Innovation Without Borders: The Importance of Transatlantic Data Flows to Healthcare Innovation and Delivery

The judgment of the Court of Justice of the European Union (“CJEU”) in Data Protection Commissioner v. Facebook Ireland Limited, Maximillian Schrems (C-311/18) (the “Schrems II” case) has created legal uncertainty around the future of international transfers of personal data from the European Union to the United States and other third countries. There is a risk that data protection authorities across Europe will interpret and enforce the judgment differently and that some authorities might order the suspension of certain transfers.

The suspension of data transfers critically needed by pharmaceutical and medical device companies would have serious consequences impacting both healthcare innovation and healthcare delivery. These activities would be made more difficult at a time when healthcare systems are already under tremendous stresses due to the COVID-19 pandemic. Thus, while Schrems II has created many uncertainties, one thing is certain — patient care will suffer if life sciences companies lose the ability to transfer personal data from the EU to US.

The transfer of data between the EU and the US for pharmaceutical and medical device development and support purposes serves the public interest in the protection of human health. These data transfers are crucial to continued delivery of life-saving health care services and innovation to address unmet medical needs. Numerous safeguards ensure that the data transferred is used only for permissible purposes. And importantly, there is no reason to believe these transfers pose any of the risks to privacy that were of concern in the European Court of Justice Schrems II judgment.

The undersigned organizations urge that policymakers and data protection authorities understand the importance of continued data transfer in health care between the United States and Europe and work to ensure that these essential activities are not disrupted while revisions are adopted or a successor is developed to the EU-U.S. Privacy Shield Framework.

Discussion Paper By:
AdvaMed (the Advanced Medical Technology Association in the US)
EFPIA (the European Federation of Pharmaceutical Industries and Associations)
IPMPC (the International Pharmaceutical & Medical Device Privacy Consortium) and
MedTech Europe (the European trade association representing the medical technology industry)