Clause 109 - Co-ordinating and promoting regulatory practice etc.

Care Bill [Lords] – in a Public Bill Committee am 11:30 am ar 30 Ionawr 2014.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Paul Burstow Paul Burstow Democratiaid Rhyddfrydol, Sutton and Cheam 11:30, 30 Ionawr 2014

I beg to move amendment 91, in clause 109, page 95, line 35, after ‘Health;’, insert—

‘() the Chief Nursing Officer of the Department of Health,’.

Photo of Hugh Bayley Hugh Bayley NATO Parliamentary Assembly UK Delegation, NATO Parliamentary Assembly (President)

With this it will be convenient to discuss amendment 169, in clause 109, page 95, line 41, at end insert—

‘(j) the Chief Nursing Officer of the Department of Health;

(k) the Medicines and Healthcare Products Regulatory Authority.’.

Photo of Paul Burstow Paul Burstow Democratiaid Rhyddfrydol, Sutton and Cheam

As was said at the beginning of the previous sitting, we are very nearly there. I did not see a man on the way here with a sign saying, “The end is nigh”, but none the less it feels like we are pretty much at the end of the road in this wonderful process. I look forward to the two days of Report, the next stage of the Bill.

The amendment is short but, as I hope the Minister will agree, perfectly formed. Its intention is to correct a defect that I think must have resulted purely from an oversight. Clause 109, which outlines the co-ordination and promotion of regulatory practice with regard to the Health Research Authority, lists numerous individuals or organisations that should be part of the consideration of how the HRA operates. Subsection (1) contains a long list that includes, quite rightly, the Secretary of State, those responsible for licensing medicines, the Health and Social Care Information Centre, the chief medical officer and several other bodies.

One problem with comprehensive lists is that later they can be interpreted as excluding rather than including, so I wanted to ensure that we did not erroneously exclude the voice of a rather important profession in such matters: the Department’s chief nursing officer, who seems to me to have some interest in supporting the Health Research Authority in the discharge of its responsibilities, ensuring that the nursing profession plays its part in promoting access to and awareness of trials, and supporting patients and families in decisions that are sometimes difficult and complex. I therefore tabled the amendment to ensure that the central and fundamental role of nursing is reflected properly. I hope that the Minister can give us some reassurance that its omission was an oversight that the Government are keen to correct. I look forward to his response.

Photo of Hugh Bayley Hugh Bayley NATO Parliamentary Assembly UK Delegation, NATO Parliamentary Assembly (President)

It has been the practice so far in our discussion of the Bill to debate amendments and therefore not clause stand part. My intention with this group is to continue on that basis, so if people want to speak more widely about the clause and not just about the narrow amendments, they are free to do so.

Photo of Sarah Newton Sarah Newton Ceidwadwyr, Truro and Falmouth

Thank you very much, Mr Bayley. I would certainly like to take that opportunity, so I welcome your decision.

When I was travelling in on the tube this morning, I did not see, “The end of the world is nigh”, but I did notice a Cancer Research UK advert proclaiming, “Three times more people than are in this carriage are saved by research each day”. It struck a chord with me about the importance of these discussions. Getting the regulation right for how we undertake medical research is critical, not only because that research saves and improves lives but because the UK is a world-leading centre for research, and we have world class universities in life science and medical research. The purpose of setting up the Health Research Authority was to facilitate safe and ethical research and, by working with relevant partners, help create an environment in which applying to do research is simpler and people get quicker decisions. That will be an important part of getting the regulatory regime right. Will the Minister therefore confirm that, as the HRA becomes an arm’s length organisation, the anticipated triennial review will take place so that its achievements so far can be noted, lessons can be learnt and improvements considered?

I have the great fortune of being a member of the Science and Technology Committee, which undertook an inquiry into medical research and clinical trials. In that, we noted the significant positive steps that the Government had taken to build trust among the public about the safety of participation in clinical trials and how well received the HRA has been so far. I want clarity on whether the HRA’s important work, such as its 2013 “OK to ask” campaign, which encouraged people to participate in clinical trials by raising awareness, will be part of its new regulatory regime as proposed in the Bill, so that protection of those participating in clinical trials and promotion of participation is there in equal measure.

The UK Clinical Trials, which the Government introduced, is great: it helps more people understand how they can participate in research and enables more research to be carried out. In the Minister’s summing up, will he confirm that the HRA will have, as its key role, not only protecting people, but promoting participation in medical research so that the UK’s world-leading academics can continue to pioneer new treatments? That work is not just a benefit to our constituents; it contributes a great deal to growth in the economy, which the Government see as being science and technology based.

Photo of Jamie Reed Jamie Reed Shadow Minister (Health)

I almost regret mentioning the gentleman with the sandwich board that said, “The end is nigh,” not least because I forgot to mention which constituency he represented—I am sure that it was a marginal seat.

I thank the right hon. Member for Sutton and Cheam for tabling his amendment and starting the debate on this group of amendments. He has demonstrated a  sound and impressive knowledge of the Bill and the pertinent issues throughout our Committee sittings. I do not think that we have disagreed in principle at any time, even if our opinions have diverged at certain points on the most effective means of achieving our aims. Our agreement here is no surprise, given the wording of his amendment and that of amendment 169, which is in my name and that of my hon. Friend the Member for Leicester West. Both amendments would make additions to subsection (1).

The subsection states that the HRA must co-operate with a number of groups to exercise effectively its

“functions relating to health or social care research, with a view to co-ordinating and standardising practice relating to the regulation of…research”.

So far, so good. The explanatory notes state:

“The aim of this…is to encourage co-ordination and standardisation of practice of such bodies and persons when carrying out functions relating to the regulation of health and social care research.”

That is a commendable aim, the achievement of which would undoubtedly improve the efficiency of undertaking research, which would be to the benefit of health service professionals and patients.

I share the right hon. Gentleman’s concern about omissions from the list in the subsection and he made a good point about the nature of a comprehensive list. Amendment 169 deals with two omissions: the chief nursing officer and the Medicines and Healthcare products Regulatory Authority. I thank the Royal College of Nursing for its help and advice on the first part of the amendment. It believes that the omission of the chief nursing officer is an oversight that must be rectified. It stated:

“The nursing profession has a fundamentally important contribution to make in health and social care research, recognised by the UK Clinical Research Collaboration...and National Institute for Health Research”.

The college goes on to argue:

“The paucity of evidence of what works in care and caring practices could be a factor in identifying what constitutes good levels of care. In times of austerity when resources are limited it is more important than ever to ensure that care and caring practices are both compassionate and effective.”

I am sure that the Committee agrees with such arguments. If those are not sufficient to justify the inclusion of a chief nursing officer, the RCN gives further reasons:

“Research is essential to develop the knowledge base to underpin nursing practice and ensure that the deployment and interventions of the largest health care workforce are both efficient and effective.”

As the right hon. Gentleman has set out, there is simply no justification for the omission of chief nursing officer from the list. I hope that the Minister will agree with the arguments and accept the amendment. If not, I hope he will explain why.

Our amendment goes further: we want to see the Medicines and Healthcare products Regulatory Authority included in the list. I understand that the licensing authority is referred to in the list, but, under the Medicines Act 1968, the function is conferred on a group of Ministers to act as the licensing authority, so there is legislative reasoning for the inclusion of the MHRA. With the functions of the clause to promote co-operation and research and the regulation of research, it is essential that the body responsible for regulating medicines in the UK is included.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring that they work and are acceptably safe. Underpinning all its work lie robust and fact-based judgments to ensure that the benefits justify the risks. That is the blurb from the MHRA website. It clearly has a role to play in the standardisation of research practices. Can the Minister outline the role he expects the MHRA to play in relation to the functions of the HRA in subsection (1)? The benefits of involving the regulator of medicines and medical devices in the research and the development of medicines and medical devices is surely apparent to all. The MHRA expertise on the efficacy and safety of products cannot be surpassed, and it must have a part to play in this area.

One of the key objectives for the MHRA is to support research and ensure, through the application of better regulation principles, that regulation does not stifle innovation. As such, its place in the process becomes even clearer. Subsection (l)(i) gives the Secretary of State power to introduce regulations that would give direction for other groups to be included in the list, with which the HRA must co-operate. Can the Minister give assurances that both the chief nursing officer and the MHRA will be included when the regulations are introduced, and can he assure the Committee that that will be done sooner rather than later? If he can give those assurances, there will be no need for me to test the will of the Committee.

Photo of Daniel Poulter Daniel Poulter The Parliamentary Under-Secretary of State for Health

I am pleased to confirm to the Committee that the consensual nature of our proceedings will continue in our discussions on the clause. We have had speeches from Government and Opposition Members highlighting the importance of facilitating research and ensuring, as my hon. Friend the Member for Truro and Falmouth said, that the UK can be proud of our international standing as a centre of international research and a centre of excellence for that research. The clauses on the role and function of the HRA are about facilitating and supporting the development of UK plc as an international centre for research. They are also about strengthening the ethical criteria for research and streamlining the process to make it easier for clinicians, researchers, patients and the public to understand how ethical approvals are given in medical research.

My hon. Friend the Member for Truro and Falmouth asked whether the Government will carry out a review of the HRA and its functions. The answer is yes, absolutely; I can confirm that. It will be undertaken, as appropriate, after the HRA’s creation as a non-departmental public body once the Bill is enacted.

I hope that I can also reassure my right hon. Friend the Member for Sutton and Cheam. The move to establishing the HRA’s functions in statute will pave the way to cementing Britain’s place in the world as a leader in international research. Amendments 91 and 169 directly concern the HRA’s role and functions and the people who have a duty to co-operate with that body. Specifically, the amendments deal with the bodies that are required directly to co-operate with each other in respect of functions related to health and care research, with a view to co-ordination and standardising regulated practice, under clause 109(1).

It is worth reflecting on the fact that the HRA is already making excellent progress as a special health authority in co-operating with other bodies to create a unified approval process for research and promote consistent, proportionate standards for compliance and inspection. Sir John Tooke, of the Academy of Medical Sciences, gave evidence to the Joint Committee that scrutinised the draft Bill, which was chaired by my right hon. Friend, saying:

“In terms of successes in its early days, we welcome the relationships that have been forged with the MHRA and devolved administrations. Those are very important if this is going to act as a coherent body. We also welcome the broader stakeholder engagement because we will only resolve these issues if we involve all the parties that are involved in the process. The creation of the Collaboration and Development Steering Group is a very important step in that regard.”

I am sure that my right hon. Friend remembers that.

Both amendments would add the chief nursing officer of the Department of Health to the list of persons and bodies under duties of co-operation in clause 109(1). Amendment 169 would also add the Medicines and Healthcare products Regulatory Agency to the list of bodies.

We all recognise the valuable contribution that nursing research can make to improving health. It may be useful if I outline some of the valuable contributions from work that is going on, which I am sure will reassure Committee members. Through the National Institute for Health Research’s policy research programme, the Department supports several projects on nursing care, led by or involving nurses. Research funded by the NIHR is typically multidisciplinary and often involves a range of health care professionals. The NIHR supports a range of other research on nursing and care. Committee members will be reassured to know that clinical research nurses comprise the largest research group involved in delivering clinical research in our NHS. There are more than 3,000 nurses in the NIHR clinical research networks. Two nurses have been given the senior investigator award, which is that body’s most prestigious award. One of those, Professor Nicky Cullum, from Manchester university, was made a dame for services to nursing in the Queen’s birthday honours list last year.

The integrated clinical academic training programme for nurses, midwives and allied health professionals and the NIHR fellowship programme support 100 annual training places on clinical academic training masters programmes for nurses and allied health professionals, 18 clinical doctorate research fellows and clinical lecturers, who are nurses, and 10 NIHR doctoral fellows, who are nurses.

The amendments would add the chief nursing officer of the Department to the list of persons and bodies that must co-operate with one another. However, the Department does not have a chief nursing officer, so the amendments as drafted would not work. The Department has a director of nursing. The chief nursing officer is based in NHS England, as my right hon. Friend will remember from piloting the Health and Social Care Act 2012.

Clause 109(1) lists the persons or bodies with whom the HRA must co-operate in exercising its functions: the Secretary of State, the licensing authority for the purposes of the Medicines Act 1968, to which I will  return in a moment, the Health and Social Care Information Centre, the chief medical officer of the Department, the Human Fertilisation and Embryology Authority, the Human Tissue Authority, the Care Quality Commission and the Administration of Radioactive Substances Advisory Committee. Those bodies and individuals have statutory functions relating to the regulation of health or social care research. For that reason, we want them to be under a reciprocal duty to co-operate with one another and the HRA.

Unlike the Department’s chief medical officer, neither NHS England’s chief nursing officer nor the Department’s director of nursing have statutory functions relating to regulation of research. It may be useful if I explained why the chief medical officer has such a statutory function. This is not about creating arbitrary distinctions between doctors and nurses and different parts of the medical profession; we value multidisciplinary research and nurses are leading the way in much of the work being done by the NIHR. The CMO's function in this regard relates to previous statutes.

The post is listed because it holds specific statutory functions related to the research under the Abortion Regulations 1991. The regulations require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it. Disclosure of such information is restricted, apart from in specific circumstances which include disclosure for the purposes of scientific research. The Chief Medical Officer is responsible for determining whether disclosure can be made.

I have sympathy with the amendment and I hope I have assured hon. Members with what I have said that, in delivering its functions, the existing Health Research Authority is working, and the new authority will work, with a wide range of bodies with an interest in health and social care research. Subsection (3) gives the authority a freestanding duty to promote the co-ordination and standardisation of practice relating to the regulation of research. In meeting this duty the authority will work with bodies and persons with an interest in multidisciplinary research, including those with an interest in the contribution of the nursing profession and NHS providers, in addition to those persons listed with specific statutory functions.

The existing special health authority employs a number of people with a nursing background, including the head of the National Research Ethics Service, who has previously held a number of clinical nursing posts. Around three quarters of research ethics committees have at least one nurse member and as we are expecting a smooth transition from the special health authority to the non-departmental public body when the Bill is passed, the new body will have similar nurse representation. I am sure my right hon. Friend will agree that that is very strong nurse representation.

More broadly, I reassure hon. Members that the main objective of the Health Research Authority requires the authority to facilitate the conduct of safe, ethical research in performing its functions. It will, of course, do this in the multidisciplinary way we have been discussing today. In meeting this objective, the authority must facilitate all types of high quality, ethical research, including research that is multidisciplinary in nature. In the explanatory notes we now explicitly state that the definitions of health research and social care research are not restricted to any particular professional group—so, for example, they would include nurse-led research.

Turning to the amendment which would add the Medicines and Healthcare products Regulatory Agency, the MHRA, to the list in subsection (1), I am pleased to reassure the hon. Member for Copeland that there is already a duty of co-operation with the agency. As an agency of the Department of Health, the MHRA is not established in statute, which is why it is not listed by name in the clause. However, it does have statutory functions relating to the regulation of health research, as it is the licensing authority for the purposes of the Medicines Act 1968. It is, therefore, the body listed in subsection (1)(b). The MHRA is responsible for regulating all medicines and medical devices in the UK.

It might be worth highlighting an example of the MHRA’s statutory functions under the Medicines for Human Use (Clinical Trials) Regulations 2004, which implement EU Clinical Trials Directive 2001/20/EC. Clinical trials of medicinal products in human subjects require authorisation by the competent authority, which is the MHRA in the UK. The MHRA therefore assesses applications from sponsors to conduct clinical trials of medicinal products. The HRA, which would become a member of the UK Ethics Committee Authority under the Bill, provides for the ethics of clinical trials of medicinal products to be assessed. So both the HRA and the licensing authority, which is the MHRA under the Bill, have relevant statutory functions relating to the regulation of research. That is an example, also, of the streamlining of research that we have been describing throughout our discussions this morning.

Subsection (1)(b) already creates a reciprocal duty of co-operation between the MHRA, the HRA and the other bodies listed in this section, by virtue of the fact, as we have discussed, that the MHRA is the licensing authority for the purposes of the Medicines Act 1968. I hope that I have explained why neither the NHS England’s chief nursing officer nor the Department of Health’s director of nursing are specifically mentioned in subsection (1), and that hon. Members are reassured that the Health Research Authority will have an interest in multidisciplinary research by virtue of its main objective. I also hope that hon. Members are reassured that subsection (1)(b) would already create a reciprocal duty of co-operation between the HRA, the MHRA and the other bodies listed. With these explanations and reassurances, I hope that hon. Members will not feel the need to press their amendments.

Photo of Paul Burstow Paul Burstow Democratiaid Rhyddfrydol, Sutton and Cheam 11:45, 30 Ionawr 2014

I am grateful to the Minister for the reassuring way he has set out the conduct that he expects the Health Research Authority to adopt. I am now clear why this clause may not be the most appropriate place to put a technically deficient amendment. None the less, I hope that the Minister will ensure that the Health Research Authority engages further with the RCN, which is clearly sufficiently concerned about this matter to raise it in briefings to members of the Committee and sought the tabling of this amendment. I hope that the Minister’s words will also reassure the RCN and on that basis I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 109 ordered to stand part of the Bill.

Clause 110 ordered to stand part of the Bill.