Read the Conversation
EF: As an industry expert, do you see 2024 as a challenge or an opportunity?
KK: I see 2024 as both a challenge and an opportunity. The Polish market is facing some challenges as a result of the amendments to the reimbursement bill. These amendments have created a new situation that manufacturers and pharmaceutical companies find difficult to adjust to. All the stakeholders are prepared for this new situation that they need to navigate.
The first phase of these amendments came into force on November 1, 2023. The second phase will commence on the first day of 2024 and in the middle of that year. This is the timetable that is planned for the implementation of the new framework. One of the new instruments will stimulate production in Poland and affect the government and domestic producers differently. We want to support domestic producers such as Polpharma, Adamed, and Biofarm, as well as international companies. The supporting measures were supposed to stimulate production in Poland, but the implementation of changes is too slow.
We also want to support the companies that invest in and produce medicines strictly in Poland. These companies qualify as domestic producers. These companies will be entitled to reimbursement benefits because of their impact on the Polish market and the drug safety they provide for Polish patients. There will be a co-payment for the drugs they produce, with a 10 percent price cut for the medicines produced in Poland and 15 percent for the products produced in Poland from (including) Polish API.
This level of the price cut for co-payment is not a great stimulator for Polish patients to choose Polish products. As the representative of domestic producers, we proposed that this support should be concerned with the producers (all portfolios), not medicines one by one. As a partner in the Polish reimbursement and economic system, you should be entitled to some benefits. The government has proposed some steps in the right direction due to challenges such as COVID-19, supply chain changes, and the Ukrainian-Russia war. Although these are steps in the right direction, we want more steps, which is a challenge for us.
There is a lot of discussion on the European level around the Green and Blue Deal. Production in Europe is influenced by many factors that affect costs and prices. Poland is facing one of the highest levels of inflation, and prices are at almost the lowest level in Europe (in the pharmacy channel). We have discussed measures to deal with price levels and ensure that Polish medicines are unaffected by inflation. We are also taking on this challenge to ensure our medicine exports remain competitive.
We recently had an election in Poland, and we are changing government. This will see a change in the Ministry of Health, which is responsible for drug policy, and all of the industry actors. This creates an opportunity for us because we will be able to push for provisions that can stimulate local production and improve local medicines, which is an important issue for us.
We have also engaged the Ministry of Economic Development to discuss the critical medicines that are important for Poland. These discussions are also ongoing at the European level because we have to create a comprehensive list of these drugs. This list of drugs should contain the most popular and innovative drugs that must be produced in Europe. We have put Poland forward as the location where the manufacture of critical drugs could take place.
The challenges we face in the Polish domestic sector are not as many as those in other countries that face drug shortages. Poland has emergency stocks and procedures to deal with any shortages. Poland could share some proven instruments with the European Union regarding a drug tracking system. We have a system that tracks drugs using a code. This code can be used to track the drugs from the producers to the wholesalers, and from the wholesalers to the pharmacies. The product locations are known at all times.
EF: What is the role of Medicines for Poland, and what are your current priorities?
KK: Our priority is to create an environment where the new amendments bring a positive impact to the producers and the patients. The environment should eliminate problems, shortages, and barriers in the way medicines are distributed.
One of the paths to reimbursement for medicines is in pharmacies when the patient is co-paying, and this is the path on which our companies are most influential. There are also drug reimbursement programs for the most innovative and expensive drugs used mostly by companies associated with the employers' union`s Infarma. This is the structure of the Polish reimbursement sector.
In the last four years, spending on new drugs and new paths of healing has increased by 100 percent on the path of drug programs, from 4 billion zloty to almost 9 billion zloty. During the same period, expenditure for reimbursement in the pharmacy channel increased only by half a billion zloty. This is a challenge for Medicines for Poland. Spending more money on innovative drugs is perfectly fine because patients and the market want those drugs, but we take into account that most of the population of Poland and the EU is healing by generics and biosimilars. For public health, these drugs are even more important because we treat more patients with them.
Another task that we would like to highlight is access to biosimilars in Poland. Access to biosimilars in Poland is growing. However, there are strict criteria for reimbursing drug programs involving biosimilar drugs and some limits put on the reimbursement of these drugs by pharmacies. Access to biosimilars in Poland is still several times worse than in other EU countries. Biologics take time to create, but we can expand the market for these drugs for the benefit of the patient. We are adjusting prices to a realistic level in the Polish market for generics and biosimilars. Therefore, we postulate that biosimilar medicines should be available not only in hospitals but also in outpatient clinics.
EF: You are in talks with various stakeholders and members. How do you balance the priorities of these different stakeholders?
KK: It is certainly not easy. We currently have 17 members and represent a third of DDD-reimbursed Polish pharmaceuticals. Fifty percent of DDD in the Polish market is from our members because they are the biggest companies in the generic and biosimilar sectors. They include Polpharma and Adamed. All these companies are involved in our production market and contribute to manufacturing medicines in Poland. Most of the companies in our association have manufacturing facilities.
EF: How do Medicines for Poland work with companies nationally and internationally to bring investments into Poland?
KK: We cooperate strictly with our members in the local and international markets to promote growth in these markets. We collaborate with our government and agencies to encourage them to invest abroad and attract investment to Poland. We discussed the importance of creating an attractive biosimilar market. We just need to cooperate with other Polish agencies to develop it. We also collaborate with biosimilar startups to create an environment that makes investing in Poland easier and more attractive. We have the capabilities and specialists for this market. I believe it is important to improve the situation.
We have had a lot of success due to the challenges we are facing, such as the draft amendments that are coming into force in 2024. Reimbursement is very important to the members of our group, and they have raised concerns about a provision that suggests that many Polish drugs in the reimbursement system must be removed from our list and no longer qualify for reimbursement. We worked with the government to show them how to draft provisions within the reimbursement system that were endangering the local production industry. After an extensive collaboration, we managed to craft a provision that was beneficial for all parties.
We also highlighted the provisions about supporting domestic production. These are some of our successes. This is the first time the Polish government has worked on understanding and focusing on drug security. This is a step in the right direction, and we see this as a success.
At the European level, we contributed to creating the SPC manufacturing waiver. We were involved in the discussion with the European Parliament, which supported our statement of the importance of the SPC waiver. This was codified into law, and we believe this is important for our European manufacturers. Poland has been engaged in a re-negotiation of the reimbursement decisions every 3 years. Our company can claim success in this process because we fought the situation when they wanted to price cut our products. This was successfully rejected 2 years ago, but in 2024 will be the next negotiation with the government. We have a common goal with the government - Poland's drug safety.
EF: Do you have any final messages for our readers?
KK: We need to have a helicopter view of the European and Polish markets because, for years, the national payers thought they could make generic and biosimilar products cheaper and cheaper. We created a report in 2015 that described the situation and importance of having domestic producers. We looked at the situation in Greece, Ukraine, and Russia. This was before the pandemic, and we foresaw these problems.
Europe is going through some changes in healthcare. There is now a focus on medicine security because if there are no medicines, a lot of patients will die. We cannot save lives without medicines. We must look at developing something like the Semiconductors Act or the Agriculture Act on the European level. We also discussed opinions to support the medicines production in the EU. We cooperate with members of the European Parliament, for example, EKES (European Economic and Social Committee), and Medicines for Europe because medicines security is important and strategic like military and energy security.
