Following the transposition of the European Union Tissues and Cells Directives into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007, the HTA (as a risk based regulator) focused on directing its resources to ensuring that those activities that posed the greatest risk in terms of the quality and safety of tissues and cells used in human application were brought within the regulatory framework.
This risk based approach included the consideration that the use of acellular material (such as demineralised bone) in human application posed a significantly lower risk in terms of quality and safety than the use of cellular material.
The HTA took the proportionate, risk based decision to direct its resources to ensuring that all establishments engaged in activities involving the use of cellular material were regulated: this objective has now been achieved. A corollary of this risk based approach was that the HTA would not commence with regulating activities involving the use of acellular material unless a risk based need or other imperative arose.
Over the last few months a series of adverse events involving acellular material has been brought to the HTA’s attention. In light of these events and following extensive communications with the European Commission and other competent authorities the HTA has reconsidered its position on the regulation of acellular material. There is now a clear imperative for the HTA to regulate acellular material to enable it to work with other competent authorities to regulate (in particular), the distribution of this material within the EEA.
All establishments that are involved in the import, export and /or storage of acellular material prior to distribution must apply for an HTA licence by 6 April 2009. This will ensure compliance with the licensing provisions of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It will also ensure that the HTA is able to fulfil it’s responsibilities as a competent authority under the European Union Tissue and Cells Directives.
Issued 17 February 2009