By Catherine Saez
The World Health Organization has been able to rely on a little-known mechanism financed by the pharmas to help countries strengthen their preparedness and response to a flu pandemic.
As COVID-19 is tearing through regions, most countries seem to have been caught unprepared. However, the world has been bracing for the next large influenza pandemic since 1918, and the World Health Organization leveraged the benefits of a little-known mechanism helping countries strengthen their preparedness and response to a flu pandemic, to support the COVID-19 response. The pharmaceutical industry, mostly financing the mechanism through annual contributions, says it is glad that progress in influenza preparedness could be leveraged to fight the current pandemic.
Questions remain, however, on the application of an international agreement providing benefits to countries sharing their biological materials in case there are business profits deriving from those materials.
That question was solved for the influenza virus with human pandemic potential in 2011 when the Pandemic Influenza Preparedness Framework (PIP Framework) was adopted. The framework aims to help countries become more resilient in case of an influenza pandemic and at the same time, ensure fair access to vaccines and diagnostics to fight off the pandemic. The PIP Framework includes a mechanism through which in exchange for access to virus biological material from the WHO Global Influenza Surveillance and Response System (GISRS), pharmaceutical and diagnostic companies pay an annual Partnership Contribution to the WHO.
“Timeliness of payments may be improved but overall WHO has received approximately 97% of each year’s US$ 28M, which is a testament to industry’s continued support for the aims of the Framework” - A WHO Official
As of June 2020, the total sum collected from the industry amounted to US$ 198,244,525, only slightly short of the initial target of US$ 28 million a year. “Timeliness of payments may be improved, but overall WHO has received approximately 97% of each year’s US$ 28M, which is a testament to industry’s continued support for the aims of the Framework,” a WHO official told the Geneva Observer. “Industry contributions are absolutely key to helping WHO support countries in the preparedness work they are undertaking,” the official added. The contribution is divided between preparedness activities (70 percent), a fund set apart to be used in the case of a pandemic (30 percent), and the rest being used by the PIP Secretariat.
The PIP Framework preparedness activities are framed by a High-Level Implementation Plan (the second one which runs from 2018-2023), and are directed towards low and middle-income countries. According to the latest PIP Framework Progress Report 2018-2019, during that period, US$27.4 million of the Partnership Contribution were spent on capacity-building in six specific areas: laboratory and surveillance, the burden of disease, regulatory capacity-building, risk communications and community engagement, planning for pandemic product deployment, and influenza pandemic preparedness planning. Most of the spending went to laboratory and surveillance capacity-building (US$18.5 million).
GISRS, Influenza Pandemic Preparedness Stepping Stones for COVID-19 Response
According to the WHO, its Global Influenza Surveillance and Response System have been key in the early stage of the COVID-19 outbreak, notably as its capacities were used to ship samples of the virus to reference laboratories. Later GISRS served the epidemiological and virological surveillance of the virus.
GISRS includes National Influenza Centres, WHO Collaborating Centres, Essential Regulatory Laboratories, and H5 Reference Laboratories (diagnosis of influenza A/H5 infection). Over 140 GISRS laboratories are testing for COVID-19 using capacities strengthened through the PIP Framework activities.
The training provided in the context of the PIP Framework, in particular in influenza surveillance, served for COVID-19 detection and response. The August 2020 WHO Influenza newsletter explained how capacities developed through the PIP Framework with the Partnership Contributions were leveraged to tackle COVID-19 in different regions. For example, in the Eastern Mediterranean Region, all 22 countries of the region had a national rapid response team (RRT) in place, which served in the COVID-19 response, in particular, to detect, monitor, and control the pandemic.
In Europe, national influenza pandemic preparedness plans have been set up over the last six years and provided the foundation for developing COVID-19 Country Preparedness and Response Plans, according to the newsletter. In the same way, the Pan American Health Organization (PAHO) supported member states to incorporate COVID-19 into their existing surveillance systems for influenza. WHO’s South-East Asia region countries have established diagnostic capacity for COVID-19, illustrating the progress gained after a decade of preparedness activities in the region to improve laboratory capacities for pandemic influenza.
During the 2018-2019 biennium, countries in all six regions of the WHO benefitted from the Partnership Contribution. Laboratory and surveillance capacity-building activities, for example, were provided in a number of countries, including Nigeria, Ethiopia, Bolivia, El Salvador, Afghanistan, Egypt, Morocco, Armenia, Tajikistan, Uzbekistan, Bangladesh, Indonesia, Myanmar, Cambodia, Lao, and Viet Nam. Influenza Pandemic Preparedness Planning capacity-building activities were carried out in countries such as Mali, Niger, Colombia, Egypt, India, Indonesia, Cambodia, and China.
Influenza Surveillance Challenged
While the attention has been focused on the COVID-19 pandemic for months, WHO Director-General Tedros Adhanom Ghebreyesus warned during a media briefing in June that influenza surveillance had either been suspended or declining in many countries and there has been a sharp drop in the sharing of influenza information and viruses. This decline, he said, is the result of combined factors, including the repurposing of staff and supplies and overburdened laboratories. This drop in sharing “may have short-and long-term effects,” he said, “such as the loss of capacities to detect and report new influenza viruses with pandemic potential.” The WHO, he added, published guidance on how to integrate surveillance for COVID-19 into routine influenza surveillance as a way to track both viruses, and how to prepare for the co-circulation of influenza and SARS-CoV-2 viruses.
Industry Supportive of Use of Influenza Preparedness for COVID-19
A source from the International Federation of Pharmaceutical Manufacturers & Associations told the Geneva Observer that “Considering the similarities between SARS-CoV-2 and influenza virus, it is not surprising that the systems built for pandemic influenza preparedness are being leveraged for the COVID response.” “The biopharmaceutical industry absolutely does not see an issue with exploring synergies here when the ultimate beneficiary is global public health. Indeed, this is aligned with the industry commitments for COVID-19 made just days after the pandemic was declared in March,” the source said. “As things stand today, the biopharmaceutical industry has no basis for concerns that PIP PC funds are being used for COVID-related activities at the expense of pandemic influenza preparedness ones.” “Right now, all our efforts should be on ensuring the best response to the COVID-19 pandemic and supporting WHO’s work,” the source said.
Questions Remain about Virus Access and Benefit-Sharing
Although synergies between influenza and COVID-19 can be leveraged, the large difference between the two viruses is the issue of benefit-sharing. The PIP Framework was tailored so that it provides benefit-sharing with the countries providing samples of influenza viruses with human pandemic potential. This benefit-sharing obligation does not apply to SARS-CoV-2. Under the Convention on Biological Diversity (CBD), member countries are expected to provide a fair and equitable sharing of benefits arising from the utilization of genetic resources. This was enacted by the adoption in 2010 of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization.
According to Sangeeta Shahsikant, legal advisor for the Third World Network, “It is clear that access and benefit sharing arrangements in the form of the PIP Framework premised on the principles of the Convention of Biological Diversity has supported the surveillance, sample collection and sequence sharing, laboratory testing with respect to Covid 19.” “Without the ABS [access and benefit-sharing] system of the PIP Framework, the challenges would have been greater. What is absent, however, is a similar framework for Covid-19 and other pathogens collected at the international level,” she said. “As seen in the case of Covid-19, there is significant disparity and inequity in terms of access to diagnostic kits and therapeutics, and this is also likely to be the case for vaccines as developed countries race to sign deals granting them priority access. Hence the need for access and benefit sharing agreements premised on the Convention of Biological Diversity for Covid-19 and other pathogens of pandemic potential.”