IFPMA Response to the Release of the ACT-A Evaluation Report

Published on: 28 October 2022

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) was a founding member of ACT-A when it was launched in April 2020. We welcomed the vision of the ACT-A to involve the private sector, including the innovative pharmaceutical industry, to join this unique global collaboration set up to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines in the wake of the pandemic.

After two intensive years of collective response to the pandemic, we welcomed the opportunity to contribute to the consultation process (including the survey and interview with Thomas Cueni, Director General of IFPMA), which has resulted in the ACT-A Evaluation Report. We appreciate having the opportunity to provide comments on the report.

We were pleased to see the report flag a number of key elements that we considered either instrumental to ACT-A’s success, or detrimental to delivering on its mission, such as the lack of available funding for procurement at the onset of the pandemic, insufficient country readiness, the need to invest in health system strengthening, and the importance of open trade. In general, we would like to indicate that we had been expecting the report to be a robust analysis providing evidence-based recommendations. As it currently stands, we feel it has been limited to a summary of the different views shared by participants contributing to the survey and interviews

We would like to share several key concerns:

First, the report failed to evaluate robustly ACT-A’s performance per se (separately from the performance of the different pillars). The report should have analyzed ACT-A’s governance mechanism and how it contributes or not to its success. The report was a missed opportunity to underscore what the real-life experience of the COVID-19 pandemic response has shown – namely that a multistakeholder partnership that includes industry, public agencies, multilateral organizations, financial institutions, governments, civil society, and philanthropic organizations is the only viable solution to managing pandemic crises. While this was the basis upon which ACT-A was set up, engagement with the private sector has regrettably been uneven across the different ACT-A pillars over the past two years. While COVAX’s approach was inclusive and manufacturers including IFPMA, as well as developing countries vaccine manufacturers DCVMN, had opportunities to share their expertise, the same could not be said for the therapeutics pillar. We resorted to publishing an Open Letter on ACT-A Therapeutics and Ongoing Roadblocks to Enhancing Access[1] to this effect. We believe the report should have underscored the incorporation of this inclusiveness principle into inter-pandemic governance mechanisms.

Second, we were surprised that the report failed to mention the key role the pharmaceutical industry played in delivering on ACT-A’s mission, in particular with respect to the acceleration of development and production of COVID-19 tests, treatments, and vaccines. In just two years, the innovative pharmaceutical industry has developed COVID-19 vaccines and treatments at record speed and in historic quantities, with 47 vaccines authorized or approved by at least one country, 36 approved therapeutics worldwide, 381 manufacturing deals for COVID-19 vaccines with a total of 15 billion vaccines produced, and 148 manufacturing deals for therapeutics. Supply very swiftly was able to outstrip demand[2].

Third, the report presents technology transfer as an underused solution in the COVID-19 response. It fails to acknowledge the unprecedented effort of the pharmaceutical industry to facilitate access, including through voluntary agreements, many of which featured technology transfer (approx. 88%). In just the first year of COVID-19 vaccines, there were more than 300 manufacturing and production deals around the globe, the vast majority of which (approx. 75%) involve some sort of licensing and transfer of technology, and at least 30 of them on mRNA vaccines.

Furthermore, while the report largely relays calls for even greater levels of COVID-19 technology transfer, particularly for low-income countries, it does not provide a robust analysis of its likelihood for success and impact. While addressing COVID-19 in these countries is critically important, there are many complex factors that must be addressed to ensure the safe, high-quality production of these vaccines, including those related to site selection and capabilities, national regulations and licensure requirements, and workforce skills.

With regards to therapeutics, our member companies have signed voluntary license agreements (bilaterally and through Medicines Patent Pool) along with enabling the transfer of technology to scale up sublicensees’ manufacturing capabilities. Our member companies have also engaged with ACT-A’s procurement partners to put in place timely supply agreements for several million treatment courses to reach LMICs, while also submitting for emergency and full regulatory approvals and WHO pre-qualification in record time. For all this, our companies continue to adhere to tiered pricing as a guiding principle for access.

Despite these efforts, we remain concerned that COVID-19 vaccines and treatments are still not reaching those who need them in a timely and efficient manner due to a number of issues, several of which rest with ACT-A. We believe that the world should aim to do better in the future – by preparing to respond faster and more equitably. No one stakeholder alone can fully address such issues, and we are committed to collaborating with all relevant actors.

In July 2022, the pharmaceutical industry launched the “Berlin Declaration – biopharmaceutical industry vision for equitable access in pandemics,” which presents global leaders with a proposal that could help ensure the supply of pandemic vaccines, treatments, and diagnostics are delivered as early as possible in future pandemics to those who need them most. The declaration is an acknowledgement that, while innovation and manufacturing scaling-up succeeded in an unprecedented manner during COVID-19, efforts to achieve equitable access were not fully realized. The absence of an adequate financing mechanism upfront and a lack of country readiness played an important role in inhibiting equitable and timely access to vaccines.

In line with the Declaration, IFPMA is calling for discussions with G7, G20, multilateral organizations and other decision-makers involved in pandemic preparedness to explore how industry’s offer to prioritize and reserve an allocation of real-time production for distribution to priority populations in lower-income countries would contribute towards the holistic and equitable solution the world needs.

 

About IFPMA

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere.

For more information, visit ifpma.org.

For further information, please contact:

Abigail Jones

Director, Communications

+41 22 338 32 00

a.jones@ifpma.org

 

 

[1] Open Letter on ACT-A Therapeutics and Ongoing Roadblocks to Enhancing Access – IFPMA

[2] As COVID-19 vaccine output estimated to reach over 12 billion by year end and 24 billion by mid-2022, innovative vaccine manufacturers renew commitment to support G20 efforts to address remaining barriers to equitable access – IFPMA