Understanding the Human Transplantation (Wales) Act 2013

1. Human Transplantation (Wales) Act 2013. How it works in clinical practice

2. Human Transplantation (Wales) Act 2013 Human Transplantation (Wales) Bill received Royal Assent September 2013 Sets out how consent is to be given in Wales to the donation of organs and tissues for transplantation. Believe a change in law to a soft opt out will result in a 25-30 % increase in organ donations or 15 additional donors. Will be effective from 1st December 2015

3. Creation of 2 types of legal consent from 1 December 2015 Express consent Yes I want to donate my organs No I don’t want to be an organ donor Appoint/ nominate a representative Deemed consent (opt out system/presumed consent) Unless a person has taken the deliberate step of recording they do not want to be an organ donor after death, then they will be regarded as having no objection to organ donation and their consent will be deemed to have been given.

4. Deemed consent will apply to Adults: • Over the age of 18 • Who have lived in Wales for 12 calendar months ormore and are ordinarily resident in Wales in a voluntary capacity • Who have not expressed or recorded a decision • Who also diein Wales

5. Deemed consent will NOT apply to people…. Visitors to Wales Have lived in Wales <12 months or who are not ‘ordinarily residents’ Who lack capacity to understand the notion of deemed consent < 18 years of age

6. Or people who have…. Novel Transplants Welsh residents who die elsewhere Not what he wanted No Appointed a representative to make a decision regarding donation on their behalf No Opted In or Out Family or friends that object because they know the deceased would not have consented Join the Organ Donor Register 0300 123 23 23

7. Making an approach that reflects the patients decision and Welsh Legislation

8. ODR Registration Appointed Representative to make decision Do want to be a donor Do Not want to be a donor No registration on the ODR

9. ODR Registration Yes- I Do want to be a donor Core Elements of Approach • Presumptive approach empathising honouring • patient’s decision. • Establish whether this was the patients last known decision • Avoid any suggestion that the families permission is also required. • Objective is to describe what will be required for patient’s • decision to donate to be fulfilled. • Ultimate aim is to encourage the family to accept patient’s • donation decision to want to save lives through transplantation

10. ODR Registration NO - I Do Not want to be a donor Core Elements of Approach • Share recorded ODR decision with family. • Establish whether this was the patients last known • decision • If family offer information that patient wanted to donate either • written or verbal (witnessed) check what evidence exists to support • this and if it is more recent then the ODR registration • If more recent and evidence is reasonable then the ODR Registration • could be overturned.

11. ODR Registration Name/s & contact details of individual/s whom patient has appointed will be recorded on ODR Appointed Representative • Frame the approach that the patient had made and recorded a • decision for an Appointed Representative to make a decision • about donation on their behalf (Due to data protection • the identity of the Appointed Rep cannot be disclosed without • seeking permission from them first) Core Elements of Approach

12. Sequence of obtaining consent when patient is Not on the ODR 1 Establish with family/friends whether first person consent exists i.e. had the patient made a decision in regard to organ donation? 2 Establish with family whether the patient nominated/appointed a representative to make a decision about donation on their behalf 3 In Wales - establish if patient fulfils criteria to apply deemed consent If not 4 Family consent/authorisation from person in highest qualifying relationship If not If not applicable

13. Establish with family/friends whether first person consent exists i.e. had the patient made a decision in regard to organ donation? I am now going to talk to you about the unique position ... ...go on to save lives and transform the life of somebody through O.D ...ever talked to you about O.D at any time Yes No

14. Establish with family whether the patient nominated/appointed a representative to make a decision about donation on their behalf Checked ODR, has registered a decision Appointed a representative That's someone to make the Decision about becoming an organ Donor on his behalf Not registered on the ODR Some people ask a friend not Necessarily immediate NOK To make this decision on their behalf Do you know of anybody else s/he may have discussed organ donation with

15. In Wales - establish if patient fulfils criteria to apply deemed consent,no knowledge of the Law Ever talked to you about organ donation at any time? The Law in Wales does not make organ donation compulsory Made it easier for those who want to donate The Law encourages people to think about what they would like to do, register or share their decision

16. In Wales - establish if patient fulfils criteria to apply deemed consent, knows about the Law Ever talked to you about organ donation at any time? It is really important for me to ask You a few questions

18. Family consent from person in highest qualifying relationship If consent cannot be deemed consent must be sought from a person in a qualifying relationship This is how consent is obtained under the HTA 2004, the only difference is that the donation conversation has established the patient had not made a decision in life and consent cannot be deemed

19. Implications for the UK • Welsh resident dying outside of Wales • HTA 2004 or HTA (Scotland) 2006 • Need to check donor register (opt in, opt out or appointed rep decision) • Deemed consent will not apply outside of Wales (though a presumptive approach could be made) • Non-Welsh resident dying in Wales • They fail the 3-stage residency test • Current rules and approach apply • Will be able to opt out for the first time and appoint a representative