Human Transplantation Bill

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Plans to change the rules on organ donation in Wales moved a step closer with the publication of the Human Transplantation (Wales) Bill on 3 December 2012. Welsh Assembly Ministers tabled the Bill to introduce a "soft opt-out" system for consent to deceased organ and tissue donation in Wales, under which consent to donation will be deemed to have been given unless an individual objects during his or her lifetime. If the Bill is passed by the Welsh assembly it could come into force by 2015. 

Deemed and express consent

The Bill sets out the legal framework for how consent for the donation of organs and tissues for transplantation will be given in Wales.  It sets out two types of legal consent to the donation of organs and tissues in Wales:  express consent and deemed consent.

People over the age of 18 who have lived in Wales for 6 months or more and die in Wales, will be deemed to have given their consent to donation, unless they have stated that they did not wish to be a donor, i.e. that they have opted out. 

For everyone else who dies in Wales, express consent to donation will still have to be given to the donation of their organs and tissue.  Therefore children, people who lack capacity, people who do not live in Wales or have not lived in Wales for 6 months or more will still have to give their express consent to donation, either themselves during their lifetime or by their next of kin. 

The Bill introduces a Welsh register and individuals will be able to record whether they agree to their organs being donated or not.  When an adult Welsh resident who had the capacity to consent dies in Wales, and had registered either a wish to be considered as an organ donor, or their wish not to be an organ donor, this will be acted upon. 


Whilst many welcome the Bill and sees it as an effective way to increase the number of organ donors in Wales as well as increasing awareness about organ donation, others have urged the government to take steps to ensure that concerns and risks identified are managed and addressed prior to the implementation of the Bill.

The role of families

Concerns have been raised about what role families will play in this new system.  The Bill emphasises that families will continue to play a part in the process.  Families will not have the right to veto the donation if there is an express consent or deemed consent in place, but if they are able to provide evidence that would satisfy a reasonable person that the deceased did not wish to be a donor, this will be accepted and donation will not go ahead.  Clinical teams will have a duty of care towards the surviving relatives and if there are very strong objections or distress, then organ donation is unlikely to go ahead. The intention, therefore, is that families will still have an important role to play in the process. Many have welcomed this particular aspect and view it as a key safeguard in the Bill. 


The Welsh Government commissioned a survey to understand the attitudes of people in Wales to organ donation and to the proposed bill.  The survey suggests almost half of the Welsh public (49%) supports a change. However, 21% of those surveyed stated that they needed more information to decide.  This highlights a key area of challenge for the Welsh Government if it is to effectively implement and operate the new system.

Communication with Welsh residents about the new system will be vital to ensuring the system operates successfully.  At the heart of the proposals is the concept of deemed consent.  In order for an individual’s decision to remain paramount, they must be aware of the action they are required to take, if any, to make their views known.

Campaigners have urged the Welsh Government to put in place an effective communication strategy to ensure that every person living in Wales is aware of the system and how it affects them.   The Government views the ability for individuals to opt-out this as a key safeguard to concerns about eroding an individual’s ability to consent.  For this to be an effective system which relies on an individuals’ ability to opt out, it must ensure that individuals are aware of their rights in this respect and have capacity to exercise these rights. Particularly important will be ensuring that young people approaching their eighteenth birthday are provided with sufficient important to enable them to make an active decision prior to deemed consent applying to them.  Healthcare workers and GPs will play a pivotal role in this communication campaign. 


The Bill introduces a new system of organ donation for Welsh residents and a Welsh register.  The system in operation in England will be unaffected by the proposals in Wales.  This means that two distinct systems and two registers will be in operation. This will undoubtedly create challenges where Welsh residents, registered on the Welsh register, die in England.  Campaigners have urged the Welsh Government to investigate potential challenges prior to the implementation of the Bill to ensure that the NHS England works collaboratively with the NHS Wales to ensure that information about Welsh resident’s views can be accurately ascertained and shared , particularly in emergency situations.

Data protection

The Information Commissioner’s response to the Bill has emphasised the importance of providing members of the public with adequate information about who will be holding their data on the register, how it will be held and what will happen to it. This is particularly important when sensitive personal data is collected on the register, such as information about a person’s ethnic origin or their religious beliefs.  The Information Commissioner has also advised that along with an explanation as to how residents’ personal data will be used, they should also be advised of any third party that may be involved in processing their data, such as NHS Blood and Transplant.  The Information Commissioner has urged the Welsh Government to give due to consideration to such issues and ensure that relevant safeguards are in place to protect Welsh residents’ personal data prior to the implementation of the Bill.

The future

The Bill is at stage one of the four-stage process for the consideration of a Public Bill in Wales.  The Bill will now be considered by a committee and once the committee has reported on the Bill the Assembly will debate and decide whether to agree the general principles of the Bill.  

The Welsh Government is clearly committed to the introduction of a soft opt-out system for organ donation inWales and is hopeful that the Bill will be approved by the Assembly with both Plaid Cymru and the Liberal Democrats expected to support the Bill.  Those who oppose the Bill, however, hope that the Assembly closely scrutinises the Bill before it is passed to ensure that their concerns are managed and addressed.  At present therefore it remains to be seen what the form the final Bill will take, however, it is clear that Wales is likely to see significant changes to its organ donation and tissues for transplantation system in the not to distant future.