Unsuccessful constitutional complaint challenging the marketing authorisation for a veterinary drug granted under the mutual recognition procedure

Press Release No. 45/2021 of 01 June 2021

Order of 27 April 2021
2 BvR 206/14

In an order published today, the Second Senate of the Federal Constitutional Court rejected a constitutional complaint challenging the marketing authorisation for a veterinary medicinal product, which was granted to the complainants’ competitor by the Federal Office of Consumer Protection and Food Safety under the mutual recognition procedure in accordance with the Medicinal Products Act (Arzneimittelgesetz – AMG). Neither the marketing authorisation notice nor the administrative court judgments upholding the notice violate the complainants’ fundamental rights under Art. 12(1) of the Basic Law (Grundgesetz – GG) or Art. 16 of the Charter of Fundamental Rights of the European Union. In its reasoning the Court held that it is not only the fundamental rights of the Basic Law that must be interpreted in light of the European Convention on Human Rights, the Charter of Fundamental Rights and the constitutional traditions common to the Member States as specified by the highest competent courts, but that the Charter of Fundamental Rights, too, must be interpreted in light of the European Convention on Human Rights and the constitutional traditions common to the Member States as specified by the highest competent courts. However, in the present case, the outcome would have been the same, regardless of whether Art. 12(1) GG or Art. 16 of the Charter was invoked.

Facts of the case:

With their constitutional complaint, the complainants challenge the marketing authorisation for a veterinary medicinal product, which was granted to one of their competitors by the Federal Office of Consumer Protection and Food Safety under the EU’s mutual recognition procedure in accordance with § 25b(2) AMG.

Complainant no. 1 is the holder and owner of the rights to the marketing authorisation documents for the veterinary medicinal product Baytril. Complainant no. 2 is the exclusive licensee of these rights in Germany and the holder of the national marketing authorisation for Baytril. In 1993, the authority competent for marketing authorisation of medicinal products in the United Kingdom granted national marketing authorisation for the drug Baytril. In the context of the procedure to renew the marketing authorisation in 2004, and upon request of the UK authority, a company belonging to the complainants’ group provided data on Baytril’s ecotoxicity that had been compiled by the legal predecessor of complainant no. 1.

The third-party company summoned to join the proceedings before the administrative courts holds marketing authorisations for the veterinary medicinal product Enroxil, which is essentially identical to Baytril, in the Czech Republic, Hungary and Poland. On the basis of the UK marketing authorisation for Baytril, the UK authority granted a national marketing authorisation for Enroxil as a generic medicinal product on 9 September 2005. In 2006, a company representing the joined party requested that the Federal Office of Consumer Protection and Food Safety grant a national marketing authorisation for Enroxil in Germany under the mutual recognition procedure in respect of the UK marketing authorisation. During the examination of the application for marketing authorisation, the Federal Office of Consumer Protection and Food Safety found that documents on the drug’s environmental impact were lacking. Thereupon, the UK authority submitted the assessment report prepared in 2004 for the extension of the UK marketing authorisation for Baytril, which also included the ecotoxicity data prepared by the legal predecessor of complainant no. 1. On this basis the Federal Office of Consumer Protection and Food Safety granted the marketing authorisation for the drug owned by the joined party.

The objection lodged by the complainants against the marketing authorisation notice was dismissed as inadmissible by the Federal Office of Consumer Protection and Food Safety. The complainants’ challenge before the administrative courts was unsuccessful in all instances.

In their constitutional complaint, the complainants claim a violation of their fundamental rights derived from Art. 12(1), Art. 14(1) and Art. 19(4) first sentence GG as well as of their right deriving from Art. 101(1) second sentence GG.

Key considerations of the Senate:

The constitutional complaint is admissible but unfounded.

I. 1. Within the scope of application of EU law, the question which fundamental rights standards German authorities and courts must apply generally depends on whether the legal matter to be decided is fully determined by EU law.

a) Acts of German public authority that are fully determined by EU law will in principle not be measured against the standard of the fundamental rights of the Basic Law.

aa) By authorising the Federation to transfer sovereign powers to the European Union (Art. 23(1) second sentence GG), the Basic Law accepts the precedence of application accorded to EU law by the act of approval to the Treaties. In principle, this precedence of application of EU law over domestic law also applies with regard to conflicting provisions of constitutional law with the consequence that in case of a conflict in a specific case, national constitutional law is inapplicable. This, however, does not affect the validity of the Basic Law’s fundamental rights or the validity of any other domestic law.

bb) In accordance with Art. 23(1) first sentence GG and the Federal Constitutional Court’s established case-law, a prerequisite to the precedence of application of EU law, which precludes a review of measures taken by German authorities on the basis of the fundamental rights of the Basic Law, is that the fundamental rights of the European Union guarantee a sufficient level of fundamental rights protection.

cc) As EU law currently stands, it can be presumed that these conditions are in principle satisfied. In this respect, the fundamental rights of the Basic Law only serve as a backup guarantee, notwithstanding Federal Constitutional Court review on the basis of the ultra vires doctrine (ultra vires review) and on the basis of constitutional identity (identity review).

b) Whether a legal matter is fully determined by EU law generally depends on the provisions from which the legal consequences for the case at issue derive, i.e. whether the legal relationship at issue and the specific legal consequences following from it are determined by EU law or by domestic law. It is the provisions applicable to a specific case and their context that are relevant, not the general area of law in question.

2. Assuming that the use and processing of the complainants’ ecotoxicity data by the Federal Office of Consumer Protection and Food Safety was not fully determined by EU law, the marketing authorisation notice would have to be measured against Art. 12(1) GG.

a) In that case, the fundamental rights of the Basic Law would have to be interpreted in light of the Charter of Fundamental Rights of the European Union. Just as the Charter grew from the Member States’ different fundamental rights traditions and must be interpreted in harmony with these traditions, the Charter must also be taken into consideration as a guideline for interpretation, in addition to the European Convention on Human Rights, when it comes to the guarantees of the Basic Law. In addition, the Federal Constitutional Court has always been guided by the constitutional traditions of other democratic states under the rule of law when interpreting the fundamental rights of the Basic Law. 

b) In respect of occupational freedom, this standard has been sufficiently clarified and differentiated in the case-law of the Federal Constitutional Court.

3. If it were assumed that the use and processing of the complainants’ ecotoxicity data by the Federal Office of Consumer Protection and Food Safety was fully determined by EU law, the marketing authorisation notice would have to be measured against Art. 16 of the Charter.

a) In this case, the fundamental rights of the Basic Law, the guarantees of the European Convention on Human Rights and the fundamental rights of the other EU Member States would also have to be taken into account. Like the Charter of Fundamental Rights, these rights are primarily rooted in common constitutional traditions of the Member States and are thus a manifestation of common European and universal values. They have their basis in the protection of human dignity, they guarantee protection that is essentially comparable in terms of rights holders, entities bound by them and structure, and they are to a large extent congruent. Against this backdrop, it is not only the interpretation of the fundamental rights of the Basic Law that is inspired by the European Convention on Human Rights, the Charter of Fundamental Rights and the constitutional traditions common to the Member States as specified by the highest competent courts, but also the interpretation of the Charter of Fundamental Rights that must reflect the European Convention on Human Rights and the constitutional traditions common to the Member States as specified by the highest competent courts.

b) Therefore, when interpreting and applying Art. 16 of the Charter, it must be taken into account that this provision is embedded in European and universal legal traditions and developments.

4. In the present case, the standards of the Basic Law and of the Charter are essentially congruent. Both recognise commercial and business secrets as part of occupational freedom, are based on a broad understanding of interference and only allow such interferences on an effective statutory basis.

II. On the merits, neither the marketing authorisation notice nor the administrative court judgments upholding it violate the complainants’ fundamental rights under Art. 12(1) GG or Art. 16 of the Charter.

1. It is irrelevant with regard to the legal assessment of the notice at issue whether the reference marketing authorisation granted by the authority in the United Kingdom was lawful. The Federal Administrative Court (Bundesverwaltungsgericht) correctly held that the Federal Office of Consumer Protection and Food Safety was not required to examine potential shortcomings in lawfulness in the UK authority’s decision to grant marketing authorisation. In this respect, the complainants would have had to challenge potential violations of the law by contesting the reference marketing authorisation in the United Kingdom.

2. The situation is different when it comes to the marketing authorisation granted by the Federal Office of Consumer Protection and Food Safety . Whether this marketing authorisation violates the complainants’ fundamental rights under Art. 12(1) GG or Art. 16 of the Charter hinges instead on the question of whether the use and processing of the ecotoxicity data compiled by the complainants was part of the Federal Office’s tasks and how much latitude and decision-making responsibility it had. However, the Federal Administrative Court did not identify this in detail with regard to § 23 and § 24b as well as § 25b AMG 2005.

3. Nevertheless, even if the use of the ecotoxicity data in the notice at issue entails a reference to the complainants’ ecotoxicity data without their agreement within the meaning of § 24b AMG 2005, which would result in an interference with the complainants’ fundamental right under Art. 12(1) GG or Art. 16 of the Charter that is attributable to the Federal Republic of Germany, such interference would be justified by § 25b in conjunction with § 23(1) no. 3 AMG 2005.

a) Regardless of whether and to what extent § 24b(1) first sentence AMG 2005 was compatible with Art. 13(1) of Directive 2001/82 EC as amended by Directive 2004/28/EC, the latter provision was not directly applicable and therefore not capable of setting aside § 24b(1) first sentence AMG 2005.

For this reason, the question of whether the use of the rights holder’s ecotoxicity data was permissible in the present case must be decided on the basis of § 24b(1) first sentence in conjunction with § 23(1) no. 3 AMG 2005 – assuming that such use in the recognition procedure of the generic medicinal product by the Federal Office of Consumer Protection and Food Safety constitutes a reference made without agreement. In the case of the initial marketing authorisation of a generic medicinal product, this provision permitted a reference to those documents submitted for prior marketing authorisations, including an assessment of potential environmental risks contained in these documents, insofar as the reference medicinal product had been granted marketing authorisation for at least eight years or at least eight years ago. The same would have applied accordingly to the recognition of a generic medicinal product under the procedure set out in § 25b(1) AMG.

b) There are no constitutional concerns with regard to the validity of § 25b in conjunction with § 24b(1) first sentence and § 23(1) no. 3 AMG 2005. The potential interference with occupational freedom and the distortion of competition resulting from the use of the ecotoxicity data compiled by the complainants in favour of the joined party in the initial proceedings serve an interest of the common good and are not particularly serious with regard to Art. 12(1) GG.

4. Given that the challenged marketing authorisation notice granted by the Federal Office of Consumer Protection and Food Safety thus had a sufficient statutory basis, a violation of Art. 14 GG or of Art. 17 of the Charter, as well as of Art. 19(4) and Art. 101(1) second sentence GG can ultimately be ruled out, too.