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Politics, Policy & Law

Biopharmas ask Biden to reject compulsory licensing of COVID-19 medicines

Mar 9, 2021 | 12:06 AM GMT

The U.S. biopharmaceutical industry is urging the Biden administration to oppose a proposal for the World Trade Organization to issue a waiver of IP protections for COVID-19 vaccines and drugs. The industry push comes ahead of a debate on the topic expected this week at the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights.

The idea of giving countries the ability to impose compulsory licensing requirements on vaccine manufacturers has been championed by the governments of South Africa and India. In a proposal submitted to the WTO TRIPS Council in October, they asserted that patents and trade secrets have prevented developing countries from manufacturing COVID-19 vaccines and therapies. The proposal calls for the suspension of IP on COVID medical countermeasures for the duration of the pandemic crisis.

WHO Director General Tedros Adhanom Ghebreyesus endorsed the proposal last week. “The flexibilities in the TRIPS agreement are there to be used in emergencies,” he said March 4 in a speech on financing COVID-19 vaccines for Africa. “If not now, then when?”

The Trump administration, along with the EU, U.K., Japan, Switzerland and a handful of other developed countries, prevented WTO consideration of the IP waiver proposal in December. The Biden administration has not made a public statement on its position.

In a letter to President Joe Biden released Monday, BIO President and CEO Michelle McMurry-Heath expressed “strong concerns” that an IP waiver would set back efforts to expand access to COVID-19 vaccines. She said it is “both a wrong-headed and ineffective means of spurring further efforts at access,” arguing that scientific and regulatory barriers make it impossible to successfully manufacture a vaccine “by anything other than cooperative, collaborative partnerships.”

McMurry-Heath wrote that a TRIPS waiver “could spur a spate of confusing, mutually inconsistent and heavy-handed ‘compulsory’ demands by governments all over the world for supply and technology transfer, which would distract from the need for coordinated international efforts and the cooperative work that currently is being advanced, and thus ultimately undermine the very goals of quick, safe access that it seeks to promote.”

PhRMA Monday released a similar letter signed by the CEOs of 31 pharmaceutical companies, including COVID-19 vaccine and therapy manufacturers and developers AstraZeneca plc (LSE:AZN; NASDAQ:AZN), Eli Lilly and Co. (NYSE:LLY), Gilead Sciences Inc. (NASDAQ:GILD), GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Merck & Co. Inc. (NYSE:MRK), Pfizer Inc. (NYSE:PFE), Sanofi (Euronext:SAN; NASDAQ:SNY) and the U.S. unit of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK).

The PhRMA letter argues that waiving IP rights would “undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing.”

PhRMA also asserts that an IP waiver is unnecessary. “Despite the immense challenge of scaling manufacturing on novel technologies, current estimates are that COVID-19 vaccine manufacturers will supply approximately 10 billion doses by the end of 2021, enough to vaccinate the entire current global vaccine eligible population.”

Is there a third way?

The dispute over the proposed waiver of COVID-19 medical products IP poses a challenge to WTO Director General Ngozi Okonjo-Iweala, who took the helm of the organization on March 1.

Prior to her appointment at WTO, Okonjo-Iweala chaired the board of Gavi, the Vaccine Alliance. She has served in senior positions at the World Bank and government of Nigeria.

In comments at press conferences and in public speeches, Okonjo-Iweala has advocated for a “third way” that meets the needs of developing countries for access to COVID-19 vaccines and therapies, rewards innovation and does not abrogate IP rights. She wants to break the logjam at the WTO by pushing developers to license pandemic countermeasures to manufacturers in developing countries.

In a commentary published in the Financial Times, Okonjo-Iweala cited the examples of COVID-19 vaccine developers that have licensed their products to manufacturers in developing countries such as the Serum Institute of India. “We must find a ‘third way’ on intellectual property that preserves the multilateral rules that encourage research and innovation while promoting licensing agreements to help scale-up manufacturing of medical products. Some pharmaceutical companies such as AstraZeneca, Johnson & Johnson and the Serum Institute of India are already doing this.”

Okonjo-Iweala also called for WTO countries to “intensify co-operation to ensure equitable and affordable access to vaccines, therapeutics and diagnostics” and to “minimize or remove export restrictions and prohibitions that hinder supply chains for medical goods and equipment.”

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