In its decision of 12 September 2019, the Federal Administrative Court, Case No. 3 C 3.18, set aside the decisions of the Administrative Court Cologne of 22 September 2015, Case No. 7 K 6109/14, the Higher Administrative Court NRW of 17 February 2017, Case No. 13 A 2505/15, and ruled accordingly:
“It is determined that the maintenance of the prescription requirement for desloratadine also for oral use in the indications of allergic rhinitis and urticaria in adults, adolescents and children from two years of age in Annex 1 of the Drug Prescription Regulation violates the rights of the plaintiff.
The fundamental dispute over the conditions and timing of the release of an active substance from the prescription obligation on a national level began in 2013 and lasted until autumn 2019, because both courts of lower instance had not allowed both the appeal to the Higher Administrative Court and the appeal to the Federal Administrative Court, and Hexal with Preu Bohlig each time had to fight for the higher instance by means of a non-admission appeal.
All the more satisfactory is the strengthening of the constitutionally guaranteed rights of the pharmaceutical manufacturer by this decision.
This positive legal decision in third instance in favor of Hexal will have far-reaching consequences for the OTC Switch, the procedure with which prescription drugs are released for free sale.
Hexal is the marketing authorisation holder of two nationally approved drugs containing the active ingredient desloratadine.
All centrally and nationally approved drugs with the active ingredient desloratadine in Germany are to date prescription-only.
With regard to medicinal products that are approved in the central procedure according to Regulation (EC) No. 726/2004, the prescription status is also decided in the European approval procedure. Similarly, the release of a centrally authorised medicinal product from the prescription requirement is carried out at the European level in application of the “Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use”.
The prescription obligation for medicinal products nationally authorised in Germany is regulated in § 48 AMG and the prescription procedure provided for therein. Active substances subject to prescription are all listed in Annex 1 of the Drug Prescription Regulation (AMVV), which is issued and amended by the Federal Ministry of Health in agreement with the Federal Ministry of Economics and Technology by statutary order with the consent of the Bundesrat. By statutory order, substances are included in Appendix 1 or deleted again and thus active substances are subject to prescription or released from prescription.
Desloratadine is still listed in Appendix 1 of the AMVV and therefore nationally approved drugs with the active substance desloratadine are subject to prescription.
The first approval of desloratadine was granted on January 15, 2001, therefore desloratadine is a substance whose effects and side effects are known and have been evident from scientific evidence for more than 10 years.
Furthermore, according to the vote of the Committee of Experts for Prescription Obligations of 25 June 2013, it is neither a substance that can endanger health when used as intended, if it is used without medical supervision, nor is there a frequent misuse, which is why at the 70th meeting of the Committee of Experts for Prescription Obligations on 25 June 2013, it was decided to release the active substance desloratadine for oral use with the indications “allergic rhinitis” and “urticaria” in a single dose of 5 mg, 1.25 mg, 2.5 mg and in a maximum daily dose of 5 mg.
However, the BMG refused to implement the vote of the Expert Committee with the argument that the implementation of the vote of the Expert Committee on Prescription Obligations would mean that the release from the prescription obligation would only be effective for the nationally approved drugs. Since the centrally approved drugs can only be released from the prescription requirement by the EU Commission, this could not be communicated to the public. In order to prevent a split market, the implementation of the vote would be waived until the prescription obligation for drugs containing desloratadine approved by the EU Commission is lifted.
Differences in prescription requirements in the individual Member States and for nationally and EU-wide authorised medicinal products on a single market are, however, already inherent in the system of Directive 2001/83/EC, as Article 74a of the Directive shows. According to this provision, it is in fact not unusual, but desired by the legislator of the directive, that during a period of one year after approval of the first change in the classification of a preparation as subject to prescription/nonprescription, other preparations continue to be placed on the market with the other classification for one year. In addition, the public is familiar with differences in prescription status for preparations with the same active substance and indication knows throughout that prescription and non-prescription medicinal products with identical active substance and only minor differences in indication or even only in package size are permanently marketed in parallel.With the current decision of the Federal Administrative Court that Hexal is violated in its rights by the maintenance of the prescription obligation for desloratadinealso for oral use in the indications of allergic rhinitis and urticaria in adults, adolescents and children over two years of age in Annex 1 of the Drug Prescription Regulation, the listing of desloratadine in Annex 1 of the AMVV can no longer be justified, so that the Drug Prescription Regulation must be amended with regard to the listing of desloratadine in Annex 1.
Initially, the Federal Administrative Court clarified positively and clearly that the plaintiff’s petition can in the present case be pursued with a declaratory action directed against the legislator of the prescribing regulation and that the filed declaratory action is therefore admissible. While the Administrative Court of Cologne had still assumed that the complaint was admissible but unfounded, the OVG NRW had already denied its admissibility with some astonishing constructions. The Federal Administrative Court rejected this pleasingly clearly.
Contrary to the opinion of the Court of Appeal, the Medicines Act would not provide for any procedure in relation to a person conforming to a regulation for the desired amendment of an existing prescription obligation to which the plaintiff could be primarily referred to in order to enforce her rights.
In particular, the plaintiff could in any event not be expected to have to clarify questions of administrative doubt in criminal or fine proceedings from the prosecution bank, which the OVG NRW had regarded as a possibility.
Even administrative proceedings at the enforcement level could not bring the plaintiff any closer to her request, since the supervisory authorities do not have the authority under Section 69 of the German Medicines Act (AMG) to permit the conduct in question.
The same also applies to the enforcement dispute referred to by the Court of Appeal regarding an obligation under Section 28 of the German Medicines Act to secure the labelling requirement. Such an obligation would only serve to implement a decision taken at the approval level.
Although a legal relationship with the licensing authority could be established, this would also not cover the present case. The plaintiff could therefore not achieve her legal protection request even in such proceedings. In this respect, the Federal Administrative Court has clearly presented in detail that the intended change to the prescription obligation does not fall within the scope of § 29 AMG.
Moreover, also the defendant had obviously taken the view that the Medicines Act does not provide for any administrative procedure in relation to the regulatory authority or the supervisory authorities for the requested change to the prescription requirement of an authorised medicinal product. After all, it has taken over the plaintiff’s application to the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices).
The Federal Administrative Court clearly states with regard to the admissibility of the action that effective legal protection for the requested amendment of an existing prescription obligation can only be granted in the legal relationship to the legislature. The plaintiff must not be primarily referred to indirect procedural paths which are not laid down in the Medicines Act and which can never lead to success in the administrative proceedings themselves.
The Federal Administrative Court also takes a pleasingly clear position on the merits of the declaratory action. In particular, the Federal Administrative Court could also decide on the merits because the legal dispute was ready for decision.
The scope granted to the legislator in the decision on the maintenance of an existing prescription obligation was limited and related to the criteria specified by the legislator. Neither the aspects put forward by the defendant nor any other obvious considerations justify the unrestricted retention of the prescription requirement for drugs containing the active substance desloratadine.
Section 48 (2) sentence 1 No. 3 AMG reflects the prerequisites for the order to repeal it as actus contrarius, so that it is decisive whether a medicinal product can endanger human health if it is used without medical supervision. The Federal Administrative Court has expressly stated that, contrary to the view of the defendants, the legislator has not granted it any “free discretion” beyond this to consider further concerns. The legislator is not entitled to an original legislative right. His authority is based solely on the law that empowers him.
The arguments put forward by the defendant as to why desloratadine should continue to be subject to prescription would all correspond to the systematics of pharmaceutical law. They are the result of the lack of full harmonisation in the field of pharmaceutical law and do not give rise to health risks. The same applies to indirect consequences which could result from the connection to the prescription obligation in the reimbursement system of the statutory health insurance.
The Federal Administrative Court correctly states that it is not clear why health hazards within the meaning of § 48 (2) sentence 1 no. 2 of the German Medicines Act (AMG) should in themselves result from the dual nature of the pharmaceutical system in the European Union.
In the present case, the decision of 12.09.2019 established that the maintenance of the prescription requirement for desloratadine for oral use in the indications allergic rhinitis and urticaria in adults, adolescents and children aged two years and over in Annex 1 to the Drug Prescription Regulation violates the rights of Hexal. This finding also includes the obligation of the BMG to delete desloratadine from Annex 1 of the Drug Prescription Regulation, otherwise Hexal would continue to be infringed. This would be a violation of the mandatory requirement under constitutional law enshrined in Article 19 (4) of the Constitution for the effective implementation of legally binding administrative court rulings.
It is to be expected that the BMG will comply with the administrative court’s decision fully and without objection and accordingly amend Annex 1 and will not simply ignore it as has happened recently – for example in Bavaria. The legislator of the VwGO, which came into force on 1.4.1960, assumed that it did not take more to comply with a judgement by the authority than a threatening hint. The assumption was that all bearers of official authority, i.e. also authorities, would respect judicial decisions and voluntarily comply with their obligations. Nevertheless, the legislator has wisely foreseen enforcement against authorities by referring to the rules of the ZPO in § 167 VwGO in order to guarantee complete legal protection.
Recently, the Munich Constitutional Court, decision of 9 November 2018, file number 22 C 18.1718, was forced to present a question to the European Court of Justice on compulsory detention for non-compliance with a legally binding judgment to the European Court of Justice. In this case, the correctness of the legally binding ruling of the Administrative Court of Munich of 9 October 2012 has been established since a ruling of the Federal Administrative Court of 27 February 2018, file number 7 C 26.16. The decision of the Administrative Court of Munich of 27 February 2018, file number 7 C 26.16, has been passed. Nevertheless, the Minister President of Bavaria declared in the State Parliament that the judgment would not be complied with. In its EuGH submission, the VGH Munich therefore stated that the State of Bavaria had determined both vis-à-vis the courts and publicly, and this by its highest ranking political office bearer, not to fulfil the judicially imposed obligations and that in the meantime several penalty payment threats and determinations had remained fruitless. The VGH Munich was pleasingly clear in its decision that this deliberate disregard of legally binding court decisions by the executive authority was unacceptable.
