Headnotes

to the Order of the Second Senate of 27 April 2021

2 BvR 206/14

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.

2. 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.

3. The fundamental rights of the Basic Law, the guarantees of the European Convention on Human Rights and the Charter of Fundamental Rights of the European Union are rooted primarily in common constitutional traditions of the Member States and are thus a manifestation of common European and universal values.

4. Just as the interpretation of the fundamental rights of the Basic Law is guided by the European Convention on Human Rights, by the Charter of Fundamental Rights and by the constitutional traditions common to the Member States as specified by the highest competent courts, so, too, must the interpretation of the Charter of Fundamental Rights reflect the European Convention on Human Rights and the constitutional traditions common to the Member States as specified by the highest competent courts.

FEDERAL CONSTITUTIONAL COURT

- 2 BvR 206/14 -

IN THE NAME OF THE PEOPLE

In the proceedings
on
the constitutional complaint

the Federal Constitutional Court – Second Senate –

with the participation of Justices

Vice-President König,

Huber,

Hermanns,

Müller,

Maidowski,

Langenfeld,

Wallrabenstein

held on 27 April 2021:

1. The constitutional complaint is rejected.

Reasons:

A.

[Excerpt from Press Release No. 45/2021 of 1 June 2021

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 (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit ) under the EU’s mutual recognition procedure in accordance with § 25b(2) of the Medicinal Products Act (Arzneimittelgesetz – 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 of the Basic Law (Grundgesetz – GG) as well as of their right deriving from Art. 101(1) second sentence GG.

End of excerpt ]

[…]

B.

[…]

C.

The constitutional complaint is admissible but unfounded.

I.

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 (see 1. below). If this is not the case, the decision of the Federal Office must be measured against the standard of the domestic fundamental rights, especially those enshrined in Art. 12(1) GG (see 2. below). If the legal matter is fully determined by EU law, the Charter of Fundamental Rights of the European Union applies, particularly its Art. 16 in the present case (see 3. below). As a rule, this does not lead to different outcomes (see 4. below).

1. Regardless of whether they apply domestic or EU law, authorities and courts must always consider the significance and scope of the fundamental rights. Whether they are to rely on the fundamental rights set out in the Basic Law or on the Charter of Fundamental Rights depends on whether or not the legal matter at issue is fully determined by EU law (see a) below). As a general rule, this is decided on the basis of the provisions from which the legal consequences for the case at issue are to be derived (see b) below).

a) Acts of German public authority that are fully determined by EU law will not, in principle, be measured against the fundamental rights enshrined in the Basic Law (cf. Decisions of the Federal Constitutional Court, Entscheidungen des Bundesverfassungsgerichts – BVerfGE 73, 339 <387>; 102, 147 <162 ff.>; 118, 79 <95 ff.>; 121, 1 <15>; 123, 267 <335>; 125, 260 <306 f.>; 129, 78 <103>; 129, 186 <199>; 140, 317 <334 para. 36>; 152, 216 <233 ff. para. 42 ff.>).

aa) By authorising the transfer of 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 in respect of conflicting provisions of constitutional law with the consequence that, in the event of a conflict in a specific case, domestic constitutional law is inapplicable (cf. BVerfGE, 126, 286 <301>; 140, 317 <335 para. 38). On the basis of Art. 23(1) GG, the legislator deciding on European integration matters may exempt from the comprehensive binding effect of the fundamental rights and other guarantees under the Basic Law not only EU institutions, bodies, offices and agencies but also German authorities and courts that execute EU law (cf. BVerfGE 126, 286 <301>; 140, 317 <335, para. 39>; [...]). This, however, does not affect the validity of the fundamental rights enshrined in the Basic Law (cf. BVerfGE 152, 216 <235 para. 47>; Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 36) or the validity of any other domestic law.

bb) In accordance with Art. 23(1) first sentence GG, a prerequisite to the precedence of application of EU law, which – as established in the case-law of the Federal Constitutional Court – precludes reviewing measures taken by German authorities on the basis of the fundamental rights of the Basic Law, is that a sufficiently effective fundamental rights protection be guaranteed through the application of the fundamental rights of the European Union (cf. BVerfGE 73, 339 <376, 387>; 102, 147 <162 ff.>; 118, 79 <95>; 129, 186 <199>; 152, 216 <235 para. 47>). The Basic Law puts the individual and their fundamental rights at the heart of the German legal order, declares the essence of the fundamental rights and the core of human dignity to be inviolable (cf. Art. 19(2) and Art. 79(3) GG) and also guarantees this protection with regard to Germany’s participation in the European Union. Accordingly, EU law can only prevail over the fundamental rights enshrined in the Basic Law if the protective guarantees of these rights are upheld in substance. If the fundamental rights set out in the Basic Law are subordinated as the applicable standard of review by the precedence of application of EU law, the level of protection afforded by the Charter of Fundamental Rights must be essentially equivalent to the level of fundamental rights protection that is regarded as indispensable under the Basic Law; in particular, the Charter must guarantee the essence (Wesensgehalt ) of the fundamental rights in general (cf. BVerfGE 73, 339 <376, 387>; 102, 147 <162 ff.>; 118, 79 <95>; 129, 186 <199>; established case-law). The examination of equivalence of the level of protection must therefore be made on the basis of a general assessment of the fundamental right in question (cf. BVerfGE 152, 216 <236 para. 47>).

cc) As EU law currently stands – most notably under the Charter – it must be assumed, in line with established case-law, that these conditions are in principle satisfied (cf. BVerfGE 73, 339 <387>; 102, 147 <162 ff.>; 118, 79 <95 ff.>; 129, 186 <199>; 152, 126 <236 para. 48>; established case-law). Where EU law has precedence of application, the fundamental rights of the Basic Law serve only as a back-up guarantee. Any invocation of this back-up guarantee is subject to strict substantiation requirements (cf. BVerfGE 102, 147 <164>; 152, 216 <236 para. 48>).

This is without prejudice to the instruments of review reserved by the Federal Constitutional Court: the review on the basis of the ultra vires doctrine (ultra vires review) and the review on the basis of constitutional identity (identity review) (cf. BVerfGE 123, 267 <353 f.>; 126, 286 <302 ff.>; 134, 366 <382 ff. para. 22 ff.>; 140, 317 <336 f., para. 42 and 43>; 142, 123 <194 ff. para. 136 ff.>; 146, 216 <252 ff. para. 52 ff.>; 151, 202 <287 ff. para. 120 ff.>; 152, 216 <236 para. 49>; Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 40). The Federal Constitutional Court guarantees the protection of fundamental rights that is indispensable according to Art. 23(1) third sentence in conjunction with Art. 79(3) and Art. 1(1) GG unconditionally and in the individual case. However, constitutional identity as enshrined in Art. 1(1) in conjunction with Art. 23(1) third sentence and Art. 79(3) GG will, as a rule, likely not be engaged when invoking fundamental rights that have been specified through the Charter (cf. Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 40).

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.

The type of legal act chosen (Art. 288 of the Treaty on the Functioning of the European Union – TFEU) does not in itself give rise to definitive conclusions: regulations (Art. 288(2) TFEU), too, can contain opening clauses affording Member States latitude, just as directives (Art. 288(3) TFEU) can set definitive and binding standards (cf. BVerfGE 152, 216 <247 para. 79). Moreover, the distinction – which is less firmly established in EU law and in the law of some other Member States than in German law […] – between legal provisions containing indeterminate legal concepts and provisions explicitly affording discretion is also unhelpful for establishing whether a matter is determined by EU law (cf. BVerfGE 152, 216 <247 para. 80).

Instead, the question whether a legal relationship is fully determined by EU law must be decided through the interpretation of secondary and tertiary EU law according to accepted methodology. The specific provision of EU law at issue must be assessed as to whether it seeks to accommodate diversity and different value decisions or only serves to give effect to special factual circumstances in a sufficiently flexible manner, and whether ordinary EU legislation is guided by the aim of uniform application of the law (cf. BVerfGE 152, 216 <247 f., para. 80>; CJEU, Judgment of 29 July 2019, Funke Medien NRW, C-469/17, EU:C:2019:623, para. 40 with further references).

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 this context, the fundamental rights of the Basic Law must also be interpreted in the light of the Charter (cf. BVerfGE 152, 152 <177 ff. paras. 60 ff.>). Just as the Charter grew from the Member States’ different fundamental rights traditions – including the German one – and must be interpreted in harmony with these traditions, when it comes to the guarantees of the Basic Law, the Charter must also be taken into consideration as a guideline for interpretation. In accordance with the principle of the Basic Law’s openness to international and European law, the Basic Law requires the interpretation of the fundamental rights and the advancement of the protection of fundamental rights to be informed by the development of international human rights protection, and in particular by the European fundamental rights tradition (cf. BVerfGE 152, 152 <177 para. 61>). Within the framework of the guarantees provided by the European Convention on Human Rights, which are already binding on all Member States, this does however leave room for an autonomous interpretation of German fundamental rights that arrives at different value decisions on individual points, which reflects the scope in EU law for diversity in matters that are not fully determined by EU law (cf. BVerfGE 152, 152 <178 f. para. 62>).

b) In respect of the protection of occupational freedom, the case-law of the Federal Constitutional Court provides a nuanced set of standards.

aa) Art. 12(1) GG grants all Germans the right to freely choose their occupation or profession, their place of work and their place of training. It also protects the right to freely practise an occupation or profession, which, pursuant to Art. 19(3) GG, also applies to legal persons if they carry out an activity for profit-making purposes that, by its nature and type, can be carried out by both legal and natural persons alike (BVerfGE 50, 290 <363>; 105, 252 <265> 147, 50 <141 para. 234>; 148, 40 <50> para. 26>; established case-law).

The free practice of an occupation or profession is, in principle, comprehensively protected by Art. 12(1) GG (cf. BVerfGE 85, 248 <256>). It includes the right to determine oneself the type and quality of goods and services placed on the market (cf. BVerfGE 106, 275 <299>) and thus to choose one’s prospective clientele (cf. BVerfGE 130, 131 <141>) as well as how to economically exploit one’s occupational or professional work (cf. BVerfGE 97, 228 <253>; 118, 1 <15>).

The fundamental right of occupational freedom also guarantees, in principle, the protection of business and trade secrets (cf. BVerfGE 32, 311 <317>; 105, 252 <265>). These include all facts, circumstances and events relating to an enterprise which are not known to the public but are accessible only to a limited group of persons and whose non-disclosure is in the justified interest of the rights holder (cf. BVerfGE 115, 205 <230>; 128, 1 <56>). Trade secrets essentially comprise technical know-how in the broadest sense, while business secrets relate primarily to commercial know-how. The latter includes sales, earnings, business records, customer lists, suppliers, terms, market strategies, documentation on creditworthiness, calculation documents, patent applications and other development and research projects which may substantially affect the economic situation of a business (cf. BVerfGE 137, 185 <255 para. 181>).

Art. 12(1) GG, however, guarantees neither success in the marketplace nor future business opportunities. Rather, the competitive positions of market participants and opportunities to generate profits are subject to the risk of constant change, depending on the circumstances and operating conditions of the market (cf. BVerfGE 148, 40, <50 para. 27>). Accordingly, fundamental rights do not confer upon market participants an entitlement to unchanging competition conditions. The freedom of occupation and competition guaranteed by Art. 12(1) GG, however, protects individual participants from impairment of their competitive position by the state (cf. BVerfGE 86, 28 <37>; 115, 205 <230>; 137, 185 <243 f. para. 154>; established case-law).

If business and trade secrets are disclosed by the state, or if the state demands their disclosure, the scope of protection of Art. 12(1) GG is affected (cf. BVerfGE 115, 205 <230>; 128, 1 <56>; 147, 50 <141 para. 234>), because this can impair the exclusive use of the relevant know-how by a business for its own gain. Disclosure to competitors of competitively relevant know-how prevents the holder of the fundamental right from relying on that know-how as a basis for the successful practice of their own occupation. Business strategies can be frustrated, and the incentive to engage in innovative entrepreneurial activity can be lost if a business cannot redeem the capital cost of acquiring the relevant know-how while its competitors are able to use that know-how as a basis for their own occupational success without incurring an equivalent cost (cf. BVerfGE 137, 185 <244 para. 155>).

bb) The protection of fundamental rights under Art. 12(1) GG is not restricted to imperative interferences in the traditional sense.

The defensive dimension of fundamental rights may also be affected by indirect and factual impairments if their objectives and effects are functionally equivalent to interferences in the traditional sense (cf. BVerfGE 105, 279 <303>; 110, 177 <191>; 113, 63 <76>; 148, 40 <50 f. para. 27 f. >). Even state measures with an indirect or factual impact can interfere with fundamental rights and must therefore be sufficiently justified under constitutional law. The decisive point is whether the adverse indirect or factual impact is comparable with an interference in the traditional sense in terms of the objective of the state measure (purpose), its effects on the holder of the right (intensity) and the causal link between state action and the impairment of fundamental rights (immediacy) ([...]). In principle, disadvantages attributable to the state are to be regarded as interferences ([...]).

cc) Under Art. 12(1) second sentence GG, interference with occupational freedom is allowed only on the basis of a law that satisfies the constitutional requirements for laws restricting fundamental rights. They are satisfied if the law allowing the interference has been enacted by the competent organ, if it is adequately justified by reasons of the common good which take account of the form of activity concerned and the intensity of the relevant interference and if it conforms to the principle of proportionality (cf. BVerfGE 68, 319 <327>; 84, 133 <151 ff.>; 85, 360 <373 ff.>).

3. Assuming 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. Like most of the fundamental rights enshrined in the Basic Law, this right is a specification of European and also universal constitutional traditions by the Member States who are the authors of the Treaties and it is rooted in the development of these traditions (see a) below). This must be taken into account in the interpretation and application of Art. 16 of the Charter (see b) below).

a) The fundamental rights of the Basic Law, the guarantees of the European Convention on Human Rights and the fundamental rights of the EU Charter are primarily rooted in common constitutional traditions and are thus a manifestation of common European and universal values (see aa) below). For this reason, the European Convention on Human Rights and the constitutional traditions common to the Member States as well as their interpretation by the highest competent courts are relevant not only for the interpretation and application of the fundamental rights enshrined in the Basic Law but also for the interpretation and application of the fundamental rights of the Charter (see bb) below).

aa) The fundamental rights guarantees provided by the Basic Law, the European Convention on Human Rights and the Charter of Fundamental Rights of the European Union have their basis in the protection of human dignity (see (1) below), guarantee protection that is essentially comparable in terms of rights holders, entities bound by them and structure (see (2) below) and are to a large extent congruent (see (3) below).

(1) By way of Art. 1(1) GG and the placement of the fundamental rights provisions before the provisions governing the organisation of the state, the Basic Law emphasises the precedence attaching to the individual and their dignity over the power of the state and the assertion of its interests (cf. BVerfGE 7, 198 <204 f.>). Accordingly, under Art. 1(1) second sentence GG it is the duty of all state authority to respect and protect human dignity, which includes in particular preserving the individuality, identity and integrity of the person and fundamental equality before the law (cf. BVerfGE 5, 85 <204>; 12, 45 <53>; 27, 1 <6>; 35, 202 <225>; 45, 187 <227>; 96, 375 <399>; 144, 20 <206 f. para. 538 f.>).

Art. 1(2) GG, moreover, embeds the fundamental rights of the Basic Law in the universal tradition of human rights (cf. BVerfGE 152, 216 <240 para. 59>) and in the development of the international protection of human rights, with particular weight being attached to the European tradition and development of human rights (cf. BVerfGE 111, 307 <317 ff.>; 112, 1 <26>; 128, 326 <366 ff.>; 148, 296 <350 ff. paras. 126 ff.>; 152, 152 <177 para. 61>). The principles of openness to international and European law in the Basic Law (Preamble, Arts. 1(2), 23(1), 24, 25, 26 and 59(2) GG) ensure that this also applies in respect of further developments in universal and European protection of fundamental rights.

Since 1950, the domestic standard of fundamental rights has been guaranteed and supplemented by the European Convention on Human Rights, in the Preamble to which the High Contracting Parties pledged “to take the first steps for the collective enforcement of certain of the rights stated in the Universal Declaration [of Human Rights of 10 December 1948]” and which they have further refined by means of 16 additional protocols. Even though human dignity is not explicitly guaranteed in the European Convention on Human Rights, it assumes particular importance within that instrument. This is reflected in the prohibition of torture in Art. 3 of the Convention and in the prohibition of slavery and forced labour in Art. 4 of the Convention as well as in the Preamble, which refers explicitly to the Universal Declaration of Human Rights of 1948 (cf. also European Court of Human Rights (ECtHR), Pretty v. the United Kingdom, Judgment of 29 April 2002, no. 2346/02, para. 65).

The Charter of Fundamental Rights of the European Union also centres around the individual, as indicated by its Preamble. Art. 1 of the Charter recognises human dignity not only as a fundamental right in itself but also – according to the Explanations relating to the Charter (OJ EU C 303 of 14 December 2007, p. 17) – as “the real basis of fundamental rights”. Moreover, according to Arts. 52 and 53 of the Charter, the rights set out therein recognise both the common constitutional traditions of the Member States and the European Convention on Human Rights and – insofar as they apply to German state authority – perform essentially the same function as the fundamental rights enshrined in the Basic Law and the European Convention on Human Rights (cf. Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 37).

The common reference point for all three catalogues is thus the Universal Declaration of Human Rights of 10 December 1948, which already emphasises the key importance of the dignity of the human person in its Preamble (UN A/RES/217 A <III>; [...]). Accordingly, all three catalogues of fundamental rights ultimately concern the protection of the individual and their dignity. This protection is specified within the scope of each individual fundamental right, enabling rights holders in principle to exercise free self-determination in that area of their lives without imposition by public authority or by societal forces and structures.

1. (2) Historically, dogmatically and functionally, the fundamental rights of the Basic Law are primarily defensive rights of the individual against the state and other entities exercising public authority (cf. BVerfGE 7, 198 <204 f.>) They protect the citizens’ freedom and equality from unlawful interference by public authority. Any restrictions of a fundamental right must be proportionate and must not affect the essence of that right (Art. 19(2) GG). As objective decisions on constitutional values, as fundamental precepts enshrining values or as constitutional principles, fundamental rights also require those who exercise public authority to ensure that, regardless of how these rights affect particular individuals, they are not devoid of meaning in the reality of economic and social life and insofar serve as a basis for rights of participation, positive obligations of the state and state duties of protection. This does not undermine their primary orientation but serves to reinforce their validity (cf. BVerfGE 50, 290 <337>).

In its substance and in its interpretation by the European Court of Human Rights, the European Convention on Human Rights also contains guarantees of individual freedom and equality that are open to further development (on the Convention as a “living instrument”, cf. ECtHR, Tyrer v. the United Kingdom, Judgment of 25 April 1978, no. 5856/72, para. 31; Marckx v. Belgium, Judgment of 13 June 1979, no. 6833/74, para. 41; Airey v. Ireland, Judgment of 9 October 1979, no. 6289/73, para. 26; Rees v. the United Kingdom, Judgment of 17 October 1986, no. 9532/81, para. 47; Cossey v. the United Kingdom, Judgment of 27 September 1990, no. 10843/84, para. 35; Loizidou v. Turkey <preliminary objections>, Judgment of 23 March 1995, no. 15318/89, para. 71), and that are increasingly in line with domestic constitutions, and it safeguards these guarantees against state interference except where such interference is in accordance with the law and is necessary in a democratic society (cf., for example, Art. 8(2) of the Convention). The protection of fundamental rights by the European Convention on Human Rights is not limited to protecting the sphere of individual freedom against state interference but also – like the Basic Law – guarantees duties of fulfilment and protection ([...]).

This applies equally to the fundamental rights set out in the Charter, which protect the liberty and equality of EU citizens not only from interference by the institutions, bodies, offices and agencies of the European Union but also by authorities of Member States when they are implementing EU law (Art. 51(1) of the Charter). The addressees of the Charter, like those of the Basic Law and the European Convention on Human Rights, are bound by the principle of proportionality and must respect the essence of the fundamental rights (Art. 52(1) of the Charter). Moreover, principles are developed from the fundamental rights of the Charter – insofar as they do not have third-party effect (in respect of Article 21 of the Charter, see CJEU, Judgment of 22 November 2005, Mangold, C-144/04, ECR 2005, I-10013 <10040 f. para. 77>; Judgment of 19 January 2010, Kücükdeveci, C-555/07, EU:C:2010:21, paras. 22 and 51; crit. Danish Supreme Court (Højesteret ), Judgment of 6 December 2016 - 15/2014 -) – from which further (derivative) rights may follow ([...]). Against this backdrop, the fundamental rights of the Charter constitute an essentially functional equivalent to the guarantees enshrined in the Basic Law (cf. BVerfGE 152, 216 <239 f., para. 59>; Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 37).

1. (3) In substance too, the three catalogues of fundamental rights are largely congruent. This partly stems from the principle ensuring the higher level of protection enshrined in Art. 53 of the Convention, whereby nothing in the Convention may be construed as limiting or derogating from any of the human rights and fundamental freedoms set out under the laws of any High Contracting Party. This provision makes clear that the European Convention on Human Rights forms at least a common minimum standard for the contracting parties, and that they may go beyond that level of protection ([...]). Accordingly, when determining the scope of guaranteed rights, the European Court of Human Rights refers to both national and EU fundamental rights (cf. ECtHR (GC), Bosphorus Airways v. Ireland, Judgment of 30 June 2005, no. 45036/98, para. 148; Zolothukin v. Russia, Judgment of 10 February 2009, no. 14939/03, para. 79; Scoppola v. Italy, Judgment of 17 September 2009, no. 10249/03, para. 105; Bayatyan v. Armenia, Judgment of 7 July 2011, no. 23459/03, para. 103 ff.; TV Vest As and Rogaland Pensjonistparti v. Norway, Judgment of 11 December 2008, no. 21132/05, paras. 24 and 67, […]).

Similar considerations apply to the Charter of Fundamental Rights. In its Preamble it already invokes the common constitutional traditions of the Member States as well as the inviolable and inalienable human rights enshrined in international conventions and in the European Convention on Human Rights, thereby emphasising its aim of fleshing out, or further refining, universal and European legal principles. The Treaty on European Union of 2009 explicitly raised these fleshed-out principles to the status of primary law (Art. 6(1) TEU), but also laid out that fundamental rights, as guaranteed by the European Convention on Human Rights and as they result from the constitutional traditions common to the Member States, constitute general principles of EU law (Art. 6(3) TEU). This is clearly re-emphasised by Art. 52(3) and (4) of the Charter.

1. Against this backdrop, it is not only the interpretation of the fundamental rights of the Basic Law that is guided 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 (cf. Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 37). The same applies in respect of the European Convention on Human Rights.

(1) It is true that in the German legal order the European Convention on Human Rights ranks (only) on the level of a federal law (Art. 59(2) GG). It is therefore subordinate to the Basic Law and so is not, in principle, the main standard of review applied by the Federal Constitutional Court. According to the Court’s established case-law, however, by virtue of Art. 1(2) GG, the interpretation of the fundamental rights and of the principles relating to the rule of law enshrined in the Basic Law is informed by the guarantees of the European Convention on Human Rights (cf. BVerfGE 74, 358 <370>; 111, 307 <316 ff.>; 120, 180 <200 f.>; 128, 326 <367 ff.>; 138, 296 <355 f. para. 149>; 152, 152 <176 para. 58>), which therefore present a constitutional dimension. The same applies in respect of the Charter of Fundamental Rights of the European Union (BVerfGE 152, 152 <177 f. para. 60 ff.>) as well as in respect of the common constitutional traditions of constitutional states and their interpretation by the highest competent courts (cf. BVerfGE 32, 54 <70>; 128, 226 <253, 267>; 154, 17 <100 para. 125>).

Taking the aforementioned sources into consideration when interpreting the fundamental rights of the Basic Law not only reflects the latter’s openness to European law and the responsibility of the Federal Constitutional Court for European integration. It also takes account of Germany’s integration into the European legal sphere and the development thereof, promotes the reinforcement of common European standards of fundamental rights and prevents friction and conflicting value decisions in the protection of fundamental rights, thereby furthering its effectiveness and legal certainty.

(2) In view of the explicit requirements laid down in the Treaties, of the common roots, not least in the shared commitment to human dignity, and of the largely congruent scope of the guaranteed rights, the European Convention on Human Rights and the common constitutional traditions of the Member States and their interpretation by the highest competent courts, along with the fundamental rights enshrined in the Basic Law and the case-law of the Federal Constitutional Court, are to be relied upon for the interpretation of the Charter of Fundamental Rights. This was expressed by the Senate in its order of 1 December 2020 (cf. Federal Constitutional Court, Order of the Second Senate of 1 December 2020 - 2 BvR 1845/18 inter alia -, para. 37).

(3) This is not altered by the fact that the fundamental rights guarantees contained in the Charter, the European Convention on Human Rights and the Basic Law are not entirely congruent, for example in respect of their external form and their institutional integration (cf. BVerfGE 152, 216 <233 f. para. 44>). Many of the divergences – which are slight – are rooted less in conceptual differences between the specific guarantees than in the diverse ways in which the competent courts have interpreted them. The interpretation of the Charter, however, must not be based on particular understandings of its provisions that feature only in the legal practice of individual Member States. Where such divergences exist, it is the duty of the Court of Justice of the European Union to resolve them through the preliminary ruling procedure in accordance with Art. 267(3) TFEU (cf. BVerfGE 152, 216 <244 f. para. 71>).

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

aa) The protection of business secrets, according to established case-law of the Court of Justice of the European Union, is a general principle of EU law (cf. CJEU, Judgment of 14 February 2008, Varec, C-450/06, EU C:2008:91, para. 49; Judgment of 29 March 2012, Interseroh Scrap and Metals Trading, C-1/11, EU:C:2012:194, para. 43 f.) and is guaranteed by Art. 17(2) of the Charter (cf. CJEU, Judgment of 23 November 2016, Bayer CropScience SA-NV and Stichting De Bijenstichting, C-442/14, EU:C:2016:890, para. 97 ff.) as well as by Art. 16 of the Charter. The protection afforded by Art. 16 of the Charter covers not only the freedom to exercise an economic or commercial activity but also freedom of contract and free competition (cf. CJEU, Judgment of 22 January 2013, Sky Österreich, C-283/11, EU:C:2013:28, para. 42). The freedom to conduct a business thus includes, inter alia, the right for any business to be able to freely use, within the limits of its liability for its own acts, the economic, technical and financial resources available to it (cf. CJEU, Judgment of 30 June 2016, Lidl, C-134/15, EU:C:2016:498, para. 27; Judgment of 27 March 2014, UPC Telekabel Wien, C-314-12, EU:C:2014:192, para. 49).

This definition corresponds to the situation in German constitutional law (see para 46 ff. above) as well as to the European Convention on Human Rights. Although the latter does not contain an explicit guarantee of occupational freedom (cf. ECtHR (GC), Thlimmenos v. Greece, Judgment of 6 April 2000, no. 34369/97, para. 41), according to the case-law of the European Court of Human Rights the term “private life” in Art. 8 of the Convention must not be taken to exclude natural and legal persons’ activities of a professional or business nature (cf. ECtHR, Niemietz v. Germany, Judgment of 16 December 1992, no. 13710/88, para. 29; Societé Colas Est and Others v. France, Judgment of 16 April 2002, no. 37971/97, para. 41; Peck v. the United Kingdom, Judgment of 28 January 2003, no. 44647/98, para. 57), which means that business and trade secrets are also likely to be protected by Art. 8 of the Convention (cf. also CJEU, Judgment of 14 February 2008, Varec, C-450/06, EU:C:2008:91, para. 48).

bb) With regard to the Charter of Fundamental Rights of the European Union, a broad interpretation of interference may likewise be assumed. The broad term “any limitation” used in Art. 52(1) of the Charter means that any adverse effect of state conduct on the exercise of a fundamental right is to be understood as constituting interference (cf. CJEU, Judgment of 6 December 1984, Biovilac, C-59/83, ECR 1984, I-4058 <4079 para. 22>; Order of 23 September 2004, Axel Springer v. Zeitungsverlag Niederrhein and Others, C-435/02 inter alia, ECR 2004, I-8667 <8683 para. 49>; Judgment of 12 February 1974, Sotgiu, C-152/73, ECR 1974, I-154 <164 f. para. 11>; Judgment of 16 February 1978, Commission v. Ireland, C-61/77, ECR 1978, I-418 <451 paras. 78-80>; Judgment of 15 June 1978, Defrenne, C-149/77, ECR 1978, I-1366 <1377 f. paras. 16-18 and 19-23>; Judgment of 11 July 1974, Dassonville, C-8/74, ECR 1974, I-838 <852 para. 5>; Judgment of 31 March 1993, Kraus v. Land Baden-Württemberg, C-19/92, ECR 1993, I-1689 <1697 para. 32>; Judgment of 30 November 1995, Gebhard, C-55/94, ECR 1995, I-4186 <4197 f. para. 37>; […]). This accords with the case-law of the European Court of Human Rights, which also recognises that material acts may constitute interference (cf. ECtHR, Campbell and Cosans v. United Kingdom, Judgment of 25 February 1982, nos. 7511/76 and 7743/76, para. 26; McCann and Others v. United Kingdom, Judgment of 27 September 1995, no. 18984/91, para. 26; Vereinigung demokratischer Soldaten Österreichs and Gubi v. Austria, Judgment of 19 December 1994, no. 15153/89, para. 27;[…]), and the “broad concept of interference” that has established itself in case-law and doctrine relating to the Basic Law (see para. 51 ff. above).

cc) According to the case-law of the Court of Justice of the European Union, the freedom to conduct a business is not absolute. It may be subject to a broad range of interventions on the part of public authorities which may limit the exercise of economic activity in the public interest (cf. CJEU, Judgment of 17 October 2013, Schaible, C-101/12, EU:C:2013:661, para. 28; Judgment of 22 January 2013, Sky Österreich, C-283/11, EU:C:2013:28, para. 45 f.). Such interventions do, however, require a legal basis.

The requirement of a legal basis for any interference by public authority is recognised as a general principle of EU law (cf. CJEU, Judgment of 21 September 1989, Hoechst, C-46/87 and C-227/88, ECR 1989, I-2919 <2924 para. 19>) and is now explicitly recognised in Article 52(1) of the Charter of Fundamental Rights. This means that any limitation on the exercise of freedom to conduct a business must be provided for by law, must respect the essence of that freedom and, in compliance with the principle of proportionality, must be necessary and actually meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others (cf. CJEU, Judgment of 22 January 2013, Sky Österreich, C-283/11, EU:C:2013:28, para. 48).

The requirement of statutory authorisation for interferences is also enshrined in the European Convention on Human Rights, which states that limitations to the rights guaranteed by the Convention must be prescribed by law (cf. “prescribed by law” in Arts. 5(1) and 9-11, “established by law” in Art. 6(1) and “in accordance with the law” in Art. 8; ECtHR, Sunday Times v. the United Kingdom, Judgment of 26 April 1979, no. 6538/74, para. 47 ff.; Malone v. the United Kingdom, Judgment of 2 August 1984, no. 8691/79, para. 66; Kokkinakis v. Greece, Judgment of 25 May 1993, no. 14307/88, para. 37 ff.; […]) and in the constitutional traditions of the Member States, almost all of which recognise the requirement that interferences be based on a statutory provision (Vorbehalt des Gesetzes – cf. BVerfGE 150, 1 <96 ff., para. 191 ff. with further references> – réserve de loi , riserva di legge or comparable concepts; in the case of Estonia, for example, cf. Narits, in Merten and Papier, Handbuch der Grundrechte , Vol. X, 2018, § 297 para. 48 ff.; for Finland, see Ojanen, in ibid., § 296, para. 81; for Italy, see Ridola, in ibid., § 300, para. 26; for Lithuania, see Sileikis, in ibid., § 299, para. 65, and for Spain, see Medina Guerrero, in ibid., § 301 para. 34 ff.).

4. Ultimately, the constitutional standards of the Basic Law and of the Charter of Fundamental Rights of the European Union that relate to the present case 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 restrictions 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.

It is irrelevant in respect of the challenged notice issued by the Federal Office whether the UK reference marketing authorisation was lawful (see 1. below). In fact, whether the complainants’ fundamental rights under Art. 12(1) GG or Art. 16 of the Charter have been violated by the recognition in Germany of the marketing authorisation depends on whether obtaining and processing the ecotoxicity data compiled by the complainants was the task of the Federal Office and on the extent of its margin of appreciation and responsibility in this respect, which the Federal Administrative Court (Bundesverwaltungsgericht ), however, did not establish in detail (see 2. below). Nevertheless, this question may be left unanswered, because the acquisition and processing of the ecotoxicity data by the Federal Office was certainly conducted on an effective legal basis (see 3. below). For this reason a violation, too, 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 be ruled out (see 4. below).

1. The subject of the challenged notice is the granting of the marketing authorisation for Enroxil, or its recognition, in Germany under a mutual recognition procedure following the UK reference marketing authorisation for Enroxil of 9 September 2005. This notice had no effects whatsoever on addressees of and third parties with an interest in the reference marketing authorisation in the United Kingdom, regardless of whether the authorisation there was lawful or unlawful.

Conversely, despite the role of the UK reference authorisation in the mutual recognition procedure, its recognition by the Federal Office in principle does not depend on whether that authorisation of Enroxil was lawful or unlawful but solely on compliance with the requirements set out in Art. 12 f. and Art. 32 ff. of Directive 2001/82/EC and in § 25b of the Medicinal Products Act (Arzneimittelgesetz – AMG). Neither the Federal Office nor the administrative courts that upheld the notice were therefore required to themselves conduct a review of the lawfulness of the UK reference marketing authorisation.

The Federal Administrative Court therefore correctly held that the Federal Office was not required to examine potential shortcomings in the lawfulness of the UK decision to grant marketing authorisation and that the complainants would have had to challenge potential violations of the law by contesting the reference marketing authorisation in the United Kingdom.

2. This does not rule out the possibility that the decision of the Federal Office violated the complainants’ fundamental rights under Art. 12(1) GG or Art. 16 of the Charter because it relied on the assessment report relating to Baytril, which was based on the ecotoxicity data compiled by the complainant and forwarded by the UK authority upon request. The Federal Administrative Court did not fully identify the specific requirements to be observed when it comes to recognising another Member State’s reference marketing authorisation and hence the extent of the review obligation incumbent on the Federal Office. As a result, it did not consider what implications a potential breach of those rules would have for the complainants’ fundamental rights. This concerns both the question of the scope of the (formal) power to review application documents that is vested in the Federal Office in proceedings under § 25b(2) AMG (see a) below) as well as the question of the scope of the reserved national (substantive) power of review with regard to the assessment of a serious risk within the meaning of § 25b(2) AMG and the acquisition of ecotoxicity data in that context (see b) below).

a) The Federal Administrative Court did not establish in detail whether, in respect of the submitted application documents, the Federal Office was in any case under an obligation to review whether, in the instant case, a separate reference was made to the ecotoxicity data compiled by the complainants as part of the recognition procedure under § 25b AMG, read in conjunction with § 24b(1) first sentence in conjunction with § 23(1)(3) AMG 2005. Such a reference could have caused another interference with the complainants’ fundamental rights, an interference that would require justification.

aa) According to the findings of the Federal Administrative Court, the initial marketing authorisation of Enroxil by the UK authority on 9 September 2005 was based on an application referring to the UK authorisation of Baytril, including the ecotoxicity data compiled in 2004. The recognition was granted by the Federal Office with the aid of the assessment report on Enroxil produced by the UK authority and supplemented, upon request by the Federal Office, by the assessment report on Baytril. The Federal Administrative Court did not examine whether the (formal) review obligation of the Federal Office in the framework of a recognition procedure under Art. 32(2) of Directive 2001/82/EG in conjunction with Art. 25b(2) AMG includes checking the submitted application documents for compliance with Arts. 12 to 14 of Directive 2001/82/EC or § 24(1) in conjunction with § 23 AMG 2005 and, in that context, objecting to any potentially impermissible transfer of data.

In this respect, the Federal Administrative Court merely found that there was no provision in the mutual recognition procedure for a transfer of the application documents themselves on which the authorisation of Enroxil in the United Kingdom had been based and thus no scope for “referring” to documents within the meaning of § 24b AMG. Under Art. 32(2) of Directive 2001/82/EC, the court held, the reference point for the recognition decision is the initial authorisation in conjunction with the assessment report or the updated assessment report, as appropriate.

The court, however, did not ascertain whether, at the validation stage of the proceedings, the (formal) review obligation of the Federal Office extends beyond a mere check of completeness and involves verifying that the submitted documents fulfil the requirements of Arts. 12 to 14 of Directive 2001/82/EC or § 24(1) in conjunction with § 23 AMG 2005 or whether that is solely the task of the reference Member State.

bb) Nor did the Federal Administrative Court determine, in this context, which requirements of Arts. 12 to 14 of Directive 2001/82/EG apply specifically to providing ecotoxicity data.

Article 12(3)(j) of Directive 2001/82/EC initially contained an obligation to include in applications for marketing authorisation for veterinary medicinal products only the results of physico-chemical, biological or microbiological tests, toxicological and pharmacological tests and clinical trials. By way of derogation, for the authorisation of generic products an applicant was not required, under Art. 13(1)(a) of the Directive, to provide the results of toxicological and pharmacological tests or of clinical trials.

Following the amendment of these provisions by Directive 2004/28/EC, to be implemented by 30 October 2005, however, the fourth indent of Art. 12(3)(j) introduced an obligation to attach to an application for authorisation, in addition to the results of pharmaceutical tests, safety tests, residue tests and pre-clinical and clinical trials, the results of tests assessing the potential risks posed by the medicinal product for the environment. Art. 13 of Directive 2001/82/EC was worded to the effect that applicants seeking the authorisation of a generic product are not required to provide the results of safety and residue tests or of pre-clinical and clinical trials [...]. No specific provision was made, however, for the possibility of referring to a previous applicant’s ecotoxicity data.

Accordingly, when the German legislator transposed Directive 2004/28/EC, it initially permitted referring to a previous applicant’s ecotoxicity data under § 24b(1) first sentence in conjunction with § 23(1)(3) AMG 2005. Some time later, however, the European Commission and the European Medicines Agency reached the conclusion that reference should not be made to documents concerning environmental impact assessment even after the expiry of the protection periods. The option of referring to a previous applicant’s ecotoxicity data was thereupon deleted from § 24b(1) first sentence AMG 2005 with effect from 23 July 2009. Whether this interpretation of the requirements of Directive 2004/28/EC by the European authorities, and hence the legal situation applicable in Germany only from 2009 onward, is actually binding has not yet been clarified by the Court of Justice of the European Union.

b) With regard to potential serious risks to human or animal health or to the environment too, the Federal Administrative Court, in applying § 25b(2) AMG, did not specify which documents the Federal Office is permitted to use, which fundamental rights are affected by their use and what ordinary law prescribes in this context. In particular, it did not clarify whether, given the margin of appreciation granted to the Federal Office by § 25b(2) AMG and its corresponding (substantive) review obligation, the Office was empowered to regard the assessment report on Baytril forwarded by the UK authority as an adequate basis for its review.

According to § 25b(2) AMG, recognition of the marketing authorisation granted by the reference Member State on the basis of the assessment report sent by that State is subject to the absence of any reason to believe that the authorisation of the medicinal product represents a serious risk to human or animal health or the environment. The Member State in receipt of an application for mutual recognition thus has only a very limited margin of discretion (cf. CJEU, Judgment of 16 October 2008, Synthon BV, C-452/06, EU:C:2008:565, para. 41; Judgment of 19 July 2012, Commission v. France, C-145/11, EU:C:2012:490, para. 34 ff.).

In the case of the recognition of Enroxil, the Federal Office was therefore specifically bound by § 25b(2) AMG to review whether the product posed a risk to the environment in Germany. Which data this review was to be based on, however, was not specified by the Federal Administrative Court. In particular, it remains unanswered whether it was permissible to conduct this review on the basis of the assessment report on Baytril forwarded by the UK authority, with its underlying ecotoxicity data compiled by the complainants.

One possible argument for the review, besides the fact that environmental conditions vary quite considerably from one Member State to another, is that the European authorities, when interpreting Art. 13 of Directive 2001/82/EC, ruled out the option of referring to a previous applicant’s environmental assessment documentation and that the German legislator followed suit by amending § 24b AMG in 2009, which evidently reflects an assumption that ecotoxicity data is to be treated differently from other application documents. What the consequences are for the interpretation of Art. 32 of Directive 2001/82/EC or of § 25b(2) AMG, however, was not clarified by the Federal Administrative Court.

3. There is no need, however, to decide in this case whether the use of the ecotoxicity data in the notice at issue entails a reference to the ecotoxicity data provided by the complainants as previous applicants within the meaning of § 24b AMG 2005, which would result in a further interference with the complainants’ fundamental right under Art. 12(1) GG or Art. 16 of the Charter that would be attributable to the Federal Republic of Germany, since such interference is certainly justified by § 25b in conjunction with § 24b(1) first sentence and § 23(1)(3) AMG 2005. This does not conflict with Art. 13(1) of Directive 2001/82/EC (see a) below). § 25b in conjunction with § 24b(1) first sentence and § 23(1)(3) AMG 2005 meets the constitutional requirements and, in particular, respects the principle of proportionality (see b) below).

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, this provision of the Directive had no direct effect. In the present case it was therefore not capable of setting aside § 24b(1) first sentence AMG 2005.

aa) Under Art. 288(3) TFEU a directive is binding, as to the result to be achieved, upon each Member State to which it is addressed but it leaves the choice of form and methods to the national authorities. Directives, then, are not designed in principle for direct applicability and have to be transposed into domestic law by the national legislator. According to the established case-law of the Court of Justice of the European Union, however, a directive produces direct effects for a Member State if that state fails to transpose the directive into national law correctly or within the prescribed time limit (cf. CJEU, Judgment of 26 February 1986, Marshall, C-152/84, ECR 1986, I-737 <748 para. 46>; Judgment of 22 June 1989, Fratelli Costanzo SpA, C-103/88, ECR 1989, 1861 <1870 para. 29>; Judgment of 30 April 1996, CIA Security International SA, C-194/94, ECR 1996, I-2230 <2245 para. 42>; established case-law), if the provision is unconditional in its subject matter and sufficiently precise in its formulation (cf. CJEU, Judgment of 5 April 1979, Tullio Ratti, C-148/78, ECR 1979, I-1631 <1640 ff., para. 9 ff.>; Judgment of 20 October 1993, Balocchi, C-10/92, ECR 1993, I-5133 <5142 para. 32 ff.>; established case-law), and if it does not impose obligations on third parties.

Directives are binding, in principle, on the Member States alone and therefore, as a rule, do not of themselves impose obligations on individuals (cf. CJEU, Judgment of 8 October 1987, Kolpinghuis Nijmwegen, C-80/86, ECR 1987, I-3982 <3985 para. 9>; Judgment of 3 May 2005, Berlusconi and Others, C-387/02 inter alia, ECR 2005, I-3624 <3654 para. 73>). The state can therefore not rely on the direct effect of a provision of a directive against an individual. Nor do directives, in principle, have any “horizontal effect” in relations between private individuals ([...]). On the other hand, mere adverse repercussions on the rights of third parties do not justify preventing an individual from relying on the provisions of a directive against the state (cf. CJEU, Judgment of 17 July 2008, Arcor and Others, C-152/07 inter alia, EU:C:2008:426, para. 36).

1. Art. 13(1) of Directive 2001/82/EC exempts applicants from submitting, with their applications for authorisation, the results of safety and residue tests or of pre-clinical and clinical trials if they can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Art. 5 of the Directive for not less than eight years in a Member State or the Community.

Whether, in the context of the authorisation of a generic product, reliance on a previous applicant’s ecotoxicity data is permissible, cannot, however, be discerned with sufficient certainty from Art. 13(1) of Directive 2001/82/EC. The fact that Art. 13(1) of Directive 2001/82/EC does not contain any explicit provision on the use of ecotoxicity data in connection with the authorisation and recognition of generics suggests that such reliance is not an option. The recitals to Directive 2004/28/EC do not provide a more complete explanation either. Not until some time after the Directive had entered into force did the European Commission and the European Medicines Agency establish that referring to environmental impact assessment documents is not possible for ecotoxicity data even after the expiry of the protection period ([...]). What remains unanswered ultimately is whether the Directive confers on holders of an initial authorisation – and is possibly even bound to do so in view of the rules deriving from Arts. 16 and 17(2) of the Charter – an entitlement whereby competitors’ generics will not be authorised unless they provide their own ecotoxicity data; in that case Art. 13(1) of Directive 2001/82/EC would have no direct effect to the rights holders’ detriment.

Against this background and insofar as the Federal Office made an independent reference to the rights holder’s ecotoxicity data, this reference must be measured against § 24(1) first sentence in conjunction with § 23(1)(3) AMG 2005 in the present case. In the case of the initial marketing authorisation of a generic medicinal product, this provision permitted referring 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. According to § 25b(1) AMG, this also applied with regard to the granting of authorisation in more than one Member State of the European Union. The provision was in force until 23 July 2009 and so was applicable on 9 November 2006 when the challenged notice was issued by the Federal Office as well as on 11 May 2007, the date of the decision dismissing the objection.

b) There are no constitutional concerns with regard to the validity of § 25b in conjunction with § 24b(1) first sentence and § 23(1)(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.

Through § 24b AMG 2005, which permitted referring to previous applicants’ test results, the legislator was pursuing the legitimate aim of increasing the efficiency of the authorisation procedure and avoiding unnecessary medicinal product trials on humans and animal experiments (cf. Federal Government Bill – Draft of a Second Act Amending the Medicinal Products Act, Bundestag document, Bundestagsdrucksache – BTDrucks 10/5112, pp. 17 f. and 32; Recommendation for a decision and Report by the Committee on Youth, Family Affairs and Health, BTDrucks 10/5732, p. 32) The rule served in any case to improve administrative efficiency and so to guarantee the proper functioning of the administration in the authorisation of medicinal products, which assumes constitutional importance as a matter pertaining to legitimate interests of the state (cf., in the context of financial supervision, BVerfGE 147, 50 <164 para. 312>). The question whether and to what extent this rule also serves to prevent animal experiments and thus to pursue the state goal of animal welfare enshrined in Art. 20a GG (cf. BVerfGE 110, 141 <166>; 127, 293 <328>) or whether animal experiments – as asserted by the complainants – are not required at all in the instant case for the acquisition of ecotoxicity data may therefore be set aside.

The rule was also not manifestly unreasonable (unzumutbar ). The intensity of interference was slight, particularly as § 24b AMG 2005 did not permit access to the data on the reference medicinal product until a protection period of eight years elapsed, during which time rights holders could use all business and trade secrets without restriction as they saw fit. In this way the legislator had taken sufficient account of rights holders’ economic interests.

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