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Document 02010L0053-20100806
Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Consolidated text: Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
02010L0053 — EN — 06.08.2010 — 000.001
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►C1 DIRECTIVE 2010/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2010 ◄ on standards of quality and safety of human organs intended for transplantation (OJ L 207 6.8.2010, p. 14) |
Corrected by:
DIRECTIVE 2010/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 7 July 2010
on standards of quality and safety of human organs intended for transplantation
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject Matter
This Directive lays down rules to ensure standards of quality and safety for human organs (hereinafter ‘organs’) intended for transplantation to the human body, in order to ensure a high level of human health protection.
Article 2
Scope
Article 3
Definitions
For the purposes of this Directive, the following definitions apply:
‘authorisation’ means authorisation, accreditation, designation, licensing or registration, depending on the concepts used and the practices in place in each Member State;
‘competent authority’ means an authority, body, organisation and/or institution responsible for implementing the requirements of this Directive;
‘disposal’ means the final placement of an organ where it is not used for transplantation;
‘donor’ means a person who donates one or several organs, whether donation occurs during lifetime or after death;
‘donation’ means donating organs for transplantation;
‘donor characterisation’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability for organ donation, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
‘European organ exchange organisation’ means a non-profit organisation, whether public or private, dedicated to national and cross-border organ exchange, in which the majority of its member countries are Member States;
‘organ’ means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy. A part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
‘organ characterisation’ means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
‘procurement’ means a process by which the donated organs become available;
‘procurement organisation’ means a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of organs, and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation;
‘recipient’ means a person who receives a transplant of an organ;
‘serious adverse event’ means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;
‘serious adverse reaction’ means an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;
‘operating procedures’ means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end outcome;
‘transplantation’ means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;
‘transplantation centre’ means a healthcare establishment, a team or a unit of a hospital or any other body which undertakes the transplantation of organs and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
‘traceability’ means the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, including the ability to:
CHAPTER II
THE QUALITY AND SAFETY OF ORGANS
Article 4
Framework for quality and safety
The framework for quality and safety shall provide for the adoption and implementation of operating procedures for:
the verification of donor identity;
the verification of the details of the donor's or the donor's family's consent, authorisation or absence of any objection, in accordance with the national rules that apply where donation and procurement take place;
the verification of the completion of the organ and donor characterisation in accordance with Article 7 and the Annex;
the procurement, preservation, packaging and labelling of organs in accordance with Articles 5, 6 and 8;
the transportation of organs in accordance with Article 8;
ensuring traceability, in accordance with Article 10, guaranteeing compliance with the Union and national provisions on the protection of personal data and confidentiality;
the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with Article 11(1);
the management of serious adverse events and reactions in accordance with Article 11(2).
The operating procedures referred to in points (f), (g) and (h) shall specify, inter alia, the responsibilities of procurement organisations, European organ exchange organisations and transplantation centres.
Article 5
Procurement organisations
Article 6
Organ procurement
Article 7
Organ and donor characterisation
The information specified in Part A of the Annex contains a set of minimum data which has to be collected for each donation. Information specified in Part B of the Annex contains a set of complementary data to be collected in addition, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case.
Article 8
Transport of organs
Member States shall ensure that the following requirements are met:
the organisations, bodies or companies involved in the transportation of organs have appropriate operating procedures in place to ensure the integrity of the organs during transport and a suitable transport time;
the shipping containers used for transporting organs are labelled with the following information:
identification of the procurement organisation and the establishment where the procurement took place, including their addresses and telephone numbers;
identification of the transplantation centre of destination, including its address and telephone number;
a statement that the package contains an organ, specifying the type of organ and, where applicable, its left or right location and marked ‘HANDLE WITH CARE’;
recommended transport conditions, including instructions for keeping the container at an appropriate temperature and position;
the organs transported are accompanied by a report on the organ and donor characterisation.
Article 9
Transplantation centres
The transplantation centre shall verify before proceeding to transplantation that:
the organ and donor characterisation are completed and recorded in accordance with Article 7 and the Annex;
the conditions of preservation and transport of shipped organs have been maintained.
Article 10
Traceability
Member States shall ensure that:
the competent authority or other bodies involved in the chain from donation to transplantation or disposal keep the data needed to ensure traceability at all stages of the chain from donation to transplantation or disposal and the information on organ and donor characterisation as specified in the Annex, in accordance with the framework for quality and safety;
data required for full traceability is kept for a minimum of 30 years after donation. Such data may be stored in electronic form.
Article 11
Reporting system and management concerning serious adverse events and reactions
In particular, and with regard to paragraphs 1 and 2, Member States shall ensure that operating procedures are in place for the notification, in due time, of:
any serious adverse event and reaction to the competent authority and to the concerned procurement organisation or transplantation centre;
the management measures with regard to serious adverse events and reactions to the competent authority.
Article 12
Healthcare personnel
Member States shall ensure that healthcare personnel directly involved in the chain from donation to the transplantation or disposal of organs are suitably qualified or trained and competent to perform their tasks and are provided with the relevant training, as referred to in Article 4(3).
CHAPTER III
DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION
Article 13
Principles governing organ donation
Article 14
Consent requirements
The procurement of organs shall be carried out only after all requirements relating to consent, authorisation or absence of any objection in force in the Member State concerned have been met.
Article 15
Quality and safety aspects of living donation
Article 16
Protection of personal data, confidentiality and security of processing
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Union provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Article 8(3), Articles 16 and 17 and Article 28(2) thereof. Pursuant to Directive 95/46/EC, Member States shall take all necessary measures to ensure that:
the data processed are kept confidential and secure in accordance with Articles 16 and 17 of Directive 95/46/EC. Any unauthorised accessing of data or systems that makes identification of donor or recipients possible shall be penalised in accordance with Article 23 of this Directive;
donors and recipients whose data are processed within the scope of this Directive are not identifiable, except as permitted by Article 8(2) and (3) of Directive 95/46/EC, and national provisions implementing that Directive. Any use of systems or data that makes the identification of donors or recipients possible with a view to tracing donors or recipients other than for the purposes permitted by Article 8(2) and (3) of Directive 95/46/EC, including medical purposes, and by national provisions implementing that Directive shall be penalised in accordance with Article 23 of this Directive;
the principles relating to data quality, as set out in Article 6 of Directive 95/46/EC, are met.
CHAPTER IV
OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION
Article 17
Designation and tasks of competent authorities
Member States may delegate, or may allow a competent authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed suitable under national provisions. Such a body may also assist the competent authority in carrying out its functions.
The competent authority shall, in particular, take the following measures:
establish and keep updated a framework for quality and safety in accordance with Article 4;
ensure that procurement organisations and transplantations centres are controlled or audited on a regular basis to ascertain compliance with the requirements of this Directive;
grant, suspend, or withdraw, as appropriate, the authorisations of procurement organisations or transplantation centres or prohibit procurement organisations or transplantation centres from carrying out their activities where control measures demonstrate that such organisations or centres are not complying with the requirements of this Directive;
put in place a reporting system and management procedure for serious adverse events and reactions as provided for in Article 11(1) and (2);
issue appropriate guidance to healthcare establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal, which may include guidance for the collection of relevant post-transplantation information to evaluate the quality and safety of the organs transplanted;
participate, whenever possible, in the network of competent authorities referred to in Article 19 and coordinate at national level input to the activities of that network;
supervise organ exchange with other Member States and with third countries as provided for in Article 20(1);
ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities, in conformity with Union provisions on the protection of personal data, in particular Directive 95/46/EC.
Article 18
Records and reports concerning procurement organisations and transplantation centres
Member States shall ensure that the competent authority:
keeps a record of the activities of procurement organisations and transplantation centres, including aggregated numbers of living and deceased donors, and the types and quantities of organs procured and transplanted, or otherwise disposed of in accordance with Union and national provisions on the protection of personal data and statistical confidentiality;
draws up and makes publicly accessible an annual report on activities referred to in point (a);
establishes and maintains an updated record of procurement organisations and transplantation centres.
Article 19
Exchange of information
CHAPTER V
ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS
Article 20
Organ exchange with third countries
Organ exchange, as referred to in paragraph 1, shall be allowed only where the organs:
can be traced from the donor to the recipient and vice versa;
meet quality and safety requirements equivalent to those laid down in this Directive.
Article 21
European organ exchange organisations
Member States may conclude or allow a competent authority to conclude agreements with European organ exchange organisations, provided that such organisations ensure compliance with the requirements laid down in this Directive, delegating to those organisations, inter alia:
the performance of activities provided for under the framework for quality and safety;
specific tasks in relation to the exchanges of organs to and from Member States and third countries.
CHAPTER VI
GENERAL PROVISIONS
Article 22
Reports concerning this Directive
Article 23
Penalties
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that the penalties are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 27 August 2012 and shall notify it without delay of any subsequent amendments affecting them.
Article 24
Adaptation of the Annex
The Commission may adopt delegated acts in accordance with Article 25 and subject to the conditions of Articles 26, 27 and 28 in order to:
supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health considered as such on the basis of the scientific progress;
supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation.
Article 25
Exercise of the delegation
Article 26
Revocation of the delegation
Article 27
Objection to delegated acts
At the initiative of the European Parliament or the Council this period shall be extended by two months.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Article 28
Urgency procedure
Article 29
Implementing measures
The Commission shall adopt, where organs are exchanged between Member States, detailed rules for the uniform implementation of this Directive in accordance with the procedure referred to in Article 30(2), on the following:
procedures for the transmission of information on organ and donor characterisation as specified in the Annex in accordance with Article 7(6);
procedures for the transmission of the necessary information to ensure the traceability of organs in accordance with Article 10(4);
procedures for ensuring the reporting of serious adverse events and reactions in accordance with Article 11(4).
Article 30
Committee
Article 31
Transposition
When they are adopted by Member States, those measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
CHAPTER VII
FINAL PROVISIONS
Article 32
Entry into force
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 33
Addressees
This Directive is addressed to the Member States.
ANNEX
ORGAN AND DONOR CHARACTERISATION
PART A
Minimum data set
Minimum data – information for the characterisation of organs and donors, which has to be collected for each donation in accordance with second subparagraph of Article 7(1) and without prejudice to Article 7(2).
Minimum data set
The establishment where the procurement takes place and other general data
Type of donor
Blood group
Gender
Cause of death
Date of death
Date of birth or estimated age
Weight
Height
Past or present history of IV drug abuse
Past or present history of malignant neoplasia
Present history of other transmissible disease
HIV; HCV; HBV tests
Basic information to evaluate the function of the donated organ
PART B
Complementary data set
Complementary data – information for the characterisation of organs and donors to be collected in addition to minimum data specified in Part A, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case, in accordance with the second subparagraph of Article 7(1).
Complementary data set
General data
Contact details of the procurement organisation/the establishment where the procurement takes place necessary for coordination, allocation and traceability of the organs from donors to recipients and vice versa.
Donor data
Demographic and anthropometrical data required in order to guarantee an appropriate matching between the donor/organ and the recipient.
Donor medical history
Medical history of the donor, in particular the conditions which might affect the suitability of the organs for transplantation and imply the risk of disease transmission.
Physical and clinical data
Data from clinical examination which are necessary for the evaluation of the physiological maintenance of the potential donor as well as any finding revealing conditions which remained undetected during the examination of the donor’s medical history and which might affect the suitability of organs for transplantation or might imply the risk of disease transmission.
Laboratory parameters
Data needed for the assessment of the functional characterisation of the organs and for the detection of potentially transmissible diseases and of possible contraindications with respect to organ donation.
Image tests
Image explorations necessary for the assessment of the anatomical status of the organs for transplantation.
Therapy
Treatments administered to the donor and relevant for the assessment of the functional status of the organs and the suitability for organ donation, in particular the use of antibiotics, inotropic support or transfusion therapy.
Statement of the European Parliament, the Council and the Commission on Article 290 TFEU
The European Parliament, the Council and the Commission declare that the provisions of this Directive shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or individual legislative acts containing such provisions.
Statement of the European Commission (Urgency)
The European Commission undertakes to keep the European Parliament and the Council fully informed on the possibility of a delegated act being adopted under the urgency procedure. As soon as the Commission’s services foresee that a delegated act might be adopted under the urgency procedure, they will informally warn the secretariats of the European Parliament and of the Council.
( 1 ) OJ C 306, 16.12.2009, p. 64.
( 2 ) OJ C 192, 15.8.2009, p. 6.
( 3 ) Position of the European Parliament of 19 May 2010 (not yet published in the Official Journal) and decision of the Council of 29 June 2010.
( 4 ) OJ L 102, 7.4.2004, p. 48.
( 5 ) OJ L 281, 23.11.1995, p. 31.
( 6 ) OJ L 184, 17.7.1999, p. 23.
( 7 ) OJ L 255, 30.9.2005, p. 22.