The Act of 21 February 2019 (Journal of Laws of 2025, item 259) established a new state institution in the medical sector – the Medical Research Agency. According to Article 1, Section 7 of this Act, the Agency’s objective is to support innovative activities in healthcare, with particular emphasis on the development of non-commercial clinical trials and research experiments. One of its tasks is to support the biomedical sector by financing scientific research and development, as well as strengthening the national capacity to conduct non-commercial clinical trials. Between 2019 and 2021, the Agency contracted research projects worth approximately PLN 1 billion – 50% of the projects concerned specialization projects in oncology and cardiology, which accounted for 67% of the research budget. More importantly, the Agency was tasked with designing the Government Biomedical Sector Development Plan for 2022–2031, for which a PLN 2 billion budget was secured, originating from two sources: the National Recovery Plan and funds from the Medical Research Agency, subsidized by the Ministry of Health. Biomedicine is a field of medicine that utilizes the achievements of biological, biochemical, biophysical, and biotechnological sciences and is widely used in the early diagnosis and treatment of diseases. It utilizes innovative technologies and research results on a large scale. The global biomedical market is experiencing steady growth. Poland aspires to become a leader in this field in Eastern Europe, a goal that cannot be achieved without a unified strategy, hence the decision to create the Plan.
The legal status of an investigator is determined based on Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and the Polish Act of 9 March 2023 on clinical trials on medicinal products for human use .
If a clinical trial is conducted by a team, the principal investigator is the primary investigator. If there is only one person responsible for conducting the clinical trial, the investigator is the primary investigator. This distinction is important because it determines who can, respectively, fulfill the roles of investigator and principal investigator.
The researcher may therefore be a doctor or, pursuant to Article 49 of Regulation 536/2014, a person exercising a profession with the necessary knowledge and experience in working with patients, who is permitted to be a researcher in a given Member State.
KIEŁTYKA GŁADKOWSKI KG LEGAL participated in the conference “Longevity Biotech: Investing in a healthier future”. As part of its life science specialisation, our biotech and pharma lawyers offer comprehensive legal services to its clients in many areas of law, including extensive legal services to companies operating in the longevity biotech sector and biotech companies engaged in life extension and human health. Within this specialism our law firm offers assistance in respect of trademark protection and patent issues, regulatory law, certification, contractual, and litigation and arbitration issues. At KG Legal, we know that a key role in the biotechnology sector is innovation and responsiveness to changing market needs. Therefore, we offer our clients a proactive approach, flexibility and efficiency in action. All these qualities of our firm make us recognized as one of the leading law firms in Poland and the world, especially in the field of cross-border specialization and knowledge.
Under EU Law, namely Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (hereinafter “GDPR”) and the pending entry into application of Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directive 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (hereinafter “AIA”), the use of sensitive data (including medical data) for AI training would only be possible after obtaining consent, in cases specified by law, or when using anonymized data. AIA is not a lex specialis vis-à-vis the GDPR, so when using personally identifiable data, using data for AI model training requires meeting the requirements of both acts.
