DONATION OF TISSUES AND CELLS (14120/06)
Letter from Rt Hon Rosie Winterton MP,
Minister of State for Health Services, Department of Health to
the Chairman
I am writing to let you know about the publication
of the above document. An Explanatory Memorandum is attached (not
printed).
BACKGROUND
On 17 October 2006, the Council of the European
Union published a report from the Commission on the promotion
by Member States of voluntary unpaid donation of tissues and cells.
It is a requirement of Article 12 of Directive
2004/23/EC—a Directive setting standards for the safety
and quality of all human tissues and cells (but not blood or organs)
intended for or used in all human applications—that Member
States shall endeavour to ensure voluntary and unpaid donations
of tissues and cells and shall report to the Commission on these
measures before April 2006 and thereafter every three years. On
the basis of these reports, the Commission shall inform the European
Parliament and the Council of any necessary further measures it
intends to take at community level.
RESPONSE FROM
THE UK
The UK responded to a questionnaire circulated
by the Commission earlier this year, outling the measures taken
in the UK to ensure voluntary unpaid donation and the legislation
in place to restrict organ, tissue and cell trafficking. The attached
Report from the Commission includes the UK response (not printed).
In summary, organ, tissue and cell trafficking are offences under
the Human Tissue Act 2004 and Human Fertilisation and Embryology
Act 1990 but both Acts do allow for the reimbursement of out of
pocket expenses. In the UK, reimbursement for tissue and cell
donation is likely to be exceptional, for example meeting travelling
expenses for the donation of bone marrow and donors of eggs and
sperm can claim "reasonable expenses" which are capped.
IMPLICATIONS OF
THE REPORT
The Report's Action Plan proposes that Member
States collect detailed information on the day to day practice
of compensation which can then be shared with the Commission.
Based on that information the Commission would explore with the
Member State the need for further guidelines, greater transparency
or the need to document the expenses reimbursed. In the UK, there
is clear legislation to prevent such trafficking and no evidence
to suppose that trafficking takes place.
COMMISSION DIRECTIVE
2006/86/EC
The Committee may also wish to be aware that
on 24 October 2006, Commission Directive 2006/86/EC was published
in the Official Journal of the European Union. This Directive
is the second of two Commission Directives containing the technical
detail necessary to help implement parent Directive 2004/23/EC
to ensure the quality and safety of human tissue for human application.
We have worked hard with officials in the Devolved
Administrations and stakeholders within the regulated sectors
to ensure that the detail of this Directive meets our needs and
does not impose additional costs on tissue establishments without
sufficient evidence of benefit. For example, we have been able
to resist the introduction of an across the board requirement
for all laboratories to have Grade A (sterile) air quality standards.
UK stakeholders have indicated that they are generally happy with
the content, considering that it does not impose any unreasonable
or unjustifiable burdens.
SCRUTINY HISTORY
The European Commission first published its
proposal for Directive 2004/23/EC in June 2002 (COM (2002) 319
final). An accompanying Explanatory Memorandum and Initial Regulatory
Impact Assessment were provided by the Department of Health on
8 July 2002. They were cleared by the House of Commons and House
of Lords European Scrutiny Committees on 16 October and 30 October
2002 respectively.
The Department of Health wrote again on 19 May
2003 informing the Joint Parliamentary European Scrutiny Committees
of the results of First Reading. An Explanatory Memorandum was
sent on 13 June 2003 informing the Committees of the political
agreement reached at the June Health Council. The House of Lords
cleared scrutiny on 17 June 2003 but the House of Commons noted
that in light of the significant additional costs that could arise
as a result of the inclusion of mature gametes within the scope
of the draft Directive, that they would hold the document under
scrutiny pending receipt of a further Regulatory Impact Assessment.
In light of concerns express by the European
Scrutiny Committee in July, Ministers wrote on 2 October 2003
outlining the current status of the Directive and enclosing a
revised Regulatory Impact Assessment, the implications of which
were debated in the House of Commons on 12 November when scrutiny
was cleared. On 28 January 2004, we wrote to inform you that the
Directive had completed its Second Reading in the European Parliament
and in April 2004 that the Directive have been adopted by Health
Council. I wrote again on 28 June this year to update you on progress
in implementing the Directive and the likely costs.
8 November 2006
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