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New EU guidance on agreements sharing health data

On 1 March 2022, the European Commission (EC) published for consultation its draft revised Guidelines on Horizontal Cooperation Agreements (Horizontal Guidelines) and draft revised Horizontal Block Exemption Regulations on research & development and specialisation agreements. These are designed to help companies self-assess when cooperation with rivals may restrict competition under EU antitrust rules and in which cases such cooperation may benefit from an exemption.

The long-awaited drafts contain a number of amendments and clarifications which aim to adjust the current ten-year old rules to take into account recent societal and economic developments such as the green transition and digitalisation. The drafts include new rules on the assessment of, in particular, agreements pursuing sustainability objectives, joint purchasing agreements, bidding consortia and data sharing.

Of particular interest to pharmaceutical companies is the proposed guidance on data sharing. The EC recognises that while data sharing may generate certain efficiency gains, in some circumstances it may lead to anti-competitive foreclosure. This may happen, for example, when the data shared is of strategic importance, it represents a large part of the market and third parties’ access is prevented. The draft guidelines set out the factors that companies should take into account when assessing whether a data sharing initiative could breach EU antitrust rules.

The draft also sheds some light on the preventive measures that can be used to reduce potential antitrust concerns. The EC makes it clear that data pool participants should only have access to their own information and the final and aggregated information of other participants.

Interested parties can submit their comments until 26 April 2022. The new rules will come into force on 1 January 2023. For more information, please see our alert.