Last night the Lords had a discussion of the Health Research Authority (HRA)- the new single regulator of health research across the UK which got up and running last week. They asked about the timeline for establishing the HRA as a non-departmental public body with regulatory power across the UK, exploring the functions the HRA will have up until that point operating as a special health authority and those it may take on once it is an NDPB. This includes debating whether the Human Fertilisation and Embyrology Authority (HFEA) and Human Tissue Authority (HTA) research regulating powers will move into the HRA.
Earl Howe outlined how the government see the HRA operating as a special health authority and confirmed that there will be a consultation shortly on the movement of HFEA and HTA functions - this has been delayed from the summer. He also confirmed that the government see NIHR rather than the HRA as the body best placed to streamline the process of getting multiple NHS research & development approvals before a project can get off the ground - a current source of considerable delays. Peers expressed their concern that this may not be enough action to make the difference that is needed.
The bill will now continue to be debated by the Lords so there will be further opportunities to raise this issue if peers are not satisfied with the answers from the government.
The Academy of Medical Sciences recommended in their review of the regulation and governance of health research in the UK which was published in January 2011 that a single regulator of health research be set up, to streamline regulation and make the process more straightforward and easier to navigate.
In the Plan for Growth which published alongside the 2011 budget in March, the government committed to establishing a Health Research Authority to act as this single regulator and to take a number of other steps to streamline the regulatory process.
They government have established the Health Research Authority as a special health authority in the first instance. It came into being on 1 December and has the National Research Ethics Service (NRES) at its core. The government is planning to bring in primary legislation to establish it as proper non-departmental public body with authority across the UK in time - allowing it to take on more research regulating powers.
The House of Lords have placed an amendment (258) to the Health & Social Care Bill which if passed would establish the HRA as a non-departmental public body right now. This is to allow them to press the government for more information about what the eventual HRA will look like, what powers it will have and how it will operate. There are several amendments tabled to allow them to explore different aspects of the new regulatory. They are keen to ensure that the final HRA looks like the single regulator originally envisaged by the Academy of Medical Sciences and supported across the medical research sector.
Last night's discussion
Peers raised their concern that there would be delay before a bill is brought to parliament to establish the HRA as a non-departmental public body. And until that time, it would not be able to take on all the regulatory powers the academy originally envisaged it would have and take action to streamline the regulatory process.
They explored what powers the HRA will have? Will the HRA be able to effectively act to streamline regulation?
- Until it becomes an NDPB, the HRA will not have power right across the UK as some regulatory arrangements are devolved.
- Will it have any power to streamline the process of getting multiple NHS research and development approvals to get a research project off the ground? In the plan for growth the government set up standard operating procedures and 70-day benchmarks to create incentives to improve the current system - but peers are concerned this is not enough.
- What ability will it have to provide advice and support?
- Will it create uniform UK-wide regulation rather than different systems operating in different parts of the UK.
- Why is it not being established straight away as an NDPB and the regulatory functions of the Human Tissue Authority and Human Fertilisation and Embryology Authority moved in? Moving both HFEA and HTA research regulating functions into the HRA was the government's original plan but there is considerable debate over this. Baroness Warwick who is chair of the HTA took part in the debate. The HTA is concerned about the possibility of its functions being split up - see here for more detail of their position.
- Pushing for more clarity around the relationship with the new HRA and the MHRA which regulates clinical trials of new medicinal products.
Earl Howe's response
Earl Howe - the health minister with responsibility for health research who is leading the health bill through the lords:
- Confirmed that the government will be consulting on the future of the HFEA and the HTA shortly.
- The government intend to publish drafts of primary legislation for pre-legislative scrutiny as soon as possible in the next session of parliament (i.e. after the next Queen's speech)
- He stated that the HRA will have "substantive functions as a special health authority" addressing peers concerns that it may not be very effective until it becomes an NDPB:
- Initially it will provide a single system for researchers to apply for approval to research ethics committees.
- By 2013 the HRA will take on board the functions currently performed by the Secretary of States on the advice of the National and Information Governance Board's ethics and confidentiality committee - basically making decisions over the use of patient data for research.
- And the HRA will immediately start to coordinate with the Care Quality Commission (CQC), the HFEA, the HTA and the NIHR to coordinate relevant functions - i.e. with the idea of getting to work on streamlining processes before it is set up as an NDPB and further research regulating functions are moved into it.
- The HRA will work closely with the devolved administrations to make it easier for researchers to navigate different regulatory systems
- Earl Howe also undertook to consider how the HRA will ensure it is monitoring and horizon-scanning developments relating to all the activities within its remit.
Lord Willis asked for a timetable for the HRA to deliver all of this.
- On streamlining the process of getting multiple research & development approvals from different NHS trusts, Earl Howe agreed that the consistency and efficiency of this approval process needs to be improved. But the government feel that the National Institute for Health Research (NIHR) is the body to drive this forward not the HRA. He listed the measures NIHR are taking to try and speed the process:
- research support services framework of standard operating procedures and good practice guidance
- research passport scheme
- the 70-day benchmarks for processing approvals which NIHR funding will be conditional on meeting.
The government's reasoning for this being the best approach is due to NHS trusts being autonomous bodies which must have a clear division from the organisations that drive them and those that regulate them. In response to this, Lord Willis did ask why, if no legislation is needed, this coordination is not already working effectively and expressed doubts that this is sufficient to tackle the problem...
Earl Howe also strongly resisted the idea of establishing the HRA through this bill, suggesting this would reduce opportunities for parliamentary scrutiny of the functions of the authority. However, there was some dispute over whether this is the case - the amendments would not stop consultations on the movement of functions into the authority from happening.
This was a committee stage debate. The bill still needs to go through report stage and third reading in the House of Lords before it returns to the Commons for all the Lords changes to be agreed. So there will be further opportunities to raise this issue if peers are not satisfied with the answers from the government yesterday.
In the meantime, the Health Research Authority is getting up and running as a special health authority.