At the end of 2023, an Amendment to the Reimbursement Act came into force in Poland. We present the main changes with the comment from the CEO of Norameda of the Polish Branch, Arvydas Norvaišas.
“Poland’s pharmaceutical community has met these amendments with a strong reaction and quite a resistance. Even the process of passing the law was complex”, says A. Norvaišas.
In July 2023, the Sejm (lower house of parliament) passed a major amendment to the Reimbursement Act. Then, the Act was forwarded to the Senate for its consideration, where it was approved with more than a dozen adjustments. Finally, the Sejm rejected the amendments brought by the Senate, and the Reimbursement Act was passed as previously proposed on August 17 and came into power on November 1, 2023.
“The most striking change – substantial preferences for domestic manufacturers. It is reflected in economic benefits and facilitating procedures for locals,” says A. Norvaišas.
For example, when the drug is manufactured in Poland, the patient’s payment is reduced by 15% (compared to 10%), and there is a 50% reduction in fees for the application and HTA analysis.
“There has also been considerable debate regarding introducing a criminal liability clause for data provided in a reimbursement application,” says A. Norvaišas.
Still, one of the biggest concerns for pharmaceutical companies is the obligation to deliver to 10 wholesalers. The duty applies to drugs at risk of unavailability, published by the Ministry of Health on a special list, with the proviso that it covers only drugs covered by pharmacy reimbursement.
One of the positive changes for the pharmaceutical companies is the introduction of set margins: the margin must be at least PLN 0.50 and not higher than PLN 150 in pharmacy reimbursement and PLN 2,000 in chemotherapy/medicine programs.
“Still, there are a lot of debates on how to implement those changes as some limitations affect domestic and foreign pharmaceutical companies equally. For example, can we state that medicament is produced in Poland if most of its components are manufactured in China?” says A. Norvaišas.
According to the CEO of Norameda of the Polish Branch, the pharmaceutical community remains optimistic as there are a lot of positive developments after the elections in Poland: “A law has already been passed to fund In Vitro programmes, which will undoubtedly move other segments of the market in this direction.”
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Polish pharmaceutical market in numbers (based on PEX 2023 Q3)
The Polish market contracted slightly by -0.3% in terms of packages (PLN 1.72 billion) but grew by 9.3% in value, which amounted to 47.18 billion PLN.
The market witnessed a price increase, most notably in the segment of non-reimbursed prescription drugs – 11%, non-prescription drugs – 10.3% and reimbursed drugs – 4%.
The market growth in the prescription segment was mainly driven by the volume sold, which grew by 8.3%, while in the OTC segment, the market growth was driven by the price growth of 7.6%, with a decrease in the volume sold of 5.9%.
Among the companies, the top five were dominated by 4 Polish companies – Polpharma (PLN 2.54 billion), Adamed (PLN 1.10 billion), Aflofarm (PLN 1.07 billion) and USP Zdrowie (PLN 0.95 billion).