Dear Prime Minister,
CC. Ranil Jayawardena MP, Rt Hon Matt Hancock MP, Rt Hon Kwasi Kwarteng MP, Rt Hon Liz Truss MP, Rt Hon Dominic Raab MP
I am writing to you with regard to the Minister for International Trade’s letter of 18 March, concerning intellectual property rights and COVID-19 medical tools. As you may be aware, Médecins Sans Frontières / Doctors Without Borders (MSF) previously wrote to you, asking that you reconsider the UK’s position on the proposal submitted by India and South Africa regarding a temporary waiver for certain provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS waiver).
Read Ranil Jayawardena MP's 18 March letter to MSF International President, Dr Christos Christou
I am grateful for the Minister’s reply to our letter of 9 March, but would like to take the chance to set out our response to the points he made, ahead of upcoming TRIPS Council meeting taking place on 30 April, and the World Trade Organisation (WTO) General Council meeting taking place on 5 and 6 May.
I would also like to ask again that you please urgently reconsider your position and agree to support – or at least not to block – this proposal, which will be a crucial step towards achieving our shared goal of ensuring access to COVID-19 medical tools for all.
1. In his 18 March letter to MSF, the Minister for International Trade wrote that “The UK believes that the intellectual property framework can support innovators while enabling equitable access to innovative medical products”, whilst a “waiver of the TRIPS Agreement would risk undermining this framework’s ability to respond to current – and potentially future – crises.”
This claim fails to recognise that during this pandemic, the IP system has not been the incentive for innovation. Instead substantial amounts of public funding from the UK government and other governments and philanthropic funders has funded research and development (R&D), at-risk manufacturing and purchasing of COVID-19 medicines and vaccines. In fact, over £7 billion of public funds has contributed to the development and manufacture of the six front-runner COVID-19 vaccine candidates. Furthermore, at least two companies with leading COVID-19 vaccine candidates, AstraZeneca and Moderna, have stated that their vaccine development costs will be entirely funded by the public.
Whilst the Minister recognises the role of public funding in COVID-19 R&D, he states that this is alongside “high levels of private funding”. However, the profound lack of transparency from the pharmaceutical industry related to R&D and manufacturing costs makes it very difficult to verify these claims. MSF has long called for more transparency from the industry, so these claims can be substantiated. As such, we would ask that the UK government support and take concrete steps to ensure more transparency from industry on their costs, as a condition attached to public funding.
The TRIPS waiver proposal is for a specific duration for the purpose of waiving patents, copyright, industrial design and trade secrets for the prevention, containment and treatment of COVID-19. Hence, the suggestion that the waiver will impair the IP system in the long term has no basis.
2. The Minister claimed that “Waiving intellectual property rights risks making returns on investments more difficult, which risks diverting necessary investment away from those involved in developing safe, effective, quality vaccines, potentially delaying global progress.
These concerns are misplaced: it is clear that the companies involved in the development of COVID-19 vaccines will be making extremely substantial profits off the back of these lifesaving products. And again, it is worth noting – as set out above – that massive public investment, not the IP system, has been the incentive for innovation during the pandemic.
Given this substantial public investment in COVID-19 vaccines, they should be priced “at cost” permanently, not just for the duration of the pandemic. Companies should open their books so that “no profit” pricing claims can be independently verified. The current lack of transparency and clarity around investments into vaccine R&D, particularly from the private sector, makes it difficult for governments to negotiate fair prices.
It is not clear why the minister raises the issue of “safe…quality vaccines” here as this is a separate issue to the debate around the IP waiver. The issue of quality and safety applies to both originator and generic products and is a matter for medicines regulatory agencies, not for IP agencies. It is important that safety and quality issues should not be conflated with IP issues – both patented and off-patent products go through the same rigorous regulatory processes.
3. The Minister stated that “As more vaccine candidates become approved and supplies increase, greater competition will result in lower prices.”
MSF has witnessed and continues to witness critical supply shortages of life-saving medical products during this pandemic, including of personal protective equipment (PPE), treatments and vaccines.
Global supply should not be dependent on the purely commercial prerogatives and exclusive rights of pharmaceutical companies holding the technology. Defending monopoly protection contradicts your earlier call for COVID-19 medical products to be treated as global public goods; a call in which you were joined by other Heads of State. Since greater competition results in lower prices, the question is rather why the UK Government is not supporting all measures to scale up and diversify global manufacturing capacity now, which includes supporting the TRIPS waiver. Over three million people have died of COVID-19; this is not the time to wait for the current market system to deliver.
Moving forwards, the UK should consider how the IP system could be better adapted to respond to this and future crises. The pandemic is forcing us to do things differently and to tackle systems that are not functioning in these unprecedented times - the IP system and the barriers it creates for equitable access to health technologies is one of them.
4. The Minister claimed that “It remains unclear where case-by-case or product-by-product conditions would preclude access to required COVID-19 related technologies and supplies” and “TRIPS flexibilities are particularly useful for WTO members who do not have the domestic manufacturing capacity to produce medicines and vaccines in their own country”.
We welcome the UK reiterating support for TRIPS flexibilities which are critical mechanisms for countries to safeguard public health. However, support for the TRIPS flexibilities does not preclude support for the TRIPS waiver - these are complementary mechanisms. The UK’s support for TRIPS flexibilities including compulsory licensing recognises that there is a need to protect public health in the face of IP barriers. During a pandemic, this needs to be expanded; a “case-by-case” or “product-by-product” approach could be limiting and time-consuming when we need rapid action. Furthermore, global supply chains are interconnected; one of the benefits of the TRIPS waiver is that it would enable supporting countries to streamline their IP rules as they relate to international law.
5. The Minister argued that “It also remains unclear how the proposed waiver could operate effectively in practice, given the waiver’s proposed optional implementation into domestic law.”
The proponents of the TRIPS waiver proposed have stated that it is up to national discretion on if and how countries want to implement the waiver. More detailed discussion on the implementation can also benefit from the text-based negotiation which the UK has recently been blocking. This aims to provide maximum flexibility so that countries that choose not to implement the waiver domestically do not block other countries in doing so. As such, if the UK continues not to support the TRIPS waiver, it is possible to support other countries to make use of the mechanism by not blocking it the proposal. However, by choosing not to implement the waiver, the UK would be opting out of a crucial mechanism that could support access to lifesaving COVID-19 technologies now and in the future. Again, to advance this discussion, the UK should at the very least not block the start of text-based negotiations.
6. The Minister said that “Concerns also remain on non-IP issues – such as domestic capabilities of individual countries.”
On these concerns, particularly around acquisition, storage, distribution, and administration requirements related to vaccines, as well as regulatory challenges, the Minister rightly pointed out that these issues are outside the scope of the TRIPS Agreement. As such, the TRIPS waiver proposal does not attempt to address these issues. The TRIPS waiver would tackle the legal barriers to scale up of production of COVID-19 medical products; other solutions and mechanisms will be needed to tackle other challenges. One should not refuse to support one mechanism on the basis that it does not solve all our problems – indeed, no mechanism will. As you state later in your letter, “this pandemic means we must use all relevant policy tools to contain, treat, and prevent COVID-19.” This includes the TRIPS waiver.
7. The Minister said that “Recently, the United Kingdom and others called upon countries with alleged idle manufacturing capacity capable of producing COVID-19 related products, specifically vaccines, to inform Members of the TRIPS Council to understand how this capacity can be utilised.”
As we are seeing, the current geographically concentrated, and pharmaceutical industry-controlled, global production and supply system is not adequate to respond to this pandemic. Today, countries that have vaccine production capacity are also the ones that benefit from privileged access. Although production capacity is being scaled up dramatically, where vaccines are being produced is not fundamentally changing, which ultimately perpetuates the inequities we are all seeing.
Addressing this requires sustained efforts to enable and develop local capacities across the world to independently contribute to a more sustainable global supply system, particularly in low- and middle-income countries. It is becoming clear that there is manufacturing capacity globally that can be further developed, including in the African continent, for vaccine production. Governments, including the UK, must work together and use all available measures to harness capacities across the world, allowing for the scale-up and diversification of global manufacturing capacity, to better meet the demands of this pandemic. This includes supporting the call for the TRIPS waiver, which will give Governments new options to address the legal uncertainties and barriers that may impede the production and supply of COVID-19 medical technologies in advance - rather than waiting for barriers to hit and then having to scramble for actions. In addition, companies need to engage in technology transfer with other capable manufacturers, particularly in low- and middle-income countries. Mechanisms that enable this tech transfer must be transparent, open for worldwide coverage of supply, and open to multiple manufacturers.
8. Finally, the Minister highlighted that “By participating in the COVAX facility, countries are pooling resources, which maximise everyone's chance of accessing a vaccine.”
We welcome the UK’s financial commitment and support to the ACTA and COVAX Facility. However, the failings of these mechanisms are stark. Ninety-three percent of vaccine doses have been administered in just 10 countries, including the UK, whilst less than 2 percent have been administered in Africa. This is not equity. Whilst COVAX aims to pool resources and finances, particularly for low and middle-income countries (LMICs), this mechanism fails to address issues around limited available supplies of vaccines. As such, countries are pitted against each other in scrambling for supplies, and LMICs are pushed to the back of the queue. Therefore, supporting COVAX financially is not a sufficient or complete solution since - as recognised by the WHO - “money doesn’t help if there are no vaccines to buy.”
We remain disappointed with the UK’s decision not to support, or at the very least, not to block the TRIPS waiver proposal at the WTO. For the reasons outlined above, we hope that the UK urgently reconsider its position, and support this proposal as one mechanism which will support our shared goal towards access to lifesaving COVID-19 medical products for all.
I look forward to hearing from you and would be happy of course to answer any further questions that you or your colleagues might have.
MSF UK Executive Director