Northern Ireland Assembly
Thursday, 3 December, 2015

The Human Transplantation Bill was introduced into the Assembly on 13 October 2015. The Bill passed its Second Stage on 16 November 2015 and the Committee Stage commenced on 17 November 2015.

The Committee for Health, Social Services and Public Safety invited views/comments on the contents of the Bill.

Call for Evidence

The Human Transplantation Bill has 22 clauses:

Clause 1: Duty to promote transplantation

There are two broad duties on the Department for Health, Social Services and Public Safety. The first is to promote transplantation.  The second is to provide information about transplantation.  Then there is a specific duty to inform the public about deemed consent and the role of friends and family in affirming deemed consent.

Clause 2: Authorisation of transplantation duties

Clause 2 sets out the overall structure for the rest of the Bill. It states that transplantation activities are lawful only if there is consent. It also defines what is meant by a transplantation activity. The final part of Clause 2 applies in relation to material from outside Northern Ireland.

Clause 3: Express consent: adults

Clause 3 sets out the default position which will apply in most cases. It applies to most adults (Clause 5 applies to “excepted adults”).

Clause 4: Deemed consent: deceased adults

Clause 4 represents a change from the existing law.  If an adult has died and hasn’t made his or her views on transplantation known, then the person is deemed to have consented to transplantation. However, deemed consent is not effective unless it is affirmed by a “qualifying person” (defined in Clause 10 as a close relative or friend of long standing).

Clause 5:  Express consent: excepted adults

Clause 5 applies to two small subsets of deceased adults where express consent is required. The first subset is adults who haven’t lived in Northern Ireland for at least a year before they died.  The second subset is adults who for a significant period of time before dying didn’t have the capacity to understand the nature of deemed consent to organ donation.

Clause 6: Express consent: children

Clause 6 states that a child is never deemed to have consented to transplantation; it and gives the meaning of express consent in certain cases.

Clause 7: Express consent: transplantation activities involving excluded material

Clause 7 will only apply in unusual circumstances. It applies if the body part being transplanted is what is termed “excluded relevant material”. Consent will never be deemed for transplants involving excluded relevant material.  Express consent is required for both adults and children. Depending upon the circumstances, the express consent can be given by the person, an appointed representative, a parent or person in a qualifying relationship.

Clause 8: Deemed consent: activities involving material from living adults who lack capacity to consent

Clause 8 governs transplantations from the body of a living adult who lacks the capacity to consent to the transplantation. It only applies where there is no express consent decision in force. It allows for the Department to make regulations setting out the circumstances in which consent may be deemed.

Clause 9: Appointed representatives

Clause 9 provides that a person may appoint a representative to take a transplant decision on their behalf. The decisions of the representative will constitute express consent to transplantation activities. It sets out the procedure for making (and revoking) an appointment.

Clause 10: Qualifying relationships

Clause 10 sets out the meaning of qualifying relationship.

Clause 11: Offences

Clause 11 provides that it is an offence to carry out a transplantation activity if there is not the appropriate consent for it. There are defences to this, for example if the person reasonably believed that there was consent. It is also an offence to falsely represent that there is consent to transplantation, or that consent is not required.

Clause 12: Offences by bodies corporate

Clause 12 provides that organisations and groups can be guilty of offences under this Bill, not just individuals.

Clause 13: Prosecutions

Clause 13 provides that a person can only be prosecuted for an offence under this Bill if the Director of Public Prosecutions consents to the prosecution.

Clause 14: Annual report on transplantation

Clause 14 sets up a mechanism for post-legislative scrutiny. The Department must produce a report once a year on transplantation activities. The report must be given to the Assembly. Once every five years, the Department must report on whether this Bill is working, and on any potential ways in which the law could be amended to increase transplantations.

Clause 15: Preservation for transplantation

Clause 15 makes it lawful to keep the body of a deceased person (and preserve organs) whilst the issues of consent are being resolved. Once it is clear that there is no consent, it is no longer lawful to preserve the body. Preservation activity must be minimal and as un-invasive as possible.

Clause 16: Coroners

Clause 16 provides that coroners carrying out their jobs are exempt from the rules set out in this Bill. If a body is required by a coroner, the coroner must give consent before the body can be used for transplantation activities.

Clause 17: Relevant material

Clause 17 sets out the definition of material removed from the body for the purposes of transplantation.

Clause 18: Interpretation

Clause 18 defines various terms referred to in the Bill.

Clause 19: Orders and regulations

Clause 19 sets out the procedure for making subordinate legislation under the Bill. The subordinate legislation is subject to the draft affirmative procedure.

Clause 20: Consequential amendments to the Human Tissue Act 2004

Clause 20 and the Schedule make amendments to the Human Tissue Act 2004.

Clause 21: Commencement

Clause 21 provides that the duty to promote transplantation and the structural parts of this Bill come into operation 3 months after the Bill becomes an Act.  The rest of the Bill comes into operation on 31 May 2018.

Clause 22: Short title

Clause 22 specifies the name of the Bill.

Schedule – Consequential amendments to the Human Tissue Act 2004

The Schedule makes amendments to the Human Tissue Act 2004 which are consequent upon the making of this Bill.  These include amendments to the Codes of Practice that the Human Tissue Authority must prepare.

Any organisation or individual with an interest in this Bill is invited to submit evidence to the Committee by e-mail to: humantransplantation@niassembly.gov.uk or by post to:

The Committee Clerk, Room B32, Parliament Buildings, Ballymiscaw, Stormont, Belfast BT4 3XX.

The evidence must be structured to address the specific clauses of the Bill and, if appropriate, should include any amendments you wish to propose to the text.

Organisations or individuals responding to this call for evidence will wish to note that their submission (either in whole or part) will be published on the Committee website.

If you do not have access to the internet or e-mail facilities or you have any other enquiries, please contact the Committee Office on 028 9052 1920 or 028 9052 1841.