“Leave politics out of healthcare” – controversy swirls around BIOSECURE Act – Pharmaceutical Technology

Members of the biotech industry have voiced concerns about the impact of the BIOSECURE Act, after the bill passed through the U.S. House of Representatives last week.

During a panel discussion on supply chain challenges at the Clinical Trial Supply West Coast 2024 conference in San Francisco, Umar Hayat, Chief Technology Officer of US company Gladius Therapeutics, led criticism of the bill and said politics needed to stay out of the healthcare industry.

“Our focus should be on the advancement of science to the service of humanity in an open market and competitive manner rather than drawing boundaries,” said Hayat.

The BIOSECURE Act would prevent Federal agencies from contracting with any companies that do business with several “companies of concern”, or others from countries that are deemed to be “foreign adversaries” and whose operations are a threat to US national security.

The bill specifically lists China, Cuba, Iran, North Korea, and Russia. Both the House bill and Senate bill name WuXi AppTec, MGI, BGI, and Complete Genomics as biotech companies of concern. The House bill also names WuXi Biologics.

“This seems more like politics rather than about a security threat. We just came out of pandemic nightmare, healthcare costs are becoming unbearable to both government and public alike. My position is if you want to play politics, play politics in other industries like the automotive, electronics or telecommunications industries. Don’t play politics in healthcare where so many people are in dire need. Let science evolve and advance – wherever it comes from.”

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The US pharma industry currently relies heavily on Chinese contract manufacturers to help develop and produce therapeutics. Collaborations with these companies are often attractive due to the low costs associated with producing and sourcing active pharmaceutical ingredients abroad.

A recent GlobalData report found the legislation could affect more than 120 US drugs partnered with companies named in the bill, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery.

Following the House of Representatives vote, the BIOSECURE Act will now move on to the Senate where strong bipartisan support is predicted.

Although the Chinese government is yet to comment on the Act, WuXi, has defended itself and denied having links to the Chinese government or military.

If the bill is legislated, countries including Ireland, could be poised to benefit, as Chinese companies consider foreign direct investment in other countries. India could also be a target for pharma companies looking for manufacturing services at low costs and with a skilled workforce.