Documents considered by the Committee on 25 May 2016 Contents

5Blood and Human Tissues Directives

Committee’s assessment

Politically important

Committee’s decision

Not cleared from scrutiny; further information requested; drawn to the attention of the Health Committee

Document details

(a) Commission Report on the implementation of Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components; (b) Commission Report on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells

Legal base

Department

Health

Document Numbers

(a) (37709), 8235/16 + ADDs 1–2, COM(16) 224;

(b) (37738), 8233/16 + ADDs 1–2, COM(16) 223

Summary and Committee’s conclusions

5.1Blood and tissue donation saves lives, but donated tissue must be safe, and, where living donors are involved, collected safely. The EU has adopted frameworks which set standards of quality and safety for both blood and blood products and for human tissues and cells. These are designed to boost confidence in donation throughout the EU and to facilitate cross-border donation where appropriate. In both instances, the Commission identifies some gaps and difficulties in relation to application and enforcement of the existing provisions. The Commission will pursue these issues with individual Member States and will consider the need for a further in-depth evaluation in order to assess the relevance, effectiveness, efficiency, coherence and added value of the Directives.

5.2The Parliamentary Under-Secretary of State for Public Health, Jane Ellison, indicates that the UK is compliant with both Directives. While she makes little comment on the policy implications of the blood and blood products Report (document (a)), she observes in relation to the tissues and cells Report (document (b)) that there must be confidence “that tissues and cells imported into the UK from other EU countries have been procured or collected to the same high quality and safe standards implemented and regulated within the UK”.

5.3We agree with the Minister that UK regulators, clinicians and patients must be confident in the quality of tissues and cells imported into the UK. This we would also apply to any blood and blood products that are imported. We would ask that the Minister give us some indication of the amounts of blood, blood products, tissues and cells that are imported into, and exported from, the UK. We would also ask that the Minister indicate which of the implementation issues highlighted by the Commission cause the Government the greatest concern.

5.4We note that, in both instances, the Commission is considering “a further in-depth evaluation in order to assess the relevance, effectiveness, efficiency, coherence and added value” of the Directives. It is unusual for there to be such further evaluation, and the inclusion of “added value” is similarly unusual. Does the Government agree this evaluation is necessary?

5.5While the Government appears to be largely content with the analyses provided by the Commission, we consider that they raise issues of political importance which we accordingly drawn to the attention of the House. Noting that the Commission is contemplating an in-depth evaluation of the Directives, which could lead to legislative change with implications for the UK health sector, we draw the Reports to the attention of the Health Committee.

5.6We retain both documents under scrutiny and look forward to a response to our queries by 30 June.

Full details of the documents

(a) Commission Report on the implementation of Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components: (37709), 8235/16 + ADDs 1–2, COM(16) 224; (b) Commission Report on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells: (37738), 8233/16 + ADDs 1–2, COM(16) 223.

Background and Content

The blood and blood products Directives

5.7The European Commission reports on Member States’ implementation of EU blood safety and quality legislation—in force since 2002—and on their efforts to encourage voluntary and unpaid blood donations.

5.8The Report finds that legislation has been transposed in all but one of the Member States. Overall, the Commission concludes, there is “adequate” implementation of EU blood legislation but there are some gaps and difficulties. These relate to the application and enforcement of existing provisions and result from either technological advances or different approaches to implementation taken by Member States. The Commission notes that Member States take the necessary measures to encourage voluntary and unpaid blood donations.

5.9The Commission will consider the need for a further in-depth evaluation in order to assess the relevance, effectiveness, efficiency, coherence and added value of the Directives.

The tissues and cells Directives

5.10The Report details Member States’ implementation of the EU Directives—in force since 2004—designed to ensure high quality and safe practice in the way that tissues and cells, such as bone, skin, corneas, heart valves etc. as well as stem cells, gametes (sperm and eggs) and embryos, are donated, procured, tested, stored, processed and distributed. The Commission also reports on Member States’ application of the principle of voluntary and unpaid donation.

5.11In summary, the Commission concludes that there is an “adequate” application of the quality and safety requirements of the tissues and cells legislation in most EU Member States and EEA countries.

5.12Some gaps and difficulties are identified in relation to the application and enforcement of the existing provisions across the EU, such as: a difference in the interpretation of definitions; variation in national requirements on the safety aspects regarding living donors; and the way that inspections are carried out. The Commission believes that some of this could stem from the different approaches taken by the Member States when transposing and implementing the current EU legislation and others due to the scientific and technological developments since the adoption of the Directives. The Commission intends to follow this up with individual Member States, to identify where the legislation might not have been fully or correctly implemented.

5.13As regards the implementation of the voluntary and unpaid donation principle, the Commission reports that Member States are taking the necessary measures to encourage the voluntary and unpaid donation of tissues and cells. However, again, Member States’ interpretation of what is considered compensation and incentive does vary. For example, in the reimbursement of funeral costs, some Member States may cover some or all of the costs, where in the UK funeral costs would not be met. The Commission has also indicated that it will follow this up with Member States to be clearer in respect of how much, and when, compensation is paid for donation and to whom.

Explanatory Memoranda

Report on the implementation of the blood and blood products Directives

5.14In her EM of 11 May 2016,50 the Minister indicates that no policy implications arise from the Report. She sets out the Government’s position in the following terms:

“The four UK blood services (NHS Blood and Transplant, Scottish National Blood Transfusion Service, Welsh Blood Service and the Northern Ireland Blood Transfusion Service) have implemented the EU Blood Directives and are compliant. They also operate on the basis whereby blood is collected on a voluntary, unpaid basis. Refreshments are provided by each of the UK blood services to replace fluid and sugars. The UK blood services remain committed to the principle of voluntary unpaid donation. Although the UK blood services do not have a written policy on self-sufficiency, they do actively manage stock levels to maintain self-sufficiency and avoid shortages. The Report finds that the UK is fully compliant with the Directive.”

Report on the implementation of the tissues and cells Directives

5.15In her EM of 9 May 2016,51 the Minister observes the Commission’s recognition that the UK is compliant with the EU obligations. She explains:

“The three tissues and cells Directives were implemented into UK law on 5 July 2007, through the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. The main benefits of the Directives have been the identification of all tissue and cell retrieval in the UK; the standardisation of testing; the licensing of tissue and cell storage and distribution and robust traceability of the complete pathway from donor to recipient. The legislation has also put in place arrangements for the reporting of serious adverse events and reactions which has enabled learning to be shared across the EU.”

5.16The Minister adds a note of caution:

“The HTA [Human Tissues Authority] and HFEA [Human Fertilisation and Embryology Authority]—the UK’s two competent authorities—clinicians and patients must be confident that tissues and cells imported into the UK from other EU countries have been procured or collected to the same high quality and safe standards implemented and regulated within the UK. Therefore the UK would welcome further evaluation by the Commission to identify differences in approach or where the full requirements of the legislation have not been implemented.

“Similarly the UK notes the further work planned by the Commission to help clarify how and what is acceptable as compensation or reimbursement.”

5.17On voluntary, unpaid donation, the Minister says:

“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. Remuneration of gamete donors is regulated by the Human Fertilisation & Embryology Act 1990. It is a general condition of every licence granted by the HFEA that no money or other benefits can be given to donors unless it authorised by Directions made by the Authority. Currently, licensed clinics may compensate sperm donors a fixed sum of up to £35 per clinic visit. Egg donors may be compensated by a fixed sum of up to £750 per cycle of donation. Directions also allow for “egg sharing” arrangements, where a woman undergoing treatment agrees to release some of her eggs for the treatment of other women in return for a reduction on the cost of privately funded treatment.

“The UK is aware that the remuneration of donation in other EU member states may be less closely regulated and would be happy to work with the Commission to establish or develop clarification.”

Previous Committee Reports

None.


50 Explanatory Memorandum submitted by Jane Ellison, 11 May 2016.

51 Explanatory Memorandum submitted by Jane Ellison, 9 May 2016.




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1 June 2016