The Government has enacted the Resolution "On Approval of the Procedure for Collection, Storage and Use of Human Biological Samples for Research Purposes". This decision will allow for modern biomedical research that stimulates the development of new approaches to diagnosing diseases and creating medicines to treat previously incurable diseases.
Biobanking plays an important role in medical research, as biobanks store biological material to be used to create new treatments for diseases. Therefore, they have a huge innovative potential in the entire process of biomedical research.
The Resolution will primarily protect biobanks from various dangers associated with the storage of biological material. This will eliminate the possibility of illegal actions: deception of patients, bad faith in storage, provision of low-quality biospecimens to researchers, etc.
In particular, the law sets out requirements for improving the quality of biospecimens, compliance with ethical standards and protection of donor rights. One of the key requirements is the mandatory obtaining of informed consent from patients when collecting their biospecimens and related data, which will ensure transparency of the processes.
It should be noted that biobanking is the process of collecting and storing samples of patients' biological materials, such as blood, tissue and DNA, for use in research to study the pathogenesis of a disease. After all, timely diagnosis and treatment requires the identification of biomarkers that can be useful for for the early detection, prevention and treatment of various diseases, namely cancer, neurological disorders, cardiovascular and many other diseases.
Organisations engaged in research activities, such as universities, hospitals, diagnostic laboratories, public and private pharmaceutical companies, etc. will have the right to establish biobanks or cooperate with them on a contractual basis. However, any of these institutions will be allowed to use biological samples only for biomedical research and the use of their results in the healthcare sector.
This approach is widely used in the world's leading countries, and we are pleased to announce that Ukraine is finally making an important step forward.