Medical Innovation Bill [HL]

Lord Kakkar Excerpts

Friday 24th October 2014 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I have added my name to Amendment 15 and I hope that the Minister will give it due consideration. It is really important that the process laid out in the Bill is recorded in the patient’s clinical record. That is the one way that you can verify that things have been done properly. It is also important that there is notification to the central register, as referred to by the noble Lord, Lord Saatchi.

I also hope that the Minister will be able to give due consideration to the situations already mentioned by the noble Lord, Lord Winston, and others. It is very important that we do not make it more complicated than it is already for clinicians to be able to treat patients as they feel appropriate. It is also important that patients have the appropriate safeguards in place. While quite a lot will go into guidance, there is merit in having emergency treatment actually in the Bill as a situation where the Bill would not apply and that treatment in the best interests of the patient in an emergency can proceed by whichever means appear to be best at the time.

[Lord Kakkar (CB)]

My Lords, I declare an interest as Professor of Surgery at University College in London and as a member of the General Medical Council. I welcome the interventions of my senior clinical colleagues, the noble Lords, Lord Turnberg and Lord Winston. They have helped us to understand that, although it is hard, this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking. However, there must be safeguards to ensure the protection of vulnerable patients. A number of amendments in this grouping try to address that issue. When this Bill was first made available for public comment some years ago, I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed. I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh. He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced. I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.

There are two other amendments being considered in this group that I believe to be vital, Amendments 15 and 19, dealing with the registration and reporting of the results of innovation. There is no doubt that if this Bill is to achieve what it hopes to, the innovations that are provided as a result of having this provision available to us in clinical practice must be reported widely and be available for other clinical practitioners to consider. I know that, at this stage, the view is that other mechanisms are available that provide the opportunity for that reporting to be made, but I wonder whether the Minister might consider during the further passage of the Bill how very powerful a provision of the kind suggested in the two amendments would be in securing the greatest benefit for the largest number of patients.

Another question to have been raised on this group of amendments is that of being certain that the Bill does not apply to situations of emergency care and does not in any way interfere with the mechanisms available for ethical and appropriate clinical research. A strong research governance structure supported by strong legislation is available in our country, and this Bill should not be seen to impinge on that in any way. I am reassured by the noble Lord, Lord Saatchi, saying that the Bill does not relate to the conduct of research and should not be confused as doing so, nor does it in any way interfere with what are, as the noble Lord, Lord Winston, said, acute and deeply stressful decisions that have to be taken in the situation of providing emergency care. I hope that the Minister will be able to reassure us that other legislation, guidance and mechanisms exist to ensure that the Bill does not impinge on those two areas.

[Baroness Gardner of Parkes (Con)]

My Lords, I strongly support the Bill and hope that we will be able to reach agreement on important points today. It is essential that patients should feel safe, so all the safeguards being put forward are welcome, but patients also want to feel hope. When I think of Les Halpin, referred to by the noble Baroness, Lady Masham, I recall his rapid deterioration with motor neurone disease. When he first launched the idea of doing something, it was hard to detect that there was anything wrong with him. Within no time at all, it seemed—but probably it was about a year—he could not stand; he was in a wheelchair; and he had to have his head supported. It was unbelievable. What he wanted, not only for himself but for others, was hope.

The noble Baroness, Lady Masham, referred to Ebola, where they are trying things, irrespective of whether they know they are right, and in many cases they are probably working. It is hard to know. When I was chair of the hospital that has the Ebola clinic here in the UK, we had a case and the man recovered. In those days, there was no treatment other than just isolation and patients relying on their own strength to pull through. The noble Lord, Lord Winston, related a story about an ectopic pregnancy. It was interesting to see there how there was a conflict between two highly qualified medical practitioners. If he had not bravely taken that action, irrespective of any action that might be taken against him, that woman would not have survived. We do not want to make the procedure so enormously complicated that, by the time you have the result, it is too late for the person that you are aiming to help. On the other hand, I think that everyone agrees that the recording of the information, referred to by the noble Lord, Lord Turnberg, in speaking to his amendments, is essential. Unless it is recorded and open for use by everyone, it might help one individual, but no one will know what happens and how to help any others afterwards on a wide scale.

I think that everything that can be said on this Bill today will be said. I remember at Second Reading that the noble Lord, Lord Winston, was worried about people being sued for failure to innovate. I feel that that is only a remote prospect and should not be worried about too much. If all the safeguards are put in place, I believe that that will not happen. I strongly support the Bill and hope that the Minister will assure us that we will be able to proceed with it.

--- Later in debate ---

[Lord Blencathra (Con)]

My Lords, I say, for the record, that I have been here throughout but below the Bar of the House, so I am not suddenly intervening in the debate.

Inevitably, the Bill of my noble friend Lord Saatchi has been driven by terminal cancer care, and we understand the motivation. As regards the discussions on the first group of amendments, I agree with the noble Baroness, Lady O’Neill, that we have heard from some of Britain’s most distinguished “scalpel” experts but we need to hear a bit more from physicians who have responsibility for long-term and chronic care. That is why I totally support my noble friend’s Bill and the amendments he has proposed but I also support Amendment 6 proposed by the noble Lord, Lord Winston. I support it but I hope that it may not be necessary and that my noble friend Lord Saatchi will see that it is already taken care of in the Bill. However, I would like to flag up in this debate that it is important that the Bill covers innovative drug treatments, including drugs which are not necessarily authorised or approved in this country.

One does not want to get into describing personal medical things—it is a bit grubby. However, as an enthusiast for the Bill, who has experience of innovation approved by medical authorities in this country and has participated in some innovative treatments not approved in this country, I think that the House should hear from the users at the sharp end, so to speak.

I was diagnosed with MS in 1996. It is slow, progressive and each year it slightly tightens its grip. I would say to our distinguished lawyers, as I said at Second Reading, that when one goes to see one’s consultant, one does not go with a lawyer in hand to see whether the consultant makes mistakes and one can sue him. I suspect that, like me, a hundred thousand other MS sufferers and those with Parkinson’s and motor neurone disease all go along to ask, “What is new? Have you seen the latest research? What have you got? Is there anything that will work?”. We know that at the moment there is no cure for MS, although I think that researchers are getting pretty close to finding one, but we want to get palliative care.

As I say, I do not want to go into details but some of the side-effects of increasing MS are pretty nasty and, frankly, life is not worth living unless those side-effects are dealt with. For many MS sufferers, as the nerve endings die, particularly in the legs and feet, the feet drag. No problem there, as one loses some strength in the legs, one can have a wheelchair. But many people suffer a complete loss of bladder control. If one has to go to the loo every 10 minutes, life is just not worth living. An innovative treatment was developed by the Swiss, which was then experimented by the National Hospital in London. Those Botox injections directly into the bladder were not a life-saver but they made life worth living again. Without going into details, I fought my way through to become patient No. 51 in the clinical trials. That treatment has now been approved by NICE after all these years.

I am not saying that I am typical of patients with this sort of slow, progressive disease but I suspect that I am typical of many who will try any innovative treatment. I am 16 days into a treatment with a new drug, Fampridine, which is approved for use in this country but only, I think, in the national neurological hospital in the wonderful Queen Square. I believe that in clinical trials of the drug, 40% of people experienced a 40% improvement in their ability to lift their feet a tiny bit. However, lifting one’s feet a quarter of an inch when one is walking is very beneficial as it stops one tripping over every dead fly on the carpet.

As I say, at the moment there is no cure for MS but these innovative treatments are making life better. After just 16 days of my experimental treatment, I certainly feel a marginal improvement—at least I am not declining further. That may be the only hope one can offer many people—not that we can fix them but we will make the quality of their lives better for the long term and we will try to hold the disease at bay. Therefore, the provisions of Amendment 6 are absolutely apposite.

In October or November of last year, an American research institute, the Scripps Institute, reviewed about 10,000 drugs currently approved in the United States for various conditions and treatments. The staff there discovered, partly by accident, that there was one drug prescribed for Parkinson’s which seemed to repair the myelin sheath, certainly in their laboratory animals suffering from MS. I understand from my research that American doctors have slightly more power to prescribe off-label treatments than do British doctors. If it is in the patient’s best interests, they are entitled to prescribe a medicine which is not authorised or approved for that condition. British doctors do not seem to have that same flexibility or freedom, except perhaps if a drug is prescribed for adults and a child has those same symptoms, they may off-label prescribe a quarter of a pill or half a pill, like half an aspirin given to children with an illness. As I say, British doctors do not seem to have that freedom or flexibility.

The vast majority of people do not have the benefits I have of contacting an American doctor and managing to get my hands on some of those pills. They are prescribed in this country for a certain condition but no doctor can prescribe them for MS patients at present. It will be another five or 10 years by the time all the trials are conducted. I appreciate that this Bill is not about laboratory experiments or turning us into lab rats, although I am happy to go much further than the terms of my noble friend’s Bill and be a lab rat for some of these things. However, unless physicians treating long-term chronic illnesses can prescribe off-label treatments, which they think are in the best interests of the patients, this Bill will have failed. I hope that we can include off-label treatments.

I am obviously not an expert but I am deeply interested—I declare that interest as a patient—in the cocktails of drugs that seem to be available. For many treatments—it is the same for HIV and many others— there is no magic pill about to come on the market that will fix them. However, doctors have discovered that a combination of drugs, cocktails of various things, may have palliative or curative effects. I am on various cocktails of drugs, involving daily injections, weekly pills and various tablets. I can say that most of these are approved in this country but some are not. I am not taking illegal drugs but tablets and pills that have not been approved by NICE but which I, unlike the vast majority of patients in this country, can acquire from abroad. So I hope that if the Bill goes through and if the treatments mentioned in Amendment 6 are automatically included I will, one day soon, able to try those drugs without having to acquire them from doctors in New York. I hope that that would apply to many other patients in this country.

I am supportive of all the contents of Amendment 6 but if my noble friend says that it is not necessary, I am happy to go along with that.

[Lord Kakkar]

My Lords, I have some concerns about the wording of Amendment 6. Is it intended, for instance, to restrict the use of an agent or intervention that has been tested in a completely different situation—there may be some peer-review publication or some clinical validation in a completely different situation—but where it is proposed to use the treatment for another condition? One will recall that Gleevec was an agent developed principally for the management of patients with chronic myeloid leukaemia; it was an interesting biological compound that targeted a specific mutation in a signalling pathway in cells in that form of leukaemia. Many years later, it was noticed that that signalling pathway mutation was also seen in a particularly rare form of tumour, a gastrointestinal stromal tumour. Those who were innovating decided to use the drug because the genetic mutation appeared to be the same for treating that particular type of tumour to great effect. Would the description of innovation in the amendment have prevented that happening?

Proposed new paragraph (d) of the amendment deals with the question of devices or instruments. What happens if they have been developed and regulated for a particular intervention, and then an innovator decides to use them for a completely different condition? They will have been made available for regulated use but not for the condition in question. Would this amendment therefore restrict that type of innovation?

[Lord Winston]

I do not think that it restricts anything at all but actually makes the Bill of the noble Lord, Lord Saatchi, workable. We need some kind of definition of what an innovation is. That is all the amendment tries to achieve. It is not in any way restrictive. Of course, if one decides to put a plastic tube that is normally used to infiltrate the trachea into another organ, this amendment will permit that to happen, when currently it would not be allowed.

NHS: Five Year Forward View

Lord Kakkar Excerpts

Thursday 23rd October 2014 Lords Chamber

[Earl Howe]

My noble friend is absolutely right in what he says. The report lays great emphasis on the prevention agenda, not only through the work done in the public health arena by Public Health England and local authorities, but also through secondary prevention by the NHS itself: preventing the need for people to enter hospital in the first place. I fully agree with my noble friend about the potential role of pharmacists. Actually, that role has been enlarged over the past few years in an encouraging way with such things as medicines use reviews and the Healthy Living Pharmacy agenda. We want to go further and pharmacists are keen that we should do so.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman of University College London Partners. This ambitious programme will require very strong leadership. What arrangements are going to be put in place to develop strong clinical leaders across the different sectors and environments of the health delivery system that will be required to ensure that this become reality?

[Earl Howe]

One of the great features of the Government’s reforms is to put clinical leaders in charge of designing the way that care is delivered throughout the country. That point is often overlooked. It is, of course, the quality of that leadership that we should focus on. That quality is variable and why NHS England, Health Education England and partners in the system are looking as carefully as they can at how to improve that quality of leadership. I direct the noble Lord’s attention to certain passages in the Forward View, which talk about the need for all the bodies in the system to work together: NHS England, Monitor, the NHS Trust Development Authority, the Care Quality Commission, Health Education England, NICE, Public Health England—all working together to achieve greater alignment and greater common purpose in the way that these proposals are implemented.

Health and Social Care Act 2012: Risk Register

Lord Kakkar Excerpts

Wednesday 9th July 2014 Lords Chamber

[Earl Howe]

My Lords, it is possible to monitor how the Act is working without publishing the risk register. It is quite true that the transition to the new commissioning system is over. However, the risk register related expressly to the implementation of the reforms and the system is still bedding down. Therefore, we are still of the view that it is inappropriate to publish the register.

[Lord Kakkar (CB)]

My Lords, I declare my interest as professor of surgery at University College London and chairman of UCL Partners. At the time of its Second Reading, the Minister was kind enough to indicate that the Health and Social Care Act would enjoy post-legislative scrutiny after three rather than five years. Does that remain the intention?

[Earl Howe]

My Lords, I undertook to publish an assessment of the implementation of the 2012 Act within three years, so the noble Lord is right. News on that front will be forthcoming very shortly.

Health: Secondary Care

Lord Kakkar Excerpts

Thursday 26th June 2014 Lords Chamber

[Earl Howe]

My noble friend is right. This is absolutely central to raising our performance as a country in successfully treating cancer. We are doing several things. We have piloted a tool to help GPs to identify patients whom they might not otherwise refer urgently for suspected cancer. The tool covered lung cancer, as well as others. Across England, 502 GP practices took part in the pilot. Initial indications are that the tool is extremely helpful. There is also an e-learning tool that offers accredited professional development for GPs. The Royal College of General Practitioners has also identified cancer as an enduring priority. It is working with Cancer Research UK and other partners in promoting models of best practice.

[Lord Kakkar (CB)]

My Lords, I declare my interests as professor of surgery at University College, London, and chairman of UCLPartners. Better integrating primary and secondary care is crucial to ensuring patient safety, improved clinical outcomes and the most effective resource utilisation. What progress has been made in defining whole pathway metrics for integrated care to best inform rational commissioning of these services?

[Earl Howe]

Several things are in train. One of those, as the noble Lord will know, was reflected in the legislative reform order that we debated in the Moses Room two days ago. It will cut down the administrative burden of joint commissioning by NHS England and CCGs, as well as the burden currently being experienced by CCGs in joint commissioning between themselves. More importantly, we need to incentivise the system for integrated care, and that is what the better care fund is designed to do. It will ensure that patients receive joined-up care, whether that is in acute settings, in the community or, indeed, from social care.

Health: Innovative Medicine

Lord Kakkar Excerpts

Tuesday 1st April 2014 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I congratulate the noble Baroness, Lady Thomas of Winchester, on securing this important debate. In so doing, I declare my own interests in healthcare, in particular that I am chairman of UCLPartners and the UK business ambassador for healthcare and life sciences. I, too, congratulate Her Majesty’s Government on their early access scheme, recently announced, which is important for patients and healthcare professionals and in securing the ecosystem around the delivery of life sciences in our country. That is vital not only for the delivery of innovative healthcare, advancing clinical outcomes and improving the ability of our patients to benefit from advances in medical research, but because the life sciences sector in our country plays such an important role in the economy more broadly.

As we have heard from the noble Baroness, Lady Thomas, the scheme is fundamentally driven to ensure that innovative medicines that have undergone a degree of thorough scrutiny by way of clinical evaluation could be made available to patients with life-threatening and debilitating conditions before they would normally have received their full licensing, which is very important. I ask the noble Earl how Her Majesty’s Government plan to ensure equity of access to the scheme, bearing in mind that these innovative products will not, at the stage when they will become available as part of the scheme, have had approval for cost-effectiveness through the processes of the National Institute for Health and Care Excellence. Therefore, it is important that careful attention is paid to ensuring that, if those innovative medicines are to be provided as part of a specialist commissioning infrastructure within NHS England, it is done in such a way that patients throughout the NHS in England can avail themselves of those important innovations, because they will be some of the most vulnerable patients whom we see with life-threatening conditions or chronic disabling and debilitating conditions.

In that regard, I wonder whether the noble Earl can give a view on the potential role that academic health science networks, such as UCLPartners, might play in promoting access to innovative therapies as part of the early access scheme. As part of their original designation and licence obligations, the academic health science networks had to give undertakings with regard to the diffusion at scale of innovation across the populations for which they have responsibility. Do Her Majesty’s Government see a role for the academic health science networks in the early access scheme with regard to those diffusion of innovation obligations? If so, does the noble Earl believe that the arrangements for funding the academic health science networks, bearing in mind that the scheme will run for a number of years, are sufficiently secure?

Beyond the important contributions that Her Majesty’s Government have driven over the past four years in innovation in healthcare, through the development of the academic health science centres and networks and through the promotion of the National Institute for Health Research and its translational medicine research elements, which are vital to the early access scheme by encouraging industry and other biotechnology partners to work with the institute to undertake the research evaluation that will bring those innovative medicines more quickly to bear in the management of patients in the most desperate of circumstances, there is also the important question of the legal framework within which innovation can take place. That relates to innovation not across the system but to an individual clinician innovating for an individual patient and, therefore, the culture of innovation in our healthcare system.

The noble Lord, Lord Saatchi, recently promoted the Medical Innovation Bill, which is intended to address the important question of whether a legal impediment to innovation resulting from an accumulation of case law has changed the way in which clinical practice is discharged. I know that on 22 November 2013 the Secretary of State recognised, in a Written Statement, that there may well indeed be unintended consequences of the way in which case law is now interpreted that will stifle innovation with regard to the individual clinician providing care for the individual patient. As a result, Her Majesty’s Government are currently undertaking a broad consultation on the question of whether a Bill to help to clarify those ambiguities in law is necessary. Can the noble Earl provide some further insights into how the consultation is proceeding and where Her Majesty’s Government’s thinking is with regard not only to dealing—as they have done effectively—with the systems issues about innovation at scale and pace for large populations, but to the ability of individual clinicians to practise innovative care in a responsible and structured framework for the individual patient in front of them, often making use not only of personalised medicine and the revolutions in genomic medicine that will drive individual decision-making for patients, but also of this impressive early access scheme?

Medical Act 1983 (Amendment) (Knowledge of English) Order 2014

Lord Kakkar Excerpts

Tuesday 11th March 2014 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I rise, somewhat cautiously, as the third medical speaker in a row. I welcome the order.

It is worth noting that in 2013, the GMC had 13 fitness- to-practise cases that involved concerns about the language skills of doctors. In its 2011 review, the England Revalidation Support Team found 66 cases where the responsible officer has dealt with linguistic concerns. Part 3 of the order is therefore particularly important because it relates to fitness to practise. I hope that we will have an assurance today that in a fitness-to-practise procedure the doctors will not themselves be paying for the English language competence test. I have a bit of a concern, if they are paying for it themselves, that there may be a seeking out of a centre that is different from another centre, so it has to be fully conducted by the GMC, although it seems completely reasonable that the payment for the test prior to licence to practise is borne by the person applying for a licence to practise.

I understand from the GMC that it will be using the International English Language Testing System—IELTS—which costs from £130 to £145 depending on where you sit it, and that that will remain valid for about two years, on the recommendation of the Commonwealth. There is evidence that language skills, if they are not used, begin to decay after about two years.

It is also important to recognise that in this order we are talking about “ordinary” English language; we are not talking about testing medical English. It has been suggested that the dictionary for medical English is about the same size as the dictionary for another European language. It is a huge language. However, many of the words are very similar across the different European languages—although, of course, they are very different in some other languages.

We are talking about the ability of a doctor to take their medical knowledge and translate it into what you could call everyday English so that they can communicate it to patients. One point that I hope will be part of a fitness-to-practise procedure, however, is a recognition that communication involves far more than language. In terms of communication skills and communicating, although about 20% of communication is verbal, much of it is non-verbal. When you look at complaints against doctors in relation to the way they have communicated, although they sometimes have very good English language skills, other aspects of their non-verbal communication might reveal an attitude that is below the standard that one would expect from somebody on the GMC register.

I have to say, from my experience of teaching postgraduate students, that at Cardiff University they are required to sit the IELTS. It is a good test of English language skills. Since it was introduced as a statutory requirement by the university, we have found that it has become easier to teach and to mark the work done by those whose first language is not English. When teaching communication skills, it is easier to separate out the non-verbal problems from the verbal problems.

My view is that this is an important regulation. The ability to look back at those currently practising in the UK about whom there are concerns is crucially important and the GMC needs to be empowered to do so. I would just sound a note of caution following on from the remarks of the noble Lord, Lord Turnberg; of course we do not know what is set out in the curricula of different places. Medical students can graduate from some universities with almost no patient contact at all. If they are moving into training jobs, there is a concern that the baseline level of their medical training may be very different. This order may be the first step towards looking at the competences that we expect of a doctor coming from anywhere in the world in relation to practising in the UK.

[Lord Kakkar (CB)]

My Lords, I declare my interest as a member of the General Medical Council and I would like to take this opportunity to congratulate the noble Earl and Her Majesty’s Government on dealing with this important issue in what I think we can all agree is a very sensitive way. There is no question but that our health services are vitally dependent on a steady flow of doctors coming from all parts of the world, including the European Union. Not only can they learn from our healthcare system, they can also serve in it. But it is absolutely right that a professional regulator must enjoy the confidence of the public, and it is the responsibility of the General Medical Council first and foremost to ensure that patients are protected and that clinical practice in our country is safe.

For that confidence to exist, the public have to be sure in their own minds that the elements of what they would consider to be essential clinical practice—the ability to practise in a responsible and safe way—are met and tested by the General Medical Council whenever it feels the necessity to do so. The ability to communicate effectively, and therefore to use our language in a way that the public and patients appreciate and would expect, is an essential part of the responsibility of the regulator of the medical profession. As we have heard during this short debate, it is anomalous that the GMC is able to ask that question of potential registrants and licensees from outside the European Economic Area, but has not been able to do so of those who come from within the European Union. It is quite right that the Government have focused on this issue and decided to act in this fashion.

The fact that this order makes provision not only for the question at the time of licensing of a professional, when concerns about language skills might have been raised during the provisional registration process, but also that the new category of considering the ability to use language and to communicate becomes part of the broader question in fitness-to-practise considerations, is vitally important. It means that not only at the time of coming on to the register and being licensed to practise in this country, but throughout the practice itself, the public and patients can now feel confident that the General Medical Council will be in a position to act if it needs to do so. The importance of that cannot be overestimated.

We have heard about the additional question of competence skills, which is a matter that your Lordships have considered in the course of a number of debates in the Chamber over the past few years. The issue remains to be addressed, but I think that most would agree that ultimately, wherever a doctor comes from in the world, whether they have trained and qualified in our own country, elsewhere in the European Union or elsewhere in the world, they should be expected to demonstrate their skills to the same standard and to deploy those skills throughout their professional career in a way that enjoys the confidence of the people of our country.

[Viscount Bridgeman (Con)]

My Lords, I rise with some diffidence as the first layman to address your Lordships in this debate. I, too, thank the Minister for his statement and pay tribute to his department for the leadership that it has shown in securing from the Commission the remedying of what was a glaring and potentially dangerous anomaly in the 2005 directive. The Commission has produced a very satisfactory outcome.

I believe the United Kingdom is among the first member states, if not the first, to incorporate the changes introduced by the revised directive into legislation. I note that the order is headed:

“Health Care and Associated Professions”.

I hope the new language-testing arrangements will be incorporated as early as possible into other branches of healthcare—I have nursing in mind in particular. I think it is the experience of many that nurses from the EEA are almost invariably pleasant, caring and considerate. They of course play a huge role in this country, but I know that many patients have had difficulty in communicating and in making themselves understood.

There are many reasons why this is a matter of some urgency, but I will suggest just one. I think I am right in saying that the practice of putting great emphasis on patients’ notes goes back a long way in the UK; possibly more emphasis than some other member states, even those with advanced healthcare arrangements. It is therefore all the more important that nurses from the EEA are proficient not only in spoken but in written English, a point which the noble Baroness, Lady Finlay, made in connection with doctors. As one facetious journalist put it,

“the difference between a microgram and a milligram is a coffin”.

I hope the Minister can give your Lordships the assurance that progress is being made in extending the provisions of the revised directive right across the healthcare profession, not least with nurses. I hope that this will include the fitness-to-practise hurdle, which is so important in reinforcing the ongoing responsibility of the relevant regulators for their members.

NHS: NICE-appraised Medicines

Lord Kakkar Excerpts

Thursday 27th February 2014 Lords Chamber

[Earl Howe]

It is important to distinguish between a technology appraisal, where, if favourable, there is a clear funding direction for the NHS—in other words, it must fund the drug if the doctor thinks that it is appropriate for the patient—and a clinical guideline, where NICE issues best practice advice for the NHS. There is no funding direction attached to that. However, clinicians are expected to take account of NICE guidelines in everything that they do.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman-elect of University College London Partners, one of the designated academic health science partnerships. Is the noble Earl content that the funding arrangements to be put in place by NHS England for the 15 designated academic health science networks are appropriate and will ensure that they can discharge their substantial obligations under their licence agreement, including the adoption of NICE guidance among the populations for which they are responsible?

[Earl Howe]

The noble Lord asks a very important question. It is slightly wide of the Question on the Order Paper, which relates to a particular set of statistics. However, I can tell him that I am broadly satisfied with the level of funding for AHSNs, and NHS England has given its commitment to maintain its support for them going forward.

NHS: Patient Data

Lord Kakkar Excerpts

Tuesday 25th February 2014 Lords Chamber

[Earl Howe]

I entirely agree with the noble Lord. This is a vital programme which will bring real benefits to patients. It has major potential benefits for research and public health. It commands generally wide stakeholder support. However, there is no doubt that concerns over how this has been explained to patients have been raised and those concerns need to be addressed. I agree that the next six months will be crucial in pursuing that aim but it is essential that this programme commands public support.

[Lord Kakkar (CB)]

My Lords, I declare an interest as professor of surgery at University College London. What assessment have Her Majesty’s Government made of the proposed European data protection regulation which, if passed, has the potential to impact seriously on our national strategies with regard to health informatics and biomedical research?

[Earl Howe]

My Lords, we take that concern extremely seriously. The draft text that has been published by the so-called LIBE committee would, if enacted, pose serious obstacles for our research effort in this country. We are taking every opportunity and using every effort to persuade both the Parliament and the European Commission that the original text is the one we should go with. That work is on-going and the Ministry of Justice is leading on it.

Mesothelioma: Research Funding

Lord Kakkar Excerpts

Thursday 16th January 2014 Grand Committee

[Lord Kakkar (CB)]

My Lords, I join in congratulating the noble Lord, Lord Alton of Liverpool, on having secured this important debate, and in so doing declare my own interest as professor of surgery at University College London. Responding to discussion on Report on 17 July last year, the noble Earl, Lord Howe, made a number of important points with regard to the opportunity to build capacity in the research base available to address the important problem of mesothelioma. I would like to explore first with him what progress has been made in the four specific areas that he kindly mentioned during that debate.

The first was the opportunity for the National Institute for Health Research to seek the assistance of the James Lind Alliance to determine priorities with regard to mesothelioma research, bringing together not only the research community but patients and other stakeholders. Secondly, there was a commitment that the National Institute for Health Research would be in a position to issue a highlight notice to the research community identifying that the institute—in consultation, I assume, with the Office for Strategic Co-ordination of Health Research—had identified mesothelioma as a key national priority research topic, thereby activating not only research groups with a specific ongoing interest in mesothelioma but those with peripheral interests that could be brought to bear to address the question of mesothelioma research. I wonder whether that notice has been issued and, if not, when it is planned that it would be.

Thirdly, there was the offer that the National Institute for Health Research would make its research design service available to the research community, specifically to start identifying designs of clinical studies that could be undertaken to help to advance our understanding of mesothelioma research. Lastly, there was a commitment to bring together interested parties in research funding, particularly Cancer Research UK and the Medical Research Council, to have a conference of experts and those parties interested in mesothelioma research to determine how a national co-operative effort could be taken forward. I wonder whether any of those undertakings have indeed happened or in what timeframe it is planned that they might be discharged.

It is clear that the situation in which mesothelioma research finds itself is nothing new. At many times, and for many other diseases, there has been recognition that a new strategic research focus needs to be developed at national level. I would argue that with the National Institute for Health Research now well established and in place in the NHS in England, we are uniquely positioned to take forward a strategic approach, not only to building research capacity but in ensuring collaboration across those groups devoted at the moment to mesothelioma research and other groups who have technologies and interests—we have heard peripheral examples of the management of acute myeloid leukaemia—so that they are brought together with some strategic focus and direction. I wonder whether the Minister is able to provide your Lordships with an understanding of what point those discussions have reached.

In addition, we now have across the NHS in England well established academic health science networks, 15 of which cover the entire country. I declare my interest as chairman elect of University College London Partners. I wonder whether opportunities might be brought to bear for promoting research and collaboration between academic institutions, the NHS and industry, which are at the core of the purpose of the academic health science networks. Those 15 networks would then be asked to see how they might contribute, through their participant organisations, in a national research effort to promote further understanding and a more accelerated research programme on mesothelioma.

Tobacco: Packaging

Lord Kakkar Excerpts

Thursday 28th November 2013 Lords Chamber

[Earl Howe]

My Lords, it is clear from the debates in the other place and from our debates in Committee on the Children and Families Bill, that there is emerging evidence that needs to be considered. That evidence has emerged since the consultation. I am not in a position to make a judgment on that. I think Sir Cyril Chantler is the best person to do it.

[Lord Kakkar (CB)]

My Lords, I declare my interest as a member of the board of UCL Partners, currently chaired by Sir Cyril Chantler, and I congratulate Her Majesty’s Government on the excellent choice of Sir Cyril to lead this important review. Can the noble Earl confirm that Sir Cyril will be completely free to define both the methodology that he will apply for the review and the question that he will address?