The 77th World Health Assembly- WHA goes on to mark the deadline for the conclusion of a pandemic agreement as well as amended International Health Regulations 2005 that look to make the planet much better prepared for the next pandemic.
In response to the challenge of future global pandemics, the biopharmaceutical industry developed a specific set of commitments when it comes to equitable access to essential medical countermeasures in the course of future pandemics. Demonstrating the commitment of the private sector in order to prioritize the requirements of all individuals as well as communities affected because of a pandemic, companies are well prepared to leverage their individual expertise along with their resources so as to address the challenges posed by pandemics and make sure that no one is left behind. This represents a major step forward in promoting equity and inclusivity when it comes to the distribution of vital resources.
Attaining equitable access to medical countermeasures needs a comprehensive solution and should not be based on connecting access to pathogen samples and sequence data so as to meet benefit-sharing obligations. It is indeed critical so as to preserve the innovation ecosystem as well as the research incentives that happened to be effective in the fight against COVID-19. Scientists require rapid access to pathogens and data without conditions in order to quickly develop safe and effective countermeasures to save lives.
Equitable Access Commitments within the Pandemic Agreement
Developing on the commitment contained within the Berlin Declaration, there is a support that the pandemic agreement goes on to create a broad multistakeholder partnership for Equitable Access, to which companies can go ahead and voluntarily associate through their adoption of a collection of Equitable Access Commitments, that would be legally binding and enforceable via contracts.
Companies can go ahead and independently adopt one or more of the following Equitable Access Commitments in the periods in between the pandemics and/or throughout pandemics based on what every company could best contribute in view as far as its circumstances are concerned, such as size, technology platform, location, research and development pipeline, or even manufacturing capabilities.
In pre-pandemic time, commitments to commence, go on, or enhance:
Basic or applied R&D on vaccines or therapeutics against the pathogens of pandemic potential, such as through the use of novel technologies like artificial intelligence, supercomputing, and robotics;
Novel platform technologies, with the objective of having numerous platforms ready for a pandemic as well as exploring collaborations with the relevant public and private entities, specifically in low-income countries- LICs and lower-middle-income countries- LMICs;
It is well to be noted that the geographically diverse as well as comprehensive clinical trial sites along with networks, including by way of the expanding clinical research sites within the underserved areas;
Manufacturing-distribution capabilities in the case of relevant therapeutics or vaccines, including through the public and-or private partnerships, supply agreements, or even voluntary technology transfer agreements, in order to support globally enhanced manufacturing as well as fill and finish capacity;
Financial as well as the technical support to the LICs and LMICs when it comes to the capacity building for pandemic preparedness and also the response, such as genomic, environmental, or laboratory disease surveillance; establishing or even enhancing clinical trial capacity; strengthening as well as retention of the health workforce; making the regulatory systems robust; or running additional laboratory capacities that can indeed be relevant.
Post a pandemic is declared, commitments to:
Reserve a specific percentage of the real-time production volume of a therapeutic or vaccine that’s relevant for equitable distribution on the basis of public health risks, needs, and demand. This can very well include a portion anticipated as a donation to the LICs and/or a portion negotiated under the equity-based tiered pricing by way of lowest tiers dedicated to LICs and LMICs. In a repurposed medicinal product case, attention should be taken to ensure the security of supply for care in the case of patients who continue to require the product for its existing indications as well as uses;
Fast scale-up of production along with distribution capabilities, where possible within geographically diverse locations. This may go on to have enhancing the availability of raw materials, APIs, or consumables for the manufacturing of relevant therapeutics or even vaccines, and can be done in partnership with relevant WHO programs;
Leverage voluntary license as well as technology transfer partnerships so as to ensure that their innovative medical countermeasures go ahead and reach the patients, with special attention to the requirements of LICs and LMICs;
Establish, elevate, and also prioritize a research push so as to identify candidate vaccines as well as new and/or repurposed therapeutics that are relevant to the pandemic;
Make its library of molecules available to the relevant third parties on fair conditions for the requirement of developing a relevant therapeutic or vaccine;
Lend financial as well as technical support to the LMICs when it comes to capacity building so as to support research, manufacturing, or even supply for the relevant therapeutics or vaccines;
Be in collaboration with the WHO and others when it comes to treatment guidelines for the relevant audiences so as to optimize delivery as well as the administration of relevant therapeutics or vaccines.
Enablers
It is well to be noted that the pandemic agreement goes on to offer a unique opportunity to establish a comprehensive system for better as well as a more equitable pandemic preparedness and response. For Partnership to deliver on the mission, four enablers are of specific importance:
All countries, but specifically those governments with manufacturing facilities, commit, via the pandemic agreement, in order to allow for unrestricted exports of pandemic medical countermeasures, manufacturing inputs, and raw materials.
Robust regulatory systems as well as the use of regulatory strategies to make sure of the accelerated availability of pandemic vaccines as well as treatments, in line with the G7 100 Days Mission. Internationally harmonized and streamlined approvals will be instrumental when it comes to improving equitable access. Member states are required to facilitate the distribution of donations by way of ensuring that such products get approved for usage in that member state, such as through WHO Emergency Use Listing, even based on reliance on the approval of a strict regulatory authority as well as prequalification.
Access to pathogens and relevant data that’s unconditional and recognition of the pandemic agreement as a Special International Instrument- SII in sync with the Nagoya Protocol, hence decreasing the delays that are caused by national access and benefit-sharing laws.
Inclusive governance via a partnership where WHO happens to have a major role but also encompasses all the stakeholders that will go on to contribute to the execution of the agreement, which would include industry, in roles that are appropriate to their capacity as well as expertise.
