PhRMA Seeks IP Protections for COVID-19 Vaccine Developments

In an official letter to President Joe Biden, PhRMA and over 30 leaders in the biopharmaceutical warned that eliminating intellectual property (IP) protections in COVID-19 vaccine development could undermine global response to the pandemic.  

Intellectual property is the foundation for both the development and sharing of new technologies, the group explained. The world has benefited from the innovation support from intellectual property. 

But in October 2020, India and South Africa proposed to suspend critical IP provisions of the TRIPS Agreement.

These suspensions included the protection and enforcement of copyrights, industrial designs, patents, and trade secrets on COVID-19 innovations until widespread vaccine is in place. 

IP protections have been crucial to accelerating the research and development of new COVID-19 treatments and facilitating sharing of technology and information to scale up manufacturing and meet global needs. 

Eliminating those protections would undermine the global response to the pandemic, including ongoing efforts to tackle new variants, the group explained. 

Additionally, eliminating protections would create confusion that could potentially undermine public confidence in vaccine safety, as well as create barriers to information sharing. 

“In requesting the waiver, India and South Africa argued without evidence that intellectual property is hindering the global response to the pandemic and that the waiver would help scale up research, development, manufacturing and supply of needed products,” the coalition of biopharmaceutical organizations said in the letter. 

The US government has supported other governments, including the European Union, United Kingdom, Japan, Canada, Switzerland, Brazil, and Norway, to oppose this waiver.

The coalition stated that they encourage the Biden Administration to maintain this longstanding support of innovation and American jobs by continuing to oppose the TRIPS IP waiver.

And to manage ongoing COVID-19 manufacturing demands, the group stated that it will work with other manufacturers worldwide with expertise, technical capabilities, and facilities to speed up production and distribution of these vaccines. 

Despite the pressing challenge of suspending critical IP provisions of COVID-19 vaccine manufacturing, current estimates put COVID-19 vaccine manufacturers at supplying approximately 10 billion doses by the end of 2021.

This is enough to vaccinate the entire current global vaccine-eligible population. 

In the letter, the industry leaders also emphasized that the current FDA-authorized COVID-19 treatments and vaccines would not have been possible without collaboration between research-based biopharmaceutical companies, US and global governments, multilateral organizations, nongovernmental institutions, and others.

Specifically, they applauded Biden on the Administration’s funding and support of the COVAX facility, a global vaccine program led by WHO.

At the end of January, NIAID Director Anthony Fauci, MD, said in a speech that the US would remain a member of the World Health Organization (WHO) under President Biden and would join COVAX. 

This move will advance efforts for COVID-19 vaccines, therapeutics, diagnostic distribution, access to care, and research and development, Fauci stated.

Under the Trump administration, the US relied on Operation Warp Speed to manage vaccine development and distribution. The initiative’s goal was to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021. 

Biden’s decision to join COVAX will allow the US to increase its vaccine supply substantially.

In December, COVAX stated that it will secure access to 2 billion doses of safe and effective vaccines that are suitable for all patients and widely and available by the end of 2021. 

These vaccine doses include 500 million doses of Johnson & Johnson’s vaccine candidate, up to 900 million doses or more of either the AstraZeneca-Oxford or Novavax candidates, and 200 million doses of the Sanofi-GSK vaccine candidate.