The government is asking for our views on the future of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). Both of these independent authorities have a role in regulating research involving human embryos and tissue, respectively. They have launched a consultation today and we have three months to respond - it will close on 28 September 2012.
Back in July 2010, the government reviewed all the arms-length bodies (ALBs) associated with the NHS - the so-called "bonfire of the quangoes". This included plans to close the HFEA and HTA and move their research regulating functions into the Health Research Authority (at the time referred to simply as a "new research regulator"). Their other functions would move into the Care Quality Commission.
However, concerns were raised over how this would work, particularly how to ensure the regulatory expertise and horizon-scanning - which the authorities do to keep up with the new regulatory challenges presented by scientific progress - was not lost, and ultimately to ensure that the public could still have confidence in how this research is regulated.
The proposed move of functions was raised in debate in the Lords several times - particularly during debate of the Health and Social Care Act 2012 where the newly established Health Research Authority was considered.
The HTA has a page on their website outlining their position on the proposed move - they are concerned about their research regulating functions being split from their other regulatory functions:
We continue to believe that the functions we regulate should stay together to ensure public confidence, and we are less concerned where those functions transfer, as long as they can be carried out effectively.
The government announced that they would consult on the changes before deciding their way forward. When Earl Howe originally announced these consultations he suggested that this would be a two stage process:
my department is planning to undertake a public consultation exercise this summer about where HFEA and HTA functions are best transferred. We regard this as a key part of the process. We will consult on any subsequent use of powers agreed in the Public Bodies Bill to effect those transfers. Effectively therefore, there will be two consultations.
The Academy of Medical Sciences recommended the creation of a single Health Research Agency in their review of the regulation and governance of health research. This included a proposal (recommendation 13 a) that the new agency should:
Increase clarity, consistency and efficiency by bringing together the provision of ethics opinion and 'specialist approvals and licenses' to:
- provide a single ethics opinion.
- provide 'specialist approvals and licences', (e.g. for studies involving patient data, human tissue, gene therapies or human stem cells).
The Health Research Authority was established in December to bring all the health research regulating functions together in one place with an aim to streamline the regulatory process, maintaining robust regulation but making it simpler to get research projects off the ground. It has the interests of patients at its heart to ensure we undertake the very best research:
The purpose of the HRA is to protect and promote the interests of patients and the public in health research.
It is currently operating as a special health authority but the government is planning to introduce legislation in a future care and support bill to establish it as a non-departmental public body.
The HFEA and HTA also have a strong remit to engage with the public and ensure they have confidence in how they regulate health research.
What does the consultation say?
- All functions should transfer to the Care Quality Commission except the HFEA functions relating to research that would pass to the Health Research Authority; and the HFEA and HTA be abolished.
- All functions should transfer, as set out above, but a limited number of functions that would transfer to organisations other than the CQC.
- The HFEA and HTA should retain their functions but deliver further savings.
The consultation sets out these options and what would be involved to establish each in more detail. This is quite complicated as the HFEA covers the whole of the UK, but the HTA covers England, Wales and Northern Ireland - not Scotland, which is covered by different human tissue legislation. They also have EU obligations, acting as competent authorities for different pieces of legislation. The Health Research Authority currently exists as a special health authority which only has authority over England. When it is established as a non-departmental public body it will have authority across the UK. So there are lots of different responsibilities to juggle in making changes to the system.
The consultation contains detailed background (chapter 2 and Annex C) on the HFEA, the HTA, the Care Quality Commission and the Health Regulatory Authority.
Chapter 3 outlines the three options and what would be involved in each - looking in detail at where various regulatory functions would move. Throughout the consultation asks for comments and suggestions on how this might work.
Annex A summarises all the questions.
We have until 28 September 2012 to respond.
This is a big change to who regulates medical research and AMRC will be working with our members to respond to this consultation. We are also expecting the draft Care and Support Bill to be published shortly. This will contain clauses to establish the Health Research Authority as a non-departmental body - the Health Research Authority that the government are proposing should take over some of the research regulating functions of the HFEA and HTA - so the outcomes of this consultation will inform discussion of this draft bill.