## Facts

- The case involved Laboratoires Pharmaceutiques Bergaderm SA and Jean-Jacques Goupil challenging the European Commission's decision to withdraw marketing authorizations for certain medicinal products.
- The applicants claimed the Commission's action constituted a sufficiently serious breach of EU law and resulted in financial losses.
- The case came before the European Court of Justice (ECJ), which took the opportunity to clarify the conditions for EU institutional liability.
- The context included established doctrines for State liability (Francovich) and prior standards for institutional liability (Schöppenstedt).

## Issues

1. Whether the Commission's withdrawal of marketing authorizations amounted to a sufficiently serious breach of a superior rule of law intended to confer rights on individuals.
2. How the criteria for EU institutional liability should be formulated, especially in relation to existing standards set out in Schöppenstedt and Francovich.
3. Whether there was a direct causal link between the alleged breach by the Commission and the damages claimed by the applicants.

## Decision

- The ECJ clarified that the conditions for establishing institutional liability should closely mirror those for State liability, subject to necessary adaptations.
- The Court set out that a "sufficiently serious breach" required consideration of several factors, including the clarity of the rule breached, the amount of discretion held by the institution, whether the infringement was intentional, whether any legal error was excusable, and the stance of other institutions.
- The ECJ reaffirmed the need for the breached rule to be a "superior rule of law intended to confer rights on individuals" and found it essential that such a rule provide identifiable, individual rights.
- The Court held that liability also required the existence of a direct causal link between the breach and the damage suffered, with harm needing to be a foreseeable consequence of the institution’s action.
- By merging the Schöppenstedt and Francovich criteria, a more coherent and predictable framework for liability was established.

## Legal Principles

- The "sufficiently serious breach" standard requires evaluation of the rule's specificity, the institution's discretion, intentionality, excusability, and positions of other institutions.
- A "superior rule of law" must grant specific rights to individuals to serve as the basis for institutional liability.
- Institutional liability under EU law is predicated on (1) a sufficiently serious breach, (2) the breach of a superior rule of law intended to confer individual rights, and (3) a direct causal link between breach and loss.
- The ECJ endorsed harmonization of State and institutional liability criteria for a more consistent application in EU law.

## Conclusion

The Bergaderm judgment established a unified and accessible standard for EU institutional liability by merging the Schöppenstedt and Francovich criteria. The clarified framework supports greater accountability of EU institutions and protection of individual rights, with its principles guiding subsequent case law on damages for breaches by EU bodies.

Laboratoires Pharmaceutiques Bergaderm SA and Jean-Jacques Goupil v Commission (Case C-352/98 P) [2000] ECR I-5291