Where is fair and equitable benefit sharing of medical products?

Although WHO issued a blueprint in March which linked rapid sharing of coronavirus materials and sequence information to fair and equitable sharing of resulting medical innovations, developing countries have yet to see any progress in the realisation of this blueprint. Sangeeta Shashikant and Edward Hammond explain.

THE World Health Organisation (WHO), in an announcement in March, linked rapid sharing of SARS-CoV-2 virus materials and sequence information to fair and equitable benefit sharing. But how this linkage will be operationalised remains obscure.

[‘Digital sequence information’ is a placeholder term adopted by the UN Convention on Biological Diversity (CBD) while it discusses a permanent term and definition for sequence information related to genetic resources. It is generally regarded to include DNA and RNA sequences and protein (amino acid) sequences. Many experts also include in the term additional genetic and genomic information such as protein structures and epigenetic information.]

WHO’s blueprint for COVID-19 research and development titled ‘Coordinated Global Research Roadmap: 2019 Novel Coronavirus’ published in March has identified access and benefit sharing as one of the immediate next steps to contribute to controlling the pandemic outbreak.

WHO said that an agreed action is: ‘[b]roadly and rapidly share virus materials, clinical samples and data for immediate public health purposes – It was agreed that virus materials, clinical samples and associated data should be rapidly shared for immediate public health purposes and that fair and equitable access to any medical products or innovations that are developed using the materials must be part of such sharing’.

Developing countries have responded positively to WHO’s call for broad and rapid sharing; as of 21 April, they have generated and uploaded 855 complete SARS-CoV-2 sequences into the major international database used by researchers. These sequences are critical to ongoing public and private efforts to develop COVID vaccines and therapeutic treatments.

Yet there is little progress in defining exactly how the blueprint's parallel call, for fair and equitable access to medical products and innovations, will be realised.

The R&D blueprint is the outcome of a global forum on research and innovation for COVID-19 organised on 11-12 February by WHO in collaboration with the Global Research Collaboration for Infectious Disease Preparedness and Response (GLOPID-R), an international network of funders to facilitate coordination and information sharing.

A fundamental guiding principle of the blueprint is ‘Committing to fair and equitable access’ and, in that context: ‘[a]n unambiguous commitment to global solidarity and equitable access to advances made’; ‘[a] global effort to enable the scaling-up of any successful intervention’; and ‘[a] coordinated effort to facilitate effective, fair and equitable access based on public health needs’.

The blueprint also recognises that ‘access to the benefits of research is critical’ and that ‘scale up manufacturing of products (speed, access, cost)’ is an important component of successful implementation of the roadmap.

It further calls on research funding grants to ‘include clauses that promote timely sharing of research data relevant to the outbreak response’.

The origins of access and benefit sharing may be traced back to the Convention on Biological Diversity, which came into force on 29 December 1993. A key objective of the CBD is the ‘fair and equitable sharing of the benefits arising out of the utilisation of genetic resources’.

This was further elaborated in the Convention’s supplementary Nagoya Protocol on Access and Benefit Sharing which entered into force on 12 October 2014. To date, the CBD has 196 Parties while the Nagoya Protocol has 116 Parties.

These binding international instruments are built on the agreement that States have sovereign rights over their own natural resources and that access to genetic resources is subject to prior informed consent of the State providing the resources, and further requires fair and equitable sharing of benefits arising from the commercial and other utilisation of genetic resources with the providers of such resources.

Pathogens such as SARS-CoV-2 are within the scope of these instruments. Sharing of pathogen samples and digital sequence information is crucial for the rapid development of diagnostics, therapeutics and vaccines.

Notably, in January 2020, China rapidly shared with the Global Initiative of Sharing All Influenza Data (GISAID), sequences of viruses from early cases of COVID-19, kickstarting global research and development efforts. Since then, sharing of COVID-19-related samples and digital sequence information has continued rapidly especially from developing countries.

SARS-CoV-2 is also mutating as it passes from person to person, just like other viruses. The potential significance of these mutations for drug and vaccine development remains unclear.

There are also a number of reports, as yet unconfirmed, of re-infection of COVID-19 victims, indicating that it is possible that infection with SARS-CoV-2 may not create full immunity.

The situation thus strongly suggests that there will be an ongoing need for global epidemiological genomic surveillance of the virus. This means continued sharing of SARS-CoV-2 samples and sequence data to allow tracking of mutations to determine if a particular vaccine or drug will remain effective or if, as in the case of influenza, there will be a need for treatments to change in line with the virus (mutations).

It is this ‘unhindered’ sharing that is enabling rapid research and development of diagnostics, medicines and vaccines across the world

However, a narrow focus on sharing of SARS-CoV-2 samples and data without addressing mechanisms for sharing of the research outcomes, technologies and medical products that result from the use of these samples and data, risks creating a situation of winners and losers.

The PIP Framework

In this context, it is worth recalling the H5N1 outbreak in the South-East Asian region in 2006 which revealed the virus sharing system of the Global Influenza Surveillance Network (GISN) to be a system of winners and losers.

Countries would share virus samples with the WHO-designated laboratories (then mostly based in developed countries) that made up the GISN system. These laboratories would develop a candidate influenza vaccine virus which would be shared with the pharmaceutical industry, often without the consent of the country providing the virus sample.

The industry received not only the candidate vaccine virus for making the vaccine, but also vast government subsidies and the profits from vaccine sales.

Developed countries entered into advance purchase agreements with the pharmaceutical industry to reserve supplies of influenza vaccines and antivirals in the event of a pandemic.

Industry and WHO-designated laboratories also claimed patents over the parts of the shared biological materials and sequences.

Meanwhile countries that freely shared the virus samples (often developing countries) did not have timely access to affordable vaccines and antivirals or to relevant information about the virus samples shared, while the patent system was used to appropriate the viruses and sequences they shared.

The inequalities and inadequacy of the GISN became glaringly clear with the H1N1 pandemic in 2009, when wealthy countries secured access to vital pharmaceutical supplies through advance purchase agreements, while many other countries, especially in Latin America, lacked access.

In 2011, WHO adopted a landmark agreement, the Pandemic Influenza Preparedness Framework or commonly known as the PIP Framework, which set out international rules with regard to access to influenza viruses of pandemic potential (IVPP) and fair and equitable sharing of benefits arising from their use.

For the first time, access to potentially pandemic influenza viruses was linked on an ‘equal footing’ to access to vaccines and other benefits, recognising both as ‘equally important parts of the collective action for global public health’.

Effectively, the PIP Framework is a multilateral instrument built on CBD principles of access and benefit sharing, with commitments on access to medicines, vaccines, supplies and diagnostic kits in the context of influenza pandemic response.

With the Framework, WHO has entered into binding contracts with vaccine and pharmaceutical manufacturers to secure firm commitments to deliver diagnostics, antiviral products and vaccines during a pandemic.

According to WHO, through 13 signed Standard Material Transfer Agreements (SMTA) as at May 2019, it has secured approximately 420 million doses of influenza pandemic vaccine and 10 million treatment courses of influenza antivirals that it would be able to send to countries in need at the time of a flu pandemic, representing ‘four times the amount of vaccine the Organisation had access to during the 2009 pandemic’.

The SMTA also provides the option of manufacturers providing royalty-free licences to manufacturers in developing countries for the production of pandemic influenza vaccines, adjuvants, antiviral products and diagnostics needed in a pandemic.

The Framework also requires annual partnership contributions by influenza vaccine, diagnostic and pharmaceutical manufacturers using the WHO Global Influenza Surveillance and Response System (GISRS), for a total of $28 million (i.e., ‘50% of the running costs of the WHO GISRS’, which were in 2011 estimated to be $56.5 million), with the understanding that this partnership contribution will change over time.

To date, WHO has collected a total of $198 million, with 70% allocated for national capacity-building activities to strengthen preparedness while 30% is maintained for future pandemic response.

In 2016, a WHO Expert Review Group described the Framework as a ‘bold and innovative tool for pandemic influenza preparedness’, adding that the basic premise of this innovation is the principle of placing virus sharing and benefit sharing on an ‘equal footing’ which, according to the Expert Review Group, ‘remains relevant today’.

Lessons for COVID-19

In recent years, the vaccine and pharmaceutical industry, developed countries and sometimes even the WHO secretariat have raised concerns over the implications of the CBD and the Nagoya Protocol, stressing the importance of rapid sharing of pathogen samples and digital sequence information but sidelining the role and importance of fair and equitable benefit sharing and especially the need for rapid sharing of technologies and medical products to respond to a pandemic outbreak.

And yet today, developing countries are sharing their SARS-CoV-2 samples and sequence information but their huge concerns over intellectual property and other barriers to access are not being addressed.

Governments are concerned about whether they will have access to much-needed technologies and medical products such as diagnostics, but also therapeutics and vaccines as they are developed and rolled out.

On a daily basis, there are news reports about shortages and a scramble for medical supplies. A New York Times report titled ‘In Scramble for Coronavirus Supplies, Rich Countries Push Poor Aside’ notes: ‘As the United States and European Union countries compete to acquire scarce medical equipment to combat the coronavirus, another troubling divide is also emerging, with poorer countries losing out to wealthier ones in the global scrum for masks and testing materials. Scientists in Africa and Latin America have been told by manufacturers that orders for vital testing kits cannot be filled for months, because the supply chain is in upheaval and almost everything they produce is going to America or Europe.’

Apart from availability, another challenge is affordability as ‘countries report steep price increases, from testing kits to masks,’ the report adds.

As therapeutics and vaccines emerge, shortages are to be expected and most affected are likely to be less developed nations. Voluntary mechanisms, while commendable, are unlikely to deliver medical products and manufacturing technologies needed to ramp up production.

What is needed is for WHO to operationalise fair and equitable benefit sharing by securing firm and binding commitments from vaccine, pharmaceutical and other manufacturers with respect to availability and affordability of medical products and the sharing of knowledge and technology.                         

*Third World Resurgence No. 343/344, 2020, pp 66-68