Health authorities in the United States and around the world have declared an end to the COVID-19 public health emergency. But some countries and activist groups continue pushing for the World Trade Organization (WTO) to expand a 2022 IP waiver on COVID-19 vaccines to treatments and tests.
At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting an investigation and will issue an accompanying report compiling the facts on COVID-19 treatments and diagnostics to help inform the position of the Biden administration. That report is due on October 17.
Here are four things you need to know:
- Supply for COVID-19 treatments significantly exceeds demand and industry collaborations have supported patient access to this supply across the globe.
Since the beginning of the pandemic, the biopharmaceutical industry has entered into more than 170 partnerships and agreements to ensure global access to affordable or no-cost therapeutics. The global IP system is not only responsible for the innovation behind COVID-19 treatments, but also enabled the rapid scaling up of production.
- Patents are not preventing patients from accessing COVID-19 treatments.
Trade and regulatory challenges as well as last-mile distribution and administration challenges are the true barriers to access. Few low and middle-income countries (LMICs) have even authorized or approved COVID-19 therapeutics for use in their markets. And even where COVID-19 therapeutics have been approved, in-country delivery and administration barriers, including a lack of adequate storage facilities and technology, limited transportation and a shortage of health workers, have impeded broader access. In 64% of countries surveyed by the WHO, health workforce challenges were the most-cited bottleneck for therapeutics. Tariffs on medicines have been found to increase final prices by up to 80% of the original sales price.
- Waiving IP rights will not solve patient access barriers to COVID-19 treatments.
IP protections enabled R&D partnerships to develop innovative solutions in record time and facilitated hundreds of partnerships globally to manufacture COVID-19 vaccines and treatments at scale. While some have pushed for a TRIPS waiver as a means to increase access, the reality is that compulsory licensing results in declining or stagnating medicine imports from countries with significant innovative biopharmaceutical industries, delays in the launch of new treatments and may even increase prices.
- Extending the TRIPS waiver to COVID-19 therapeutics will not help patients.
The TRIPS waiver approved in 2022 has not increased patient access to COVID-19 vaccines. In fact, the WTO has not documented a single instance of the TRIPS waiver resulting in increased vaccine production. Expanding the TRIPS waiver would only serve to undermine incentives for innovation, threatening R&D for COVID-19 and other diseases to the detriment of patients. Many COVID-19 products have broader applications, including cancer, HIV, hepatitis C and rheumatoid arthritis, all of which would be put at risk.
The Biden Administration should follow the facts: Undermining IP rights will deter innovation, harm patients and leave the world vulnerable to future global health challenges.
Please click here to read PhRMA’s testimony to the USITC detailing why extending the TRIPS waiver to therapeutics and diagnostics would fail to address the real barriers to access. Click here to see what other stakeholders are saying about expanding the TRIPS waiver.