Today the Department of Health (DH) has published the Government’s response to the consultation on Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017. The Regulations will transpose EU Directives on coding and import for tissues and cells into UK law. We expect the amendment Regulations to come into force in the UK on 1 April 2018.
The Directives will primarily affect individuals who hold a Human Tissue Authority (HTA) licence in the human application (HA) sector.
About the Directives
There are two directives:
- The coding Directive
This will affect all HTA establishments licensed for human application and brings in measures to implement a Single European Code (SEC)
- The import Directive
This will affect any establishment that currently is, or will in the future be, importing tissues and cells for human application.
The DH’s consultation on the draft Regulations took place in March 2017. It sought views on a range of questions regarding implementation, including the estimate of the likely cost of implementing both directives for establishments licensed by the HTA.
How to comply
To support professionals working in the HA sector, the HTA has developed guidance aimed at particular groups of establishments, including:
- private tissue banks/establishments that store tissues and cells for potential future use;
- commercial importers and distributors;
- haematopoietic stem cell (HSC) registries and transplant centres;
- tissue banks; and
- establishments that procure starting material for the manufacture of Advanced Therapy (Investigational) Medicinal Products (AT(I)MPs).
There is also further information available on our website.
HTA Chief Executive, Allan Marriott-Smith said: “These Directives aim to facilitate traceability and to ensure that there are equivalent standards for imported tissues and cells in the UK. These objectives support our aim to make sure human tissue is stored and used safely, ethically, and with proper consent.
We are committed to working with our stakeholders to ensure a smooth transition and proportionate approach to implementation. To do this effectively, we encourage establishments to read our guidance and to contact us for further information.”
- The Human Tissue Authority (HTA) is an executive agency of the Department of Health, established by the Human Tissue Act 2004.
- The HTA is the regulator for human tissues, cells and organs. The HTA is also the Competent Authority for ensuring the quality and safety of organs intended for Transplantation, and tissues and cells for human application.
- Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.www.hta.gov.uk