The Commission presented a 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.

The report is based on the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey) and 2014 (implementation of the voluntary and unpaid donation (VUD) principle) and follows up on the Commission communication published in January 2010 as well as the two reports on the application of the principle of VUD for tissues and cells issued in 2006 and 2011 .

Overall application of the Directives : this Report reveals an overall adequate application of the current quality and safety requirements of the EU tissues and cells legislation in most of the responding EU Member States and EEA countries.

Significant progress has been made in many areas, also through the active support by Commission funded projects and other initiatives:

since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of human tissue and cells for clinical application. These actions allowed for the development of guidelines and manuals in areas of common interest such as inspections and vigilance, included training courses for Member States Competent Authorities and their inspectors and brought together professionals in the tissue banking sector for the development of detailed technical guidance in line with the EU legal requirements; an additional support on training of tissue establishment personnel was given through EU-funded projects such as European Quality System for Tissue Banking (EQSTB) and European Good Tissue Practices (EuroGTPs). Good practices developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues and Cells; as regards the risk of transmission of communicable diseases thorough tissues and cells, the collaboration with ECDC proved extremely valuable. In addition to providing regular updates during the bi-annual meeting of the tissue and cell expert sub-group on the epidemiological situation relevant to the tissue and cell sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provided a valuable contribution to policy and decision making in this sector at both national and EU level; the Commission developed - in close cooperation with Member States - a Rapid Alert Platform for Tissues and Cells (RATC) which facilitates web-based communications between Member States in case of alerts relating to human tissues or cells transferred across borders

However, the report points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, requirements on the safety aspects regarding living donors, inspections framework), some of them owing to the different approaches taken by the Member States when transposing and implementing the current EU legislation and others due to the scientific and technologic developments since the adoption of the Directives.

Another important issue highlighted by some Member States was the need to foster harmonisation of the inspection practices in the Member States. Even though most of the Member States reported using the Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments, there is no common agreement on the classification of shortcomings identified during inspections (e.g. classification of minor, major and critical deficiencies).

The Commission will follow-up with Member States to address situations where the legislation might not have been fully or correctly implemented.

Voluntary and unpaid donation (VUD) principle : as regards the implementation of the VUD principle, the Commission survey showed that Member States overall comply with Article 12 of Directive 2004/23/EC requiring them to take the necessary measures to encourage VUD. However, Member States interpretation of what is considered compensation and incentive vary.

Only 17 Member States reported having guiding principles regarding the possibility to compensate tissue and cell donors, but in many cases these principles were just a description of the practices allowed at national level. An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.

In conclusion , the gaps and difficulties identified suggest that a further in-depth evaluation might be useful. The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2004/23/EC and its implementing Directives.

COM(2016)0223
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EUR-Lex
SWD(2016)0127

EUR-Lex
SWD(2016)0128

The Commission presents its Second Report on Voluntary and Unpaid Donation of Tissues and Cells in accordance with Directive 2004/23/EC . The report is based on the Members States' responses to a report template on voluntary and unpaid donation of tissues and cells. All Member States submitted a report to the Commission. In addition, Liechtenstein and Norway submitted a report (in total 29 reporting countries).

The report aims to provide an overview of the practice of voluntary and unpaid donation of tissues and cells, focusing on 1) legislative provisions, guidelines and policies; 2) compensation and incentives; 3) promotion and advertising, and 4) procurement and supply.

Compliance: the report shows that Member States overall comply with Article 12 of Directive 2004/23/EC, requiring Member States to take the necessary measures to endeavour to ensure voluntary and unpaid donations of tissues and cells. Largely in line with the findings of the first report on voluntary and unpaid donation of tissues and cells (issued in 2006), this report shows that legislative provisions and guidelines on voluntary and unpaid donation of tissues and cells are well established across the EU. 27 out of the 29 reporting countries have such legislative provisions or guidelines in place.

Compensation: 19 of the reporting countries have some form of compensation or incentive structures for donors of tissues and cells (excluding reproductive cells), such as reimbursement of travel and medical costs. For reproductive cells, about half of the countries provide some forms of compensation or incentives, including reimbursement of travel costs, refreshments and compensation linked to loss of earnings. In addition, four countries give some form of compensation or incentives to relatives of deceased donors.

Promotion: 19 countries have undertaken some form of measures to promote voluntary and unpaid donation of tissues and cells, such as awareness raising and information campaigns. In addition, 23 countries have restrictions or prohibitions on advertising the need for, or availability of, human tissues and cells with a view to offering or seeking financial gain or comparable advantage (in line with article 12 of Directive 2004/23/EC).

Procurement and supply of tissues and cells : the report shows that the majority of the countries have public collectors/suppliers or a dual system of public and private collectors/suppliers. With regards to supply, 11 countries report having policies in place to endeavour to promote self-sufficiency of tissues and cells, and 17 countries have bilateral or other forms of agreements/collaboration structures to ensure national supply of tissues and cells. However, almost half of the countries report some form of shortages of tissues and cells, including bone marrow and gametes.

As set out in Article 12 of Directive 2004/23/EC, the Commission shall inform the European Parliament and the Council of any necessary further measures it intends to take in the field of voluntary and unpaid donation of tissues and cells. Based on the findings of this report, the Commission will now, together with the Member States, reflect on the potential need for further measures, keeping in mind that the Commission's legal mandate is limited to quality and safety of tissues and cells.

COM(2011)0352
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The Commission presents its report on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Overall, the report states that the implementation of the Directives by the Member States is satisfactory. This concerns in particular the following:

the requirement to designate a competent authority or authorities and to establish accreditation/designation/authorisation/licensing systems of tissue establishments; pinspections systems; registries of tissue establishments; systems to report, investigate, register and transmit information about serious adverse events and reactions; and testing requirements.

The degree of implementation of some other measures suggests that further efforts and actions by Member States are needed. This concerns the following:

the development of specific systems for authorising the tissue and cell preparation process; finalisation of the accreditation/designation/authorisation/licensing process in respect of each individual establishment; the carrying out of inspections in all Member States; monitoring of imports/exports; fulfilment of the reporting requirements (tissue establishments' annual reports on activities, register of accredited/designated/authorised/licensed tissue establishments at the level of the Member States and at EU level -EUROCET-); preparation of annual reports on adverse events and reactions for the Commission.

The Commission is working with the Member States to help them develop operational solutions in response to the remaining challenges.

In July 2009 there were five infringement procedures open for failure to achieve full transposition of the Directives in two Member States.

The report also notes that some of the difficulties identified by Member States were linked to the implementation of testing requirements, in particular in the Medically Assisted Reproductive Technologies (MART) sector. The interpretation of the air quality standards that tissue establishments need to apply while tissues and cells are being processed is also a matter of concern among Member States. More guidance on coding systems, inspections, import/export and vigilance requirements was also sought by Member States. The report states that an efficient coding system is a crucial, but not exclusive, element in the traceability chain and ultimately in any vigilance system for human tissues and cells. The human tissue and cell chain is dependent on a robust codification system, which will secure the information flow from donation to transplantation and vice versa. The European coding system should ensure that the pre-existing traceability/coding systems can be maintained and further developed by the Member States, whilst ensuring a minimum level of compatibility between them.

The Commission is endeavouring to provide Member States and competent authorities with appropriate support in these areas.

COM(2009)0708
EUR-Lex

LEGISLATIVE ACT: Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

CONTENT: this Directive implements Directive 2004/23/EC, which calls for the establishment of specific technical requirements for each one of the steps in the human tissues and cells application process, including standards and specifications with regard to a quality system for tissue establishments. It establishes technical requirements for an accreditation, designation, authorisation or licensing system for tissue establishments and for the preparation processes at the tissue establishments in Member States.

The Directive applies to the coding, processing, preservation, storage and distribution of:

- human tissues and cells intended for human applications; and

- manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other directives. However, it does not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos).

The main points are as follows:

- requirements for the accreditation, designation, authorisation or licensing of tissue establishments are set out in Annex I. They cover the organisation and management, personnel, equipment and materials, facilities/premises, documentation and records and quality review;

- requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes are set out in Annex II, and include the air quality standard during the processing of tissues and cells;

- since the use of tissues and cells for human application carries a risk of disease transmission and other potential adverse effects in recipients, specific requirements for traceability and a Community procedure for notifying serious adverse reactions and events are set out;

- to facilitate traceability and information on the main characteristics and properties of tissues and cells, the Directive lays down the basic data to be included in a single European code.

Lastly, provisions of the Directive concerning traceability and the reporting of serious adverse reactions and events also apply to the donation, procurement and testing of human tissues and cells.

ENTRY INTO FORCE: 14/11/2006.

TRANSPOSITION: 01/09/2007. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 10 of the Directive (European coding system) by 1 September 2008.

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OJ L 294 25.10.2006, p. 0032-0050

This Report has been prepared in accordance with Article 12 of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells . It analyses measures taken by the Member States to ensure voluntary and unpaid donations. It covers the donation of tissues and cells from a general point of view and has been complemented, where appropriate, with the results of the report on reproductive cells.

The Report finds that although the principle of voluntary unpaid donation is recognised by the Member States, the concrete interpretation of this principle differs from one Member State to another. Most, namely 62.5% of all the EU Member States, allow some form of compensation to be offered to donors of tissues and cells. In cases where compensation is permitted compensation comes in the form of expenses only. Although the Directive permits compensation for “inconvenience” only one Member State does so. Largely because “inconvenience” can easily be misinterpreted as an incentive. It is more difficult to objectively quantify compensation for inconvenience than it is for expenses incurred.

As far as the actual amounts reimbursed are concerned the Commission confirms that it has received scant information from the Member States. The amount of compensation paid depends on individual circumstances, the number of times a donor has visited the hospital, the type of treatment needed, the effect of voluntary donation on an individual’s ability to work etc.

Different initiatives exist to promote the principle of voluntary unpaid donations. Techniques are diverse and include advertising, student information programmes and donor days. The promotional measures do not always cover the unpaid character of the donation focusing instead on the need to increase donation. Not all Member States have provisions in place that restrict or prohibit the advertising of tissues and cells for financial gain. Those restrictions that do exist vary.

Based on the above, the Commission proposes the following lines of action:

- The collection of more detailed information on the day-to-day practice of compensation at different hospitals or procurement organisation.

- Investigating the possibility of issuing guidelines on the principle of unpaid donation based on the information received. The guidelines would promote, for example, greater transparency regarding compensation for donation – specific mention of the amount paid or expenses reimbursed.

- Investigating the possibility of issuing guidelines on Article 12 (2) of the Directive and the need for appropriate restrictions/prohibitions on advertising for the financial gain of donating tissues or cells.

COM(2006)0593
EUR-Lex

ACT: Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

CONTENT: this Commission Directive relates to the establishment of specific technical requirements for each step in human tissue and cell application processes and implements Directive 2004/23. This is being done in order to avoid and minimise any adverse risks to human health. Risks can be reduced by careful donor selection, testing of each donation and the application of procedures to procure tissue and cells in accordance with rules and processes established and update according to best available scientific advice. Under the terms of the Directive, all tissues and cells, including those used as starting material for the manufacture of medicinal products to be used in the Community, must meet the safety requirements set out in this Directive.

There are special procedures governing reproductive cells, which due to their specific nature require certain unique requirements. For example, for the donation of reproductive cells between partners that have an intimate physical relationship, it is justified to require less stringent biological testing – given that in such a case the risk for the recipients is less than for donation from a third party. In order to minimise the risk of cross-contamination, biological testing of the donor will only become necessary in cases where the donated cells are processed, cultured or stored.

The Directive defines a number of related terms including, inter alia , reproductive cells, partner donation, direct use, quality system, standard operating procedures, validation or qualification, traceability and procurement organisation. The Directive states that, with the exception of partner donation of reproductive cells for direct use, Member States are obliged to ensure that the procurement of human tissues and cells is accredited, designated, authorised and licensed under certain strict criteria, the conditions of which are set out in the Directive. The provisions governing laboratory tests required of donors as well as the selection criteria of donor’s tissues and cells are set out in Annexes attached to the Directive. In additions Member State authorities are obliged to follow procurement procedures relating to tissue and/or cell donation that are compatible with requirements set out in Annex to the Directive. The authorities may authorise the direct distribution of specific tissues and cells, from where the procurement is carried out, to a health care establishment for immediate transplantation.

TRANSPOSITION: 1 November 2006.

ENTRY INTO FORCE: 1 March 2006.

32006L0017
OJ L 038 09.02.2006, p. 0040-0052

Directive 2004/23
OJ L 102 07.04.2004, p. 0048-0058

COM(2004)0080
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T5-0570/2003
OJ C 091 15.04.2004, p. 0029-0090 E

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Debate in Parliament

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SEC(2003)0906
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10133/3/2003
OJ C 240 07.10.2003, p. 0012-0024 E

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COM(2003)0340
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T5-0182/2003
OJ C 064 12.03.2004, p. 0391-0505 E

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OJ C 085 08.04.2003, p. 0044-0050

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COM(2002)0319
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OJ C 227 24.09.2002, p. 0505 E

COM(2002)0319
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