274. Deputy Mattie McGrath asked the Minister for Justice and Equality to respond to concerns (details supplied) about the Assisted Decision-Making (Capacity) Bill 2013; and if she will make a statement on the matter. [3128/16]


Minister for Justice and Equality (Deputy Frances Fitzgerald): The Assisted Decision-Making (Capacity) Act 2015 enshrines a series of robust protections for those who lack decision-making capacity and has introduced significant reforms that will assist in enabling Ireland to ratify the UN Convention on the Rights of Persons with Disabilities. The Act has been specifically devised to safeguard the rights of persons with capacity difficulties, including as regards their bodily integrity.
With regard to the specific matters raised by the Deputy, these are policy matters for the Department of Health who have provided me with the following responses:
"On the issue of organ donation, section 4(3)(a) of the Act clarifies that any decision about the donation of organs from living donors who lack capacity will be determined by the High Court. Entrusting such matters to the High Court provides protection to potentially vulnerable people who are not in a position to make the decision about living organ donation for themselves.
On the issue of the withdrawal of life-sustaining treatment, the wording of section 4(3)(b) clarifies that where an application is made to the courts in the context of a dispute or where legal clarity is required about a decision to withdraw life-sustaining treatment, then that case will be heard in the High Court.
On the issues raised regarding the definition of basic care, for the purposes of this Act, basic care includes (but is not limited to) warmth, shelter, oral nutrition, oral hydration and hygiene measures, but does not include artificial nutrition or artificial hydration. An advance healthcare directive refusing basic care would not be applicable and would not be upheld.
The legislative framework for advance healthcare directives outlined in the Act does not in any way pertain to euthanasia or assisted suicide. The provisions for advance healthcare directives do not affect the existing law in Ireland relation to murder or manslaughter or the operation of section 2 of the Criminal Law (Suicide) Act (1993).
With regard to the Deputy's query concerning clinical trials, there is an international consensus in relation to the participation of people who lack capacity in clinical research (including clinical trials). While it is essential that such vulnerable individuals are appropriately protected, it is deemed ethically problematic to unnecessarily exclude such categories of people from research that could potentially benefit them or others suffering from the same illness.
Clinical research involving people who lack capacity is covered by both national and international instruments, including the HSE's National Consent Policy. On the issue of clinical trials, the EC (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (SI No. 190 of 2004) (as amended) provides an extensive framework to protect all those participating in clinical trials, which includes people who lack capacity. In addition, the Clinical Trials Regulation (Regulation (EU) No 536/2014), which is due to come into force in 2016, also contains extensive provision relating to the protection of people lacking capacity."