The First Civil Senate of the Federal Court of Justice, which is responsible, among other things, for competition law, ruled today that the dispensing of a prescription-only medicine by a pharmacist without the presentation of a prescription is illegal under competition law.
The parties operate pharmacies. The plaintiff complains that the defendant handed out a prescription medication to a patient without a doctor's prescription. He considers this to be a violation of section 48 (1) of the German Medicines Act (AMG), according to which prescription-only medicines may not be dispensed without a doctor's prescription. The plaintiff therefore filed a claim against the defendant for injunctive relief, information, a declaration of liability for damages and reimbursement of warning costs. The defendant objected that, on the basis of information obtained by telephone from a doctor known to it, it could assume that it was entitled to dispense the medication without a prescription.
The Regional Court granted the action except for a part of the warning costs. On appeal by the defendant, the Higher Regional Court dismissed the action. It held that the defendant was not entitled to dispense the medicinal product without a prescription because there was no urgent case in the sense of § 4 of the Ordinance on the Prescription of Medicinal Products (AMVV). However, due to the special situation at the time, in particular due to the defendant's minor fault, the defendant's one-time violation of the law was not suitable to noticeably impair consumer interests.
On appeal by the plaintiff, the Federal Supreme Court restored the defendant's conviction according to the first instance judgment. The duty to prescribe pursuant to § 48 AMG serves the protection of patients from dangerous wrong medication and thus health purposes. According to the established case law of the Federal Court of Justice, consumer interests are always noticeably impaired by infringements of regulations regulating market conduct, the purpose of which is to protect public health.
The defendant was also not exceptionally entitled to dispense the medicinal product without a prescription due to the special circumstances of the dispute pursuant to § 4 AMVV. It is true that the pharmacist can, in principle, rely on a decision by the doctor on the prescription of the prescription-only medicine. However, the exceptional provision of § 4 AMVV requires a therapeutic decision by the attending physician based on his or her own prior diagnosis. In urgent cases, however, it is sufficient if the pharmacist is informed of the prescription by telephone. The necessary therapeutic decision is lacking if a pharmacist persuades a doctor to prescribe for a patient unknown to the doctor. Since there was no acute health risk at the time of the visit to the defendant's pharmacy, the patient could also be expected to visit the emergency medical service in the neighbouring town.
Judgment of the Federal Supreme Court of 8 January 2015 - I ZR 123/13 - Dispensing without prescription
Lower courts:
Ravensburg Regional Court - Judgment of 15 November 2012 - 7 O 76/11 KfH 1
Stuttgart Higher Regional Court - Judgment of 13 June 2013 - 2 U 193/12
Source: Press release of the BGH
Goldberg Attorneys at Law 2015
Attorney at Law Michael Ullrich, LL.M. (Information Law)
Specialist lawyer for information technology law
E-mail: m.ullrich@goldberg.de
