The HTA (Human Tissue Authority) is announcing new rules for bone and skin products to protect patients from diseases such as HIV, Hepatitis C and CJD. The HTA already regulates the use of tissue containing cells to treat patients. The new rules will apply to material from humans that does not contain any cells.
The new rules mainly apply to two types of acellular product:
- products from bone used in orthopaedic surgery, such as hip or knee operations, or dentistry
- products from skin used to promote wound healing after injury or burns
The new rules will only affect those companies who import or store acellular products prior to distribution to end users. Companies must apply to the HTA for a licence by 6 April 2009 although earlier applications are welcomed. The HTA policy on acellular material has been revised in light of adverse events happening in other parts of Europe and on the advice of the European Commission.
Dr Sandy Mather, Director of Regulation at the Human Tissue Authority, said: “We have reviewed the risks to patients from bone and skin products after a number of cases where patient safety has been put at risk in Europe. Although the risk of transmitting disease through acellular healthcare products is very small, the diseases that could be transmitted are very serious and include HIV and CJD. This regulation will give us the opportunity to ensure that we can trace the person that the products came from, that products have been rigorously tested before use and that we can easily recall any products that have a risk attached.”
Adrian McNeil, Chief Executive of the Human Tissue Authority, said: “These new rules would prevent fraudulent products entering UK health service. There are examples of bone and skin products being imported into the UK that are not traceable to their donors. The body parts scandal involving the broadcaster Alistair Cooke saw products being imported into the UK with fraudulent origins. Acellular bone products from donors that had cancers, and may have had infectious diseases, entered the European healthcare system.”
- This regulation forms part of the European Union Tissue and Cells Directives (EUTCD).
- The EUTCD came into force from 7 April 2006 throughout the EU and was transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations on 5 July 2007. The HTA is one of two Competent Authorities in the UK for the EUTCD.
- The HTA will require all establishments that carry out activities involving acellular material to have applied for a licence by 6 April 2009 although earlier applications are welcomed.
- The Human Tissue Authority (HTA) is an independent watchdog that protects public confidence by licensing and inspecting organisations that store and use tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. We also give approval for organ and bone marrow transplants from living people through an independent assessment process.
- The HTA provides advice and guidance about two laws: the Human Tissue Act and the Quality and Safety Regulations. These laws ensure human tissue is used safely and ethically, with proper consent.
- More information about the HTA can be found on our website: www.hta.gov.uk.