Research-Based Biopharmaceutical Industry on the TRIPS Waiver Discussions

· There is no evidence that IP has been a barrier to COVID-19 vaccine production or access, nor acknowledgment of the critical role IP has played in the research, development, and production of novel, safe, and effective vaccines and therapeutics.

· To date, industry has entered into 381 partnerships for COVID-19 vaccines and 150 for COVID-19 therapeutics, of which over 88% and 79%, respectively, involve technology transfer.

· IP protections allowed for years of research and investment at risk to bear fruit and today we have 11 vaccines with WHO Emergency Use Listing and 36 therapeutics approved across the world. Biopharmaceutical companies continue to research and invest. Academia and industry have 659 (192 in clinical phase) vaccine candidates and 1,706 (885 in clinical phase) therapeutic candidates in the pipeline.

· By May 2021, less than six months after the first vaccine authorization, monthly production output was close to a billion vaccine doses;4 enough to vaccinate the world if countries were willing and able to share. At that time, industry called on governments to remove trade restrictions, share doses and prepare health systems to roll out vaccinations

The associations representing the global research-based biopharmaceutical industry reaffirm that weakening the intellectual property (IP) framework as proposed in the “Quad compromise” is unnecessary and harmful to innovation. An IP waiver does not address inequitable access to COVID-19 vaccines and will put global health security at risk. It will undermine innovation and industry’s ability to partner, invest at risk, and respond quickly to future pandemics.

Industry has worked around the clock, taking a “business NOT as usual” approach to tackling the COVID-19 pandemic, focusing significant resources to push the boundaries of science, develop workable solutions and secure the capacity to scale up manufacturing once solutions were found, while at the same time ensuring patients would continue to receive existing medicines. This resulted in the fastest ever vaccine development and authorization (in just 326 days).

Despite these strides in science and manufacturing, for the past 18 months, the World Trade Organization (WTO) Member States have been discussing various ways to weaken the IP framework. To this day, there is no evidence that IP has been a barrier to COVID-19 vaccine production or access, nor acknowledgment of the critical role IP has played in the research, development, and production of novel, safe, and effective vaccines and therapeutics.

From the outset of the pandemic, industry knew that it would need to scale up quickly, seeking to build capacity before approvals were granted, partnering wherever possible, all while pledging to not compromise on quality, safety and efficacy. To date, industry has entered into 381 partnerships for COVID-19 vaccines and 150 for COVID-19 therapeutics, of which over 88% and 79%, respectively, involve technology transfer. IP protections allowed for years of research and investment at risk to bear fruit and today we have 11 vaccines with WHO Emergency Use Listing and 36 therapeutics approved across the world. Biopharmaceutical companies continue to research and invest. Academia and industry have 659 (192 in clinical phase) vaccine candidates and 1,706 (885 in clinical phase) therapeutic candidates in the pipeline.

By May 2021, less than six months after the first vaccine authorization, monthly production output was close to a billion vaccine doses;4 enough to vaccinate the world if countries were willing and able to share. At that time, industry called on governments to remove trade restrictions, share doses and prepare health systems to roll out vaccinations (“5 steps to urgently advance COVID-19 vaccine equity”), a message repeated in March 2022 when critical bottlenecks in vaccine delivery and administration, often linked to weak healthcare systems, were becoming even more evident (“Three Priorities to Urgently Increase COVID-19 Vaccine Access”). Today, it is universally recognized that COVID-19 vaccine supply is not the barrier to access with global vaccine production capacity vastly exceeding demand and doses needed to inoculate and provide boosters to the world.

During this pandemic, there have been many lessons learned that can improve equitable access for future pandemics. We must redouble our collective efforts to achieve health equity, while ensuring health systems and delivery infrastructure are strengthened. COVID-19 vaccines and treatments were only possible because of decades-long investment in research and an enabling IP framework that encouraged swift, voluntary partnerships across the private, public, and academic sectors.

The TRIPS waiver discussion lacks evidence and the IP framework has fallen victim of political posturing. This week, as the WTO meets for the 12th Ministerial Conference, leaders must keep in mind that weakening the IP framework will jeopardize global health security. A much better approach is to focus on the real challenges to COVID-19 vaccine access including removing trade barriers, addressing distribution challenges, strengthening healthcare systems, and partnering to drive innovation and access.