Noted for its ‘wide spectrum of expertise in pharmaceutical law‘, the team at Czyzewscy Kancelaria Adwokacka
is adept at handling the gamut of regulatory issues relating to the registration and advertising of drugs, in addition to acting in post-registration proceedings. Praised by clients for being the ‘highest legal specialist with the deepest understanding‘, practice head Katarzyna Czyżewska regularly advises clients on the reimbursement, financing, and distribution of drugs and healthcare services, in addition to assisting with issues relating to clinical trials. Maciej Huzior left the firm.
Healthcare and life sciences in Poland
Czyzewscy Kancelaria Adwokacka
Practice head(s):
Katarzyna Czyżewska
Other key lawyers:
Agnieszka Kulawiak; Natalia Łukawska
Testimonials
‘Reactivity, adaptability, and excellent knowledge of the pharma sector.’
‘Katarzyna Czyżewska is strongly invested in clients’ interests, and has excellent knowledge of the pharma sector. Agile.’
‘Wide spectrum of expertise in pharmaceutical law and labour, they are general law experts. Very close collaboration, usually give very fast responses.’
‘I would like to point out Katarzyna Czyżewska, she often engages personally and is a great expert. Katarzyna has a very wide perspective – giving not only legal advice but also advice within a business context.’
‘They are specialists in IP law. They have vast knowledge with regards to the life sciences market, not only in terms of the legal environment but also from a very practical perspective. Their legal advice to pharma companies and associations is truly supportive of market practice. ’
‘Katarzyna Czyżewska is the highest legal specialist with the deepest understanding of the pharma market, providing the most tailor-made solutions. Her knowledge and practical support results in her finding the most optimal legal solutions for clients.’
‘Natalia Łukawska is a highly qualified lawyer, truly understanding the market and also greatly supporting businesses with her practical approach.’
Key clients
IZBA GOSPODARCZA FARMACJA POLSKA
CSL BEHRING
SERVIER
ADVANCED ACCELERATOR APPLICATIONS
OPELLA
PFIZER
KLOSTERFRAU
MERCK
THEA
LABORATOIRES EXPANSCIENCES
Work highlights
- Advised Izba Gospodarcza Farmacja Polska on the new versions of draft laws in Poland, which involved public discussions and consultations.
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j.
Hailed as being ‘absolutely unique in the Polish market‘, Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j. acts for a diverse client base of healthcare providers, medical device producers, and biotech companies in the full range of sector-specific matters. Practice co-head Paulina Kieszkowska-Knapik advises a number of industry associations and pharmacies on distribution structures, co-operations between pharmacies and online platforms, and the reimbursement of orphan drugs and medical products. Fellow co-head Ewa Rutkowska assists both Polish and global corporates across the pharmaceutical and medical devices industries with public consultations, as well as acting in product liability disputes. Michał Chodorek is noted for his expansive expertise in drug development and manufacturing projects, in addition to regulations governing the division of IP rights to discoveries. Michał Tracz‘s primary areas of focus are food supplements and biocidal products, and he was promoted to partner in February 2023. Bartłomiej Sasin is another active team member.
Practice head(s):
Paulina Kieszkowska-Knapik; Ewa Rutkowska
Other key lawyers:
Michał Chodorek; Michał Tracz; Bartłomiej Sasin; Justyna Nowak; Katarzyna Kęska; Monika Kupis
Testimonials
‘The law firm is characterised by extensive knowledge. They answer quickly and thoroughly. They are very meticulous and at the same time are businesslike. They provide great support on a daily basis, as well as in emergency situations.’
‘I would like to highlight three people, Katarzyna Kęska, Justyna Nowak, and Monika Kupis, for their exceptional knowledge and support. These are three exceptional lawyers. They have a very insightful approach, are able to present various ideas, indicate individual risks and mitigate these risks.’
‘KRK is absolutely unique in the Polish market. They combine in-depth knowledge in life sciences, regulatory and antitrust matters with a top quality and business-oriented approach.’
Key clients
Celon Pharma S.A.
Mabion S.A.
The Employers’ Union of Innovative Pharmaceutical Companies, INFARMA
WPD Pharmaceutical sp. z o.o.
Work highlights
- Advised MABION S.A. on a transaction which involved the conclusion of an agreement with Novavax Inc., under which the client will participate in the production of the Covid-19 Novavax vaccine.
- Advising several companies developing AI/ML medical devices on issues relating to their design, development, qualification, and validation.
- Representing two global pharmaceutical companies producing Covid-19 vaccines in claims brought by patients who were vaccinated and suffered adverse reactions.
Baker McKenzie Krzyzowski i Wspólnicy Sp.k.
Noted for its ‘unparalleled’ knowledge of Polish reimbursement rules, the team at Baker McKenzie Krzyzowski i Wspólnicy Sp.k. is well placed to advise clients on product distribution schemes and the transf of reimbursement approvals. ‘Skilled and bright’ team lead Juliusz Krzyżanowski is known for his expansive expertise in pricing and reimbursement issues within the pharmaceutical industry. Marcin Fiałka is particularly adept at handling matters involving pharmaceutical market regulations, dietary supplements, and medical devices, as well as advising on related data privacy procedures.
Practice head(s):
Juliusz Krzyżanowski
Other key lawyers:
Marcin Fiałka
Testimonials
‘I really enjoy working with B&M in Poland. Juliusz Krzyżanowski is always willing to help. He keeps us updated on all new regulations that may affect our business, connects with his colleagues in other countries and is very responsive.’
‘The team has regulatory expertise 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 I knew that we are in good hands.’
‘I work mainly with Juliusz Krzyżanowski. He is a trustworthy advisor and partner with an objective view on the issues involved in a particular case. He always tries to fit our needs into legal possibilities.’
Key clients
Astellas Pharma
Berlin-Chemie/Menarini
CSL Behring
Swedish Orphan Biovitrum
3M
Izba Gospodarcza FARMACJA POLSKA
Ascensia Diabetes Care Poland
Work highlights
- Advised Izba Gospodarcza, FARMACJA POLSKA, on the legislative process pertaining to a major amendment to the Act on Reimbursement of Medicinal Products, Foodstuffs Intended for Special Nutritional Purposes and Medical Devices.
- Advised Swedish Orphan Biovitrum on the establishment of a distribution model for its newly launched product.
- Advising CSL Behring on various reimbursement-related regulatory issues, including emergency access to medicinal products.
DLA Piper Giziński Kycia sp.k.
DLA Piper Giziński Kycia sp.k. houses an ‘outstanding‘ practice, known for its broad regulatory expertise in relevant distribution and advertising matters. The group also handles a variety of issues involving public procurement processes, and public education campaigns. ‘World-class regulatory lawyer’ Andrzej Balicki leads the team, maintaining a stellar reputation for advising on both domestic and EU regulatory frameworks governing the manufacturing and promotion of medical devices and pharmaceuticals. The ‘fantastic’ Jolanta Dąbrowicz regularly represents distributors and manufacturers of medical devices before the Main Pharmaceutical Inspectorate, the Main Sanitary Inspectorate, and the National Health Fund.
Practice head(s):
Andrzej Balicki
Other key lawyers:
Jolanta Dąbrowicz; Michał Orzechowski
Testimonials
‘Outstanding team. Especially strong for regulatory, public procurement and distribution in the life sciences sector.’
‘Andrzej Balicki shines as an inspirational leader and a real mentor for the team. He is a role model of a modern lawyer. He combines business acumen with terrific legal skills. Jolanta Dąbrowicz is fantastic for sector-related issues. Michał Orzechowski handily navigates through the intersection of competition and procurement law.’
‘DLA Piper are well known as specialists in healthcare and life sciences. They have very broad knowledge and experience.’
‘Highly professional team excelling in all crucial aspects of industry sector-related advice. Great understanding of current and upcoming life sciences regulations.’
‘Andrzej Balicki is a fantastic leader. He is very inspirational to the whole team and always presenting creative solutions. He has also a great understanding of public policy issues and trends in the legislation. A top life sciences lawyer on the market. Jolanta Dąbrowicz is a truly exceptional lawyer. She understands not only the legal but also technical aspects of sector-specific regulatory requirements.’
‘Andrzej Balicki stands out not just as a great technical lawyer but as a problem solver who understands sector specificities. Andrzej is also a great leader of the team. Jolanta Dąbrowicz has great experienced regarding regulatory issues. She very easily identifies and manages complex legal issues.’
‘Andrzej Balicki is a terrific life sciences lawyer. I am always impressed by his exceptional skills and confidence in the most difficult matters. Andrzej has a tremendous grasp of public policy aspects influencing healthcare businesses. Innovative and passionate regulatory lawyer.’
‘Andrzej Balicki is a world-class regulatory lawyer. He has a top-notch grasp of public policy and legislative processes. Andrzej has also great strategic thinking skills. Jolanta Dąbrowicz is an outstanding expert in food supplements law. I really enjoy working with them.’
Key clients
AbbVie
Allergan
Brass Research and Development
Clinmark
Ipsen
Kartos Therapeutics
Life Healthcare Group
Phibro Animal Health Corporation
Philips
Polpharma
Respiromix
Smith & Nephew
UCB Pharma
URGO Laboratoria Polfa Łódź
USP Zdrowie
Tymofarm
Żabka
Vedim
ExploRNA
Thea
Resmed
CMR Surgical
Work highlights
- Advising CMR Surgical on the distribution of its surgical technology in Poland, including assisting with public procurement matters.
- Advising Philips on new rules concerning the advertising of medical devices.
- Advising Smith&Nephew on a number of reimbursement matters regarding its medical devices, including participation in reimbursement negotiations before the Ministry of Health.
Domanski Zakrzewski Palinka
Domanski Zakrzewski Palinka‘s practice is known for handling a broad array of matters for clients, including M&A, research and development projects, and compliance issues. The group leverages its deep regulatory bench strength to advise clients on the manufacturing and promotion of pharmaceutical products. In December 2023, Mateusz Mądry arrived to head up the department; he brings in-house experience working at the Ministry of Health, the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products, and the European Medicines Agency to the group.
Practice head(s):
Mateusz Mądry
Other key lawyers:
Marcin Matczak
Testimonials
‘Very knowledgeable, exceptional, commercial knowledge of the pharma sector, very practical approach.’
‘Easy to understand communication.’
‘Awareness of business realities and out of the box mindset – they work together, and don’t just provide legal advice.’
‘Strong leadership, long-lasting relationships with organisations. Their key strength is their commercial/distribution expertise.’
‘Wide experience and knowledge of multiple topics and practical aspects of the law, which makes it easier to find solutions and rapidly execute projects/solve problems.’
Key clients
MSD Polska sp. z o.o.
AstraZeneca Pharma Poland Sp. z o. o.
Pfizer Polska sp. z o.o.
Teva Pharmaceuticals Polska
Takeda Sp. z o.o.
Telemedicine Working Group
Mylan Healthcare sp. z o.o. (Viatris group)
Polish Federation of Hospitals
Astellas sp. z o.o.
GSK (GSK Commercial sp. z o.o. and GSK Services)
Servier Polska Sp. z o.o.
Bausch Health Poland Sp. z o.o.
AbbVie Polska Sp. z o.o.
Sanofi
Vetoquinol Biowet sp. z o.o.
Roche Diabetes Care Polska Sp. z o.o.
Super-Pharm Holding
Organon Polska sp. z o.o.
Olimp Laboratories Sp. z o.o.
DrEryk S.A.
Work highlights
- Advising Takeda on the reimbursement of blockbuster drugs.
- Advising a large Polish pharmaceutical company on compliance issues, internal procedures, risk management, and the distribution of medicinal products, as well as handling contentious matters.
Eversheds Sutherland Poland
Jointly led by Marta Gadomska-Gołąb and Aleksandra Kunkiel-Kryńska, the team at Eversheds Sutherland Poland handles a broad array of issues involving the protection and transfer of patient data, and the advertising of medical devices. Gadomska-Gołąb has a great deal of expertise in matters concerning clinical trials and research and development projects within the healthcare sector, regularly advising on product safety and distribution, and medicinal product labelling. Kunkiel-Kryńska assists both Polish and international manufacturers, importers, and distributors with public procurement projects, as well as handling consumer claims.
Practice head(s):
Marta Gadomska-Gołąb; Aleksandra Kunkiel-Kryńska
Other key lawyers:
Jowita Prokop
Testimonials
‘The whole Eversheds team has been responsive and on time, and had useful analyses.’
‘Jowita Prokop was my main contact at Eversheds and did a terrific job with all our requests.’
Key clients
Gdziepolek
Hemp & Health
Medicare
Polish Coalition for Personalised Medicine – Association
Samsung
Work highlights
- Advising GdziePoLek on regulatory issues, including rules regarding the advertising and sale of medicinal products.
- Advised Samsung on all regulatory aspects concerning the introduction of a new medical device to the market, as well as assisting with issues related to promotion and advertising.
- Advising Allecco on the regulatory aspects of the sale of medicinal products, as well as the registration and marketing of medicinal products, dietary supplements, cosmetics and other products.
Kancelaria Tomasik Jaworski
The wide-ranging team at Kancelaria Tomasik Jaworski handles a vast range of issues on behalf of its diverse client base, including legislative proposals, licensing disputes, and public tender guidelines for in vitro medical devices. Marcin Tomasik and Tomasz Jaworski jointly lead the team; the former handles a range of mandates concerning medical devices, while the latter’s primary areas of focus are public tenders, product liability cases, and relevant IP issues.
Practice head(s):
Marcin Tomasik; Tomasz Jaworski
Key clients
PharmaNET
European Bank for Reconstruction and Development
Johnson & Johnson Poland Sp. zo.o.
Gedeon Richter Polska Sp. z o.o.
MedTech Poland
Polish Association of Pharmaceutical Industry Employers
Ferrero Polska Commercial Sp. zo.o.
Roche Diagnostics Polska Sp. zo.o.
Phytopharm Klęka S.A.
Roche Diabetes Care Polska Sp. zo.o.
IBSA Poland Sp. z o.o.
Implantcast Polska Sp. z o.o.
Medac Gesellschaft fur Klinische Spezialpraparate mbH(Sp. z o.o.) Oddział w Polsce
Dr. Max Sp. z o.o.
Europharma M Rachtan Sp. z o.o.
Lorenz Bahlsen Snack World Sp. zo.o.
Balton Sp. z o.o.
Celon Pharma S.A.
Neuraxpharm Polska Sp. z o.o.
Work highlights
- Acting for Konfederacja Lewiatan in pending proceedings before the European Commission in connection with potential non-compliance of the Polish ban on advertising of pharmacies with EU law.
- Representing PharmaNET in a bundle of disputes in administrative courts regarding the validity of licenses for running pharmacies.
Kieltyka Gladkowski KG Legal
Kieltyka Gladkowski KG Legal maintains its stellar reputation for handling technology-related issues within the medical devices industry, regularly assisting distributors with EU and Polish marketing requirements, and bio-pharma companies with obtaining approval to market biosimilars in Poland. Dividing her time between Kraków and Warsaw, the ‘outstanding‘ Małgorzata Kiełtyka leads the team alongside the ‘excellent‘ Kazimierz Jakub Gładkowski. Kiełtyka is well placed to advise on a broad range of transactional and regulatory issues across the sector, including labelling and advertising, distribution channels, and entry procedures. Gładkowski has deep knowledge of issues related to clinical trials, frequently assisting clients with pharmacovigilance issues.
Practice head(s):
Małgorzata Kiełtyka; Kazimierz Jakub Gładkowski
Testimonials
‘What sets this practice apart is their comprehensive knowledge of the industry. Their expertise spans a wide range of areas, including pharmaceuticals, medical devices, clinical research, and regulatory compliance. This in-depth understanding enables them to provide tailored solutions that align perfectly with the unique needs and objectives of clients.’
‘Kazimierz Jakub Gładkowski and Małgorzata Kiełtyka exemplify excellence and distinction in the legal field. With their extensive experience and diverse specialisations, they offer clients a level of legal counsel that is truly exceptional.’
‘Kazimierz Jakub Gładkowski stands out as an excellent lawyer.’
‘Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are extremely experienced in the field of life sciences, and are able to handle complex matters even under time constraints.’
‘Kazimierz Jakub Gładkowski is my main contact. He is a real pleasure to work with, pragmatic and knowledgeable. ’
‘Highly professional in legal practice, with a track record in healthcare, life sciences and medical device projects.’
‘Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are outstanding professionals in the life sciences sector.’
‘Kazimierz Jakub Gładkowski and Małgorzata Kiełtyka are both very high skilled lawyers, each with their own specific qualities, they are both very smart and are highly experienced and skilled in healthcare and life sciences.’
Key clients
BioLaw Europe
Life Science Cluster Poland
Advantage Austria
Work highlights
- Advised a US corporate investor on the protection of the activity of the client’s retail market share of medicines.
- Acted for a client in defence litigation concerning an allegedly defective medical device.
- Advised the global manufacturer of a drug whose final dose is sold in disposable dispensers on information obligations in the leaflet attached to the medicinal product.
NGL Legal
NGL Legal houses a ‘talented‘ team which assists its diverse client roster of medical device manufacturers and distributors, and companies in the aesthetic medicine industry, with the gamut of issues. The group regularly handles compliance and advertising matters. Practice head Agnieszka Majka has vast knowledge of product liability disputes and safety issues, in addition to the regulatory aspects of clinical trials and market surveillance. Medical device specialist Celina Bujalska is well versed in mandates involving the launch and registration of new products, as well as internal investigations. Since publication, Anna Wiktorow-Bojska has moved to WKB Lawyers.
Practice head(s):
Agnieszka Majka
Other key lawyers:
Celina Bujalska
Testimonials
‘Their professionalism and attention to detail were evident throughout the entire process. Their ability to decipher complex legal matters related to clinical trials and translate them into clear, accessible language was truly remarkable.’
‘One of the standout qualities of NGL was their willingness to engage in open and transparent communication. They actively sought to understand our vision, and took the time to listen to our specific needs and concerns. I wholeheartedly recommend NGL to anyone seeking legal support in projects. Their exemplary performance and collaboration have undoubtedly made a positive and lasting impact.’
‘The team’s strengths lie in their professionalism, client-friendliness, broad expertise and ability to get the job done in time. They are dedicated to achieving the best possible outcome for us, no matter how complex or challenging the case may be. They provide personalised attention to our needs and concerns. I feel we are in capable, reliable hands.’
Work highlights
- Representing a global manufacturer and distributor of medical devices in an internal investigation regarding alleged irregularities in its interactions with healthcare professionals.
- Advising a global pharmaceutical company on a comprehensive analysis of legal requirements related to commercial advanced therapy medicinal products, as well as the revision of clinical trial agreements.
- Representing a global manufacturer of medical devices in court proceedings regarding liability for an allegedly defective implantable medical device.
Soltysinski Kawecki & Szlezak
Soltysinski Kawecki & Szlezak houses a team of ‘excellent specialists‘, who assist with the labelling of foodstuffs, handle public procurement disputes, and advise on the exploitation of regulatory niches. ‘Outstanding‘ practice co-head Ewa Skrzydło-Tefelska is noted for her knowledge of IP issues, including patent infringement actions and unfair competition cases, and regularly represents clients before the Supreme Administrative Court. ‘Very talented‘ co-head Jacek Myszko advises both international and domestic clients on the regulatory issues surrounding the wholesale distribution of medical devices and medicinal products, in addition to advising on clinical trial agreements.
Practice head(s):
Jacek Myszko; Ewa Skrzydło-Tefelska
Testimonials
‘SK&S has a very well-organised team of lawyers who demonstrate exceptional skills in understanding and meeting client expectations.’
‘We cannot say enough about the team’s diverse and unique experience. They are indeed excellent specialists who always dive deep into the problem and the solutions they propose touch upon all important aspects, not only the narrow question they receive.’
‘Jacek Myszko is extremely responsive and, like the whole team, very well rounded in terms of pharmaceutical, healthcare, intellectual property, medical devices, and foodstuff matters. He is tackling the most niche, often precedent-setting matters with the utmost skill.’
‘Excellent team with great members and an exceptional head, Ewa Skrzydło-Tefelska.’
‘Ewa Skrzydło-Tefelska is an outstanding, excellent lawyer with vast experience, unique talent and amazing knowledge. Always quick to answer, proactive attitude, very helpful.’
‘Jacek Myszko is a very talented lawyer, very responsive, proactive, with superb skills.’
Key clients
Wolt Polska Sp. z o.o.
E&J Gallo Winery
Polski Związek Pracodawców Przemysłu Farmaceutycznego
Work highlights
- Represented a major honey producer in the course of honey adulteration proceedings.
- Advised a major global wine producer on the regulatory aspects of its introduction to the market and advertising of alcoholic beverages.
- Advising a major EU CRO company on various aspects of cross-border services rendered to EU and non-EU sponsors of clinical trials organised in Poland.
CMS Cameron McKenna Nabarro Olswang Posniak i Bejm sp.k.
CMS Cameron McKenna Nabarro Olswang Posniak i Bejm sp.k. houses a broad team known for its expansive knowledge of relationships between medical representatives and healthcare professionals, regulatory inspections, and post-market responsibilities. Practice head Agnieszka Starzyńska is well versed in matters involving clinical trials and the placing of products on the market, in addition to the regulatory regime governing food supplements and cannabis. Katarzyna Łoś has broad expertise in the marketing, distribution, and development of products within the pharmaceutical and food industries.
Practice head(s):
Agnieszka Starzyńska
Other key lawyers:
Katarzyna Łoś
Key clients
Coopervision Poland
Partner in Pet Food
Bausch & Lomb
Cytiva
Sonova
Syneos
Constantia Flexibles
Boston Scientific
ICON
PZ Cussons
Work highlights
- Advising Coopervision on various regulatory and compliance matters relating to its soft contact lenses and related products.
- Advising Sonova Group on compliance issues relating to its interactions with healthcare providers.
- Advised Constantia Flexibles on pre-transactional due diligence in relation to a manufacturer of food packaging, including the regulatory and food law aspects.
DBS Law Firm
Agata Bzymek-Waśniewska and Marta Sroka-Maleta jointly lead the team at DBS Law Firm; the former is noted for her broad expertise in sector-specific labour law issues, and promotional, logistics, and distribution issues within the pharmaceutical industry, while the latter is particularly active on mandates concerning changes to pharmaceutical, reimbursement and IP legislation. The ‘very well seasoned‘ group exhibits deep regulatory knowledge of orphan drugs and international drug launches. Andrzej Siwiec was promoted to partner in January 2023, and has extensive regulatory knowledge, advising on a range of market access and business development projects.
Practice head(s):
Agata Bzymek-Waśniewska; Marta Sroka-Maleta
Other key lawyers:
Joanna Mączko-Forgiel; Andrzej Siwiec
Testimonials
‘The team is very knowledgeable in the specialised life sciences regulations across the EU. Good practical advice without making matters excessively complex.’
‘Andrzej Siwiec is always responsive, addresses queries promptly, has a good understanding of life sciences regulations, provides practical advice.’
‘Here is a testimony to all the outstanding work they are all doing: I am grateful and appreciative of all the tenacious efforts, creative problem-solving and teamwork they all contribute.’
Key clients
Alpen Pharma Polska
Avanzanite Bioscience
GOFARM
Plich Advisory & Investments
Polski Lek (MASPEX group)
SESTEC
Teva Operations Poland
Teva Pharmaceuticals Polska
Your Health Medical Centre
Mokotooth Prestige Dental
Medicines for Poland
LEK-AM
Work highlights
- Advising a global pharmaceutical corporation on a possible change to its business model in Poland.
- Advising a Dutch pharmaceutical company on the preparation of a multi-jurisdictional launch and the commercialisation of a medicinal product for a rare disease.
- Advising a pharmaceutical group on all legal issues connected with the marketing and advertising of its newly-launched product.
Dentons
Praised for its ‘exceptional‘ industry knowledge, the team at Dentons regularly assists clients with the acquisition of wholesale and pharmacy trade licenses, as well as handling disputes concerning the withdrawal of licences. Adam Odojewski leads the team, and is noted for his deep knowledge of licensing issues within the pharmaceutical industry, and his regulatory expertise in the laws governing medicinal products and medical devices.
Practice head(s):
Adam Odojewski
Testimonials
‘Exceptional and practical GDP knowledge.’
‘Co-operation with Adam Odojewski is always fruitful and substantive.’
‘Practitioners demonstrated exceptional industry knowledge, allowing them to provide a substantive response to the case in a short time. The contact established allowed for direct and quick communication.’
‘Adam Odojewski and his team have extremely high competences, substantive industry knowledge and high levels of effectiveness. The communication was quick, and understandable.’
‘Dentons combines perfect legal capabilities with impressive market knowledge. The team is diligent in its support, providing clear and concise advice.’
‘Adam Odojewski understands business needs and the sector, and delivers clear and pragmatic advice.’
Key clients
Convatec
Mayoly Poland
Acuity International
Adamed Pharma
Affidea Group
AmeriCares
Argenta
Delfarma
Dr. Max
Egis Polska
Hoya
GlaxoSmithKline (GSK)
Johnson & Johnson
Nikalab
Sensor Cliniq
SP ZOZ MSWiA w Poznaniu im. Prof. L. Bierkowskiego
Ziko
Work highlights
- Represented a pharmacy network in a dispute with the Polish regulatory authorities, who were seeking to revoke the operating licences of 17 of the client’s pharmacy stores.
- Represented Delfarma in administrative proceedings initiated by the pharmaceutical authorities to revoke the client’s wholesale distribution authorisation on the basis of alleged non-compliance.
- Advising AmeriCares, a US-based global non-profit organisation, on issues relating to its presence and activities in Poland in response to the humanitarian crisis in Ukraine.
Fairfield
Fairfield maintains a diverse offering, with broad expertise in certification and pharmacovigilance-related issues within the medical devices industry. Practice co-head Oskar Luty has longstanding experience in matters relating to the advertising and reimbursement of medical devices, regularly advising on novel provisions of the Medical Devices Act. Fellow co-head Marcin Flak frequently assists clients with the implementation of distribution schemes and pharmaceutical inspections. Karol Korszuń, who completes the trio of practice heads, advises numerous manufacturers and market authorisation holders on public reimbursement and drug marketing issues. Oskar Platta is also recommended.
Practice head(s):
Oskar Luty; Marcin Flak; Karol Korszuń
Other key lawyers:
Oskar Platta
Testimonials
‘Fairfield is a professional law firm, specialising in various fields of law. Its uniqueness lies in the fact that the client feels taken care of in every area. The advice given is understandable, accessible and clear. The people who make up the team are professionals.’
‘The individual who stands out is Oskar Luty – a great mentor and a person who has a lot of legal knowledge, and knows how to convey it in an accessible way.’
Key clients
INFARMA
POLMED
Zwiazek Pracodawcow Producentow Przemyslu Spirytusowego
Zentiva
Angelini Pharma
Adamed
Accord Healthcare
Merck
Aristo Pharma
Avon
Boston Scientific
Olympus
Abbott
Stryker
FM Logistic
Polish Hypertension Society
B.Braun
MagnaPharm
Molnlycke
Stada
Resmed
Spark&Mortar
Polpharma
Biocodex
Alcon
Amplifon
Aspironix
Work highlights
- Advised POLMED on the preparation of industry guidelines for new regulations on medical device advertising.
- Advised Infarma on the amendment of the Pharmaceutical Law and the legislative process of adopting amendments to the Regulation of the Minister of Health relating to the advertising of medicinal products.
- Instructed by the POLMED chamber to advise on all stages of the legislative process of the amendment of the Reimbursement Act.
Kochanski & Partners
Kochanski & Partners‘ practice is noted for handling a broad array of mandates, including trade mark infringement actions and allegations, and proceedings concerning tenders. The team is also known for its medtech expertise, advising on medical records management and cloud-based IT solutions. Noted for his specialism in marketing and the formation of distribution systems, Krzysztof Zięba leads the team, and often assists clients with the negotiation of trade and distribution agreements, as well as acting in pharmaceutical product marketing disputes.
Practice head(s):
Krzysztof Zięba
Key clients
Reckitt Benckiser
Hasco TM
nOvum Fertility Clinic
Krynica Vitamin S.A.
Natural Pharmaceuticals
Techdow Pharma Poland
Shenzhen Hepalink Pharmaceutical Group Co. Ltd
Corza Medical
Work highlights
- Representing HASCO Lek against its competitor Swiss Pharma International in various trade mark infringement cases.
- Advising Reckitt Benckiser on the distribution network for OTC products as well as medical devices.
- 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.
Osborne Clarke
Osborne Clarke houses a broad practice known for handling a vast array of matters on behalf of clients from the healthcare and life sciences sectors, including appearances before the Polish Office of Public Tenders, advertising claims, and IP licensing schemes. The group is also noted for acting in trade mark infringement disputes and reimbursement proceedings before the Economic Commission of the Ministry of Health. Practice head Agnieszka Sztoldman has a great deal of experience in negotiating IP agreements, regularly advising clients on their IP portfolios in the context of M&A deals.
Practice head(s):
Agnieszka Sztoldman
Key clients
Grifols International, Grifols Polska
Perrigo International
Aflofarm Farmacja Polska
IPD Analytics
Best Natural Product
EVER Neuro Pharma GmbH
Globiana (Cavatina Holding SA)
TCC Community Campaign
Virbe
WaiWai
L’Oreal
Huel
Work highlights
- Advising Perrigo, an American Irish–registered manufacturer of private label over-the-counter pharmaceuticals and a global OTC medicines producer, on assessing advertising claims related to one of its blockbuster products in various jurisdictions in terms of risks associated with regulatory law and fair competition market standards.
- Representing Khadi Naturprodukte GmbH, a global maker of Indian cosmetics, in ongoing trade mark disputes with individuals who sold similar items.
Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A.
Hailed by clients as comprising ‘true enthusiasts who know medical law like no-one else‘, the Poznań-based team at Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A. acts for hospitals in the full range of healthcare-related issues, including medical malpractice claims, the collaboration of Polish hospitals with foreign healthcare funders, and medical documentation management. Magdalena Cieślińska-Dopierała regularly handles disputes involving cases against the National Health Fund, and patient claims against medical entities involving the violation of patient rights and medical errors. ‘Undisputed specialist’ in labour and medical law Ewelina Jeglikowska regularly assists clients with administrative issues, and managerial contracts and remuneration systems, while Anna Piotrowska-Musioł primarily represents public healthcare facilities in disputes concerning the provision of healthcare services.
Practice head(s):
Anna Piotrowska-Musioł; Ewelina Jeglikowska; Magdalena Cieślińska-Dopierała
Testimonials
‘The wide range of issues and diversity of matters in the medical industry requires the firm not only to have exceptional specialists, but also to respond to frequent changes in regulations. Sowisło Topolewski is for me the best partner for healthcare and science-oriented organisations in Poland.’
‘From the very beginning of our cooperation with the Sowisło Topolewski law firm and its medical law team, I have been impressed by their professionalism, commitment and effectiveness. The team operates in accordance with the highest ethical standards. I have always felt that interests are protected and all activities are conducted with integrity. Understanding the context and specific goals of the client is their priority. They are true enthusiasts who know medical law like no-one else.’
‘The team are true experts. Their commitment, knowledge and professionalism in the field of medical law is amazing and worthy of the highest recognition. Their ability to combine law with medical aspects is invaluable. They help medical professionals understand complex legal issues related to healthcare, which translates into peace and self-confidence in difficult times. I thus express my deep gratitude and respect for the exceptional work of this team.’
Key clients
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
Wojewódzki Szpital Wielospecjalistyczny im. dr Jana Jonstona w Lesznie
Ginekologiczno-Położniczy Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego w Warszawie
Szpital Powiatowy im. Jana Pawła II w Trzciance
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Leszczyńskie Centrum Medyczne Ventriculus Spółka z ograniczoną odpowiedzialnością z siedzibą w Lesznie, „Kalmedica” Spółka z ograniczoną odpowiedzialnością z siedzibą w Kaliszu
Wojewódzki Szpital Zespolony im. dr Romana Ostrzyckiego w Koninie
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów Samodzielny Publiczny Zakład Opieki Zdrowotnej
Terapia Medyczna „TERAMED” Sp. z o.o. z siedzibą w Poznaniu
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Słupcy
Work highlights
- Represented Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie in a dispute against the National Health Fund concerning €20.26m in remuneration for the lack of performance of a contract.
- Assisted Wielospecjalistyczny Szpital Miejski im. Józefa Strusia z Zakładem Opiekuńczo-Leczniczym. Samodzielny Publiczny Zakład Opieki Zdrowotnej z siedzibą w Poznaniu przy ul. Szwajcarskiej 3 with the preparation of an application for an investment aimed at expanding the hospital and creating new departments.
Taylor Wessing Poland
The ‘excellent‘ team at Taylor Wessing Poland is known for its extensive expertise in the regulations governing the advertising of medical devices on both an EU-wide and domestic level. The team also has a great deal of experience in handling the filing of trade marks and trade mark portfolio management. Issues surrounding the launching of clinical trials for medical devices are another area of strength. Przemysław Walasek leads the team with his exceptional knowledge of sector-specific IP, data protection, and technology issues. Bartosz Świdrak counts many major medical devices, food, and pharmaceutical companies among his core clients.
Practice head(s):
Przemysław Walasek
Other key lawyers:
Bartosz Świdrak
Testimonials
‘Taylor Wessing Poland understood and explained the new publicity and advertising law in an excellent way. They are one of the experts in that field.’
‘The team was really nice, everyone solved quickly my doubts. They are very proactive, too, and keep you in the loop with new updates that might interest you, especially Bartosz Świdrak.’
‘Excellent team, very open to new ideas, accessible and responsive.’
Key clients
Estheticon (Multiestetica)
Polpharma
Knapp AG
Biotest AG
BTL Polska
Theramex
Apotex
Sight Sciences
Align Technology
Biomaxima S.A.
InspireMD
Work highlights
- Advising Align Technology on advertising rules.
- Advised Polpharma on intellectual property issues, in particular on contributory liability for patent infringement under Polish law.
- Assisted Sight Sciences with launching clinical trials for medical devices, including drafting and negotiating clinical trial agreements with research sites and investigators in Poland.
Wardynski & Partners
Wardynski & Partners‘ provides clients with a diverse offering, with the team’s workload involving data sharing initiatives, novel EU medical and in vitro devices regulations, and public-private partnerships. Practice head Joanna Krakowiak is a ‘top-notch specialist‘, who regularly assists clients with communication strategies and advertising campaigns. Having joined the practice from Fairfield in early 2023, Marcin Rytel maintains his strong focus on regulatory issues, particularly in relation to market authorisations, and public financing systems for regulated products.
Practice head(s):
Joanna Krakowiak
Other key lawyers:
Marcin Rytel
Testimonials
‘Joanna Krakowiak is outstanding, she is reliable, hard working, patient, and proactive. Great person to work with.’
‘The team demonstrates the breadth of legal expertise and knowledge on matters relevant for my industry; they provided extensive support in connection with the recent changes in the EU and Polish medical device regulations, including many practical tips and advice on how to adapt my company’s operations to the new requirements.’
‘Joanna Krakowiak has extensive knowledge and has successfully been supporting my company on a variety of projects, mainly related to new challenges stemming from the new EU and Polish medical device regulations. She demonstrates a proactive approach.’
Key clients
Bio-Rad Laboratories, Inc. (NYSE)
QIAGEN N.V.
CNS Pharmaceuticals Inc
Autonomix, Inc. (USA)
Moleculin Biotech, Inc.
Nouryon Chemicals International B.V. (part of Caryle Group)
HTL-Strefa
ExceedOrphan s.r.o.
Jagiellonian University
Bioforum (part of EuropaBio) – NGO
Work highlights
- Advised Bio-Rad Laboratories on its acquisition of 100% of the shares in Curiosity Diagnostics sp. z o.o. from Scope Fluidics SA for a total sum of up to $170m consisting of an upfront payment and future milestone payments.
- Assisted CNS Pharmaceuticals Inc with the drafting and negotiation of a contract for the supply of berubicin to the Pomeranian Medical University.
- Assisted Autonomix with the launch of a medical device clinical investigation relating to an innovative method of pain mitigation.