A leader for difficult times

One year has passed since the Minister assumed the position. What year was it like and what challenges did you have to face?

It was a year full of ambitious challenges for me, and I tried to approach them comprehensively. The fact that the Minister of Health appointed the Team for the standing up of the State Pharmaceutical Inspection and the advanced stage of work in which we are now, is certainly a success. All projects related to the development of the pharmacist profession in which we participate as GIF are also important to me. This is not part of the competences of our office, but it is an additional goal for us in terms of developing common solutions and cooperation. I know that pharmacists have waited several years for these solutions; covid-19 has become a kind of "springboard" for representatives of the medical professions, thanks to which the process of expanding competences runs more efficiently. Pharmacists should benefit the most from this.

The Minister of Health appointed a Team for the development of solutions in the field of clinical pharmacy and the activities of pharmacists in medical entities, along with a list of diagnostic tests performed by pharmacists. Our team includes both practitioners and theoreticians. We work dynamically, so I expect quick and satisfying results. Personally, I am involved in activities in the field of pharmaceutical care, drug review and vaccinations. As GIF, we consulted many projects that are already implemented today. From the beginning, we approached them enthusiastically, with the faith that they would succeed and a willingness to cooperate.

I was able to raise, without increasing the number of jobs, project readiness, for example by appointing a new organizational unit - the Office of the Main Pharmaceutical Inspector. We create an information policy more effectively, conduct communication projects, and respond to social needs in the area of ​​reports, analyzes and strategies. I was also able to appoint - for the first time in the history of GIF - the position of the organ's press spokesman.

The successes include shifting the office to the path of greater cooperation with other public administration units. We have signed agreements with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the Ombudsman for Small and Medium Enterprises. We also work with many other units, including research and scientific, we exchange information and support projects. For me, it is extremely important because I take the position that cooperation is always the foundation of effective action based on responsiveness and flexibility. This is my vision of the office. From the perspective of the organizational formula, the State Pharmaceutical Inspection should, above all, be vertical. This will optimize its operation. In all activities of the Inspection and in the projects we consult, the overriding goal is to ensure the safety of patients. The availability of drugs is very important, as well as the acquisition of knowledge and taking effective actions related to this issue in order to counteract drug shortages on the market. GIF regulates and checks whether entrepreneurs comply with the legal provisions. We also have a procedure for issuing negative decisions in relation to entrepreneurs who do not respect the provisions, do not care about the interests and safety of patients. Ultimately, our control always serves patients.

In your vision, is the office a modern, computerized facility?

Computerization is essential today. There is no other way. The prerequisite for the computerization process is administrative readiness and well-qualified processes. The GIF is not at this stage yet. Computerization is certainly a strategic goal for us, but at the moment we need to finalize organizational issues and standardize the activities of the Inspection. Computerization is the next step, which will also meet the needs of entrepreneurs and general problems related to the excess of duties imposed on staff.

Do you see GIF as an office focusing on control and penalties, or rather an institution-partner?

Definitely a partner. I believe that despite our role in supervising the market, we are able to act through dialogue and cooperation with organizations associating entrepreneurs. We can be a regulator who listens and talks. Tightening up our actions should only apply to entrepreneurs who do not comply with the law. We know the mechanisms of bypassing the regulations by some entrepreneurs. But these are individual issues.

One of the disputed topics last year was the franchise on the pharmacy market and the divergent decisions of the WIFs. Why has GIF issued an announcement on this?

When it comes to provincial inspectors, I would like to emphasize that we are not currently noticing any discrepancies in the procedures in the area of ​​franchise. Some time ago, we saw the need to present one consistent position of the State Pharmaceutical Inspection. The announcement was addressed to entrepreneurs expecting a transparent interpretation of the regulations, the position of the office regarding the refusal to grant or transfer a permit in connection with the concluded franchise agreement. By the way, we managed to harmonize the position with the Ombudsman for Small and Medium Enterprises and the President of the Office of Competition and Consumer Protection. The provincial pharmaceutical inspectors did not need this communication to refer to the franchise issue. This could be a new position for entrepreneurs: franchisees and franchisors. Currently, relatively few new permits are issued. The pending administrative proceedings mainly concern the franchise or the formula for transferring the permit in connection with the creation of a new entity. We note cases in which the buyer, by concluding a franchise agreement and accompanying agreements, may collide with the anti-concentration provisions in connection with Art. 99 sec. 3a. A franchise, like any contract, should be tested for compliance with the law. Remember that the pharmacy market is rationed, which means that the entrepreneur must meet certain conditions. And this applies to all contracts concluded between entrepreneurs (premises contracts, loan contracts, franchise-related contracts). Our office examines whether the conditions laid down by law have been met. There are incidental cases in which the authorization for running a pharmacy is not actually granted or transferred, because the relationship of the franchisee's dependence on the franchisor is too far-reaching. We use the interpretation of the acquisition of control and the concept of a dominant entity, which refers to the conceptual framework of the provisions of the Act on Competition and Consumer Protection. We operate in accordance with the Pharmaceutical Law and the Act on OKiK, which indicate in which cases control is taken over. If the buyer actually concludes a contract that goes too far, then we refuse to grant permission.

What are the goals of the verticalisation of the Pharmaceutical Inspection?

The patient is always at the center of our interests. An efficiently operating Inspection increases drug safety, which is shaped at every stage of the distribution chain, from manufacturers to pharmacies. Producers have a niche to develop here - and a huge challenge: increasing API production in our country. The next in the chain, wholesale distributors, also have many improvements and logistic solutions to work out. Likewise, pharmacies are now increasing the availability of vaccines by creating vaccination points. PIF also adds an important element to the overall issue of drug safety. Through constant monitoring of the availability of drugs, it is able to anticipate possible shortages and prevent such situations in advance. Good organization of PIF means increasing the efficiency of the state in terms of not only supervision, but also the development of this market, it means safety and good access to high-quality drugs for patients in Poland. The verticalisation will certainly meet the expectations of entrepreneurs related to the standardization of processes and the interpretation of regulations. This is one of its strategic goals. Pharmaceutical law is constantly changing that is difficult to keep up with from the perspective of market stakeholders. After verticalization, a uniform and stable interpretation of the law will function within one decision-making center related to market control and supervision. I think that ultimately it will increase trust in the office and public administration, which I really care about.

What stage of upright standing are we at?

In the process of verticalization, GIF feels responsible for the preparation of documents, analyzes and concepts, for cooperation in the preparation of legislative projects. The team appointed by the minister of health, dealing with issuing opinions on our concepts and assumptions, works dynamically and efficiently. Today, we understand verticalization as a process that is to lead to the creation of one organ, instead of seventeen (sixteen WIF and one GIF). At the present stage, we are talking about the Main Pharmaceutical Inspectorate, which will cover the entire country.

What awaits GIF in 2022?

In the first week of the new year, we submitted the draft PIF Strategy for 2022-2025 for external consultation. It is a document setting the framework for functioning in the context of the reorganization and reform of the Inspection. The road is bumpy, so the strategy will provide a safe platform for the direction of change. I would definitely like to complete the verticalisation process and, after consolidation, achieve a certain synergy between all WIFs (we will gain sixteen directors in one integrated institution). I see this as an opportunity to expand the operational capacity and know-how in our market. This year, I expect the publication of the report of the Clinical Pharmacy and Hospital Pharmacists Team. I hope to run this office for another year with current and future employees in a sense of security and mutual trust. I want to guarantee order and stability for all employees and the office.