Drug Companies: Medical Trials

Baroness Brinton Excerpts

Monday 24th February 2014 Lords Chamber

[Earl Howe]

My Lords, during the course of last year, the Government gave detailed evidence to the Science and Technology Committee on the issue of data provision in respect of clinical trials. The committee made a number of helpful recommendations on the removal of barriers to transparency. In our formal response, we set out how we would work to achieve the aims of greater transparency. In the light of that response, the Government are looking into the recommendations of the PAC report on the stockpiling of Tamiflu and access to clinical trials data, published in January. We will give our formal response to the report next month.

[Baroness Brinton (LD)]

My Lords, evidence shows that the chances of a complete trial being published are roughly 50%. The recent EU clinical trials draft directive will require all trials to be registered before they start, and full results to be published within a year. However, the regulation will be applicable only to trials starting from this year. How do the Government plan to ensure that pharmaceutical companies will release medical records for drugs that were launched before 2014?

[Earl Howe]

My noble friend raises a topical question. The industry’s trade body, the Association of the British Pharmaceutical Industry made clear, in its code of practice in 2012, that companies are obliged to publish all clinical trial results within a year of marketing authorisation and publicly register new clinical trials within 21 days of the first patient being enrolled. That, of course, is a forward-looking exhortation, but we are encouraged by the fact that the industry is taking an increasingly responsible view in this area by publishing data voluntarily, as demonstrated by companies such as GSK, AstraZeneca and Johnson & Johnson. We want to encourage more companies to do the same.

Health: Folic Acid

Baroness Brinton Excerpts

Monday 24th February 2014 Lords Chamber

[Earl Howe]

My Lords, as the noble Countess says, the issues are in many ways similar. As she knows, in the case of fluoride, Parliament has taken the decision that it should be a local matter and that is how the system now works.

[Baroness Brinton (LD)]

My Lords, given that there is a delay in the Government’s decision, what is being done to ensure that young women are informed about the importance of having some supplements? Waiting until they are pregnant is clearly too late.

[Earl Howe]

My Lords, government advice on taking supplements is available to women through a number of channels, including Healthy Start, NHS Choices, Start4Life, The Young Woman’s Guide to Pregnancy and the Information Service for Parents. To improve maternity services for women, NICE has published a comprehensive suite of evidence-based clinical guidelines in this area.

Food and Soft Drink Industry: Sugar

Baroness Brinton Excerpts

Tuesday 11th February 2014 Lords Chamber

[Earl Howe]

My Lords, the reason that we meet the food industry is to ask it to do more than it is doing at the moment. If that is what the noble Baroness means by the Government’s links to the food industry, then I make no apology for them. Our current emphasis is on overall calorie reduction, of which sugar can form a part. The scope for reformulation to reduce sugar levels varies widely depending on the food, and a reduction in sugar levels does not always mean that the overall calorie content is reduced. The Scientific Advisory Committee on Nutrition is currently undertaking a review of carbohydrates, as part of which it is looking at sugar. Its report will inform our future thinking.

[Baroness Brinton (LD)]

It is shocking that a 375-gram portion of Sharwood’s sweet and sour chicken with rice contains six teaspoons of sugar. Some of our supermarkets, notably Waitrose, are working with their suppliers to reduce the amount of sugar in processed food, but many are not. What steps are the Government taking to ensure that all supermarkets and suppliers follow those setting a good example and reduce the amount of sugar, as well as clearly labelling sugar, in their processed foods?

[Earl Howe]

My noble friend raises a series of important issues. I can tell her some encouraging news on this front. Sainsbury’s and Tesco, for example, have pledged to reduce the sugar content in their own-brand soft drinks. We are asking other supermarkets to follow suit. I think that the noble Baroness will be aware that Lidl made an encouraging gesture the other day in pledging not to display sweets at till exits. However, we are working across a range of areas, not just reformulation of food but pack size, introducing low-sugar or no-sugar alternatives, and looking at ways in which food is promoted.

NHS: Black and Minority Ethnic Nursing Directors

Baroness Brinton Excerpts

Monday 10th February 2014 Lords Chamber

[Earl Howe]

My Lords, just to correct the noble Lord, the latest figure I have from 2012 is that total ethnic minority groups in nursing, midwifery and health visiting comprise 19.7% of the nursing workforce. That underscores the basic point that he made. One cannot aspire to 19.7% of those ethnic nurses becoming nurse leaders because there is only a limited number of leadership posts. However, we are clear that this should be a priority for the NHS.

The answer to the noble Lord’s second question is that the Equality and Diversity Council has published some refreshed guidelines. One of its goals is to have a representative and supportive workforce throughout the NHS. It is putting that in train by asking NHS organisations to monitor their equality performance jointly with their patients, communities and staff.

[Baroness Brinton (LD)]

My Lords, ten years ago, the noble Lord, Lord Crisp, described the NHS as being snow-capped—that is, all white at the top. Since his departure as Chief Executive of the NHS in 2005, there are now fewer leaders from visibly different backgrounds and, as we have heard, pitifully few executive directors of nursing. What are the Government doing to ensure that this matter is kept at the top of the agenda and to assure us that we will hear about the success of the programme as it continues?

[Earl Howe]

My Lords, I have already mentioned some of the initiatives that are in train. However, I can tell my noble friend that, within the NHS Leadership Academy, there are two programmes specifically for nurses and midwives that map to foundation, mid and executive level leadership development. There is the front-line leadership programme which is for staff who have leadership responsibilities—for example, ward sisters and nurses working in primary care. We expect 6,000 nurses and midwives to participate in that programme in the first year. There is also the senior operational leaders programme which provides senior nursing clinicians with an opportunity to enhance their leadership skills.

NHS: Competition

Baroness Brinton Excerpts

Monday 10th February 2014 Grand Committee

[Baroness Brinton (LD)]

My Lords, I am grateful for being allowed to speak in the gap, and I congratulate the noble Lord, Lord Turnberg, on securing this debate. The noble Baroness, Lady Thornton, may wish to know that the noble Lord, Lord Clement-Jones, had hoped to speak in this debate, but is speaking instead on the Immigration Bill in the main Chamber.

I am pleased that he and other Liberal Democrats persuaded the Government to make some key changes to Part 3, on procurement, in the Health and Social Care Act, which limited private practice in the NHS and beefed up Monitor with regard to the promotion of competition, in order to provide reassurance that other factors could and should be taken into consideration.

This nuance in the debate is often lost by the two opposing views of pro- and anti-competition. Not all competition is bad, as the noble Lord, Lord Turnberg, has pointed out. The Labour Government were quite content to have it in the NHS. I, for example, was using Healthcare at Home, which was contracted by a number of hospitals prior to the coalition Government to provide domiciliary support for patients injecting medication at home. The service and support were excellent, and the economies of scale, I am sure, enabled them to provide that at a good price. The ancillary contracts are, I hope, less contentious than deciding how to contract out core clinical services: those issues are justly more sensitive. That is why I am grateful to my noble friend Lord Clement-Jones for his perseverance last year in pushing for amendments to the regulations to ensure that cost is not the only guide to winning a procurement contract. Transparent, proportionate and non-discriminatory processes must be evidenced to support procurement decisions.

The new guidance will remove doubt about where quality and competition interact, and Monitor’s role in taking the lead over the OFT and the Competition Commission is a positive step forward. The Monitor guidance on the National Health Service (Procurement, Patient Choice and Competition) Regulations 2013 makes this abundantly clear. For commissioners, this will mean a considerable change in approach to procurement. Finally, the guidance is so explicit that cost alone is not the route to follow that even the competition lawyers will have to take note. Patient need, quality, and improvement of service are key factors that must be taken into account.

The EU directive on public procurement due to be implemented during this year reinforces this. The new regime for health service contracts requires that,

“award criteria can take into consideration important elements in the provision of health services including quality, continuity, accessibility, comprehensiveness of services and innovation”.

Further, the directive makes it clear that,

“greater emphasis is put on considering environmental and social issues in public procurements … Simply considering price, rather than quality, as the only award criterion will be discouraged”.

I hope that this will provide clarity for future CCGs as they start to consider whether they need to tender.

Finally, we should remember the core principle in competition and choice in the provision of healthcare services in the NHS in England, which is that competition should be employed where it serves the interests of patients; it must not be an end in itself. NHS England has said that competition is just one means of improving the quality and efficiency of NHS clinical services and securing value for money. I would ask my noble friend the Minister, given all the noise we are hearing at the moment about problems with competition lawyers and others disagreeing about where the lines are drawn, whether the EU directive guidance and the Monitor guidance will clarify matters enough to remove that doubt. If that is the case, I hope that improved transparency, a focus on patient needs and proportionality will act as the guardians of our excellent services in the NHS.

NHS: Seven-day Working

Baroness Brinton Excerpts

Thursday 6th February 2014 Lords Chamber

[Baroness Brinton (LD)]

My Lords, I, too, thank the noble Lord, Lord Ribeiro, for securing this key debate. It is shocking that your chances of receiving prompt treatment and, indeed, of surviving are worse if you are admitted to hospital over a weekend or on a bank holiday. The 2011 Freemantle report provided the evidence that more than 500 deaths could be prevented in London each year purely by increasing consultant cover in acute medical and surgical units.

The good news is that there are early adopters and pathfinders who are demonstrating that it can be done. I hope your Lordships’ House will indulge me with a personal anecdote. I was very unwell over Christmas and had the good fortune to be admitted to the acute admissions unit at Watford General Hospital. The unit was set up in 2009 to help reduce pressures on A&E and the main hospital. The £12 million 120-bed unit shares the building with A&E but all referrals have to come from a GP and the maximum length of stay is 72 hours, although stays are usually much shorter. Consultants are on duty 24 hours a day and see patients as they are admitted so care is tailored very quickly. The AAU and A&E share their own MRI scanner, X-ray and ultrasound unit, a catheterisation unit for angioplasty, blood testing facilities and pharmacy. My experience of the care was outstanding: tests, scans, monitoring and observation and treatment were all prompt, and I felt that the entire clinical team worked smoothly as one unit. I know that I am not alone in my praise for the unit.

Seventy-two hours seems to be about the right length of time. I have seen reports of other acute units where the time is only 36 hours. Recently a Leeds hospital reported that there is still pressure on the main wards from this shorter timescale.

The briefing from the Royal College of Surgeons states:

“Seven day services may also reduce pressure and stress on doctors. For example, consultants can spend much of Monday morning dealing with weekend admissions that are waiting for review or discharge”.

However, this does not affect just doctors: radiologists and many other clinical support staff are similarly affected by the Monday morning catch-up that impacts on an already busy week. Can the Minister assure the House that the NHS will provide robust modelling and review structures using the examples of early adopters to ensure that seven-day working is introduced carefully and effectively?

There needs to be a realistic timetable and a full understanding of the workforce issues—not just consultants or contracts and payments, but also appropriate staffing levels right through the NHS. It therefore seems sensible to move ahead on urgent and emergency care first and then reassess for wider clinical services, rather than rushing ahead with elective care at the start.

Many people are concerned about the costs of adopting a seven-day working system. With careful modelling—and with units such as the one I described earlier—in addition to inevitable new costs, we will find that there are some cost savings. Overall, the biggest change will be in culture and attitude. The NHS heart is willing. We all need to use our heads and energy to make it happen.

Health: Birth Defects

Baroness Brinton Excerpts

Wednesday 18th December 2013 Lords Chamber

[Earl Howe]

My Lords, mandatory fortification of food is, by any standards, a big step; it is not a decision to be taken lightly. The issue that we have been facing is that the survey data used by the Scientific Advisory Committee on Nutrition is more than 10 years old. The latest data available on the folate status of the population will be available early next year, and we feel that it is prudent to use that information to assess the risks and benefits of fortifying flour with folic acid before we make our decision.

[Baroness Brinton (LD)]

My Lords, international academic research since 2005 has shown that including folic acid in bread and cereal products is important and that it reduces neural tube defects by between a quarter and a half, so it undoubtedly helps raise the levels of folic acid in women before and during pregnancy. However, it is not at the level that would remove all possibility of NTDs. Research says that folic acid supplements are recommended, too. What will the Government do to alert women who are thinking about having a baby to take supplements before becoming pregnant?

[Earl Howe]

My Lords, we recognise that some women do not always access maternity services early or attend regularly for antenatal care, and that poorer outcomes are therefore reported in some cases for mother and baby. Maternity services need to be proactive in engaging all women. To help reduce variation and improve services, NICE has published a comprehensive suite of evidence-based clinical guidelines and quality standards for maternity services. We are also promoting the taking of folic acid supplements through a number of channels including Healthy Start, NHS Choices, Start4Life, and the Information Service for Parents.

G8 Summit on Dementia

Baroness Brinton Excerpts

Tuesday 17th December 2013 Lords Chamber

[Earl Howe]

The noble Lord is absolutely right, but he will recall that the question yesterday dealt with the WISH summit, which was focused specifically on mental health and not on dementia. I did not mean to imply that there should be any less emphasis on tackling stigma in both areas.

[Baroness Brinton (LD)]

My Lords, I, too, welcome the result of the G8 dementia summit, but what progress is being made in appointing nurses who specialise in dementia in the same way that there are nurse specialists for cancer, rheumatology and epilepsy? Dementia UK’s admiral nurses are wonderful and provide real help to patients and families, but there are a mere 103 for an estimated population of 800,000 dementia patients.

[Earl Howe]

My noble friend raises a very important point. I come back to the point that I made a short while ago: people with dementia in practice access all parts of the health and care system. We want all staff who care for people with dementia to be trained to the level of their engagement so as to deliver high-quality care for people with dementia. I mentioned that dementia training was a key part of Health Education England’s mandate. Already, 100,000 NHS staff have received dementia training. As my noble friend will know, decisions on the commissioning of admiral nurses are made locally, but I recognise the work that they do.

NHS: Walk-in Centres

Baroness Brinton Excerpts

Tuesday 10th December 2013 Lords Chamber

[Earl Howe]

My Lords, when any service change is proposed, we expect that the four tests which the Government laid down early on in their term of office should be followed. One of those is a patient and public consultation or involvement in the decision. Another is clinical buy-in. I can give the noble Baroness the assurance that this is what local area teams of NHS England would expect to see in any proposals involving the closure of a walk-in centre.

[Baroness Brinton (LD)]

My Lords, does my noble friend share my concern that the NHS is paying twice for patients who regularly use walk-in centres due to the capitation payment to GPs and activity payment to other care systems? Could part of the alternative provision to closed walk-in centres be that all GP practices follow the good practice of those who already extend opening hours for early and late sessions and Saturdays?

[Earl Howe]

The noble Baroness makes an extremely good point. One of the findings of the Monitor review was that, when responsibility for walk-in centres was handed down to local commissioners in 2007, many of them were decommissioned because they were duplicating services locally and GPs felt that they were paying twice for the same thing. I am sure that the ideas the noble Baroness has put forward will have a resonance in many areas.

Health and Social Care Act 2012: Risk Register

Baroness Brinton Excerpts

Wednesday 4th December 2013 Lords Chamber

[Earl Howe]

My Lords, the Government are fully committed to transparency and openness, but they need also to be able to manage large and complex projects and programmes efficiently and effectively. If requests for information are made that threaten to compromise their ability to do that, as is the case here, then the Government have to weigh up whether releasing what is being asked for is, on balance and bearing in mind the consequences, in the public interest. Up to now, we have taken the view that the public interest is not served by publication.

[Baroness Brinton (LD)]

My Lords, the previous Government refused to release Department of Health strategic risk registers in response to three requests under the Freedom of Information Act. Can my noble friend the Minister tell the House whether there is a discernible difference between this Government and the previous one in their approach to the publishing of risk registers?