The organs debate -explaining the issues

19/8/2013

Why was the Seanad recalled this week, following a successful petition by Fianna Fail Senator Mark Daly, to debate EU organ donation law and how it applies to Ireland? There has been considerable public confusion about what is quite a complex issue.

One thing the Seanad debate is not about, however, is whether or not Ireland should have an 'opt-out' organ donation system - that is a separate issue currently being addressed by Health Minister James Reilly.

One thing the debate of recent weeks is about is finding the best way to increase organ donation and transplantation rates in Ireland. Everyone agrees this is desirable, but there are differing views on how this should be achieved.

The motion put before the Seanad reads:

“That Seanad Eireann resolves that Statutory Instrument No. 325 of 2012 - European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 be annulled”.

The Irish Kidney Association (IKA) and the Irish Donor Network have differing views on the adequacy of the Irish legislation and on the issue of consent for organ donation. They outline their views below :

Mark Murphy - IKA:

The Statutory Instrument 325 is the interpretation by the Department of Health of the EU Directive on Organ Donation & Transplantation EU/53/10.

Under this law, instead of creating a competent authority for all the requirements of organ donation and transplantation, the Department divided up the responsibilities or competencies required for the quality and safety issues involved across two agencies of the state, the HSE and the Irish Medicines Board (IMB).

In the IKA's opinion, this decision by the Department of Health, missed out completely on the spirit of the EU Directive, which was developed to complement the EU Commissions Action Plan on Organ Donation & Transplantation, that mapped a clear pathway for improving organ donation rates across all member states.

Most EU member states already had a transplant competent authority and almost all now have one. We are now, the only remaining member state not to establish a single authority.

Keeping the competencies divided ensures that the 10 point action plan and the directive remain without leadership and direction.

No doubt, the issue of cost will be presented as a counter agreement.

In a recent letter to Minister Reilly, I advised that the overall competent authority should be incorporated into his own department, to save costs, and from there the quality and safety requirement of the directive could be given to the appropriate agencies of the state, maintaining the leadership in-house to control and coordinate all the other responsibilities that a transplant authority could undertake to drive the action plan.

Responsibilities of the transplant authorities across Europe include "allocation of organs, registries of consent, audit of donor activity in hospitals, training of procurement teams, employments and training of organ donor coordinators for the intensive care setting, transplantation logistics, transplant coordination, press enquiries, organ donor awareness campaigns, donor cards etc"

So in summary - if the statutory instrument was rewritten establishing one transplant authority, the authority would then allocate the responsibilities across the agencies of the state including the quality and safety competencies of the EU Directive, but not exclusively, and it would embrace the EU action plan creating and driving the Irish Action Plan for Organ Donation and Transplantation.

The issue of consent for organ donation is not part of this debate - separately, Minister Reilly has a consultation process in place on the implementation of a 'soft' opt-out system of consent for organ donation.

(In an 'opt-out' system, unlike the current 'opt-in'  or informed consent system, a person's organs would be used after their death unless he or she specifically prohibits this. A soft opt-out system involves giving a good deal of weight to the views of the next of kin on donating the organs when a person dies and their organs may be available for donation under an opt-out system.)

The IKA will make a submission to the process on an opt-out system, although this process does not invite opinion as to whether soft-opt-out consent is a good idea or not. It only wants to seek submissions on how to implement the new consent system.

The IKA has argued against a policy of 'presumed consent' for organ donation.

It told the Oireachtas Health Committee earlier this year that the previous system of 'presumed consent' did not work in Spain, which improved its organ donation rates considerably only after organising and streamling the organ donation process; training and placing organ donor coordinators into hospitals nationally and establishing a single authority.

The unfortunate timing of the two separate subjects - the Seanad debate on the implementation of the EU Directive and the public consultation on consent simultaneously has well and truly confused the media and the public on both topics.

Philip Watt - Irish Donor Network:

While public awareness on organ donation and transplantation is always useful, such discourse needs to focus on the real issues if lives are to be saved.

The problem is not a rather dry but important EU directive regulating the quality and safety of human organs for which the Seanad has been recalled by Senator Mark Daly.

The real issue is not quality and safety (although we can never be complacent on these issues) but the rate of transplantation in Ireland, which falls far behind many of our European neighbours.

We are behind top performing donation and transplant countries because of our increasingly out-dated organ donor system, because of the lack of donor coordinators in our major ICU hospitals and because of the paucity of HSE resources for the National Organ Donation and Transplant Office headed by Professor Jim Egan.

The Irish Kidney Association contends it is opposed to the move to a soft opt-out form of organ donation and that 'soft opt-out has failed'.

By contrast, all the other patient groups in the Irish Donor Network (IDN) in Ireland are in favour of the move to soft opt out in combination with donor coordinators and a resourced transplant office.

These groups include Cystic Fibrosis Ireland; Alpha One Foundation; Irish Heart and Lung Association and the Irish Lung Fibrosis Association.

If soft opt out has 'failed' in other countries, why is it that the top performing countries in the Council of Europe area have such a system, including Spain, Croatia and Belgium? Ireland tends to be in mid-table mediocrity when it comes to European organ donation rates, when our ambition should be much higher.

In 2012, there were a total of 78 deceased donors in Ireland which resulted in 244 organs being retrieved. This equates to a donor rate of 17.03 per million population (PMP).  In comparison, Spain and Croatia have rates that are consistently higher than 30 PMP.

If soft opt out has 'failed' why is it that all the main patient groups in the UK, including the Kidney Federation, support soft opt out?

Why is it that the Welsh Assembly recently approved soft opt out by a massive majority and why is it that England and Northern Ireland and possibly Scotland are likely to soon follow suit?

The UK situation shows that even where a good transplant infrastructure exists, patient groups and government both recognise the value of an opt out system. In this context, donor coordinators and soft opt out go hand in hand.

The Irish government is wisely not proposing a hard opt-out model of organ donation for Ireland. Death is not just an event that impacts on the individual but on the whole family.

Soft opt-out assumes that everyone wants to donate, but if they don't, they can opt out, usually through an online system where they can express their decision.

Soft opt out provides the further protection that next of kin can veto organ donation.

This is much better than our present system, which relies on us carrying an organ donor card at all times and requires us to let our next of kin know our donation wishes in the event of a tragic accident. Unsurprisingly, under this system in 2008 it was estimated some 21% of potential organ donors were missed.

Soft opt-out is not a panacea for solving all our problems, but it will make a major impact.

It needs to be accompanied with the appointment of skilled hospital donor coordinators and a resourced national organ donation and transplant office.

This framework could catapult Ireland into the top five performing countries in Europe and make a huge difference for the 650 people desperately waiting for a lung, heart, kidney, liver or pancreas transplant in Ireland.

 

 


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