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