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Arm's length from the Government, not from us

3 September 2012
By Henny Braund
Chief executive, Anthony Nolan
Appeared in BioNews 671

The political debate around the Government's Arm's-Length Body Review has centred on whether any change will deliver greater accountability, financial efficiencies or cuts to services. For Anthony Nolan, a charity that helps provide stem cells for patients who need life-saving transplants, the review is more nuanced.

As a collector and provider of stem cells from blood, bone marrow and umbilical cords, we fall under a range of domestic and international regulators and accrediting bodies in both clinical and research arenas. We'd be the first to propose measures for these bodies to work better together, but we have stopped short of calling for our UK regulators to be merged. In the light of the current consultation on the future of the Care Quality Commission (CQC), the Human Tissue Authority (HTA) and the Human Fertilisation and Embryology Authority (HFEA), it's right that we share our views and allow them to inform the debate.

The Government's preferred option for the HTA and HFEA is to merge them into the CQC. For us, that raises some concerns. The CQC regulates almost every provider of health or social care service in England: an enormous, ambitious undertaking. Adding the fast moving and highly specialised area of tissue and cell provision could leave us with a regulator that quickly falls behind the current thinking.

This isn't a concern about the competence of CQC in guiding the organisations they oversee, though they have told the Government they are not quite ready to take on these additional responsibilities.

Our concern is rather about focus. We have a regulator whose board has learnt some pretty complicated detail about cells, laboratory techniques, medical practice, genetics, national and international law. In turn, the board is supported by an expert executive. Board members play an active role in sector working groups, for example in transplant, ensuring they can guide the organisation with a clear awareness of their stakeholders' evolving needs. With both the board and executive unlikely to survive a merger with the CQC, it's hard for us to see how this level of focus could be maintained.

The HTA is not just a passive regulator of what can be done in a lab or with a patient or donor. It is an active influencer of progress in the EU and beyond. Anthony Nolan searches for donors for UK patients throughout the world, importing about 600 cell units each year. It is essential for those patients' safety that the laws governing international transfers of cells and tissues are up to date with scientific knowledge. HTA both influences international practice and learns from it. This role may not remain effective if HTA becomes a peripheral department of a much larger organisation, where other issues will always be at the top of the agenda.

It's not just the size of our field that would limit HTA's influence within the CQC. We would be impeded by the lack of controversy. Among other things CQC watches over hospitals, abortion clinics, cosmetic surgery and care homes. There are countless reasons for political involvement or media attention to ensure something is always of more concern to CQC management than tissue and cell provision. The parallel merger of the HFEA would add yet more challenging issues such as 'three-parent embryos' and fertility treatments resulting in the destruction of embryos.

The prospect of efficiency savings from the merger can also be challenged. The HTA has around 50 staff, running its operations from an office owned by a government department and shared with other organisations, such as the Medicines and Healthcare Products Regulatory Agency, with which they collaborate closely. As a small organisation, the HTA has already delivered the low hanging fruit in terms of efficiency - including 27 percent in cash savings - and gets by on less than a million pounds a year of government funding. The HTA is now looking at smarter ways of working, including with other regulators, to deliver further efficiencies.

The CQC, with over 1,000 staff regulating 22,000 service providers, is still tackling major challenges. A merger at this stage would inevitably impose on the HTA the inefficiencies of the larger organisation. And while sharing back office functions may deliver additional value to the CQC, it is not clear that the HTA would benefit from legal, financial or other services where, again, their needs are peripheral to the main thrust of the CQC's responsibilities.

Anthony Nolan is a facilitator of stem cell transplants and also a charity seeking to save the lives of patients with blood cancer. Our view is that the HTA could sit well inside the CQC at some point in the future if the concerns outlined here were addressed. But the CQC is itself a body undergoing major transition. We have to wait to see how the CQC emerges from its metamorphosis before bolting on important additional responsibilities.

Ultimately, we want a regulator that works closely with us to protect the safety of patients and donors. Such a regulator needs to be at arm's length from the government, not from us.

SOURCES & REFERENCES
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