Prescription-only medicines without a prescription?

The dispensing of a prescription-only medicine by a pharmacist without presentation of a prescription is unlawful under competition law. This has been decided by the First Civil Senate of the Federal Court of Justice (BGH), which is responsible inter alia for competition law.

A pharmacy had dispensed a prescription-only medicine to a patient without a medical prescription. The operator of another pharmacy saw in this a violation of § 48 Abs. 1 AMG, according to which prescription-only medicines must not be dispensed without a medical prescription. He therefore sued his competitor for cessation, information, determination of liability for damages and reimbursement of warning letter costs. The latter defended himself by arguing that he had been entitled to dispense the medicine without presentation of a prescription on the basis of information obtained by telephone from a doctor known to him.

The Regional Court (LG) initially granted the claim except for part of the warning letter costs. The Higher Regional Court (OLG) Stuttgart, however, dismissed the claim in the context of the appeal and assumed that although the pharmacist had not been entitled to dispense the medicine without a prescription, because there was no urgent case in the sense of § 4 AMVV, the pharmacist's one-time violation of the law had not been suitable, due to the special circumstances at the time, in particular because of minor culpability, to noticeably impair consumer interests.

Decision of the Court

By judgment of 8 January 2015 – Az. I ZR 123/13, the Federal Court of Justice (BGH) restored the judgment against the pharmacy operator from the court of first instance. The prescription requirement pursuant to § 48 AMG serves to protect patients against dangerous medication errors and thus health purposes. According to the BGH, violations of provisions regulating market conduct that aim to protect the health of the population always noticeably impair consumer interests.

The pharmacist was also not entitled to dispense the medicine without a prescription due to the special circumstances of the dispute. Although the pharmacist may generally rely on a decision by the doctor to prescribe the prescription-only medicine, the exception provision of § 4 AMVV requires a therapeutic decision by the treating doctor based on his own prior diagnosis. In urgent cases, however, it is sufficient if the pharmacist is informed of the prescription by telephone.

In the opinion of the BGH, however, the required therapeutic decision is lacking if a pharmacist persuades a doctor to prescribe a medicine for a patient unknown to the doctor. Since in the present case there was no acute health hazard at the time of the visit to the pharmacy, the patient could also reasonably have been expected to seek the medical emergency service in the neighbouring town.

Conclusion

The dispensing of a prescription-onlymedicine by a pharmacist without presentation of a prescription isunlawful under competition law in principle. Only in exceptional cases can a pharmacist be entitled to dispense a medicine even without presentation of a prescription, for example under the conditions of § 4 AMVV, if the use of the prescription-only medicine cannot be deferred.