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News.
15.02.2016
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Since the Reimbursement Act came into effect, patients have been fighting to access treatment using innovative therapies. Frequently, the only hope they have is a targeted import procedure, which can be used to import medicines unavailable in Poland for the needs of individual patients. The targeted import procedure enables treatment to be provided with medicines whose price is generally beyond patients’ financial capacity.
The judgment passed on 9 February 2016 by the VAC in Warsaw could lead to a change favourable for patients in how reimbursement regulations are interpreted. In this judgment the VAC in Warsaw upheld the position we put forward in the appeal against the Minister of Health’s decision to refuse reimbursement for medicine for a boy suffering from muscular dystrophy. The boy’s condition required urgent treatment with a medicine currently unavailable in Poland.
Targeted import procedures are available for two types of product: those that are unavailable in Poland, and those that have not been registered in the European Union. According to a Ministry of Health interpretation, only the first are subject to financing pursuant to article 39 of the Reimbursement Act.
The court upheld the arguments of lawyers in our Life Sciences Practice that this interpretation was incompliant with the constitutional principle of equality and public authorities’ obligation to provide children with special healthcare. Restricting access to treatment for some patients merely because the medicine they need was admitted to trade in the European Union by way of a centralised procedure leads to the paradoxical situation where one decision gives the patient a chance of treatment while another – through a funding refusal – does not.
The judgment is not yet final; the Minister of Health could still file a cassation appeal against it. If, however, the judgment stands it could provide a source of hope for a wide circle of patients who are most in need.
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: iod@dzp.pl.
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