Czyzewscy Kancelaria Adwokacka houses a broad practice known for its strong regulatory focus, particularly in relation to reimbursement law, the use of AI within the healthcare sector, and public tenders. Katarzyna Czyżewska leads the team with her vast regulatory knowledge, often handling matters concerning the reimbursement of services and medicinal products, clinical trials, and distribution. Agnieszka Kulawiak is a key contact for contractual issues surrounding advertising campaigns, in addition to appearing before the Main Pharmaceutical Inspector. Promoted to partner in June 2024, Natalia Łukawska is known for her expertise in the promotion of medical products and devices, often acting in unauthorised advertising proceedings. Piotr Kujawa joined the team in March 2024, bringing his broad commercial experience.
Healthcare and life sciences in Poland
Czyzewscy Kancelaria Adwokacka
Praxisleiter:
Katarzyna Czyżewska
Weitere Kernanwälte:
Agnieszka Kulawiak; Natalia Łukawska; Piotr Kujawa
Referenzen
‘The teams is always prepared and always available. The team understand how business works.’
‘Katarzyna Czyżewska is available every time. She always has time to explain everything. In my opinion, she has a lot of knowledge about pharmaceutical business.’
‘I appreciate working with Agnieszka Kulawiak. She has a lot of knowledge in the area of dietary supplements and medicinal products. I really like working with her.’
Kernmandanten
Izba Gospodarcza
Servier
Sanofi
Opella
Pfizer
CSL Behring
Klosterfrau
Stallergenes
Novartis
Gedeon Richter
Advanced Accelerator Applications
Laboratoires Expansciences
Thea
Highlight-Mandate
- Advised Izba Gospodarcza, representing its members in the public consultations and the legislative process for adoption of a new Reimbursement Law in Poland.
- Assisting several clients with implementing new systems and procedures related to the protection of whistle-blowers.
- Advising several clients on the advertising and marketing of drugs, medical devices, cosmetics, food and other products.
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j.
Paulina Kieszkowska-Knapik and Ewa Rutkowska jointly lead the team of ‘top-tier specialists’ at Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j., which assists a lucrative client roster of global pharmaceutical companies, pharmacies, and biotech corporations. The group often assists key clients focusing on AI and medical device development. Kieszkowska-Knapik is well-known for her expertise in reimbursement issues, particularly in relation to orphan drugs and the online sale of medicinal products, while Rutkowska is a key contact for product liability litigation. Michał Tracz is an expert in food and cosmetic products, while Michał Chodorek stands out due to his specialism in medical data use, and the implementation of AI in medical devices and machine learning in healthcare. Key figures within the team include Bartłomiej Sasin, who is noted for his expertise in reimbursement and market access issues, and Justyna Nowak, who is recommended for her strong focus on dietary supplements and clinical trial matters.
Praxisleiter:
Paulina Kieszkowska-Knapik; Ewa Rutkowska
Weitere Kernanwälte:
Michał Chodorek; Michał Tracz; Bartłomiej Sasin; Justyna Nowak; Katarzyna Kęska
Referenzen
‘Ewa Rutkowska and Katarzyna Kęska deserve attention – both have huge experience. They come with specific solutions, they are open to dialogue. It is a pleasure to work with them. They adapt to the client’s needs and have extensive experience and expert knowledge.’
‘A very strong life sciences practice, long experience in the field, client oriented, well-staffed with new talents from the market. They are great for all pharmaceutical law topics, for new technologies and AI, product liability, competition law aspects.’
‘Paulina Kieszkowska-Knapik has immense experience in the field. Her engagement is exceptional. Ewa Rutkowska has great experience in product liability. Michał Chodorek stands out when it comes to pharmaceutical law and new technologies.’
Kernmandanten
Celon Pharma S.A.
Mabion S.A.
The Employers’ Union of Innovative Pharmaceutical Companies
WPD Pharmaceutical sp. z o.o.
Highlight-Mandate
- Advised MABION S.A on a major transaction, and concluded an agreement with Novavax Inc., under which Mabion will participate in the production of the Covid-19 (NVX-CoV2373) Novavax vaccine.
- Advised several clients developing AI / ML medical devices on various issues related to the design, development, qualification, and validation of the AI / ML medical device.
- Advising two global pharmaceutical companies producing Covid-19 vaccines on the claims of the patients who were vaccinated with the covid-19 vaccines and suffered adverse reactions.
Baker McKenzie Krzyzowski i Wspólnicy Sp.k.
Noted for its ‘outstanding performance’, the team at Baker McKenzie Krzyzowski i Wspólnicy Sp.k. is recommended for its vast knowledge of reimbursement issues and drug approval procedures. The group is also well-equipped to advise on distribution schemes. Praised by clients for providing ‘superb service and unrivalled sectoral insights', practice head Juliusz Krzyżanowski is an expert in matters involving clinical trials, advertising, and investments into the healthcare space. Marcin Fiałka is adept at handling data privacy issues, with a strong focus on pharmaceutical market regulations and data processing work.
Praxisleiter:
Juliusz Krzyżanowski
Weitere Kernanwälte:
Marcin Fiałka
Referenzen
‘The Baker McKenzie Pharmaceutical team are not only regulatory experts with in-depth knowledge of pharmaceutical and reimbursement regulations. They are also excellent negotiators, and one can see their practical corporate background. They are familiar with market trends from the inside out. In this particular transaction everything was in a perfect setup and knew that we are in good hands.’
‘I work with Juliusz Krzyżanowski, who is trustworthy advisor with an objective view on the issues involved in a particular case. He always tries to fit our needs into legal possibilities. He is knowledgeable and has entire understanding of the business. Provides proposals to the point.’
‘Proactive engagement, incredibly responsive, sectoral knowledge and expertise.’
Kernmandanten
3M
AbbVie
Alnylam Pharmaceuticals
Ascensia Diabetes Care
Astellas Pharma
Baxter
BeiGene
Berlin-Chemie
Menarini
Bristol-Myers Squibb
CSL Behring
Eli Lilly
Lundbeck Poland
MSD
Novo Nordisk
PTC Therapeutics
Swedish Orphan Biovitrum
UCB Pharma
Zimmer Biomet
Takeda Pharma
Thea Pharma
Theramex
Regeneron
Izba Gospodarcza
American Chamber of Commerce
Highlight-Mandate
- Advised Isba Gospodarcza on the legislative process regarding the amendment to the Polish Act on Reimbursement.
CMS
CMS houses a broad team which is known for its expertise in post-marketing issues, anti-corruption work, and reimbursement procedures. The ‘very talented’ Agnieszka Starzyńska leads the team, and stands out due to her broad experience in product development and marketing, clinical trials, and service agreements. Katarzyna Łoś left the firm in March 2024, and the ‘ambitious and hardworking’ Urszula Gondek joined the team in March 2024 from Czyzewscy Kancelaria Adwokacka, contributing her deep knowledge of public procurement and commercial issues surrounding medical devices and medicinal products.
Praxisleiter:
Agnieszka Starzyńska
Weitere Kernanwälte:
Urszula Gondek
Referenzen
‘Agnieszka Starzyńska is very proactive, and thinks about client from a broad perspective. She is very strong on the competition law aspects of pharma field.’
‘Great knowledge of pharmaceuticals, medical devices and food supplements regulations, and understanding of business environment and needs.’
‘Agnieszka Starzyńska is a very talented lawyer who always provides accurate and tailored advice. She is great in day-to-day collaboration, very responsive and business-orientated. Definitely a great expert and exceptional partner for business clients.’
Kernmandanten
Coopervision Poland
Boston Scientific
Fielmann
Holi Health
Partner in Pet Food
Cytiva
Sonova
Syneos
ICON
PZ Cussons
Highlight-Mandate
- Advised Coopervision on various regulatory and compliance matters relating to their soft contact lenses and related products.
- Advised Boston Scientific, a multinational manufacturer of medical devices, on matters concerning various regulatory and commercial aspects related to operating a regulated business in Poland.
- Advised FIelmann, a German optician retail chain, on the regulations relating to eye examinations conducted in its stores in Poland.
DLA Piper Giziński Kycia sp.k.
Hailed by clients as a ‘premier team in the Polish market’, DLA Piper Giziński Kycia sp.k. often assists with public procurement mandates and the full spectrum of issues relating to the pricing and advertising of medicinal products. The ‘outstanding’ Andrzej Balicki leads the team, and is known for his longstanding experience in both domestic and EU regulations governing pharmaceutical, diet supplement, and medical device products. Balicki is particularly adept at handling reimbursement negotiations and public procurement matters. ‘Extraordinary product lawyer’ Jolanta Dąbrowicz is a key member of the team who often assists distributors and manufacters with administrative disputes before the Main Pharmaceutical Inspectorate and the National Health Fund.
Praxisleiter:
Andrzej Balicki
Weitere Kernanwälte:
Jolanta Dąbrowicz; Michał Orzechowski
Referenzen
‘A team with a remarkable track record in the life sciences market. I particularly appreciate their proactive approach and in-depth knowledge of industry trends.’
‘Andrzej Balicki is an outstanding lawyer in the life sciences sector with a great deal of expertise. I particularly value his deep understanding of the sector which enables him to offer strategic advice that combines legal and business aspects.’
‘DLA Piper has an outstanding team in Poland, with one of the best healthcare and life sciences lawyers on the market – Andrzej Balicki and Jolanta Dąbrowicz. They are very smart, proactive and successfully advise their clients. Portfolio of clients is also impressive.’
Kernmandanten
CMR Surgical
ExploRNA Therapeutics
Théa Polska sp. z o.o.
Smith & Nephew
Brass Research and Development
Mayoly
Philips Polska sp. z o.o.
Gemini Polska sp. z o.o.
AbbVie
ResMed
Zakłady Farmaceutyczne Polpharma
Transpharmation
Ipsen Poland
Phibro Animal Health Corporation
Polpharma
Respiromix
USP Zdrowie
Tymofarm
Vedim
Gilead Sciences
Kartos Therapeutics
Highlight-Mandate
- Advised CMR Surgical on its contracting with public hospitals.
- Advised a global pharmaceutical company on its collaboration with national health consultants and provincial health consultants in Poland.
- Acting for ExploRNA Therapeutics in negotiations with potential partners.
Eversheds Sutherland Poland
Highlighted by clients for its ‘excellent understanding’ of the regulatory landscape within the life sciences sector, Eversheds Sutherland Poland’s practice handles the full gamut of marketing work. Marta Gadomska-Gołąb jointly leads the team alongside Aleksandra Kunkiel-Kryńska; Gadomska-Gołąb has longstanding experience in reimbursement issues and distribution model-related work, while Kunkiel-Kryńska is recommended for her knowledge of commercial matters within the life sciences space. Jowita Prokop regularly assists clients with medicinal product registration, and unfair competition mandates.
Praxisleiter:
Marta Gadomska-Gołąb; Aleksandra Kunkiel-Kryńska
Weitere Kernanwälte:
Jowita Prokop
Referenzen
‘The team at Eversheds Sutherland stands out for its deep knowledge and experience in the healthcare sector. This allows the firm to take a practical approach to problem-solving and have an excellent understanding of regulations and the rapidly changing legal landscape.’
‘Clients looking for comprehensive legal support in this area can rely on their extensive experience and flexibility in handling complex and sophisticated matters. The team also excels in efficient communication, quick response times, and their ability to collaborate with clients at every stage of a project.’
‘The individuals I work with at Eversheds Sutherland stand out due to their high level of competence, deep legal knowledge, and excellent understanding of our industry.’
Kernmandanten
Gdziepolek
Hemp & Health
Medicare
Polish Coalition for Personalised Medicine
Samsung
Highlight-Mandate
- Advising GdziePoLek on the issue of permits in the pharmacy market and the grounds for their revocation in the event of acquisition of control resulting in excessive concentration in the pharmacy market.
Kancelaria Tomasik Jaworski
Kancelaria Tomasik Jaworski often acts for industry associations and non-governmental organisations, and major pharmaceutical companies in administrative proceedings before the Pharmaceutical Inspection Authorities, in addition to the full spectrum of commercial matters. Practice co-head Marcin Tomasik regularly assists a diverse client base of medical device, nutrition, and pharmaceutical clients with unfair competition and regulatory compliance work. Co-head Tomasz Jaworski is well-versed in public procurement work within the medical device and pharmaceutical spaces.
Praxisleiter:
Marcin Tomasik; Tomasz Jaworski
Weitere Kernanwälte:
Filip Gołba
Referenzen
‘Strong experience in healthcare legislation, very professional cooperation and quick reaction to new challenges (e.g. AI Act introduction in the EU).’
‘Very professional and positive attitute, business oriented thinking, flexibility and quick communication.’
‘Thorough understanding of legislative process. Skilled litigators who work closely with various industry associations.’
Kernmandanten
Association of Employers of Pharmacies
European Bank for Reconstruction and Development
Johnson & Johnson Poland Sp. z o.o.
Gedeon Richter Polska Sp. z o.o.
MedTech Poland
Polish Association of Pharmaceutical Industry Employers
Ferrero Polska Commercial Sp. z o.o.
Roche Diagnostics Polska Sp. z o.o.
Roche Diabetes Care Polska Sp. z o.o.
IBSA Poland Sp. z o.o.
Implantcast Polska Sp. z o.o.
Medac Gesellschaft fur Klinische Spezialpraparate mbH
Highlight-Mandate
Kieltyka Gladkowski KG Legal
The offering at Kieltyka Gladkowski KG Legal is well-equipped to handle matters involving clinical trials, with a strong emphasis on regulatory and commercial issues. The team often assists with the registration of software as a medical device. Małgorzata Kiełtyka is well-known for her vast knowledge of procedures for market entry, advertising issues, and mandates concerning labelling, while Jakub Gładkowski stands out due to his longstanding experience in joint ventures and M&A, in addition to investments.
Praxisleiter:
Małgorzata Kiełtyka; Jakub Gładkowski
Referenzen
‘Quality legal advisory combined with international expertise and industry sector understanding.’
‘Kieltyka Gladkowski KG Legal’s team stands out for its deep expertise and tailored support in the healthcare and life sciences sectors, which has proven invaluable to Austrian companies operating in the Polish market. What sets this practice apart is its client-focused approach, combining a comprehensive understanding of Polish, EU, and international healthcare regulations with a commitment to delivering practical solutions in this highly regulated field.’
‘The team excels in providing precise and timely advice on complex regulatory matters, ensuring that businesses stay compliant with evolving healthcare and life sciences legislation, such as marketing authorisations, clinical trials, pharmacovigilance, and product liability. Their ability to navigate the intricate web of compliance requirements, including medical device and pharmaceutical regulations, is remarkable.’
Kernmandanten
BioLaw Europe
Life Science Cluster Poland
Advantage Austria
Highlight-Mandate
- Advised an international client on clarification with the Polish medicine regulatory office of the post-clinical trial duties of the sponsor of innovative genetic drug to provide medicinal products and the procedures for compassionate use.
- Advising an American client on EU Regulations 745 and 746 on the classification of software as a medical device for in vitro diagnostic procedures, where the status of the product is complicated by modern AI computational functionality enabling the prediction of a disease in a healthy patient over a 10-year period.
- Advised an American trader on the introduction of high-quality Korean skincare cosmetics and novel food to the e-commerce retail market, including panax ginseng extract from organic DMZ farming, and in addition to regulatory requirements, the firm ensures the performance of the obligations of the responsible entity and all customs and transaction security issues.
Rymarz Zdort Maruta
Rymarz Zdort Maruta regularly acts for a lucrative, global client base, which notably includes Takeda Pharmaceutical Company Limited, Eli Lilly Poland Sp. z o.o., and Bausch + Lomb. Michał Czarnuch has deep knowledge of cases involving corruption allegations, healthcare service financing, and the restructuring of healthcare providers. Tomasz Kaczyński is noted for his longstanding experience in product registration, advertising, and distribution issues, in addition to the law governing dietary supplements and franchising. Marcin Pieklak is a key contact for pharmaceutical companies seeking advice on reimbursement procedures.
Praxisleiter:
Michał Czarnuch; Tomasz Kaczyński; Marcin Pieklak
Referenzen
‘Not only excellent knowledge of pharmaceutical law, medical device law and food law, but also vast knowledge of the practical aspects of running a business in these areas.’
‘Tomasz Kaczyński is an excellent and very experienced lawyer with a great understanding of customer needs and attitude.’
‘Michał Czarnuch stands out for his intelligence and reliability in operational work. Working with him, I am confident that tasks will be completed, and I will receive a high-quality final product. If I need anything additional, he is capable of making adjustments and taking on extra work on his own initiative.’
Kernmandanten
Celon Pharma S.A.
Exeltis Poland Sp. z o.o.
Benefit Systems S.A.
Ravimed Sp. z o.o.
Polska Izba Ubezpieczeń
Hemolens Diagnostics Sp. z o.o.
Bausch + Lomb
Coloplast AG
Eli Lilly Poland Sp. z o.o.
Takeda Pharmaceutical Company Limited
Highlight-Mandate
- Advised Exeltis Poland Sp. z o.o. on the establishment of cooperation schemes with telemedicine clinics, the launch of a diagnostic test classified as a medical decice, and reimbursement procedures for core products.
- Advised Coloplast AG on the financing of medical devices by the National Health Fund to one of the manufacturers of special purpose dressings.
- Advised Celon Pharma S.A. on optimising the company’s distribution structure, managing multinational distribution, and establishing co-promotion agreements and innovation funds.
Soltysinski Kawecki & Szlezak
Jacek Myszko co-leads the team at Soltysinski Kawecki & Szlezak alongside Ewa Skrzydło-Tefelska. The firm is well-versed in work concerning distribution models for medicinal products, and the regulatory aspects of acquisitions within the clinical research and food spaces. Myszko assists both domestic and international clients with advertising issues, market exclusivity, and contracting matters between healthcare providers, while Skrzydło-Tefelska’s primary area of focus spans unfair competition, and patent and trade mark cases. Ewelina Woike-Reguła often advises on product classification and labelling matters within the food, pharmaceutical, and cosmetics industries.
Praxisleiter:
Jacek Myszko; Ewa Skrzydło-Tefelska
Weitere Kernanwälte:
Ewelina Woike-Reguła
Referenzen
‘We typically engage with SK&S on matters pertaining to pharmaceuticals and patent law. The team members are highly skilled and versatile. The SK&S lawyers provide the excellent level of legal expertise and market awareness. This applies also to the niche problems requiring the highest level of knowledge and most sophisticated approach.’
‘They have an excellent track record of liaising with renowned academic figures, whether they are SK&S professors or external experts. Therefore we also use the opportunity to engage SK&S lawyers in projects like preparing an excerpt for multi-jurisdictional legal commentary regarding second medical claims in patent law.’
‘Jacek Myszko consistently displays the highest level of expertise. Jacek is one of Poland’s most prominent lawyers specialising in the life sciences industry. The combination of Jacek’s exceptional skills and SK&S’s status as a top, one-stop shop law firm (coupled with its excellent track record in virtually all commercially viable areas of law), makes them an unstoppable force in the legal industry.’
Kernmandanten
Wolt Polska sp. z o.o.
E&J Gallo Winery
Polski Związek Pracodawców Przemysłu Farmaceutycznego
Velocity Clinical Research
Oda Medical sp. z o.o.
Darling Ingredients Inc.
Highlight-Mandate
- Advising an industry association of distributors of e-cigarettes in Poland on the new legal regime that will apply to nicotine products in Poland, including representation in the course of senate committee meetings, evaluation of the draft laws, taxation models etc.
- Advised Velocity Clinical Research on acquisition of KO-MED, Clinmedica (Polish clinical sites companies).
- Advising E&J Gallo Winery on various regulatory matters related to the introduction of new types of wine products on the market.
Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A.
In Poznań, Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A.‘s ‘exceptional’ team is known for its specialism in healthcare institution investment mandates and medical malpractice claims. Ewelina Jeglikowska‘s area of expertise lies at the intersection between medical and labour law, often assisting healthcare institutions with medical staff employment issues and management contracts. Anna Piotrowska-Musioł stands out due to her focus on contractual issues with the National Health Fund and regularly assists public healthcare entities with payment cases. Magdalena Cieślińska-Dopierała is recommended for her deep knowledge of public procurement proceedings concerning healthcare provision, in addition to acting in medical error claims and cases concerning the infringement of patient rights.
Praxisleiter:
Ewelina Jeglikowska; Anna Piotrowska-Musioł; Magdalena Cieślińska-Dopierała
Weitere Kernanwälte:
Michał Górski
Referenzen
‘What truly sets Sowislo Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A. apart is their deep understanding of the healthcare and pharmaceutical industries. They don’t just provide legal advice; they understand the specific challenges we face, especially when it comes to hospital pharmacy operations and pharmaceutical law.’
‘The medical law team at Sowislo Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A. has been outstanding in every aspect. I’ve worked closely with Anna Piotrowska-Musioł, and she has consistently provided top-notch legal support, showing a deep understanding of the healthcare sector. Her practical advice and strategic thinking have been invaluable, especially in navigating the complex regulations that affect our day-to-day operations.’
‘Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A. provides exceptional services, because they are dedicated to public hospitals. Medical law in Poland is changing at a rapid pace, and the office’s team helps not only to avoid the consequences resulting from the organisation’s inadequacy, but also proposes ready-made optimal solutions.’
Kernmandanten
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
Wielospecjalistyczny Szpital Miejski im. Józefa Strusia z Zakładem Opiekuńczo-Leczniczym Samodzielny Publiczny Zakład Opieki Zdrowotnej z siedzibą w Poznaniu przy ul. Szwajcarskiej 3
Szpital w Puszczykowie im. Prof. S.T. Dąbrowskiego Spółka Akcyjna z siedzibą w Puszczykowie
Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych „Dziekanka” im. Aleksandra Piotrowskiego w Gnieźnie
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów Samodzielny Publiczny Zakład Opieki Zdrowotnej
Specjalistyczny Zespół Opieki nad Matką i Dzieckiem w Poznaniu
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA wPoznaniu im. Prof. Ludwika Bierkowskiego
Ginekologiczno-Położniczy Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Wojewódzki Szpital Wielospecjalistyczny im. dr Jana Jonstona w Lesznie
Wojewódzki Szpital Zespolony im. dr Romana Ostrzyckiego w Koninie
Hospital Investment Group sp. z o.o.
IC Solutions sp. z o.o.
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Pruszkowie
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Słupcy
Szpital Powiatowy im. Jana Pawła II w Trzciance
Leszczyńskie Centrum Medyczne Ventriculus sp. z o.o. z siedzibą w Lesznie
Terapia Medyczna „TERAMED” sp. z o.o. z siedzibą w Poznaniu
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. Marszałka Józefa Piłsudskiego w Płońsku
“Szpital św. Józefa” sp. z o.o. z siedzibą w Mikołowie
Faurum Sp. z o.o.
Highlight-Mandate
- Acted for Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów (Wielkopolska Centre for Pulmonology and Thoracic Surgery) in the stage of appeal against the negative opinion on the rationale for the investment (the Instrument for the Assessment of Investment Applications in the Healthcare Sector – IOWISZ) issued by the Minister of Health regarding the implementation of a project.
- Advised Ginekologiczno-Położniczy Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu (Heliodor Święcicki Gynaecological and Obstetrics Hospital of the Poznań Medical university), on the admissibility of handing over reproductive cells of a deceased donor to his parents, the sole heirs.
- Represented the Wielospecjalistyczny Szpital Miejski im. Józefa Strusia zZakładem Opiekuńczo-Leczniczym, Samodzielny Publiczny Zakład Opieki Zdrowotnej (Józef Struś Multi-Speciality Municipal Hospital with a Treatment and Care Facility) located inPoznań at ul. Szwajcarska 3 in a medical malpractice case concerning a diagnostic error resulting from the failure to carry out a general urinalysis and urine culture, which, in the plaintiff’s opinion, allegedly contributed to the development of sepsis and ultimately to the emergence of a nephrostomy and amputation of the fingers and toes.
Clifford Chance, Janicka, Kruzewski, Stosio i wspólnicy spólka komandytowa
Noted for its strong focus on corporate transactions within the healthcare and life sciences spaces, Clifford Chance, Janicka, Kruzewski, Stosio i wspólnicy spólka komandytowa is also known for its focus on clinical trials and spin-offs. Practice head Marcin Ciemiński specialises in white-collar crime and crisis management, while Anna Miłoszewska is a regulatory expert who stands out for her strong focus on market access and manufacturing issues, often acting in commercial disputes.
Praxisleiter:
Marcin Ciemiński
Weitere Kernanwälte:
Anna Miłoszewska
DBS Law Firm
Praised by clients for its ‘superb’ commercial understanding, DBS Law Firm handles the full spectrum of transactional mandates within the sector. ‘Very dedicated, precise, skilled and communicative’ practice co-head Marta Sroka-Maleta has longstanding experience in reimbursement law and patent litigation, while co-lead Agata Bzymek-Waśniewska is a key name for advertising, distribution, and compliance issues, with a strong focus on labour law mandates within the pharmaceutical industry. Andrzej Siwiec is recommended for his vast expertise in market access issues, and pharma-focused IP work.
Praxisleiter:
Marta Sroka-Maleta; Agata Bzymek-Waśniewska
Weitere Kernanwälte:
Andrzej Siwiec; Katarzyna Kroner
Referenzen
‘Extensive experience in the pharmaceutical industry. Searching for the best solutions for business. Accurate risk assessment and recommendation.’
‘Andrzej Siwiec provides fast feedback on cases in a understandable way, very good longterm experience, giving explanations for his judgment while also coming up with other options to reach the client’s goal.’
‘Dynamic, well-prepared team willing to meet the client’s needs. Very flexible and very good commercial understanding which is an added value in a legal team.’
Kernmandanten
Alpen Pharma Polska
Avanzanite Bioscience
Gentili Pharma
GOFARM
Foundation – Centre of Medical Charity
LEK-AM
Plich Advisory & Investments
SESTEC
Spinprot
Teva Operations Poland
Teva Pharmaceuticals Polska
Your Health Medical Centre
Highlight-Mandate
- Representing a client in a high-stakes brand protection litigation in the healthcare and life sciences sector.
- Acting as lead counsel in a demanding cross-border acquisition of rights to a medicine.
- Acting as Polish law counsel in a complex cross-border sale of medical assets involving numerous jurisdictions.
Dentons
Notably acting for Johnson & Johnson, Acuity International, and Americares, the team at Dentons often advises on the supply of medicinal products and operation of healthcare facilities in response to humanitarian crises. The team is also well-equipped to handle administrative proceedings concerning the revocation of licenses. Adam Odojewski is well-equipped to assist clients with the full range of issues concerning licensing across the medical device, pharmaceutical product, and dietary supplement industries.
Praxisleiter:
Adam Odojewski
Kernmandanten
American Heart of Poland
Genesis Pharm
Skamex
Euroleki
GlaxoSmithKline
PharmaNET
Dr. Max
Convatec
Mayoly Poland
Acuity International
Delfarma
Affidea Group
AmeriCares
Argenta
Hoya
Accord Healthcare
Philips
Highlight-Mandate
- Assisted a pharmaceutical client with implementing a new distribution model for medicinal products in EU and non-EU countries.
- Represented a pharmacy network in a major dispute with the regulatory authorities in Poland who were seeking to revoke the operating licences of seventeen of the client’s pharmacies and a further dozen pharmacies at risk.
- Assisted Convatec with its groundwork to conduct a clinical trial of its medical device in Poland in accordance with the EU Regulation 2017/745 and represented the company in obtaining the necessary approval from the regulatory authority to commence the study in Poland.
Domanski Zakrzewski Palinka
Noted by clients for its ‘unmatched’ industry experience, Domanski Zakrzewski Palinka's offering handles a varied workload of drug advertising matters and clinical trials. Mateusz Mądry leads the team, utilising his prior experience at the European Medicines Agency to advise major pharmaceutical companies on market access and competition issues. The ‘exceptional’ Marek Paluch is a key contact for medical device and pharmaceutical clients seeking advice on distribution and manufacturing issues, in addition to appearing before the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products in administrative proceedings.
Praxisleiter:
Mateusz Mądry
Weitere Kernanwälte:
Marek Paluch
Referenzen
‘The team’s leaders: Mateusz Mądry is a strong name in pharmaceutical and public law. The team stands out for its expertise in public (administrative) and constitutional law, pharmaceutical law, medical devices law.’
‘I value them in particular for their expertise in public/constitutional law, understanding of regulatory aspects, expertise in medical devices, their understanding of business, and their proactiveness.’
‘The practicality in DZP advisory and practical knowledge of the industry are key factors towards our cooperation. Also diversity, Partner’s engagement and easy to go communication style makes DZP as our main external advisor.’
Kernmandanten
Bausch Health Poland sp. z o.o.
DrEryk S.A.
GSK
Teva Pharmaceuticals Polska
Global Pharma CM S.A.
NovoNordisk Pharma sp. z o.o.
Viatris Healthcare sp. z o.o.
Abbvie sp. z o.o.
Chiesi Poland sp. z o.o.
Eli Lilly
AstraZeneca Pharma Poland sp. z o.o.
Lek-am sp. z o.o.
Bausch & Lomb Poland sp. z o.o.
Biofarm sp. z o.o.
DrZdrowie S.A.
Ogólnopolska Izba Gospodarcza Wyrobów Medycznych POLMED
Biocam sp. z o.o.
Regenova Therapeutics sp. c.
Synthaverse S.A.
Aurovitas Pharma Polska sp. z o.o.
Highlight-Mandate
Fairfield
Jointly led by Oskar Luty, Marcin Flak, and Karol Korszuń, the ‘faultless’ team at Fairfield stands out for its focus on the medical devices industry, and is rated by clients as being ‘absolutely the best in the Polish market’. Luty is well-known for his specialism in all matters relating to medical devices, with a strong emphasis on promotional and reimbursement issues. Flak utilises his longstanding experience to advise on the implementation of distribution schemes, often representing industry associations, while Korszuń regularly assists market authorisation holders, pharmaceutical product wholesalers, and manufacturers with reimbursement and marketing issues.
Praxisleiter:
Oskar Luty; Marcin Flak; Karol Korszuń
Weitere Kernanwälte:
Oskar Platta
Referenzen
‘Fairfield is our go-to legal partner for the Polish market for all life sciences work. They are well connected, understand the law and policy very well and provide excellent quality and practical advice.’
‘Oskar Luty is a great person to work with. He’s very smart and a fast thinker, practical and result oriented. We love to work with him.’
‘We love Oskar Luty and the team. Everyone we work with who knows the team at Fairfield adore them. The team is faultless: intelligent, practical, realistic, helpful, eloquent and rapid. Every single time, they meet their timeframes. Crucially, they have a deep understanding of eccentricities and peculiarities of the sector and the Polish market and the Polish regulators.’
Kernmandanten
Infarma
Polmed
Zentiva
Angelini Pharma
Adamed
Accord Healthcare
Merck
Aristo Pharma
Avon
Boston Scientific
Olympus
Abbott
Stryker
FM Logistic
Polskie Towarzystwo Nadciśnienia Tętniczego
B.Braun
MagnaPharm
Mölnlycke Health Care
Stada
Resmed
Spark&Mortar
Polpharma
Biocodex
Alcon
Amplifon
Aspironix
Highlight-Mandate
- Advised Polish Chamber of Commerce for Medical Devices POLMED during legislative works on creating clear paths for reimbursement of innovative medicaldevices using artificial intelligence.
- Prepared a report for the POLMED on the national medical device rental, analysing the operation of the current national rental service in terms of meeting the requirements of the law and the adaptation of the rental service to the existing health care system in Poland.
Kochanski & Partners
Kochanski & Partners's broad offering handles a varied workload of data privacy issues within the medtech industry, M&A, and public procurement mandates within the clinical trial space. Practice co-lead Katarzyna Sabiłło joined the team in 2024, drawing on her prior experience as a pharmacist to assist with marketing authorisations and registration processes, in addition to advising on reimbursement issues. Fellow co-head Piotr Kochański is well-equipped to handle commercial disputes and technology transfers within the life sciences sector.
Praxisleiter:
Katarzyna Sabiłło; Piotr Kochański
Weitere Kernanwälte:
Krzysztof Zięba
Referenzen
‘We cooperate directly with legal advisors or patent attorneys with long practical experience which enables us to build trust in the law firm.’
‘Wide range of specialisation altogether with good number of lawyers. Readiness to accept or discuss clients remarks, changes in legal aspects. Very high engagement in the cases, even on aspects which are not legal. Initiative in new solutions, new steps to take.’
Kernmandanten
Clinical Trials Solutions
KO-MED Centra Kliniczne
Corza Medical
Shenzhen Hepalink Pharmaceutical Group Co. Ltd
B. Braun Group
Clininote
Reckitt Benckiser
Hasco Lek
Hasco TM
nOvum Fertility Clinic
Krynica Vitamin S.A.
Techdow Pharma Poland
Highlight-Mandate
- Representing HASCO Lek against its competitor Swiss Pharma International in various trademark infringement cases.
- Advising Corza Medical on the distribution of products and representing the client in the field of public procurement law in a number of tender procedures of different values.
- Advising Reckitt Benckiser on the verification of distribution contracts related to pharmaceutical products and medical devices.
Osborne Clarke
Osborne Clarke's ‘skilled and experienced’ practice is noted for handling advertising matters involving medical devices, preliminary injunctions, and IP issues surrounding the use of AI in the life sciences space. The team is also well-equipped to advise on clinical trial agreements and reimbursement proceedings, often assisting multinational clients. The ‘exceptional’ Agnieszka Sztoldman leads the team, and is recommended for his vast expertise in patent and trade mark enforcement work.
Praxisleiter:
Agnieszka Sztoldman
Weitere Kernanwälte:
Bartłomiej Sadura
Referenzen
‘This is a top team with many skilled and experienced life sciences lawyers. They work on very interesting assignments that require innovative approach.’
‘Agnieszka Sztoldman – up and coming and dynamic lawyer with lots of experience in the field.’
‘The Healthcare and Life Sciences team of Osborne Clarke is outstanding. The have an in-depth knowledge of the legal and regulatory aspects concerning the healthcare business, including specifics related to the pharma, medical devices, medical services and other matters. They closely follow the latest developments and industry trends and provide very relevant insights.’
Kernmandanten
Grifols International
Perrigo International
Align Technology
IPD Analytics
MorphoSys AG
EVER Neuro Pharma GmbH
Vorwerk International
KO-MED Sp. z o.o.
Clinical Trials Solutions Sp. z o.o.
Lindt & Sprüngli
Highlight-Mandate
- Advising Grifols on public procurement and representing the client in multiple tender proceedings before the Polish Office of Public Tenders.
- Advised Perrigo International on various issues related to brand protection, including against direct competitors.
- Advising Lindt & Sprüngli on regulatory and advertising issues, including food product advertising campaigns within the context of regulatory limitations.
Taylor Wessing Poland
Taylor Wessing Poland houses a broad offering which handles M&A and joint ventures, and distribution and manufacturing issues. The team is also well-versed in data protection and competition work within the sector. Przemysław Walasek leads the team with his longstanding expertise in both contentious and non-contentious IP, data protection, and technology work. Bartosz Świdrak regularly assists a varied client list of food, pharmaceutical, and medical device corporations.
Praxisleiter:
Przemysław Walasek
Weitere Kernanwälte:
Bartosz Świdrak
Referenzen
‘The most important for me is very short response time. All answers are always accurate, written in an understandable way.’
‘During my cooperation with Taylor Wessing I have a great pleasure to work with Bartosz Świdrak, who is characterised by his commitment to every case regardless of its importance. I always receive a response, and the answers are always comprehensive, concise and very helpful.’
Kernmandanten
Sunday Natural Products GmbH
PKO BP S.A.
mwb fairtrade Wertpapierhandelsbank AG
Biotest AG
BTL Polska
BioMaxima S.A.
Inogen
Knapp AG
Theramex
Highlight-Mandate
- Advised Sunday Natural Products GmbH (Sunday Natural) and its founder on the sale of a stake in Sunday Natural to private equity investor CVC Capital Partners VIII (CVC Fund VIII).
- Advised the German investment bank mwb fairtrade Wertpapierhandelsbank AG on the launch of the Warsaw-based company LM PAY S.A., specialising in the financing of medical and dental services, on the Düsseldorf Stock Exchange.
- Advised BTL Polska on healthcare and medical devices law, contract and competition law, and various aspects of advertising regulation.
Wardynski & Partners
With a strong focus on issues relating to the food industry, Wardynski & Partners is adept at advising on overseas clinical trials, and matters relating to labelling. Practice head Joanna Krakowiak utilises her ‘unparalleled depth of knowledge’ of the sector to advise on M&A, marketing authorisation procedures, and clinical study-related work. Marcin Rytel handles the full gamut of issues relating to medical devices, pharmaceutical products, and food, in addition to acting in administrative proceedings.
Praxisleiter:
Joanna Krakowiak
Weitere Kernanwälte:
Marcin Rytel
Referenzen
‘Wardyński & Partners lawyers are highly focused on providing business-oriented advice. They excel at striking the right balance between identifying risks and offering solutions. Their counsel is consistently professional and of the highest standard. They are responsive, creative, and always ready to assist in all aspects of company’s activities. We are always well informed about any changes in the current legislation.’
‘Joanna Krakowiak is a professional advisor, highly skilled at assessing risk and translating theoretical knowledge into practical application. She is capable of addressing complex and highly intricate topics even in cases when the final legislation is not implemented yet.’
‘Wardyński & Partners provide us with an excellent legal support, they were very efficient in a pioneer project within the scope of medtech. They have deep understanding of the practical and business driven aspects of complex regulatory challenges.’
Kernmandanten
Ingersoll Rand Inc.
Straumann Polska Sp. z o. o.
Autonomix Medical Inc.
Moleculin Biotech Inc.
Croma Pharma Sp. z o. o.
ALDI Sp. z o. o.
HTL Strefa S.A.
AIDS Healthcare Foundation
Dolnośląskie Centrum Onkologii we Wrocławiu
Kulczyk Investments Group
Lenus Pharma GmbH
Teekanne GmbH & CO. kg
CANPACK Group
Wendel
Highlight-Mandate
- Advised Ingersoll Rand Inc. on the Polish aspects of its acquisition of ILC Dover Group.
- Advised Straumann Polska Sp. z o. o. on adapting its operations to the EU Medical Device Regulation and the Polish Medical Devices Act.
- Advised Autonomix Medical Inc. on a cross-jurisdictional project for a US-based medtech company Autonomix Medical Inc.
WKB Lawyers
WKB Lawyers houses an ‘outstanding’ team with broad knowledge of clinical trials. Practice co-head Ewa Jaroszyńska-Kozłowska is recommended for her vast expertise in unfair competition, particularly in relation to trade marks, while co-head Agnieszka Wiercińska-Krużewska stands out due to her knowledge of marketing issues. Anna Wiktorow-Bojska, Jolanta Pietrkiewicz-Knecht, and Jolanta Prystupa joined from NGL Legal, the Polish Office of Registration of Medicinal Products, Medical Devices and Biocial Products, and Wardynski & Partners respectively.
Praxisleiter:
Ewa Jaroszyńska-Kozłowska; Agnieszka Wiercińska-Krużewska
Weitere Kernanwälte:
Anna Wiktorow-Bojska; Jolanta Pietrkiewicz-Knecht; Jolanta Prystupa; Magdalena Zielińska-Kuć
Referenzen
‘The team enables close cooperation between specialists in different fields. The team possessed the ability to master complex problems and a very craftsman-like, meticulous study of life sciences issues.’
‘Particularly outstanding partners: Ewa Jaroszyńska-Kozłowska – very extensive experience, great ability to analytically approach a case, assess it from a bird’s eye view and take the right strategies. Direct, attentive to the client’s assessment and interests. Ewa provides invaluable support.’
‘Anna Wiktorow-Bojska is an exceptional team leader.’
Kernmandanten
Polski Bank Komórek Macierzystych S.A.
Fundacja K.I.D.S. Klub Innowatorów Dziecięcych Szpitali
Highlight-Mandate
- Advising supermarket chains on the regulatory aspects regarding food (launch of new food products, labelling of products, assessment of allergen safety) as well as representing them in proceedings before inspection authorities and administrative courts concerning alleged food fraud.
- Advised leading manufacturer and distributor of medicines and medical devices on regulatory aspects of their business activity as well as assist in compliance matters.
- Advised Polski Bank Komórek Macierzystych S.A on data protection issues and medical secrecy on a daily basis, including performing the DPO function, advising the management board, risk analysis, helping identify and notify data protection violations, and assistance with implementation of new services.