Amendment 10

Medicines and Medical Devices Bill - Report (1st Day) – in the House of Lords at 6:43 pm on 12th January 2021.

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Baroness Sheehan:

Moved by Baroness Sheehan

10: Clause 1, page 1, line 17, at end insert—“(d) the importance of prioritising the protection of human rights including citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;(e) the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights which include but are not limited to the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted.”

Photo of Baroness Sheehan Baroness Sheehan Liberal Democrat Lords Spokesperson (International Development)

My Lords, I rise—metaphorically—to move Amendment 10 in my name and those of the noble Baroness, Lady Bennett of Manor Castle, and the noble Lords, Lord Alton of Liverpool and Lord Crisp. It is a pleasure to have their names on an amendment to ensure that affordable medicines for all must be a consideration when regulations are made with respect to human medicines.

The price of a medicine is often determined not by the cost of production but by artificial and opaque determinants by big pharma. Egregious examples of price gouging abound. With such opportunities for eye-watering profits, the temptation to protect them is great. Big pharma has developed myriad unethical practices to do just that. Many of these were detailed in Committee by a number of noble Lords; I do not propose to repeat them today. However, I do not want to skate over the consequences. People, even those under NHS care, suffer and/or die because of a lack of medicines that are available but not affordable.

Let me give a couple of examples. The row over the cystic fibrosis drug Orkambi went on for three years, with the NHS held to ransom, as the manufacturer Vertex refused to lower the price to an affordable one. A House of Commons debate on Orkambi was finally triggered after an online petition reached more than 100,000 signatures. A threat by the government Minister to invoke a compulsory licence, known in the UK as a Crown use licence, to allow the manufacture of the drug by a third party at a more reasonable price was all it took for Vertex to reduce its price. It is estimated that, in those three years, more than 200 people died here in the UK for lack of a drug that should have been affordable much earlier. Let us just think about that for a moment.

Just last year, we had the unacceptable behaviour of Gilead over remdesivir, then thought to be the only effective drug against Covid-19. At the height of last year’s spike in cases, rationing of the drug had to be put in place in the NHS because the US had bought up all available supplies of the drug. Australia, Canada and Germany have revised their national patent laws to enable them to issue compulsory licences to respond to Covid-19 more effectively. Here, the Commons International Trade Committee made this recommendation:

“The Government should also evaluate the case for enabling compulsory licensing of therapeutic drugs or vaccines in respect of COVID-19 to make them available as quickly, widely and cheaply as possible.”

Can the Government assure us that they will invoke a Crown use licence without hesitation if necessary? I hope that the Minister can give that assurance at the Dispatch Box; we have had some conversations about this. If she does so, there will be no need for me to seek the opinion of the House.

I want to move on to the subject of non-exclusive voluntary licensing. Even though he is not at the Dispatch Box, I thank the noble Lord, Lord Bethell, for his letter in response to the questions asked in Committee. In that letter, he restated the Government’s view that non-exclusive voluntary licensing is providing enough incentives to create new inventions and accelerate the development of health technologies.

However, evidence from European studies shows that over half of newly patented drugs have no added therapeutic value. Have the Government carried out any reviews into whether patents are incentivising research and development into the drugs and health technologies that the public need? For example, are pharmaceutical companies putting resources into the development of vaccines for new virus threats as they emerge, and into vaccines against existing diseases such as TB and HIV? Are they working at full throttle to develop a new generation of antibiotics that will be effective against antimicrobial resistance? I am grateful to the noble Baroness, Lady Bennett of Manor Castle, for bringing this up in her earlier speech this afternoon. However, is it these companies’ job to safeguard public health? Can we rely on them to do it on our behalf? We need a review to know whether they are doing it.

If there are no plans to carry out this useful investigation, will the Minister give an assurance that she will advocate for one? That will go some way to reassuring me and other noble Lords that the Government’s confidence in the existing system of patents to deliver the public health goods to safeguard us all is justified. It will also go some way towards answering those who believe that the current model works only to the advantage of unscrupulous pharmaceutical companies, whose sole raison d’être is to garner extreme profits.

To summarise, my two asks of the Government are, first, whether they will give an undertaking of their willingness to use Crown use licences and, secondly, whether they will meet me and other interested parties to explore terms for a government review into whether big pharma meets public health needs.

I would like to say a few words about the supply of vaccines for Covid-19. In his letter to me and the noble Lord, Lord Alton, the Minister, the noble Lord, Lord Bethell, stated that the Government are exploring the role of the WHO’s COVID-19 Technology Access Pool, or C-TAP, to see whether it can improve access to vaccines. Please can they get a move on? Events of the past several weeks have shown us with pinpoint clarity that we are in a race against time, as new and more transmissible variants emerge.

The fact is that UK support for the Medicines Patent Pool and the eventual agreement of pharmaceutical companies to share their patents on antiretroviral drugs made the production of more affordable drugs possible. This transformed the HIV response; we need to do the same again now. We need the UK Government to support the C-TAP and get companies to share their technologies, otherwise the situation we have with shortages of vaccines in the UK will continue—not just here but everywhere, to the detriment of us all. If, however, companies refuse to share their vaccines, medicines and tests then the UK Government, and all Governments, must use their legal rights to implement the public health safeguards within the TRIPS Agreement. At the very least, that means invoking compulsory licences.

If the Government are serious about getting this vaccine to everyone in the UK and the rest of the world, they must also support the TRIPS waiver so that unhelpful intellectual property protections on Covid-19 tools can be removed. The TRIPS waiver is a proposal put recently to the WTO TRIPS council by South Africa and India, meaning that certain parts of the TRIPS Agreement should be waived for the duration of the pandemic to help us all combat its effects, because this would allow countries to collaborate in the research and manufacture of vaccines, medicines and tests to meet global demand.

With almost 2 million lives lost due to Covid-19, this is no time for restrictions in manufacturing capacity in the name of pharma profiteering. We know the power of the pharmaceutical lobby, and the influence it can bring to bear, but in this crisis human rights must take priority over intellectual property rights.

Photo of Baroness Bennett of Manor Castle Baroness Bennett of Manor Castle Green

My Lords, it is a great pleasure to follow the noble Baroness, Lady Sheehan, and to join the noble Lords, Lord Alton of Liverpool and Lord Crisp, in backing her important amendment. The introduction the noble Baroness provided was powerful and comprehensive, so I will not speak at length. I endorse the two asks she put to the Minister; it is important that we hear very clear, direct answers to them.

As the noble Baroness powerfully put it, there is a contest between public need and private profit, and we know that the reality of how our current system works is that private profit comes first. That means that human rights and public health trail behind. We know that so much of our healthcare system has been dragged in the direction of the disastrous US model, the most extreme example on the planet of a private, profit-driven healthcare system that has disastrous outcomes for massive costs. We also know that there are healthcare systems around the world that spend even less than we do but have a very fair and reasonable distribution of resources and money.

We often talk about these issues in moral terms; we must make sure that everyone has these medicines, and I endorse that moral approach, but in the context of the Covid-19 pandemic, nationally and globally, we must come back to the phrase, “No one is safe until everyone is safe.” It is in everyone’s interest that everybody in the UK and around the world has access to the best possible medicines and medical devices and that the research effort and all that wonderful power of human ingenuity are put into the best possible causes and results for public health, for the good of us all.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I spoke at some length on this issue in Committee and am delighted that the noble Baroness, Lady Sheehan, has given us the opportunity to explore it again. She has done so with her usual thoroughness and thought. I am also pleased to follow the noble Baroness, Lady Bennett, who spoke so well. The noble Lord, Lord Bethell, has exchanged letters, as the noble Baroness, Lady Sheehan, referred to; that has been extremely helpful, as she intimated, and I think will avoid the need for a Division, but it is right we explore this issue thoroughly.

I will not repeat all the detailed arguments made in Committee, but, in headline terms, Amendment 10 is being considered in the context of exclusive intellectual property rights which can in some circumstances create monopolies, leading to high prices and supply issues for medicines and medical devices. We are seeing those issues come to the fore in the Covid-19 response.

In an Oral Question that I asked on the Floor of your Lordships’ House on 30 November to the Trade Minister, the noble Lord, Lord Grimstone, I argued that in the context of hundreds of millions of Covid vaccines being held in the United Kingdom and the significant sums of public money invested in developing new drugs and treatments, notwithstanding the need to generate funds to enable future research and development, when companies such as Gilead repurpose drugs such as remdesivir and charge $2,340 for a Covid treatment that Liverpool University estimates can be done for $9, the Government should invoke their powers in such circumstances to use Crown licences to prevent patent monopolies impeding access to medicine, to ensure equitable access, prevent exploitative profiteering and recognise that affordable drugs and their fair distribution are a public good that this country should be at the forefront in providing.

In November, the Minister the noble Lord, Lord Grimstone, responded:

“There are existing mechanisms that facilitate the sharing of intellectual property—for example, the Medicines Patent Pool, which has been so successful with HIV. To follow up on this point, we are committed to identifying whether and how C-TAP could add value to the existing infrastructure.”—[Official Report, 30/11/20; col. 503.]

It would be extremely helpful to me and I think to the House this evening if the noble Baroness, Lady Penn, could tell us what progress has been made in that examination of whether and how C-TAP could add value.

It is simply obscene and no better than speculative profiteering when wholly disproportionate mark-ups are added to the price of a drug. It brings to mind wartime profiteering—profits being generated while other people are making great sacrifices for the common good.

It is hugely important during this pandemic that access to medicines is a fundamental right of all, and it would be good to hear the noble Baroness’s assessment of the impact that the extremely unwelcome reduction of our aid programmes from 0.7% to 0.5%—already reduced in real terms because of the fall in GNI—will have on our ability to ensure access to life-saving medicines in some of the most deprived and poorest parts of the world.

Perhaps the noble Baroness can also say what assessment has been made of the impact of the export ban, made last year on over 80 medicines to help ensure an uninterrupted supply of medicines for NHS hospitals during this public health emergency? That is highly understandable, but how has it affected access to medicines in the developing world, and are we able to increase production of some of those drugs to enable exports to be resumed? In November, the noble Lord, Lord Grimstone, promised to find out how much of the overseas aid budget has been reserved to help to pay for accessible drugs for developing countries. Perhaps the noble Baroness, Lady Penn, can tell us today.

As a young man, I got to know very well a family with three children, two of whom had cystic fibrosis. I became acutely aware of the nature of that terrible affliction. So I followed with great interest the experience of the UK trying to get access to the cystic fibrosis drug Orkambi, which was mentioned by the noble Baroness, Lady Sheehan. By issuing a compulsory licence instead of going through years of stalled negotiations with Vertex Pharmaceuticals, lives could have been saved.

Parents of children with cystic fibrosis were forced to watch their child’s health deteriorate as Vertex, a US drug company, pushed for the National Health Service to pay the highest possible price for Orkambi. In response to the stalled negotiations and Vertex refusing to offer access to Orkambi on reasonable and affordable terms, Ministers stated that the UK Government would explore all options, including using a Crown use licence, to get access to the drug. The threat of a Crown use licence eventually influenced Vertex to reduce the price for Orkambi to a level that the National Health Service could afford.

That fight for the NHS to get access is just one example of the growing crisis in medicine prices globally, which using TRIPS flexibilities could help address. Over the last five years, access to drugs for the treatment of hepatitis C, breast cancer and rare diseases have all been delayed, rationed or denied to NHS patients due to price.

The ability of Governments to issue Crown use licences when patent monopolies prevent access to a medicine is a hugely important safeguard, and effectively enables a Government to issue a licence to another manufacturer to produce a generic version of a patented drug at a lower price. With medicines becoming ever more expensive, countries such as Australia, Canada and Germany have revised their national intellectual property laws to simplify the issuance of a compulsory license during a public health emergency. Is it not high time we did the same?

Photo of Baroness Walmsley Baroness Walmsley Co-Deputy Leader of the Liberal Democrat Peers 7:00 pm, 12th January 2021

My Lords, I support this amendment. When we discussed this issue in Committee, I raised the matter of Section 57A of the Patents Act 1977 and the Minister pointed out that compensation needs to be awarded to a patent holder for any loss of profits as a result of the use of a Crown use licence and argued that this should be set against the potential savings that purchasing more affordable generic alternatives enabled by a Crown use licence could bring about. Tonight, I repeat that this has never been tested in court.

The noble Baroness, Lady Sheehan, and the noble Lord, Lord Alton, mentioned Orkambi. The fact is that if the Government had issued a Crown licence and Vertex had decided to take the Government to court for compensation, the Government would probably have won the case, because they had a very strong case. Any reasonable person would have concluded that three years of failed negotiations showed that Vertex could not make the case that the NHS would definitely have bought the product from them had a Crown use licence not been issued. Had they taken the thing to court, the Government would probably have won the case, and the fact that they did not means that they really missed an opportunity to set a useful new precedent by fighting an interpretation that would render the entire Crown use provision next to useless.

I shall add just a few words about the Covid-19 pandemic. Many countries, such as Germany, Hungary, Canada and Australia, have made alterations to their patent laws to make issuing a compulsory licence easier, in the interests of public health. That is because, in those countries, it is accepted as a valuable tool that can help overcome pricing and manufacturing barriers to accessing crucial vaccines, medicines and diagnostics which could help save millions of lives. Will the UK Government follow this example, set a precedent, next time the opportunity presents itself, and make the necessary changes to our law to make it easier, not more complex, to use our legal right of issuing a Crown use licence to protect public health?

Photo of Lord Crisp Lord Crisp Crossbench

My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.

This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.

Photo of Baroness Jolly Baroness Jolly Liberal Democrat

My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?

On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.

Photo of Baroness Wheeler Baroness Wheeler Shadow Spokesperson (Health and Social Care), Opposition Deputy Chief Whip (Lords)

My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.

As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.

Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.

On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?

Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.

Photo of Baroness Penn Baroness Penn Baroness in Waiting (HM Household) (Whip)

My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS.

As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.

I will answer the two questions put by the noble Baroness, Lady Sheehan, directly. On the question of Crown licences, if the Government deemed it necessary, we would make use of compulsory licensing or Crown use provisions, but we have made it clear to interested partners that we do not believe this is required at this point in time. The second question put by the noble Baroness was on whether the Government had carried out any review into the efficacy of the patent system to incentivise research and development into vaccines, therapeutics and health technologies. In 2011 a review by Professor Ian Hargreaves into the UK’s IP system was commissioned, to look at whether it was sufficiently well designed to promote innovation and economic growth. The review found that

“the UK’s patent system has played a well understood role in supporting innovation” across the economy, including in pharmaceuticals, and plays an important role in incentivising investment in research and development. However, I acknowledge that some time has passed since that review was undertaken. There have been other specific issues raised by the noble Baroness and other noble Lords in this debate, and I would be happy to meet with interested parties to discuss those issues further.

I will now address the concerns raised by noble Lords about access to medicines and vaccines globally. The Government are committed to improving equitable access to essential medicines for people in low-income and middle-income countries. That is why the UK is the largest donor to Gavi, the vaccine alliance, having supported it since its inception in 2000. In the context of the Covid-19 pandemic, the Government recognise that the world urgently needs access to safe, effective, quality and affordable vaccines, diagnostics, medicines and other health technologies. As part of this, we remain committed to the arrangements in the TRIPS agreement, including the public health safeguards that it provides for signatory countries.

The existing IP framework supports research and development for new medicines and technologies, while voluntary licensing mechanisms and other flexibilities, as noted by the noble Baroness, ensure the transfer of and access to technology and know-how. Indeed, a strong IP framework was integral to the rapid development of safe, clinically effective vaccines.

The Government continue to think that the fastest way to deliver vaccines across the globe is to fund efforts such as the COVAX facility and the access to Covid-19 tools accelerator. To that end, we have committed up to £548 million to COVAX, which is one of the largest contributions made by any country. This will enable developing countries to access vital vaccines against Covid-19.

The noble Lord, Lord Alton, and the noble Baroness, Lady Wheeler, asked for an update on C-TAP. The Government continue to discuss C-TAP with stakeholders to identify where they can contribute to this initiative for global benefit. We recognise the need to understand how industry and research institutions can assist this initiative and we are currently working with the WHO to facilitate this.

Further, the existing flexibilities in the international IP framework and opportunities for voluntary arrangements are already being used to support the global response to Covid-19. For example, AstraZeneca has reached a licensing and technology transfer agreement with the Serum Institute of India to supply 1 billion doses of its vaccine to low-income and middle-income countries. Another initiative, DiaTropix, brings together British and Senegalese partners to share technology to produce 10 million Covid-19 antibody tests by March 2021, for use across west Africa.

I hope that this reassures noble Lords that the Government are prioritising access to medicines, vaccines and therapeutics in the UK and internationally, including for the poorest and most vulnerable. On that basis, I hope that the noble Baroness, Lady Sheehan, is able to withdraw her amendment.

Photo of Baroness Sheehan Baroness Sheehan Liberal Democrat Lords Spokesperson (International Development) 7:15 pm, 12th January 2021

My Lords, this has been a stimulating debate and I sincerely thank all noble Lords and noble Baronesses who have taken part. That very much includes the Minister, who responded with her customary courtesy and thoughtfulness.

I thank the noble Baroness, Lady Bennett of Manor Castle. As ever, she brought up the issue of human rights and how they must not be trumped by intellectual property rights—sentiments I agree with 100%.

I thank the noble Lords, Lord Alton of Liverpool and Lord Crisp, who raised a question central to the whole issue of intellectual property rights: who actually pays for the investment in drug development? This is shrouded in secrecy and we must try to shed some light on it. I hope that we can explore that in discussion when we have the meeting the Minister has very kindly agreed to. Drug development is done not just by private companies; taxpayer-funded research and R&D institutions play a huge part, as do philanthropic organisations and NGOs.

I am very grateful to my noble friend Lady Walmsley for raising Section 57A, which the noble Lord, Lord Bethell, brought up as a defence against using compulsory licensing. It is a moot point, as my noble friend said. I think that the argument the Government used would in fact nullify the whole concept of Crown use.

I thank my noble friend Lady Jolly for the focus she placed on the major challenges developing countries face, even more so now that DfID no longer exists and 0.7% has been reduced to 0.5%.

I thank the noble Baroness, Lady Wheeler, for her words. She was absolutely right to draw attention to the collated briefing of the Royal College of Physicians and its partners in highlighting prices in the NHS for both generic medicines and those that enjoy patent rights.

I thank the Minister, and I will take her up on her offer of a meeting in due course. I beg leave to withdraw the amendment.

Amendment 10 withdrawn.