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DZP succeeds in overturning SAC case law unfavourable for patients

06.10.2016

Autorzy:
Marta Balcerowska
Anna Hlebicka-Józefowicz
Sabina Kornacka-Wieteska

On 5 October 2016 the Supreme Administrative Court (SAC)  passed a judgment that followed a pro-constitutional interpretation, favourable for patients, of the Reimbursement Act, overturning current SAC case law in cases of this type. The judgment is final and non-revisable.

Unlike in previous cases, the arguments put forward by DZP for direct application of the Constitution and the need for it to be taken into account in interpreting article 39 of the Reimbursement Act were upheld by the SAC. The Court agreed with the arguments prepared by our Life Science Practice lawyers: Marta Balcerowska, Associate, Szymon Łajszczak, Associate, Anna Hlebicka-Józefowicz, Associate, and Sabina Sztaba, Associate, according to which a literal interpretation of the provisions of the Reimbursement Act leads to the absurd situation where a medicine authorised in the European Union is unavailable to patients applying for funding for treatment with this medicine through a refusal to classify it as reimbursable.

To date, patients with rare diseases applying for access to medicines used in their treatment (orphan medicines) have faced difficulties over whether a parallel import procedure can be used, enabling medicines unavailable in Poland to be imported for individual use. If this procedure is not applied, medicine prices generally greatly exceed patients' financial capacity.

The SAC judgment may lead to patient-friendly changes to how reimbursement provisions are interpreted in this procedure. The SAC upheld the position taken by DZP in a response to a cassation appeal filed by the Minister of Health, which had refused to reimburse a medicine for a boy suffering from muscular dystrophy, and dismissed the Ministry's appeal. The Court found that, despite the fact that the provisions of the Reimbursement Act and the Pharmaceutical Law that the case concerned were contradictory, applying a pro-constitutional interpretation, taking into account the need to ensure that everyone is entitled to healthcare and imposing on the public authorities the obligation to provide equal access to healthcare services and a special care environment for children, means that medicines with European authorisations but practically unavailable in Poland can now be reimbursed.

The SAC judgment saw a departure from prior case law. Favourable Voivodship Administrative Court judgments issued to date in similar cases have been questioned by the SAC.

The judgment by the VAC in Warsaw passed on 9 February 2016.