The Commission presented a report on the implementation of the 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.

This overarching report is a summary, drawing from 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 VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011 .

Implementation of the EU blood legislation : the report revealed an overall adequate level of application of the current quality and safety requirements of the EU blood legislation. The implementation of the EU blood legislation by Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the field through authorisation, inspection, and vigilance.

Significant progress has been made in many areas, often through the active support of 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 blood and blood components. These actions brought improvements in areas of common interest such as quality management and inspection and donor selection and included training courses for Member States Competent Authorities and their inspectors; as regards the risk of transmission of communicable diseases thorough blood and blood components, the collaboration with ECDC proved extremely valuable. In addition to providing regular updates during the bi-annual meeting of the blood expert sub-group on the epidemiological situation relevant to the blood sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provide a valuable contribution to policy and decision making in this sector at both national and EU level.; the Commission developed, in close cooperation with the Member States, a Rapid Alert Platform for Blood (RAB) which facilitates web-based communications between Member States in case of alerts with relevance in two or more Member States.

However, the report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.

Whilst overall Member States seem to correctly implement the provisions concerning inspections, a number of Member States reported difficulties related to staffing , which makes compliance with the required 2-year inspection interval challenging. Several Member States expressed interest in applying instead a risk-based prioritisation planning for inspections. There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections. Also the inspection approaches vary significantly towards mobile and satellite sites, hospital blood banks, plasma collection centres and potential third country players.

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) : the VUD survey shows that Member States overall comply with Article 20 of Directive 2002/98/EC requiring them to take the necessary measures to encourage VUD. However, Member States' perceptions of what is considered compensation and incentive vary .

The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation. Reimbursement of travel costs can cover the actual costs or be a standard lump sum. Time off work varies from less than half a day to up to two days. Some countries foresee compensation for loss of earnings in some circumstances.

Less than half of the countries reported having national guiding principles to define what form of compensation or other practice is allowed and under which circumstances.

Quality and safety of blood and blood components : safety and quality of the blood supply is an important issue for EU citizens, with 56% of respondents to the Eurobarometer survey on Blood and Cell and Tissue Donation citing the risk of contracting a disease as a major concern when accepting donated substances.

As regards the selection of eligible donors , Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.

As regards testing and inactivation technologies , the report noted that the minimum serological testing for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C carried out for every whole blood and apheresis donation are performed by authorised laboratories. Member States can add tests for specific components or epidemiological situations. They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.

Sixteen countries report having pathogen inactivation technologies in place. Inactivation techniques are mainly used for plasma although pathogen inactivation of platelets is likely to be more common going forward. Member States also highlight the need for good validation of testing technologies, and also pathogen inactivation technologies, in order to achieve an effective level of safety and quality.

In conclusion , the gaps and difficulties identified may 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 2002/98/EC and its implementing Directives.

COM(2016)0224
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SWD(2016)0129

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SWD(2016)0130

In accordance with the requirements of Directive 2002/98/EC the Commission presents its 2nd report on voluntary and unpaid donation of blood and blood components. The report is based on the Members States' responses to a report template on voluntary and unpaid donation of blood and blood components, which was sent to the competent authorities for blood and blood components during the spring of 2010. All Member States submitted a report to the Commission, together with Croatia and Norway.

This second report aims to provide an overview of the practice of voluntary and unpaid donation of blood and blood components in the EU, focusing on legislative provisions/guidelines and policies; incentives; promotion, and collection and supply . It should, however, be noted that although the report touches on areas related to pharmaceuticals, its focus is on blood and blood components.

The report shows that Member States overall comply with Directive 2002/98/EC , requiring Member States to take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensure that blood and blood components are in so far as possible provided from such donation. Largely in line with the findings of the first report on voluntary and unpaid blood donation (issued 2006), this report shows that legislative provisions and guidelines on voluntary and unpaid blood donation are well established across the EU. All but one of the 29 reporting countries have such provisions in place. Ireland has no legislative provisions or guidelines governing the principle of voluntary and unpaid donation of blood and blood components.

Most reporting countries have some form of incentive structures for blood donors, such as refreshments, small token and reimbursement of travel costs. Several countries also offer blood donors employed in the public sector time off work. The study indicates that there are no major differences in incentives for whole blood donors and apheresis (plasma, platelets…) donors. 27 out of the 29 reporting countries have undertaken some form of measures to promote voluntary and unpaid blood donation, such as awareness raising and information campaigns.

Concerning collection and supply of blood and blood components , the report shows that collectors/suppliers of whole blood and plasma are predominately public in the EU, Norway and Croatia. About half of the reporting countries have the capacity for plasma fractionation . In these countries, actors in the field of plasma fractionation are mainly private (71%). With regards to supply, the competent authorities for blood and blood components report relatively limited shortages of blood and blood components, ranging from around 14% (for whole blood) to 0% for white blood cells. About 75% of the countries have policies in place to contain or ensure the effective clinical use of blood, as well as to promote self-sufficiency of blood and blood components.

Based on the findings of the 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 mandate is limited to quality and safety of blood and blood components.

COM(2011)0138
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The Commission presents its report on the application of Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Three Commission implementing Directives supplement the provisions of Directive 2002/98/EC: Commission Directive 2004/33/EC as regards certain technical requirements for blood and blood components; Commission Directive 2005/61/EC as regards traceability requirements and notification of serious adverse reactions and events; and Commission Directive 2005/62/EC as regards Community standards and specifications relating to a quality system for blood establishments. Member States may maintain or introduce more stringent protective measures than those of the Directive 2002/98/EC, provided that they comply with the provisions of the Treaty. For instance, 26 Member States apply additional testing requirements to take into account their specific national epidemiological situation. No Member State indicated particular problems in intra-community exchanges of blood and blood components due to more stringent measures in other Member States.

This report is based on the replies to questionnaires on transposition and implementation that Member States send to the Commission on a yearly basis upon request. All Member States except Estonia have submitted a report on the activities undertaken in relation to the provisions of the Directive in 2008.

The Commission reports that overall, the implementation of the Directives is satisfactory . This concerns in particular the following measures:

the requirement to designate a competent authority or authorities; the establishment of inspection systems and control measures; haemovigilance 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:

1) the finalisation of the accreditation/designation/authorisation/licensing process in respect of each individual blood establishment : under Article 5(1), Member States must ensure that activities relating to the collection and testing of human blood and blood components, whatever the intended purpose, and to their preparation, storage and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated/authorised/accredited/licensed by the competent authority for that purpose.

As of December 2008, 21 Member States had completed the designation/authorisation/accreditation/licensing of all existing blood establishments in their respective territories (Belgium, Czech Republic, Denmark, Germany, Ireland, Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, the Netherlands, Austria, Poland, Slovakia, Finland, Sweden and the United Kingdom). This means that 775 blood establishments (‘BE’) were already authorised in the EU at the end of 2008. Bulgaria (5 BE), Malta (1 BE), Portugal (24 BE) Romania (42 BE) and Slovenia (3 BE) are currently finalising the d esignation/authorisation/accreditation/licensing process and expect to complete this work in the course of 2009;

2) the carrying out of inspections in all Member States: under Article 8(1), Member States must ensure that the competent authority organises inspections and appropriate control measures in blood establishments to check that the requirements of the Directive are complied with. All Member States except Cyprus have inspection and control systems in place. 22 Member States conducted regular inspections of blood establishments in 2008.

In four Member States inspections of blood establishments are performed by regional or autonomous communities’ services (Germany, Spain, Italy and Poland). In the rest of the Member States, inspections are performed by the central competent authority. In eleven Member States, the authority granting the designation/authorisation/ accreditation/licensing is the same as the one performing inspections (Czech Republic, Denmark, Germany, Ireland, Greece, Latvia, Luxembourg, Hungary, Finland, Sweden and the United Kingdom);

3) the annual report on adverse events and reactions for the Commission : Member States must submit an annual report to the Commission on the adverse reactions and events notified to the competent authority or authorities in accordance with Article 8 of Directive 2005/61/EC. The annual report on haemovigilance covering the period from 1 January to 31 December 2007 was submitted to the Commission by 23 Member States (Belgium, Bulgaria, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, France, Hungary, Ireland, Italy, Lithuania, Latvia, Malta, the Netherlands, Poland, Portugal, Romania, Slovenia, Sweden, Finland and the United Kingdom). The competent authority or authorities should organise inspections and carry out control measures as appropriate whenever there is a serious adverse reaction or event. Four inspections were conducted in this respect during 2008.

Furthermore, the collection of reports on blood establishments’ activity in the preceding year is a good practice that should be encouraged as it is a valuable source of information for both regulators and citizens.

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

COM(2010)0003
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C(2009)8541

The Commission has presented its first report on the implementation of the blood directive (Directive 2002/98/EC). This report provides an overview of the situation in the 15 Member States that belonged to the European Union as of 31 December 2003. It concerns the implementation of the Directive’s requirements, in particular those relating to inspection and control.

Other issues dealt with include :

IMPLEMENTATION (Article 4): Member States may maintain or introduce more stringent protective measures than those of the Directive while ensuring compliance with the Treaty’s provisions. Ten Member States avail of this option. Nine of them planned to maintain existing requirements for nine months after 8 February 2005, in order to give blood establishments additional time to comply with the Directive.

OBLIGATIONS ON MEMBER STATES AUTHORITIES :

- Blood establishments (Article 5) : Member States must ensure that an appropriate mechanism is in place so that the activities of blood establishments comply with the Directive’s requirements. As of December 2003, 14 Member States had designated a competent authority in accordance with this provision.

- Hospital blood banks (Article 6) : hospital blood banks in 7 Member States had been informed of the requirements applicable to them.

- Inspection and control measures (Article 8) : the competent authority in 7 Member States had organised inspections and control measures in blood establishments in order to ensure compliance with the Directive’s requirements. The timeliness of inspections and control measures, however, varied from every six months to every three years. Six Member States have empowered officials representing the competent authority to carry out inspections and control measures in blood establishments and facilities of third parties in their State that have been entrusted by the authorised blood establishment to carry out

evaluation and testing procedures. Eleven confirmed that these officials are empowered to examine any documents related to the inspection, subject to the provisions in force in the Member State at the time of the entry into force of the Directive which place restrictions on these powers. Three Member States had not yet empowered officials to take samples for examination and analysis. Two states had organised such inspections and controls and 4 had not. Five indicated that such notification was part of their haemovigilance procedures . Six Member States indicated that their blood establishments were aware that serious adverse events and reactions had to be notified to the competent authority in accordance with the procedure and notification format. Eight Member States already have procedures in place to enable blood or blood components associated with serious adverse events and reactions to be accurately, efficiently and verifiably withdrawn from distribution.

PROVISIONS FOR BLOOD ESTABLISHMENTS (Articles 9-10) : blood establishments must designate a responsible person with at least the minimum qualifications. Ten Member States comply with the formal academic requirements, however, practical experience was not always required.

Eight Member States already allow for the delegation of tasks specified for the responsible person to other persons qualified by training and experience, although in one the actual responsibility is not assigned. Five Member States had informed their blood establishments that, where the responsible person or such other persons are permanently or temporarily replaced, they must immediately provide the name of the new responsible person and his or her date of commencement to the competent authority. Nine Member States confirmed that personnel directly involved in the collection, testing, processing, storage, and distribution of human blood and blood components is qualified for their tasks and has been provided with timely, relevant and regularly updated training.

QUALITY MANAGEMENT (Articles 11-13) : eleven Member States have ensured that each blood establishment institutes and maintains a quality system based on the principles of good practice. Shortcomings, however, were acknowledged in some Member States. Nine Member States reported that blood establishments are required to maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms and provide access to these documents for officials entrusted with inspection and control. Most Member States have procedures in place to ensure that blood establishments maintain records of their annual activities, basic testing requirements, and the information provided to and obtained from donors as well as donor suitability requirements. HAEMOVIGILANCE (Articles 13-15) : all Member States had taken measures to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on its territory were traceable from donor to recipient and vice versa.

PROVISIONS FOR QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS:

- Donors (Articles 16-19) : eleven Member States already provided information to donors as normal practice, and thirteen required information to be supplied by donors. Nine Member States reported that evaluation procedures and donation deferral criteria were in place in blood establishments for all donors of blood and blood components. Fourteen Member States indicated that provisions are in place for assessing the suitability of individuals to donate blood, including an examination of and an interview with the donor prior to any donation.

- Voluntary and unpaid blood donation (Article 20) : eleven Member States had taken measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible derived from them.

- Testing of donations (Article 21) : fourteen Member States reported that their blood establishments test each donation of blood and blood components in conformity with requirements listed in Annex IV. Eight Member States had procedures in place to ensure that blood and blood components imported into the Community were tested in conformity with these requirements.

- Storage, transport and distribution conditions (Article 22) : twelve Member States already had relevant requirements in place.

- Quality and safety requirements for blood and blood components : seven Member States reported that their blood establishments have to ensure that the quality and safety requirements for blood and blood components meet high standards.

DATA PROTECTION : twelve Member States had taken measures to ensure that all data, including genetic information, collated within the scope of the Directive to which third parties have access,

have been rendered anonymous so that the donor is no longer identifiable. Nine have data security measures in place as well as safeguards against unauthorised data additions, deletions or modifications and transfer of information. Procedures to resolve data discrepancies are in place in 6 Member States with improvements required in a few others. Eight have measures in place to ensure no unauthorised disclosure of such information.

INFORMATION EXCHANGE, PENALTIES AND TRANSPOSITION

- Information exchange : the Commission has convened a meeting with the competent authorities designated by the Member States, delegations of experts from blood establishments and other relevant parties on 25 September 2005 to exchange information on the experience acquired with regard to the implementation of this Directive.

- Penalties : Member States must lay down rules on the penalties for infringements of the national provisions, take all measures necessary to ensure that they are implemented, and notify the Commission of the provisions by 8 February 2005 at the latest and without delay for any subsequent amendments affecting them. Four Member States indicated that penalties and fines already existed.

- Transposition : at the beginning of 2006, thirteen Member States subject to the report adopted transposition measures. Two Member States have informed the Commission that procedures for transposition are underway, but that they have not yet informed the European Commission of the laws, regulations and administrative provisions transposing the Directive. The Commission will evaluate the measures of transposition of the Directive in all Member States.

COM(2006)0313
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In accordance with Directive 2002/98/EC on setting standards relating to human blood and blood components, this report summarises the measures taken by the Member States to encourage voluntary unpaid donations and identifies the measures the Commission intends to take in order to promote self-sufficiency in the EU through voluntary unpaid donations. This is a comprehensive report examining and analysing in detail measures taken in the Member States.

Voluntary and unpaid donations : Voluntary unpaid donations have a long tradition in many of the EU Member States, notably France, Luxembourg, Northern Ireland, Slovenia, the former Czechoslovakia, Belgium, Denmark, the UK, Finland and the Netherlands. The report notes that interpretation of the principle of voluntary and unpaid donations varies across the Member States. This is illustrated in the level of expenses covered or time given off work to donate blood.

Promotion of voluntary unpaid blood donations : The promotion of voluntary unpaid blood donations is vital for donations to succeed. Activities vary and include publications such as guides or advertising to specific target groups and student awareness programmes. Events include “World Blood Donor Day”, which generated a lot of publicity. Student awareness campaigns have been developed in the UK, with Scotland designing an extensive school and university recruitment programme. Ireland produced an educational video and Latvia provided explanations on the processing of blood and donor requirements. The Report finds that different initiatives exist to promote the principle of voluntary and unpaid donations, using techniques as diverse as marketing actions, student programmes and e-initiatives. Some of the actions are related to the promotion of donations, others are more specific and relate to the promotion of unpaid donations. The Commission suggests there is a growing need to determine best practices.

Commission Action: The Commission will continue to encourage Member States to promote voluntary, unpaid donations. Under the Community Health Programme it will commission a European wide study to determine best practices for promoting voluntary and unpaid donations. Lastly, the Commission intends to continue discussions on EU blood donation self-sufficiency.

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LEGISLATIVE ACT : Commission Directive 2005/61/CE implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events.

CONTENT : In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements dealing with traceability, a Community procedure for notifying serious adverse reactions and events and the notification format. Notification of suspected serious adverse reactions or serious adverse events should be submitted to the competent authority as soon as known. This Directive therefore establishes the notification format defining the minimum data needed, without prejudice to the faculty of Member States to maintain or introduce in their territory more stringent protective measures.

The Directive lays down those technical requirements, which take account of: Council Recommendation 98/463/EC on the suitability of blood and plasma donors and the screening of donated blood in the European Community; Directive 2001/83/EC on the Community code relating to medicinal products for human use; Commission Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components, and certain recommendations of the Council of Europe.

Accordingly, blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma, intended for distribution in the Community, should meet equivalent Community standards and specifications relating to traceability and serious adverse reaction and serious adverse event notification requirements as set out in this Directive.

The Directive also determines common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

ENTRY INTO FORCE : 21/10/2005.

TRANSPOSITION : 31/08/2006.

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LEGISLATIVE ACT : Commission Directive 2005/62/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments.

CONTENT : In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements including Community standards and specifications with regard to a quality system for blood establishments. A quality system for blood establishments must embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing.

This Directive lays down those technical requirements, which take account of: Council Recommendation 98/463/EC on the suitability of blood and plasma donors and the screening of donated blood in the European Community; Directive 2001/83/EC on the Community code relating to medicinal products for human use; Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; Commission Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components, certain recommendations of the Council of Europe, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, recommendations of the World Health Organisation, as well as international experience in this field.

The Directive provides that guidance on good practice must be developed by the Commission to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained.

Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, must meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this Directive.

The Directive provides that a quality system is to be applied for any blood and blood components circulating in the Community and that Member States must ensure that for blood and blood components coming from third countries, there is a quality system in place for blood establishments in the stages preceding importation equivalent to the quality system provided under this Directive.

Finally, the Directive also determines common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

ENTRY INTO FORCE : 20/10/2005.

TRANSPOSITION : 31/08/2006.

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