Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Sheehan (LD)]

My Lords, I will raise an issue that was not raised in the other place; I cannot hope to do it justice in four minutes. However, it is topical and urgent and, as confirmed by the Public Bill Office, within scope.

A safe and effective vaccine for Covid-19 is critical if we are to return to life as we knew it just a few short months ago. One does not yet exist. There are promising candidates out there, but we know from our experience in setting up an efficient testing regime that it is not easy to get from concept to delivery, however much of a world-beater a candidate may be. Bearing that in mind, thought and planning are necessary to help us beat this disease. Moreover—this point lies at the crux of my contribution today—we must act in unison with all countries of the world to ensure equitable access for all to any successful vaccines and treatments, because until everyone is safe, no one is safe.

Our experience here also shows that a small number of local cases can very soon become an outbreak and stringent restrictions have to be reimposed, Glasgow being the most recent example. It does not need a great leap of imagination to extrapolate this to the global stage. We really do all have to work together and co-ordinate action. Pharmaceutical companies have to play their part too.

Let us suppose that a safe and effective vaccine is found. The volumes of production required to inoculate the entire global population will be staggering and vastly outstrip the manufacturing capacity of individual companies. Holding exclusive licences over Covid-19 health technologies will not only affect pricing and hinder further research but prevent countries producing the volumes needed. Given that the UK, US, Japan and the EU countries have already secured over 1.8 billion of CEPI’s estimated 2 billion to 4 billion dose volume available until the end of 2021, the sharing of IP and know-how will be key to scaling up manufacturing capacity to meet global demand, in particular to ensure that low and middle-income countries can access a Covid-19 vaccine. To control the spread of Covid-19, it is crucial for all countries to be able to vaccinate the minimum 20% of their population necessary to protect key workers and vital health systems that, once lost, will take much time and money to reinstate.

Together with partners such as Gavi and CEPI, the WHO has been working to co-ordinate global action, resulting in myriad acronyms—the ACT accelerator, the AMC COVAX facility and CTAP, among many others. It is good that the Government have supported these initiatives, but—this is the huge part—they lack safeguards to ensure that vaccines and treatments, often resulting from huge investment from public purses, will be made available for all at a fair price.

I will give just a couple of examples of why these safeguards are so necessary. Gilead’s Remdesivir has been proven to reduce the need for mechanical ventilation for Covid-19 patients in hospital. However, with monopoly protection, Gilead was able to charge the US $2,340 per five-day treatment course of the drug, despite the substantial amount of public funding to develop the drug and researchers at the University of Liverpool calculating that the drug can be made for $9 at a reasonable profit. AstraZeneca has said it will supply the vaccine at cost to the UK Government during the pandemic phase, but what price will the NHS have to pay post pandemic? What happens to the money paid in advance if the vaccine is not approved? The contract between the UK Government and AstraZeneca has still not been published.

The Bill represents a timely opportunity to ensure that intellectual property rights support public health imperatives, as per the 2001 Doha declaration on trade-related aspects of intellectual property rights, TRIPS. The Government also have another tool in the issuance of Crown-use licences, similar to steps taken by countries such as Australia, Canada and Germany. In conclusion, will the Government take up the International Trade Select Committee’s recommendation to evaluate the case for measures to allow compulsory licensing, so that Covid-19 technologies are available as quickly, cheaply and widely as possible?

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Masham of Ilton (CB) [V]]

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.

[Baroness Sheehan (LD) [V]]

My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.

The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.

The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

The implementation of the recommendations of the Cumberlege report would afford an opportunity for the Government to do, and be seen to do, the right thing by patients, particularly women whose avoidable suffering has been caused by medical mistreatment over decades—all too often because of what looks like inherent misogyny on the part of male medics and a consequent trivialisation of the pain, discomfort and longer-term harm which so many women have had to endure. Parliament now has the opportunity not only to put measures in place ensuring that voices are heard in the future but to insist that an independent taskforce is appointed to implement the recommendations of the Cumberlege review without further delay. It is also a chance to bury those who have told the noble Baroness that they intend to bury her report and its recommendations. I wish her amendments well.

[Baroness Sheehan (LD) [V]]

My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.

I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read

“the appropriate authority must act with a view to ensuring”.

This offers greater purpose of intent on the part of the Government of the day than the existing

“the appropriate authority must have regard to”.

It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.

It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.

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Moved by

[Baroness Sheehan]

19: Clause 1, page 1, line 12, at end insert—
“(d) 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 (“TRIPS Agreement”) which include but are not limited to—(i) the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted;(ii) the right to determine what constitutes a national emergency and circumstances of extreme urgency;(iii) the freedom to establish the regime of exhaustion of intellectual property rights.”

[Baroness Sheehan (LD) [V]]

My Lords, I metaphorically rise to move Amendment 19, which is in my name and that of my noble friends Lady Jolly and Lord Sharkey and the noble Lord, Lord Alton, whose support is always very welcome. I look forward to the contributions from other noble Lords who have signalled their intention to speak. It is a matter of deep frustration that a number of noble Lords who wished to contribute to this debate are instead committed to the equally important debate on the internal markets Bill, which is pitted directly against this Bill.

Amendment 19 has been tabled simply to ensure that fair access to medicines is a core aim of the Bill. It would root the Bill in the International Covenant on Economic, Social and Cultural Rights of 1966, which is a binding international human rights treaty that we in the UK ratified in 1976. The amendment would put into the Bill the fundamental right of every citizen

“to access medicines as part of the right to the highest attainable standard of physical and mental health.”

Fair access to medicines is an issue at the forefront of concerns expressed by patients’ groups. There are regular reports in the media about price gouging by pharmaceutical companies. Furthermore, one of the key calls in the collated briefing of the Royal College of Physicians, the Faculty of Pharmaceutical Medicine and the British Association of Dermatologists is that:

“The Bill must include provisions which allow for review of processes for issuing sole manufacturing licenses and consider the use of price control mechanisms in relation to costs of production, to increase access to medicines at fair prices.”


Yet this issue was not brought up during the Bill’s passage through the other place, nor does it feature directly in any other amendment before the Committee. So I hope that your Lordships will forgive what will be a rather full presentation of the important issues raised in the amendment.

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

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

[Lord Bethell (Con)]

I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.

[Baroness Sheehan (LD) [V]]

My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.

I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.

At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.

The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.

My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.

I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?

I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.

On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.

In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

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.”

[Baroness Sheehan (LD) [V]]

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.

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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.

[Baroness Sheehan (LD) [V]]

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.