The First Civil Senate of the Federal Court of Justice, responsible inter alia for competition law, ruled today that the dispensing of a prescription-only medication by a pharmacist without a prescription is inadmissible under competition law.
The parties operate pharmacies. The plaintiff objects that the defendant dispensed a prescription-only medication to a patient without a medical prescription. He considers this a violation of Section 48 Paragraph 1 of the German Medicines Act (AMG), which stipulates that prescription-only medications may not be dispensed without a medical prescription. Consequently, the plaintiff sued the defendant for injunctive relief, information, declaration of liability for damages, and reimbursement of warning costs. The defendant argued that, based on information obtained by telephone from a physician known to her, she was entitled to dispense the medication without a prescription.
The Regional Court granted the claim except for a portion of the warning costs. Upon the defendant's appeal, the Higher Regional Court dismissed the claim. It held that while the defendant was not entitled to dispense the medicinal product without a prescription, as there was no urgent case within the meaning of Section 4 of the German Regulation on the Prescription of Medicinal Products (AMVV), the defendant's single violation of the law was not capable of perceptibly impairing consumer interests due to the specific situation at the time, particularly given the defendant's minor fault.
Upon the plaintiff's appeal on points of law (Revision), the Federal Court of Justice reinstated the conviction of the defendant according to the first-instance judgment. The prescription requirement under Section 48 AMG serves to protect patients from dangerous medication errors and thus health purposes. According to the consistent jurisprudence of the Federal Court of Justice, violations of regulations governing market conduct that aim to protect public health always perceptibly impair consumer interests.
The defendant was also not exceptionally entitled to dispense the medicinal product without a prescription under Section 4 AMVV due to the specific circumstances of the case. While a pharmacist can generally rely on a physician's decision regarding the prescription of a prescription-only medication, the exceptional provision of Section 4 AMVV requires a therapeutic decision by the treating physician based on their own prior diagnosis. However, in urgent cases, it is sufficient if the pharmacist is informed of the prescription by telephone. The necessary therapeutic decision is lacking if a pharmacist induces a physician to issue a prescription for a patient unknown to the physician. Since there was no acute health risk at the time of the patient's visit to the defendant's pharmacy, it was also reasonable for the patient to seek out the emergency medical service in the neighboring town.
Judgment of the BGH of January 8, 2015 – I ZR 123/13 – Dispensing without Prescription
Lower Courts:
LG Ravensburg – Judgment of november 15, 2012 – 7 O 76/11 KfH 1
OLG Stuttgart – Judgment of June 13, 2013 – 2 U 193/12
Source: Press Release of the Federal Court of Justice
Goldberg Attorneys 2015
Attorney Michael Ullrich, LL.M. (Information Law)
Specialist Attorney for Information Technology Law
E-mail: m.ullrich@goldberg.de
