After a 14-year court case, Dr. August Wolff obtains with Oppenhoff & Partner’s aid an ECJ ruling authorising the marketing of the drug Linoladiol N

A fourteen-year-old lawsuit concerning marketing authorisation restrictions for the drug Linoladiol N of the company Dr. August Wolff GmbH & Co. KG Arzneimittel came to a close at the end of March 2019 before the European Court of Justice (ECJ). According to the ECJ, the Committee for Medicinal Products for Human Use (CHMP) committed an error of law when drafting its opinion on the drug’s safety: the impartiality of the rapporteur-general could not be guaranteed. In the last instance, this led to the EU Commission's decision, which was based on the expert opinion and which severely restricted the marketing authorisation of the drug in question, being revoked and declared null and void.

Linoladiol N is a prescription drug containing estradiol that is used to treat atrophic symptoms in post-menopausal women. Following the drug’s initial marketing authorisation in Germany in 1978, the Federal Institute for Drugs and Medical Devices [Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM] refused to renew the marketing authorisation in 2005. Dr. August Wolff, the marketing authorisation holder, represented by Peter Klappich, lawyer and partner at Oppenhoff & Partner, was initially unsuccessful in the action brought before the Administrative Court of Cologne, which dismissed the case.

After the repeal of this judgement by the Higher Administrative Court of Münster and the renewed granting of marketing authorisation in March 2013, however, the European Commission decided upon application of the BfArM in August 2014, among other things, to make the marketing authorisation subject to severe restrictions. Dr. August Wolff appealed against this decision before the General Court of the European Union (EGC) on grounds that, among other things, an expert opinion on which the decision had been based had not been drawn up objectively: The rapporteur-general had acted in a dual capacity, as she was also a staff member of the BfArM - the authority that had initiated the review procedure on Linoladiol N before the CHMP of the European Medicines Agency (EMA) and that had initially not renewed the marketing authorisation for Linoladiol N. The EGC dismissed the action in the first instance.

Dr. August Wolff appealed against this to the ECJ. The ECJ shared the opinion of Dr. August Wolff and considered the appointment of the BfArM employee as rapporteur-general to be a violation of the principle of careful and impartial examination anchored in Article 41 of the Charter of Fundamental Rights of the European Union. It therefore repealed the ruling of the EGC of October 2016 and declared the decision of the EU Commission null and void. Linoladiol N may now contin-ue to be used as before.

Peter Klappich, Oppenhoff & Partner, commented: "The judgement is significant because the ECJ has clarified that objective impartiality may be impaired if a conflict of interest can lead to a conflict of offices. In the case up for decision, the CHMP should have taken into account the fact that the BfArM had refused to renew the marketing authorisation and that an action opposing the refusal was pending before the German courts, of which it was aware. Under this aspect, uninvolved third parties might legitimately assume that the BfArM was pursuing the interests it represents at national level and that the behaviour of the BfArM employee might be biased. I am pleased to see that the ECJ has not approved the bias, but rather has considered it a disregard of the duty of impartiality anchored in Article 41 of the Charter."

Representatives of Dr. August Wolff GmbH & Co. KG Arzneimittel: Peter Klappich, Dr. Corinna Schmidt-Murra, Oppenhoff & Partner
Representatives of the European Commission: B.-R. Killmann, A. Spisos, M. Šimerdová
ECJ Judges: T. von Danwitz, K. Jürimäe, C. Lycourgos, E. Juhász, C. Vajda
Advocate General of the ECJ: P. Mengozzi
Docket number: C-680/16 P

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