This audio is automatically generated. feedback.
Bills under consideration in Congress could impose a deadline for U.S. companies to cut ties with several Chinese biotechnology companies.
The Biosecure Act was approved by the House Oversight and Accountability Committee earlier this month and is expected to cause major disruption to the U.S. biotechnology industry if it is ultimately passed by Congress and signed into law.
U.S. biotechnology companies rely heavily on Chinese manufacturing to bolster supply chains for critical products and medicines. 3rd in the world According to the Brookings Institution, biopharmaceutical manufacturing capacity will grow by 10% in 2020. A whopping 79% Of the 124 biopharmaceutical companies surveyed in May, at least one had one or more contracts or products with a China-owned or China-based contract manufacturer, according to BIO.
In the House of Representatives, already Passed out of Senate committee The potential impact of the bill, which aims to limit contact with companies that could raise national security concerns, is beginning to take shape.
Deadline until 2032
The revised version of the bill would give biotech companies a grace period to terminate existing contracts with five specific Chinese biotech companies, extending the deadline until 2032.
This timeline reflects the findings of a BIO survey, which found that U.S. biotech companies believe it will take up to eight years to change manufacturing partners.
“As we move forward to strengthen the resilience of the U.S. biomanufacturing industry, we must also ensure a pathway for millions of affected patients to have uninterrupted access to life-saving treatments,” BIO CEO and president John Crowley said in a statement. “As we relocate our manufacturing base to the U.S., we will work closely with Congress to pursue a comprehensive set of policies and long-term efforts to increase cutting-edge domestic biomanufacturing capacity and capabilities nationwide and maintain our position as a medicine chest to the world.”
The bill would protect U.S. biotechnology companies, including a key partner of the company, up to 25% of drugs The bill would also force U.S. companies to sever ties with MGI, BGI and Complete Genomics.
The House named five entities in the bill that are “all part of either the BGI Group or the WuXi Group,” said Rep. Raja Krishnamoorthi (D-Ill.). Discuss the latest version of the bill At a May 15 amendment hearing before the House Oversight and Accountability Committee.
Krishnamoorthi said the US government had determined that BGI Group, the world’s largest genomics research organisation, and its affiliates in WuXi were “implicated in the perpetration of human rights abuses”.
BGI is also accused of collecting data and intellectual property and sending it back to China and WuXi AppTec to “copy.” The bill would require the Office of Management and Budget to compile a list of biotechnology companies controlled by foreign hostile powers that it believes pose national security concerns, would prohibit executive agencies from contracting with or spending funds on these companies, and would stipulate that U.S. companies would be ineligible to receive subsidies if they work with the named Chinese biotechnology companies and their affiliates.
Advance
The House is heading for a vote Lawmakers are expected to debate the bill before heading home for the Fourth of July holiday, and it could be passed by the end of the year as part of another legislative package, such as the National Defense Authorization Act, according to STAT News.
However, the Biosecure Act has not yet been enacted. Wuxi Biologics and Wuxi AppTec Both companies are actively lobbying Congress to block the bill. They maintain they have never mishandled or transferred any intellectual property.
The move by the bill is aimed at U.S. manufacturing. Record drug shortagesAs demand for ADHD medications and GLP-1 for weight loss continues to rise, manufacturers are struggling to keep up, and those that don’t currently have production ramped up in the U.S. may face challenges working with overseas partners.
According to BIO research, the most complex manufacturing changes are Already approved medicines“We have very limited biomanufacturing options” as well as Chinese contractors. Thirty percent of survey respondents said they have programs or contracts with Chinese biotechnology companies to manufacture approved drugs, suggesting the bill could result in new supply constraints.
