Poland’s prescription dilemma, how to unpack new Prescription and Dispensing Report

The Polish Ministry of Health has unveiled a comprehensive report compiled by the Prescription and Dispensing Working Group, summarising twelve months of intensive efforts to evaluate and overhaul the country’s prescription and dispensing systems.

The 113-page document outlines an ambitious reform plan to address the systemic issues within Poland’s complex prescription process.

"It should be regarded as a valuable attempt to organise the prescription ecosystem," Michał Byliniak, General Director of INFARMA, told Euractiv.

A controversial start

The project gained significant attention in early 2024 when reports suggested the group was considering a radical shift in prescription policy.

The proposal was to replace brand names with active pharmaceutical ingredients (APIs) on prescriptions, meaning doctors would prescribe the chemical compound rather than a specific branded product, leaving the final decision to pharmacists. The aim was to streamline the prescription process and reduce the burden of determining reimbursement levels on prescribers.

The idea provoked immediate backlash from the pharmaceutical industry, which had been excluded from the working group’s deliberations. “Despite our repeated requests, we were not included in the working group,” Krzysztof Kopeć, president of the Polish Association of Pharmaceutical Industry Employers – National Drug Producers, told Euractiv.

Nevertheless, the Association argued that prioritising generic names could favour cheaper imports from countries like China and India, putting local manufacturers at a disadvantage.

The controversy prompted swift responses from political figures, including Health Minister Izabela Leszczyna, who assured the public that no political decision had been made to enforce such changes. She emphasised that the reform was still in its early stages and no need for alarm existed until concrete regulations were drafted.

The provision was ultimately not included in the final document. “We appreciate that Minister Leszczyna has put an end to these harmful ideas,” Kopeć added.

Proposed reforms

The report’s recommendations are built on three main pillars: tightening legal regulations, incorporating advanced digital solutions, and fostering collaboration and education among all stakeholders.

The report’s authors did not shy away from highlighting the flaws, describing the current system as resembling “Swiss cheese” due to the numerous loopholes that enable misuse and ultimately drain public funds. “Like cheese, some gaps are larger, others smaller, but they all share one thing in common: they represent a problem we decided to tackle,” they wrote.

The key recommendations have been compiled into a table highlighting 48 specific areas of focus.

A key focus is enhancing the transparency of the system to prevent abuse and ensure public funds are spent effectively. To this end, the group suggested the implementation of modern IT tools to automate processes such as determining drug reimbursement levels and minimising errors.

In addition, the reforms include restructuring the e-prescription system, revising funding for pharmacy compounding, and updating the rules around prescription protocols. These changes aim to create a more sustainable, efficient, and patient-friendly system that aligns with the demands of modern healthcare.

The report emphasises the need for simultaneous implementation of these recommendations due to their interdependent nature. Given the urgency and significant public interest in some of the suggested measures, legislative work on certain proposals commenced ahead of the final adoption of the document and the formal conclusion of the group’s work following a decision by the Minister of Health.

Industry reactions

The pharmaceutical industry remains cautious. As Byliniak explained to Euractiv, “Poland’s prescription system, despite its advanced IT infrastructure, is one of the most complex in Europe and requires an overhaul that reflects the technological, analytical, and regulatory changes of the past decade.” Byliniak noted that while the proposals are a positive start, the ultimate assessment will depend on how these ideas translate into concrete legislation.

He emphasised that the final assessment of the proposed solutions will need to rely on a detailed analysis of specific legislative proposals. INFARMA hopes that the forthcoming changes will improve patient access to medications and reduce the bureaucratic burdens faced by doctors and pharmacists.

Undoubtedly, a simple, clear, and precise model for issuing and dispensing prescriptions is essential for the effectiveness and safety of therapies, as well as for ensuring compliance with medical recommendations. Byliniak said it helps to eliminate the risk of errors and supports patients in the correct use of medications.

[Edited by Vasiliki Angouridi, Brian Maguire]