Drug turnover: Flawed law endangers patients

Jerzy Mazurek, along with his partner - also a pharmacist - started running their first own pharmacy in 2001 in Warsaw. When they opened several more, they said: enough. But pharmacy chains began to push their way into the market, and they realized that if they didn't continue to grow, they would disappear from the market. They reached 19 outlets in Mazovia. They did not introduce a single branding, image or pricing policy. The pharmacies retained their individual character.

Between 2015 and 2018, like many others, they sold drugs to clinics. - This cooperation was constant. We chose entities that were large and reliable, so that there were no problems with payments," Mazurek recalls.

The calm before the storm

In 2015, they had their first inspection from the Provincial Pharmaceutical Inspectorate, which checked sales to NZOZs. At that time, the correctness of the issuance of requisitions was also verified. - There were no serious objections or post-inspection recommendations, much less any question of initiating proceedings, Mazurek argues. As proof, he cites the report of that inspection. In 2017, inspections appeared at 8 of his facilities. They checked the fulfillment of the clinics' medical orders for drugs, with the main focus on the correctness of their issuance and fulfillment. - We bought 2 photocopiers to prepare copies of all invoices and requisitions in time. At that time, too, there was no signal that these sales were illegal, nor any prohibition to continue them," he says.

After the inspections, nothing happened for a long time. It was only at the end of 2018 that proceedings were initiated to revoke the license. During this period, there had already been quite a few articles in the media regarding the export of medicines from the country, and Minister Zbigniew Ziobro announced a fight against the drug mafia.

In April 2018, regulations were also changed - clinics were ordered to purchase drugs only for their patients, and those with wholesalers were given 12 months to separate these activities. The idea was to prevent so-called "stock transfers" of drugs from clinics to wholesalers, which allowed their further resale, sometimes including export from the country.

Closing 6 pharmacies for representing a group of owners?

Proceedings to revoke the licenses of our interviewee's pharmacies were started by the GIF in 2018-2019. After - note! - 7 years of proceedings, in early 2024, the GIF ordered the closure of one of his pharmacies. The inspection's decision confirms that the pharmacy's actions were legal, but it didn't like them, so it thinks the owners shouldn't like them either. Such demands should have been denied. Since the pharmacy didn't refuse, it means that the owner doesn't give a guarantee for the proper running of the pharmacy and the pharmacy's license should be revoked.

On the day the GIF decision is received, the owner must close the facility. The drugs in his possession can no longer be sold or returned to the wholesaler. They have to be disposed of, and this is an additional cost. These are much more rent, employees, termination notices, etc. (the sums go into the hundreds of thousands of zlotys).

The owners immediately filed a complaint with the court, but according to the regulations, this must be done through the GIF, and the latter has a statutory 30 days to change the decision if necessary. GIF, of course, did not change it, but forwarded the documents to the court on the last possible day. In subsequent cases he later did the same. Along with the complaint, a request is sent to the court to suspend implementation of the decision until a final judgment is obtained. With the court's decision, the pharmacy was allowed to return to business after 3-3.5 months. - However, the cost of the stoppage was enormous, and even months after opening we are doing at most 80% of our previous turnover," Mazurek points out.

Together with about 30 other pharmacists in a similar situation (the inspectorate has also been closing their establishments since 2018), they founded the "Closed Pharmacy" Association. In total, they represent about 100 establishments, but according to their information, there are at least several hundred pharmacy closure cases pending throughout the country due to the reverse distribution chain.

In September 2024, together with MP Grzegorz Plak, they met with the Chief Pharmaceutical Inspector - Lukasz Pietrzak. The latter agreed only to the presence of the MP and one representative of the pharmacy owners. A few days later, Mazurek received by letter decisions to close... 6 more outlets. As proof, he sends the dates on which his permits for 6 of his pharmacies in Warsaw and Ząbki were revoked: September 24, 25, 26, the last on October 1, 2024. The meeting with the chief inspector took place on September 26.

- There had been silence for many years, so it can hardly be considered a coincidence. People are now afraid to speak up," says Mazurek. In fact - one of the owners of the closed establishments withdrew from talks with our editorial board on the subject.

Each of these decisions of the GIF was appealed to the courts, and these courts - in all cases - suspended the closure of the pharmacies. Four of its establishments are still operating thanks to the rulings of the courts of first instance, and 2 are still operating thanks to the rulings of the courts of second instance. The GIF always appeals these decisions, claiming that the closure of a pharmacy is not a big loss for the owner, and that the continued operation of the facility is a greater threat to patients than immediately depriving them of the ability to buy the remaining drugs from the prescriptions they have started. Interestingly, the proceedings took 7 years instead of 30 days and the pharmacies continued to operate the entire time and no one was harmed, Mazurek points out. The court cases are ongoing.

"The Chief Pharmaceutical Inspector - when he issues a decision revoking a pharmacy's license - has a statutory option to suspend the implementation of this decision until a final judgment is issued. However, to date, the authority has not once used this option," the Closed Pharmacy Association emphasizes on its pages.

Same situation - 3 different decisions by inspectorates

In the regulations governing the opening of a pharmacy, there is a requirement for the applicant's warranty. On the other hand, in the regulations specifying in what situations an establishment should be closed, the lack of a guarantee is not listed as such a reason. - This is not coincidental. In a situation where an entity operates 100 pharmacies, and the employees of one of them break the regulations and it has to be closed, this indicates a loss of the entity's warranty. However, the loss of warranty cannot be a reason to close other establishments, as the legislator explicitly states in Section 103 of the Pharmaceutical Law. It is the violation of the regulations stipulated in the law that causes the loss of the permit and, as a result, the warranty, and not, as GIF claims, the loss of the warranty causes the loss of the permit," Mazurek explained.

However, the courts accept the GIF's allegations formulated in this way - Mazurek has had one pharmacy closed down by a final NSA verdict, and other owners have had a dozen more closed down (there have been about 15-17 final verdicts to date). - The courts accept the GIF's argument that although the pharmacy sold to the clinic in accordance with the law, it could have refused to do so. And if it didn't, it loses its warranty and should be closed down, Mazurek explains. He believes that this is the result of a "media campaign" against pharmacists and making people believe that there was a shortage of medicines as a result of their activities, although documents show otherwise (see further below).

The fact that the case may be viewed differently by the Inspectorate is evidenced by the fact that in analogous cases the GIF or WIF issued 3 different types of decisions:

• That the sale was legal;
• That the sale is legal, but the WIF does not accept it and further such activity will be a reason to initiate proceedings to revoke the license;
• That we are closing the pharmacy.

As proof, Mazurek provides us with 5 decisions of the GIF and WIF (some anonymized) on analogous situations of pharmacies from 2015 2017. The first decision from 2019. - The owner faces no consequences, although he gets instructions not to act like this again. In the second - from 2024. - he loses his license to operate a pharmacy. In 3 other decisions from 2016 and 2021 - pharmacies in Poznan and Warsaw (data to the editor's knowledge) - the WIF did not see any violation of the law, although the points did what we describe above.

The Closed Pharmacy Association stresses on its pages that between 2015 and 2017 there was no information or communications from the GIF, WIF or ministries of health or justice that would prohibit such sales. "Pharmacists acted in the belief that their actions were in compliance with the law," the association adds. "We cannot accept that the GIF treats us, pharmacists and pharmacy owners, as criminals. We are not criminals!" - write members of this Association in an appeal to the Minister of Health.

Allegations baseless and misguided, and GIF is passing the buck

We speak with Prof. Dr. and legal counsel Ryszard Strzelczyk, who represents pharmacy owners, about the allegations the GIF is making against pharmacies that are closing down. He says the GIF is skimming over the facts in the allegations it is making: - When reading the allegations, one gets the impression that pharmacies are making millions. Meanwhile, when a package of a drug cost PLN 640, the pharmacist had only less than PLN 21 in gross revenue from it - the official margins. GIF presents this PLN 640 as the pharmacist's earnings, and this is a simple lack of integrity.

In addition, the pharmacy's earnings in the case of the sale of drugs to both the clinic and the patient were identical.The professor confirms that a warranty - that is, integrity and honesty in one's professional life as well - is needed when issuing a pharmacy license. - However, there is no provision in the pharmaceutical law that explicitly states that the loss of the warranty is equivalent to the closure of the pharmacy, he points out.

In his opinion, even if one were to agree with GIF's assertion that the loss of the warranty means the loss of the authorization, one cannot agree with the view that the loss of the warranty could be caused by the sale of medicinal products to NZOZs run by entities that also own pharmaceutical wholesalers. - This was not prohibited at the timeThe allegation is therefore completely unfounded," he stresses.

What's more, it was the GIF that issued approvals to all of these clinics to operate wholesalers, and it was the GIF that was responsible for inspecting these entities. If, in the GIF's opinion, operating these two activities simultaneously was a potential threat, it was enough to deny the license.

He also mentions that until August 1, 2018, such sales were basically the norm. At that time, many NZOZs were run precisely by entities that also owned pharmaceutical wholesalers.

Another accusation GIF made against pharmacies - they were selling drugs from the list of medicinal products at risk of unavailability in the territory of Poland to NZOZs, and these drugs could end up abroad. The snag is that pharmacies sold them to NZOZs in the country. On the other hand, the export of such drugs abroad could be carried out by pharmaceutical wholesalers, and always with the prior approval of the GIF. - Moreover, in the case of my clients, the GIF did not find any case of exporting the drug abroad. The allegation is therefore extremely misguided emphasizes Prof. Strzelczyk.

The third allegation was that pharmacies did not check whether NZOZs ordered drugs for the purpose of providing health services to their own patients. - At the time, pharmacies did not have to do so because the regulations at the time allowed clinics to freely dispose of purchased drugs including, for example, supplying drugs to other clinics owned by the owner. Such an obligation was only introduced in 2018 when a provision came into force requiring that the procured drugs be used exclusively for the needs of the procuring NZOZ. The allegation is therefore completely without merit," Prof. Strzelczyk stresses.

NIA: We will never side with pharmacies that have been involved in drug exports

Marek Tomkow, president of the Supreme Chamber of Physicians, stands on the side of the GIF in this dispute. - They (pharmacy owners - ed.) participated in this practice of exporting drugs abroad. If someone sold gigantic amounts of drugs to the NZOZ, they were fully aware that the facility was not using it for its own needs. And these were scarce medicines," he explains.

When we point out that the pharmacies were doing what the law did not prohibit at the time, Tomkow admits that the pharmacies were taking advantage of "legal loopholes." But he argues that they were violating the Pharmacist Code of Ethics. - These pharmacists acted to the detriment of the patient, because at the time there was a shortage of these drugs, such as oncology drugs and anticoagulants. This is not a basis for closing a pharmacy, but the GIF invokes its arguments," Tomkow points out. He stresses that a pharmacist is supposed to practice his profession in such a way as not to exploit loopholes in the law. Violators of the code of ethics end up before the pharmacy court.

The president of the "Closed Pharmacy" union argues that there was no shortage of medicines for Polish patients. In 2021-thanks to parliamentary interpellations-they obtained data that indirectly proves this. - After the legislation came into force in August 2018 changing the rules for the purchase of medicines by NZOZs, which resulted in the termination of the described demands, the number of medicines reaching patients did not increase at all. For many items, it even decreased. That is, the earlier sale of these drugs to outpatient clinics by several thousand pharmacies did not cause a shortage for our patients," the interviewee explains.

As proof, he makes available the interpellations of Jaroslaw Sachajko and Pawel Szramka from February and April 2021. In them, the Health Ministry disclosed lists of more than 100 drugs that clinics bought (including neulasta, kreon 25,000, fostex, ins. Astrapid penfil) and their availability to patients between 2015 and 2020. Most of them were indeed as or more available by 2018 than they were after the introduction of regulations banning sales to NZOZs with wholesalers.

A 2017 report by the Supreme Audit Office (NIK) on the provision of access to medicines, which we accessed, states that the director of the GIF's Supervision Department assures that drug shortages in at least 5% of pharmacies were most common in 4 western provinces. "Therefore, the effects were very limited and did not affect the health and life risks of patients." This would confirm Mazurek's words.

The Closed Pharmacy Association claims that about 7 thousand establishments are threatened with closure, because that is how many, according to data obtained from MP interpellations, traded drugs with NZOZs, which at the same time had wholesalers. We reach an interpellation from 2020, in which Confederation MPs claimed that up to 8,000 establishments could be threatened with closure - that's how many were supposed to carry out such trade when it was not banned.

In an interview with Medexpress, Marek Tomkow admits that at the time many pharmacies in the market sold drugs to NZOZs with wholesalers. - But most did not do so in wholesale quantities. There is no risk of closing 7,000 pharmacies he points out.

- No pharmacy sold drugs in wholesale quantities, because the quantities of drugs that reached pharmacies were limited by manufacturers. As proof, he presents data from the decision revoking the authorization (e.g., Xarelto 30 op. per month, Clexane 9op./dose per month, Twynsta 6 op. per month, Rispolept Consta 6 op. per month, Zoladex 6 op. per month - and this is all the total amount to 6 clinics). In addition, the GIF is also closing pharmacies that had total sales to dispensaries of 100-200 thousand zlotys throughout the controlled period," says Jerzy Mazurek.

We asked the GIF whether it wants to close down establishments that only did this trade on a large scale, or also those that did it on a small scale. And if so, where is the line between the two. We did not get an answer to this question.

Marek Tomkow reassures that the possible closure of a pharmacy is a series of decisions by the relevant institutions: first the WIF, then the GIF, and finally the court, and often in 2 instances. These analyze individual situations and make adequate decisions.

GIF revoked licenses for 118 pharmacies

We asked the General Pharmaceutical Inspectorate 6 questions about the phenomenon, statistics, GIF decisions, their reasons for action. We did not receive a response to them. We were sent only the unsigned content of an elaborate statement. Below are its most important elements:

• "The authority has consistently taken the position that the fulfillment of demands by pharmacies was and is one of the forms of supplying outpatient clinics with medicinal products provided for by law - as long as under the guise of a legitimate mechanism does not fall an action detached from the needs of the medical entity, whereby large quantities of medicinal products are dispensed from pharmacies, which it is obvious that they do not serve its activities and will not be used by these facilities to carry out their tasks. This is because these medicines will not reach patients."
• "The sale of medicinal products on demand was and is unacceptable if there could be non-medical use of medicinal products in this regard, i.e. in a situation where the medicinal product indicated on the demand could not be used in a medical establishment, in accordance with its business profile."
• "Sales of medicinal products outside the above-mentioned list combined with additional relevant circumstances, such as the type of medicinal product (...), the wholesale volume of these products, sales to entities hundreds of kilometers away from pharmacies fulfilling the demands, or finally sales to entities not conducting registered medicinal activities or running parallel wholesalers, constituted the essence of the cases on the basis of which the GIF's revocation decisions to date were made."
• "In connection with the above violations since 2017. The GIF has issued approximately 118 rulings revoking public pharmacy licenses in this regard (...). The Administrative Courts, when adjudicating cases of complaints against the GIF decision (...), largely apply interim protection measures in these cases, suspending the implementation of the final GIF decision, so entrepreneurs can conduct business until the case is finally decided by the court."
• "Decisions issued by the GIF in the last two years alone involved cases in which drugs worth more than PLN 52 million were taken out on the basis of this mechanism, thereby repeatedly depriving patients of access to pharmacotherapy."

Let's add that in 2015-2017 the pharmaceutical market in Poland was worth almost PLN 100 billion. Thus, these 52 million zlotys represented 0.05% of the market value (sic!).

2,300 pharmacies have disappeared from the market. NIA: Approx.

At the end of 2017, there were 13,600 of these outlets, while according to a January 2025 report by the Employers of Poland, this number dropped to 11,360. That is, in seven years, more than 2,300 outlets disappeared from the market. A lot of credit for this also goes to the "Pharmacy for the pharmacist" law, which drastically limited the possibility of creating new outlets. Thus, pharmacies mainly closed, because the cost of maintaining them grew disproportionately to profits.

The president of the Supreme Pharmacy Chamber is not worried about this situation. Tomkow believes that we had too many pharmacies in the country, because some of them were involved in participating in the export of medicines abroad. We now have a similar number of establishments as in Germany or the UK, with those countries having significantly more people than Poland.

The owners of pharmacies that are being closed, or threatened with closure, cannot come to terms with these decisions, especially since "strangely enough," as they say, they only apply to selected pharmacies. They feel aggrieved by the fact that the state prepared imprecise regulations allowing other entities to export medicines and the position of WIF, GIF, courts and prosecutors at the time confirmed the legality of such transactions. After a few years when the phenomenon due to the change in regulations no longer existed (which is the best proof that the change in these regulations was needed), consequences began to be drawn for situations that have long since ceased to exist, based on the new regulations. Withdrawing licenses from pharmacies are decisions on which all parties lose: patients - lack of access to a neighborhood pharmacy, pharmacists - loss of their life's work, the state - loss of the taxpayer, in which not so long ago enormous resources were invested to survive the COVID period. In addition, a huge amount of full-value medicines must go to the trash.

For the state and government offices, it is also about image, efficiency and credibility.

If there are any irregularities in the health care system today that cause "danger to the health and lives of patients," will the relevant authorities not respond until 2032?