The response to the consultation on draft Quality and Safety of Organs for Transplantation Regulations 2012 is now available.
This replaces Directive 2010/53/EU on the standards of quality and safety of human organs intended for transplantation. The objective of the Directive is to set standards across the European Union and the UK is required to be compliant from 27 August 2012.
Over 400 key organisations and individuals in the transplantation sector were contacted to invite them to respond. A total of 37 responses were received.
An overwhelming majority of respondents rejected the proposed implementation approach. They saw little or no benefits from the UK implementing the Organ Directive. Respondents were concerned about cost burdens arising from implementation, and preferred current arrangements under NHS Blood and Transplant (NHSBT) and commissioners to continue. Respondents did not accept the need for a new competent authority and licensing regime to regulate organ transplants.
The response document summarises the comments received and sets out how the proposals are being taken forward. The Department has revised the approach set out in the consultation document and has proposed amending final implementation of the regulations as follows:
- organisations will have the freedom to make their own arrangements and identify how they will comply with the requirements of the Directive
- to avoid duplication the Human Tissue Authority (HTA) will now only require individuals to be competent and signpost requirements in their Directions allowing transplantation centres to rely on existing training programmes
- in recognition that the UK is already compliant with the Directive requirements there is no need to duplicate existing regulations by placing a requirement on the HTA to develop additional standards
- most of the criminal sanctions have been removed in relation to the final Regulations with the sole exception of operating without a licence. Other sanctions will now be regulatory whereby not providing documentation, or failing to allow access to premises, will incur a regulatory and not a criminal sanction
- there were concerns that licensees will have to pay the HTA for a licence as set out in the consultation-stage impact assessment. The Department has therefore agreed to increase HTA’s grant-in-aid for 2012-13 in order that it may subsidise licence fees for a transitional period