BETA


2002/0128(COD) Human tissues and cells: quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI LIESE Peter (icon: PPE-DE PPE-DE)
Former Responsible Committee ENVI LIESE Peter (icon: PPE-DE PPE-DE)
Former Committee Opinion BUDG VIRRANKOSKI Kyösti (icon: ELDR ELDR)
Former Committee Opinion CONT
Former Committee Opinion JURI BARTOLOZZI Paolo (icon: PPE-DE PPE-DE)
Lead committee dossier:
Legal Basis:
EC Treaty (after Amsterdam) EC 152-p4

Events

2016/04/21
   EC - Follow-up document
Details

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.

2016/04/21
   EC - Follow-up document
2016/04/21
   EC - Follow-up document
2011/06/17
   EC - Follow-up document
Details

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.

2010/01/07
   EC - Follow-up document
Details

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.

2006/10/24
   EU - Implementing legislative act
Details

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.

2006/10/16
   EC - Follow-up document
Details

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.

2006/02/08
   EU - Implementing legislative act
Details

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.

2004/04/07
   Final act published in Official Journal
2004/03/31
   CSL - Final act signed
2004/03/31
   EP - End of procedure in Parliament
2004/03/02
   CSL - Act approved by Council, 2nd reading
2004/03/02
   CSL - Council Meeting
2004/02/05
   EC - Commission opinion on Parliament's position at 2nd reading
2003/12/16
   EP - Text adopted by Parliament, 2nd reading
2003/12/16
   EP - Decision by Parliament, 2nd reading
Documents
2003/12/15
   EP - Debate in Parliament
2003/11/04
   EP - Committee recommendation tabled for plenary, 2nd reading
Documents
2003/11/04
   EP - Vote in committee, 2nd reading
2003/11/04
   EP - Committee recommendation tabled for plenary, 2nd reading
Documents
2003/10/20
   EP - Amendments tabled in committee
Documents
2003/10/01
   EP - Committee draft report
Documents
2003/09/04
   EP - Committee referral announced in Parliament, 2nd reading
2003/08/11
   EC - Commission communication on Council's position
2003/07/22
   CSL - Council position
2003/07/22
   CSL - Council position published
Documents
2003/07/22
   CSL - Council Meeting
2003/07/11
   CSL - Council statement on its position
Documents
2003/06/02
   CSL - Council Meeting
2003/05/28
   EC - Modified legislative proposal published
2003/04/10
   EP - Text adopted by Parliament, 1st reading/single reading
2003/04/10
   EP - Decision by Parliament, 1st reading/single reading
Documents
2003/04/09
   EP - Debate in Parliament
2003/03/25
   EP - Committee draft report
Documents
2003/03/25
   EP - Amendments tabled in committee
Documents
2003/03/25
   EP - Amendments tabled in committee
Documents
2003/03/25
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2003/03/25
   EP - Vote in committee, 1st reading/single reading
2003/03/25
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2003/03/20
   EP - Committee opinion
Documents
2003/03/06
   EP - Committee opinion
Documents
2002/12/11
   ESC - Economic and Social Committee: opinion, report
2002/12/02
   CSL - Debate in Council
Documents
2002/12/02
   CSL - Council Meeting
2002/10/02
   EP - LIESE Peter (PPE-DE) appointed as rapporteur in ENVI
2002/10/02
   EP - LIESE Peter (PPE-DE) appointed as rapporteur in ENVI
2002/07/18
   EP - VIRRANKOSKI Kyösti (ELDR) appointed as rapporteur in BUDG
2002/07/11
   EP - BARTOLOZZI Paolo (PPE-DE) appointed as rapporteur in JURI
2002/07/01
   EP - Committee referral announced in Parliament, 1st reading/single reading
2002/06/26
   CSL - Debate in Council
Documents
2002/06/26
   CSL - Council Meeting
2002/06/19
   EC - Legislative proposal
2002/06/19
   EC - Legislative proposal published

Documents

History

(these mark the time of scraping, not the official date of the change)

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activities
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  • date: 2003-06-02T00:00:00 body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: X018
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  • date: 2003-09-04T00:00:00 body: EP type: Committee referral announced in Parliament, 2nd reading committees: body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter
  • body: EP committees: body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-387&language=EN type: Committee recommendation tabled for plenary, 2nd reading title: A5-0387/2003 date: 2003-11-04T00:00:00 type: Vote in committee, 2nd reading
  • date: 2003-12-15T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20031215&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2003-12-16T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-570 type: Decision by Parliament, 2nd reading title: T5-0570/2003 body: EP type: Decision by Parliament, 2nd reading
  • date: 2004-03-02T00:00:00 body: CSL type: Council Meeting council: Environment meeting_id: 2566
  • date: 2004-03-31T00:00:00 body: CSL type: Final act signed
  • date: 2004-03-31T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2004-04-07T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32004L0023 title: Directive 2004/23 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2004:102:TOC title: OJ L 102 07.04.2004, p. 0048-0058
commission
  • body: EC dg: Health and Food Safety commissioner: --
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council
  • body: CSL type: Council Meeting council: Environment meeting_id: 2566 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2566*&MEET_DATE=02/03/2004 date: 2004-03-02T00:00:00
  • body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2524 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2524*&MEET_DATE=22/07/2003 date: 2003-07-22T00:00:00
  • body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: 2512 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2512*&MEET_DATE=02/06/2003 date: 2003-06-02T00:00:00
  • body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: 2470 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2470*&MEET_DATE=02/12/2002 date: 2002-12-02T00:00:00
  • body: CSL type: Council Meeting council: Health meeting_id: 2440 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2440*&MEET_DATE=26/06/2002 date: 2002-06-26T00:00:00
docs
  • date: 2002-06-19T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2002/0319/COM_COM(2002)0319_EN.pdf title: COM(2002)0319 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2002&nu_doc=319 title: EUR-Lex url: https://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2002:227E:SOM:EN:HTML title: OJ C 227 24.09.2002, p. 0505 E summary: type: Legislative proposal body: EC
  • date: 2002-12-11T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:1361)(documentyear:2002)(documentlanguage:EN) title: CES1361/2002 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2003:085:TOC title: OJ C 085 08.04.2003, p. 0044-0050 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2003-03-06T00:00:00 docs: title: PE325.485/DEF committee: BUDG type: Committee opinion body: EP
  • date: 2003-03-20T00:00:00 docs: title: PE327.240/DEF committee: JURI type: Committee opinion body: EP
  • date: 2003-03-25T00:00:00 docs: title: PE319.423 type: Committee draft report body: EP
  • date: 2003-03-25T00:00:00 docs: title: PE319.423/AM type: Amendments tabled in committee body: EP
  • date: 2003-03-25T00:00:00 docs: title: PE319.423/AMC type: Amendments tabled in committee body: EP
  • date: 2003-03-25T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-103&language=EN title: A5-0103/2003 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2003-04-10T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-182 title: T5-0182/2003 title: OJ C 064 12.03.2004, p. 0391-0505 E summary: type: Text adopted by Parliament, 1st reading/single reading body: EP
  • date: 2003-07-11T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=11379%2F03&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 11379/2003 type: Council statement on its position body: CSL
  • date: 2003-07-22T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=10133%2F03&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 10133/3/2003 url: https://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2003:240E:SOM:EN:HTML title: OJ C 240 07.10.2003, p. 0012-0024 E summary: type: Council position body: CSL
  • date: 2003-08-11T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2003/0906/COM_SEC(2003)0906_EN.pdf title: SEC(2003)0906 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=SECfinal&an_doc=2003&nu_doc=906 title: EUR-Lex summary: type: Commission communication on Council's position body: EC
  • date: 2003-10-01T00:00:00 docs: title: PE331.685 type: Committee draft report body: EP
  • date: 2003-10-20T00:00:00 docs: title: PE331.685/AM type: Amendments tabled in committee body: EP
  • date: 2003-11-04T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-387&language=EN title: A5-0387/2003 type: Committee recommendation tabled for plenary, 2nd reading body: EP
  • date: 2003-12-16T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-570 title: T5-0570/2003 title: OJ C 091 15.04.2004, p. 0029-0090 E summary: type: Text adopted by Parliament, 2nd reading body: EP
  • date: 2004-02-05T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2004/0080/COM_COM(2004)0080_EN.pdf title: COM(2004)0080 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2004&nu_doc=80 title: EUR-Lex summary: type: Commission opinion on Parliament's position at 2nd reading body: EC
  • date: 2006-02-08T00:00:00 docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006L0017 title: 32006L0017 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2006:038:TOC title: OJ L 038 09.02.2006, p. 0040-0052 summary: 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. type: Implementing legislative act body: EU
  • date: 2006-10-16T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2006/0593/COM_COM(2006)0593_EN.pdf title: COM(2006)0593 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2006&nu_doc=593 title: EUR-Lex summary: 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. type: Follow-up document body: EC
  • date: 2006-10-24T00:00:00 docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006L0086 title: 32006L0086 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2006:294:TOC title: OJ L 294 25.10.2006, p. 0032-0050 summary: 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. type: Implementing legislative act body: EU
  • date: 2010-01-07T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2009/0708/COM_COM(2009)0708_EN.pdf title: COM(2009)0708 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2009&nu_doc=708 title: EUR-Lex summary: 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. type: Follow-up document body: EC
  • date: 2011-06-17T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2011/0352/COM_COM(2011)0352_EN.pdf title: COM(2011)0352 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=352 title: EUR-Lex summary: 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. type: Follow-up document body: EC
  • date: 2016-04-21T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2016/0223/COM_COM(2016)0223_EN.pdf title: COM(2016)0223 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2016&nu_doc=0223 title: EUR-Lex summary: 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. type: Follow-up document body: EC
  • date: 2016-04-21T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2016:0127:FIN:EN:PDF title: EUR-Lex title: SWD(2016)0127 type: Follow-up document body: EC
  • date: 2016-04-21T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2016:0128:FIN:EN:PDF title: EUR-Lex title: SWD(2016)0128 type: Follow-up document body: EC
events
  • date: 2002-06-19T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2002/0319/COM_COM(2002)0319_EN.pdf title: COM(2002)0319 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2002&nu_doc=319 title: EUR-Lex summary:
  • date: 2002-06-26T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2440*&MEET_DATE=26/06/2002 title: 2440
  • date: 2002-07-01T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2002-12-02T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2470*&MEET_DATE=02/12/2002 title: 2470
  • date: 2003-03-25T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary:
  • date: 2003-03-25T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-103&language=EN title: A5-0103/2003
  • date: 2003-04-09T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20030409&type=CRE title: Debate in Parliament
  • date: 2003-04-10T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-182 title: T5-0182/2003 summary:
  • date: 2003-05-28T00:00:00 type: Modified legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2003/0340/COM_COM(2003)0340_EN.pdf title: COM(2003)0340 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2003&nu_doc=340 title: EUR-Lex summary:
  • date: 2003-07-22T00:00:00 type: Council position published body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=10133%2F03&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 10133/3/2003 summary:
  • date: 2003-09-04T00:00:00 type: Committee referral announced in Parliament, 2nd reading body: EP
  • date: 2003-11-04T00:00:00 type: Vote in committee, 2nd reading body: EP summary:
  • date: 2003-11-04T00:00:00 type: Committee recommendation tabled for plenary, 2nd reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-387&language=EN title: A5-0387/2003
  • date: 2003-12-15T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20031215&type=CRE title: Debate in Parliament
  • date: 2003-12-16T00:00:00 type: Decision by Parliament, 2nd reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-570 title: T5-0570/2003 summary:
  • date: 2004-03-02T00:00:00 type: Act approved by Council, 2nd reading body: CSL
  • date: 2004-03-31T00:00:00 type: Final act signed body: CSL
  • date: 2004-03-31T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2004-04-07T00:00:00 type: Final act published in Official Journal docs: title: Directive 2004/23 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32004L0023 title: OJ L 102 07.04.2004, p. 0048-0058 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2004:102:TOC
other
  • body: CSL type: Council Meeting council: Former Council configuration
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers
procedure/dossier_of_the_committee
Old
ENVI/5/19456
New
  • ENVI/5/19456
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32004L0023
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https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32004L0023
procedure/subject
Old
  • 4.20.01 Medicine, diseases
  • 4.20.02 Medical research
  • 4.20.05 Health legislation and policy
New
4.20.01
Medicine, diseases
4.20.02
Medical research
4.20.02.06
Clinical practice and experiments
4.20.05
Health legislation and policy
procedure/title
Old
Medicine: standards of quality and safety of human tissues and cells
New
Human tissues and cells: quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution
activities/3/docs/0/title
Old
X017
New
2470
activities/3/docs/0/url
Old
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=X017*&MEET_DATE=02/12/2002
New
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2470*&MEET_DATE=02/12/2002
activities/3/meeting_id
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X017
New
2470
activities/17/docs/1/url
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http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2004:102:SOM:EN:HTML
New
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2004:102:TOC
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities
  • date: 2002-06-19T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2002/0319/COM_COM(2002)0319_EN.pdf celexid: CELEX:52002PC0319:EN type: Legislative proposal published title: COM(2002)0319 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers
  • body: CSL meeting_id: 2440 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2440*&MEET_DATE=26/06/2002 type: Debate in Council title: 2440 council: Health date: 2002-06-26T00:00:00 type: Council Meeting
  • date: 2002-07-01T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee: BUDG date: 2002-07-18T00:00:00 committee_full: Budgets rapporteur: group: ELDR name: VIRRANKOSKI Kyösti body: EP responsible: False committee_full: Budgetary Control committee: CONT body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter body: EP responsible: False committee: JURI date: 2002-07-11T00:00:00 committee_full: Legal Affairs and Internal Market rapporteur: group: PPE-DE name: BARTOLOZZI Paolo
  • body: CSL meeting_id: X017 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=X017*&MEET_DATE=02/12/2002 type: Debate in Council title: X017 council: Employment, Social Policy, Health and Consumer Affairs date: 2002-12-02T00:00:00 type: Council Meeting
  • body: EP committees: body: EP responsible: False committee: BUDG date: 2002-07-18T00:00:00 committee_full: Budgets rapporteur: group: ELDR name: VIRRANKOSKI Kyösti body: EP responsible: False committee_full: Budgetary Control committee: CONT body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter body: EP responsible: False committee: JURI date: 2002-07-11T00:00:00 committee_full: Legal Affairs and Internal Market rapporteur: group: PPE-DE name: BARTOLOZZI Paolo docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-103&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A5-0103/2003 date: 2003-03-25T00:00:00 type: Vote in committee, 1st reading/single reading
  • date: 2003-04-09T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20030409&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2003-04-10T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-182 type: Decision by Parliament, 1st reading/single reading title: T5-0182/2003 body: EP type: Decision by Parliament, 1st reading/single reading
  • date: 2003-05-28T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2003/0340/COM_COM(2003)0340_EN.pdf celexid: CELEX:52003PC0340:EN type: Modified legislative proposal published title: COM(2003)0340 type: Modified legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers
  • date: 2003-06-02T00:00:00 body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: X018
  • body: CSL meeting_id: 2524 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=10133%2F03&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC type: Council position published title: 10133/3/2003 council: Agriculture and Fisheries date: 2003-07-22T00:00:00 type: Council Meeting
  • date: 2003-09-04T00:00:00 body: EP type: Committee referral announced in Parliament, 2nd reading committees: body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter
  • body: EP committees: body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A5-2003-387&language=EN type: Committee recommendation tabled for plenary, 2nd reading title: A5-0387/2003 date: 2003-11-04T00:00:00 type: Vote in committee, 2nd reading
  • date: 2003-12-15T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20031215&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2003-12-16T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P5-TA-2003-570 type: Decision by Parliament, 2nd reading title: T5-0570/2003 body: EP type: Decision by Parliament, 2nd reading
  • date: 2004-03-02T00:00:00 body: CSL type: Council Meeting council: Environment meeting_id: 2566
  • date: 2004-03-31T00:00:00 body: CSL type: Final act signed
  • date: 2004-03-31T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2004-04-07T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32004L0023 title: Directive 2004/23 url: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2004:102:SOM:EN:HTML title: OJ L 102 07.04.2004, p. 0048-0058
committees
  • body: EP responsible: False committee: BUDG date: 2002-07-18T00:00:00 committee_full: Budgets rapporteur: group: ELDR name: VIRRANKOSKI Kyösti
  • body: EP responsible: False committee_full: Budgetary Control committee: CONT
  • body: EP responsible: True committee: ENVI date: 2002-10-02T00:00:00 committee_full: Environment, Public Health, Consumer Policy rapporteur: group: PPE-DE name: LIESE Peter
  • body: EP responsible: False committee: JURI date: 2002-07-11T00:00:00 committee_full: Legal Affairs and Internal Market rapporteur: group: PPE-DE name: BARTOLOZZI Paolo
links
European Commission
other
  • body: CSL type: Council Meeting council: Former Council configuration
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers
procedure
dossier_of_the_committee
ENVI/5/19456
reference
2002/0128(COD)
instrument
Directive
legal_basis
EC Treaty (after Amsterdam) EC 152-p4
stage_reached
Procedure completed
subtype
Legislation
title
Medicine: standards of quality and safety of human tissues and cells
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject