The Queen announced lots of new Bills on 8th May - including a couple which are important for medical research. The Care Bill and the Intellectual Property Bill - the Care Bill includes clauses that will establish Health Education England (HEE) and the Health Research Authority (HRA) as non-departmental public bodies - both of which play an important role in supporting research in the NHS, educating NHS staff and regulating health research respectively. The Intellectual Property Bill includes clauses designed to provide an exemption for research in the Freedom of Information Act. Both Bills have been published and debates are beginning in Parliament this week. We will be following them closely and working with parliamentarians to ensure the best outcomes for research and patients.
The Care Bill
The Care Bill is going to be scrutinised first by the House of Lords and then the House of Commons; the first big debate is second reading which is scheduled for Tuesday 21 May. You can read the Bill and follow its progress here. The Bill follows a draft Care and Support Bill which was scrutinised by a committee of peers and MPs in the last session of parliament. They took evidence - AMRC submitted written evidence and were invited to speak to the committee. In the light of this, the committee made recommendations for how the Bill could be improved. The government has responded to each of these recommendations in turn and made some changes which are now in the new Care Bill. The Bill covers lots of areas - including care and the government's response to the Francis report - so the section relating to HEE and HRA is relatively small. Part 3 Chapter 1 and Schedule 5 & 6 concerns HEE, Chapter 2 and Schedule 7 & 8 is HRA. What do we think? Health Education England We are really pleased that the duty to promote research and the use of research evidence placed on HEE has been strengthened to mirror that on the Secretary of State for Health, NHS England and CCGs. But we would like to clarify that this duty also applies to Local Education and Training Boards – these are committees of HEE that coordinate education at a local level. It is very important for education and training at a local level to have regard to the need to promote research. When we asked almost 400 health professionals whether they have experienced barriers to being involved in medical research over the last two years, one in five of the GPs and nurses responding felt that they lack the necessary skills or experience to take part in medical research and a third (34% and 32% respectively) told us they were not very confident in talking about research with their patients. HEE should ensure that all NHS staff are given the tools to understand research and to assess and use evidence to inform their decisions when caring for patients or supporting clinical staff. LETBs will play a key role in ensuring that NHS staff gain these skills at a local level so it is important that the duty extends to them. Our Vision for Research in the NHS goes into more detail, including a call for each LETB to include skilled research professionals. Health Research Authority The process of obtaining local R&D approvals is currently the cause of considerable delays in gaining the necessary approvals for research studies to go ahead. The government has attempted to address these difficulties by giving the HRA the power to write guidance on these processes and requiring local Trusts to comply with this. We welcome this but we would like more detail about how the HRA will be able to make sure local Trusts comply with this guidance. The HRA's role in promoting transparency was a key issue considered during scrutiny of the draft Bill. The government has stated that transparency is included within the requirement to encourage safe and ethical research which is already on the HRA. The HRA has published its plans to promote transparency this week. Patients and the public should be confident that the findings of research that they have participated in will be used and disseminated to benefit others. Clinical trials are conducted across the world, so action to increase transparency and improve healthcare needs to be taken on a global scale. We believe the HRA has a key role to play in promoting transparency alongside other bodies. We will be working with parliamentarians ahead of the debates this week to raise these ongoing issues and get further clarification.
The Intellectual Property Bill
This Bill is also starting in the Lords, with its second reading taking place on Wednesday 22 May. Read a copy of the Bill and follow its progress here. Clause 19 introduces an exemption for research to the Freedom of Information Act. This is intended is to prevent the Freedom of Information Act being used to make researchers share data they are collecting as part of their research before it is peer reviewed and published. This allows an exemption where there is a clear intention to publish. This follows debate during the Protection of Freedoms Bill in the last session of Parliament where concerns were raised that FOI could be used to force researchers to release data they are collecting before they themselves have analysed this - raising concerns both that data could be misinterpreted or that rival researchers could gain access to other's data. Similar protection exists in Scotland. The Justice Committee considered these issues last year and recommended:
31. We recommend section 22 of the Act should be amended to give research carried out in England and Wales the same protection as in Scotland. While the extension of section 22 will not solve all the difficulties experienced by the universities in this area, we believe it is required to ensure parity with other similar jurisdictions, as well as to protect ongoing research, and therefore constitutes a proportionate response to their concerns. Whether this solution is sufficient and works satisfactorily should be reviewed at a reasonable point after its introduction. (Paragraph 214)
We strongly supports steps to increase transparency and accessibility of data by those who need, with relevant safeguards to protect confidentiality. It is important to make research data widely available to the research community to maximise public benefit. However, this must be done in a timely and responsible manner to ensure that data can be verified, built upon and used to advance knowledge and its application to generate improvements in health. We'll be looking at this closely to see if it achieves that balance. You can read more about these issues in this summary of a debate held last year on this topic with Baroness O'Neil, Mark Walport and George Monbiot.
These Bills will go through scrutiny in the Lords and then move to the Commons. We will be following them closely and working with parliamentarians to raise the implications for research and ensure the best outcomes for research and patients.