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.