Written Evidence Submitted by Human Rights Watch

(CLL0050)

We write on behalf of Human Rights Watch to submit evidence to the UK Parliament’s Science and Technology Committee and Health and Social Care Committee’s upcoming joint inquiry into lessons learned from the UK government’s response to the coronavirus pandemic.

Human Rights Watch is an independent, nongovernmental organization that investigates and reports on human rights in more than 90 countries worldwide. We have documented the human rights impacts of the pandemic in many parts of the world.[1]

Universal and equitable access to a safe and effective Covid-19 vaccine is critical to preventing severe illness and death while protecting livelihoods, getting children back to school, and enabling economic recovery. In October, Human Rights Watch published a report, “Whoever Finds the Vaccine Must Share It”: Strengthening Human Rights and Transparency Around Covid-19 Vaccines. The report describes how the world is headed down a dangerous path as rich governments prebook hundreds of millions of vaccine doses for their own use, leaving low- and middle-income countries to wait for whatever is left over.

The UK has the opportunity to take a leading role in ensuring that any vaccines found to be safe and effective can be made widely available on a fair and equitable basis and priced affordably for all. The UK has been one of the world’s top governments funding vaccine research and development, and has committed to participate in the COVAX Facility, a global vaccine procurement mechanism aimed at helping low- and middle-income countries get access to vaccines. Yet the UK government continues to sign bilateral deals securing vaccines exclusively for its own uses, and has so far opposed an effort at the World Trade Organization led by India and South Africa to temporarily waive some intellectual property rules during the pandemic to ensure tests, treatments and vaccines needed for the pandemic response can be widely produced.    

The focus of this submission is how the UK government can strengthen human rights and transparency around Covid-19 vaccines.

Vaccine Development and Funding Landscape

Governments are using public money to fund Covid-19 vaccines on an unprecedented scale. By mid-September, the Australia-based think tank Policy Cures Research (PCR) estimated that governments had given over US$19 billion for Covid-19 vaccine research, development, manufacturing, and distribution.[2] The UK has been one of the world’s top donors, pledging over US$470 million by mid-September.[3]

As of November 12, 48 vaccine candidates were in clinical trials, and 164 others were in earlier research stages, according to the World Health Organization (WHO).[4] Eleven vaccine candidates were in the final phase (phase 3) of clinical trials, including the vaccine being developed by University of Oxford/AstraZeneca in the UK. In November, several companies announced promising early clinical trial results.[5]

In the high stakes race for a potential vaccine, commitments to meet human rights obligations and transparency have been largely absent. There is a lack of transparency around funding of Covid-19 vaccines with public money. The United States has published heavily redacted versions of agreements with vaccine developers; Brazil too published its agreement with AstraZeneca with substantial redactions, undercutting the value of transparency and undermining the ability to evaluate the full impact of the terms and conditions attached on universal and equitable vaccine access. Nevertheless, they are a step in the right direction. In contrast, the UK government has not made its contracts with vaccine developers, which were secured with public funds, open to public scrutiny. This lack of transparency makes it difficult for civil society to know if the government negotiated any equitable access provisions.

Some governments in high-income countries are directly negotiating opaque bilateral deals with pharmaceutical companies or other entities to reserve future vaccine doses, mostly for their exclusive use. In September 2020, Oxfam International reported that high-income countries have already reserved 51 percent of the doses of several leading vaccine candidates, even though those countries represent only 13 percent of the world’s population.[6] Global Justice Now reported that more than 80 percent of Pfizer’s vaccine doses have already been bought by a handful of countries.[7] The UK has prebooked 40 million doses of the Pfizer vaccine.[8] These deals undermine universal and equitable global access to any vaccine found to be safe and effective, especially for low- and middle-income countries.

The Pandemic Response Requires Global Cooperation and Solidarity

Like other infectious diseases, Covid-19 can spread rapidly across borders. Future vaccines may not provide lasting immunity, potentially leaving countries vulnerable to seasonal cycles or waves of infection. The protection of any one country’s population from Covid-19 is highly dependent on and interconnected to the protection of populations in other countries.

Protecting human rights in the context of a global pandemic requires the “international assistance and cooperation” that the International Covenant on Economic, Social and Cultural Rights (ICESCR) calls for.[9] The United Nations Committee on Economic, Social and Cultural Rights, which monitors compliance with the ICESCR underscored that “[p]andemics are a crucial example of the need for scientific international cooperation to face transnational threats.”[10] They concluded that “[i]f a pandemic develops, sharing the best scientific knowledge and its applications, especially in the medical field, becomes crucial to mitigate the impact of the disease and to expedite the discovery of effective treatments and vaccines.”[11] The International Monetary Fund has said that strong international cooperation on Covid-19 vaccines could speed up global economic recovery and add US$9 trillion to global income by 2025.[12] A growing movement of advocates, including Covid-19 survivors and the loved ones of those who died, are calling for a “people’s vaccine.”[13]

Addressing Vaccine Scarcity and Intellectual Property Barriers

The huge need worldwide for a safe and effective vaccine demands preparation for large-scale production. The global demand for any safe and effective vaccine is projected to far exceed supply.[14] Several barriers to scaling up the manufacture of Covid-19 vaccines could be addressed through government action, including conditions tied to vaccine funding that require technology transfer and the sharing of IP to allow mass manufacturing of successful vaccine candidates.

Vaccine manufacturing is specialized and know-how is one of the key barriers to expanding production.[15] The WHO says transfer of technology is critical for manufacturing and distributing vaccines rapidly.[16] Technology transfer requires companies, universities, and institutes to share what they consider “proprietary” data and know-how about the vaccine and its manufacturing processes, including intellectual property such as patents and trade secrets.

The Costa Rican government in May spearheaded a call to action with the World Health Organization to create the Covid-19 Technology Access Pool (C-TAP) – a common shared pool of rights to technologies, data, and know-how that everyone around the world could use to manufacture any medical products needed to tackle Covid-19, including vaccines.[17] To date, only 40 other governments have endorsed the C-TAP Solidarity Call to Action.

In October 2020, India and South Africa proposed that some provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) be waived, to allow all countries globally to collaborate with one another, without running into the morass of laws and restrictions governing IP. If adopted, the proposal could enable the sharing of technology and know-how to expand access to the medical technologies needed to save lives and prevent severe illness during the pandemic.

The UN High Commissioner for Human Rights recently urged “the broadest possible sharing of scientific knowledge, and the broadest possible access to the benefits of scientific knowledge.” Other UN experts recently welcomed the TRIPS waiver proposal and stated, “International cooperation and assistance between developed and developing countries are crucial in ensuring that all relevant health technologies, intellectual property data and know-how on COVID-19 vaccines and treatment are widely shared as a global public good.”[18]

Human Rights Watch wrote to the UK government on 8 October 2020 urging support for the proposal. We have included that letter as an annex to this submission.

The UK government has so far declared its opposition to the proposal, arguing that intellectual property rights “provide incentives to create new inventions” and claimed the proposed waiver was “an extreme measure to address an unproven problem.”[19] The UK government’s response appears to disregard historical experience– especially from the struggle to overcome IP barriers for generic and affordable treatment for HIV/AIDS. It fails to acknowledge the links between affordable pricing and IP, ignoring expert opinions by IP rights lawyers, and disregarding the growing risk of lawsuits challenging the IP of companies involved in Covid-19 vaccines.[20] Voluntary corporate commitment to open and non-exclusive licensing has been low, making government use of regulatory tools essential to ensure vaccines are widely available.

The UK government also cited its contributions to the COVAX Facility, described above, in its arguments against the TRIPS waiver. Such donations, while important for achieving the facility’s ambitious goal to provide vaccine access for low- and middle-income countries, do not obviate the need for solutions to intellectual property barriers. In particular, while the UK government supports COVAX, it continues to prebook vaccine doses, undermining the effectiveness of any global procurement mechanism. The UK government’s response fails to acknowledge that existing TRIPS flexibilities address only patents and provide cumbersome procedures product-by-product, country-by-country. TRIPS flexibilities offer no solutions to enable technology transfers, including sharing data and other information that can be considered as “trade secrets.” The effects of the COVAX Facility will be limited unless the intellectual property barriers contributing to vaccine scarcity are also addressed, along with the pre-booking of vaccines by rich countries. Participating governments like the UK should work to fully align the COVAX Facility with the principles and spirit of C-TAP.   

Open and non-exclusive licensing unleashes the potential of scientific research that uses public money to maximize public benefit, preventing any one company from holding or controlling access to the data, know-how, and IP required to manufacture vaccines.

Making Vaccines Affordable for All

Some recipients of government funding—universities and pharmaceutical companies— have suggested they will adopt pricing strategies that are “not-for-profit” or at minimal profit.[21] The information thus far disclosed is scant or vague. Where a little more information about potential pricing is made available, experts have raised concerns that the cost risks putting vaccines out of the reach of poor countries and people living in poverty.[22] The estimates reported vary from as little as US$3 per dose to US$72 per dose. Most potential Covid-19 vaccines are expected to require two doses per person, and unlike some other vaccines, Covid-19 vaccines likely will not be once-in-a-lifetime. They will generate recurring expenses and be particularly financially burdensome for low- and middle-income governments as well as those living in poverty. 

Regulating prices to maximize affordability is especially important because in many contexts, vaccines will only be accessible and affordable for communities if they are free at point of care. Worldwide, nine percent of the world’s population lives in extreme poverty, surviving on less than US$1.90 per day.[23] In June 2020, the World Bank projected the pandemic could push between 70 and 100 million people into extreme poverty—living on less than US$1.90 a day—in 2020.[24] The pandemic is also projected to widen the poverty gap between women and men and drive a 9.1 percent increase in poverty among women.[25]

Governments have a human rights obligation to take measures, individually and collectively, to ensure companies, universities, and other entities receiving public money use it in ways that maximize vaccine affordability for the benefit of people globally.

Committing to Transparency

People have a right to know how governments spend public money. They have a right to know what measures governments are taking to protect public health and ensure public money is used for public benefit. But governments have yet to disclose even the key terms and conditions under which they have funded companies, universities, and other entities for Covid-19 vaccines. Transparency is crucial to hold governments accountable for fulfilling their international human rights obligations both within their own borders and beyond them.

Recommendations

We respectfully request that the committees make the following recommendations to the UK government:

• Endorse and implement the WHO's COVID-19 Technology Access Pool (C-TAP).
• Cooperate with other governments to map out the global capacity to manufacture the needed supply of Covid-19 vaccines, and to develop a strategy to fund and support the creation of additional manufacturing capacity especially in low- and middle-income countries to ensure rapid and diversified large-scale production.
• Pledge not to sign bilateral deals with vaccine developers to prebook future vaccine doses in ways that undermine equitable global allocation according to public health need.
• Support India and South Africa’s October 2020 proposal at the World Trade Organization to waive some provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and use TRIPS flexibilities at the country-level.
• Urgently introduce legislation to provide expedited compulsory licenses for all Covid-19 health products, including vaccines.

• Commit to transparency around Covid-19 vaccine funding by:
• Publishing all contracts signed by the UK government related to Covid-19 vaccine research, development, manufacturing, or distribution.
• Publishing which option (Committed Purchase Arrangement or Optional Purchase Arrangement), what percentage of their population (10-50%) and the total number of doses that the UK has elected to receive through COVAX.
• For each vaccine candidate funded by the UK government, publicly disclose and periodically update the following information:
• How each candidate compared on a set of common criteria used to assess them (for example, cold-chain, previous use of technology; efficacy); 
• Due diligence and related results regarding: pricing; the patent landscape for the vaccine candidate; legal disputes surrounding the vaccine candidate; manufacturing capacity for the underlying vaccine platform technology, identifying what manufacturing capacity is booked up, what is available, and what can be repurposed or scaled up.
• Take steps to help develop vaccine manufacturing capacity in low-and-middle-income countries to build more resilient and self-sufficient supply chains in those countries, aligned Sustainable Development Goals 3 and 9; publicize and periodically update all relevant parliamentary committees about these steps.
• Attach concrete conditions to all funding for Covid-19 vaccine research, development, manufacturing, or distribution requiring technology transfer, that is, recipients should share all intellectual property (IP), data, and other know-how to enable mass manufacturing of successful vaccine candidates. Specifically, ensure agreements to fund Covid-19 vaccines, at a minimum, require recipients to provide open, non-exclusive, and royalty-free licensing for pre-existing IP owned and any future owned IP modeled on the “Open COVID Pledge.”
• Attach concrete conditions to all vaccine funding to ensure vaccines are priced transparently, and to prioritize affordability and minimize any debts for low- and middle-income countries and not profits for vaccine-developers. Specifically, ensure agreements to fund Covid-19 vaccines, at a minimum, require that compliance with vaccine price commitments is verified through an independent third-party financial audit and the audit report be published.
• As a participating government in the COVAX Facility, call on Gavi and CEPI to:
• Design the COVAX Facility in a way that is aligned with the WHO’s C-TAP;
• Publish all agreements with vaccine developers and manufacturers.
• Attach conditions to their funding related to technology transfers; open and non-exclusive licensing; and transparent and affordable pricing, verifiable by independent third-party audits that are made public.

(November 2020)