Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many...

Recent months have seen intensified global calls for an intellectual property waiver of COVID-19 related vaccines, treatments and related products. Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and...

EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as ‘‘repositioning’’) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the ‘‘+1’’, was enacted on...

Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and technology. This foundational technology enables modification of the genetic structure of living organisms with unprecedented precision. Potential applications include both plant, animal and...

Almost every aspect of the COVID-19 response, from vaccines, diagnostics, and therapeutics to medical equipment, tracking systems, software, and other innovations, are or will become subject to some form of exclusive rights. Many of these involve intellectual property rights (IPRs). By offering...

As the COVID-19 pandemic continues to ravage the globe, many nations have started to relax stringent restrictions in an effort to restart the economy. While Member States of the European Union have approached reopening without the use of antibody testing for COVID-19, such testing may be central...

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory...

Stipulations on de-identification and scientific research in the European General Data Protection Regulation (GDPR) help research organizations to use personal data with fewer restrictions compared to data collection for other purposes. Under these exemptions, organizations may process specific...