BioTechniques News
Tristan Free
Welcome to our H2 regulation and policy update for the biotech industry and the life science research sector. Here, we review some of the biggest regulatory changes to come into effect so far this year and the upcoming regulations and policies to be aware of.
The US
Priority review vouchers return
Early in February this year, the Rare Pediatric Disease Priority Review Voucher program was reauthorized by Congress, having lapsed back in 2024. You can see an explanation of this program in our earlier industry review from the beginning of the year, but it is great news for small biotech and pharma companies working on rare disease therapeutics, giving them a better chance of turning a profit on their work. Under the new authorization, this program will run for the next 3 years, sundowning on the 30th of September 2029.
US national security designations
The United States Department of Defense maintains a list of ‘Chinese military companies’ and if a biotech company gets added to this list, it is most likely on the way to being designated a ‘biotechnology company of concern’ under the BIOSECURE Act. Biotech and pharma companies receiving federal contracts, grants or loans are not permitted to use the technology or services of any companies with this label. On the 8th of June this year, WuXi AppTec (Shanghai, China), which provides a vast range of services to the pharmaceutical sector, was added to this list, paving the way for its ‘…of concern’ designation. At the time of writing, this has yet to occur and WuXi AppTech have filed a lawsuit against the Department of Defense, objecting to the listing. WuXi Biologics, its independent sister company, has not been added to the list.
Grant funding changes
An interesting email landed in my inbox recently, informing me of a virtual meeting with Congresswoman Rosa DeLauro to discuss a proposed rule from the Office of Management and Budget (OMB) that “would require all federal grants to be approved by the president’s political appointees,” with the additional suggestion that the grants themselves would be subject to political criteria and controls.
This comes in response to the OMB’s proposed overhaul of 2 CFR Part 200, better known as the Uniform Guidance for Federal Financial Assistance, a framework that manages over $1 trillion in federal grants and assistance, $150 billion of which relates to research and development grants. The proposed changes essentially boil down to shifting more control from scientists and research officials to the OMB and political appointees, cementing what was previously ‘guidance’ as binding regulation and introducing mandatory reviews of all discretionary awards prior to their issuance.
The reaction to the announcement has been overwhelmingly negative, with many interpreting the move as a way of bypassing Congress to exert unnecessary partisan political control over research and the life sciences.
The argument for the changes is that they will “improve transparency, accountability and oversight for the use of federal funds”, clarify regulatory structure to avoid duplicate effort and variable requirements across different agencies, and to make the projects resulting from funding more efficient by reducing the “burden” placed on them by DEI mandates and other “unnecessary add-on requirements.”
Speaking to BioTechniques, Michael Weiner, founder and CEO of two Connecticut-based biotech companies, AbbraTech and Precision Biotools (both CT, USA), gave his opinion on the proposal.
“The secret to American technological dominance has always been simple: we fund the best ideas based on raw merit and objective peer review, not political alignment. Safeguarding this highly technical selection process ensures that federal investments yield real societal progress and provide stable careers for the next generation of professionals.
Introducing non-technical, political oversight to scientific proposals creates a potentially dangerous bottleneck. Furthermore, allowing the government to retroactively cancel active research grants based on shifting, arbitrary definitions of ‘national interest’ introduces a massive risk to our scientific community.
When early-career researchers face the threat of having their funding abruptly pulled for political reasons, the brightest minds will walk away from critical research.
To keep America competitive, scientific evaluation must remain in the hands of qualified experts, insulated from political whims. I strongly urge objective, merit-based peer review.”
Sequencing superstars share their secrets for successful commercialization
Biotech industry leaders reveal intriguing insights into the European biotech landscape and offer sage advice for anyone working in, or looking to establish, a biotech start-up.
Europe
AI acts in place and arriving soon
The rollout of the European AI Act began in 2024, but the main body of the act comes into play on the 2nd of August this year, including Article 50’s transparency laws and the enforcement of the act for general purpose AI models, prohibitions, transparency rules and AI literacy. You can browse the act at the link above, find a timeline of its implementation here and there is a handy guide of the EU AI Act for biotech here. The US FDA and the European Medicines Agency also released a joint document at the beginning of 2026 providing Guiding principles of good AI practice in drug development.
The European Biotech Act
This act, which aims to accelerate clinical trials, streamline regulations for genetically modified organisms and improve funding access in order to revitalize Europe’s life science sector, was proposed in December 2025 and is still under debate in the European Parliament.
There are two acts in discussion. Act I and Act II; the first is focused on health – encompassing advanced therapies, diagnostics and clinical trials – while the second is focused on industrial strategy – covering biotechnology and biomanufacturing, chemicals and green materials.
A feedback period for Act 2 opened in June and is still open, with the resulting legislative initiative on European Biotech due to be released in Q3 this year. Here is the best article I have found summarizing the key changes likely to come into effect and how to start preparing for them, from the law firm Fieldfisher (London, UK).
New UK Knowledge Asset Management Hub
The UK’s Intellectual Property Office launched a Knowledge Asset Management Hub in June this year. The Hub is designed to help research institutions and universities “identify, protect and commercialize” their intellectual property. It is built of four key components:
- Institutional IP strategy guidance: practical frameworks to help universities and research organizations develop and implement IP strategies and policies at an organizational level
- Project-level IP risk and opportunity tools: resources to help teams identify and manage IP considerations within individual research projects, from early-stage collaboration agreements through to commercialization
- Patent data analysis and IP due diligence resources: tools to support the assessments that underpin licencing, spin-out formation and investment decisions
- Knowledge Asset Management Toolkit: guidance recognizing that effective knowledge asset management requires strategic and operational management
Think we missed something? Want to tell us how these changes are impacting you? Contact tristan.free@tandf.com.
The opinions expressed in this article are those of the author and do not necessarily reflect the views of BioTechniques or Taylor & Francis Group.
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