Health and Care Bill

Baroness Chakrabarti Excerpts

Lords Hansard - Part 1 & Committee stage
Wednesday 9th February 2022 Lords Chamber

Moved by

[Baroness Chakrabarti]

292: After Clause 148, insert the following new Clause—
“Public health condition for investment in research into vaccines and other health technologies
(1) Any relevant research or development funded or part-funded by public finances is subject to the public health condition.(2) The Secretary of State, UK Research and Innovation, the National Institute for Health and Care Excellence, the Intellectual Property Office and all public authorities must ensure that the public health condition is fulfilled in respect of such research or development and any material benefit derived from it.(3) The public health condition is that—(a) a proportionate share of any intellectual property resulting from the public funding (including intellectual property in all research, pre-clinical and clinical data, safety and efficacy information and manufacturing capability) is subject to Crown ownership and openly licensed,(b) a proportionate share of any private profit resulting from the public funding is re-invested in further public health-related research, and(c) any proportion of public funding is published and taken into account in relation to the setting of reasonable prices for the public procurement of medicines domestically and internationally.(4) In addition, the Secretary of State must utilise, and actively support other countries to utilise, the full range of flexibilities within the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) for the purposes of public health. (5) In the event of the World Health Organization declaring a pandemic, the Secretary of State must immediately—(a) waive UK-registered patents, industrial designs, other intellectual property rights, and protections relating to undisclosed information relating to—(i) vaccines,(ii) medicines,(iii) diagnostics and their associated technologies, and(iv) materials,necessary for combatting a pandemic internationally, (b) issue relevant emergency compulsory directions to enable the domestic manufacturing of generic and biosimilar products, and(c) support and implement any proposal to temporarily waive elements of the TRIPS Agreement at the World Trade Organization to assist wider global manufacturing of and access to health technologies.”Member’s explanatory statement
This new Clause ensures public benefits in exchange for public financing of research and development. It would require the Secretary of State to support public health flexibilities under the TRIPS Agreement and, in the event of a pandemic, domestic and international knowledge-sharing to combat the emergency.

[Baroness Chakrabarti (Lab)]

My Lords, Amendment 292 is in my name and that of my noble friends Lady Lawrence of Clarendon and Lord Boateng, and the noble Baroness, Lady Bennett of Manor Castle. I thank noble Lords from across the Committee and the People’s Vaccine Alliance—Saoirse Fitzpatrick of STOPAIDS, in particular—for their advice.

Last year, the Prime Minister lauded the successes of the UK’s vaccination programme as a result of “greed and capitalism”, but the virus-busting vaccines, treatments and tests were in no small part funded by taxpayers, supporting the work of scientists at universities, research institutions and small-scale biotech companies across the world. Over €93 billion of public money has gone into developing vaccines and therapeutics. The AstraZeneca vaccine developed at Oxford University was over 97% publicly funded.

Public investment at the beginning of the research process assumes the biggest risk at the point when there is no certainty that a product will be successful. It is only when effectiveness is clearer that big pharma swoops in and uses exclusive intellectual property rights to hold a monopoly over that product in the market. The risk is socialised but rewards are privatised and, crucially, monopolised. The NHS is paying twice for medicines: once for research and again through procurement.

Some estimates show the public paying for up to two-thirds of drug development, including research and clinical trials. Drugs are getting only more expensive, with estimates that the NHS procurement bill increased by nearly 10% over the last couple of years, to £20.9 billion. Yet there is still no guarantee of production at the volumes required to meet demand or that patients will be able to access health technologies at affordable prices, nor that scientists will be able to make use of the data, knowledge and technologies generated in the research process to develop improved follow-on products. Due to the opaqueness of the pharmaceutical industry, it is very difficult to track public funding. The terms of agreement, actual costs and prices charged—all these are kept behind closed doors.

The amendment seeks to change that for health technologies developed with public funding, as well as to define emergency procedures to expedite a sharing of research, data and intellectual property in the case of a pandemic. By adhering to the “public health condition”, the Secretary of State and all public authorities would ensure that

“a proportionate share of any intellectual property resulting from the public funding … is subject to Crown ownership and openly licensed … a proportionate share of any private profit from public funding is re-invested in further public health-related research, and … public funding is published and taken into account in … the setting of reasonable prices for the public procurement of medicines domestically and internationally.”

Open licensing would allow production in a competitive generic market, bringing down the price of medicines. A study published in the BMJ showed how the price of oncology drugs could decrease by between 75% and 90%. We saw this with ARVs for HIV/AIDS, and how crucial that was in fighting that pandemic by reducing costs from over $10,000 per person per year to under $100. Reinvesting a proportion of profits could ensure that they go towards health priorities rather than financialised practices or the development of me-too drugs—sufficiently different to obtain patent protection but without added therapeutic value, compared with existing products.

There is recent precedent for more transparency and conditionality around public funding in Italy and France, while the European Union is looking at how to track public funding and measure societal impact. Even our Government are beginning to think about public interest conditions for future pandemic tools to ensure access in low- and middle-income countries. This is a recommendation of the UK’s pandemic preparedness partnership’s 100 Days Mission report, published during the UK’s G7 presidency.

There are also circumstances where there has been no public funding but the price or volume restrictions of a product are preventing widespread access. In that case, the amendment calls for a recommitment to the use of pre-existing public health safeguards within the Trade-Related Aspects of Intellectual Property Rights—TRIPS—Agreement. These flexibilities include the use of compulsory licences when intellectual property monopolies prevent access to a medicine. They enable a Government to license another manufacturer to produce a generic or biosimilar version of a patented health technology at a much lower price. These can be used at any time by any WTO member; they have already been implemented more than 100 times between 2011 and 2016.

The need to use flexibilities has never been greater, with ever more drugs coming to market with a price tag of over £1 million per dose. For example, the NHS is currently paying a list price of £1.795 million for a single dose of Zolgensma to treat spinal muscular atrophy—SMA. It is the most expensive drug in the world, despite public and philanthropic funding. A Crown-use licence would permit the Government to allow a third-party manufacturer to make a biosimilar version at a discounted price.

We must also stand with other countries in the face of huge and unconscionable pressure from big pharma when TRIPS flexibilities are used. In 2007, we supported the Thai Government when they applied for a compulsory licence to produce a more affordable antiretroviral drug to treat HIV and were met with a threat from the pharmaceutical company AbbVie that they would lose access to all its other products. We could show leadership and solidarity again. Multinational corporations, whether tech, pharma or other corporations that noble Lords have considered in your Lordships’ House in recent times, warrant international democratic governance, regulation and restraint. Hence the last part of the amendment.

In future pandemics, we must not remake the continuing mistakes of this one. Monopolies which profiteer from poverty and sickness are bad enough at the best of times. But in a global emergency, when so many ordinary citizens, health workers and ethical businesses have sacrificed so much by way of livelihoods, liberties and lives, such conduct is totally amoral. Pharmaceutical companies’ refusal to share manufacturing know-how has led to grotesque vaccine inequity. Only 10% of people in low-income countries have received a single jab. So the amendment stipulates immediate action as soon as the World Health Organization declares a pandemic. The temporary—I stress, temporary —waiver of UK registered patents, industrial designs and other intellectual property rights relating to undisclosed information necessary for combating a pandemic, and emergency compulsory directions to enable domestic manufacturing, would mean that any company within the UK with the capacity could be making these products. It would allow products to be shipped internationally and allow companies across the world access to the critical data and rights to produce pandemic tools at scale for their own people.

The Indian and South African proposal to temporarily waive the TRIPS agreement is supported by more than 100 countries. It is only opposed by the European Union, Switzerland and our own Government. The waiver could allow the 100-plus potential mRNA producers across Latin America, Asia and Africa access to critical clinical data and manufacturing know-how required to make mRNA vaccines, without fear of litigation in the worldwide race to beat variants of the virus.

New treatments are in high demand, and high-income countries have already brought up the lion’s share. We will be facing a treatment apartheid on top of a vaccine one if the United Kingdom and others do not shift their position urgently. Just last week, it was reported that the director-general of the WTO, Ngozi Okonjo-Iweala, was hopeful of a breakthrough in the long-standing waiver discussions. However, it is incredibly important that any compromise is not overly restrictive geographically or in terms of products or types of intellectual property.

The UK Government must stop saying that a waiver will take too long to implement while simultaneously blocking its agreement. They should end their group hug with the EU, Switzerland and big pharma and start embracing and empowering the global south and wider world. The line that temporarily waiving TRIPS will stifle future innovation ignores the public money that funded the riskiest parts of developing vaccines and treatments, and how innovation works. Sharing research data and clinical trials results with great minds around the world creates the conditions for competitive collaboration, vying to have the best results but also sharing lessons learned and supporting each other. This is how we have made great leaps in the past, as with the human genome project, where public funding supported a global collaboration which has changed modern science.

This is about improving access to affordable, life-saving health technologies for our NHS and the world to combat pandemics and improve health. It is about ensuring that we get the best from our biomedical innovation, especially when we are investing so much money and expertise and putting human beings through clinical trials. In a global health emergency, not sharing life-saving knowledge is as wicked as blocking access to emergency exits from a crowded building in a raging fire. I beg to move.

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

My Lords, I call the noble Baroness, Lady Brinton, who is taking part remotely.