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Organ donation has been in the news recently with the Prime Minister announcing in the Sunday Telegraph that he wants to “start a debate on the presumed consent” approach to donations.
This summer, a separate report will look into moving the NHS Organ Donor Register, a core product of Connecting for Health, into a compulsory system where all patients will have their details uploaded as a donor unless individuals request to opt out of the national register, or family members object.
At the moment the national Organ Donor Register is an optional system reliant on donors registering before their details are added onto the system by UK Transplant. There are currently nearly 15m people – almost 25% of the population – on the register.
So in order to make such a change, what are the IT requirements and issues that will need to be considered?
What will the main differences be as a result of the change?
Last summer NHS chief medical officer Sir Liam Donaldson, called for a change, saying that after death people should automatically have their organs removed for transplant, unless they opted out while alive.
The Prime Minister now agrees, telling the Sunday Telegraph Britain should move to a new consent model, to boost numbers on the donor register.
“A different consent system, more like the one used in Spain, could serve to increase donation levels significantly. Of course, any opt-out system would – in cases where the potential donor is not on the register – leave the final decision with the family: that is only right and proper.”
Currently, the NHS Organ Donor Register is a confidential, computerised database operated and maintained by UK Transplant – a Special Health Authority within the NHS with a UK-wide remit. Anyone who registers has their details uploaded to the system containing the name, date of birth, sex and address of each potential donor and the organs they are willing to donate.
Moving to the Spanish model would involve a ‘soft’ opt-out mechanism. The Director of the National Transplant organisation in Spain, Dr Rafael Matesanz, told E-Health Insider: “Even if the person hasn’t themselves opted-out of donation, the views of relatives are sought and they can refuse consent. About 20 to 24% of relatives refuse, but the majority who don’t makes a huge difference.”
Like Spain, the British government wants to move the national database to a system containing details of all patients, with the onus on them or their families to opt-out from organ donation. Dedicated organ donation coordinators will be in place at every NHS trust to check if a patient has given permission or not, and only they will have access to the NHS Organ Donor Register.
Who will have responsibility for the database and data protection?
New measures recommended by the government taskforce included the recruitment of around 100 extra donor transplant coordinators to work with hospitals and guide and support bereaved families through the donation process – employed centrally by NHS Blood and Transplant.
Should the government accept this recommendation, and go down the Spanish route, then these coordinators would be able to access the system in hospitals to see if the patient has opted out or not.
A DH spokesperson told EHI: “The dedicated subgroup will be considering the implications for clinical practice of different consent systems. Professionals from many disciplines may be involved in dealing with consent or dealing with dying patients or their families, including donation specialists, intensive care specialists, nurses, palliative care specialists and bereavement staff.”
A UK transplant spokesperson added that they would expect to have tight security in place with any new system, in the same way as the current system does: “We can categorically state that no-one who is applying to add, amend or withdraw a registration has direct access to that database. We make every effort to ensure the accuracy of the information submitted to the register and a number of checks are built into the registration system for this purpose.
“All requests to withdraw entries from the register are acknowledged by letter and we send a letter of confirmation to every new applicant who submits an on-line registration. The register exists specifically for people to record their wishes but it is important that they also discuss these wishes with their relatives.”
What will Connecting for Health have to do?
The government’s taskforce will advise on what systems and infrastructures would need to be put in place to support different consent systems.
As a core system of CfH, the agency has already been playing a key part in ensuring the information is electronically transmitted to those who need it, including forwarding information electronically to the United Kingdom Transplant Support Services Authority, (UK TSSA), using UN EDIFACT (United Nations Electronic Data Interchange For Administration, Commerce and Transportation) and enabling electronic transfer of details between GP practice systems and the health authority Organ Donor Register System.
Currently, CfH says that patients are able to express their organ donation preferences using HealthSpace, and part of the scope of the review underway by the government taskforce will look into how a new ‘presumed consent’ model may be interfaced with systems under the National Programme for IT.
What legislation will need to be considered?
Under Part 1 of the Human Tissue Act 2004, it is unlawful to remove, store, or use human organs and other tissue for scheduled purposes without appropriate consent.
The DH says that it has instructed its taskforce to consider whether the presumed consent model will fall into the appropriate consent definition. The group will also be looking at the interaction with other legislation such as the Human Rights Act 1998 and the Mental Capacity Act 2005.
What are the arguments for and against presumed consent?
The BMA supports the call for a switch in the system. A BMA poll found 64% of respondents would support a soft system of presumed consent.
A spokesperson told EHI: “The BMA supports the introduction of a carefully planned system of presumed consent. Moving to a system that presumes consent, rather than presumes objection (as currently occurs), would not only increase organ donation rates, but it would also be more likely that the wishes of the deceased person would be respected.
“The BMA believes that a full and open debate must occur before any changes are made in this complex and sensitive area. In addition, if presumed consent is adopted, it is vital that a high profile publicity campaign is carried out before presumed consent comes into force so that patients are fully informed about their rights under the new system.”
However, patient groups have said the decision should be totally up to the individual, and not made for them by the government.
Joyce Robin of Patient Concern, said: “They call it consent, but it isn’t consent at all. They are relying on inertia and ignorance to get the results they want.”
Katherine Murphy, of the Patients Association charity, told EHI: “We don’t think a private decision, which is a matter of individual conscience, should be taken by the state. It is dangerous to presume patients’ wishes at a time when difficult decisions need to be made immediately. It is not always possible to contact a next of kin in time so we must not take for granted that presumed consent for all is the answer.”
If you would like to add your name to the Organ Donation Register, phone 0845 60 60 400 or go to www.uktransplant.org.uk.
Joe Fernandez