The sale of a new drug or medical device and clinical trials is a process between two opposing interest groups. On the one hand, it is about patient protection and the safety of the pharmaceutical market. On the other hand, it is about creating a legal environment that will accelerate the creation of new drugs.
Both goals are important. It is important to create the right legal balance. The balance between patient protection and facilitation of modern medicines and medical devices makes Europe attractive for locating new innovations in technology and creating new medicines and medical devices.
Placing legal priorities in creating law is a political compromise between the speed of producing a new drug and blocking innovation justified by patient safety.
The attractiveness of Europe for the pharmaceutical business compared to other global markets depends on the proper placement of priorities.
Conducting a clinical trial does not relieve the investigator and sponsor from civil liability arising from the clinical trial, under Polish law provisions. The sponsor and the investigator are civilly liable for any damage caused to a clinical trial participant resulting from their actions or omissions. The above general principles of liability for damage arising in connection with conducting a clinical trial create a legal mechanism of liability and illegality of the act under the Polish Act of March 9, 2023 on clinical trials of medicinal products for human use (Journal of Laws, item 605).
Given the current medical standards, the birth of a new medicinal product (drug) can only become a fact as part of a long-term and expensive research and development process. Such a process carries a high risk of failure. Typically, the research and development process takes many years and its effectiveness is low. However, such research is undoubtedly needed.
“Medical Cannabis in Poland” – this is the topic of the presentation for the “Food, Agriculture, and Cannabis Committee” meeting of ABA on 15th February 2024.
As a law firm cooperating with clients in matters of cross-border investments, KIEŁTYKA GŁADKOWSKI KG LEGAL tries to keep up to date with information on regulatory changes in neighboring jurisdictions for the purposes of the expansion and investment plans of our foreign clients.
In this article, we present general information about legislative changes in Ukraine in the field of medical cannabis.
KIELTYKA GLADKOWSKI KG LEGAL PROVIDES ITS FOREIGN CLIENTS WITH LEGAL SUPPORT IN UNDERTAKINGS RELATED TO MEDICAL CANNABIS LOGISTICS CENTRES IN POLAND FOR DISTRIBUTION TO UKRAINE
Legislative changes in Ukraine.
In Ukraine, on December 22, 2023, a bill on the legalization of cannabis for the production of medicines was passed. It provides for the authorization to use medical cannabis for the prevention and treatment of various diseases. This medicinal product will, of course, be available only on prescription, and its sale will only be carried out by pharmacies that have the required licenses and can offer appropriate storage conditions. Additionally, each plant, batch of processed products, unit of packaged products, and packaging of cannabis-based medicine will be marked with a unique electronic identifier. The project also envisages the creation of a special information database in which data from these identifiers will be entered.
