26 June (Sangeeta Shashikant and K.M. Gopakumar) – The European Commission has released an “EU Strategy for COVID-19 vaccines” that is premised on sealing advance purchase agreements with vaccine producers to secure production of vaccines in the European Union and sufficient supplies for its Member States.
Launched on 17th June 2020, the EU Strategy marks a major shift from earlier calls for global collaboration and solidarity in ensuring affordable equitable access to vaccines globally.
The Strategy follows the formation of an “Inclusive Vaccine Alliance” (IVA) by France, Germany, Italy and the Netherlands to pool national resources to secure access to vaccines supplies for the European population.
However, it would seem that the EU Strategy is the result of growing concerns over falling behind the United States which has signed advance purchase agreements with pharmaceutical companies. These agreements offer large amounts of money to support the research and development and manufacturing of potentially effective COVID-19 vaccines, in return for guaranteed access to a set number of doses for U.S. domestic use.
Bloomberg reported on an EU internal memo dated 25th May which states that the EU plan aims to emulate the U.S. Biomedical Advanced Research and Development Authority, which is “financing different projects even before any are proven to work, with the hopes of having two or three successful candidates that allow for quick distribution among U.S. citizens”.
AstraZeneca has reached an agreement with Europe’s IVA, spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020.
According to a Reuters report of 18th June, the “European Commission is in advanced talks with pharmaceuticals giant Johnson & Johnson to reserve or make an up-front purchase of its COVID-19 vaccine under development”. The report quotes an EU health official as noting that “EU is also seeking a deal with French vaccine-maker Sanofi”.
The EU Strategy states that “[i]n order to support companies in the swift development and production of a vaccine, the Commission will enter into agreements with individual vaccines producers on behalf of Member States” hence endorsing advance purchase agreements with vaccine producers.
It adds “[i]n return for the right to buy a specific number of vaccines doses in a given timeframe and at a given price, part of the upfront costs faced by vaccine producers will be financed by the Emergency Support Instrument” (ESI). The budgetary authorities, the European Parliament and the Council, have made Euro 2.7 billion available under the ESI.
The Strategy justifies the advance purchase agreements (APAs) as “an insurance policy which transfers some of the risk from industry to the public authorities in return for assuring Member States equitable and affordable access to a vaccine, should one become available”.
However, the same Strategy notes “[s]ignificant levels of EU support have already been made available to vaccine producers”.
A brief section of the Strategy is on “Global Solidarity”, appearing to be an afterthought following a far more detailed plan for ensuring access for European Member States.
It notes the steps taken by the Commission to its commitment to universal, equitable and affordable access to COVID-19 vaccines. There was particular reference to the end of May 2020 pledging campaign the Commission initiated that raised Euro 9.8 billion, and its partnership with other governmental and non-governmental organizations including the Coalition for Epidemic Preparedness Innovation and GAVI, the vaccine alliance as part of the ACT-Accelerator.
[The ACT-Accelerator is a World Health Organization initiative launched in April 2020 to form a global collaboration to accelerate the development, production and equitable access to new COVID-19 diagnostics, therapeutics and vaccines.]
The EU Strategy adds that the “Commission is ready to support the development and operation of an inclusive international COVID-19 procurement mechanism that facilitates early and affordable access to vaccines and other tools for all who need it across the world”.
A press release on the Strategy clarifies that the European Commission “is ready to explore with international partners if a significant number of countries would agree to pool resources for jointly reserving future vaccines from companies for themselves as well as for low and middle-income countries at the same time”.
It further states that “[h]igh-income countries could act as an inclusive international buyers’ group, thus accelerating the development of safe and effective vaccines and maximise access to them for all who need it across the world.”
The Strategy also adds its support for “voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly, to promote equitable global access as well as a fair return on investments”.
Civil Society Concerns
On 10th June, prior to the release of the Strategy, a letter endorsed by 69 signatories including civil society organizations, public health experts and academics, expressed alarm that the EU was opting for preferential access agreements for its citizens over global collaboration and solidarity for equitable allocation.
The letter states “[b]y seeking to replicate the model used by the U.S., the EU joins and spurs a global race for preferential access to COVID-19 vaccines where countries and regions outbid each other rather than collaborate. This is problematic, we should not repeat the mistakes of the HIV and H1N1 epidemic when financial means rather than health needs defined access to life-saving health products”.
“The purchasing of potential COVID-19 vaccines that would cater to EU member states’ needs first would sharply contrast with the European Commission’s highly visible leadership in a global response to COVID-19, and the assertion of Commission President von der Leyen that COVID-19 vaccines will be “our universal, common goods”, as well as other European heads of states’ similar calls for solidarity and worldwide collaboration”, the letter states.
The signatories highlight that “supply should not be preferentially allocated to Europe only or Europe first in derogation of its global solidarity commitment to equitable global access”.
The letter stresses that “true commitment to equitable global access for COVID-19 vaccines demands that the pooled procurement and the mapping of needs by the EU member states fit within a global effort and framework managed and coordinated by the WHO, enabling the allocation and distribution of vaccines according to internationally agreed medical and ethical criteria. Particularly, the needs of frontline health workers and people living in low- and middle-income countries, who have limited access to effective and equitable healthcare services and treatments, require priority access and protection”.
The letter refers to a recent poll by the Wellcome Trust that shows broad support for global vaccine allocation according to need, even if this was at the expense of preferential domestic access.
The letter calls on the EU to “facilitate open access to and the right to use all technologies, know-how, materials, regulatory data and intellectual property related to all COVID-19 vaccine candidates at the global level, and seek to negotiate and facilitate transparent technology transfer agreements to producers in other regions, including the US, Asia, Latin America, and Africa, to greatly expand manufacturing capacity, thus accelerating the global availability of needed supplies”.
“Instead of increasing dependency on selected pharmaceutical companies with limited internal capacity to deliver better, faster or affordable access, the Commission should aim to maximize the global capacity of vaccine development, manufacture and supply of multiple effective vaccines to enable as many people as possible to be catered to as soon as possible,” it added.
The signatories call for “An inventory of global manufacturing capacities, including all independent vaccine manufacturers from developing countries, and barriers for upscaling global manufacturing and production of effective vaccines, should be established. The use of public funding should be geared towards addressing those barriers and increasing and maximizing capacities”.
Implications of EU Strategy
The EU Strategy proposes EU level centralized procurement. It does not rule out additional bilateral or plurilateral advance purchase agreements (APAs) between EU Member States and pharmaceutical companies. For instance, EU Member States may additionally participate in the GAVI Covax facility, which also seeks to secure access by way of advance agreements with pharmaceutical companies.
Effectively, the various APAs aim to guarantee access for high income countries, prior to meeting the needs of developing countries. The EU pays lip-service to global solidarity with its proposal for a high-income buyers scheme for the supply to low and middle countries. The scope and conditions of the scheme are unclear, and risk creating a competing APA that further undermines global equitable allocation under the auspices of WHO and dividing the international community.
The various competing APAs, will also neutralize the effect of competition. The race to sign APAs for vaccines, signalling a demand for a particular vaccine (with unproven effectiveness) as well as the lack of transparency in the price as well as terms and conditions for access, only empowers pharmaceutical companies to divide and rule, maintaining market monopoly and high prices in times of dire pandemic needs.
Further, the APA route to vaccine procurement also bears the danger of procurement of vaccines with sub-optimal efficacy. Since the purchase is already committed through contract, there could be pressure to continue with the contract.
The APAs also raise questions on intellectual property protection and technology transfer. Given that a large part of vaccine development has been publicly financed, and additionally the APAs are seen as a way to “de-risk” investments, there is little justification for denying the sharing of the intellectual property, technology and know-how to scale-up manufacturing, especially in times of a pandemic.
The EU Strategy makes a mockery of calls by EU leaders to treat COVID-19 vaccines as a “global public good” and the WHO resolution WHA 73.1 which calls for “universal, timely and equitable access to, and fair distribution of, all quality, safe, efficacious and affordable essential health technologies and products … required in the response to the COVID-19 pandemic as a global priority” and “the spirit of unity and solidarity, the intensification of cooperation and collaboration at all levels in order to contain and control the COVID-19 pandemic and mitigate its impact”.
There is an even deeper risk: the sabotaging of a coordinated global response by the WHO that prioritises equitable access and allocation of COVID-19 vaccines at affordable prices, taking into account public investment in the research and development of the vaccines, as well as cooperating on expanding and scaling up manufacturing and supply capacity globally.