Case C-221/10 P

Artegodan GmbH

the other parties to the proceedings being:

European Commission

and

Federal Republic of Germany

‛Appeal — Second paragraph of Article 288 EC — Non-contractual liability of the Union — Conditions — Sufficiently serious breach of a rule of law conferring rights on individuals — Decision withdrawing marketing authorisations for medicinal products for human use containing amfepramone’

Summary of the Judgment

1. Non-contractual liability — Conditions — Sufficiently serious breach of a superior rule of law protecting individuals — Infringement of the system of the division of powers between the institutions and the Member States — Liability — Condition

   (Art. 288, second para., EC)

2. Procedure — Res judicata — Scope

3. Appeals — Grounds — Grounds of judgment vitiated by a breach of European Union law — Operative part well founded for other legal reasons — Rejection

4. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Conditions for suspension or withdrawal of authorisation relating to therapeutic efficacy of a medicinal product

   (Council Directive 65/65, Art. 11)

5. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Grounds laid down by Directive 65/65

   (Council Directive 65/65, Art. 11)

1.  Where the unlawfulness of a legal act is in issue, whether the non-contractual liability of the European Union is incurred depends on the fulfilment of a set of conditions, including the existence of a sufficiently serious breach of a rule of law that is intended to confer rights on individuals.

   In that respect, whilst a failure to observe the system of the division of powers between the various institutions of the European Union, whose aim is to ensure that the balance between the institutions provided for in the Treaties is maintained, and not to protect individuals, cannot be sufficient on its own to render the European Union liable towards the traders concerned, the position would be different if a measure of the European Union were to be adopted which not only disregarded the division of powers between the institutions but also, in its substantive provisions, disregarded a superior rule of law protecting individuals.

   As a consequence, the General Court erred in law by holding that the infringement by the Commission of the rules governing the division of competences between the Commission and the Member States resulting from Directive 75/319 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products is not of such a kind as to cause the European Union to incur non-contractual liability on the ground that those rules are not intended to confer rights on individuals, without taking account of the case-law, according to which such an infringement, when it is accompanied by an infringement of a substantive provision that is intended to confer such rights, is capable of giving rise to that liability.

   (see paras 80-82)

2.  In order to ensure the stability of the law and of legal relations, and the sound administration of justice as well, it is important that judicial decisions which have become definitive after all rights of appeal have been exhausted, or after the time allowed for exercising those rights has passed, may no longer be called into question.

   In that regard, firstly, res judicata extends only to the matters of fact and law actually or necessarily settled by the judicial decision in question and, secondly, it attaches not only to the operative part of that decision, but also to the ratio decidendi of that decision which is inseparable from it.

   (see paras 86, 87)

3.  If the grounds of a judgment of the General Court disclose an infringement of European Union law but its operative part is shown to be well founded on other legal grounds, the appeal must be dismissed.

   (see para. 94)

4.  The express wording of Article 11 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products shows that the competent authority is required to suspend or revoke the marketing authorisation of a medicinal product for human use when that product proves to be harmful in the normal conditions of use, or its therapeutic efficacy is lacking, or its qualitative and quantitative composition is not as declared.

   Those substantive criteria for the suspension or withdrawal of a marketing authorisation must be interpreted in accordance with the general principle that the protection of public health must unquestionably take precedence over economic considerations.

   As regards, in particular, the assessment of the criterion for the suspension or withdrawal of a marketing authorisation relating to the lack of therapeutic efficacy of a medicinal product, Article 11 of Directive 65/65 states that ‘therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product’, which by no means indicates that only an observation of the short-term effects of a medicinal product, and not an observation of the long-term effects of that medicinal product, is relevant for the examination of that criterion.

   It follows that, as regards the criterion relating to the assessment of the efficacy of a medicinal product, Article 11 does not preclude the competent authority from deciding, taking account of the pathology which the medicinal product concerned is intended to treat, to rely on a criterion of long-term efficacy in order to carry out a benefit/risk assessment of that medicinal product.

   (see paras 98-101)

5.  The adoption of a decision to withdraw a marketing authorisation is justified only if, following a benefit/risk assessment of that medicinal product, concrete and objective factors make it possible to hold that there is a negative benefit/risk assessment for the medicinal product concerned.

   In that respect, the existence of a consensus within the medical community regarding a development of the assessment criteria of the therapeutic efficacy of a medicinal product and the questioning, within that community and following that development, of the therapeutic efficacy of that medicinal product constitute, in the same way as the identification of scientific data or new information, concrete and objective factors capable of acting as a basis for the finding of a negative benefit/risk assessment of that medicinal product.

   (see paras 102, 103)

Case C-221/10 P

Artegodan GmbH

the other parties to the proceedings being:

European Commission

and

Federal Republic of Germany

‛Appeal — Second paragraph of Article 288 EC — Non-contractual liability of the Union — Conditions — Sufficiently serious breach of a rule of law conferring rights on individuals — Decision withdrawing marketing authorisations for medicinal products for human use containing amfepramone’

Summary of the Judgment

1. Non-contractual liability — Conditions — Sufficiently serious breach of a superior rule of law protecting individuals — Infringement of the system of the division of powers between the institutions and the Member States — Liability — Condition

   (Art. 288, second para., EC)

2. Procedure — Res judicata — Scope

3. Appeals — Grounds — Grounds of judgment vitiated by a breach of European Union law — Operative part well founded for other legal reasons — Rejection

4. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Conditions for suspension or withdrawal of authorisation relating to therapeutic efficacy of a medicinal product

   (Council Directive 65/65, Art. 11)

5. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Grounds laid down by Directive 65/65

   (Council Directive 65/65, Art. 11)

1.  Where the unlawfulness of a legal act is in issue, whether the non-contractual liability of the European Union is incurred depends on the fulfilment of a set of conditions, including the existence of a sufficiently serious breach of a rule of law that is intended to confer rights on individuals.

   In that respect, whilst a failure to observe the system of the division of powers between the various institutions of the European Union, whose aim is to ensure that the balance between the institutions provided for in the Treaties is maintained, and not to protect individuals, cannot be sufficient on its own to render the European Union liable towards the traders concerned, the position would be different if a measure of the European Union were to be adopted which not only disregarded the division of powers between the institutions but also, in its substantive provisions, disregarded a superior rule of law protecting individuals.

   As a consequence, the General Court erred in law by holding that the infringement by the Commission of the rules governing the division of competences between the Commission and the Member States resulting from Directive 75/319 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products is not of such a kind as to cause the European Union to incur non-contractual liability on the ground that those rules are not intended to confer rights on individuals, without taking account of the case-law, according to which such an infringement, when it is accompanied by an infringement of a substantive provision that is intended to confer such rights, is capable of giving rise to that liability.

   (see paras 80-82)

2.  In order to ensure the stability of the law and of legal relations, and the sound administration of justice as well, it is important that judicial decisions which have become definitive after all rights of appeal have been exhausted, or after the time allowed for exercising those rights has passed, may no longer be called into question.

   In that regard, firstly, res judicata extends only to the matters of fact and law actually or necessarily settled by the judicial decision in question and, secondly, it attaches not only to the operative part of that decision, but also to the ratio decidendi of that decision which is inseparable from it.

   (see paras 86, 87)

3.  If the grounds of a judgment of the General Court disclose an infringement of European Union law but its operative part is shown to be well founded on other legal grounds, the appeal must be dismissed.

   (see para. 94)

4.  The express wording of Article 11 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products shows that the competent authority is required to suspend or revoke the marketing authorisation of a medicinal product for human use when that product proves to be harmful in the normal conditions of use, or its therapeutic efficacy is lacking, or its qualitative and quantitative composition is not as declared.

   Those substantive criteria for the suspension or withdrawal of a marketing authorisation must be interpreted in accordance with the general principle that the protection of public health must unquestionably take precedence over economic considerations.

   As regards, in particular, the assessment of the criterion for the suspension or withdrawal of a marketing authorisation relating to the lack of therapeutic efficacy of a medicinal product, Article 11 of Directive 65/65 states that ‘therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product’, which by no means indicates that only an observation of the short-term effects of a medicinal product, and not an observation of the long-term effects of that medicinal product, is relevant for the examination of that criterion.

   It follows that, as regards the criterion relating to the assessment of the efficacy of a medicinal product, Article 11 does not preclude the competent authority from deciding, taking account of the pathology which the medicinal product concerned is intended to treat, to rely on a criterion of long-term efficacy in order to carry out a benefit/risk assessment of that medicinal product.

   (see paras 98-101)

5.  The adoption of a decision to withdraw a marketing authorisation is justified only if, following a benefit/risk assessment of that medicinal product, concrete and objective factors make it possible to hold that there is a negative benefit/risk assessment for the medicinal product concerned.

   In that respect, the existence of a consensus within the medical community regarding a development of the assessment criteria of the therapeutic efficacy of a medicinal product and the questioning, within that community and following that development, of the therapeutic efficacy of that medicinal product constitute, in the same way as the identification of scientific data or new information, concrete and objective factors capable of acting as a basis for the finding of a negative benefit/risk assessment of that medicinal product.

   (see paras 102, 103)