Medicines and Medical Devices Bill

Lord Stunell Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Lord Patel (CB) [V]]

Thank you, Chairman. It is a pleasure to resume where the Committee left off last Monday. I will speak to Amendment 19, in the name of the noble Baroness, Lady Sheehan. I congratulate the noble Baroness, who spoke with eloquence and passion. On Zoom, you can see faces more clearly and you could tell by looking at her while she was giving her speech that she really feels for the cause. I will speak briefly to support the noble Baroness in her efforts to use human rights legislation to get medical therapies available to patients, particularly in developing countries.

I am no expert in human rights law, but I have seen at first hand what lack of everyday medicines, which we in developed countries have easy access to, does to patients in need in developing countries. In my own medical speciality of obstetrics, I have come across situations where mothers die, or end up with lifelong disability, for lack of availability of cheap medications that would have saved them from dying of childbirth-related haemorrhage. Medicine that costs less than £2 would have saved those mothers’ lives in a very short time.

Despite progress, over 2 billion people worldwide face obstacles in getting the medicines that they need. The current research and development model is mostly market driven and is ill equipped to deliver medicines for neglected tropical diseases and emerging infectious diseases that only affect those in developing countries. Only 1% of the total number of new medicines coming to market are licensed for treating tropical and rare diseases in poorer countries. Another big barrier is the pricing mechanism that makes what we may regard as cheap medicines unavailable in poorer countries because of cost. A human rights model, proposed by the WHO and the United Nations, for making more treatments available in poorer countries, faces serious obstacles because of world trade and patent regulations. The monopoly market power of patent rights plays against the availability of medicines for poorer countries.

All that being said, a soft-power model can sometimes be effective. The Bill & Melinda Gates Foundation has had considerable success in its efforts to create an access-to-medicine index for pharma to demonstrate its commitment to getting medicines to the developing world. One example is the generic medicine for treatment of hepatitis C, but some pharma companies prevent early recourse to generic versions of medicines through extending patent laws by using tactics such as data exclusivity. I heard an announcement today that, if the Sanofi and GSK vaccine works, they will provide 200 million doses of it free to the developing world. That is good news, but it is far away from the billions of doses that we will require.

If there is a serious desire for the world to make treatments available to patients in poorer countries, at a price that they can afford, laws will be needed to change the market-driven model to a more rigidly applied human-rights-driven one. The noble Baroness is right to highlight the problem. The Government can help by working with other Governments to create opportunities for easier access to medicines for developing countries. There has to be a way to get around the model of profit versus patients.

[Lord Stunell (LD) [V]]

My Lords, I endorse what the noble Lord, Lord Patel, has said about the excellent speech of my noble friend Lady Sheehan. I support her arguments and those of all the previous speakers. I could never hope to bring the level of expertise that the noble Lord, Lord Patel, does to this subject.

I want to focus, very simply, on what happens next—and what happens next is based on what has happened so far. Proposed new subsection (2)(d) in Amendment 19 is an affirmation of the International Covenant on Economic, Social and Cultural Rights, which was first passed in 1966 and the United Kingdom Government ratified 10 years later in 1976. My first question, therefore, is to ask the Minister: do the UK Government still stand by that covenant, or is it another piece of international legislation that can be broken in certain limited and specific circumstances? I think that noble Lords will want to hear the Minister say very clearly that the Government are still committed to the full meaning of that covenant. If he does, I hope he will also acknowledge that the key feature of that covenant is that it requires access to medical care and treatment to be affordable and available to all. That is exactly what the second part of Amendment 19 is talking about. It aims to give teeth and real substance to that covenant and to make sure that medicines and treatment are indeed affordable and available to all.

What is the risk that we are guarding against? Why do we need to do this? The noble Lord, Lord Patel, also focused on those questions. Although there are many risks, the leading risk which this amendment deals with is greedy pharmaceutical companies. The story of Gilead selling its drug in the United States for £2,300, when it can be manufactured with a profit for £9, was drawn to our attention by the noble Lord, Lord Alton, on Monday. That is just one of many examples of companies unscrupulously using their monopoly to reap profits at the expense of those who need the treatment. Sadly, there have been many other examples of it. In the current worldwide search for a vaccine, the pressure on companies to deliver a treatment, and the pressure from communities throughout the world to receive it, means that the risk of profiteering and gouging are very much higher.

Of course pharmaceutical companies are fully entitled to recover their costs, and that should include the costs of their research, including for the research on products which they cannot bring to market for one reason or another; and of course they should be entitled to make a profit as well. But in the case of Covid-19 vaccines, nearly all the money has been pumped into the research from the public via Governments around the world. Hundreds of millions of pounds from the United Kingdom Government have gone to these firms. The Government therefore have some really powerful levers to pull to make sure that there is fair and equitable pricing by those companies and fair and equitable sales around the world.

Of course, the truth of the matter is that we have a WTO TRIPS agreement that protects pharmaceutical companies’ monopoly purchasing. But attached to that is the Doha declaration of 2001, which gives Governments the right to step in to prevent that profiteering and price gouging. Under the declaration, the United Kingdom has in principle the right to grant compulsory licences so that other manufacturers can make the product in an alternative way at an alternative price. We need to hear from the Minister today that the UK Government will use the powers available to them in the Doha declaration to prioritise the safeguarding of access to medicines for all right round the world. “All” has to mean all, not just within the United Kingdom but worldwide, as my noble friend Lady Sheehan made so clear, especially in low and middle-income countries.

The role of the United Kingdom in ensuring that an effective worldwide response to Covid actually happens may well require compulsory licensing using the basis provided by the Doha declaration. Certainly, having that basis, and having this amendment passed, gives the Government a credible threat that they will indeed make sure that medicines are available for all. I look forward to hearing the Minister agree that, if not Amendment 19 itself, at least a loud and clear commitment from the Government to implement their powers under the Doha declaration is very much a part of their armoury in tackling the current situation.

Pancreatic Cancer

Lord Stunell Excerpts

Monday 8th September 2014 Westminster Hall

[Eric Ollerenshaw]

My hon. Friend makes an important point. It is difficult for Ministers and boards to make decisions about what is or is not fashionable. Nothing we are trying to do, in getting pancreatic cancer higher up the agenda, is aimed at taking away from the advances being made for other cancers. We all welcome those. We simply want fairer funding ourselves, and some recognition of the impact of this particular cancer. We are not asking to take away from anything else, but unfortunately we are asking the Minister for something extra.

I come now to the Recalcitrant Cancer Research Act, which my hon. Friend the Member for Peterborough (Mr Jackson) mentioned. It was passed in 2012 in the United States, and requires the director of the US National Cancer Institute to prepare a special strategy for recalcitrant cancers in the US. A recalcitrant cancer is defined as a cancer type with a five-year survival rate of less than 20% that kills more than 30,000 US citizens a year.

The result of the Act has been more focus on pancreatic and lung cancer research in the US, as well as a welcome increased focus on and awareness of those cancer types more generally. I would like the Minister to consider whether the British Government need to produce their own recalcitrant cancer research strategy, commissioned and produced either by the Department of Health or the National Institute for Health Research. Such a strategy should focus not just on pancreatic cancer but on other cancers of unmet need—those with low survival rates.

If a British strategy were to use the US definition of “recalcitrant”, it would cover pancreatic cancer, which has a survival rate of just under 4%; lung cancer, for which it is 10%; oesophageal cancer, for which it is 15%; brain tumours, for which it is 19%; and stomach cancer, for which it is 19%. That would help to give a focus.

[Sir Andrew Stunell (Hazel Grove) (LD)]

I apologise to my hon. Friend for arriving late—I was at a Statutory Instrument Committee. My brother-in-law died of pancreatic cancer in July in the United States. I draw my hon. Friend’s attention to the fact that research has then to go on to produce outcomes, and we are still a long way from that. I hope he will agree that it will be a long-term project.

[Eric Ollerenshaw]

I thank the hon. Gentleman for that. I think everybody here—all the people who signed the e-petition and the hon. Members who are here to support the debate—realises that it will be a fairly long journey. We are trying to say that we want a quicker start to that journey, please, given what has happened.

I will not detain hon. Members for too much longer, but I want to finish by mentioning a hobby-horse that I have mentioned in previous debates: the need for more and more effective treatments for pancreatic cancer to be made available on the NHS. The treatments do not need to be discovered; they already exist. Last week, I spoke in the House about the need for the National Institute for Health and Care Excellence to reform if it is ever to be fit for purpose, at least when it comes to ensuring that patients have access to cancer drugs. That is evidenced by the fact that in 2011-12, NICE, as it is called, rejected 60% of the cancer medicines it assessed—an increase since 2010. Simply put, that means that drugs licensed for use in the UK are not being made routinely available on the NHS to all who need them.

The cancer drugs fund for England was introduced in 2010 to clear up the mess—we welcome the fund—and because of it 55,000 patients have been able to access drugs they would not otherwise have managed to access. Those drugs have extended patients’ lives, giving them more time to spend with their loved ones. Unfortunately, the CDF is funded only until 2016. Doctors have to apply for drugs from the fund, which are not routinely available, and any drug on the list could in theory be removed by the CDF panel at any time.

The drug Abraxane, for metastatic pancreatic cancer patients, was added to the CDF list in March this year, following a public campaign and a debate held in the main Chamber. Sadly, however, things have moved on. The Health Secretary recently announced that the CDF will get more money, but the accompanying announcement said that the CDF will be reformed. The precise wording was that it would be more closely “aligned with NICE” and that a new cost-benefit analysis will be introduced when new drugs are considered. Imagine the alarm, Mr Chope, when Sir Andrew Dillon, the chief executive of NICE, said to the Health Committee last week:

“We would like to move away from a situation where…the Cancer Drugs Fund then says yes to the treatments we have said no to…I don’t think that makes any sense. It’s not a criticism of the decision to allocate more money to cancer. It’s about an alignment of processes and methodologies that we need to get sorted out…There is no reason at all why we can’t provide the basis for NHS England’s decisions on cancer treatments just as we do for all other treatments.”

I say to Sir Andrew that there is a reason why: as I have already said, NICE does not work for cancer patients. To treat cancer as if it were like other diseases when it causes so many deaths and when the population is ageing—we know the likelihood of cancer increases with age—is to take a step backwards.

I would be grateful if the Minister commented on the cancer drugs fund. We are worried at the moment. Abraxane has been considered by the fund. We are grateful that it has received ministerial sign-off in Wales. The cancer drugs fund agreed to list it, but now that is with NICE. I hope I am wrong on this, but I suspect that in the near future it will be rejected by NICE for routine use in the NHS in England. It is the first advance in some kind of pancreatic cancer treatment for 40 years, and it looks likely that NICE will reject it. That is a disgrace.

I have held up the Committee for too long, but I do not mind because of the importance of the issue. Just to finish, next year 8,800 people will be diagnosed with pancreatic cancer, of whom 80% to 90% will probably not survive beyond six months. Thousands of relatives and friends will then enter a parallel world: the cancer world.

Oral Answers to Questions

Lord Stunell Excerpts

Tuesday 10th June 2014 Commons Chamber

[Mr Jeremy Hunt]

Because we are making the NHS safe. We are taking action to deal with the issues that the hon. Gentleman’s Government swept under the carpet. The NHS is getting safer and more compassionate. It is delivering more care to more people than ever happened under the Labour Government. We are proud of our record on the NHS, and we will not make the NHS better by pretending that problems do not exist when they do.

[Sir Andrew Stunell (Hazel Grove) (LD)]

Stockport Mind reports that it takes on average 12 months to receive the first appointment for cognitive behavioural therapy after diagnosis. What action can be taken to improve that standard in Greater Manchester?

[Norman Lamb]

I mentioned earlier that when the last Labour Government introduced the 18-week waiting time standard they left out mental health. That is at the heart of the problem. We are committed to changing that and to introducing access standards in mental health, and we plan to start next year.