Healthcare and life sciences in Poland
Healthcare and life sciences boutique Czyzewscy Kancelaria Adwokacka has a strong regulatory practice, advising clients on issues including clinical trials, pharmacovigilance, batch recalls and manufacturing. It is also noted for assisting clients with ancillary issues, including personal data protection, anti-monopoly and unfair competition law, trade marks, public tenders, litigation and employment. In addition to the pharmaceutical industry, the group is instructed by clients in the cosmetics, food and medical device industries. Katarzyna Czyżewska is the key name, with solid experience in the regulatory aspects of pharmaceutical law.
‘Excellent English, very prompt and to-the-point advice, good knowledge; not only of law but also of market practices and approach taken by the authorities.‘
‘Strong expertise in Polish regulatory law.‘
‘Delivers practice-oriented and easy-to-digest advice that helps businesses to make decisions.‘
Advanced Accelerator Applications
- Supports the Polish Chamber of Commerce with consultations regarding new life sciences legislation; draft opinions on new acts and representing the client in regard to new legislation.
- Advising pharmaceutical companies, including Servier and Pfizer, on reimbursement issues.
- Assisting Klosterfrau, Servier and Advanced Accelerator Applications with matters relating to drug advertising.
Domanski Zakrzewski Palinka's team is noted for the 'broadness of its expertise', which includes corporate transactions in the healthcare sector, issues relating to medicine development and marketing and regulatory advice. It is jointly led by administrative law expert Michał Czarnuch, who specialises in pharmaceutical law, medical law, advertising law, EU law and competition law, and Marcin Matczak, whose focuses include biotechnology law and regulation. Tomasz Kaczyński is recommended for advice on distribution structures and senior associate Marcin Pieklak has developed a practice in financing for drugs, medical devices and food supplements from public funds.
‘Comprehensive advisory skills, good understanding of business, can work under time pressure, flexible solutions.‘
‘Excellent knowledge in the bioscience environment.‘
‘The team is very professional and comprises subject matter experts that we were always able to rely on. The advice is always timely, with a client-oriented approach.‘
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j.
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j. is a healthcare and life sciences specialist firm, which caters to clients in the pharmaceutical, medical, food and cosmetics sectors. The 'extremely knowledgeable' group is well placed to advise on regulatory, competition and consumer issues, as well as representing clients in disputes with competitors and administrative authorities. Jointly heading the team, Paulina Kieszkowska-Knapik is a noted expert in pharmaceutical and healthcare law, and Ewa Rutkowska has developed a strong focus on product liability. Natalia Łojko, who was promoted to partner in 2019, regularly assists clients with distribution, advertising, clinical trials compliance issues, reimbursement and contracting for health services.
‘Paulina Kieszkowska Knapik is a strategic thinker, understanding business and the market. Her advice goes beyond classic legal work.‘
‘Ewa Rutkowska has exceptional knowledge and differentiated, long-term experience in all aspects of the life science sector‘
‘This is the strongest, most reputable legal team in the sphere of life sciences in Poland. They have vast experience and know how in this area. They built their reputation through years of advising innovative companies and industry associations.‘
- Advising an industry association on changes to the legal environment.
- Acting for a number of pharmaceutical companies on their clinical trials in Poland.
The multi-disciplinary team at Baker & McKenzie Krzyżowski i Wspólnicy Spółka Komandytowa provides a full service to clients operating in the healthcare and life sciences industries, with expertise in regulation, reimbursement, distribution and advertising matters. The group is also noted for contentious work, including representing defendants against patient claims. In addition, transactional work is another active area, and the group is often instructed on M&A transactions involving healthcare companies and their portfolios. The department, which is led by IT and IP expert Marek Rosiński, houses corporate and regulatory lawyer Paweł Hincz and senior associate Juliusz Krzyżanowski, whose experience is in pharmaceutical, medical and food law and drug reimbursement.
‘Paweł Hincz and Juliusz Krzyżanowski are truly dedicated lawyers. I know I can trust them. They are always available and their advice is concise and practical.‘
‘Marek Rosiński has excellent knowledge and business understanding.‘
‘Totally individual approach to the client. Responsible and honest advice.‘
CSL Behring Beteiligungs- und Verwaltungs
Les Laboratoiores Servier
Aflofarm Farmacja Polska
Association of Polish Pharmaceutical Wholesalers Employers
American Chamber of Commerce in Poland
Ascensia Diabetes Care Poland
- Ongoing support on CSL Behring’s operations in Poland, including in relation to distribution agreements and contact with the regulatory authorities, as well as a potential dispute with a hospital, under the Falsified Medicines Directive.
- Advising Les Laboratoires Servier on local aspects of the global acquisition of an oncology business from Shire.
- Acting for Aflofarm Farmacja Polska on manufacturing, marketing authorisation and export issues to EU and third countries.
DLA Piper's lawyers are active across life sciences sectors, including pharmaceuticals, medical devices, food and healthcare. The group has particular acumen in regulatory issues and product liability, but is also instructed on issues related to marketing, distribution and advertising. In addition, the group is able to draw on the firm's wider expertise in data protection, IP, corporate transactions and tax, as well as an international office network, providing clients with a full service across multiple jurisdictions. Andrzej Balicki heads the department, with experience in regulatory advice and commercial transactions. Senior associate Jolanta Dąbrowicz specialises in pharmaceutical, medical devices and healthcare law.
‘Superbly prepared and highly knowledgeable team with high awareness of healthcare sector trends. The team has the full range of skills for the sector.‘
‘The life sciences team is business oriented, energetic and creative. In my view this is a top quality team.‘
‘Andrzej Balicki is a clear leader of the team and is my first contact point in all matters. He is very energetic, pragmatic and solution-oriented.‘
Brass Research and Development
URGO Polfa Łódź
Smith & Nephew
- Advising a multinational healthcare equipment manufacturer on practical issues relating to sales and the advertising of reimbursed medical devices.
- Acting for a global baby food manufacturer on contracting schemes in clinical trials of baby food and food for special medical purposes.
- Advising Allergan on negotiations of sales agreements for its medical devices.
The life sciences team at Eversheds Sutherland Wierzbowski is part of the firm's commercial group, allowing it to provide services to industry clients relating to IP and data protection. New technologies are a particular area of expertise, and co-head Marta Gadomska-Gołąb has developed a specialism in personalised medicine and telemedicine. The group has a strong regulatory practice, assisting with product compliance, safety and registration, as well as public reimbursement and marketing. It also advises clients on issues including obtaining licences for manufacturing pharmaceuticals and obtaining marketing authorisation. Aleksandra Kunkiel-Kryńska is the other leader of the team, and has experience of consumer law, contract law and advertising law issues.
‘The practice provides business oriented advice. The lawyers want to understand the business and learn about its actual needs. It makes the cooperation very effective and efficient.‘
‘Aleksandra Kunkiel-Kryńska and Marta Gadomska-Gołąb are the individuals that make the practice great and outstanding. They are engaged in cooperation with clients and do their best to help and assist in any field required.‘
AstraZeneca Pharma Poland
Mead Johnson Nutrition
Polish Coalition for Personalised Medicine Association
OPDF (Organization of Polish Pharmaceutical Distributors)
- Advised Medicare Galenica on modifications to the scope of its pharmaceutical wholesaling licence.
- Acted for Allecco on day-to-day issues relating to its online pharmacy platform on Allecco.pl.
- Advised Aspen Pharmaceuticals on regulatory matters and distribution models for medicinal products.
Kancelaria Tomasik Jaworski
Key names at life sciences boutique Kancelaria Tomasik Jaworski are founders Marcin Tomasik and Tomasz Jaworski. The firm is primarily focused on regulatory, litigation and public procurement issues for clients in the pharmaceutical and medical device industries, as well as food producers. A stand-out feature of the group is that it represents a large variety of Polish industry organisations, which cements the firm's position at the forefront of Polish life sciences regulatory advice. In a key matter, Tomasik and Jaworski assisted the European Bank of Reconstruction and Development with a consultancy project regarding the reform of medicines registration in Ukraine, aimed at harmonising standards with the EU.
‘Long-term experience in pharmaceutical sector. Thorough understanding of business. Ability to provide strategic advice.‘
‘Marcin Tomasik and Tomasz Jaworski are both deeply engaged in clients’ matters with exceptional market and industry knowledge. ‘
‘Very open-minded team with good understanding of business. Good value for money. ‘
‘Marcin Tomasik is solution-oriented lawyer with good understanding of healthcare business and needs of in-house legal department.‘
Association of Employers of Pharmacies “PharmaNET”
European Bank for Reconstruction and Development
Johnson & Johnson
Polish Association of Pharmaceutical Industry Employers
Roche Diabetes Care
Phytopharm – Europlant Group
Polish Association of Cosmetic and Detergent Industry
- Advised the European Bank for Reconstruction and Development on a project to assist the Ukrainian Ministry of Health on improvements to its pharmaceutical registration procedures to bring it into line with EU standards. Also prepared the legal and organisational framework for the establishment of a new medicines agency in Ukraine.
- Acting for Pharma Net, the Association of Pharmacy Employers, on various aspects of pending reform to the Polish pharmacy market.
- Advised Ferrero on the branding of various products manufactured and distributed by the client and its competitors, to ensure compliance with regulatory requirements and fair competition.
Key areas for Soltysinski Kawecki & Szlezak are advising Polish and foreign producers and distributors of medical products on regulatory issues, IP enforcement and their investments. The team also has particular expertise in food law, assisting clients with bringing products to the Polish market, and handling matters such as labelling, the use of health claims and market communication. It also acts for pharmaceutical wholesalers on inspections and post-inspection proceedings, regulatory advice, as well as on the spectrum of corporate and commercial transactions. Ewa Skrzydło-Tefelska is an expert in the application of EU law in Poland and senior counsel Jacek Myszko is an IP and regulatory specialist.
‘A major strength of the team is their capability of looking at the problem in a holistic way.‘
‘The team is up-to-date with the new developments regarding pharmaceutical legal frameworks in other jurisdictions and swiftly uses gathered arguments in the national context.‘
‘Jacek Myszko is very open-minded, provides excellent service and is ready to jump into new (sometimes unusual) projects.‘
Polski Związek Pracodawców Przemysłu Farmaceutycznego
Bunge Group companies
- Advised Polski Związek Pracodawców Przemysłu Farmaceutycznego, as a representative of employers in the pharmaceutical sector, on its consultation with the government regarding policy and legislation.
- Advised Anheuser-Busch InBev on clearance of new labelling for all products on the Polish market and on the change of distributor for the Polish market.
- Represented Bunge Group in litigation it brought against Unilever regarding the misuse of health claims in its advertising of a key product.
Clifford Chance's group is led by white-collar criminal defence and regulatory expert Marcin Ciemiński, making it well placed to handle litigation arising out of the healthcare and life sciences sector. On the advisory front, lawyers advise on pharmaceutical law issues, including registration and reimbursement. Medical law is another area of expertise for the team, and it often assists clients in their dealings with the National Health Fund, as well as advising entrepreneurs on conducting medical activity in Poland. The impressive client roster includes pharmaceutical, medical and chemical companies, distributors, consumer goods companies and investment funds.
‘It’s a team of extremely knowledgeable experts who also work closely within areas of expertise to produce a most versatile solution for client.‘
‘High culture of cooperation, professionalism and responsibility.‘
The team at Dentons provides regulatory, litigation and tax advisory services to companies across the life sciences sector, including domestic and international pharmaceutical manufacturers and distributors, industry bodies and healthcare providers. Jointly leading the group, Wojciech Kozłowski is a seasoned litigator and Karina Furga-Dąbrowska is a tax advisory expert and also coordinates the firm's life sciences group across the central Europe region.
Polish Federation of Food Industry Union of Employers (PFFI UE)
Polish Employers’ Union of Pharmaceuticals Industry (PZPPF)
- Representing GlaxoSmithKline in a serious product liability case where a patient alleges that adverse side effects of administered medicines contributed to an incident that led to life-changing injuries.
- Advising one of the shareholders on the sale of a 50% stake in LekAm, a leading Polish pharmaceutical company.
- Providing Ipsen Poland with day-to-day legal and regulatory advice.
Fairfield is a specialist firm in healthcare and life sciences, with a practice covering all aspects of their clients' operations in Poland. Particular areas of expertise include data protection, advertising, reimbursement, regulatory issues, labelling, unfair competition, public procurement, employment law, and corporate law and transactions. The group also handles civil and criminal disputes, representing a variety of doctors and pharmacists. A medical law expert with a specialism in issues relating to medical devices, Oskar Luty jointly leads the team with pharmaceutical and food law specialist Marcin Flak.
‘Very business-oriented team, strategic thinking and delivering above expectations.‘
‘A highly-qualified team with a deep understanding of the pharmaceutical industry.‘
‘Oskar Luty is a top expert in reimbursement , medical device and pharma law, with wealth of expertise regarding the dialogue with public healthcare officials, health funds.‘
Zwiazek Pracodawcow Producentow Przemyslu Spirytusowego (Association of Spirit Producers)
POLMED (Medical Devices Trade Association)
PTMSZ Polish Association of Lifestyle Medicine
- Advised Zentiva Poland on its demerger with Sanofi-Aventis.
Hogan Lovells (Warszawa) LLP draws on the firm's global office network to advise an impressive set of international clients on the full life-cycle of their products. The group is often instructed on clinical trials, off-patent strategy and litigation defence across multiple jurisdictions. Senior associate and product law expert Agnieszka Majka leads the group and focuses on regulatory issues, product liability, dispute resolution and white-collar criminal defence. The firm's other departments also often service clients in the life sciences sector; employment, IP, competition and corporate being of note. Ewa Kacperek leads on IP issues in the sector.
Fundacja Szpitala Klinicznego Dzieciątka Jezus “My Life”
- Advising a global manufacturer of medical devices on various matters and issues connected with product liability for allegedly defective products.
- Assisting several clients with respect to conducting clinical trials in Poland and around the EU.
- Acting for Mylan Group and its affiliates on various areas of law.
KG Legal Kieltyka Gladkowski is a life sciences and healthcare boutique, which handles matters spanning product labelling, licensing and regulations, as well as assisting clients with regulatory and data protection issues. The group has developed a specialism in medical cannabis law and regulation, advising foreign clients on their entry into the Polish market. Małgorzata Kiełtyka jointly leads the team alongside Kazimierz Jakub Gładkowski.
‘Very skilled and proactive team.’
‘Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are very talented in all areas of life sciences in Poland.‘
‘Małgorzata Kiełtyka is a true expert in her field and has a perfect understanding of the life sciences sector.‘
- Advised an international group of companies on registering medical cannabis in Poland.
Kondrat & Partners
Kondrat & Partners' team is jointly headed by pharmaceutical law expert Mariusz Kondrat and Justyna Stefańczyk-Kaczmarzyk, who is a noted expert in pharmaceutical and food law. It is instructed by a number of international companies with life science operations in Poland on the spectrum of day-to-day issues, as well as obtaining marketing authorisation. On the contentious front, the group is instructed by a range of clients in proceedings before the Polish authorities, particularly in relation to wholesale permits and distribution issues. Sławomir Molęda is another key member of the team, specialising in medical and pharmaceutical law.
Orion Pharma Poland
Pierre Fabre Medicament
- Advising Nuticia on a number of matters, including regulatory compliance, marketing and advertising compliance, distribution agreements, food law, product labelling and competition law.
- Acted for Movianto on logistics and distribution agreements, advertising and marketing law, obtaining manufacturing and import authorisation.
Monika Duszyńska Kancelaria Adwokacka Law for Lifesciences
Monika Duszyńska Kancelaria Adwokacka Law for Lifesciences is a boutique firm with a focus on providing life sciences companies with advice on regulatory issues, compliance and their day-to-day operations. Founding and managing partner Monika Duszyńska has substantial experience of regulatory matters, reimbursement of medicines and medical devices, compliance, contracts and clinical trials, and is supported by associate Marta Moszczyńska, whose expertise includes commercial law and litigation.
‘They really focus on pharma clients and therefore they can be truly effective in helping firms from this sector.‘
‘Monika Duszyńska is one of the best experts in the area of legal aspects of biological drugs usage.‘
‘Professionalism. Flexibility. Willingness to deep dive into the matters. Diplomacy in communication. Effective search in different sources.’
Izba Gospodarcza “Farmacja Polska”
- Providing Izba Gospodarcza Farmacja Polska with frequent legal advice on various regulatory topics (including reimbursement) in the course of the public consultation on draft laws and regulations.