Publication date: November 12, 2025
DEFINITIONS
Biotechnology is the application of science and technology to living organisms, their parts, and models, in order to improve the properties of living and non-living materials, applied scientific research, products, and services. This definition was developed by the Organisation for Economic Co-operation and Development (OECD). Another definition was provided by the UN Convention on Biological Diversity: biotechnology refers to any technological solution that uses biological systems, living organisms, or their derivatives to produce or modify products or processes. Biotechnology has been identified as one of the areas most likely to contribute to the development of the global economy in the coming years, as it does not pose a direct threat to humans or the environment; on the contrary, its use and development aim to increasingly improve resource utilization while maintaining sustainable development and environmental protection policies. Biotechnology is a field with enormous potential, as its development creates a significant number of new jobs, and development in this area will bring results that will improve the operation of many economic sectors, reducing costs and increasing profits. It has been recognized as a critical technology from the perspective of economic security.
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Publication date: November 12, 2025
What essentially is GLP?
The problem of regulating diligence clauses in employment contracts in the laboratory industry is essential on the basis of Polish and EU law. These issues shall also consider the general consequences of breaching employee obligations in the form of the so-called Good Laboratory Practice (GLP) principles.
For some time in the business turnover we can observe the practice of including in employment contracts clauses concerning professionalism and professional diligence in the actions of future employees. As a rule, the clause at issue imposes an obligation on the employee to perform their tasks in a professional manner, adequate to their position and in accordance with standard operating procedures. In addition, all actions of the prospective employee must conform to the recommendations and directives of the supervisor and comply with the applicable law.
The laboratory industry is no exception in this area. It imposes an obligation on employees and contractors to act not only diligently but also based on the principles of Good Laboratory Practice. These principles have been in place since 1978 and regulate issues such as quality assurance in drug testing and development, the prevention of pharmaceutical scandals, and ensuring performance standards for laboratory areas. In addition, the principles regulate such key issues as staffing, space requirements and the quality of equipment and inspection processes for laboratory areas.
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Publication date: November 12, 2025
Artificial intelligence (AI) is currently finding widespread use in healthcare. A prime example is the Polish National Health Fund (NFZ) initiative, which utilizes AI to analyze patient data stored in the Fund’s databases. This data is then analyzed with the support of machine learning tools to make strategic decisions regarding the health of Poles. This approach will certainly simplify the work of doctors by searching for and analyzing the desired information, undoubtedly reducing their workload. However, such a solution may raise several issues and legal requirements related to regulations regarding the protection and processing of personal data.
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Publication date: November 07, 2025
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.
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Publication date: October 23, 2025
Investigator status
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.
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