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Drug Industry Not Especially Worried About Nationalist Approaches on COVID-19 Vaccine

Countries should be coordinating how drugs will be distributed once they are proven to work, drug industry representatives say. Senior officials at the trade group for biologic drugs and the trade group for generics, along with the head of Pfizer's global trade policy, were speaking on a Washington International Trade Association webinar May 14 about the global supply chain for pharmaceuticals and the search for a COVID-19 cure.

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Joseph Damond, executive vice president for international affairs at the Biotechnology Industry Organization (BIO), noted that companies and universities are doing 444 investigations on drugs, and 24% are potential vaccines, 32% are antivirals, and 44% could be treatments for the COVID-19 symptoms. Of the drugs being investigated, 50 were invented by U.S. firms, 32 by Chinese companies, 22 by Swiss firms, 18 by German firms and 16 by British companies.

Pfizer is one of the companies testing a possible vaccine, and Elissa Alben, the company's leader of global trade policy, said that effort is in concert with a German company. Pfizer is planning to manufacture in Michigan, Massachusetts, Missouri, Belgium, and other sites, even before the scientists know if it works. “We need governments to really collaborate and not treat this as a zero-sum game,” she said.

Damond raised the possibility that the government would order Pfizer to direct all its vaccines to the U.S. first, but Alben dismissed that possibility, given that a European manufacturing location will already be up, and a German firm is a partner.

Damond said it would be a mistake for countries to insist on having pharma factories within their borders for the COVID vaccine so they can control distribution. “If people are concerned about affordability and cost, and they should be, developing 50 sites around the world where very small batches are made is not a good way to ensure affordability,” he said. “Scalability is going to be important both to supply and to cost.” The U.S. is talking about locating more pharmaceutical manufacturing of generic drugs and active ingredients in the U.S., as politicians are alarmed by claims that China is the source of 80% of active ingredients needed for basic drugs used in the U.S.

Moderator Wendy Cutler, of the Asia Society Policy Institute, asked Jonathan Kimball, vice president of the Association for Accessible Medicines, if that 80% number is accurate, or is it 50%, or 13%, as she's seen in various claims. Kimball said: “Anyone is really guessing at the percentage of API manufactured anywhere in the world -- no one is collecting the data.” He said that based on manufacturing sites, 28% of America's drugs are produced domestically, and 13% come from China. When you judge by value, China provides 15%, and Ireland is the largest source, he said.

With the Coronavirus Aid, Relief, and Economic Security (CARES) Act, there will be more data in the future, he said, as the act requires companies to report their sources.

Kimball said that “the goal of onshoring and increasing U.S. generic medicines is something we support,” after there's a study of how vulnerable the supply chain is for critical medicines. He said his group assumes the report would identify 150-200 drugs. The trade group wants guaranteed contracts for price and volume for drugs the government wants produced domestically, with those contracts serving the Bureau of Prisons, Veterans Affairs, the Pentagon and the national strategic stockpile. If those don't exist, companies could invest hundreds of millions of dollars and then be undercut by cheaper imports, he said.