Waiving IP rights for COVID-19 vaccines sends the wrong message to innovators


Pamela Fralick

Innovative Medicines Canada


Responding to a health crisis like COVID-19 requires global leadership, innovation, and safe rapid response. But on June 17, 2022, nations took a collective step backward and agreed to intellectual property (IP) waiver on patents for COVID-19 vaccines at the World Trade Organization’s (WTO) Ministerial Conference (MC12). The IP waiver is not only the wrong solution to address barriers to vaccine equity, but it could also undermine the industry’s ability to respond quickly to future health crises.

Since the start of the pandemic, the life sciences sector, governments, and healthcare stakeholders have come together to achieve the unthinkable.  The first vaccine was approved, only 326 days after the COVID-19 virus sequence was shared. This set a record for the fastest vaccine development and authorization process in history, beating the previous record-holder– the mumps vaccine – by a whopping three years.

The scale-up effort that followed was nothing short of remarkable. By May 2021, only a few months after the first COVID-19 vaccines came off the manufacturing lines, global production had reached nearly one billion doses per month, with 11 billion doses produced by the end of 2021. If doses were shared through effective mechanisms, there would be enough supply to vaccinate the elderly and vulnerable populations around the globe.

Since then, orders for COVID-19 vaccines have slowed down, and some developing countries have turned away doses due to hesitancy, administrative, and infrastructure issues. Prime Minister Justin Trudeau acknowledged that “vaccine supply is no longer the key constraint to combating COVID-19 around the world” in a statement following the Global COVID-19 Summit in May. Despite this, 164 WTO member nations, including Canada, agreed to move forward with an IP waiver for COVID-19 vaccines at MC12. Members will decide if the waiver will be extended to include treatments and diagnostics in the coming months. This is a misguided decision that doesn’t address the true barriers to equity and ignores the critical role IP rights play in encouraging the kind of innovation that ultimately helped billions of people avoid the worst of COVID-19.

Reasonable and reliable IP protections give innovators the confidence to invest significant time and resources into research and development (R&D) that spans over many years. In the case of COVID-19, advancements like mRNA and viral vector-based vaccines were made possible thanks to decades of research within a robust innovation ecosystem. To this day, there is no evidence that IP has been a barrier to COVID-19 vaccine production or access.

Robust IP protections have also allowed innovators to collaborate with reliable and proven partners who are properly equipped to produce required vaccine volumes, all while meeting the highest quality and safety standards. In fact, 381 voluntary industry partnerships for COVID-19 vaccines and 150 for COVID-19 treatments have been undertaken so far, where 88 percent and 79 percent, respectively, involved technology transfer, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

While we need swift action and a shared responsibility amongst the global public, private, and charitable sectors to improve equitable access to vaccines and other resources during a health crisis, it must start with an honest evaluation of the existing barriers to equity. In a recent publication, IFPMA identified ten lessons learned from the pandemic to help solve  these barriers. Key recommendations include strengthening delivery infrastructure, encouraging regulatory agility, and taking steps to prevent vaccine and trade nationalism. Through the Berlin Declaration, the biopharmaceutical industry also identified priorities for all stakeholders to ensure a more equitable rollout of vaccines, treatments, and diagnostics ahead of future pandemics. It underscored the industry’s willingness to reserve real-time allocations of these resources for priority populations in lower-income countries and measures to make them more available and affordable as part of the solution.

The window of opportunity to meaningfully learn from our shortcomings in this pandemic is closing fast, especially as variants of the COVID-19 virus and other emerging health threats, like delayed treatments and antimicrobial resistance, pick up steam. IP waivers will not address pandemic preparedness or vaccine access. On the contrary, IP waivers undervalue the very science, innovation and collaboration needed to prepare for tomorrow’s crises.