Médecins Sans Frontières submission to the Foreign Affairs Committee inquiry into Global Security (GHS0004)

Introduction As an international medical humanitarian organisation, Médecins Sans Frontières (MSF) seeks to ensure that the medical tools urgently needed to respond to COVID-19 are accessible, affordable and available to all countries, including the countries where we work. Today, in nearly 60 countries MSF is providing treatment and care for people with COVID-19, while ensuring that essential health services for people suffering from other diseases continue uninterrupted.1 However, since the beginning of the pandemic, a lack of access to essential medical supplies has undermined MSF’s ability to respond. These experiences have shown us that, in order to mount an effective response to COVID-19, all existing and future treatments, and diagnostics must be accessible and available for everyone. In responding to the inquiry by the Foreign Affairs Committee, MSF considers that there are critical measures, which the UK government must put in place to make this goal a reality, and to make sure that their commitments2 to global equitable access for COVID-19 medical products are followed through with actions.

1. What role should the FCDO play in bringing about a resolution to the COVID-19 pandemic and preventing future pandemics? Our best chance of bringing the COVID-19 pandemic to an end is to ensure that everyone everywhere has access to effective, safe and affordable medical tools to prevent, diagnose and treat COVID-19, as and when they become available. Ensuing equitable access to COVID-19 medical tools is both a moral duty and a necessity to end this pandemic. Many heads of state, including in the UK, have stated that no-one is safe until everyone is safe.3 Yet, these words and commitments have so far not solidified into actions. MSF is concerned that access to successful vaccines or treatments is being limited by narrow political or commercial interests. Past experiences have shown that when available supplies are limited, this can lead to nationalistic control and hoarding, and result in barriers to access predominantly for low- and middle- income countries (LMICs). The UK has so far signed bilateral deals for seven potential COVID-19 vaccines. This makes the UK one of the world’s highest per-capita buyers, with 355 million doses purchased;4 around five for each citizen.5 The UK has less than 1% of the world’s population, but has reserved nearly 10% of all the potential doses of the leading COVID-19 vaccine candidates. More broadly, wealthy nations representing just 13% of the world’s population have already purchased more than half of the promised doses of leading COVID-19 vaccine candidates.6 With limited global supplies of COVID-19 vaccines anticipated, this leaves low-resource countries with very little or none of the remaining supply. The advance purchase agreements for potential COVID-19 vaccines that the UK and other rich countries have directly agreed with pharmaceutical companies will also fatally undermine the objectives of the COVID-19 Vaccine Global Access (COVAX) Facility and its ability to procure vaccines for LMICs (see question 3 below). Since there is likely to be continued unprecedented global demand for any successful future COVID-19 treatments or vaccines, we must ensure that their production can be scaled up as rapidly as possible to maximise available supplies and access for all. In this context, it is critical that (IP) do not limit access to future COVID-19 medical tools due by blocking the scale up of supply or through high prices. Over a hundred countries around the world have recognised the artificial supply limitations that can be caused by IP and have proposed or supported an international waiver on IP protection at the World Trade Organisation (WTO).7 This waiver would lift countries’ obligations to grant and enforce IP protections, including and trade secrets, where this can further the prevention, containment and treatment of COVID-19. While other measures, such as Crown Use licensing or compulsory licensing, would overcome IP barriers on a ‘country by country’ or ‘product by product’ basis, the IP waiver recognises the need for collective global action to tackle these barriers and rapidly increase production of all successful COVID-19 products. In October, MSF alongside a number of civil society organisations sent an open letter calling on the UK government to support this waiver.8 Despite the unprecedented opportunity that it offers for the massive scale up of COVID-19 products to meet global needs, the UK has stated that they do not support this proposal,9 instead favouring voluntary measures that rely on pharmaceutical companies’ willingness to meet global health needs. However, previous experiences with the voluntary licensing of patents have demonstrated the limitations of relying on the goodwill of pharmaceutical companies.10 The UK government states that they have seen no evidence that IP monopolies are a barrier to accessing COVID technologies. However, there are multiple examples of IP monopolies that have left people unable to access the health tools they urgently need.11 High prices of patented have undermined access to treatment for people with HIV/AIDS,12 tuberculosis13 and .14 Barriers due to IP have limited the availability of more affordable pneumonia vaccines for children in LMICs.15 A number of disputes over COVID-19 vaccines have already delayed the development of potentially effective tools.16, 17 In the US, there have been several calls for company 3M to release its patent for the N95 respirator due to limited supplies of this critical piece of personal protective equipment (PPE).18, 19 A very recent example of IP barriers hindering access in the UK is that of remdesivir, one of the new antiviral drugs to enter clinical trials for the treatment of COVID-19, but has since shown limited efficacy.20 Remdesivir was developed by US pharmaceutical corporation Gilead Sciences with considerable public funding and government support for clinical trials.21 Gilead holds primary patents on the drug in more than 70 countries, which may block entry of generic producers until 2031. While Gilead has signed voluntary licenses for the manufacture and distribution of remdesivir in LMICs, these voluntary licenses exclude nearly half of the world’s population, including the UK.22 As a result, in early October there was a shortage of remdesivir in the UK, forcing the NHS to ration its supplies.23 In the context of a global shortage of a patented product, such as remdesivir, the only way the UK could guarantee access for its population would be through issuing a Crown Use license for manufacture in the UK, overriding Gilead’s patent. Implementing the IP waiver would enable patents such as those on remdesivir to be waived automatically, enabling the rapid scale up of generic production. It is deeply immoral, and unwise, in the midst of an unprecedented global pandemic for the UK government to decide that we must wait for an otherwise avoidable loss of life before taking action to overcome this fatal obstacle to access, denying ourselves the best chance of bringing this pandemic to an end. As such, the UK should:  Fully support the adoption of the proposed WTO waiver on IP protection.  Suspend all patents and exclusivities related to COVID-19 technologies in the UK.  Refrain from bilateral deals with pharmaceutical companies and hoarding of potential future COVID-19 vaccines while there is limited global supply capacity. Global collaboration is the only way to ensure equitable access for all. This can only be achieved through full cooperation with the WHO Fair Allocation Mechanism (FAM).24 Supporting documents:  MSF Access Campaign technical briefing on the and South proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies  MSF Access Campaign position paper on the sharing of technologies for COVID-19 to ensure equitable access for all  MSF Access Campaign Technical Brief: Overcoming intellectual property monopolies in the COVID- 19 pandemic

2. What should the FCDO be doing to support research and distribution of a COVID-19 vaccine?

The UK government has committed over £474.5 million to the research and development (R&D) of potential future COVID-19 vaccines, diagnostics and treatments. The UK has also contributed £250 million to the Coalition for Epidemic Preparedness Innovations (CEPI) towards international vaccine research efforts for infectious diseases. While MSF welcomes these commitments, further actions are needed to ensure that these innovations reach all those who need them, including those living in LMICs. Globally, billions of dollars are being transferred to pharmaceutical companies to cover their costs. For example, AstraZeneca have stated that their costs in developing the COVID-19 vaccine, developed with public funds at Oxford University, will be fully offset by governments.25 Over US$10 billion in public funds has been poured into the R&D, clinical trials and manufacture of six front-runner potential COVID-19 vaccines.26 Many companies are therefore taking limited financial risks, or none at all, nor are they responsible for the innovations underpinning many of these COVID-19 products. Yet, they have still gained control over them. Scenarios such as this have throughout modern history led to huge global inequalities in access to lifesaving medical tools.

With millions of pounds of public money going into R&D for future COVID-19 medical technologies, it is critical that the final products are sold ‘at cost’. Pharmaceutical companies must not be allowed to profiteer from public funding when governments are forced to buy back the products whose development they initially funded. In addition, there is a critical need to increase manufacturing capacities around the world, in particular in LMICs. This is vital to ensure that the necessary quantities of final products can be produced at the scales needed to meet demand once they are approved. UK public funding agencies currently have no clear policies in place directing their grantees to ensure effective technology transfer, open-sharing or licensing of COVID-19 medical technologies. However, this is essential to facilitate diversified and sustainable follow-on development and global manufacturing, especially in LMICs.

The government has refuted the need to attach any safeguards to its COVID-19 R&D funding by expressing confidence in the policies and practice of the institutions that a significant proportion of their funding is being channelled through, including the WHO’s Access to COVID-19 Tools Accelerator (ACT-A). However, neither Gavi nor CEPI, both key institutions within ACT-A, have taken action to tackle IP barriers that could lead to high prices or prevent large-scale manufacturing. Similarly, neither institution has introduced measures to ensure that final prices are affordable or that conditions within their agreements with pharmaceutical companies ensure that every dose is allocated in line with the WHO FAM. The UK government should not relinquish its responsibility to introduce stringent public interest conditions on its funding that guarantee equitable access.

In April, 25 civil society organisations and experts wrote an open letter to the UK government to demand that any COVID-19 medicines or technologies created with public funds are available to all, patent-free.27 Following this, over 130 cross-party parliamentarians, led by the APPG Vaccinations for All, wrote to the government urging them to attach conditions to public R&D funding that would guarantee equitable access to COVID-19 vaccines.28

It is critical that the UK government ensures that publicly funded R&D contributions lead to equitable access to COVID-19 medical products by attaching the following conditions to the funding:

 Final products are sold ‘at cost’, and are accessible to all, including LMICs.  Recipients of R&D funding are transparent about the following: o R&D costs, public funding contributions, production costs and prices they charge in different countries o data (including genetic data, promising compounds, clinical trial protocols and results) o Relevant patents and their status o Supply capacities and licence agreements  Exclusive rights are not granted for the final products, in order to facilitate production and supply, and ensure affordability. All products should be openly licensed.

Supporting document: Technical Brief: Achieving equitable global access resulting from the ACT Accelerator 3. How can the FCDO ensure that COVAX is successful? What are likely to be the main challenges associated with worldwide distribution of a vaccine?

Gavi’s COVAX Facility and the COVAX Advance Market Commitment (AMC) aim to ensure global equitable access to COVID-19 vaccines.29 However, MSF has concerns about how this facility will work to ensure meaningful global equitable access. In June, MSF published six critical recommendations to ensure it meets these aims.30 This was followed by a joint letter from MSF and over 40 civil society organisations and individuals to Gavi’s Board, including its UK board members, requesting urgent changes to the COVAX Facility to ensure equitable access to COVID-19 vaccines.31

The UK should use its critical position as a donor and board member of Gavi to ensure that the COVAX Facility meets its key aim of global equitable access by:

 Demanding ‘at-cost’ prices from pharmaceutical companies. Profits should not be made off the back of this pandemic.  Stipulating that pharmaceutical corporations receiving funding from the COVAX Facility must make their accounts open to the public so the production costs of any potential COVID-19 vaccines can be independently verified. Additionally, Gavi must share transparently all agreements made with industry.  Tying any COVAX Facility funding to requirements that companies participate in technology transfer and open licensing, to broaden the manufacturer base and help improve supply availability.  Demanding fair or no co-financing requirements. The success of the COVAX AMC depends on the ability of LMICs to afford co-payment, but the current proposed price for LMICs through the COVAX AMC is expensive and needs to be significantly lowered or removed. Gavi should take a long-term, flexible approach with countries that struggle to afford co-financing requirements.

Furthermore, to ensure an effective global response to the pandemic, vaccines for frontline healthcare personnel and those working in social care settings in all countries must be made available as a matter of the utmost urgency. Although the WHO-led global FAM spells out these needs, the concrete mechanism to ensure its implementation remains unclear. As such, the UK should support the realisation of guaranteed access for frontline health workers by committing to share a portion of the vaccines they obtain through advanced purchase agreements with the COVAX AMC, starting from the very first vaccine shipment.

In addition, proportional shares of vaccines should be made available to populations in crisis-affected humanitarian settings, including refugees, asylum seekers, marginalised communities and people living in conflict areas. These are groups who have the least access to, or are excluded altogether from, national health services. In line with other high-income countries that have secured multiple bilateral deals for COVID-19 vaccines,32 the UK should contribute doses towards the development of a global humanitarian stockpile to meet the needs of populations in crisis-affected humanitarian settings.

Supporting document: COVID-19 Vaccine Global Access (COVAX) Facility: Key considerations for Gavi’s new global financing mechanism

4. What role can the FCDO play in persuading countries to remove tariffs on COVID-critical products and how can the FCDO encourage further information sharing between countries?

First, to help persuade other countries to act collaboratively and maximise global access to products developed or produced within their borders, the UK should lead by example. As well as the examples related to COVID-19 vaccines given above, the UK has also displayed nationalistic approaches and hoarding of COVID-19 treatments. Following preliminary data in June on the use of COVID-19 treatment dexamethasone, and its positive impacts on hospitalisation and mortality, the UK government immediately put in place an export ban. At the time, this was condemned as ‘morally questionable’ by MSF and other health campaigners.33 The UK should instead work collaboratively with other countries to ensure that vital and limited supplies are distributed equitably, prioritising those most at risk.

Secondly, it is not possible for the UK and other countries to share information that they do not have. There is currently very little transparency from the surrounding COVID-19 medical products, including around production costs, prices, clinical trial data, supply capacities and licence agreements. Despite millions of pounds of UK public funding subsidising COVID-19 R&D, the government is not currently linking this funding to requirements for more transparency from recipients. This is critical information, which they could then share with other countries.

Third, the UK should demand global open-licensing for COVID-19 technologies as a condition of public R&D funding to maximise global access and collaboration with manufacturers in other countries (see question 2 for more details).

Finally, the UK’s support for the WTO IP waiver (see question 1) would encourage unprecedented information, knowledge and data sharing, and collaboration between and within countries to maximise available supplies and ensure equitable access to COVID-19 technologies.

As such, the UK should:

 Refrain from export bans and hoarding COVID-19 medical products.  Attach conditions to public R&D funding to ensure: o Transparency from the recipients of R&D funding (see question 2 above). o Exclusive rights are not granted for COVID-19 medical products, to facilitate production, supply and guarantee affordability. All products should be openly licensed (see question 2 above).  Fully support the adoption of the proposed WTO waiver on IP protection (see question 1 above).

December 2020 References

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