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.

Health Protection Agency

Lord Patel Excerpts

Thursday 7th October 2010 Lords Chamber

[Earl Howe]

My Lords, as the noble Baroness will know with her long experience, health and safety at work is a cornerstone of good industrial policy. Certainly, I am not aware of any plans of my department to affect the strength and force of current health and safety rules.

[Lord Patel]

My Lords, which of the tasks currently carried out by the HPA will not be carried out in the future?

[Earl Howe]

My Lords, I have to defer an answer to that because we will shortly publish a White Paper about our plans for the public health service. Following that the public and interested professionals will be invited to feed in their views on exactly how that service should be configured.

Food: Regulation and Guidance

Lord Patel Excerpts

Thursday 7th October 2010 Lords Chamber

[Lord Patel]

My Lords, I thank the noble Lord, Lord Whitty, for securing this timely debate. I was encouraged to hear the Minister say during Questions today that the public health function in future will come under the direct responsibility of the Secretary of State. My reasons for saying so will become obvious.

I should like to speak about two substances added to our food which have a significant adverse affect on our health. The first, which has already been mentioned, is sodium chloride, which in small quantities is essential for our diet and for making food tasteful. The second substance, trans fats or trans fatty acids, has no nutritional value and is not essential to our diet.

Sodium chloride, or salt, is essential in small quantities. The maximum amount of daily salt intake recommended is six grams a day for an adult—about a teaspoonful—much less for children and no greater than one gram per day for a baby. It is not easy—in fact it is very difficult—to know exactly how much salt you eat in a day without knowing the exact content of salt in each type of food and the amount of food you eat. About 75 per cent of the salt we eat is already in the food we buy—cereals, bread, biscuits, ready meals, sauces, pizzas, yoghurt; the list is endless. Many prepared foods have a very high content of salt.

Is six grams of salt a day essential? No, it is not—the less the better—particularly if you suffer from hypertension or certain other diseases. The majority of the population consume more salt than the daily recommended amount. There is a strong link between salt intake and hypertension, which increases the risk of cardiovascular disease, coronary heart disease and stroke. Scientific evidence has shown that salt intake can vary blood pressure by as much as 9 millimetres of mercury. Certain foods—fast foods, crisps and ready meals—have a much higher content of salt. It is food often eaten by children and certain groups of the population. The food industry has responded but not well enough. The Food Standards Agency’s target for salt reduction by 2012, in the view of many, does not go far enough. Labelling for food and salt content is often confusing. Salt is often labelled as sodium. To establish salt content from a label which gives sodium content, you have to multiply by two and a half times. How people would know that 0.6 grams of sodium per 100 grams in a packet of crisps or cereal is high salt content? Better labelling of foods and a reduction in salt content of prepared food are required.

The second substance that I referred to, hydrogenated fats or trans fats, which is added to many foods, is in some respects even more harmful. Hydrogenated fats, trans fats, or trans fatty acids, is found in a lot of our food, particularly food consumed by children and low-income families. Hydrogenation is a process for turning liquid oil into solid fat. During the process a type of fat—trans unsaturated fat—is formed. The process produces cheap fats, but also destroys labile omega 3 fatty acids. This reduces the propensity of fat to become rancid and therefore is useful to industry. It increases shelf life and helps deep frying. That is why industry likes it. It has no nutritional value and is not essential to our diet.

Consumption of trans fats raises cholesterol levels. It changes the ratio of good to bad cholesterol. Not surprisingly, trans fatty acid is associated with increased risk of coronary heart disease and stroke. Industrially produced trans fatty acids may also promote systemic inflammation in the vessels, endothelial dysfunction, resistance to insulin leading to diabetes, adiposity and cardiac arrhythmia. It is estimated that a reduction in their consumption by even 1 per cent of total energy intake would prevent 11,000 cases of heart disease and 7,000 deaths per year.

The risk to health from industrially produced trans fatty acids is far greater per calorie consumed than for any other dietary micronutrients, including saturated fats, which we are all told not to eat too much of. Risk occurs even at low consumption. Trans fats are found in deep-fried foods, prepared meals, biscuits, cakes, pastries, snacks, crisps and chocolate. Yesterday, I had a biscuit with my tea in the Peers’ Dining Room which undoubtedly had trans fats in it.

What has been the response? In 2007, Alan Johnson, the then Health Secretary, asked the Food Standards Agency to investigate trans fats. It concluded that no action was needed because, on average, consumption was half the recommended amount; that is, 2 per cent of all energy comes from trans fats. However, as the then president of the Faculty of Public Health, Professor Alan Maryon-Davis, rightly said—I declare an interest as a fellow of the faculty—there is no known safe level of consumption of trans fats. More recently, the current president of the faculty, Professor Lindsey Davies, accused the food industry of being profoundly irresponsible for adding unhealthy amounts of fat and salt to its products and proposed introducing legal minimum health standards if food producers and retailers do not take action to remove such products from foods. Professor Davies has had support from many, including the Royal College of General Practitioners, the Royal College of Physicians and many patient groups. I, too, certainly support her call. Both the faculty and the Royal Institute of Public Health, as part of a 12-step manifesto for better health, proposed that consumption of trans fatty acids should be eliminated in the UK by next year.

The Department of Health asked the National Institute for Health and Clinical Excellence, NICE, to produce public health guidance on the prevention of cardiovascular disease at population level. It recommended accelerating the reduction in salt intake from a maximum intake of 6 grams per day by 2015 to 3 grams by 2025, ensuring that children’s intake does not exceed age-appropriate guidelines and establishing an independent system for monitoring salt levels in commonly consumed foods. For trans fats, it recommends eliminating the use of industrially produced trans fatty acids added to foods for human consumption, directing the bodies responsible for national surveys to measure and report on the consumption of industrially produced trans fatty acids by different population groups and considering using legislation to ensure universal implementation of the Food Standard Agency’s front-of-pack traffic light labelling system. That system is easily understood by the population.

Many countries have banned the use of trans fats in foods, including New York in the USA, Denmark and Austria. Australia is considering it, along with Canada and many other countries.

Yes, people should take responsibility for healthy eating, but so should government, regulators and the industry that sells the food. They should make sure that food is healthy, nutritious and certainly not harmful. I hope that the Minister will reassure the House that the Government will take steps to implement the far-reaching public health reform guidance from NICE, particularly in relation to levels of salt and trans fats in foods and food labelling.

--- Later in debate ---

[The Earl of Erroll]

My Lords, I join this debate to say a few words. I thank the noble Lord, Lord Whitty, who had a deep experience in Defra, for allowing us to have the debate.

I wanted to look at it from the point of view of whether regulation is effective and whether it is always right. I come from a tradition whereby I do not like being told what to do the whole time. I may well get it wrong, and if I die early as a result of overeating or overindulging in the wrong things, that puts a cost on the health service but will save a fortune in my dementia and old-age care and its provision on a very close though not quite one-to-one basis—

[Lord Patel]

My Lords, that is not necessarily so.

[The Earl of Erroll]

Well, I keep being told that I am bound to die if I eat too much chocolate and that I am a chocoholic. Is dark chocolate bad or good for you? We could debate that endlessly.

Mid Staffordshire NHS Foundation Trust

Lord Patel Excerpts

Wednesday 9th June 2010 Lords Chamber

[Earl Howe]

My Lords, we are not targeting the targets with this inquiry. They are not the main point at issue. The noble Lord is right that the main point at issue is the failure of care, but that is also, as we hope this inquiry will show, a systemic failure. That is the point of the inquiry. I do not doubt anything that he said about the commitment of previous Ministers to putting care above any rigid adherence to targets; I fully accept the good faith of Ministers in the previous Administration in that regard. However, the noble Lord will know that what Ministers say is very often not interpreted in the same way on the ground in the NHS. When people in the NHS hear things coming out of Whitehall, they are inclined to adhere rigidly to what they are told to do. That is part of the problem, but it is not the problem that I want to emphasise in this context. We need to understand how the wider performance management and regulatory system failed to spot the problems earlier and deal with them and why so few professionals felt that they could challenge what they saw. Understanding the lessons from that and the culture in which the events at Mid Staffs were allowed to happen will be key to informing and shaping our plans for the future.

[Lord Patel]

I declare an interest as chairman of the National Patient Safety Agency. I concur with what the Minister just said: the regulatory authorities that scrutinise the performance of trusts failed Mid Staffordshire. I was criticised for publishing reports of all trusts linked to two parameters of quality of patient safety: trusts’ reporting of incidents and mortality ratios. On both those criteria, Mid Staffordshire would have failed, as other trusts fail now. We need an inquiry that identifies parameters of quality and safety that could be embedded across the whole of the NHS so that we can identify failing hospitals early on and remedy them. I support the inquiry.

[Earl Howe]

I pay tribute to the noble Lord for his work, in particular for his work with the National Patient Safety Agency. As he will know, hospital standardised mortality ratios are something of a vexed topic. Professor Sir Bruce Keogh, the NHS medical director, has established a working group that will review how those ratios are derived and recommend what method should be used consistently for the NHS in future. The aim is to provide simple, practical guidance on how the ratios should be interpreted and used with other sources of information. Once the technical basis for this work has been developed, it is planned that patients and patient groups will be invited to become closely involved.

Genomic Medicine: S&T Committee Report

Lord Patel Excerpts

Wednesday 9th June 2010 Lords Chamber

Moved By

[Lord Patel]

To move that this House takes note of the Science and Technology Committee Report on Genomic Medicine.

[Lord Patel]

My Lords, the sequencing of the human genome in 2000, and the technological advances that made that possible, brought with them the possibility that these advances could benefit healthcare. The Government of the day recognised this by the publication of the White Paper, Our Inheritance, Our Future, in 2003. The investment that followed resulted in the provision of services mainly for the treatment of single gene disorders.

Several further advances have resulted in the development of molecular and genetic tests, both for identifying risk of disease and treatment. As genome sequencing technologies improve and more genetic tests become available, new models of service delivery will have to be considered. We are familiar with the association of diseases such as cystic fibrosis, Huntingdon’s disease, sickle cell and others with defects in single genes. The sequencing of the human genome in 2000 affords scientists the opportunity to explore the association of gene mutations in more common diseases such as diabetes, heart disease, cancers, Parkinson’s disease, mental health and many others. The development of genetic tests has made it possible to target treatment to patients most likely to benefit, identifying patients sensitive to certain drugs such as Warfarin—an anticoagulant—and retroviral drugs for the treatment of HIV and many others.

In the world of competing priorities and cost savings, how are the advances in genetics and clinical genetics going to be translated into clinical practice? We should be certain of one thing: that scientific advances will lead to the identification of newer drugs, allowing for the treatment of more diseases and the identification of patients most likely to benefit from treatment. Without the planned introduction of validated tests, the effective treatments available across the whole of the NHS will not occur. A postcode lottery in the provision of care will develop, as it already has in relation to the use of currently available genetic tests for single gene diseases.

The purpose of our inquiry was to explore the current state of genomic science and its implications on healthcare. We also briefly explored the ethical and legal implications of genetic information. The report is presented in seven chapters, each focusing on different issues. It is based on the written evidence given in response to our call for evidence, and oral evidence from some 140 individuals representing nearly 110 organisations. We make 54 recommendations. All the evidence is presented in part 2 of the report, running to nearly 360 pages. We also carried out a visit to the National Institutes of Health in Bethesda, Maryland, to get evidence from the USA. It was presented to us in 34 sessions over three days.

The previous Government responded to our report, accepting some of the recommendations. However, in general the response was poor and failed to recognise the reasons for some of our recommendations. The coalition Government now have an opportunity to scrutinise the report and, I hope, produce a more studied response over the coming months. I hope, though, that by the end of today’s debate the Minister will commit the Government to taking forward some of the key recommendations, particularly those related to the White Paper on genetics and the new Institute of Bioinformatics.

Let me briefly allude to some of the advances in genomic science with implications for healthcare, and refer to some of the dramatic advances reported since the publication of the report in July 2009. Watson and Crick described the structure of DNA in 1953, working in Cambridge. Fred Sanger, also from Cambridge, reported on the methodology of sequencing the human genome in 1977. The mapping of the complete human genome was reported in 2000 and cost around $3 billion. The mapping of the second human genome cost around $180 million. The third mapping—that of James Watson—cost around $1.3 million. The pace of the sequencing technology is such that both the speed of doing the sequencing and the cost is coming down by the month. The most recent report suggests the cost to be in the region of $10,000, with the prediction that within one to two years it will be down to $1,000 or even lower.

Moore’s law that applied to developments in microprocessing may well apply to the sequencing of the genome—some say to the point that regular and repeated sequencing of an individual patient’s genome will be routine practice in clinical medicine. High-throughput sequencing technologies open up myriad opportunities: the identification of rare variants of DNA that have a large effect in an individual’s risk of developing disease; gene mutation in cancers; de novo mutations in a range of diseases; monitoring the progress of disease; and effective treatment. Costs may even be less if targeted sequencing is used. Protein encoding axons of the 23,000 or so human genes comprise 1 per cent of the genome but contain 90 per cent of the mutations that cause disease. Of course, more scientific work is still necessary to increase the accuracy and relevance of the vast amount of information.

The United Kingdom will need adequate capacity for fast sequencing. Currently, only a few companies worldwide provide this. One of them, Oxford Nanopore Technologies is based in the United Kingdom, but China is building this capacity fast. Recent reports in the Lancet, New England Journal of Medicine and New York Times reported the identification of rare mutations of single-gene diseases such as Clarcot-Marie-Tooth disease, Miller syndrome and ciliary dyskinesia. These suggest that the identification of rare mutations of common multigene diseases, such as diabetes, heart disease, cancer, Alzheimer’s and others, using whole genome sequences, will be possible—and soon.

The scope of our report did not allow exploration of the role of environment in DNA modifications and disease without genome alteration in the science of epigenetics. Clearly, though, the ability to map the epigenome is crucial, as key elements in the development of disease are controlled by the epigenome—the chemical modifications not encoded in DNA that control how and when genes are expressed.

Pacific Biosciences, a company based in Menlo Park, California, which I visited last year, reported two weeks ago on an integrated system it has developed that simultaneously reads a genome sequence and detects an important epigenetic marker called DNA methylation, which reduces gene expression and is linked to disease development in many types of cancers. With the further refinement of technology, we might be heading towards a full-scale methylation map at a cost of hundreds of thousands of dollars. It will change our understanding of the behaviour and functionality of cells with identical genomes, and their association with disease development. While companies like Oxford Nanopore Technologies in the UK are developing such technologies, bigger investment is needed if the UK is to maintain its lead.

A recent report in the Lancet illustrates further benefits of rapid sequencing. Investigators were looking for novel mutations—rare variants in DNA—that could modulate a response to drugs. A 40 year-old healthy male with a family history of premature coronary heart disease, aortic aneurism and sudden death had his genomal sequence analysed. The report identified 63 known pharmacogenetic variants that could affect the person’s response to commonly used drugs, such as statins, Warfarin and Clopidogrel.

That brings me to pharmacogenetics—the way in which genetic variations across the genome affect drug metabolism. The right drug at the right dose for the right patient is the way to go for medication in future. Current estimates suggest that 400,000 patients a year in the NHS suffer severe drug reaction, with 15,000 to 20,000 resulting in fatal outcomes. We also make recommendations about the stratified use of medicines, an area of potential UK leadership if the right investment is made now. An increasing range of cancer drugs, such as Herceptin, Iressa and Erbitux, are effective in patients only if they have specific mutations in P13 kinase and other pathways. Breast cancer patients with HER2 receptors respond to the drug Herceptin. Similarly, patients with non-small cell lung cancer with EGF receptors respond to the drug Iressa. Further developments in molecular and genetic tests will lead to more patients being treated in a similar way.

The UK can lead in the development of the stratified uses of medicine. Cancer Research UK alone has been involved in the development of 30 cancer drugs that are used across the world. There is a need for a national strategy. The research community, the research councils, the National Institute for Health Research, industry and private funders can all drive that. Cancer Research UK has established networks that, within five years, will use genetic tests to guide cancer treatments for all patients in the United Kingdom. The potential for United Kingdom plc in this area is huge. The Department of Health and the Department for Business, Innovation and Skills need to support the development of an innovative platform for the stratified use of medicines, bringing Cancer Research UK, the Technology Strategy Board, the research councils, the NIHR and the ABPI together.

Many other recent advances are reported, such as area-based tests for prediction of prognosis and a guide to best treatment for acute and chronic leukaemias, sequences of bacterial genomes for treatment of TB in drug-resistant cases, tracking the spread of MRSA from person to person in the population and many others.

Assessing clinical utility and validity before the use of tests in the NHS will be crucial. Our recommendation that NICE should do that should be accepted. The United Kingdom has fallen behind, when previously it led in clinical trials. Two days ago, I met representatives from Novartis, having previously met representatives from other big pharmas. The interpretation of the regulatory framework in the United Kingdom, which is different from the interpretation of the same regulation in the rest of Europe, and the bureaucracy that each individual trust has put in place for clinical trials make doing clinical trials in the United Kingdom difficult. We have now dropped from number two in the world to number 17, with most of the trials now going to China. I hope that the review by Sir Michael Rawlins will address that, but the Government also need to be aware of that and do more.

I turn to another of our key recommendations. I hope that I have convinced the noble Earl that all of the developments that I have described so far have implications for healthcare research and for UK plc and that good information collection is crucial. Our report strongly recommended that a new institute of biomedical informatics should be established, together with training to develop expertise in bioinformatics. Sir Mark Walport of the Wellcome Trust said in his oral evidence:

“I have visited the set-up in Dundee and it is very powerful in terms of informatics, providing better patient care and is doing very sound research”.

I extend an invitation to the noble Earl for a private visit to see it for himself. Dundee is not that bad a place.

My recent visits to academic centres, hospitals and companies in the United States—the universities in San Francisco, Stanford, Berkeley and Harvard, as well as Houston medical city and Massachusetts General Hospital—have demonstrated how sequencing technologies for genomes and epigenomes are being used in clinical practice and how genetic and molecular tests are routine in the care of the patient. We may be well behind in that. If we do not invest as a country in infrastructure and support industry, we will pay higher costs, as we already do for the use of certain tests, such as BRCA1 and BRCA2 for the identification of the risk of breast cancer in individuals. The United Kingdom has the capacity to lead, both in life sciences and in synthetic biology. Life science developments with engineering science can lead to the development of technologies and molecular markers.

With these advances will come ways of delivering healthcare and identifying disease risk which will drive public health policies. They will change the ways in which disease is diagnosed, disease progression is monitored and treatment is chosen. They will deliver early measurement of the effectiveness of the treatment through use of molecular tests as the epigenome changes. Medical care will be personalised, which will have implications for the way in which commissioning takes place. PCTs are struggling now with commissioning and I wonder how they and GP commissioning will work for personalised medicine. Will we not run the risk of even more the postcode lottery in the care of patients? Apart from the instances that I referred to in diagnosis and treatment of single gene disorders and their screening, where there is great variation in care in the United Kingdom, there are many other examples, such as the variation in genetic tests for breast cancer. There is also great variation in the identification, screening and treatment of patients and relatives with the mutation leading to long QT syndrome, which causes sudden death, usually in young people, and is now a preventable disease, and there is variation in the screening of patients for the stratified use of medicine in cardiac disease and some cancers. These are only some examples, but we also have a high incidence of late diagnosis of cancer, leading to poor outcomes.

There are several other issues that, no doubt, the other noble Lords on the committee and others will cover. However, let me ask the noble Earl some questions. Will the coalition Government stand by some of the commitments made by the previous Government? Will the current Government go further and commit to produce a White Paper on genetics and clinical genetics? Let us give them some time; let us say 18 months. Will the Government commit to establishing an institute of biomedical informatics? Will they support the development of innovative platforms for the stratified use of medicine?

While not all the current promise of genomic and epigenomic science may come to fruition, there is already irrefutable evidence that developments in science will have implications in healthcare. There is also good evidence that the UK has the opportunity to benefit from investing in both technology development and science. Too often in the past, as happened with monoclonal antibodies—now a £2 billion per year business—CAT scanning, MRI, ultrasound and many drugs, we do the good science but are poor at converting it to commercialisation. We need to change that if our economy is to benefit. The subject is so important that I hope that the Science and Technology Committee will return to it in two or three years.

I shall conclude with some well deserved and most sincere thank yous. It was a privilege to be asked to chair the inquiry by the Science and Technology Committee. An added bonus was to have such talented members in the committee, who were all fun to work with and very supportive. The committee was supported by our clerk, Elisa Rubio, until near the end, when she had to leave on maternity leave. We also had full support from our science adviser, Rachel Newton, and the clerk to the Science and Technology Committee, Miss Christine Salmon Percival, who also performed the brilliant task of converting scientific gobbledegook into the understandable, readable report that we see. Last but not least, I thank our specialist adviser, Professor Tim Aitman, who handled us all with respect and kept us informed and educated. Only rarely did he show his frustration at our lack of understanding. He worked truly hard, despite his clinical and academic workload. To all of them I say a huge thank you, because without their effort the report would not have been possible and they certainly made my task easier.

I also wish to put on record my thanks and that of the committee to Dr Francis Collins, a great proponent of personalised medicine, who led the sequencing of the human genome that was reported in 2000. He is now the director of the National Institutes of Health in Bethesda, Maryland. He organised our visit to the United States and co-ordinated the presentations by experts from all over the US. He and his colleagues put huge efforts into making sure that our visit was informative, which it was. I thank him and his team. Finally, we had to have the debate today, for today is Professor Tim Aitman’s birthday. I am sure that the whole House will want me to wish him happy birthday from us all.

--- Later in debate ---

[Lord Patel]

My Lords, I thank the Minister for his response. I quite understand that, at this early stage in their life, the new Government are unlikely to commit to major projects. I am, of course, disappointed by the fact that they will not take some things forward but, on the other hand, I am extremely encouraged that the Minister committed himself to look at other things further or to observe their progress, particularly through the strategy board. It is encouraging that the pathology service mentioned in the report by the noble Lord, Lord Carter of Coles, will be taken forward.

As far as information technology is concerned, I think that the Minister’s advisers will be proven wrong. We know what kind of biomedical information system we require. We also know that, if we have an adequate bioinformatics system, it will regenerate information that will be helpful not only for healthcare but for developing biomarkers.

On the whole, I thank the Minister. I know that he takes medical issues seriously and that he will do so in future. I thank all noble Lords who took part in this debate and I am gratified that so many did so. Finally, my noble friend Lord Winston should do more guest performances because he is rather good at them. I look forward to hearing him again.

Motion agreed.

House adjourned at 9.30 pm.

Queen's Speech

Lord Patel Excerpts

Thursday 3rd June 2010 Lords Chamber

[Lord Patel]

My Lords, I congratulate the noble Earl, Lord Howe, on his well deserved ministerial appointment. When it comes to health policy, he is undoubtedly the most experienced member of the health team, having done the job in opposition for over 10 years and seen off several Ministers in that time.

On several occasions I have heard the Secretary of State, Mr Andrew Lansley, speak of his vision for better healthcare, and I have had an opportunity to discuss with him how the quality and safety of healthcare can be improved. I believe him to be concerned about the poor quality of care and to have a genuine commitment to making it better.

The gracious Speech outlined several areas where government legislation is to come. The Coalition: Our Programme for Government outlined several areas of possible health policy changes, many of which I find myself in support of, including the creation of an independent NHS board, a department of public health and a greater voice for clinicians and patients. While we have to wait for the legislative details, I hope, as a Cross-Bencher, to continue to help to improve the legislation in these areas.

While I believe reducing administrative costs in the NHS by a third to be right and possible, I am disappointed not to see mention of specific cost savings in the coalition manifesto. I hope the Government will look again at the role of strategic health authorities, their current size and budgets, and their function, particularly following the creation of the NHS board, and at the National Quality Board, the Care Quality Commission, the role of Monitor, PCTs and other organisations. There is also a need to look at the number of PCTs, which is currently in the region of 152. The number could easily be reduced to 30 or 40 and, given enhanced powers, they would bring efficiency and cost reduction.

The coalition Government’s health programme outlines quality and safety of healthcare to be important in delivering better outcomes. The key driver to achieve this will be the quality of commissioning, so the first and foremost task will be to develop good commissioning for quality and safety. Currently both are woefully done. Commissioners should be expected to promote quality and safety improvement. They should ensure that provider quality accounts—published by healthcare providers—properly reflect the concerns of patients and the public, and are properly scrutinised. Commissioners should provide assurance that the services commissioned are of appropriate quality to detect early warnings of potential decline, and intervene where standards are not met. Commissioners should be responsible for improving the scope and effectiveness of quality and safety. They should also promote innovations, with financial incentives and penalties for patient-safety incidents defined as “never events”, similar to those operated by Medicare and Medicaid in the United States. Poor quality and unsafe patient care is expensive. The key to delivering high-quality, safe care is good documentation, as I witnessed recently in several hospitals in the United States.

The Government also intend to bring in GP-led commissioning and to improve the quality of general practice. I hope that, in doing so, account will be taken of lessons learnt from previous experience of GP-led commissioning to ensure that the prime purpose of commissioning will be to deliver benefits to the patients and efficiency savings; and to ensure accountability of public expenditure. Can commissioning GPs be accountable officers, as CEOs are in NHS trusts and PCTs? Does the Minister agree that greater clarity is required in the respective roles of regulators, commissioners and the National Quality Board in promoting and ensuring quality and safety?

The Government’s commitment to tackling health inequalities is very welcome. However, the key determinants of poor health are economic and social. To succeed will require effective working across several government departments—a key test for the coalition Government. There is in the Government’s programme for health a distinct lack of any mention of public health and preventive health measures, apart from the creation of a department of public health. Could the Minister comment on which policies the Government will bring in to reduce harm related to alcohol, tobacco and nutrition? Increasing obesity, related to the high sugar and fat content of foods, now affects nearly 30 per cent of children. The high salt content of ready-made foods accounts for significant health problems in the older population. What is the Government’s strategy in these areas?

I finish on a positive note. I find nothing wrong in the ambitions of the Government’s health programme. I hope we will now have appropriate legislation and policies to deliver it. Cutting bureaucracy and useless administration, and delivering safe patient care in a safe environment, with more of the care delivered by competent professionals, will—to borrow a phrase that the Minister may well recognise—deliver,

“some of the best health in Europe”.

I hope the Government commit themselves to that.