Legislation Malta

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.