It was announced at the end of July that following the
Government's review of arm's length bodies, there will be a reduction in the
number of the health regulatory bodies. The aim is to cut costs and reduce
duplication so that the work done is by means of the most efficient use of
resource. In terms of the impact on those working in the regenerative medicine
field, the relevant regulatory bodies include the HFEA (Human Fertilisation and
Embryology Authority), the HTA (Human Tissue Authority), the HPA (Health
Protection Agency) and the MHRA (Medicines and Healthcare products Regulatory
Agency).
One role of the HFEA is in relation to human embryo storage
and research including the derivation of human embryonic stem cell lines
(hESCs). However, the HFEA's remit stops at the point at which the hESC lines
are generated and (as a condition of a licence to conduct such research)
deposited in the UK Stem Cell Bank.
The HTA regulates the removal, storage and use of human
tissue, including stem cell lines where they are intended for use in human
clinical application such as a medicinal product, the HTA also governs the
donation, procurement and testing of those cells to ensure that they are in
compliance with the EU Tissues and Cells Directive.
The MHRA regulates medical devices and medicines which are
to be brought to market. Included in the MHRA's remit are products and
therapies derived from tissue engineering whether classified as an Advanced
Medicinal Therapy, or not.
The HPA is relevant in this context primarily through the
fact that the National Institute of
Biological Standards and Control (NIBSC) merged in to the HPA on the 1 April
last year. NIBSC hosts the UK Stem Cell Bank which acts as a depository for
human stem cell lines of all types, but in particular hESCs derived under
licence from the HFEA.
The proposal from the Government's review is no make no
change to the MHRA, abolish the HPA but to retain both the HFEA and the HTA for
the time being. The functions of the HPA will transfer to the new Public Health
Service in due course and the functions of the HFEA and HTA will in time be
transferred by the end of this current parliament. One of the key questions is
what entity will assume those functions - it is not yet clear whether it will
it be to a new regulator, the Care Quality Commission and/or the Health and
Social Care Information Centre.
There has been a mixed reaction to this initial government
review. There have been proposals before to merge at least the remit of the
HFEA and HTA into one regulator. During the pre-legislative review of the Human
Tissue and Embryos draft Bill 2007, the Joint Committee made the recommendation
against merging the HFEA and HTA into a single authority - RATE (the Regulatory
Authority for Tissue and Embryos). There was concern at the time that a
combined body would lack the necessary expertise for either regulatory
function. However, many thought that this concern could be addressed by way of
specialist sub-committees. The benefit for those working in the regenerative
medicine field, especially those working with hESCs, could be simplified
interaction with a single regulator that would be responsible for the initial
licence for research, through to compliance with requirements for cells that
are to be used in human clinical application and the onward interaction with
the MHRA in taking that to market.
However, there is time for much debate on the pros and cons
of who will assume responsibility for the roles that the HFEA and HTA play and how
they will inter-relate. Any change to the current set up would need to be by
way of primary legislation amending both the Human Embryology and Fertilisation
Act 1990 and the Human Tissue Act 1994 which established the HFEA and HTA
respectively. However, this could be seen as an opportunity to streamline some
of the conflicts or overlap that are perceived to be the case in dealing with
the HFEA and HTA as two distinct regulators, particularly from the perspective
of a hESC line that has commercial applications as a medicinal product.
Philippa Montgomerie
DLA Piper Scotland LLP
August 2010