In brief

• The Ministry of Health proposes amending eight laws, including the Pharmaceutical Law, to make access to expensive therapies easier.
• The draft introduces individual reimbursement, provides for continuity of treatment after a pre-registration access programme, and favours medicines manufactured in Poland.
• The discount for patients choosing a Polish medicine is to rise from 15 to 30 percent.

Individual reimbursement instead of fundraising

Deputy Health Minister Katarzyna Kacperczyk believes that treatment should not depend on the wealth of a patient's wallet or on whether money can be raised through a public fundraiser (Zmiany w refundacji leków: tańsze leki z Polski, lista leków krytycznych i cyfryzacja importu – farmer.pl). The ministry plans to introduce individual reimbursement, a mechanism for financing therapy unavailable within the standard reimbursement system, including for medicines imported from abroad (Nawet pół roku czekania na refundowany lek. Projekt nowelizacji ma skrócić tę drogę – Rynek Zdrowia).

Changes to the regulations

The draft provides for amending eight laws, including the Pharmaceutical Law. The Council of Ministers took up the draft on Tuesday, 27 October (Duże zmiany dla pacjentów. Rząd przebudowuje refundację leków – TVN24). Government spokesperson Adam Szłapka announced that patients will receive needed medicines faster thanks to simplified reimbursement procedures. The changes will also cover medicines used in rare diseases, medicine imports, the participation of patient representatives in reimbursement, and the rules for financing therapies from public funds. One of the key proposals is to introduce into law the definition of an orphan medicine, meaning a product intended for treating rare diseases.

Continuity of treatment after a pre-registration programme

The ministry wants to ensure further treatment for patients who were enrolled in a pre-registration drug access programme once that programme ends (Lek działał, ale badanie się skończyło. Ministerstwo chce, by pacjent nie został bez terapii – rynekzdrowia.pl). The ministry also proposes that pharmaceutical companies co-finance part of the costs of such treatment.

Target import and the patient account

Applications for reimbursement of medicines imported from abroad will be submitted and tracked through the Internet Patient Account. This is intended to bring order to so-called target import and increase patients' control over the process.

Incentives for domestic production

The government announces incentives for medicines manufactured in Poland. The discount for a patient choosing such a preparation is to rise from the current 15 to 30 percent (Tańsze polskie leki w aptekach. Rząd zmienia zasady refundacji i premiuje krajową produkcję – igryfino.pl). The ministry reports nearly 200 changes to the reimbursement system.

What's next

The draft moves on to the further legislative procedure. Patients with rare diseases and haematology-oncology conditions, who most often need expensive therapies unavailable within the standard system, will feel its effects most (Marcin Skonieczka: Postępy w refundacji terapii hematoonkologicznych są niezadowalające - MedExpress.pl – medexpress.pl).

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