There is consent for a special derogation from the rules of "Pharmacy for Pharmacists"

• The Ministry of Health has issued a decision regarding the possibility of opening a pharmacy on the premises of the hospital in Poznań - Rynek Zdrowia has learned
• The pharmacy operated in this location until the COVID-19 pandemic. Statutory restrictions were an obstacle to its reopening.
• The pharmacist fought for a positive decision for two years. The hospital management, the Wielkopolska voivode and the Chief Pharmaceutical Inspector got involved in the case
• The formality should now be to re-submit an application for a permit to run a pharmacy.

The need to ensure access to medicinal products for patients at the hospital in Poznań justifies the granting of consent to run a publicly accessible pharmacy, despite the existence of legal restrictions - we read in the resolution of the Ministry of Health.

This is about a pharmacy that wanted to reopen on the premises of the J. Struś Multi-Specialist City Hospital in Poznań. We described this topic in our pages.

Let us recall: The Wielkopolska Province Pharmaceutical Inspector (hereinafter: WWIF) initially issued a negative decision for the pharmacist, arguing that there were five other well-connected entities located approximately 460-960 meters from the proposed hospital pharmacy. It referred to the provisions of the act known as "Pharmacy for Pharmacists" (amendment to the Pharmaceutical Law; hereinafter: pf), which in 2017 introduced significant restrictions on the location of facilities.

The thing is that the pharmacy on the premises of the city hospital was already operating. It closed during the COVID-19 pandemic, when the facility was renamed a single-purpose hospital, accepting only patients infected with the SARS-CoV-2 coronavirus.

In March 2023, a tenant was found interested in renting space in the hospital to reopen the pharmacy. To do so, she needed to obtain permission from WWIF.

Since it was formally a new application for a permit to run a pharmacy, the inspector assessed it through the prism of the applicable provisions of the Pharmaceutical Law. And stated that he had to issue a negative decision.

This is because, in accordance with Article 99, paragraph 3b of the Pharmaceutical Law, a permit may be issued to an authorised entity only if, on the date of submission of the application, the distance from the planned location of the pharmacy to the nearest functioning publicly available pharmacy is more than 1,000 metres (this is the so-called geographical limitation ).

If the distance is between 500-1000 metres , an additional demographic premise is also subject to verification, requiring a determination whether the number of inhabitants in a given commune, per one pharmacy, is at least 3000 people .

In the described case from Poznań, the number of inhabitants per one pharmacy is 2,074 people (based on data from the Central Statistical Office).

In the Poznań case - taking into account the above demographic and geographical limitations - it was not possible to open a new pharmacy on the hospital premises. However, the applicant and the Poznań hospital authorities argued that patients expect easy access to medicines, preferably on the hospital premises. Some of them have limited mobility and find it difficult to move to locations where other pharmacies operate. A list of support signed by some of the patients and hospital staff was provided as confirmation.

However, WWIF indicated in its decision that the distance between pharmacies is calculated in a straight line and the legislator did not provide for any exceptions in the form of real time and actual distance, taking into account architectural barriers and difficulties occurring between pharmacies.

In the described case, the average walking time was estimated at about 15 minutes . There is a bus stop at the hospital, which allows you to get to the chosen pharmacy even faster.

There is an exception that allows you to bypass the restrictions

However, since the regulations are clear, why this exchange of arguments? The Pharmaceutical Law provides for a procedure that allows for the non-application of restrictions from the "Pharmacy for Pharmacists".

According to art. 99 sec. 3e-h pf the Minister of Health may consent to the issuance by WIF of a permit to run a pharmacy without restrictions. The argument for issuing such a decision should be the "important interest of patients".

In order for the Minister of Health to issue a decision, the WIF must grant a permit or promise to issue a permit to run a pharmacy. This means that the pharmaceutical inspector takes on the assessment of the premises justifying the omission of restrictions in the interest of patients. Only then does the applicant obtain the opinion of the commune head, mayor or city president (depending on the planned location of the pharmacy), and then the MZ makes the final decision.

On March 28 and October 14, 2024, the hospital director asked the second instance body - the Chief Pharmaceutical Inspector - to uphold the appeal, pointing to the important interests of patients.

GIF, as we reported in April this year, issued a decision annulling the contested decision of WWIF and referred the case for reconsideration. Formally, it is the case that GIF cannot oblige WWIF to issue a positive opinion on omitting the restrictions, because there is no legal basis for this. However, the provincial pharmaceutical inspector had to conduct the proceedings again, taking into account the "guidelines" of GIF.

In the decision of the Chief Inspector, we read that the WIF "did not consider many important circumstances of the case, which were relevant for assessing the important interest of patients and the need to provide them with access to medicinal products".

The provincial inspector did not take into account, for example, that the Poznań hospital is one of the largest facilities providing medical services in the region. For example, in 2022, over 49.6 thousand patients were treated in its departments, while over 56 thousand people were admitted to specialist clinics.

Many of them come to the hospital from all over the region and do not know where they can find a pharmacy in the area. Patients staying in the facility for a longer period of time may need additional medications or dietary supplements that they will not be able to obtain because: there is no pharmacy in the hospital and they are not allowed to leave the facility.

For GIF, it was important that the director of the Poznań hospital clearly indicated the need for a publicly accessible pharmacy to operate in the facility. He argued that patients were not interested in using nearby pharmacies due to their unfavorable location among residential estates and parking problems. The hospital management also had to deal with patients' complaints that there was no possibility of buying medicines and using pharmaceutical services in the facility. Patients believed that this gap in their care resulted from the decisions of the hospital authorities.

According to GIF, the provincial inspector did not notice how big a need there might be for patients to have a pharmacy operating on the hospital premises. First and foremost for those using holiday and night health care or those with conditions that make it difficult to move.

The Chief Inspector was also not convinced by the WIF argument that patients arriving from outside the hospital would have trouble filling long-term prescriptions. The GIF stressed that the number of such prescriptions would probably constitute only a part of the prescriptions filled in the pharmacy, and the needs of patients usually also include various types of over-the-counter medicines and medical devices.

Moreover, in the opinion of GIF, the premise for not lifting the restrictions cannot be "the lack of patient complaints regarding the availability of medicinal products due to the small number of pharmacies in the city of Poznań, or regarding the opening hours of pharmacies". The hospital patients clearly complained about the lack of a pharmacy on the hospital premises, as evidenced by the petition signed by many of them.

Patient signatures influenced the decision of the pharmaceutical inspection

WWIF Grzegorz Pakulski has finally concluded that the pharmacy can reopen on the hospital grounds.

In the new decision, he noted that the hospital provides comprehensive care for patients in a wide range of medical activities. The lack of a pharmacy facility results in the hospital management constantly receiving further complaints and reservations from patients regarding the lack of access to a pharmacy on the premises of the hospital.

WWIF concluded that "it is in the interest of patients to open a publicly accessible pharmacy in the indicated location in order to enable patients to purchase prescribed medicinal products immediately after the end of a medical visit or stay in individual hospital wards."

The Inspector also admitted that the hospital is one of the largest facilities providing medical services in the region, runs a Hospital Emergency Department, specialist clinics and provides night and holiday care not only for patients from the Wielkopolska Province, but also for patients from all over Poland.

What's more, the hospital management's letter indicated that the facility's services are often used by patients from distant locations who have no idea where nearby pharmacies are located, because their sole purpose is to solve health problems. This is also a nuisance for people with various conditions, such as those that make it difficult to move.

The location of the pharmacy in the hospital building - in the opinion of WWIF - will facilitate the quick purchase of necessary medicinal products. The inspector emphasized that he took into account letters of support from the hospital patients, which was a manifestation of the fact that the initiative to establish a pharmacy in this location "arouses public interest and meets with the approval of patients and hospital staff".

The WWIF decision was positively reviewed by the Mayor of Poznań, Jacek Jaśkowiak . "Considering the important public interest and the arguments in its favor (...), the issuance of a positive opinion by this body is fully justified," wrote Jaśkowiak.

Now the Ministry of Health has issued a positive decision taking into account the arguments of the pharmaceutical inspection.

The Ministry drew attention to the fact that the pharmacy would be located on the ground floor of the hospital building near the general reception and specialist clinics. This would provide patients using medical services in this entity with access to medicinal products without having to leave the hospital building, which will result in patients having a shorter route to the pharmacy. This is - according to the Ministry of Health - particularly important in the case of the elderly and disabled.

The Ministry of Health also assessed that access to the nearest pharmacy is difficult due to parking problems and limited public transport.

Now, a pharmacist who wants to open a pharmacy in a Poznań hospital will have to re-apply to WWIF for a permit to run a facility. Given all the decisions issued earlier, this should be just a formality.

We wrote in Rynek Zdrowia about the cases in which the pharmaceutical inspection decides to make an exception to the restrictions of the "Pharmacy for Pharmacists" policy.

Write to the author: [email protected]

Copyrighted material - reprint rules are specified in the regulations .