Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts (hereinafter referred to as the “Medicines Act”) is the fundamental legislation in force in the Slovak Republic governing the conditions for the handling of medicines and medical devices, as well as the requirements for ensuring the quality of medicines and medical devices. One of the areas explicitly regulated by the Medicines Act is the prescribing of medicines, medical devices, and dietary foods by prescribing physicians. Members of the National Council of the Slovak Republic have advanced an amendment to the Medicines Act to the second reading, which, among other things, introduces changes precisely in this area.
Pursuant to the currently applicable provision of Section 119(13) of the Medicines Act, when prescribing a human medicine, medical device, or dietary food, a prescribing physician is prohibited from specifying to the patient at which public pharmacy or medical device dispensary the patient should pick up the human medicine, medical device, or dietary food.
It follows from the aforementioned provision that a prescribing physician must not abuse the trust that patients place in them and recommend a specific pharmacy or medical device dispensary where patients should pick up their prescribed medicines, medical devices, or dietary foods. In practice, there have been (and continue to be) recurring situations where a prescribing physician recommends a specific pharmacy to a patient on the grounds that, for example, the electronic prescription was sent only there, or that the prescribed medication is unavailable at other pharmacies and cannot be ordered. Not only is such conduct by the prescribing physician contrary to good practice, but it is also contrary to the law, and the physician thereby violates several legal provisions, as it is the patient’s legal right to choose the pharmacy or medical device dispensing facility where the medication, medical device, or dietary food will be dispensed, regardless of whether the physician issued the patient a paper prescription or an electronic prescription (e-prescription), or regardless of the accuracy or inaccuracy of the information provided by the physician regarding the availability of the prescribed medication.
The main objective of the new legal provision in Section 119(13) of the Medicines Act, introduced by the amendment to the Medicines Act, is to ensure that the influencing of a patient by the prescribing physician is considered unfair competition. The change is primarily driven by the fact that the legislation of the Slovak Republic allows pharmaceutical care to be provided by legal entities owned by prescribing physicians (unlike natural persons—pharmaceutical care cannot be provided by a natural person who is authorized to prescribe medicines, medical devices, and dietary foods).
Under Section 44 of the Commercial Code, unfair competition is defined as conduct in economic competition that is contrary to the principles of fair competition and is capable of causing harm to other competitors or consumers. In the case of pharmacies, natural rivalry between them cannot be avoided; however, competition among pharmacies must be fair and lawful. The conduct of a physician who induces and influences a patient to select a medication, medical device, or dietary food prescribed by the physician at a pharmacy, or at a medical device dispensary that the physician owns or in which the physician holds a business interest, is contrary to good business practices and meets all the criteria for unfair competition.
If the amendment enters into force, the wording of Section 119(13) of the Act on Medicines will be as follows: “In connection with the issuance of a medical prescription, a medical referral, or a prescription record, it is prohibited to direct, recommend, or in any way—including through other persons—influence the patient’s choice of a pharmacy care provider for the purpose of dispensing prescribed human medicines, dietary foods, and medical devices.”
In our legal opinion, the aforementioned legal provision fulfills its purpose, which is, among other things, to protect the patient’s right to freely choose a pharmacy care provider, and establishes a prohibition on precisely such specific conduct by the prescribing physician, which was absent in the previous legal provision, or was not sufficiently regulated in view of the scope and content of the prescribing physician’s conduct and conduct through other entities.
The update to Section 119(13) of the Medicines Act thus aims to classify the conduct of a physician who violates the statutory prohibition and influences a patient in the selection of a healthcare provider as unfair competition.
