What happened
China included biological medicines and medical devices as key industries in which it aims to become self-reliant in its 14th Five-Year Plan (2020-2025). In the “two sessions” legislative plenaries in March 2024, President Xi Jinping emphasized the importance of “new quality productive forces” including biotechnology.
In mid-May, a US House of Representatives committee passed an amended version of the US BIOSECURE Act, which, amongst other provisions, bars companies from US government contracts if they do business with prohibited entities, with a 2032 deadline to wind down any existing relationships.6 A Senate committee passed similar legislation in March.
In February, President Biden issued an executive order to prevent the bulk transfer of Americans’ sensitive personal data, including genomic data, biometric data and personal health data, to countries of concern.7
What’s next
Governments are likely to continue to treat biotechnology and advanced pharmaceuticals as a strategic sector, leading to more de-risking and economic security policies affecting the sector.
In the US, the BIOSECURE Act will continue to move through the legislative process and is likely to be enacted in some form later this year. Washington could also introduce more restrictions on cross-border trade and investment in biotech with countries seen as geopolitical competitors, and possibly industrial policies to promote greater domestic innovation in and manufacturing of these products.
China will continue to build the infrastructure to develop its domestic biotech industry, including a talent pool, investment and regulatory policies that support the growth of home-grown corporations. In response to US actions, China could consider introducing export restrictions for the raw ingredients needed for key drug supplies (it manufactures about 40% of the global supply of active pharmaceutical ingredients or APIs).
India and Vietnam stand to benefit from the diversification of life sciences manufacturing. The United States-India Trade Policy Forum, for instance, recently focused on the opportunity to de-risk and diversify the global pharmaceutical supply chain.8 And Vietnam will continue to implement a 2023 initiative to develop the country’s pharmaceutical industry by 2030.9
Business impact
Pharmaceutical companies should evaluate their global manufacturing and supply chain strategies and assess whether they need to adjust to emerging geopolitical dynamics. Establishing or expanding supply chains with contract drug manufacturing organizations (CDMOs) in countries with favorable ties to governments in their consumer markets is likely to be a common strategy.
There may be M&A opportunities associated with the implementation of the BIOSECURE Act or similar legislation in other markets, as such laws could result in some foreign companies selling facilities to third parties – private equity, competing CDMOs, or another biopharma company – to continue operating.