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Bristol, 14 March 2016
Dear EEBA Member
Each EEBA President serves for three years and Jesper Hjortdal has now completed his extremely successful term of office. Jesper remains on the EEBA Committee as the Immediate Past President and his wealth of experience and knowledge will be invaluable as EEBA continues to develop and increase its influence within Europe and beyond. Jesper’s achievements over the past three years are beyond question and, as your new President, I hope with your help not only to build on his success and consolidate his initiatives but also to introduce some new objectives.
A new President also means a new Vice President and it is with great pleasure that I welcome Iva Dekaris who was successful in the recent ballot of members. Iva has served previously as President, which means that I am doubly fortunate in the support and advice available to me from both Iva and Jesper. Added to this, the Committee and our Special Interest Groups remain strongly committed to the aims and mission of EEBA “to help provide tissues and cells of optimum quality and safety for transplantation and the treatment of eye diseases, according to the highest medical and scientific standards, and making them available to as many patients in need as possible in an ethical and humanitarian way, in accordance with the Declaration of Helsinki and applicable national and international laws and regulations”.
Underpinning the work of the Committee and keeping the machinery of EEBA running smoothly is of course the invaluable contribution from our Executive Officer, Gary Jones.
Some of the key objectives that I think are especially important to address include:
Establishing a bioethical framework for EEBA. As such, the EU Tissues and Cells Directives (EUTCD) have established principles for the quality and safety of ocular tissue for patient treatment but it is not their remit to cover ethical principles. EEBA’s Minimum Medical and Technical Standards pre-date the EUTCD but are kept under review to ensure that they comply with the Directives, while acknowledging that not all EEBA members are based in countries that are bound by the EUTCD. Establishing agreed ethical principles, such as co-operation and collaboration rather than competition between eye banks, voluntary unpaid donation of eyes and corneas for the greater good in line with the WHO’s Guiding Principles for Transplantation and the Council of Europe’s Oviedo Convention, guidance for the import/export of ocular tissue and the related concepts of self-sufficiency and sustainability, biovigilance and openness and transparency in the supply of ocular tissue.
Reviewing the data collected for the EEBA Annual Directory. The Directory has been an invaluable resource over the years and I feel it would be timely to review the activity data that are collected every year. Such data become increasingly valuable the more complete the dataset and the best way to encourage the participation of members in this is to ensure that the data collected are seen to be relevant and useful. This has clearly been the case in the past but with changes in eye banking and transplant practices over the past few years your thoughts and input would be an invaluable part of the review process. An initiative that started under Jesper’s presidency, and in which EEBA is a partner, is the development of an EU Corneal Transplant Registry. Following on from their successful establishment of the European cataract and refractive surgery registry, ESCRS, along with EEBA and the registries in the Netherlands, Sweden and the UK, jointly applied to the EU for funding support for this exciting project. In December, the EU notified us that our application had been successful and the final administrative arrangements are being put in place in preparation for the start of the project.
Maintaining and increasing our influence with regulators and others such as the Council of Europe. To this end, I am co-chairing with Mona Hansson (Stockholm) the drafting group for the Council of Europe 3rd edition of its Guide to the Quality and Safety of Tissues and Cells for Human Application. The Council of Europe includes 47 Member States, of which 28 are in the EU. So it is a much broader organization and its Tissues and Cells Guide forms an invaluable resource for advice and guidance across all tissues and cells used for treating patients. EEBA’s input into this Guide is valuable as it may also be taken up by regulators and used in eye bank audits and inspections. Arrangements were made through the organizers of the recent Aarhus EEBA Meeting to provide access to members to the 2nd edition of the Guide. The Council of Europe intends to make the 3rd edition freely accessible (i.e., without charge).
Enhancing EEBA representation in the field of Regenerative Medicine. There is currently much discussion within Europe concerning substances of human origin (SoHO) and the boundaries between ‘traditional’ tissues and cells and advanced therapeutic medicinal products (ATMP), which are regulated under different EU Directives. Regenerative medicine is a rapidly developing area and a new Special Interest Group, chaired by Stefano Ferrari, has been formed to represent EEBA in this exciting area. In addition, on the initiative of Esteve Trias (Barcelona), EEBA has joined the European Association of Tissue Banks, the European Blood Alliance and the European Society for Bone Marrow Transplantation to form a group for the “Common representation of SoHO Associations within Official Institutions of European Union”. The purpose is to work with the EU to provide expert advice in our particular areas of activity, especially where the boundaries between tissues and ATMPs are uncertain. EEBA should continuously try to participate in projects related to tissue transplantation and provide informed comment to external agencies whenever possible.
Supporting eye banks in the implementation of the Single European Code. EEBA has in the past offered practical support and guidance to its Members during the development and implementation of the EU Tissues and Cells Directives. This support is a continuing need with, for example, the impending implementation of the Single European Code (SEC) for tissues and cells. Those attending the Aarhus Meeting were able to attend a workshop on the SEC and hear an authoritative talk on what must seem a complex issue for those eye banks that do not already use a coding system, such as ISBT 128 or Eurocode, for their ocular tissues.
I welcome this opportunity to serve you as EEBA President and look forward to working together with you for the next three years. I value any comments, support, suggestions and assistance that you as individual Members can offer EEBA for the continued development of European eye banking. Participation at our Annual Meetings, putting yourselves forward for election to the EEBA Committee, contributing expertise to our Special Interest Groups, and offering to organize future Annual Meetings are all ways in which you can make a valuable contribution towards our Association as the foremost forum for promoting eye banking in Europe.