragile or robust. The key would seem to be the extent to which the consent of the family members of the deceased is being sought. The further one drifts away from that principle, be it through an opt-out or opt-in arrangement, the more fragile the structure becomes, not only for reasons associated with the convention or the Constitution but also for reasons that underpin medical practice. The whole concept of medical practice is based on one of the central tenets of informed consent. Thus, if one moves to an opt-in or opt-out system that takes the rights, needs and decisions of the family away and establishes a right to veto its decisions or views, for example, it begins to sit uncomfortably with the tenet of consent that underpins medical practice.

At its centre, this debate is about consent. I am not quite sure whether presumed consent is necessarily going to increase the figures on donation. Some of the evidence would suggest that it may do so marginally but perhaps it will not do so at all. One of the key concerns must be about the issue of medical practitioners and protecting them. A key aspect of any legislation introduced should be to set out the consent process clearly. In the United Kingdom, for example, the Human Tissue Act goes through a system of defining qualifying relationships in terms of next of kin and it stipulates people who must be consulted. Underneath that, it introduces codes of practice that provide another layer of detail on what is required. That would probably be envisaged in the legislation that may be introduced.

In one sense, the issue of presumed consent may well provide a positive context or starting point for a conversation between a medical practitioner and the deceased's relatives in an intensive care unit. That may well be positive. However, from a legal perspective, I am not certain whether it is important that there be an opt-in or opt-out arrangement, but the key is to note that the further one drifts away from the issue of consent from relatives, the more potentially challengeable or fragile any legislative structure becomes.

That is a summary of my views on some of the legal implications flowing from an opt-in or opt-out system. There is further detail in the document that has been circulated. I will be happy to answer questions.