On 28 September 2023, an amendment to the Pharmaceutical Law Act was introduced to strengthen the provisions of the Pharmacy for Pharmacists Act (2017). The amendment is colloquially referred to as the “Pharmacy for Pharmacists 2.0 amendment” or AdA 2.0.
According to the amendment, only a pharmacist can own a pharmacy. In addition, the pharmacist will not be able to hold shares in companies that control pharmacies and will not be able to establish a chain with more than four pharmacies under competition and consumer protection laws. In addition, a member of the governing body of a company authorized to operate a pharmaceutical wholesaler or a medicinal products intermediary will similarly not be able to take over an entity running a retail pharmacy. Finally, if an unauthorized person (that is, non-pharmacist) takes over a pharmacy or pharmacy chain, the pharmaceutical inspector can revoke their authorization and prevent them from doing so.
The aim of these regulations is to prevent entities operating as pharmacy chains or franchises from taking over companies operating pharmacies. The Pharmacy for the Pharmacist Act introduced in 2017 made it impossible for those entities to open new pharmacies. As a result, they began to increase their market shares by taking over and buying smaller pharmacies. AdA 2.0 contains provisions to close this loophole. It also gives the pharmaceutical inspectorate the right to revoke licenses and impose a fine of up to PLN 2 million on entities that violate these regulations.
Although AdA 2.0 only refers to the pharmacy retail market, it also introduces changes for pharmaceutical wholesalers. Moreover, it contains a range of sanctions for violating the regulations it introduces. These include both financial penalties and administrative sanctions such as the withdrawal of the license to operate a pharmacy.
The amendment also includes a provision that reduces the frequency of pharmaceutical inspections in wholesalers and entities that operate wholesalers. Currently, such inspections must be carried out every three years. According to the new regulation, the Chief Pharmaceutical Inspectorate will repeat inspections every five years. Some pharmacists view this is as a purely formal and long-awaited change. It results from the insufficient resources of the Chief Pharmaceutical Inspectorate to inspect wholesalers.