Life Sciences Horizons Brochure 2025 - Flipbook - Page 26
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2025 Horizons Life Sciences and Health Care
EU Data Act: FRAND requirements for B2B data sharing
The EU Data Act requires that manufacturers that
hold data collected and generated by their connected
products (“data holders”) allow users to access these
data, and share them with third parties selected by
the user. To encourage and promote fair data sharing
practices between companies, data sharing must be
based on fair, reasonable, and non-discriminatory
terms (FRAND).
Companies are free to negotiate the data-sharing terms. Terms
more commercially favorable to one party are allowed. Different
terms for comparable data recipients are allowed if this is based
on objective, non-discriminatory considerations. The data holder
must demonstrate that the terms are fair, reasonable, and
non-discriminatory. The European Commission will develop –
and likely adapt before September 2025 – non-binding contractual
clauses that may be helpful for creating and negotiating datasharing terms.
The use of data-sharing terms must not be contrary to good
faith and fair dealing, and must not grossly deviate from good
commercial practice in data access and use. The EU Data Act
provides a non-exhaustive list of always unfair terms and
presumed unfair terms. Data holders must demonstrate that
the presumed unfair terms are not unfair in the specific case.
The FRAND test applies:
Unfair and unilaterally imposed terms will not be binding. If
a term is deemed unfair, the contract remains valid without it,
unless the term is inseparable from the contract.
To navigate these challenges effectively, data holders must take
a proactive and strategic approach. As a first step for preparing for
data sharing requests, we advise data holders to:
assess and implement technical and organizational measures
to be able to fulfil data transfer requests;
assess existing measures and implement additional measures
to protect IP rights, trade secrets and confidential business
information and safely share data with users and third
parties; and,
prepare contractual terms for third-party data recipients
to protect business interests, trade secrets and IP rights.
only to terms relating to data use and data sharing, such
as access to and use of data, liability, remedies for breach of
contract, and termination of data-related obligations; and,
when these terms are unilaterally imposed without the
influence of the other party, such as take-it-or-leave-it
situations or situations where a stronger bargaining power
has been abused and resulted in excessive terms. Terms
negotiated, influenced, and agreed upon by parties are
not subject to the FRAND test.
Chantal Van Dam
Counsel
Amsterdam
