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EF: How do you see 2024 as a challenge or an opportunity?
AG: Last autumn, parliamentary elections took place in Poland, reshaping the political landscape. Our priority this year is to establish strong relations with the new authorities, built on mutual trust and constructive dialogue. We can continue our growth if the government doesn't impose restrictive rules. Given the rapid aging of our part of Europe, the market is bound to expand significantly, currently at a rate of 5 to 10% per year.
EF: What are your priorities for the upcoming years? What are you focusing on as an association?
AG: Within our organization, we currently boast a membership of 110 companies, comprising 70% distributors and importers, with the remaining 30% constituting manufacturers. We need to ensure that our member companies operate in a business-friendly environment thanks to which patients and healthcare professionals have access to medical devices needed in their therapy and work. To achieve these goals, we communicate the value of medical technologies to payers, policymakers, and society. On an everyday basis, we take different actions which include, but are not limited to:
- Constant cooperation with decision-makers and healthcare system key opinion leaders to ensure that the interests of the MD/IVD industry are protected and looked after.
- Indicating changes that need to be introduced in the Polish law and healthcare system so that both Polish patients and HCP’s have proper access to medical devices and technologies available on the market.
- Participation in public consultations on draft laws that influence the functioning of the medical devices market.
- Promoting the idea of medical devices being important components of patients’ treatment and diagnosis and thus being key elements of healthcare systems.
In the Polish healthcare system, there are different ways of public financing for medical devices depending on the type of the product and its final user (whether these are HCPs, hospitals, laboratories or patients themselves). They can be bought in public tenders by hospitals or by patients on doctor’s prescriptions. We try to provide decision-makers with the ideas of proper solutions for each of these MD groups.
Currently, our primary challenges revolve around solving legal issues and barriers, being the consequences of the largest amendment to the Polish Act on the Reimbursement of Medicinal Products, Foodstuffs Intended for Special Dietary Purposes and Medical Devices.
The amended law, among other things, empowers the Ministry of Health to set fixed prices for medical devices used in hospitals in connection with publicly financed healthcare services.
This poses a significant challenge as it contradicts the principles of a free market. While the rule has yet to be applied, we're working to change it, aiming for a positive impact on our industry.
Other issues to be solved, that are not related to the above-mentioned amended law, include:
- creating a legal framework for faster public financing for innovative medical devices.
- creating a legal framework for using digital medical devices within public financing
- dialog with decision-makers in order to convince them to regularly update the list and limits of public financing of medical devices available to patients on doctor’s prescriptions.
- implementing changes in reporting of patients’ laboratory test results to the national health databases
EF: How do you balance and prioritize the topics you are working on for your members?
AG: The Management Board sets the general line of POLMED’s actions and general associations’ goals and policies. On an everyday basis, we operate through structured groups devoted to a particular matter sector, or type of medical devices. Members decide what group they want to actively participate in. Those groups set their particular goals and activities.
EF: How do you see the digital trends you are working on? How do you see the entire digital aspect evolving regarding AI and big data impacting your members?
AG: In Poland, the number of distributors greatly outweighs the number of manufacturers. Therefore, critical decisions, especially concerning AI and sustainability, typically originate in manufacturing countries. In our context, discussions revolve around hospitals' openness to adopting AI solutions, with a key focus on data safety. We prioritize urging the purchase of secure devices, emphasizing the importance of data safety. Poland has a growing landscape of startups venturing into AI device manufacturing. Although the field is expanding, my knowledge of regulatory aspects is limited to distribution concerns rather than manufacturing.
Recently, during a trip to Taiwan, I observed their significant efforts in AI and machine learning. Poland is also witnessing growth in manufacturing AI devices, but I can't delve deeply into regulatory matters. One governmental challenge we face is establishing an agency or urgency to oversee AI. While a Ministry of Civilization might be in Poland, their expertise doesn't extend to devices. It's a developing scenario, and addressing these issues requires collaboration.
EF: Could you describe Poland’s medical technology offering and how innovative it is?
AG: The data regarding the number of medical devices available on the Polish market comes from the Polish database of devices, but it's crucial to note that it's a significant estimation. Over the last four years, I've been actively involved in conferences and meetings, around 40 per year. I always highlight that there are approximately 300,000 registered devices and 16,000 pharmaceutical products in Poland. This diversity of devices surpasses medicinal products, showcasing innovation. The European Patent Office data show that medical technology is the second most innovative industry in Europe.
EF: How does Poland's medical device manufacturing sector compare to other European countries?
AG: Europe can be broadly divided into manufacturing and distribution countries. For instance, Portugal faces challenges similar to Poland's, and we fall into the distribution category. We import more medical devices than we manufacture while countries like Germany, France, Switzerland, and Spain are on the manufacturing side.
However, it should be noted that the Polish MD manufacturing sector has grown in recent years. There are substantially more medical technologies and devices manufactured in Poland and our manufacturers have been constantly developing new products and improving those already introduced to the market.
Considering our geographic location, with Ukraine as our neighbor, we receive numerous inquiries, making Poland an ideal hub for manufacturing and distributing devices globally. Some major companies are already investing in manufacturing here, capitalizing on the strategic position for reaching both Ukraine and Europe. This trend is growing, with global companies opting to establish their manufacturing presence in Poland.
EF: Is prevention and early diagnosis something the industry is talking about, and is it a trend to which medical devices are moving?
AG: We acknowledge the industry's awareness, but our major hurdle is the government's reluctance to invest more in medical devices, early diagnosis and creating a proper law environment together with public financing rules around them. I've consistently emphasized that medical devices played a crucial role during COVID. Medical devices make it possible to diagnose, treat and carry out rehabilitation. Together with pharmaceuticals and doctors, they are a key element of curing patients. However, we're witnessing some shifts, limited to individual healthcare problems, with a recognition of the importance of devices. For example, there's a transition from diabetes strips to CGM devices, reflecting changing perspectives. While the pharmaceutical sector is substantial, we aim to alter the government's mindset, acknowledging the importance of investing in devices for the nation's progress.
EF: Do you have any final message for the readers?
AG: Poland is located in central Europe and this factor itself demonstrates the great potential of our country. Poland is the 5th largest country in the European Union, with a population of around 37 million. Among the EU nations, Poland's economy holds the sixth position. Poland is well known for its well-educated and hard-working labor force.
All the above-mentioned factors make our country a good and safe place to invest and cooperate with.
