WIREDGOV

Tissue authority to set EU transplant standards

News Release issued by the COI News Distribution Service on 10 March 2011

The Human Tissue Authority (HTA) has been selected as the body that will set standards for the quality and safety of transplant organs across the EU, the Department of Health said today.

The Authority has been named as the competent organisation for England and Wales for the EU Organ Directive and will take the lead on developing a regulatory framework and implementation into legislation by August 2012.

It is the first time a formal regulatory framework has been developed for the donation and transplant of organs. The aim is to standardise the systems and processes used by member states. It will also help facilitate the more effective exchange of organs between member states in the small number of occasions where this is necessary.

The ultimate goal is to ensure common high quality and safe standards for the donation, procurement, transportation, traceability and follow up of donated organs for transplant across the EU.

The Department of Health will work with the HTA, other health administrations, NHS Blood and Transplant and transplant community to:

create an overall framework that will ensure the all organisations involved in organ donation and transplantation comply with the Directive;develop a system to license procurement and transplantation; confirm arrangements for reporting serious adverse events and reactions;issue guidance to healthcare providers involved in all stages of the transplant chain; andsupervise organ exchange with other member states.

The Department of Health considered a number of possible organisations but the HTA was chosen because it best demonstrates the necessary expertise and has established a reputation in ensuring that its regulation is proportionate, effective and efficient. It already regulates the procurement, storage and transport of tissue and cells under the Human Tissue Act of 2004 and is responsible for licensing all tissue establishments.

Public Health Minister Anne Milton said:

“Being an organ donor is a truly selfless act and is the ultimate gift anyone can give. Our duty is to ensure it is done as safely as possible.

“I am pleased the HTA has agreed to carry out this important role. Organ transplantation in this country has an excellent safety record and can transform a patient's life. The HTA are extremely well placed to build on the successful system we have already to make sure the standards for quality and safety are upheld."

Commenting on the appointment Craig Muir the Chief Executive of the Human Tissue Authority said:

“We are very pleased to have been chosen as the Competent Authority for the EU Organ Donation Directive. The Directive will improve the quality and safety of organs to be transplanted into patients across Europe, which will benefit UK citizens.

“We look forward to engaging stakeholders and working with DH and the EU to ensure that regulations are proportionate and meet the required standards.”

Notes to Editors

1. For further information please contact the DH newsdesk on 020 7210 5221
2. We need to be compliant with the EU Directive 2010/53 EU by August 2012
3. A full copy of the EU Directive can be found here:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:207:0014:0029:EN:PDF
4. The number of organ donations and transplantations has grown steadily across the EU and thousands of lives are saved every year through this medical procedure. Organ transplantation is now the most cost-effective treatment for end-stage renal failure
5. Currently, there are wide variations in quality and safety requirements between Member States. A Directive is needed to ensure a high level of health protection throughout the EU by establishing common standards of quality and safety of human organs intended for transplantation and for those exchanged between EU countries each year.
6. With the interests of the public and those it regulates at the centre its work, the HTA aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent. The HTA regulates organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. It also gives approval for organ and bone marrow donations from living people.

Contacts:

Department of Health
Phone: 020 7210 5221
NDS.DH@coi.gsi.gov.uk