COMMISSION DIRECTIVE 2006/86/EC
of 24 October 2006
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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (1), and in particular Article 8, Articles 11(4) and 28(a), (c), (g) and (h) thereof,
Whereas:
(1)
Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.
(2)
In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC 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.
(3)
An accreditation, designation, authorisation or licensing system for tissue establishments and for the preparation processes at the tissue establishments should be established in Member States in accordance with Directive 2004/23/EC, in order to ensure a high level of protection of human health. It is necessary to lay down the technical requirements for this system.
(4)
The requirements for accreditation, designation, authorisation or licensing of tissue establishments should cover the organisation and management, personnel, equipment and materials, facilities/premises, documentation and records and quality review. Accredited, designated, authorised or licensed tissue establishments should comply with additional requirements for the specific activities they carry out.
(5)
The air quality standard during the processing of tissues and cells is a key factor that may influence the risk of tissue or cell contamination. An air quality with particle counts and microbial colony counts equivalent to those of Grade A, as defined in the European Guide to Good Manufacturing Practice, Annex 1 and Commission Directive 2003/94/EC (2), is generally required. However, in certain situations, an air quality with particle counts and microbial colony counts equivalent to those of Grade A standard is not indicated. In these circumstances it should be demonstrated and documented that the chosen environment achieves the quality and safety required for the type of tissue and cells, process and human application concerned.
(6)
The scope of this Directive should embrace the quality and safety of human tissues and cells during coding, processing, preservation, storage and distribution to the healthcare establishment where they will be applied to the human body. However, it should not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos). The provisions of this Directive concerning traceability and the reporting of serious adverse reactions and events apply also to the donation, procurement and testing of human tissues and cells regulated by Commission Directive 2006/17/EC (3).
(7)
The use of tissues and cells for human application carries a risk of disease transmission and other potential adverse effects in recipients. In order to monitor and reduce these effects, specific requirements for traceability and a Community procedure for notifying serious adverse reactions and events should be set out.
(8)
Suspected serious adverse reactions, in the donor or in the recipient, and serious adverse events from donation to distribution of tissues and cells, which may influence the quality and safety of tissues and cells and which may be attributed to procurement (including donor evaluation and selection), testing, processing, preservation, storage and distribution of human tissues and cells should be notified without delay to the competent authority.
(9)
Serious adverse reactions may be detected during or following procurement in living donors or during or following human application. They should be reported to the associated tissue establishment for subsequent investigation and notification to the competent authority. This should not preclude a procurement organisation or an organisation responsible for human application from also directly notifying the competent authority if it so wishes. This Directive should define the minimum data needed for notification to the competent authority, without prejudice to the ability of Member States to maintain or introduce in their territory more stringent and protective measures which comply with the requirements of the Treaty.
(10)
In order to minimise transmission costs, avoid overlaps and increase administrative efficiency, modern technologies and e-government solutions should be used to perform the tasks related to the transmission and treatment of information. These technologies should be based on a standard exchange format using a system suitable for the management of reference data.
(11)
To facilitate traceability and information on the main characteristics and properties of tissues and cells, it is necessary to lay down the basic data to be included in a single European code.
(12)
This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.
(13)
The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 29 of Directive 2004/23/EC,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Scope
1. This Directive shall apply to the coding, processing, preservation, storage and distribution of:
(a)
human tissues and cells intended for human applications; and
(b)
manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other directives.
2. The provisions of Articles 5 to 9 of this Directive, concerning traceability and the reporting of serious adverse reactions and events shall also apply to the donation, procurement and testing of human tissues and cells.
Article 2
Definitions
For the purposes of this Directive, the following definitions apply:
(a)
‘reproductive cells’ means all tissues and cells intended to be used for the purpose of assisted reproduction;
(b)
‘partner donation’ means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;
(c)
‘quality system’ means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly;
(d)
‘quality management’ means the coordinated activities to direct and control an organisation with regard to quality;
(e)
‘Standard Operating Procedures’(SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
(f)
‘validation’ (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use;
(g)
‘traceability’ means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells;
(h)
‘critical’ means potentially having an effect on the quality and/or safety of or having contact with the cells and tissues;
(i)
‘procurement organisation’ means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment;
(j)
‘organisations responsible for human application’ means a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells.
Article 3
Requirements for the accreditation, designation, authorisation or licensing of tissue establishments
A tissue establishment must comply with the requirements set out in Annex I.
Article 4
Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes
Preparation processes at the tissue establishments must comply with the requirements set out in Annex II.
Article 5
Notification of serious adverse reactions
1. Member States shall ensure that:
(a)
procurement organisations have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells;
(b)
organisations responsible for human application of tissues and cells have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to the quality and safety of tissues and cells;
(c)
tissue establishments that distribute tissue and cells for human application provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in (b).
2. Member States shall ensure that tissue establishments:
(a)
have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse reactions as referred to in paragraph 1(a) and (b);
(b)
have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.
3. Member States shall ensure that:
(a)
the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority of the information included in the notification set out in Part A of Annex III;
(b)
tissue establishments notify the competent authority of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications;
(c)
tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex III.
Article 6
Notification of serious adverse events
1. Member States shall ensure that:
(a)
procurement organisations and tissue establishments have procedures in place to retain the records and to notify tissue establishments without delay of any serious adverse events that occur during procurement which may influence the quality and/or safety of human tissues and cells;
(b)
organisations responsible for human application of tissues and cells have procedures in place to notify tissue establishments without delay of any serious adverse events that may influence the quality and safety of the tissues and cells;
(c)
tissue establishments provide to the organisation responsible for human application information about how that organisation should report serious adverse events to them that may influence the quality and safety of the tissues and cells.
2. In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up shall be considered to be a serious adverse event. All persons or procurement organisations or organisations responsible for human application performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the competent authority.
3. Member States shall ensure that tissue establishments:
(a)
have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse events as referred to in paragraph 1(a) and (b);
(b)
have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.
4. Member States shall ensure that:
(a)
the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority of the information included in the notification set out in Part A of Annex IV;
(b)
tissue establishments evaluate serious adverse events to identify preventable causes within the process;
(c)
tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex IV.
Article 7
Annual reports
1. Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority. The Commission shall submit to the competent authorities of Member States a summary of the reports received. The competent authority shall make this report available to tissue establishments.
2. Data transmission shall comply with the data exchange format specifications as set out in Annex V, part A and B, and shall provide all the information necessary to identify the sender and maintain its reference data.
Article 8
Communication of information between competent authorities and to the Commission
Member States shall ensure that their competent authorities communicate to each other and to the Commission such information as is appropriate with regard to serious adverse reactions and events, in order to guarantee that adequate actions are taken.
Article 9
Traceability
1. Tissue establishments shall have effective and accurate systems to uniquely identify and label cells/tissues received and distributed.
2. Tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, in an appropriate and readable storage medium.
Article 10
European coding system
1. A single European identifying code shall be allocated to all donated material at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material and to provide information on the main characteristics and properties of tissues and cells. The code shall incorporate at least the information set out in Annex VII.
2. Paragraph 1 shall not apply to partner donation of reproductive cells.
Article 11
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2007, at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 10 of this Directive, by 1 September 2008.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 12
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 13
Addressees
This Directive is addressed to the Member States.
Done at Brussels, 24 October 2006.