- We draft and review documentation of multi-centre clinical trials, ensuring that the method of conducting the trials complies with EU and national law, particularly in cardiology and oncology, including biological drugs.
- We advise on procedures for obtaining informed consent of patients for participation in clinical trials and processing of their personal data, as well as authorisation of clinical trials, insurance against risks, and in crisis situations.
- We are active in projects involving donation of medical data, and drafting of data-sharing agreements.
- We advise on the impact of the draft EU Pharma Package on the biotech sector. We monitor the legislative process at the EU level and draft expert opinions on this topic.
- We have prepared expert opinions for research centres on the legal aspects of applying innovative therapies in healthcare, in particular access to advanced therapy medicinal products, the hospital exemption, off-label use, and compassionate use programmes.
- We supported an American biotech firm in negotiation and drafting of a contract for supply of berubicin to a medical university for the purpose of a non-commercial clinical trial funded by the Polish Medical Research Agency.
- We assisted in establishing a research consortium between an American biotech firm and a leading oncology centre in Poland.
- We participated in a dispute over the data exclusivity period for a leading cardiology medicine.
- We have advised on matters involving the methods for distribution of medicines as well as the possibilities for using logistics platforms.
- We have supported companies (including firms offering a broad range of regulated products) in marketing and advertising initiatives for medicinal products, including cooperation with medical professionals.
- For an international company, we conducted an analysis of the permissibility of promotion of veterinary drugs among veterinarians.
- We advise one of the world’s largest companies in the medical devices industry, developing, manufacturing and exporting safety lancets, personal lancets, and syringes for injection of insulin, offering its products on numerous markets, including the EU, the US, and Asia.
- We advise on preparing for certification of manufacturing processes for custom-made medical devices for use in surgery, for compliance with the requirements of the MDR, the IVDR, and the Medical Devices Act.
- We are advising an American firm in a pilot clinical trial of an innovative pain treatment using medical devices for in-vitro diagnostics.
- We advised one of the largest companies in the dental medical devices industry in adjusting its marketing content (directed to professionals and laypeople, via social media and influencers) to comply with the new rules for advertising of medical devices in Poland.
- For a leading producer of medical devices and dermatological cosmetics, we evaluated advertising campaigns and rules for cooperation with aesthetic medicine practitioners.
- In proceedings before the Minister of Agriculture, we succeeded in upholding decisions extending the registration of key plant protection products in the client’s portfolio for additional years—insecticides used in smart crop protection which are safe for pollinating insects.
- We advise producers of health-promoting products in classification and labelling of products on the borderline between dietary supplements and FSMP, as well as in proceedings before the Chief Sanitary Inspector and local regulatory bodies.
- We assess the justification for nutritional, health and environmental claims and advise on the conditions for using such claims in labelling and advertising of products.
- We have advised on projects for introduction of “clean labels” and “natural” marketing messages (use of terms such as “natural,” “homemade,” “containing X,” “enriched with Y,” or “no preservatives”).
- We obtained the reversal of a fine of PLN 1 million imposed on a meat producer in contracts with agricultural producers.
- We obtained a ruling from the province administrative court finding that the client’s business situation was injured without justification by an appellate administrative body, in a case involving labelling of products of dairy origin.
- We represent a leading producer of plant protection products in a dispute concerning product exclusivity periods.
- We advise on drafting of agreements for contract manufacturing and labelling of private-label products, and establishing the rules for responsibility between producers.
- We assist in legal vetting of entities along the supply chain, and in assessment of requirements for development and implementation of sustainability strategies (ESG).
- We are advising a leading retail chain in rolling out food labelling using the Nutri-Score system and verification of the correct classification and labelling of products offered for sale, including private-label products, as well as promotion and advertising of various types of FMCGs.
- We advise on drafting and modification of terms and conditions of online stores for the purpose of distance sales of alcohol and other regulated products.
- We advise producers of tobacco products on the Polish market launch of alternative nicotine products (nicotine pouches and nicotine-free e-cigarettes).
- We advise on the regulatory framework for marketing of products containing CBD, hemp cultivation, and pharmaceutical-grade medical marihuana.
- We assess the labelling and advertising of various types of consumer goods (e.g. toys, textiles and batteries) for mandatory and voluntary product information.
- We prepared a report on the legal framework for delivery of telemedicine solutions in Poland.
- We have participated in high-profile M&A transactions on the healthcare market (such as the acquisition of a network of ophthalmology clinics operating in Poland, Czechia and the UK).
- We advised on the acquisition of a company involved in artificial intelligence in healthcare and a company developing a groundbreaking technology using augmented reality and AI to support surgeons during operations.
- We advised a pharmaceutical company investing seed capital in a Polish tech startup enabling doctors to operate a private medical practice using a subscription model via telemedicine solutions.
- We were retained by a local government to conduct a legal audit of a hospital.
- We assisted an industry investor in building a network of veterinary clinics in Poland.
- We represented a client in disputes arising out of the use of medical procedures and medical devices in orthopaedic surgery.