Public Bodies Bill [HL]

Lord Patel Excerpts

Wednesday 9th March 2011 Lords Chamber

The difficulty here is partly ethical. It is interesting that, for the patient herself, those fertilised eggs are her babies and she may, not unreasonably, insist on having two of them back even though she has been advised to have a single-embryo transfer. That problem needs to be thought about. At the moment, as we have dealt with this it has not been well addressed. It is an extremely difficult issue. So I hope that my noble friend Lady Thornton does not push this measure to a Division as I would find it difficult to support the amendment under its present form.

[Lord Patel]

Briefly, I find myself in support of what was said by the noble and learned Lord, Lord Mackay of Clashfern, and also by my friend in the professional sense, the noble Lord, Lord Winston. I was involved as an officer when the Royal College of Obstetricians and Gynaecologists, together with the Medical Research Council, set up the voluntary licensing authority because it was felt that there was a need to reassure the public that the new science of in vitro fertilisation was not going to lead, as the newspapers then had it, to creating monsters in a Petri dish. Fortunately, two years after that, the noble and learned Lord, Lord Mackay of Clashfern, led the Bill that became the Act that established the Human Fertilisation and Embryology Authority. For the reason already rehearsed, it was necessary to make sure that the public could be reassured. More importantly, it was set up to make sure that clinical practice followed strict rules about what should be good practice and about people engaged in in vitro fertilisation and fertility.

I was not a specialist in in vitro fertilisation, but as an obstetrician I saw the results of the initial practices of multiple pregnancies, to which the noble Lord, Lord Winston, just referred. Every obstetrician in the land was crying out that there should be some kind of advice or regulation from the HFEA that would control the number of embryos that were inserted. The evidence existed that putting more and more embryos in might result in more pregnancies but also in multiple births that resulted in handicapped babies.

We have two issues here. First was the responsibility of the HFEA in making sure that clinical practices were improved to improve the outcome for both the parents and the babies. Second is the regulation related to research practices, especially in embryo research. I have no doubt whatever that the research regulation aspect of the HFEA needs to be maintained.

I go further in saying that there is a great need to bring some co-ordination in the whole area of the medical research regulatory framework; it is very fragmented. In my previous role as a National Patient Safety Agency chairman, while I was responsible for running the National Research Ethics Service for England and Wales, I found that there were issues relating to ethics for some of the medical research that, because it was fragmented, we had to address, as it was not being addressed by any of the existing regulatory authorities. The report from the Academy of Medical Sciences gives us an opportunity, which I hope the Government will grasp soon, to produce a national medical research regulatory authority that brings in all the regulation that is required. As the noble Lord, Lord Warner, said, the report did not say that it should include the HFEA and the Human Tissue Authority. In his consultation, he also said that they were not addressing the issue of the HFEA and the HTA because they were awaiting the results of the debate that we are now having, and the Bill that we will have relating to National Health Service reform and social care.

I accept that we need a research regulatory authority. Now the issue is whether we need, particularly with the HFEA, to regulate clinical practice related to in vitro fertilisation. If NICE is going to have the new role of setting standards in all areas of clinical practice that will deliver better outcomes, and if we have a regulatory authority—the CQC, which may need to improve its performance and may need resources to be able to do so—we have to ask why we would have a regulation confined to one area, sensitive though it might be. Given the performance of the authority hitherto, we have to ask whether we are going to throw out something so precious; I accept that some of the aspects that the HFEA has been awarded are very precious. I accept that we were the first country in the world to bring about regulation for in vitro fertilisation, which others followed, because it was then necessary. It laid down the template of how clinical practice in a sensitive area such as in vitro fertilisation should be handled. However, as the noble and learned Lord, Lord Mackay of Clashfern, said, we have moved on. I think we might be at a stage where we need a more overarching regulation that promotes good clinical practices and therefore good clinical outcomes.

[Baroness Deech]

My Lords, on a factual point, may I correct the impression—it may have been a mistake— that the previous speakers have given that any number of embryos can be implanted in a patient? The HFEA brought down the number of embryos from three to two and is working towards one. That was in the face of relentless resistance from patients, who wanted the best chance of becoming pregnant, and indeed many—but not all—of the clinicians and embryologists, who said, “We know what’s best for our patients”. The impression should not be given that an unlimited number of embryos are implanted. The number is two and they are working towards one.

[Lord Winston]

Forgive me for correcting that impression. Many units limited the number of embryos well before the HFEA did. At Hammersmith Hospital, we limited the number of embryos two years before the HFEA did. We were not alone; a number of units did that because we were very concerned. The idea that medical practitioners do not feel responsible for the pregnancy that is induced is, I think, a dangerous precedent. It is just not true. Of course there is a problem when patients put you under pressure, and it is a very difficult ethical issue that needs to be resolved.

[Lord Patel]

My Lords, I think I have lost my thread, but I have said what I wanted to say.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, I begin by expressing my thanks to all noble Lords for the opportunity to debate these amendments. As the noble Baroness, Lady Thornton, pointed out at the beginning of her remarks, following the Government’s concession in withdrawing Schedule 7 in its entirety, these amendments would have the effect of putting the Human Tissue Authority and Human Fertilisation and Embryology Authority out of scope of the Bill.

Our starting point in approaching these issues is a clear objective to streamline the process of regulation and, consequently, reduce costs and the administrative burden on establishments while continuing to offer the necessary protection for the public. The Bill presents us with an opportunity to achieve that. Our aim is to streamline healthcare and medical research regulation and so reduce bureaucracy. That approach is supported by leading assisted reproduction clinicians and their professional bodies and by the Academy of Medical Sciences.

The scope for streamlining is clear. We estimate that around 80 per cent of the centres currently licensed by the HFEA are also either regulated by the Care Quality Commission or are in premises that the commission regulates. Some 60 per cent of the centres licensed by the HTA are similarly covered by the CQC. It therefore seems unsustainable to continue to have these regulatory systems running in parallel. The question posed by my noble friend Lord Newton of Braintree as to whether the CQC wants to take on this work can best be answered by reference to the regulatory activity that it already performs. In any event, as regards the pace at which we take this, we intend to develop arrangements for the transfer of functions in consultation with the CQC over the next few years, and no transfer of functions will take place until that process is complete. However, the Government recognise that there are number of noble Lords with concerns about the proposal to transfer the functions of these two bodies, and not for a minute would I wish to minimise the nature of those concerns.

Let me be clear—both the HFEA and the HTA are models of regulatory authority that were right for the times in which they were created and which have done an admirable job in meeting the demands placed on them. However, as my noble and learned friend Lord Mackay of Clashfern pointed out, times change, and most pertinently so has the way in which we regulate the delivery of healthcare. With the establishment of the CQC along with the possibility—and I put it no stronger than that at the moment—of the creation of a new regulatory body for medical research, alternative structures are becoming available to ensure a more joined-up system. This provides, as I have said, the opportunity to streamline the process of regulation and reduce costs.

The powers in Clause 5 would allow us to achieve that without disturbing the underlying legislation, which captures the ethical safeguards that Parliament has so carefully set in place. Any future proposals to abolish these two bodies will be provided for in future primary legislation. I am happy to reiterate my assurance that there is no intention to revisit the provisions in either the Human Tissue Act or the Human Fertilisation and Embryology Act that provide the important ethical safeguards necessary to maintain public confidence in these sensitive areas. I would say to my noble friend Lord Willis and to the noble and learned Baroness, Lady Butler-Sloss, and the noble Baroness, Lady Deech, that means that future arrangements to regulate tissue and embryos must adhere strictly to the provisions of the two relevant Acts.

Noble Lords have raised particular concerns about the need to preserve the expertise these bodies have built up in the ethically sensitive subjects they deal with and the need to preserve the confidence of both professionals and the public in the way that these regulatory functions are carried out. The Government recognise the genuine nature of these concerns and we are determined that changes will not be at the expense of regulatory rigour or expertise.

I say to my noble friend Lord Willis that expertise will not be lost. It is envisaged that expertise will follow functions; for instance, through staff transfers and expert reference groups. Noble Lords have questioned the capacity of the CQC to assume these responsibilities. It will be given the capacity and the resources to carry out any widened functions. The CQC already has a proven track record of taking on the oversight of a specialist area. It took on the Mental Health Act Commission functions and I believe has successfully maintained oversight and focus on that area.

The noble Baroness, Lady Thornton, expressed concern that our whole approach in this area seemed unnecessarily complex. The powers that we are debating today will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the ALB review. In order to abolish the HFEA and HTA or to transfer their research-related functions to any new research agency we will require powers under future primary legislation.

It may help if I try to provide a rough outline as to how and when we expect things to happen. We intend publically to consult on proposals to transfer all of the HFEA and HTA functions to other bodies in the late summer of 2011. Then during 2012-13 we would prepare draft orders for formal consultation under the provisions of this Bill dealing with the transfer of functions other than research functions. If appropriate we would then be able to lay the orders before Parliament. The process would enable noble Lords and other interested parties to see, comment on and debate the proposals as they progress. In order to avoid the piecemeal transfer of functions we would intend to ensure that the timetables for necessary future primary legislation and the commencement date of orders made under this Bill are aligned so that they come into force at the same time.

Without the inclusion of these bodies in Schedule 5 to the Public Bodies Bill we would have to provide for the transfer of their functions entirely within future primary legislation and this would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act could be reopened for debate and would afford less time for consideration and comment than the progressive approach which I have just outlined. I seek to impress upon noble Lords that that is a very powerful reason for wishing to grant the Government the powers we are seeking as regards these two bodies.

The noble Lord, Lord Warner, indicated that, in his view, the report by the Academy of Medical Sciences does not give sufficient backing to the idea that embryo research should be covered by the new research regulator. I would simply point him, if I may, towards paragraph 9.5.1 of the report which explicitly refers to the new body, if it is set up, having responsibility,

“for ‘specialist’ approvals and licences within the HRA around data, tissue and embryos, gene therapy and exposure to radiation”.

I think, as I read that, it was very much in the minds of the authors of the report that the research functions of the HFEA should be brought within the scope of a health research regulatory agency.

The noble and learned Baroness, Lady Butler-Sloss, expressed her worries about the information functions of the HFEA and the absence of a clear plan by the Government for what should happen to those functions. She is right, we have not fully made up our minds about where those functions should best sit, but that is one of the main reasons why we wish to consult on this. We need to ask the public and interested parties where these functions should sit, and there will be an impact assessment with the consultation.

My noble friend Lord Willis asked about the possibility of setting up a single research agency without primary legislation. He is technically right; we could do that. I should emphasise that we have not decided whether to accept the AMS recommendation to establish a single research agency—we think that there are merits in the proposal and we will be making an announcement shortly—but if we were to propose setting up such an agency we could do so initially by creating a special health authority. However, we could not legally transfer the research-related functions of either the HTA or the HFEA to that body. We could not make a transfer of functions to a special health authority without amending the 2006 Act.

The case was simply put by my noble and learned friend Lord Mackay of Clashfern. Essentially, we are asking the Committee to agree to grant the Government permission to consult on these matters. I hope that the noble Baroness will not seek to press her amendment today but instead will consider that a good purpose will be served by reflecting on the comments that I have made in response. In view of our concessions—

Health: Cancer

Lord Patel Excerpts

Wednesday 2nd March 2011 Lords Chamber

Asked by

[Lord Patel]

To ask Her Majesty’s Government what proposals they have for improving outcomes for cancer patients.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, we published Improving Outcomes: A Strategy for Cancer on 12 January, which sets out a range of actions to improve outcomes for cancer patients. Earlier diagnosis is crucial to improving outcomes, and we have set out plans to deliver this through improving GP access to diagnostic tests, supporting symptom awareness initiatives, and extending cancer screening programmes. We are also improving access to treatment and the quality of support for survivors.

[Lord Patel]

I thank the Minister for his Answer, which is very helpful because it prompts two questions. First, when does he think the procedures which he has put in place will succeed and cancer outcomes will improve, and in the mean time what is likely to happen to cancer outcomes? Secondly, could he also say what the state of radiotherapy treatment in England is?

[Earl Howe]

My Lords, the strategy we have laid out is an ambitious one. It aims to save an additional 5,000 lives every year by 2014-15. That programme is supported by over £750 million of additional money over the next four years. It sets out actions to prevent cancer incidence and to improve the quality and efficiency of cancer services and of patients’ experiences of care. We are giving ourselves a little time, but we are under no illusions, and this is an agenda to be pursued very energetically. We are putting considerable additional money—from memory, it is £150 million—into radiotherapy services, but we also feel that there is an important issue around the use of existing radiotherapy equipment, which is often not utilised as effectively as it could be.

Health: Influenza Vaccination

Lord Patel Excerpts

Thursday 20th January 2011 Lords Chamber

[Earl Howe]

My Lords, almost all vaccines, except the seasonal flu vaccines, are procured centrally because central procurement provides a cost-effective arrangement that can take account of the variation in supply and demand. It also gives us the ability to track where the batches of vaccine have gone. We are therefore looking at taking into the department the procurement of the seasonal flu vaccine.

[Lord Patel]

Last time we discussed this subject, I asked the Minister why the advice given by the Centers for Disease Control and Prevention in the United States was so different from the advice from our committee on vaccination. My question this time is: is the Minister sure that the advice that he gets from our committee takes into account evidence that other countries gather and on which they base their advice? The CDC’s advice in the United States is to vaccinate everybody over the age of six months.

[Earl Howe]

Yes, I am satisfied. The expert advice provided by the JCVI takes into consideration first and foremost the epidemiology of the disease in the UK, which may well differ from that in other countries. The noble Lord may be interested to know that, while the UK is experiencing H1N1 as the most prevalent flu strain, the prevalent flu strains in the United States are H3N2 and influenza B, so a very different situation applies in that country.

Health: Influenza

Lord Patel Excerpts

Tuesday 11th January 2011 Lords Chamber

[Earl Howe]

I am satisfied with the validity of the statistics. The problem is, of course, that there is always a lag. The statistics that I read out earlier in my main Answer were supplied to us by the Health Protection Agency and regard verified laboratory tested results. We have another method of assessing the number of deaths that is retrospective. After the end of the flu season we can assess whether the number of deaths has been higher than expected. Of course, we are endeavouring to improve our statistical base all the time and no doubt lessons will be learnt from this season, as they are from every season.

[Lord Patel]

My Lords, what is the basis for the differing advice in the United Kingdom about the group of people who should be vaccinated compared with that given in the United States from the Centers for Disease Control and Prevention, which advise that everyone over the age of six months should be vaccinated?

[Earl Howe]

That is precisely why we have an independent Joint Committee on Vaccination and Immunisation: to advise Ministers on these matters. Ministers are bound to take that advice. Indeed, the previous Government determined that they were legally obliged to take the committee’s advice, which is what we have done.

NHS: Targets

Lord Patel Excerpts

Monday 20th December 2010 Lords Chamber

[Lord Alderdice]

My Lords—

[Lord Patel]

My Lords—

[Noble Lords]

Cross Benches!

--- Later in debate ---

[Earl Howe]

My Lords, many of the data that will underpin the monitoring of the outcomes framework are already collected as a matter of routine but are just not used. In the outcomes framework, we shall reduce the number of outcomes to many fewer than have been in play under the previous Government’s process-based targets. We do not see our proposals as imposing unnecessary or impossible extra burdens on the NHS.

[Lord Patel]

I need to cultivate a louder voice, obviously. Can the Minister give an example of where competition in healthcare delivery has improved outcomes?

[Earl Howe]

I am sorry that the noble Lord is a sceptic on these matters. In the field of mental health care, for example, where there is a long-standing position of private sector contestability, we have seen that standards have been driven up. There is no doubt that the foundation trust model has also paved the way for higher quality in healthcare.

NHS: Global Health

Lord Patel Excerpts

Monday 20th December 2010 Lords Chamber

[Lord Patel]

My Lords, the noble Lord, Lord Dholakia, exaggerates my contribution to Ethiopia or anywhere else but I thank him for that.

On 5 May 2009, Barack Obama, in announcing a $63 billion programme of global health, said:

“We will not be successful in our efforts to end deaths from AIDS, malaria and tuberculosis unless we do more to improve health systems around the world, focus our efforts on child and maternal health, and ensure that best practices drive the funding for these programs”.

The noble Lord, Lord Crisp, to whom I am grateful for initiating this debate, remarked that the USA and certain other countries are well ahead of us in developing global health as a universal programme of the country. That is not to say that many universities in our land have not embraced the issue of global health. I declare an interest. I am affiliated with the University of Dundee in many ways. I am proud that the university has a module in year two of medical students’ training that gives them knowledge and some experience of global health. We run a summer school on a yearly basis that advances epidemiology and global health issues and we also have a major research programme in the university for developing drugs for the less well known tropical diseases.

There are also other universities, including UCL and KCL, which have also started such programmes. We need to do the same as the United States has done and drive this further, to develop a university consortium of global health in the United Kingdom that promotes learning, education, scholarships and also research. That is something we need to address and it could be addressed by the Department of Health because it is primarily a health issue.

Both our research organisations, the Medical Research Council and the Wellcome Trust, have major research programmes and fellowships that drive them. My college, the Royal College of Obstetricians and Gynaecologists, has programmes for global health but the constraint has been the ability to find funding for trainees who wish to take part in overseas training as part of their training. Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Paediatrics and Child Health have such programmes. The modules that these trainees undertake overseas are accredited on a case by case basis. The funding, however, is not available and neither is there flexibility in specialist training. That is something that again the Department of Health can assist with.

I am privileged to be associated with an international organisation that has developed training and service in areas of obstetric fistula from which some 2 million women worldwide suffer. The noble Lord, Lord McColl, has worked in this area and he referred to his commitment to working with Mercy Ships. He deserves the gratitude of those women in areas in which he has worked for years. We have developed a curriculum for training in this area of obstetric fistula which has now been accepted by all the obstetric fistula surgeons worldwide.

The organisation also works with the Bill & Melinda Gates Foundation, receiving funding from them of more than $10 million over a period of five years to develop a strengthened health system across the United Kingdom. In that respect, Scotland has a programme with which the University of Dundee is heavily involved, including a programme in Malawi for health systems. Our fifth-year medical students go there for attachment for a period of six weeks on a yearly basis.

There are good things being done in this country, but both DfID and the Department of Health can help develop these educational training programmes further. I hope that the Minister will comment on that.

NHS: Reorganisation

Lord Patel Excerpts

Thursday 16th December 2010 Lords Chamber

[Lord Patel]

My Lords, when you are a tail-end Charlie, most of the things that you wanted to say may already have been said. However, the breadth and depth of the proposed reforms are such that there is plenty left for me to say. First, I declare an interest. Like many other noble Lords, I have been a lifelong clinician—in my case for 39 years, in different forms. I have also chaired NHS regulators, standard-setting organisations in quality and safety, and facilitative organisations.

Like other noble Lords, I feel that we need much clarification of the proposed reforms. Apart from the White Paper and the myriad different documents, I have read all the speeches that the Minister has given recently. While his message has been consistent, explanation of how it will all work is not clear. No doubt when we get the legislation in your Lordships’ House we will spend many happy days scrutinising it—and, on my part, helping to improve it.

Today I have some general comments and one or two specific ones. As others have mentioned, the main conclusion of much of the coverage concerns the bringing in of major institutional reforms that attract major costs, coupled with the drive to realise greater efficiency savings in both the health and social care budgets. Small organisations such as consortia may well drive up costs or reduce clinical delivery times. GPs have said that they will need time and resources to develop and deliver a professional-led service. Will the Minister say how this will be possible?

One component of the White Paper is the introduction of an outcomes framework for holding the NHS commissioning board to account. One problem with PCTs was that they contracted with organisations rather than contracting for services and outcomes. The outcomes framework maintains the three domains of quality identified by the noble Lord, Lord Darzi—those of effectiveness, patient experience and safety—and has developed five domains, which on the face of it is all good. However, if the outcomes framework is the means by which the Secretary of State can hold the national commissioning board to account for the performance of the whole NHS, it needs to be much broader. Currently it is focused too narrowly on clinical outcomes. It should be broad and high level. Furthermore, the relationship between the outcomes framework and the commissioning framework needs careful consideration. National goals often become targets that are used for the assessment and management of performance. Does the Minister agree that the commissioning framework for assessing the performance of GP consortia needs to go beyond the outcomes framework to include the commissioning skills and performance of GP consortia?

I turn now to international comparability. Why are we not going to use an internationally recognised framework for assessing healthcare performance, such as the one developed by the OECD, especially as this not only has parallels with the proposed outcomes framework but includes health improvement and risk factors, as well as the three themes of effectiveness, safety and patient experience, with equity as an overarching dimension? The framework also needs to measure integrated care, care pathways and the quality of care, including social care. How will improvement be assessed? What will constitute acceptable and unacceptable performance and how will it be measured?

My next point relates to process measures. The framework accepts that these are important and are needed locally. Why are these not considered appropriate for the outcomes framework? The relationship between GP consortia, health and well-being boards and local authorities seems unclear. GP consortia will have to commission and deliver high-quality care. How will their accountability to the board work, in particular when contracts are held by boards and not by local authorities or consortia?

I turn to regulation. The Care Quality Commission will be the quality inspectorate. In an environment where there will be willing providers and patient choice, how will the CQC ensure the equity or safety of quality for all providers and who will monitor that? The second regulator will be Monitor—the new, stronger economic regulator—with functions to ensure access to key and essential services. What are key and essential services? What is the definition? Will they be available in each geographical area? That needs to be clarified, as does the question of who will ensure that it happens. The other function of Monitor will be to set prices. While sufficient pricing is a worthwhile ambition, the challenge is to set prices at a level that does not compromise quality. In health, as in everyday life, you get what you pay for.

The Government seem to have changed their mind about how maternity services will be commissioned. Initially, they said that they would be commissioned by the national commissioning board. Now it seems that the consortia will do that. The Minister may well be aware, however, that all the professional organisations have accepted that it would be better for the maternity services to be commissioned by the commissioning board and for the maternity networks to be developed to be able to do this.

While we await the Government’s new cancer strategy, I hope that the framework that is produced will recognise that not all cancer services will be appropriate to be commissioned by GP consortia and that commissioning groups should include clinicians with expertise in cancer. Appropriate data related to cancer diagnosis and survival will need to be included and are important as part of the outcomes framework. How information on outcomes is provided to patients so that they can make a choice will also be crucial.

On the question of competition, what evidence exists that increasing marketisation will benefit patients? Is there an example of a country that has had a defined and conscious change to a market-based approach that has led to improved patient outcomes?

Hospices and Palliative Care Services

Lord Patel Excerpts

Wednesday 15th December 2010 Lords Chamber

[Lord Patel]

My Lords, I too am grateful to the noble Viscount, Lord Bridgeman, for calling this debate and I echo his words about children’s hospices. It is on that that I will concentrate my brief remarks.

It is crucial in this debate that we consider palliative care for children as well as adults. There are 20,000 children and young people in the United Kingdom who will die before they reach adulthood. Some of them will die when very young; others will deteriorate slowly over many years. Families caring for these children and young people, often 24 hours a day, seven days a week, can feel under enormous emotional, physical and financial strain. Relationships can suffer, careers may have to be abandoned, siblings who are well can feel left out and normal family activities become almost impossible. Children’s hospices offer a lifeline to these children, young people and their families, helping ordinary people in extraordinary circumstances to cope with the challenges of everyday life. They provide a range of flexible, practical and free support at home or in the hospice to the entire family, often over many years and at any stage of a child’s illness from diagnosis for as long as it is needed.

There are currently 45 children’s hospices in the United Kingdom, 40 of which are in England. They provide flexible comprehensive care at home and in the hospice, help with pain control in children, support for families, end-of-life care and bereavement support. They are all registered charities, receiving very little statutory funding and relying on the generosity of the public. They struggle to get funding from primary care trusts. Only around 9 per cent of their funding comes from PCTs and local authorities. The palliative care funding review is a unique opportunity to put in place long-term funding. Localised GP commissioning will present serious challenges in commissioning children’s palliative care. I hope the Minister will agree that the national commissioning board should be the body responsible for commissioning palliative care for children. The key issue here is adequate funding for children’s hospices, which provide extremely valuable care to children and families and should have statutory funding.

Health: Passive Smoking

Lord Patel Excerpts

Tuesday 30th November 2010 Lords Chamber

[Earl Howe]

In answer to my noble friend’s first question, yes, the report has been forwarded to the WHO.

On illicit trade, HMRC leads on tackling the availability of illicit tobacco and has carried out—as I am sure my noble friend knows—a great deal of activity to tackle that market through its overseas network of fiscal crime liaison officers, as well as through activity at the border and inland detection work. HMRC also works closely with local authority trading standards officers. Those efforts have led to a decline in the market share of illicit cigarettes from 21 per cent in 2000 to 11 per cent, according to the latest available figures. However, he is right that hand-rolling tobacco in particular remains a problem.

[Lord Patel]

Does the Minister agree that the current packaging of cigarettes is used as a form of marketing by the tobacco industry?

[Earl Howe]

My Lords, that is the very question that we want to look at. Of course, tobacco companies regard their brands as a form of marketing and they attach value to the intellectual property that they consider to be in those brands. However, the issue from a public health perspective is whether the design of a pack actually entices non-smokers to take up smoking or indeed deters smokers from giving up. That is the question that we will examine.

Medical Profession (Responsible Officers) Regulations 2010

Lord Patel Excerpts

Tuesday 23rd November 2010 Lords Chamber

[Lord Walton of Detchant]

My Lords, I declare an interest as having been president of the General Medical Council from 1982 to 1989. I know that the GMC is particularly anxious to see these regulations go ahead because the whole question has been smouldering away for very many years. Even during my presidency, we were aware that many doctors who came before the conduct committee of the council, or before that the disciplinary committee, were not so much erring or wicked as actually not practising, in some respects, to a standard of competency appropriate to today’s world. For that reason, we tried very hard to set up a mechanism within the GMC to establish what we called at first a competence committee. However, it was not successful because we could not persuade the profession and other bodies to approve some of the recommendations that we tried to put forward.

Subsequently, the GMC embarked on a programme of performance review. Mechanisms were established to identify doctors who were not performing to an adequate standard in the health service and other bodies, but that programme too did not succeed as well as it might. It was perfectly clear that it was crucial to the interests of the public at large and of patients themselves that there was a mechanism whereby doctors would be required every five years to subject their clinical performance and performance in their appointment to a process of validation. Revalidation then became one of the essential priorities for the General Medical Council. As the noble Earl said in his introduction, the GMC believes that implementing this process of revalidation is an essential step in advancing the quality of medical regulation, improving patient safety and providing patients with greater assurance that doctors are meeting the standards that we set for the medical profession.

I appreciate to the full some of the anxieties expressed by the noble Baroness. She has criticised the nature and content of these regulations. However, as I have said, this mechanism has been smouldering away for over 20 years and it is time to make progress. The statutory basis for the responsible officer is set out in the Health and Social Care Act 2008, which amends the Medical Act 1983. The GMC is now committed to the introduction of revalidation for doctors in order to change the way in which all doctors in the UK are regulated. Under this process, to retain their licence to practise, doctors need to demonstrate to the GMC every five years that they still meet the appropriate professional standards and are continuing to develop their skills and knowledge.

The responsible officer will be the link between the local healthcare organisation, whatever it is, and the GMC, and as such will be an essential component of implementing revalidation. The responsible officer will usually be based in and employed by the organisation for which the doctor works, or with which the doctor is contracted to provide services. The GMC will need to be confident that the recommendations it receives are robust, fair and consistent, but that the process leading to the recommendations and the recommendations themselves will be subject to quality assurance and to audit. The GMC will develop guidance to assist responsible officers in carrying out their role in relation to revalidation.

We have reached a stage at which it is crucial that responsible officers are in place before the rollout of full revalidation commences. This will have the advantage of enabling the GMC to identify gaps in the coverage of responsible officers, particularly of doctors working outside the National Health Service, and to make provision for them. In its response to the government White Paper, Equity and Excellence: Liberating the NHS, the GMC comments that the abolition of PCTs and strategic health authorities, which is not expected until 2013, leaves it unclear as to where the responsible officer role in primary care and sometimes in specialist care will sit, and how the role and functions of the medical directors will be exercised. As the noble Baroness said, this matter needs to be resolved, but it must not be a reason to delay the passage of these long-awaited regulations or to stall preparations more generally. The GMC has confirmed that it will work with the Department of Health to resolve this and other issues so that it can continue to make progress towards the implementation of revalidation. I trust that the regulations will be approved.

[Lord Patel]

My Lords, I concur with the comments of my noble friend Lord Walton of Detchant. It is important that we allow these regulations to pass. As he has said, the issue of revalidation has been smouldering away, to use his words, for many years. I recall from when I served on the GMC over eight years ago that the revalidation issue predates Shipman and has nothing to do with that issue. As my noble friend has said, this is a process and it is important that the regulations should be passed because we need the responsible officers to be appointed pretty soon so that the GMC can train them up and identify any issues before the process of revalidation begins. I understand that all the devolved Administrations have agreed that it should start by autumn 2012. If that deadline is to be met, we need the responsible officers long before that.

My conversations with officers of the GMC suggest that the council is well aware of the concerns raised. They know that when the legislation to reform the NHS is brought forward, the issue of what happens in primary care with doctors working as commissioners, and how they are to be revalidated, will have to be addressed. They are confident that they will be able to do so.

As for the other professional organisations that have also commented and to which the noble Baroness referred, it is interesting that only one has raised concerns; the others have not. All the other royal colleges have been involved in working with the GMC to identify how revalidation will be carried out in their own specialties and they are satisfied with the mechanisms that will be used. They are also satisfied that the pilots that are now being carried out will identify the issues.

It is important that we now approve these regulations and allow the responsible officers to be appointed. We will have other opportunities to debate the matter again during the next stages.

[Lord Alderdice]

My Lords, it is always difficult when new Governments come into place and want to make important and sometimes radical changes to structures and arrangements while, at the same time, valuing some of the work that had been begun but not completed by a previous Government. As other noble Lords have said, the previous Government, and perhaps even an earlier one, moved towards revalidating doctors. This is a very complicated and difficult issue, but the Government moved in that direction; timetables were set but became a little delayed. However, if the Secretary of State in this new Government were to take the advice that has been proffered—that until PCTs and strategic health authorities are set aside and the new arrangements are in place we should not move to the appointment of responsible officers—we would be looking at 2014 or 2015, or after the next general election, before we could move forward. It is understandable that people should quite reasonably say that there is a dilemma here, but we must try to keep up the momentum, which is the point that the GMC has made.

It is perfectly correct that a number of matters are not yet clear and resolved. Some affect me, and I shall advert to them in a moment. The proposals for the reform of the NHS have not worked through the process—they have been announced but are not yet through Parliament—and it is not only possible but almost certain that there will be significant changes and developments. I hope my noble friend will be able to clarify some of the issues, but it would be expecting rather a lot for him not only to clarify how matters stand at the moment but to predict how they might stand further down the line when some things may have changed.

In the present situation, in most cases but not all, appraisal processes are already going on. Up until earlier this year, every year I produced a huge lever arch file containing details of all the things that I had been through. So the process is already in place and it is the responsibility of medical directors in trusts to make sure that it is in place. However, they cannot possibly carry it through themselves because so many need to be appraised. They therefore have to devolve the responsibility for the detail and the face-to-face work to someone else. Exactly the same thing will happen to the responsible officer.

Are there potential conflicts of interests? There already are because those who are responsible for the appraisals are also responsible for clinical merit awards of various kinds, for the recognition of a person’s work and for the creation or demolition of their clinics. All these conflicts are already there. That is not to set them aside and say they are unimportant—they are very important and very difficult—but we are facing something that is not in itself radically new but a problem with which we have been struggling for quite some time. Further orders may well come subsequent to this that will help to take the matter forward, but that does not mean that we should delay the current regulations.

Let me put to my noble friend a dilemma of my own on which he may or may not be able to help. What will happen to those who do not necessarily operate all the time only in the NHS in England, Scotland and Wales? I note that Northern Ireland is not included in this and, of course, the movement backward and forward between this part of the world and the Republic of Ireland is substantial. What happens if a doctor qualifies and works here for a while, then goes to work for three or four years in the Republic of Ireland and then comes back to work in the United Kingdom but the process of validation has not operated in quite the same way? Of course, we have free movement not only in these islands but throughout the European Union. What happens to those who have operated outside the UK? These are real dilemmas that have to be dealt with.

We have often heard it said that it is better to start, pilot and work your way through than to produce something that has not been tested out but is a fiat—a fait accompli. My noble colleagues on the Cross-Benches have expressed reasonable concerns and a determination to keep up the momentum for revalidation. In supporting these regulations, that is also very much my mindset, and I hope to see further developments over the next year or two.