🔵 Today, an amendment to the Pharmaceutical Law known as - Pharmacy for pharmacists 2.0 comes into force.
🔸According to the new regulations, from 28 September it is not permitted to take control, within the meaning of competition and consumer protection regulations, of an entity operating a pharmacy for the general public if:
📌the entity acquiring control is an entity other than a pharmacist with a licence to practice, or a general or partnership company whose partners are exclusively pharmacists with a licence to practice.
📌 as a result of acquiring control of an entity operating a community pharmacy, the members of the capital group to which the acquiring entity belongs would operate a total of more than 4 community pharmacies
📌 the entity acquiring control, a partner or a shareholder of the company which is the entity acquiring control:
1️⃣ is a shareholder or partner in a company or companies that run a total of at least 4 pharmacies open to the public, or
2️⃣ operates at least 4 pharmacies open to the public, or an entity or entities controlled by it in a direct or indirect manner, in particular a subsidiary or subsidiaries within the meaning of the provisions on competition and consumer protection, operate at least 4 pharmacies open to the public, or
3️⃣ is a member of a capital group within the meaning of the provisions on competition and consumer protection whose members run jointly at least 4 pharmacies open to the public, or
is a member of the bodies of a company authorised to operate a pharmaceutical wholesaler or mediator in trade in medicinal products.
‼️ The prohibition does not apply if the acquisition of control is the result of an inheritance.
🔸 Revocation of authorisation for breach of prohibition
📌 The provincial pharmaceutical inspector shall revoke the authorisation to operate a pharmacy open to the public to an entity over which control has been acquired in contravention of the aforementioned prohibition.
📌 The provincial pharmaceutical inspector shall revoke the authorisations in the number necessary to restore the lawful state, starting from the authorisations issued at the latest, unless he/she considers that the particularly important interest of patients using the services of individual pharmacies supports the revocation of other authorisations.
📌 The decision to revoke a licence to operate a community pharmacy shall be based on the state of affairs at the time of taking control.
📌 The parties to the revocation proceedings are the entity or entities over which control has been acquired. And this means that the acquiring entity does not have party rights, i.e. it does not have access to the file, cannot be heard and cannot challenge the decision to withdraw the authorisation.
🔸 For violations of the prohibition, the provincial pharmaceutical inspector imposes a penalty of between PLN 50,000 and PLN 5,000,000 by decision.
Additional amendments to the Act introduce:
📌 A reduction in the frequency of inspections by the pharmaceutical inspection from 3 to 5 years