Grzegorz Cessak, President of the Office for Registration of Medicinal Products, Medical Devices and the European Leadership of Poland: "It's not only money that matters - we need transparent regulations"
How does Poland shape drug safety in the European Union and support the development of clinical trials? This is one of the questions that Grzegorz Cessak, President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, answers in an interview with politykazdrowia.com. He also talks about how the Polish presidency influences EU strategies in the fight against drug shortages, the digitalization of research systems and what health priorities it sets for the whole of Europe.
The Polish Presidency of the Council of the European Union brought a number of significant initiatives in the area of public health – from actions for drug safety , through the digitalization of the clinical research system , to including children's mental health on the European agenda. Polish institutions, including the Office for Registration of Medicinal Products , played a key role in these processes.
From the perspective of the European Medicines Agency (EMA) , according to President Cessak, the new, expanded mandate of this institution, which includes supervision of medicine shortages and their availability , is very important.
The European Medicines Agency, together with all Member States, is strongly committed to these issues – said the President of the URPL.
As he explained, both short-term and long-term strategies are being sought to streamline procedures and improve the availability of medicines .
We are looking for opportunities to improve existing procedures and find the best solutions, he noted. He also recalled that as many as 80 percent of active substances come from outside Europe.
He pointed out the need for support not only financial but also procedural:
It must not be forgotten that not only money is important here, but also transparent and predictable regulations, simplification of procedures, and quick post-registration changes in the case of adding places for the production of medicinal products.
In his opinion, all these elements are crucial for both manufacturers and patients. President Grzegorz Cessak also noted that the topic of the effectiveness of EU mechanisms for responding to drug shortages – such as the actions of the Health Emergency Preparedness and Response Office (HERA) or the rapid notification procedure – is a permanent topic of discussion at the level of various working groups. It is worth emphasizing that the solutions adopted by the EU Council in the pharmaceutical package under consideration also fit into this strategy. At the level of the Member States , new regulations were adopted regarding a comprehensive system for managing drug shortages , including the proposed solutions such as the obligation to report the risk of shortages in advance and the requirement to have plans to prevent shortages , which will allow for more effective supply chain management .
Another solution is to coordinate actions between Member States to reduce situations where medicines are unavailable in one country while there are surpluses in another.
The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products pointed out that the key importance in this respect is Critical Medicines Act, proposed by the European Commission . Grzegorz Cessak reminds that its main assumptions are: financial support for initiatives aimed at increasing the production of key medicines and diversifying their supplies , as well as joint public procurement and monitoring supply chains . The Critical Medicines Act is to increase the availability of medicines considered critical in the Union. The aim of the document is to protect the health of citizens by supporting the diversification of supplies and the development of pharmaceutical production in Europe . The proposal is to strengthen the European pharmaceutical sector , which plays an important role in the economy. The document also assumes better access to other medicines that may currently be difficult to access on individual markets. This initiative is an important step in achieving the goal of the European Health Union, which is to provide patients from all over the EU with access to necessary therapies.
In the opinion of President Cessak, a very important element in building the attractiveness of Europe for clinical trials was the implementation of Regulation 536/2014 , thanks to which all trials were transferred to the new Clinical Trial Information System (CTIS) .
CTIS , as our interlocutor reminded us, is a harmonized application system that facilitates cooperation between sponsors and clinical trial supervisors in the European Union and European Economic Area (EEA) countries. The CEO noted that the system provides broad access to data and enables patients to track trials as well:
Patients will gain access to information on trials and will be able to use a convenient, Polish-language search engine – explained the president of the Office for Registration of Medicinal Products . – The CTIS system has been operating since January 31, 2025, the regulation on clinical trials is fully applied. To date, over 5,000 transferred trials and nearly 5,000 new ones have been posted in CTIS . Preparations are currently underway to develop a roadmap for the modernization of CTIS , which, based on the simplification of business rules, will provide a modern, sustainable and user-friendly platform.
And he added:
We have fully implemented the provisions of Regulation 536/2014 . Data transition has already been completed – explained Grzegorz Cessak . – Implementation of Regulation 536/2014 and the related transfer of all studies to the new CTIS system was a fundamental step towards standardizing and streamlining the process of conducting clinical trials in the European Union, ensuring greater transparency, safety and efficiency. of this area.
When asked what had been achieved thanks to the implementation of CTIS, the President of the URPL provided specific figures:
As I have already mentioned, we have almost 5,000 new studies in the European Union , which means almost 10,000 studies in the new system.
He emphasized that CTIS is attractive due to its flexibility, digitalization , simplification and quick access to data .
In addition to CTIS, a key initiative is ACT EU – Accelerated Clinical Trials.
This is a programme that the European Medicines Agency, together with the heads of national registration agencies, is conducting to make the European Union area more attractive for clinical trials , Cessak explained.
He noted that ACT EU brings together representatives of all groups involved in research – sponsors, researchers, supervisory authorities, and the academic community.
These are two key elements today: improving the electronic, procedural system and long-term, strategic improvements – noted the president of the URPL.
Grzegorz Cessak pointed out that Poland is implementing solutions developed at the European Union level in real time.
These good practices developed by the European Union are also transferred to our market, he assured.
He pointed out that many products of state-owned companies are on the list of critical drugs. Actions in this area are coordinated by the Ministry of Health , the Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
We – the Ministry of Health , the Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products – take great care to provide patients with critical medicines, he said.
He stressed that the Ministry of Health has a special Team for Combating Medicine Shortages , which is constantly analysing the situation together with the National Health Fund and other institutions.
The system is developed, although of course you always have to look for the best solutions – explained Grzegorz Cessak.
When asked about the most important achievements of the Polish EU Presidency, President Cessak indicated several areas: drug safety and the adoption by Member States of a compromise on the so-called pharmaceutical package , digital transformation , dialogue on the reform of regulations within the so-called "Farma Review" and children's mental health.
I believe that we managed to raise so many issues that we successfully provided topics for work on for the next presidencies following the Polish presidency, he assessed.
He also noted the high level of involvement of Polish institutions:
We were very active in all sectoral activities – both the Ministry of Health and the Office for Registration of Medicinal Products, he added.
Of particular importance – according to the President of the Office for the Protection of Human Rights – was the inclusion of the topic of mental health of children and adolescents in the priorities of the presidency.
This topic has been raised and will be continued, he assured.
In his opinion, including the topic of children's and youth mental health among the presidency's priorities was particularly important for several key reasons. First, it highlights the growing importance of young people's mental well-being in the context of their development, education and future social integration. Second, including this issue in the presidency's agenda meant drawing attention to the need to take action at international, European and national levels, which can contribute to developing effective strategies and policies supporting young people's mental health. Third, according to Grzegorz Cessak , such a step also had a symbolic meaning, showing that issues related to young people's mental health are taken seriously and deserve equal attention alongside other important social and health topics.
The President recalled that the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products was involved in this area through activities related to pharmacotherapy and clinical trials in child and adolescent psychiatry.
This is a very important topic – we need to look for the best solutions in the treatment of such diseases: in clinical trials, data extrapolation, dose selection, flexibility, single-arm clinical trials – he listed.
He added that ethical aspects are no less important:
This topic should be continued because it is very important socially, he concluded.
Grzegorz Cessak also referred to the success of the Polish presidency of the EU Council recently announced by the Minister of Health Izabela Leszczyna – namely the adoption by the member states of a compromise on the so-called pharmaceutical package
I believe that the success of the Polish presidency in reaching a compromise on the pharmaceutical package is of great importance both for Poland and the entire EU drug market - said the President of the URPL . - Poland's position as a country that actively participates in the development of innovative therapies and is able to independently produce medicines important for public health will be strengthened. This in turn translates into greater independence from foreign suppliers and minimizes the risk of interruptions in the availability of medicines. As the Minister emphasized, we have reached a consensus that seemed impossible to many. We tried to reconcile the interests of innovative entities on the one hand, but also to take into account the generic medicines market, because the availability of medicines for patients, including for modern therapies, is key here - he emphasized.
In Grzegorz Cessak's opinion, the achievements of the Polish presidency can contribute to lowering the costs of medicines on the EU market, through the development of competitive producers and innovations in the field of pharmaceutical production. As a result, patients from all over the EU will be able to benefit from more accessible and modern therapies.
In the context of drug safety , we are increasing the resilience of the health system to potential crises, related to, for example, global disruptions in supply chains . Having our own production capacities and developing new drugs improves the safety of drug availability, which is crucial for effective health care - explained the president of URPL .
To sum up, he added:
The Polish Presidency is paving the way to strengthening the EU's self-sufficiency, improving the quality and availability of medicines , and thus increasing drug safety at both the national and EU levels.
Updated: 13/06/2025 15:23
politykazdrowotna
