Polish government consults industry on 80 amendments to drug reimbursement act [Advocacy Lab Content]

A revamp of Poland’s drug reimbursement law is underway. Government officials and industry representatives have advanced discussions, and a final draft of the amendment is expected by the end of the summer.

The leadership of the Department of Drug Policy and Pharmacy of the Ministry of Health met with the pharmaceutical industry to present its plan for changes to the reimbursement law.

“A few weeks ago, we had the opportunity to submit our comments and proposals (…) we encountered a great openness to substantive dialogue from the Ministry of Health,” said Michał Byliniak, General Director of INFARMA, to Euractiv.

“These were open and constructive discussions aimed at preparing regulations that would streamline the reimbursement process, considering the experiences and capabilities of the industry,” he added.

Eighty Amendments

The Polish Reimbursement Act was amended last year. It was the first major revision of this legal act since 2012. However, some of the provisions of the Major Reimbursement Act Amendment (known as DNUR) were not met with approval by the pharmaceutical industry.

As a result, the Ministry of Health began working on changes.

Katarzyna Piotrowska-Radziewicz, Director of the Department of Drug Policy and Pharmacy, and her deputy Mateusz Oczkowski reported that nearly 270 comments were submitted during the pre-consultations.

Ultimately, 80 amendments to the reimbursement law were presented.

As Katarzyna Piotrowska-Radziewicz emphasised, “For the Ministry of Health, the starting point for the amendment was to ensure the availability of medicines for patients.”

The final draft is expected to be ready by the end of the summer, and internal consultations are scheduled for September. It will then be subject to public consultations. “We plan to introduce the changes this year,” assured Mateusz Oczkowski.

Proposed Changes

One key issue the Ministry wants to address is the complicated process of applying for reimbursement. The Ministry intends to simplify the process by introducing more transparent and efficient procedures. One of the changes will be to expand patient access to biological treatments.

Another change the Ministry of Health wants to introduce is the definition of rare diseases. At the same time, there are plans to introduce a separate reimbursement path for medicines used in their treatment. This is expected to significantly increase the availability of medical technologies for rare diseases.

Additionally, the Ministry of Health wants patients to have faster access to new therapies reimbursed within drug programs.

The Ministry of Health has also decided to withdraw one of the controversial provisions of the Major Reimbursement Act Amendment introduced last year, which allowed the reimbursement of over-the-counter drugs.

The Ministry wants to remove the provision requiring even distribution of deficit drugs to Poland’s ten largest pharmaceutical wholesalers. Lifting this requirement is intended to facilitate distribution and reduce logistical costs.

Furthermore, the Ministry of Health announced changes in the funding limits for pharmaceutical raw materials used in the preparation of prescription drugs. The pharmaceutical industry had requested the complete removal of these limits and a return to the old rules of reimbursing prescription drugs. The Ministry did not agree to these changes but proposed raising the funding limits.

Cautious optimism

The proposed changes to the reimbursement law presented by the Ministry of Health have been met with cautious optimism by the pharmaceutical industry.

“We see some new provisions that, in our opinion, if properly drafted, could speed up the reimbursement process and shorten the time from registration to making the drug available to the patient. For now, I can say that we are cautiously optimistic, but the key will be to see the actual draft of the law,” said Byliniak.

“Only at the stage of external consultations will we be able to address the proposals in detail. For now, we do not see any issues that would require intervention,” he indicated.

Mikołaj Konstanty, Vice President of the Supreme Pharmaceutical Council, emphasised that the Ministry of Health’s proposals suggest that it is indeed a comprehensive amendment.

“It is certainly a very significant project. There are individual changes that may be important for pharmacists, so we will need to, as a community, along with lawyers, thoroughly examine and analyse it. There are issues that require clarification. We are waiting for the draft itself to be able to substantively respond to it,” Mikołaj Konstanty summarised in “Health Manager”.

[By Paulina Mozolewska, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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