DIRECTORY
Europe
Austria
Legislation
Donation:
- No distinction is made between the eye and the cornea: both are considered as tissues.
- Removal of the eye is allowed.
- Organ donation is an opting out system (presumed consent): objections are registered in the ‘Widerspruchregister’ or made known personally.
Cornea banking:
- In 2008 the Austrian Tissue Safety Act (Gewebesicherheitsgesetz) based on the EC-Directives on tissues and cells was implemented.
- An accreditation by a competent authority according to the Gewebesicherheitsgesetz is executed biannually, including inspection of eye banks
Belgium
Legislation
Donation:
- A law concerning tissues and cells exists
- No distinction is made between the eye and the cornea, both are considered as tissues.
- Donation of tissues and cells in deceased persons is an opting out system (presumed consent), comparable to the organ donation in Belgium: objections are registered in a nation wide computer database system.
Cornea banking:
- Eye banks need an accreditation of the Federal agency for medicinal products (FAGG) as the competent authority.
- Inspection of eye banks is performed by the Inspector of the FAGG, representing the competent authority.
- The criteria are defined in the Law and in an additional guidance document of a working group on Tissues, organs and cells of the advisory council of the Ministry of Health.
- In Belgium there is an national association of Tissue Banks. A separate national eye banking organization does not officially exist, but there is a close co-operation between the eye banks.
Bulgaria
Legislation
Donation:
- A law concerning organ donation and transplantation exists
- The eye is considered as an organ, the cornea as a tissue
- There is a central register, where one can register his/her will
- If not in the register, the next of kin gives consent
Cornea banking:
- Eye banks are accredited by the Executive Agency for Transplantation under the Ministry of Health.
- Executive Agency for Transplantation performs inspections, they define the criteria.
- EU directives are implemented
- There is no national eye nor a national tissue bank.
Croatia
Legislation
Donation:
A law concerning organ and tissue donation and transplantation exists (2004), harmonized according to EU drectives.
A law concerning transplanting donation, banking and transplantation of eye tissue exists (2007), harmonized according to EU drectives.
Removal of the whole eye is allowed.
Organ donation is an opting out system (presumed consent): objections must be declared in a written document. A register exists at the Ministry of Health.
Cornea banking:
- Eye banks need a licence from the Ministry of Health, law and regulations require Standard Operating procedures.
- Eye banks are inspected by the Ministry of Health.
Czech Republic
Legislation
Donation:
- Act No 285/2002 Coll. concerning organ donation has existed since September 2002 (Transplantation Act).
- Commission Directives 2004/23/EC, 2006/17/EC and 2006/86/EC are implemented in Czech Directive Decree No 422/2008 Coll., concerning the detailed requirements for safeguarding the quality and safety of human tissues and cells intended for use in man and Act No 296/2008 Coll., on safeguarding the quality and safety of human tissues and cells intended for use in man and on amendments to related acts (Act on human tissues and cells).
- The ‘Regulation on health capability of donors’ covers safety aspects of donation.
- Organ/tissue donation is an opting out system (presumed consent): A ‘register of people who do not agree with retrieval of organs/tissues is existing since September 2004.
- The Czech Republic is the only country in the world where legislation requires the testing of brain tissue from every eye tissue donor for the presence of pathogenic prions from January 2007 on.
Cornea banking:
- Eye banks need accreditation from the State Institute for Drug Control as the competent authority. This is granted after inspection and evaluation with regards to Czech legislation.
- State Institute for Drug Control is an organizational unit of the state, superior authority is the Ministry of Health of the Czech Republic.
- A national Eye Bank organization does not exist.
- Eye/tissue banks are affiliated with the Czech Transplant Society.
Denmark
Legislation
Donation:
- A law concerning organ donation exists.
- A national donor register exists. Corneas are included.
- Organ donation is an opting in system; It is possible to pass on the decision to the next of kin.
- Removal of the whole eye is allowed. Whether the eye is considered as organ is uncertain; the cornea is considered as tissue.
Cornea banking:
- A National Law concerning Tissue Banking exists.
- Tissue banks are operated according to written Standard Operating Procedures.
- Eye banks need an accreditation of the National Health Association and are regularly inspected by the association.
Finland
Legislation
Donation:
- A law concerning organ, cell and tissue donation exists.
- Organ donation is an opting out system (presumed consent). The objection can be written or oral. However, donor’s relatives are always consulted.
Cornea banking:
- An accreditation by the Finnish Medicines Agency (FIMEA) as the competent authority.
- Tissue banks are inspected regularly by FIMEA.
France
Legislation
Donation:
- A law concerning organ donation exists.
- The eye is considered as organ while the cornea is considered as tissue.
Removal of the eye is only allowed in case of heart beating donors. - Organ donation is an opting in system; permission is given on a written document (donor card) or by will; the relatives are also asked for permission.
Cornea banking:
- Eye banks need an accreditation of the Agence Française de Securité Sanitaire des Produits de Santé as the competent authority. The criteria are defined by the French Transplantation Society.
Inspection is performed by the ‘Agence Française de Securité Sanitaire des Produits de Santé’. - The French Transplantation Society, is the umbrella organization for eye and tissue banking.
Each year the ‘Annuaire des Centres Français de Conservation de Cornees’ is published. Data from this Annuaire are incorporated in this Directory.
Germany
Legislation
Donation:
Laws concerning organ and tissue donation exist.
Organ donation is an opting in system. Permission has to obtained from the next of kin, in will or on written document.
Removal of the eye as well as corneoscleral excision in situ are allowed.
Cornea banking:
- The cornea and all other parts of the eye (e.g. sclera, limbus) are considered as tissues. Donation and processing of these tissues are regulated by various law and their amendments.
- All eye banks need an accreditation of their local authority and of the Paul-Ehrlich-Institute which is an agency of the German Federal Mnistry of Health.
- Inspections of eye banks are performed by their local authority and by the Paul-Ehrlich-Institute. Both are defining their own inspection criteria.
- The Section for Tissue Transplantation and Biotechnology of the German Society of Ophthalmolgy is preparing regulations and standards for accreditation and inspection.
Greece
Legislation
no further details/information currently available
Hungary
Legislation
Donation:
A law concerning organ donation exists.
Organ donation is an opting out system; objection is collected in a computer data base or expressed on a written document; if there is no objection available permission is asked from the next of kin.
Cornea banking:
- An eye bank needs an accreditation. The competent authority for accreditation and definition of the criteria and for inspection is unknown.
Ireland
Legislation
Donation:
There is no law regarding organ donation.
While legislation is lacking, permission for donation is required, either in will, written document, or consent from the next of kin.
Cornea banking:
The European Directive for 31st March 2004 on setting the standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of human tissues and cells was transposed into Irish Law by mean of a Statutory Instrument S.I. No. 158 of 2006.
Due to concerns regarding vCJD, the Irish Tissue bank stopped accepting whole globes / corneas from Irish donors with effect from the 21st of January 2024. This has been under constant review, and it is envisaged that collection from Irish donors will re start towards the end of 2024. In the interim, corneas are imported into Ireland from the US.
The tissue bank also imports sclera, Amnion, pericardium and Fascia Lata for use in ophthalmic surgery. The tissue bank also supplies allogeneic serum eye drops for the treatment of severe dry eye. This product is manufactured under GMP conditions and is authorised as a medicinally exempt product .
Italy
Legislation
Donation:
A law concerning organ donation exists.
A distinction is made between the eye and the cornea: the eye is considered as an organ, the cornea as tissue.
Organ donation is an opt out donation system, although it is standard practice to speak with designated family members of the deceased before making any decision with regard to potential procurement.opt out donation system, although it is standard practice to speak with designated family members of the deceased before making any decision with regard to potential procurement.
Cornea banking:
Eye Banks need to be accredited/certified by the ‘Centro Nazionale Trapianti’ (National Transplants Centre) as the competent authority.
Inspection of eye banks occurs by inspectors nominated by the ‘Centro Nazionale Trapianti’. The criteria are set out in the technical document “Linee Guida per il prelievo, la processazione e la distribuzione di tessuti a scopo di trapianto” (Guidelines for the retrieval, processing and distribution of tissues for the purpose of transplant) produced by the Consulta tecnica permanente per i trapianti (Permanent Technical Council for Transplants) and the Centro Nazionale Trapianti.
A national Eye Bank organization exists: SIBO (Società Italiana Banche degli Occhi = Italian Society of Eye Banks).
A tissue banking organization does not exist.
Legal requirements for corneal storage solutions have not yet been defined.
Malta
Legislation
In Malta, the following laws govern all aspects of cornea donation and cornea banking:
MT: Human Blood and Transplants Act (Chapter 483 of the Laws of Malta) MT: Human Blood and Transplants (Fees) Regulations (Subsidiary Legislation 483.09 of the Laws of Malta)
MT: Traceability Requirements and Notification of Serious Adverse Reactions and Events Regulations (Subsidiary Legislation 483.03 of the Laws of Malta)
MT: Equivalent Standards of Quality and Safety of Imported Tissues and Cells Regulations (S.L. 483.08 of the Laws of Malta)
MT: Human Tissues and Cells (Coding, Processing, Preservation, Storage and Distribution) Regulations (Subsidiary Legislation 483.04 of the Laws of Malta)
MT: Human Organs, Tissues and Cell Donation Act (Chapter 558 of the Laws of Malta)
Donation:
Organ and tissue donation is an opt-in system, and signed consent from next of kin is required.
Currently only whole eye enucleation is performed, however in-situ excision of corneas will be introduced in the near future.
Cornea banking:
MALTA – National Blood Transfusion Service (NBTS)-Eye Bank is the only licensed establishment in Malta for donation, procurement, testing, processing, storage and distribution of corneas.
License is granted by the Licensing Authority – Department of Health Regulation Malta.
Currently, hypothermic storage is used for all cornea donations in Malta.
Norway
Legislation
Donation:
- A law concerning organ donation exists.
- A distinction is made between the eye and the cornea: the eye as an organ, the cornea as tissue.
- Organ and tissue donation may only proceed when informed consent from donor and/or the next of kin is obtained.
Cornea banking:
- Eye banks need to be certified by The Norwegian Directorate of Health.
- An inspection system of eye banks exists; The Norwegian Board of Health Supervision conducts inspections.
- An annual rapport has to be sent to The Norwegian Directorate of Health and to the Norwegian Board of Health Supervision.
Poland
Legislation
Donation:
An organ donation law exists.
Organ donation is an opting out system: objections are registered in a computer data-base or on a written document.
Cornea banking:
An accreditation by the IFETB USA as competent authority is required.
Inspection of eye banks occurs by the National Agency for Preservation of Organs and Tissues of the Ministry of Health indicative for another competent authority in addition to IFETB USA.
Portugal
Legislation
Donation:
A law concerning organ donation exists.
No distinction is made between the eye and the cornea: both are considered as tissues.
Removal of the eye is allowed.
Organ donation is an opting out system (presumed consent): objections are registered in the ‘RENNDA’ (The National Register of Non-Donors).
Cornea banking:
In 2009 the European Directives on tissues and cells was transposed into national law (Lei n.º 12/2009) and have been implemented.
Tissue banks, including eye banks, must be authorized by the competent authority according to the Lei n.º 12/2009. The competent authority also performs periodic inspections or other appropriate control measures in order to ensure compliance with this law (the interval should not exceed two years).
There is no National Tissue Bank or Eye Bank Association. However, a National Transplant Coordination Organisation exists, with responsability for the regulation and standardization of all the activities concerning organ, tissue and cell donation and transplantation.
Legal requirements for corneal storage solutions has not yet been defined.
Russia
Legislation
Donation:
A law concerning organ donation exists.
A distinction is made between the eye and the cornea, the eye is considered as organ, the cornea as tissue.
Organ donation is an opting out system, objection is laid down in a written document.
Cornea banking:
An accreditation by the Ministry of Health as the competent authority is required.
Inspection of eye banks occurs by the Ministry of Health, according to their criteria.
The storage solution must meet the requirements of a drug.
Slovakia
Legislation
Donation:
A law concerning organ donation exists.
A distinction is made between solid organs and tissues, but it is not mentioned to which the eye belongs.
Removal of the eye is allowed.
Organ donation is an opting out system, objection is laid down in a written document.
Cornea banking:
An accreditation by the IFETB is required.
Inspection of eye banks occurs by the IFETB, according to their criteria.
The storage solution must meet the requirements of a drug.
Slovenia
Legislation
Donation:
Laws concerning organ and tissue donation exists.
Organ and tissue donation permission has to be obtained from next of kin, in will or on written document.
Removal of the eyes as well as corneoscleral excision in situ are allowed
Cornea banking:
The cornea and all other parts of the eye (e.g. sclera, limbus) are considered as tissues. Donation and processing of these tissues are regulated by Zakon o kakovosti in varnosti cloveskih tkiv in celic, namenjenih za zdravljene (ZKVCTC).
All banks need an accreditation issued by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenija.
Inspections of eye banks are performed by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenija
Sweden
Legislation
Donation:
In 1996 the law was changed bringing the regulations for organ and tissue donations within one law, making no distinction between organs and tissues. Before that time Sweden was divided in sectors by organ co-ordinators.
Organ and tissue donation is an opting in system. It can be expressed in will, in computer data base, on a written document (donor card) or by the next of kin.
Cornea banking:
An accreditation/permission from competent authority for Health and Social Care Inspection (IVO) is required.
Every second year the tissue establishments are inspected by IVO, and if approved the permission for the establishment is prolonged.
National criteria are defined, following the EU regulations for tissue donation and tissue establishment management. These criteria are defined in law and statutes.
The national Eye Banks meet each other on regular basis.
A regional, but not national, tissue organization exists.
Switzerland
Legislation
Donation:
Donation is regulated in the Federal Law dated 8 October 2004 concerning the transplantation of organs, tissus and cells (Transplant Law, SR 810.21).
According to the Transplant Law, all over Switzerland, organ, tissue and cell donation is an opting in system. The will can be expressed on a written document (donor card), expressed by the next of kin (“The decision of the next of kin must be guided by what they believe the deceased person would have wanted”) or a trusted person delegated by the deceased person.
Cornea banking:
According to the Transplant Law, an authorization issued by the Federal Office of Public Health as the competent authority is required.
An inspection of the eye banks is required in connection with the authorization. The criteria for authorization are defined by the Transplant Law and the corresponding ordinances.
The storage solution is considered as vehicle and requirements are defined in the Federal Law dated 15 December 2000 on Medicinal Products and Medical Devices (Law on Therapeutic Products, LTP, SR 812.21).
The Netherlands
Legislation
Donation:
Since 1998 the Act on Organ Donation (WOD) exists in the Netherlands. Furthermore, in 2003 the Act on the Quality and Safety of Body material (WVKL) was implemented, based on EU Directive 2003/24/EC. In 2006, this act was supplemented with the Resolution for Body Constituents. The described legal requirements were again adjusted in 2012 to implement EU Directive 2010/53/EC and in 2017 to implement EC directive 2015/565.
Since July 2020 the Act on Organ donation is an opt-out system also referred to as Active Donor Registration System (ADR). At age 18 everyone is asked to register his will (permission, objection, decision by the next of kin or a designated person); in case no will is available in the national registry, this will be considered a no objection statement.
Cornea / Tissue banking:
Accreditation as an Organ Bank by the Ministry of Health as the competent authority is required.
Inspection of Organ Banks is performed once every two years by the Health Care Inspectorate (IGJ).
Accredited Organ Banks process tissues and are responsible for the quality and safety, which includes all processes from donor tissue recovery to distribution of the transplants. Furthermore, they perform allocation of non-HLA-matched tissues in the Netherlands and abroad.
Donor selection, donor screening and allocation of HLA-matched and emergency tissues are performed by the Dutch Transplantation Foundation, which holds an accreditation as an Organ Center.
United Kingdom
Legislation
Donation:
- The retrieval and use of tissue for transplantation is governed by the Human Tissue Act 2004. This Act requires that separate and specific consent is obtained before the removal of tissue for transplantation, research, education/training or for other purposes specified in the legislation.
- Either the donor must have given consent during his/her lifetime (e.g., donor card, National Organ Donor Register) or a nominated representative/family member must give consent on behalf of the donor.
Eye banking:
1. Cornea and sclera fall under the EU Tissue and Cells Directive 2004/23/EC and Commission Directives 2006/17/EC and 2006/86/EC. These Directives have been transposed into UK law through the Human Tissue (Quality and Safety for Human Application) Regulations 2007.The EU Directive requires tissue establishments to be licensed and tissue banks in the UK are licensed by the Human Tissue Authority (www.hta.gov.uk), the relevant UK Competent Authority for the purposes of the EU Tissues and Cells Directive.
The EU Tissue and Cells Directive set the minimum mandatory standards for tissue banks. Additional advice and guidance is provided by:
- The UK Department of Health Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) ‘Guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in Transplantation’ (www.dh.gov.uk).
- The UK Blood Services ‘Guidelines for the UK Blood Transfusion Services in the UK’ and ‘Tissue Donor Selection Guidelines – Deceased Donors’ (www.transfusionguidelines.org.uk).
- The Royal College of Ophthalmologists ‘Standards for the Retrieval of Human Eyes used in Transplantation and Research’ (www.rcophth.ac.uk).
2. Limbal Stem Cells/somatic cell therapies are classed as Advanced Therapy Medicinal Products. The regulatory framework for advanced therapy medicinal products (ATMPs) is established by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Regulation (EC) No1394/2007 on advanced therapy medicinal products amended Directive 2001/83/EC and Regulation (EC) No 726/2004. Licenced products require centralised European marketing authorisation following assessment by the European Medicines Agency (EMA). Unlicensed products, exempt from central authorisation can be supplied under the derogation permitted in Article 5(1) of Directive 2001/83/EC. Preparation on a non-routine basis in a hospital is permitted without central authorisation under Article 3 (7) of 2001/83/EC. The Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) is responsible for regulatory arrangements under the exemptions in the UK.
The ATMP Regulation (No 1394/2007) came into force on 30 December 2007. The UK’s legislation for implementing the Regulation under hospital exemption came into force on 19 August 2010. Manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Directive 2003/94/EC.
3. Autologous Plasma and Serum eye drops are regulated under the transposition into UK law by the Blood Safety and Quality Regulations 2005 of EU directives 2001/83EC, 2002/98/EC and 2004/33/EC. The UK Department of Health has designated the Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) as the relevant UK Competent Authority. Notification of serious adverse events and quality systems are regulated under Directives 2005/61/EC and 2005/62/EC.
North America
USA
Legislation
Donation:
Laws concerning organ and tissue donation exist and vary from state to state. For more informaion about individual state laws click here.
Organ donation is an opting in system. Permission has to obtained from the next of kin, in will or on written document, or by electronic registration.
Removal of the eyes as well as corneoscleral excision in situ are allowed.
Cornea banking:
The cornea and all other parts of the eye (e.g. sclera, limbus) are considered tissues. All eye banks must register with the FDA and comply with FDA regulations pertaining to tissue/eye banking. FDA inspects all registered entities.
Although not required, most, if not all eye banks are members of the
Eye Bank Association of America and subject themselves to rigorous acreditation process.
Some states have additional requirements for registration, testing and inspections.
US eye banking is probably the most standardized and advanced in the world.
Asia
Sri Lanka
Legislation
no further details/information currently available
Israel
Legislation
Donation:
A law concerning organ donation exists.
A distinction is made between the eye and the cornea: the eye is considered as organ, the cornea as tissue.
Organ donation is an opting in system, permission is obtained from the next of kin.
Cornea banking:
Inspection of eye banks by officials representing a competent authority is discussed.
A tissue banking organization does exist.