In brief

• The Ministry of Health has proposed a broad reform of drug reimbursement in Poland.
• The draft raises the reimbursement bonus for Polish-made drugs from 15 to 30 percent.
• It also covers orphan drugs, imports from abroad, and patient representation in reimbursement.

A broader overhaul of reimbursement rules

The Council of Ministers has taken up a draft amendment to the reimbursement act, which the government describes as a comprehensive reform of how medicines are funded from public money (Duże zmiany dla pacjentów. Rząd przebudowuje refundację leków – TVN24) (Rząd zmienia refundację leków. "Szybszy dostęp do potrzebnych leków" – tvn24.pl). The Ministry of Health puts the number of changes at close to 200 (Tańsze polskie leki w aptekach. Rząd zmienia zasady refundacji i premiuje krajową produkcję – igryfino.pl). The stated aim is to speed up patients' access to treatment and to strengthen the security of drug supply in Poland.

Price incentives for domestic production

Under the proposal, patients who choose a medicine made in Poland would pay less. The government plans to reward domestic manufacturers in order to reduce dependence on foreign suppliers (Zmiany w refundacji leków: tańsze leki z Polski, lista leków krytycznych i cyfryzacja importu – farmer.pl).

Rare diseases and drugs from abroad

The draft would introduce a legal definition of orphan medicines, meaning products intended for rare diseases, into Polish law. It also simplifies procedures for buying such drugs and for bringing medicines in from abroad. Patient representatives would take part in the reimbursement process.

Waiting times and the parliamentary process

One proposal is said to shorten the path to a reimbursed drug, which in some cases currently takes up to six months (Nawet pół roku czekania na refundowany lek. Projekt nowelizacji ma skrócić tę drogę – Rynek Zdrowia). The bill had its first reading at the parliamentary health committee, where it drew criticism, including over proposals to favour hospitals in drug selection (Sejmowa Komisja Zdrowia przyjęła projekt SZNUR. Branża farmaceutyczna ma zastrzeżenia – alertmedyczny.pl). The pharmaceutical industry has raised objections to parts of the draft. Earlier, the ministry said a rule on bridge funding would keep patients on therapy when a clinical study ends (Lek działał, ale badanie się skończyło. Ministerstwo chce, by pacjent nie został bez terapii – rynekzdrowia.pl).