Medicines and Medical Devices Bill

Committee (3rd Day)

Clause 1: Power to make regulations about human medicines

Debate on Amendment 19 resumed.

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.

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.

My Lords, it is a pleasure to follow my noble friend Lord Stunell. As my noble friend Lady Sheehan so clearly and compellingly explained on Monday, this amendment deals with the key question of access to medicines and is particularly relevant as we find ourselves swept along by wave 2 of the global pandemic. It is clear that, at least initially and perhaps for much longer, supply of any Covid-19 vaccines will fall behind demand. This raises the urgent question of who should receive priority access to these vaccines. Who should get them first, here and internationally? How should equitable access be decided?

The Government appear to be adopting two contrasting approaches to this question. On the one hand, we have Gavin Williamson saying:

“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available”—

and that does seem to be what we are doing. As of August, the United Kingdom was the world’s highest per caput buyer, as the noble Lord, Lord Alton, mentioned on Monday. The vaccine taskforce has placed orders for six unproven vaccines, taking its potential stockpile to 340 million doses. Of course, we do not yet know to what extent, if at all, these vaccines might work, so some duplication is obviously prudent. But on the other hand, and while securing our place at the front of the queue as Mr Williamson recommends, we are also involved in trying to work out, under the auspices of the WHO, an equitable access scheme. The rationale for that is pretty obvious. Unless we have such a scheme, rich countries will end up vaccinated well in front of poor countries. In the face of a global pandemic, that approach carries obvious risk. It also carries moral risk.

The Government have committed £60 million to the WHO COVAX facility—the Covid-19 Vaccine Global Access Facility mentioned by my noble friend Lady Sheehan on Monday. COVAX seeks to enable global collaboration and equitable access to vaccines. It views this model of pooled procurement as preferable to rich countries doing bilateral deals. We have also joined 150 countries in expressing an interest in participating in COVAX for our own vaccine purchases. But there is clearly a risk that the bilateral purchasing of vaccines by the United Kingdom and other rich nations could undermine the work of COVAX. Could I ask the Minister how we balance our Williamson approach with our COVAX approach? How are these approaches prioritised? How much should we try to secure for ourselves and how much should we share? What criteria will be used to decide what access means in practice? We know something of what people in the UK think about the issue. Some 96% of the UK public supported the idea that national Governments should work together to ensure that treatments and vaccines can be manufactured in as many countries as possible and distributed globally to everyone who needs them.

I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.

My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.

I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.

I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”

That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.

I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.

I will just explain that in a few points. First, I reassure the noble Baroness, Lady Sheehan, that the prices for branded medicines and their cost to the NHS will continue to be controlled through the 2019 VPAS scheme, which is the latest voluntary pricing scheme negotiated with the industry. This currently runs in conjunction with the statutory pricing scheme, the processes for NICE appraisals and the NHSE&I commercial arrangements. As noble Lords will know, the VPAS scheme runs out in 2023. Through a series of measures, it supports patient access to innovative new medicines, and a new scheme is envisaged to replace it.

The sustainability of the NHS is an absolute priority for the Government, and we have also been clear that in any negotiations on future trade agreements we could not agree to any proposals on medicines pricing or access that would put NHS finance at risk or reduce clinician and patient choice.

The UK also has a world-leading intellectual property regime, which achieves an effective balance between rewarding research and innovation and reflecting wider public interests such as ensuring access to medicines. I am grateful to the noble Lord, Lord Patel, for his reference to the Sanofi GSK announcement earlier today. As part of this, the UK remains committed to its obligations under the World Trade Organization’s TRIPS agreement. This includes its agreed flexibilities that support access to medicines, particularly during public health emergencies.

These principles are not only set out in our existing international commitments, but they are also in many cases enshrined in law. For example, the Patents Act 1977 contains provisions on compulsory licensing in the unlikely circumstance that this was ever required. Beyond this, we are also ensuring that our future trade deals respect and support these arrangements. This has been set out in all our negotiating objectives with free trade agreement partners. For all these reasons, they will continue to be respected by the way in which we regulate human medicines in the UK.

We remain committed to working with our international partners to support affordable and equitable access to essential vaccines, therapeutics and diagnostics, including in low and middle-income countries. On the ongoing question of how we ensure equitable access, I reassure noble Lords that multiple factors need to be considered to ensure equitable access to Covid-19 vaccines. These include increasing manufacturing and distribution capacity, measures to support or incentivise technology transfer, ensuring global supply chains remain open and ensuring that effective platforms are utilised to voluntarily share IP and know-how. Britain makes a considerable contribution on all of these.

There are existing mechanisms that facilitate the sharing of IP through voluntary licensing of intellectual property. Organisations such as the WHO are developing initiatives by learning lessons from these mechanisms, for example, expanding the mandate of an existing organisation, such as the Medicines Patent Pool, to address needs emerging from Covid.