US BIOSECURE Act: Cfm helps you find new manufacturers

On September 9, 2024, the U.S. House of Representatives approved a bill by a large majority that would blacklist certain foreign (especially Chinese) biotech and pharmaceutical companies.

The aim is to strengthen its own biotechnological development

The core goal of the BIOSECURE Act is to secure one’s own country by not exporting new technologies to countries that have been classified as critical by the US government, such as China. This applies in particular to the export of innovative substances, molecules and technologies. Production know-how for new substances should no longer end up in certain countries that work with low-price strategies.

This is also intended to ensure the security of supply in their own country and counteract the dependence of the US economy on products from countries such as China.

US biotech companies must now find alternative production sites to Chinese companies if their own production in the USA is not feasible. The US BIOSECURE Act thus protects American intellectual property and sensitive biotechnological data and at the same time promotes the country’s own biotechnological development.

Impact on the entire US biotech industry

This development will have an impact on the entire US biotech industry. However, there is grandfathering, which states that existing contracts with critical countries do not automatically become invalid. Rather, it is about regulating future business.

The law requires a redesign of supply chains and has an impact on compliance costs.

1. Supply chain disruption: Many US biotech companies rely on partners in countries affected by the BIOSECURE Act. The search for new, reliable suppliers is time-consuming, risky and expensive.
2. Cost increase: Especially in the areas of research, development and production, costs are rising due to the search for new sources of supply.
3. Legal requirements: Biotech companies must ensure that they comply with the new legal requirements.
4. Loss of market share: Biotech companies could lose market share if they do not succeed in finding alternatives to blacklisted companies in time enough.

Contact us – we support the delivery of products from countries that are not affected by the BIOSECURE Act.

We have a stable network of trustworthy, flexible and highly professional companies, including in Europe. This enables us to provide secure and compliant alternatives to U.S. companies.

Do you need support in finding alternative suppliers? Then we will be happy to assist you. We search for and establish new suppliers for you who optimally meet your requirements in terms of quality, documentation and delivery capability. Thanks to our centuries of experience, we succeed in most cases within a short time.

All you need to do is send an e-mail to info@cfmot.de and we will get in touch with you.