4 principles for urgent pharma action to combat COVID-19

In the first 12 months since the discovery of SARS-CoV-2, the world has seen unprecedented scientific successes and strong foundations for international cooperation. Several COVID-19 vaccines have already received emergency-use authorisation in multiple countries, and now almost all countries of the world, including US and China, have committed to participate in the Facility of COVAX, the vaccine pillar of the ACT-Accelerator partnership.

To combat the pandemic, active participation and new forms of collaboration between the pharmaceutical industry and public actors are still needed. Developing vaccines in 12 months’ time are the result of effective public and private collaboration. Making sure that vaccines reach the billions of people in need in the next 12 months presents an even bigger challenge, and must be approached with the same determination and ‘out-of-the-box’ thinking.

This approach is necessary to find solutions to manufacturing and distribution problems, such as delays in dosage delivery, cold storage requirements, and the ability to rapidly scale up supply. Moreover, ACT-Accelerator (ACT-A) and COVAX have yet to fill a substantial funding gap in order to meet its goals.

Norway co-chairs the Facilitation Council of the ACT-A, and we are committed to ensure that COVID-19 vaccines, therapeutics, and tests are manufactured, procured, and distributed equitably and effectively. To help translate this aspirational goal into practice, we suggest four principles to ensure global access to COVID-19 tools that could form the basis for access to all health products.

To take action on these principles, pharmaceutical companies play a crucial role. The four principles relate closely to the new results of the 2021 Access to Medicine Index which point towards best practices and concrete examples of actions that could be applied to help ensure new life-saving vaccines and therapeutics reach low and middle-income countries (LMICs) before it is too late.

Vaccines can be made widely available in countries only when filed for registration and authorized by national health authorities, or via pre-qualification from the World Health Organization (WHO). These processes are important to secure robust quality standards – one common bar to pass – to avoid some populations being offered lower-quality products where necessary data may not exist or regulatory processes are too lax. Norway is calling on pharmaceutical companies to expand their regulatory capacity and file for registration as quickly and as widely as possible, in parallel or immediately after first approval, for example by the Food and Drug Administration or European Medicines Agency. In particular, companies should work collaboratively with WHO on the emergency use listing procedure.

The 2021 Access to Medicine Index finds that more pharmaceutical companies are taking systematic approaches to ensure accessibility for medicines and vaccines by planning ahead for availability and affordability as soon as R&D projects reach late-stage clinical development. However, this still has to be translated into common practice, as coverage of late-stage products with access plans is still incomplete. Most access plans focus on availability (filing for registration) in a selection of LMICs.

COVID-19 is having an immensely negative impact on economies around the world, and vaccines should be one of the tools for returning to normal economic activity, not an additional burden on the finances of lower-income countries. High prices should not be a barrier to life-saving tools for health systems and economies. Norway is calling on pharmaceutical companies to implement pricing strategies that take the different levels of a country’s ability to pay and the exceptional circumstances of the pandemic into account. Companies should take a cost plus pricing approach for lower-income economies and agree on affordable prices with the COVAX Facility for the 92 ‘Advanced Market Commitment’ eligible countries.

The 2021 Access to Medicine Index reports that several companies already work with supranational procurers like the Global Fund to Fight AIDs, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance, and some also offer the same terms to countries outside these agreements. However, coverage of equitable pricing strategies for products outside such multilateral procurement agreements still has many gaps, with low-income countries being most consistently overlooked.

More equitable approaches to availability and affordability are particularly relevant for pharmaceutical companies that have committed to participate in ACT-A and its COVAX Facility. All companies should ensure that countries and populations are not left behind, causing harmful impacts affecting all countries in terms of potential new viral strains and economic damage.

Existing production capacity is currently not enough to reach the vaccination coverage needed. Norway is calling on pharmaceutical companies to think outside the box and implement all possible strategies to increase manufacturing capacity.

The 2021 Access to Medicine Index identifies examples of how to improve existing production and distribution processes, including AI-powered demand forecasting and closer collaboration with local distributors. It also highlights the key role that technology transfers and voluntary licensing can play when in-house manufacturing cannot meet external demand. The pharmaceutical industry should follow examples of peers who agreed to tech transfers and voluntary licensing agreements, and consider the use of even wider non-exclusive voluntary licences. Only then will it be possible to end the acute phase of the pandemic.

More transparency from all actors, including the pharmaceutical industry, will enable governments to respond to company efforts and coordinate global financing and distribution systems. It is key for global and national procurers to have more information about the number of doses ordered, and the price, as well as projected delivery capacities.

A promising trend to collect and disclose information on companies’ access to medicine strategies and results illustrates increasing transparency from companies, such as evaluations of long-term effects of access initiatives on healthcare systems and patients.

In conclusion, we believe there is a global moral and economic imperative to work collaboratively to improve expedited access to COVID-19 vaccines, therapeutics, and tests, across countries of all income levels. The rising numbers of fatalities and new COVID-19 strains show that action is urgent. As recent reports demonstrate, it is in the best interest of all governments, multinational companies, academic institutions, civil society and others to join forces. Innovative, efficient, and transparent partnerships are likely to act as catalysts to better control the pandemic and help prevent the negative impact of new virus variants that introduces risks to the incredible progress made to date through R&D.