By Dani Kass

Law360 (May 21, 2021, 9:26 PM EDT) -- Organizations representing the branded-pharmaceutical industry have published their plan to expand vaccine production and distribution in a way that would not involve waiving intellectual property rights.

The five-step plan released Wednesday by the Pharmaceutical Research and Manufacturers of America and others is a commitment for vaccine manufacturers and biotech companies that appears to be a direct response to the Biden administration's support of temporarily waiving on intellectual property protections for COVID-19 vaccines, which they oppose.

"Manufacturers, governments, and non-governmental organizations must work together to take urgent steps to further address this inequity," the groups said in a joint statement. "Immediate action must focus on stepping up responsible dose sharing and maximizing production without compromising quality or safety."

In addition to PhRMA, the statement was from the Association of the British Pharmaceutical Industry, the Biotechnology Innovation Organization, the European Federation of Pharmaceutical Industries and Association, the International Council of Biotechnology Associations, the International Federation of Pharmaceutical Manufacturers & Associations and Vaccines Europe.

They outlined a commitment to work with governments that have significant vaccine doses to share with countries that have less capital through programs like COVAX and to "expend every effort to make additional uncommitted" vaccine doses available to countries with less income.

The organizations also committed to taking efforts to maximize vaccine production, including working with governments and suppliers that provide raw materials needed for vaccines.

Without mentioning the waiver being considered by the World Trade Organization, the groups said they would work on eliminating trade barriers, particularly those that stop the "cross-border supply of key raw materials, essential manufacturing materials, vaccines along with the prioritized movement of skilled workforce needed for COVID-19 vaccine manufacturing."

The statement also calls for partnering with governments to get vaccines distributed and encouraging the development of additional vaccines, including ones that target new COVID-19 variants.

The drug industry has been fighting the WTO proposal introduced in October by countries including India and South Africa to temporarily waive IP protections for COVID-19 vaccines. The proposing countries argue that suspending IP rights would make medicine to fight the pandemic more widely available around the world. President Joe Biden's trade representative announced her support for the proposal in May.

"This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," U.S. Trade Representative Katherine Tai had said. "The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines."

The pharmaceutical industry opposed the waiver, saying that suspending IP protections would undermine the incentive to innovate treatments for future diseases, since drugmakers depend on patents to recoup their investments, and that intellectual property is not standing in the way of increasing production.

Wednesday's statement appears to be a proposal for fixing vaccine access concerns in a way that the pharmaceutical industry sees as less of a threat.

--Additional reporting by Ryan Davis. Editing by Peter Rozovsky.

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