POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
Clinical trials for medical devices are required for high- er-risk devices. The provisions of the Medical Devices Act detail the rules set by the MDR for applying for a clinical trial permit and the rules set by the IVDR for applying for a performance study permit. Under the MDR/IVDR, the route depends on the type of study and the device status. Under EU MDR rules as applied in Poland, a regula- tory inconsistency emerges for clinical investigations of CE-marked medical devices. Even when a device is used strictly within its intended purpose and the investigation involves no additional invasive or bur- densome procedures (Article 82 of the MDR), a full administrative authorisation is still required. 2.3 Public Availability of the Conduct of a Clinical Trial For medicinal products, information on clinical trials authorised under the Clinical Trials Regulation (CTR) is publicly available via the CTIS public portal, and spon- sors must upload summary results and a layperson summary to CTIS (with limited deferral possibilities in specific circumstances). The Employers’ Association of Innovative Pharmaceutical Companies (INFARMA, which is a member of the European Federation of Pharmaceutical Industries and Associations) repre- sents pharmaceutical companies engaged in research and development activities in Poland, and has vol- untarily established a publicly available database of ongoing clinical trials conducted by its members (ie, pharmaceutical manufacturers). Such industry-driven listings are supplementary and do not replace the CTR/ CTIS transparency framework. For medical devices, transparency is structured around MDR/IVDR report- ing and database obligations (the European Database on Medical Devices, or EUDAMED), and the clinical investigations/performance studies module remains under development. 2.4 Use of Online Tools to Support Clinical Trials There is no specific restriction against using online tools to support clinical trials. However, online tools must be used in a way that complies with the CTR/ MDR/IVDR requirements (including participant infor- mation, consent processes, safety reporting and data integrity), Good Clinical Practice and applicable data
protection law (GDPR and the Polish Act of 10 May 2018 on personal data protection). Recruitment mate- rials and methods (including online recruitment) typi- cally require ethics review and approval as part of the national CTR process. Sponsors and clinical investigators have to ensure that any online tools used to recruit or monitor study participants comply with the GDPR, the Polish data protection implementing act, and clinical trial/device study requirements, including having appropriate technical and organisational measures in place. 2.5 Use of Data From Clinical Trials Clinical trial datasets will typically constitute personal data and, insofar as they include data concerning health or genetic data, they will usually be classi- fied as special category data under Article 9 of the GDPR. As a rule, sponsors or other controllers should ensure appropriate pseudonymisation and separation of direct identifiers, and define clear controller and processor roles. Data obtained from the conduct of a non-commercial clinical trial may not be used for marketing purposes, nor for the purpose of obtaining a marketing authori- sation for a medicinal product or making changes to the granted authorisation, except for changes to the marketing authorisation for a medicinal product with respect to the safety of the medicinal product’s use. Processing performed to run the trial, ensure subject safety, meet regulatory obligations and maintain the trial master file/archiving is generally treated as being necessary for clinical trial compliance and oversight. Any further scientific use outside the approved proto- col (secondary research) typically requires a separate legal assessment under the GDPR and may require additional safeguards or approvals, depending on the scope and identifiability of the dataset. Transfers to third parties/affiliates are possible if prop- erly structured. International transfers outside the EEA require GDPR Chapter V safeguards to be in place. 2.6 Personal or Sensitive Data The provisions of the Clinical Trials of Medicinal Prod- ucts for Human Use Act do not specify additional
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