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Clinical Insider
Clinical Insider

Proposed US Biosecure Act already impacting US-Sino contracting

Posted by on 10 July 2024
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Drug makers are already less inclined to outsource to Chinese contractors over concerns about political plans to prohibit such relationships according to a new survey.

The survey – by a team at LEK Consulting – was designed to gauge the impact the Biosecure Act – proposed legislation that would “prohibit contracting with certain biotechnology providers and for other purposes – has had on the industry.

“While this Act’s passage before the 2024 US presidential election is unlikely, the advanced planning and the long cycles of the biopharma industry demand that the biopharmas, their service providers and their investors consider the consequences of this significant regulatory action” the authors write.

And the key finding is that – even though the proposals are still being debated – drug companies that supply the US market are thinking twice about working with contract research organizations (CROs) and contract development manufacturing organizations (CDMOs) in China.

“Confidence in working with Chinese companies has dropped by 30%-50% for US-based life sciences companies, with the CDMOs being the expected worst hit. Those outside of the US are also concerned, though much less so.”

Some 26% of respondents told the team they are already looking to shift away from their current Chinese suppliers, though only 2% have taken actual unwinding steps.

In addition, according to the authors, “68% of life sciences companies are adjusting their activities, including increasing legal and compliance requirements, planning to diversify suppliers and adding background checks for existing partners.”

Chinese market

However, for drug companies looking to sell to China the desire to work with local contact services firms, particularly during clinical development.

“China’s market continues to be attractive, and the majority of biopharmas wish to consider commercialization.

“Collaboration with Chinese service providers in clinical research, development and manufacturing is also not completely off the table, with approximately 30% of respondents considering these partnerships as likely in the next three years,” they write.


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