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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.
From 25 May 2018 the General Data Protection Regulation (GDPR) applies in Poland and other European Union countries. We would therefore like to give you several details on the subject of how DZP processes personal data.
The administrator of the personal data is Domański Zakrzewski Palinka Sp.k. (“DZP”; address: Rondo ONZ 1, 00-124 Warszawa). Data are processed for contact purposes and to impart information on changes to provisions and authority practices and on other issues, including events concerning day-to-day legal, economic and cultural issues, inter alia, by sending DZP newsletters. The above is carried out on the basis of legitimate interests, i.e. in accordance with art. 6(1)(f) of the GDPR. Data can also be processed where necessary for the conclusion or performance of a contract and for compliance with a legal obligation to which DZP is subject, i.e. pursuant to art. 6(1)(b) and (c) of the GDPR. Data can be transferred to entities with whose help DZP achieves the indicated aims, including entities maintaining IT infrastructure. Giving data is voluntary and in contractual relations is a requirement for concluding and performing a contract. It is possible to object to data processing, request access to, rectification and erasure of personal data or restriction of processing and data portability. Data are kept until an objection is made, and in contractual relations – throughout the term of the contract and thereafter for a period specified in provisions on archiving and limitations period for claims. Anyone has the right to file a complaint with the President of the Personal Data Protection Office. Questions concerning privacy at DZP can be sent to DZP’s Data Protection Inspector, Macieja Maciejewskiego, at: firstname.lastname@example.org.
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