Written evidence submitted by STOPAIDS (GHS0021)

Foreign Affairs Committee inquiry into Global Health Security

About the Authors

We are members of the Missing Medicines coalition, a network convened by STOPAIDS, committed to ensuring people everywhere get the medicines they need at prices they can afford. We use advocacy and public campaigning to build awareness of access to medicines issues in the UK and around the world and fight for the Right to Health to be realised.

We are making a submission to lend the FAC our expertise of working on issues relating to medicine access for over 20 years from the height of the HIV/AIDS epidemic through to the COVID-19 pandemic. This submission sets out key recommendations for how the FCDO can help lead an international response to the COVID-19 pandemic which is equitable and sustainable to ensure its effectiveness.

Summary

The COVID-19 pandemic has highlighted the importance of international collaboration in effective responses to global health security. COVID-19 and future pandemics do not respect borders. Vaccines and other medical advances will only be effective if the whole world can access them.

To effectively respond to the COVID-19 pandemic and future biosecurity threats, the world urgently needs effective medical tools, including diagnostics, medicines and vaccines, to be available and accessible in all countries. Concretely, this requires the research and development (R&D) of new tools, rapid scale-up of manufacturing and supply capacities, transparent and affordable prices for governments and treatment providers, and free access for people at the point of care.

Our submission explores the FCDO’s response to the pandemic, including its financial contributions and how it can more effectively utilise its position in multilateral organisations. Our submission explores the need for the FCDO to assess the usefulness of granting monopolies on urgently needed health products during a pandemic and explore solutions which prioritise access and affordability ahead of commercial agendas. We urge the FCDO to develop a robust international strategy to ensure that when health products are developed, they are made readily available to priority groups - healthcare workers and vulnerable people - around the world.

Key Recommendations:

1.1.            The UK should look at exploring alternative incentives to reward biomedical R&D which don’t result in monopolies which can raise prices and artificially restrict supply.

1.2.            To help ensure adequate and sustained support for a biomedical R&D model which prioritises its research agenda according to public health needs rather than market profit, the UK Government should reverse the decision to remove its commitment to spend 0.7 of its GNI’s official development assistance.

1.3.            The UK Government should support the adoption of the decision text proposed by India and South Africa for “Waiver from certain provisions of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) for the prevention, containment and treatment of COVID-19” (Waiver Proposal). By supporting the Waiver the UK can still choose not to implement the waiver domestically,  while allowing other countries to use it

1.4.            Where patient access or research may be restricted by exclusive intellectual property rights, the Government should issue Crown Use Licenses for any patented technologies that are potentially useful for tackling COVID-19 and actively support other countries to do the likewise.

1.5.            The UK should continue its support to the WHO politically and financially so that the organisation can scale up and improve its effectiveness and efficiency in the prevention and response of global diseases including biological security.

1.6.            The UK must maintain and scale up investment in biomedical research, especially in universities and encourage other countries to do so. This is essential for the UK to be a hub for future technology especially after leaving the EU and potentially losing EU funding for British universities research.

1.7.            The Government should ensure its COVID-19 research & development (R&D) funding leads to affordable and accessible COVID-19 technologies by attaching public interest conditions to all funding contracts.

1.8.            The FCDO should support the realisation of guaranteed access for frontline health workers by committing to share a portion of the vaccines that the UK Government obtain through advanced purchase agreements with the COVAX AMC starting from the very first vaccine shipment, and contribute doses towards the development of a humanitarian stockpile to meet the needs of populations in crisis-affected humanitarian settings. The FCDO should advocate for other self-financing countries in the COVAX that have arranged bilateral deals to also commit to this.

1.9.            The Government must use its critical position as a leading donor and board member of Gavi to ensure that  the COVAX Facility meets its key aim of global equitable access.

2. What lessons has the COVID-19 pandemic taught us about the importance of international collaboration in securing global preparedness and resilience against biosecurity threats?

2.1.            International collaboration is essential for  an effective response to biosecurity threats such as COVID-19. The pandemic has both highlighted the extent and intensity of our interconnectedness on a political, economic and social level as well as the critical importance to tackle viral threats as global and not just national public health issues. It has  also exposed the deep cracks in the willingness of many governments to work together effectively for their own national as well as for global security. Countries raced to secure products for their populations thus increasing the price and leaving others especially in developing countries with little or no supplies.

2.2.            There have been strong commitments from the UK government to respond to the pandemic in  terms of funding R&D and contributing to the ACT-Accelerator. However,  simultaneously the UK has been undermining  international efforts to equitably distribute technologies including vaccines through the procurement of millions of doses through bilateral deals. At one point, the UK had bought more than any other nation relative to population[1].  Furthermore the UK Government has not committed to supporting measures that will scale-up manufacturing to meet global demand. As explored in more detail in the answers to the below questions, the COVID-19 Technology Access Pool (C-TAP) and TRIPS Waiver proposal are such measures that could scale-up manufacturing capacity but are currently not supported by the UK.

2.3.            The pandemic has also highlighted the need for international commitments and consensus in the public health arena to take priority over the interests of the private sector, and the importance of not leaving  responses to pandemics to the whims of the market. We could have been more prepared for the COVID-19 pandemic if there was adequate and sustained support for a biomedical R&D model which prioritised its research agenda according to public health needs rather than market profit. The basic research and development as well as early clinical trials for the Oxford vaccine has been paid for by public money, providing a clear example of the essential role of sustained adequate public funding for biomedical R&D. There was research going on into corona viruses but it ceased prematurely due to the lack of sustained  public investment, and lack of private interest, due to there not being a clear financial incentive.[2]

2.4.            Therefore, in order for research into disease prevention and vaccines to happen we need to reform the way medical R&D is conducted. Fortunately, FCDO already has some institutional history - through DFID - of supporting more patient-centered R&D approaches that provide affordable medicines, such as those used by the Drugs for Neglected Diseases Initiative, DNDi. 

2.5.            DNDi is an example of a ‘delinked’ R&D approach. Delinkage is based on the premise that the costs and risks associated with R&D should still be rewarded, but that the incentives for R&D can be provided by means other than financial returns from charging high product prices.[3] The cash rewards have been described as ‘innovation inducement prizes’, ‘market entry rewards’, or ‘open source dividends’[4] and can be implemented as alternative innovation incentives to the granting of a monopoly and the associated high prices. In the absence of a market monopoly, generic competition can then drive the price of a product down, closer to the marginal costs of production.[5]This means that governments pay the true cost of  products in advance instead of paying high prices without access to the real cost of R&D and production. [6]

2.6.            Under delinkage, governments and philanthropic donors provide the funding for R&D. As R&D financing no longer relies upon monopoly-protected high prices, directionality can be set more easily according to the public health needs identified by the funding agency.[7] This creates a much more efficient system, as it pays only for the meeting of defined R&D milestones.[8]

2.7.            The Drugs for Neglected Diseases initiative (DNDi) has demonstrated how changing incentives can enable research priorities to be determined by public health needs, encourage open research, and ensure that the products are affordable and available. DNDi is a not-for-profit research organisation established to develop drugs for diseases neglected by industry, such as sleeping sickness, Chagas disease, leishmaniasis, filaria, and paediatric HIV/AIDS. DNDi has developed six new treatments since it was founded in 2003, and expects to complete 10–12 additional new treatments by 2023, including a more affordable cure for hepatitis C.[9]

2.8.            RECOMMENDATION: The UK should look at exploring alternative incentives to biomedical R&D which don’t result in monopolies which can raise prices and artificially restrict supply. In particular the FCDO should replicate the application of DNDi's financing approaches across its research portfolio.  The UK Government should commit to launching pilot delinked models for set missions, such as the development of new antibiotics,  vaccines and other ease prevention technologies.

2.9.            RECOMMENDATION: To help ensure adequate and sustained support for a biomedical R&D model which prioritised its research agenda according to public health needs rather than market profit, the UK Government should reverses the decision to remove its commitment to spend 0.7 of its GNI’s official development assistance. If any cuts to the aid budget were made, the UK Government’s funding to global health R&D, and its Product Development Partnerships portfolio, should be protected.

3. Which countries have provided good lessons in how to combat COVID-19? What have embassies been asked to do to collect best practice?

3.1.            The Government of South Africa and India made a landmark move on 2 October asking the World Trade Organization (WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved[10].

3.2.            The  aim of waiver is to prevent intellectual property (IP) barriers from restricting access to COVID-19 medicines, tools, devices and vaccines to ensure all health systems are equipped with the health technologies they need to end this pandemic. 

3.3.            The historical and recent actions by pharmaceutical corporations shows that we cannot rely on their exclusive rights and limited voluntary actions to end this global pandemic. And even though there are existing public health safeguards within the TRIPS Agreement (TRIPS flexibilities) there are often territorial and procedural restrictions that mean they can only be applied on a product-by-product basis or country-by-country basis, making this time consuming and difficult for countries to collaborate around research and manufacturing.

3.4.            For example many countries lack immediate manufacturing capacity for essential parts for a product, for example raw materials, so removing IP barriers on one component in one country alone will not be sufficient. Likewise, countries that have the capacity to produce a finished product would need to ensure that there are no restrictions for them to export the product to any other countries in need.

3.5.            Instead we need a more immediate global solution based on collaboration and solidarity with the overall aim of increasing manufacturing capacity to ensure sufficient supplies of vaccines, treatments and other health products to enable all countries to tackle COVID-19. By removing IP barriers the Waiver proposal will help this to happen; not only will it speed up research and development and maximise manufacturing capacity it will also make products more affordable by enabling generic competition to help drive down prices.

3.6.            RECOMMENDATION the UK Government should support the adoption of the decision text proposed by India and South Africa for “Waiver from certain provisions of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) for the prevention, containment and treatment of COVID-19” (Waiver Proposal). By supporting the Waiver the UK can still choose not to implement the waiver domestically,  while allowing other countries to use it.

3.7.            Aside from supporting the TRIPS Waiver, other countries have taken proactive steps to ensure that intellectual property rights are not misused leading to inflated prices and accessibility issues by reaffirming their commitment to the Doha Declaration.

3.7.1.            One such safeguard is the ability of governments to issue compulsory or government use licences, known in UK law as Crown use licences, when patent monopolies prevent access to a medicine. A Crown use license effectively enables a government to issue a license to another manufacturer to produce a generic version of a patented drug at a lower price. This allows other players to enter the market, usually reducing price closer to the true cost of production and allowing more of the product to be produced.

3.7.2.            In light of COVID-19, this option should be reaffirmed and used to access COVID-19 health technologies. Concerns over the potential impact of exclusive intellectual property rights on access have led several developed and developing countries to take steps to facilitate compulsory licensing. For example, Australia, Canada and Germany have revised their national patent laws to simplify the issuance of a compulsory license during a public health emergency. Israel issued a compulsory license with respect to lopinavir/ritonavir for use as treatment for COVID-19 while Chile, Ecuador and Colombia have issued national decrees or parliamentary resolutions to facilitate the use of compulsory license if it is required.

3.7.3.            In July 2020, The International Trade Select Committee recommended that the UK Government evaluate the case for putting in place enabling measures for allowing compulsory licensing in order to make COVID-19 technologies available as quickly, widely and cheaply as possible[11].

3.7.4.            Recommendation: Where patient access or research may be restricted by exclusive intellectual property rights, the Government should issue Crown Use Licenses for any patented technologies that are potentially useful for tackling COVID-19 and actively support other countries to do the same.

3.8.            Other examples from countries that succeeded in controlling COVID-19 better than the UK can be summarised in: early interventions, comprehensive response using evidence-based public health interventions and good communication  with the public based on transparent sharing of good plans, financial support for the vulnerable, good preparation for health systems. Such an approach created trust so that people followed public health measures. States  such as Vietnam, S Korea, Taiwan, Germany, Finland , New Zealand, Iceland provide real life examples of these approaches. Their action led to low levels of infection and death.

3.9.            Another important lesson from successful countries is the long term investment in national health systems so that they are prepared better than those who have faced austerity measures over the years. For example, compare the number of artificial ventilation equipment and staff who operate them between the investment approach  in Germany and the austerity in the UK. 

3.10.            The UK NHS played a key role in fast tracking  the clinical trials of the Oxford, and other vaccines in an effective and efficient way. This is a great advantage of investing in our NHS that is rarely mentioned.

4. How effective is the UK’s current approach to global health security?

4.1.            Over recent months the UK has led calls for global collaboration and solidarity to end this pandemic and has supported calls to recognise the role of extensive immunization against COVID-19 as a global public good”[12]. We welcome the UK’s contribution of up to £548m to the COVID-19 Vaccines Global Access (COVAX) Advance Market Commitment (AMC), as well as its contribution of £71m as a self-financing country.[13][14]

4.2.            However the COVAX Facility can only be truly effective at managing global access to future vaccines if there are enough doses to go around and this is beyond the capacities of a handful of companies.  The UK is undermining the effectiveness of COVAX by hoarding the forecasted vaccines. Moreover, the UK is not promoting better functioning of COVAX. It is built as a top down approach without meaningful involvement of developing countries governments or civil society in its governance. Moreover, COVAX inserts inequality in its design by allowing self financing countries to secure vaccines for up to 50% of its population but allows only 20% for Low and Lower Middle Income Countries population.[15] COVAX is not transparent about its deals with pharmaceutical companies or its decision making processes and it does not use its purchasing power to get companies to commit to expanding production through sharing technology and IP in the WHO C-TAP. 

4.3.            However, the UK’s bilateral deals are  undermining the ability of COVAX to purchase enough doses for developing countries. The UK needs to adopt and implement the WHO Fair Allocation Framework which priorities specific groups at risk for the first batches of the vaccines[16]. It estimates these groups to be up to 20% of populations.

4.4.            Given that the UK, like other countries, want to vaccinate as many of its population as possible, it should adopt an approach that increases the doses by enabling all potential global manufacturers to produce the vaccines. This requires sharing knowledge, data, know-how, biological material and IP. The WHO-C-TAP can work as one stop shop to allow this sharing and the licensing and facilitate technology transfer between originators and other potential producers.  The UK played a key role in establishing the Medicines Patent Pool which has increased the supply of affordable medicines for HIV, and Hepatitis C. With the facilitation of technology transfer, the C-TAP can maximise production and decrease prices. The UK should champion C-TAP now so that countries can have a fair share of a much bigger pie than the small one they are fighting for now because of companies' monopoly on technology and IP.

4.5.            RECOMMENDATION: The UK should continue its support to the WHO politically and financially so that the organisation can scale up and improve its effectiveness and efficiency in the prevention and response of global diseases including biological security.

4.6.            RECOMMENDATION: The UK must maintain and scale up investment in biomedical research, especially in universities and encourage other countries to do so. This is essential for the UK to be a hub for future technology especially after leaving the EU and potentially losing EU funding for British universities research.

4.7.            RECOMMENDATION: The UK should not oppose the TRIPS Waiver at the December 2020 WTO General Council Council meeting on 17 December 2020.

5. What role should the FCDO play in bringing about a resolution to the COVID-19 pandemic and preventing future pandemics?

5.1.            As explored in our submission, through its bilateral programs, diplomacy, funding and engagement with multilaterals; the FCDO rightly plays a critical role in bringing about a resolution to COVID-19 and preventing future pandemics.

5.2.            RECOMMENDATION: To ensure the FCDO can continue to respond to COVID-19, whilst protecting the UK’s reputation as a development champion, it is critical that the Government reverses the decision to temporarily remove its commitment to spend 0.7 of its GNI’s official development assistance. If cuts to the aid budget were made, it would put at risk the international response to COVID-19 and work being undertaken to prevent future pandemics e.g the UK’s significant funding into global health R&D and its Product Development Partnership (PDP) portfolio.  ODA is also essential for supporting the building of resilient health systems that can prevent and respond to emerging infections as well as achieve SDG3 on health.

5.3.            RECOMMENDATION: As explored in more detail in the answers to the later questions, the FCDO should use its position and relationship with multilateral organisations to secure policy and programmatic changes that advance equitable access to health technologies. This includes:

5.3.1.            For COVID-19 (in addition to the aforementioned measures), the UK should ensure that the COVAX Facility improves its decision making by enabling meaningful participation of developing countries' governments; uses its purchasing power to enhance companies joining C-TAP; ensures the implementation of the WHO Fair Allocation Framework to all countries, and to ensure transparency of all its deals and activities.

5.3.2.            With the UK being a leading funder of COVID-19 R&D that has strong relationships with multilateral organisations, research institutions and the pharmaceutical sector, the FCDO is well placed to champion the operationalisation of the C-TAP.  Indeed at the start of this decade, the UK Government played a critical role in establishing the Medicines Patent Pool.

5.3.3.            The UK can also champion the development of an iInternational treaty on pandemics under the auspices of the WHO similar to the tobacco treaty, which organises preparedness and response including the allocation of medical technologies.

5.3.4.            In partnership with DHSC, the FCDO should scale up financial contributions to WHO via assessed and voluntary contributions and encourage countries to do the same.

6. Has the UK effectively used its position in multilateral organisations to promote international collaboration in response to COVID-19 and the global health security agenda?

6.1.            Since the start of the pandemic, the UK Government has championed calls for global collaboration and the need for multilateralism. Civil society have welcomed the UK’s leading contribution of £548m to the COVID-19 Vaccines Global Access (COVAX) Advance Market Commitment (AMC), as well as an additional £71m for the COVAX Facility[17].

6.2.            The UK Government’s financial and political support WHO has been critical, especially in the face of unfair attacks on the organisation by the US administration. With the UK’s support, the ACT-A was able to be established and quickly develop critical initiatives such as the COVAX Facility.

6.3.            To effectively respond to COVID-19, we urgently need an ecosystem that advances manufacturing scale-up and equitable access to COVID-19 technologies. Through being a leading donor that represented in the boards of multilateral organisations, the UK is well placed to promote the needed international collaboration required to respond to COVID-19.  As explored in more detail in the answers to the below questions, the Government hasn’t always effectively used its position to advance international collaboration. For example:

6.3.1.            The COVAX Facility takes as a “business as usual” approach to intellectual property and pricing of vaccines. Despite unprecedented levels of public funding that went into the R&D of these vaccines, companies ultimately still have the power to control who gets access to these vaccines, when they get access and at what price.

6.3.2.            The UK Government has not endorsed the WHO’s Solidarity Call To Action[18], and has yet to publicly endorse the C-TAP.

6.3.3.            The UK Government is opposed to the TRIPS Waiver and could use its position at the World Trade Organisation to block it being adoption. This is despite over 100 countries supporting the Waiver and waiver’s voluntary nature i.e the UK Government doesn’t have to use the waiver but by not blocking it, it can support the right of developing countries to implement it.

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

7.1.            RECOMMENDATION: The Government should ensure its COVID-19 research & development (R&D) funding leads to affordable and accessible COVID-19 technologies

7.2.            In the context of the current pandemic, the world urgently needs effective medical tools, including diagnostics, medicines and vaccines, to be available, affordable  and accessible in all countries. Concretely, this requires the R&D of new tools,  rapid scale-up of manufacturing and supply capacities, transparent and affordable prices for governments and treatment providers, and free access for people at the point of care.

7.3.            The majority of R&D costs for COVID-19 technologies is funded by the public sector internationally. The UK government has committed over £474.5 million to the research and development of vaccines, diagnostics and treatments to address the Covid-19 pandemic[19].This includes £250 million granted to the Coalition for Epidemic Preparedness Initiative (CEPI) for their research into COVID-19.

7.4.            UK universities are behind some of the most promising COVID-19 technologies in development. This includes Oxford University and the Jenner Institute’s ChAdOx1vaccine candidate, which is currently undergoing Phase 3 clinical trials. Other universities are also doing critical research including in London, Edinburgh, Southampton among many others.

7.5.            Public funding for universities should be scaled up and be sustained for a long period. Many of the current vaccines developed everywhere are based on decades of intensive basic research. However, without decisive political intervention there is a real risk that the innovation and manufacturing of these vital health technologies will take longer than they should and once developed they may not reach all who need them, especially the most vulnerable.

7.6.            In the UK’s R&D funding model, there aren’t currently strong enough safeguards to ensure that research will be shared nor that technologies produced from public research will be accessible or affordable to patients that need them - whether they live in the UK or in middle and low income countries. Without these guarantees UK public funds risk being wasted since global access to COVID-19 treatments, diagnostics and vaccines is the bedrock of an effective response.

7.7.            There should be full transparency on  deals between universities and pharmaceutical companies. For example, the deal between Oxford University and AstraZeneca is secret and there are significant unanswered questions about the terms of the agreement regarding  the company’s stated commitments to non profit pricing of the vaccine and the implications of intellectual property that will directly impact the product’s accessibility, as detailed in a letter from civil society to the Jenner Institute[20]. The UK should guarantee  the stated terms of the deal do not assure us of such an important clause in order to prevent any potential  long term  post pandemic  price gouging which would have negative financial implications for the NHS.

7.8.            The Government has refuted the need to attach any safeguards on R&D funding into COVID-19 by expressing confidence in the policy and practice of the institutions that their ODA funding is channeled through. Despite the Government’s partnership with external bodies like CEPI and Gavi that could help with access to resulting COVID-19 technologies, civil society organisations have argued that the Government should not relinquish its responsibility to introduce stringent public interest conditions on their funding to ensure equitable access[21]- these are outlined in the recommendations below.

7.9.            Although the UK Government is supporting the WHO’s Access to COVID-19 Tools Accelerator (ACT-A), neither Gavi nor CEPI, both key institutions part of the ACT-A, have taken action to tackle intellectual property barriers that could lead to high prices or prevent large scale manufacturing, neither are there measures to ensure affordability of final prices or conditionalities within their agreements with pharmaceutical companies to ensure every dose is allocated in line with the WHO Equitable Allocation Framework[22].

7.10.            The UK Government has also co-sponsored the World Health Assembly’s resolution on the COVID-19 Response which included a statement around covid technologies being affordable and considered a ‘public good’.[23] The UK Government can honour their commitment by following the recommendations set out below.

7.11.            RECOMMENDATION: The Government should impose conditions on all UK funding committed to developing vaccines and treatments for COVID-19. These should ensure:

7.11.1.            An open innovation approach achieved through the mandatory sharing of know-how, clinical trial data and health technologies, to maximise innovation and collaboration in a diverse pharmaceutical and life sciences sector.

7.11.2.            Any new COVID-19 vaccines and treatments should be considered a ‘public good’ meaning they are affordable for all countries and free at the point of use for those who need them, including in countries that do not have the benefit of a publicly funded health service such as the NHS.

7.11.3.            Universal, non-exclusive licenses on any vaccine or medical product.

7.11.4.            Full transparency of all licensing agreements made between research institutes and pharmaceutical companies and other actors. This transparency would include making available information about the R&D costs; and final product prices and ‘step-in’ rights for the UK government to issue non-exclusive licenses if a licensing partner fails to comply with the requirements of providing the health technology at an affordable and fair price. Transparency is important in order to prevent practices that are against the public interest and ensure that the government has the information it needs to make informed decisions.

7.11.5.            RECOMMENDATION: The Government should dictate that public funding for research projects should be conditional on mandatory open licensing and public sharing of technologies, knowledge, know-how and data, in order to ensure public return on public investment. This should be done through mandating health products that have received public funding to share IP, research and know-how with the WHO’s COVID-19 Technology Access Pool.

7.12.            RECOMMENDATION: To ensure effective research and distribution of a COVID-19 vaccine, the FCDO must champion the open sharing of COVID-19 technologies, knowledge and data through the COVID-19 Technology Access Pool (C-TAP).

7.12.1.            The open sharing of technologies, knowledge and data is a powerful way to expedite the R&D of new medical tools. If terms and conditions on the right to use and produce these technologies allow, it can also expand and diversify production and supply capacities by enabling multiple manufacturers to produce. Furthermore, this can also facilitate the management of costs and bring prices down.

7.12.2.            Responding to this need, the WHO and partners launched the C-TAP in May 2020.[24] The WHO are inviting holders of COVID-19 health technology related knowledge, intellectual property and/or data to voluntarily share this through the C-TAP. The C-TAP will work with implementing partners who have years of experience in this field including the Medicines Patent Pool, the UN Technology Bank-hosted Technology Access Partnership and UNITAID.[25] There are five key elements to the initiative:

7.12.2.1.            Public disclosure of gene sequences and data;

7.12.2.2.            Transparency around the publication of all clinical trial results;

7.12.2.3.            Governments and other funders are encouraged to include clauses in funding agreements with pharmaceutical companies and other innovators about equitable distribution, affordability and the publication of trial data;

7.12.2.4.            Licensing any potential treatment, diagnostic, vaccine or other health technology to the Medicines Patent Pool - a United Nations-backed public health body that works to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.

7.12.2.5.            Promotion of open innovation models and technology transfer that increase local manufacturing and supply capacity, including through joining the Open COVID Pledge and the Technology Access Partnership (TAP).[26]

7.12.2.6.            There is ample evidence out there to prove that the sharing of data and rights around a global health problem delivers results. For example, at the R&D level effective knowledge sharing and democratised data created the necessary cooperative but competitive atmosphere that led to breakthroughs in the Human Genome project, which has revolutionised medical research. 

7.12.3.            When it comes to manufacturing, procuring and equitable deployment; the agreement of pharmaceutical companies to share their intellectual property rights on antiretroviral treatment marked a historical turning point in the international HIV response by enabling generic manufacturing and competition to maximise production and drive prices down.

7.12.4.            The volumes of production required to inoculate the entire global population is staggering and vastly outstrip the manufacturing capacity of the individual companies that have promising vaccines in development. As of November 23rd 2020, High Income Countries have pre-ordered more than 3.7 billion doses doses of COVID-19 vaccines[27] which leaves little left for the rest of the world. Holding exclusive licenses over COVID-19 health technologies will not only affect pricing and hinder further research but they will also prevent countries from producing the volumes required to meet global demand. The C-TAP could play an essential role in facilitating the needed IP and technology transfer to scale-up manufacturing capacity for COVID-19 therapeutics, diagnostics and vaccines.

7.12.5.            The C-TAP already has formal support from 37 countries, including Norway and the Netherlands. It has also received support from institutions including Unitaid[28] and the European Parliament[29].

7.12.6.            The UK Government has expressed their support for voluntary approaches to licensing in the COVID-19 response but yes to state whether they intend to work with the C-TAP[30]. However if High Income Countries like the UK fail to support the C-TAP, it risks fatally undermining the global response. The UK championing the formation of such a pool would place the country as a champion of universal health coverage and an innovative thinker when it comes to developing more efficient approaches to medical research and health technology production.

7.12.7.            It is paramount that there is an ecosystem to support effective technology transfer if we want to stand a chance of meeting the global demand for COVID-19 vaccines and therapeutics. This needs to be invested in now, as it’s a highly technical process, to avoid an elongated phase of inevitable vaccine stock-outs.[31]

7.12.8.            RECOMMENDATION: The Government should play a leading role in supporting the WHO to operationalise the C-TAP, creating an effective global pool of rights. The Government should use their position to ensure that the pool:

7.12.8.1.            Serves all countries and includes all necessary technologies, knowledge and data.

7.12.8.2.            Ensure rights for all to use and produce by not allowing monopolies and exclusivities to hinder innovation, tech transfer (which includes know-how), production or access to any COVID-19 health technologies.

7.12.8.3.            Ensure full transparency of stakeholder negotiations, production, prices and stockpiling to permit accountability and responsibility of all countries and organisations involved.

7.13.            RECOMMENDATION: As detailed in the earlier questions, to advance research and distribution of a COVID-19 vaccine, the UK Government should support the adoption of the decision text proposed by India and South Africa for “Waiver from certain provisions of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) for the prevention, containment and treatment of COVID-19” (Waiver Proposal).

7.13.1.            During the COVID-19 crisis, treatment providers and governments have had to grapple with intellectual property barriers (patents, trade secrets, industrial designs and copyright protections) to essential products such as respirators, ventilator valves, therapeutics and reagents for test kits[32]. In addition, new promising monoclonal antibody treatments for COVID-19 are being trialled but they are already under patent protection which would limit access in many low and middle income countries (LMICs). If effective, maximising supply and meeting global demand for these treatments will be challenging unless governments take action now to address these barriers.

7.13.2.            These are not just issues for LMICs. Last month, there was a shortage of COVID-19 medicine, remdesivir, leading to rationing on the NHS[33]. Remdesivir is under patent and owned by pharmaceutical company Gilead who have granted a voluntary license on the treatment which excludes nearly half of the world’s population, including the UK[34]. Furthermore, despite receiving more than US70.5 million in public funding to develop remdesivir, Gilead is selling the medicine at £1,802 (US$2,340) for a five-day treatment course in most countries - even though it can be manufactured for as little as £6.93 (US$9) per treatment course[35].

7.13.3.            If the waiver was granted, it would allow WTO members to choose to neither grant nor enforce patents and other IP related to all COVID-19 drugs, vaccines, diagnostics, and other technologies, including masks and ventilators. This would provide countries with the policy space needed to collaborate in research and development and manufacturing, scaling up and supplying COVID-19 tools.

7.13.4.            The UK Government rejected the text on the Waiver at the TRIPS Council meeting on 15th-16th October saying that it was not necessary whilst also stating that existing measures to overcome IP barriers would suffice[36]. 95 parliamentarians representing all major UK political parties wrote to the UK Government voicing their concern on the UK’s actions, noting the increasing evidence that exclusive rights have created barriers to accessing respirators, ventilators, testing kits and treatments for COVID-19[37].

7.13.5.            The waiver proposal comes against a backdrop of numerous public health issues throughout history from the HIV response since the early 2000s to cancer drugs today which have clearly shown that exclusive intellectual property rights create huge inequity in access.

7.14.            RECOMMENDATION: To ensure effective distribution of a COVID-19 vaccine, The FCDO must champion and use its leverage to influence other HMG departments and other Governments to adhere to the WHO’s Fair Allocation Framework.

7.15.            As highlighted in earlier questions, exasperated by the lack of technology transfer and IP sharing between pharmaceutical companies and research institutions, supplies of COVID-19 vaccines in 2021 will be severely limited. Without an international plan to manage vaccine distribution fairly, the WHO warns there will be hoarding, life-threatening shortages and price spikes for COVID-19 vaccines.

7.16.            Through the EAF, the WHO advises that once a vaccine(s) is shown to be safe and effective, and authorized for use, all countries should receive doses in proportion to their population size, albeit initially in reduced quantities.  This will enable every country to start by immunizing the highest priority populations. This initial proportional would be until all countries can reach enough quantities to cover 20% of their population. In the second phase, vaccines would continue to be deployed to all countries so that additional populations can be covered according to national priorities.

8. How can the FCDO ensure that COVAX is successful? What are likely to be the main challenges associated with worldwide distribution of a vaccine?

8.1.            Gavi’s COVID-19 Vaccine Global Access (COVAX) Facility and the COVAX Advance Market Commitment (AMC) aims to ensure global equitable access to COVID-19 vaccines.​ However, there are widespread concerns about how this Facility will work to ensure real global equitable access, and there a number of critical recommendations to ensure it meets these aims. In June, over 40 other civil society organisations and individuals wrote to the Gavi board, including the UK Gavi board members, requesting urgent changes to the COVAX Facility to ensure equitable access to COVID-19 vaccines.[38]​

8.2.            The COVAX Facility can only be truly effective at managing global access to future vaccines if there are enough doses to go around and this is beyond the capacities of a handful of companies. In the current design for the COVAX Facility, there is no meaningful involvement of developing countries governments or civil society in its governance structure. Moreover, COVAX inserts inequality in its design by allowing rich countries to secure vaccines for 50% of its population but allows only 20% of the developing countries population[39].

8.3.            The advance purchase agreements for future potential COVID-19 vaccines that the UK and other rich countries have agreed with pharmaceutical companies directly will undermine the objectives of the COVAX Facility, its ability to procure and deliver vaccines for lower income countries and allocate vaccines according to the WHO-led global Equitable Allocation Framework. The UK Government needs to acknowledge that their bilateral deals are undermining the ability of international initiative such as Covax to deliver adequate vaccines, and take urgent action to address this policy imbalance.

8.4.            In COVAX’s “business as usual” approach to intellectual property, despite unprecedented levels of public funding, companies ultimately still have the power to control who gets access to these vaccines, when they get access and at what price.

8.5.            RECOMMENDATION:  The FCDO should support the realisation of guaranteed access for frontline health workers by committing to share a portion of the vaccines that the UK Government obtain through advanced purchase agreements with the COVAX AMC starting from the very first vaccine shipment, and contribute doses towards the development of a humanitarian stockpile to meet the needs of populations in crisis-affected humanitarian settings. The FCDO should advocate for other self-financing countries in the COVAX that have arranged bilateral deals to also commit to this.

8.6.            RECOMMENDATION: The FCDO use its critical position as a leading donor and board member of Gavi to ensure that COVAX Facility meets its key aim of global equitable access through:

8.6.1.            Ensuring prices are set ‘at-cost’: The plans for the COVAX Facility accommodate pharmaceutical companies to follow a tiered pricing approach. This provides the opportunity for companies to profit from this global health crisis, particularly with there being no mechanisms to mandate companies to be transparent of their R&D costs. Gavi’s previous AMC for Pneumococcal Conjugate Vaccine (PCV) was a similar market incentive, designed to “incentivize” the pharmaceutical industry to produce sufficient supply of PCV for LMICs within Gavi’s mandate. However, there were a number of shortcomings in the design of this mechanism, which ultimately resulted in Gavi, and its donors, paying more than necessary for PCV products through the AMC. The Gavi Board must demand ‘at-cost’ prices from pharmaceutical companies. Profits should not be made off the back of this pandemic;

8.6.2.            Ensuring that transparency is fundamental to the COVAX Facility: In order to guarantee a fair price for countries participating in the AMC, Gavi must require that any agreement with pharmaceutical companies mandates transparency on all their development and production costs, and this should be made public. Pharmaceutical corporations receiving funding from the COVAX Facility must open their books publicly so it is possible to independently verify how much potential COVID-19 vaccines will actually cost to produce. Additionally, Gavi must share transparently any agreements made with industry.

8.6.3.            Ensuring that COVAX  supports tech-transfer and tackle intellectual property barriers: Gavi’s pneumococcal AMC saw higher prices and limited supply because production was monopolized by two pharmaceutical companies. For the COVAX Facility, Gavi must require that manufacturers receiving its funds share their intellectual property, technologies, know-how and data in such a way that guarantees the non- exclusive right to use, produce and supply for all competent entities worldwide. These steps , achieved through attaching ‘strings’ into contractual arrangements, will broaden the manufacturer base, helping improve supply availability. One way to achieve this is through the FCDO advocating for the ACT-A and COVAX to support and  have a close partnership with the COVID-19 Technology Access Pool.

8.6.4.            Including humanitarian organisations and NGOs: Gavi must include non-governmental purchasers in their COVAX Facility so that they can access vaccines at the lowest global price.

8.6.5.            Fair co-financing requirements: The success of the COVAX Facility’s AMC depends on the ability of low and lower middle income countries (LMIC) to afford co-payment. The current proposed price for AMC countries is expensive and needs to be lowered significantly or removed. Gavi should take a long-term, flexible approach with countries that struggle to afford co-financing requirements.

9. What role can the FCDO play in ensuring cooperation in vaccine distribution?

9.1.            Global equitable access to future COVID-19 technologies is essential to tackle this pandemic. People in countries in humanitarian crises, and frontline healthcare workers are particularly vulnerable and must be prioritised for treatment and protection. We can only end the threat of COVID-19 in the UK if it is controlled across the world.

9.2.            Civil society is concerned that access to any successful vaccines or treatments may be limited by narrow political or commercial interests. Past experiences have shown that limited supply, nationalistic control and high prices can result in barriers to access, therefore we are following these potential access barriers closely:

9.2.1.            Inadequate supply:​ Due to demand outstripping supply, there are likely to be supply shortages of whatever COVID-19 medical products are first to be approved for use. The failures of the current patent system explained above that have shaped biomedical research for decades could once again hinder scale up and access to affordable vaccines.

9.2.2.            Hoarding and nationalistic approaches: ​There is currently no globally agreed-upon enforceable framework for equitable allocation of medical tools for COVID-19. Without such an agreement there is a serious concern that governments might hoard COVID-19 treatments or vaccines, or that products developed nationally will be prioritised for their population, rather than allocated globally according to health needs.

9.2.3.            Pricing and lack of affordability:​ We do not know what the price will be for COVID-19 medical products that may emerge, but some initial indications from companies suggest that price could be a barrier to access in many regions of the world. For example, Moderna has reportedly said that they would charge $50-$60 per course.[40] This would be unaffordable in many resource constrained settings.

9.2.4.            Weak collaboration and coordination in ensuring vaccine distribution is contributing towards a vaccine arms race, where high income countries have preferential access to vaccine candidates. This approach has been highly criticised by the WHO[41], GAVI[42], The Shadow Cabinet[43][44] and other political party spokespeople[45], academics across the world[46] and the Pope[47]. These bilateral deals are leading to limited production volumes, national hoarding and unjust distribution.

9.2.5.            The FCDO has the financing, bilateral relationships and representation on relevant health mulitierals to ensure effective cooperation in vaccine distribution. However it is critical that a cross-government strategy and approach is taken. Without this, the actions being taken by the FCDO will be undermined by other Government departments.

9.2.6.            In the absence of better international coordination, despite stated public commitment to equity, higher income countries are prioritising their own citizens through bilateral deals with pharmaceutical companies. As of November 23rd 2020, High Income Countries have pre-ordered more than 3.7 billion doses doses of COVID-19 vaccines[48]. This means that a majority of leading coronavirus candidates have already been locked up by bilateral deals agreed between High Income Countries and pharmaceutical companies. There is no evidence of any direct deals made by low-income countries which suggests that low-income countries will be entirely reliant on the coverage that the COVAX Facility is able to offer from the limited pool of vaccines left-over after the bilateral deals with High Income countries are taken into account.

9.2.7.            Pfizer-BioNTech has already struck deals with rich countries for more than a billion doses of its vaccine that has been shown to be effective in 90% of people[49]. This leaves less than a quarter of its projected supply for the rest of the world.

9.2.8.            Despite pledging support for the COVAX Facility,​ the UK has also so far signed bilateral deals for seven unproven COVID-19 vaccines[50]. This makes the UK the world’s highest per-capita buyer, with 355 million purchased: around 5 doses for each citizen[51].​ The UK is less than 1% of the world’s population but yet we have reserved nearly 10% of all the potential doses of leading COVID-19 vaccine candidates. With anticipated limited global supplies of COVID-19 vaccines, this leaves other countries with limited supply and risks fatally undermining models for international coordination for vaccine distribution, like the COVAX Facility.

9.2.9.            In parallel with the UK’s bilateral vaccine deals, the government is seeking to build UK vaccine manufacturing capacity. The new Vaccines Manufacturing and Innovation Centre, and the Cell and Gene Therapy Catapult Manufacturing Innovation Centre will seek to accelerate the mass production of a successful COVID-19 vaccine in the UK[52]. Whilst this will help build much needed global manufacturing capacity, Government ministers have made clear their ambition for the UK to secure preferential access to vaccines ahead of other countries. For example, Secretary of State of Education Gavin Williamson MP stated that ‘It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available’.[53] With vaccine manufacturing predominantly centered in High Income Countries, the UK’s approach sets a dangerous trend that other countries are likely to follow.

9.2.10.            The WHO have developed the Fair Allocation Framework for all COVID-19 products[54]. Responding to the anticipated supply constraints of a COVID-19 vaccine, the Framework’s goals would be achieved by prioritising certain demographic groups across countries for initial vaccination. However the Framework lacks a concrete mechanism to ensure its implementation.

9.2.11.            Responding to the competition for vaccine candidates, the UK Government has partnered with the ACT-A to establish the COVAX Facility.[55] The UK Government has committed £60 million to the COVAX Facility to support lower income countries vaccine procurement through the Advanced Market Commitment[56]. The UK Government has also joined over 150 countries in joining the Facility for their own domestic COVID-19 vaccine procurement.[57] But as explored in our response to Question 7, the UK’s ongoing attempts to secure advanced supplies of potential COVID-19 vaccines for the UK risks fatally undermining the ability to ensure adequate vaccine supply for the COVAX Facility.

9.2.12.            RECOMMENDATION: The FCDO 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, and contribute doses towards the development of a humanitarian stockpile to meet the needs of populations in crisis-affected humanitarian settings.

9.2.13.            RECOMMENDATION: As outlined in our response to Question 7, the FCDO must use its position as a donor and board member of Gavi to ensure needed reforms to COVAX Facility that will support it to reach its key aim of global equitable access.

9.2.14.            RECOMMENDATION: The UK should vaccines doses from the UK bilateral deals available for humanitarian use to vaccinate the vulnerable populations that are not catered for by their government and fall outside the COVAX system: refugees, IDPs, people in conflict areas, and the people that provide support for them.

December 2020