Global eyecare community unveil agreement for use of eye tissue

The International Agency for the Prevention of Blindness (IAPB) is an alliance of civil society organisations, corporates and professional bodies promoting eye health through advocacy, knowledge and partnerships.
Organisation: IAPB

GAEBA Representatives signed the Framework in the Presence of the Ministry of Health for Catalonia and Dr Jose Nunez – WHO Medical Products of Human Origin Service Delivery and Safety Department, and Dr Paul Dubord Ophthalmologist and WHO Expert Advisory Panel on Human Cell, Tissue & Organ Transplantation.

Press Release Barcelona Thursday 14th June 2018: Yesterday, we unveiled the world’s first global Agreement on the use of donated human tissue for ocular transplantation, research, and future technologies.

Named Barcelona Principles, the launch took place at an event hosted by Agreement Partners – including the IAPB, and local hosts – Centro de Barraquer Ophthalmology Centre and Barcelona Tissue Bank.) in the presence of representatives of the Catalan Government.

See the agreement here

About the Barcelona Principles

“The Barcelona Principles” says Global Alliance of Eye Bank Association Representative, Associate Professor Graeme Pollock, “has evolved due to the global community seeking guidance on current ethical dilemmas – where they seek to improve tissue access to millions of waiting recipients – without compromise of their personal moral integrity and professional Custodian responsibilities to the donor, recipient and the extended community.”

“The Barcelona Principles focus on 9 key strategies, informing on the management of altruistic and voluntary donations; their subsequent utility within ophthalmology and research; their retention as a public resource for the shared benefit of all; and their accessibility by waiting recipients.

“Collectively, the Barcelona Principles support nations and regions to tackle allocation and equitable access issues in their own jurisdiction, aiding policy and practice development, and recommendations for cross-border engagement1, 2.

“The Barcelona Principles also address areas of ethical ambiguity – namely profitization and supply chains to for-profits, and their use in research and product development.

“The global community is concerned about the emergence and development of a “market mentality” around donations, and the Barcelona Principles include clear statement – that it is our collective responsibility to protect and retain stewardship of altruistic donations as a public resource for the shared benefit of all3”, says A. Prof Pollock.

The Agreement’s key 9 Strategies include:

  1. Respect the autonomy of the donor and their next-of-kin in the consent process
  2. Protect the integrity of the altruistic and voluntary donation and its utility as a public resource for the shared benefit of all
  3. Support sight restoration and ocular health for recipients
  4. Promote fair, equitable and transparent allocation mechanisms
  5. Uphold the integrity of the custodian’s profession in all jurisdictions
  6. Develop high-quality services that promote ethical CTO management, traceability, and utility
  7. Develop local/national self-sufficient services
  8. Recognise and address the potential ethical, legal and clinical implications of cross-border activities
  9. Ensure ethical practice and governance of research (non-therapeutic) requiring cells, tissue and/or organs

Note: The Barcelona Principles Adhere to the World Health Organization’s Guiding Principles on Human Cell, Tissue and Organ Transplantation4.

The Barcelona Principles were developed in partnership with the Global Alliance of Eye Bank Associations (Lead), International Council of Ophthalmology, International Agency for the Prevention of Blindness, The Cornea Society, and in regions without eye bank representation, and in regions without an eye bank association, ophthalmology societies such as the Ophthalmology Society of the West Indies, and the Pacific Eye Care Society.

The Global Alliance of Eye Bank Associations Inc.: is an internationally recognized non-government, non-aligned association of eye bank associations providing peer and professional support, knowledge exchange, advocacy, vigilance, surveillance, and research and continual education opportunities to its members, in line with local, national and international recommended Standards of Practice. www.gaeba.org

About Corneal Tissue and Corneal Transplantation: Corneal blindness is the third leading cause of blindness worldwide after cataract and glaucoma.

An estimated 12 million people are awaiting a corneal transplantation. 50 countries are considered self-sufficient, almost self-sufficient or adequate for corneal transplantation, and have a median of 6.5 month waiting list. A majority of waiting recipients reside in countries without an eye bank or routine access to donated tissue.

Global data from a 2012 study5, identified 184.576 corneal transplants were performed in 116 countries. These transplants were procured from 283.530 corneas and stored in 742 eye banks. The leading transplant indications are Fuchs dystrophy (39%), a primary corneal oedema called keratoconus (27%), a corneal disease that deforms cornea in young people and sequalae of infectious keratitis (20%)

Donations are made, voluntarily and altruistically, on death. They are donated with consent for transplantation, training and research. Unlike other organs or blood, ocular donations do not need to be matched – making them accessible to a wider group of waiting recipients.

Image on top: GAEBA Representatives signed the Framework in the Presence of the Ministry of Health for Catalonia and Dr Jose Nunez – WHO Medical Products of Human Origin Service Delivery and Safety Department, and Dr Paul Dubord Ophthalmologist and WHO Expert Advisory Panel on Human Cell, Tissue & Organ Transplantation.

For further information: heather.machin@unimelb.edu.au

Reference:

  1. International Council of Ophthalmology. Position Statement: Donation, Processing, Allocation, Advocacy, and Legislation Supporting Human Corneal Tissue for Ocular Transplant. Sept 2017. http://www.icoph.org/downloads/ICO%20Position%20Statement%20on%20Corneal%20Tissue%20for%20Ocular%20Transplant.pdf
  2. Martin DE, Kelly R, Jones GLA, Machin H., & Pollock. G. Ethical Issues in Transnational Eye Banking. Cornea. 2017. 36, 2. 252-257.
  3. Global Alliance of Eye Bank Associations. Position Statement: Commodification and Profitization of human materials and ocular services. August 2017. http://www.gaeba.org/wp-content/uploads/2017/08/GAEBA-Position-Statement-Commodification-and-profitization-of-human-materials-and-ocular-services.pdf
  4. World Health Organization. Guiding Principles on Human Cell, Tissue and Organ Transplantation. 2010. http://www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf
  5. Gain P, Jullienne R, Aldossary M, Acquart S, Cognasse F., & Thuret F. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2015. December 3.