Biotech benefits as EU and U.S. agree to enhanced data sharing framework

International research collaboration just got easier thanks to a new agreement that allows for more secure and robust sharing of data between Europe and the United States.

The EU-U.S. Data Privacy Framework, approved by the European Commission (EC) on July 10, enhances data security and privacy controls, allowing for personal data, including scientifically relevant data, to be shared with entities based in the United States.

The Biotechnology Innovation Organization (BIO) has been advocating for this agreement, with the understanding of its importance for biotech.

“Data flows between the United States and the European Union are critical for advancing biomedical research,” according to Justin Pine, BIO Sr. Director of International Affairs. “Collaborations between researchers on both sides of the Atlantic resulted in COVID-19 vaccines, revolutionized healthcare, and advanced personalized medicine.”

The collaboration that led to the agreement began a couple of years ago. Following negotiations, the Biden Administration agreed in March 2022 to put in place reforms in internet privacy, to match the safeguards in the EU, which prides itself on strong privacy protection.

This work culminated in the EC’s July 10 “Adequacy Decision,” which determined that the U.S. has sufficient privacy protection. The announcement was welcomed by the White House.

What do U.S. biotech researchers get?

The agreement facilitates more efficient processes for the transfer of clinical trial data—and other relevant health data critical for driving biomedical research—between the EU and the United States. This includes clearer access to the European Health Data Space, a network of detailed, anonymized health records established to help improve medical care and research with databases like Estonia’s Biobank, a trove of genomic information from 20% of the country’s adult population.

The arrangement will help researchers on both sides of the Atlantic, according to Pine.

“Global society depends on life science innovation—especially the critical collaborations between European scientists and international partners—to solve some of the most pressing concerns facing humanity,” he said. “Strengthening scientific cooperation between the EU and the global biotech community should be a priority.”

Institutions wishing to participate with European partners can sign up online here. Once an organization is certified at that website, they can begin sharing.