Czyzewscy Kancelaria Adwokacka is recognised as a go-to advisor on issues relating to reimbursement of medicinal products; pricing of healthcare services; and advertising of drugs, food, medical devices or cosmetics. The firm is instructed by many leading international pharmaceutical companies, including Pfizer and Sanofi. Katarzyna Czyzewska heads up the practice. Maciej Huzior, who regularly advises clients on pertinent matters involving new technologies, is another name to note. In March 2022, senior associate Agnieszka Kulawiak joined the team from an in-house position at Aflofarm Group.
Healthcare and life sciences in Poland
Czyzewscy Kancelaria Adwokacka
Practice head(s):
Katarzyna Czyżewska
Other key lawyers:
Maciej Huzior; Agnieszka Kulawiak
Key clients
Izba Gospodarcza Farmacja Polska
Sanofi
Servier
Advanced Accelerator Applications
CSL Behring
Pfizer
Klosterfrau
Stallergenes
Thea
Laboratoires Expansciences
DLA Piper Giziński Kycia sp.k.
DLA Piper Giziński Kycia sp.k. fields a 'top team' of 'highly skilled lawyers'; the group's competencies stretch across all life sciences sub-sectors, including pharmaceuticals, medical devices, food and healthcare. As well as regulatory issues and product liability matters, the firm is active in the marketing, distribution and advertising spaces. Recently, telemedicine has become an increasing focus. 'Leading expert' Andrzej Balicki heads up the practice, supported by 'very talented' senior associate Jolanta Dąbrowicz.
Practice head(s):
Andrzej Balicki
Other key lawyers:
Jolanta Dąbrowicz
Testimonials
‘This is the best team for distribution and procurement matters in the life sciences sector. Very pragmatic and down to earth, combining legal and business thinking. Top team in my view.’
‘Andrzej Balicki is an impressive lawyer and the leading expert in Poland for any matters related to the life sciences sector. He always sees the big picture covering legal, business and human aspects of projects. Highly recommended.’
‘Jolanta Dąbrowicz is fantastic for regulatory matters.’
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
Work highlights
- Assisted Ipsen with the creation of an educational campaign for patients and their guardians.
- Advising Smith&Nephew on numerous matters concerning the reimbursement of medical devices.
- Assisting Kartos Therapeutics with the formatting of clinical agreements templates used in Poland.
Domanski Zakrzewski Palinka
At Domanski Zakrzewski Palinka, the workload is split equally between project-based, strategic advice and regulatory assistance, including reacting to imminent legislative changes. Many of the team's key senior practitioners - including Michał Czarnuch and Marcin Matczak - are specialists in administrative law, operating primarily at its intersection with the pharmaceutical sector. Tomasz Kaczyński and Marcin Pieklak are noted for their expertise in product registration and reimbursement issues.
Practice head(s):
Michał Czarnuch
Other key lawyers:
Marcin Matczak; Tomasz Kaczyński; Anna Partyka-Opiela; Marcin Pieklak; Paweł Kaźmierczyk
Testimonials
‘Paweł Kaźmierczyk – great, intelligent and experienced lawyer.’
Key clients
MSD Polska sp. z o.o.
AstraZeneca Pharma Poland Sp. z o. o.
Viatris / Mylan Healthcare sp. z o.o.
Pfizer Polska sp. z o.o.
Polish Federation of Hospitals
GSK (GSK Commercial sp. z o.o. and GSK Services)
Teva Pharmaceuticals Polska
AbbVie Polska Sp. z o.o.
Telemedicine Working Group
Astellas sp. z o.o.
Takeda Sp. z o.o.
Vetoquinol Biowet sp. z o.o.
Roche Diabetes Care Polska Sp. z o.o.
Infarma. The Employers’ Union of Innovative Pharmaceutical Companies
Ministry of Health
Super-Pharm Holding
Intervet (MSD Animal health)
Olimp Laboratories Sp. z o.o.
Greater Poland Voivodeship
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j.
Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j. fields a team of 'seasoned experts' who have extensive knowledge of the pharmaceutical, medical, food and cosmetic sectors. As well as receiving instructions from national and global industry leaders, the firm also counts the Employers’ Union of Innovative Pharmaceutical Companies among its clients. Alongside its advisory work, the group frequently handles contentious mandates. Paulina Kieszkowska-Knapik and Ewa Rutkowska oversee the department; the former regularly advises on reimbursement issues, while the latter is a particular specialist in product liability work. Michał Tracz is another key name to note.
Practice head(s):
Paulina Kieszkowska-Knapik; Ewa Rutkowska
Other key lawyers:
Michał Chodorek; Michał Tracz; Bartłomiej Sasin
Testimonials
‘Exceptionally competent team demonstrating very good knowledge of the relevant laws in combination with their practical implementation.’
‘The lawyers demonstrated deep knowledge of law and practices of local authorities which enabled them to provide bespoke, client-oriented practical advice. The team was easily available and demonstrated a sense of urgency.’
‘Smart, open-minded, experienced, positive thinking, focused on problem solving.’
Key clients
Mabion S.A.
The Employers’ Union of Innovative Pharmaceutical Companies, INFARMA
Work highlights
- Advised Mabion on its agreement with Novavax relating to the production of the Covid-19 vaccine.
- Advising the Employers’ Union of Innovative Pharmaceutical Companies on the creation of a new legislative framework for a no-fault compensation fund for vaccines, a draft law on clinical trials, and a draft amendment to the reimbursement law.
- Representing two global pharmaceutical companies producing Covid-19 vaccines in claims filed by patients who suffered alleged adverse reactions.
Dentons
January 2022 marked a change of leadership at Dentons; although former practice head Wojciech Kozłowski continues to play an active role – particularly in the disputes space – the department is now helmed by Adam Odojewski. The team is able to handle the gamut of issues relating to pharmaceuticals and medical devices, including assisting with regulatory, distribution and advertising matters. One client singles the group out as ‘a team of experts who are making a difference‘. Maria Samolińska departed for BLSK in August 2023.
Practice head(s):
Adam Odojewski
Other key lawyers:
Wojciech Kozłowski; Agnieszka Wardak; Agnieszka Stefanowicz-Barańska
Testimonials
‘A team of experts who are making a difference!’
Key clients
Acuity International
Affidea
Americares
Argenta
Hoya
Medezin
Nikalab
Sensor Cliniq
Accord Healthcare
AstraZeneca
Adamed
Delfarma
DOZ / Pelion
Dr.Max
Egis Polska
GlaxoSmithKline (GSK)
Johnson & Johnson
Komtur Polska
Polpharma Biologics
Sanofi-Aventis
Super-Pharm
Ziko Apteka
Work highlights
- Advising AmeriCares, a global US-based not-for-profit organisation, on issues related to its presence and activities in Poland in response to the humanitarian crisis in Ukraine.
- Advising Affidea Group and private investment firm B-Flexion on the sale of the group to Belgian investment firm Groupe Bruxelles Lambert.
- Representing a pharmacy network in a dispute with the regulatory authorities in Poland, which concerns the revokation of licenses for the operation of 17 pharmacy stores.
Eversheds Sutherland Poland
Eversheds Sutherland Poland's practice spans the whole life cycle of products and services generated by key players from the healthcare and life sciences sectors, from registration of medicinal products, to promotional and marketing strategy, to public reimbursement. The firm also assists a significant bank of clients newly entering the industry; the group's recent advice to Samsung on regulatory issues relating to its new monitoring device is just one example of this. Marta Gadomska-Gołąb and Aleksandra Kunkiel-Kryńska lead the work.
Practice head(s):
Marta Gadomska-Gołąb; Aleksandra Kunkiel-Kryńska
Other key lawyers:
Jowita Prokop
Key clients
LifeFlow
Polish Coalition for Personalised Medicine – Association
Samsung
Gdziepolek
Pharmacy Solutions
Work highlights
- Advising Gdziepolek on the regulatory aspects of its provision of services designed to assist patients with the purchase of their medicines.
- Advising Samsung on the regulatory, promotional and advertising issues relating to its introduction of the Samsung Health Monitor.
Kieltyka Gladkowski KG Legal
Under the guidance of its 'entrepreneurial founding partners', Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski, highly specialised boutique Kieltyka Gladkowski KG Legal offers clients expertise at the intersection of technology and life sciences. The 'innovative' firm has recently advised on issues relating to biomedical engineering, distributed ledger technologies in gene therapies, patient data sharing through cloud platforms, and use of augmented reality in medical devices. The team's capabilities are further supplemented by its significant cross-border data privacy and cybersecurity experience.
Practice head(s):
Małgorzata Kiełtyka; Kazimierz Jakub Gładkowski
Testimonials
‘The firm has talented, outward-looking, ambitious lawyers.’
‘Provides clients with rapid, detailed and customer-oriented support.’
‘The partners running the firm combine professionalism with an open approach to clients’ needs, offering expertise, solutions and suggestions/recommendations far beyond the industry standard. They are also flexible and respond quickly to the unforeseen difficulties that companies are confronted with.’
‘Very innovative.’
‘Both Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are noteworthy, amicable and approchable.’
‘Entrepreneurial founding partners.’
‘I have worked with the founding partners, Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski, and found them to be talented, ambitious, and pleasant to deal with.’
‘Excellent and dynamic team.’
Key clients
BioLaw Europe
Life Science Cluster Poland
Netherlands Polish Chamber of Commerce
Advantage Austria
Work highlights
- Advising a US-based biotechnology research and development company on issues concerning clinical trials involving the participation of minors.
- Advised a big data company on the implementation of an innovative processing system for clinical trial data.
- Prepared a legal assessment of the requirements and regulatory stages necessary for the registration and authorisation of the sale of custom-made implants based on augmented reality and the use of 3D-models and algorithms.
NGL Legal
NGL Legal fields an 'enthusiastic' team which focuses on life sciences regulatory and product liability matters, as well as handling investigations and compliance-related mandates. Advising on legal issues surrounding cannabis is a particular niche specialism for the firm. Typical clients include global and domestic manufacturers and distributors of medical devices, medicinal products, and cosmetics; companies involved in clinical trials; private medical facilities; and digital health providers. Agnieszka Majka heads up the practice.
Practice head(s):
Agnieszka Majka
Other key lawyers:
Celina Bujalska; Anna Wiktorow-Bojska
Testimonials
‘They are not only professional and helpful, engaged and working in a timely manner, but also very kind which makes it a pleasure working with them.’
‘Since we started working with NGL Legal we’ve been taken good care of by a number of lawyers, including (but not limited to) Agnieszka Majka, Anna Wiktorow-Bojska and Celina Bujalska.’
‘Enthusiastic team with great knowledge of life sciences.’
Key clients
Fundacja K.I.D.S. Klub Innowatorów Dziecięcych Szpitali
MedSilesia
Technomed
Zimmer Biomet
Work highlights
- Advising a global manufacturer and distributor of medical devices on an internal investigation regarding alleged irregularities in its interactions with healthcare professionals.
- Representing a global manufacturer of orthopaedic medical devices in court proceedings regarding liability for an allegedly defective implantable medical device.
- Assisting a global company which provides health-related services across the globe with the launch of its operations in Poland.
Soltysinski Kawecki & Szlezak
Soltysinski Kawecki & Szlezak fields 'a team of top-notch lawyers' who consistently 'produce outstanding results'. The group brings together practitioners specialising in areas ranging from pharmaceutical law and biocidal products, to intellectual property and public procurement; the firm is consequently able to advise particularly well on issues occuring at the intersection of multiple fields of knowledge - including clinical trials, disputes involving healthcare entities, and projects relating to foodstuffs. Jacek Myszko and Ewa Skrzydło-Tefelska jointly lead the department.
Practice head(s):
Jacek Myszko; Ewa Skrzydło-Tefelska
Testimonials
‘The SKS team is strong and deep and we rely on them to provide clear, efficient and solid practical advice at much lower rates than other firms charge.’
‘Jacek Myszko has expertise in many areas that are crucial to our business and we rely on him heavily. He takes the time to really understand his clients, their needs, and provides guidance and advice that takes into account business realities and risks. His communication is top-notch and we appreciate how quickly he responds to requests.’
‘SK&S managed to assemble a team of top-notch lawyers. Even though they are perceived as an elite law firm, they are extremely approachable, responsive and easy to work with.’
‘We appreciate the combination of recognised academics and excellent practitioners – they produce outstanding results.’
‘Even in the most difficult cases we can rely on their knowledge and experience. They have a deep understanding of laws and practice which is very important to us. We really appreciate their overall perception of the problem, yet with great attention to the relevant details.’
‘Even though they are a local law firm, they have impressive international connections and are able to compose international groups of law firms to address cross-border issues.’
‘Jacek Myszko is always ready to shed some light on “hot” topics that are relevant to our members. Since Jacek has such a broad perspective, he is able to direct our attention to the most relevant aspects from the practical point of view.’
‘Jacek Myszko is great in terms of both knowledge and organisational skills; he is also much appreciated for his dedication and creativity.’
Key clients
Adstream UK
Victor Guedes, Ind. Com. S.A.
Wolt Polska Sp. z o.o.
Technicolor Home Entertainment Services, Inc.
PSI Pharma Support Poland Sp. z o.o.
E&J Gallo Winery
Nesperta Sp. z o.o.
Polski Związek Pracodawców Przemysłu Farmaceutycznego
Work highlights
- Advising Victor Guedes on the labelling of foodstuffs.
- Assisting Wolt with its operations in Poland, in particular issues relating to intermediation in the distribution of foodstuffs.
- Advising multiple clinical trial participants on regulatory matters related to Informed Consent Forms (ICFs).
Baker McKenzie Krzyzowski i Wspólnicy Sp.k.
Baker McKenzie Krzyzowski i Wspólnicy Sp.k. advises some of the best known pharmaceutical brands on the gamut of issues affecting their local operations, as well as on the regulatory aspects of global deals. The ‘highly skilled‘ team has recently been expanding its capabilities in the field of reimbursement, particularly in relation to innovative medical technologies. Counsel Juliusz Krzyżanowski leads the team and handles regulatory matters. Paweł Hincz left the firm for an in-house position.
Practice head(s):
Juliusz Krzyżanowski
Other key lawyers:
Marcin Fiałka
Testimonials
‘This law firm offers great support for companies like us in the pharmaceutical industry in all relevant aspects of setting up a compliant business in Poland.’
‘Juliusz Krzyżanowski is an excellent lawyer. He has a profound and comprehensive legal knowledge and great experience. This helped us to achieve excellent results in the matters he was engaged with. Apart from his excellent legal support he has a great personality so that it is always a pleasure working with him.’
‘The collaboration with Baker McKenzie is outstanding for prompt, highly professional support given in a timely manner.’
Key clients
CSL Behring
Astellas Pharma
Berlin-Chemie/Menarini
Gruppo Villa Maria S.p.A.
Work highlights
- Providing ongoing legal advice to CSL Behring regarding its operations in Poland, including assistance with reimbursement issues, public tenders, and agreements with healthcare professionals.
- Advising Astellas Pharma on multiple life science-related issues, including the sale and direct import of its medicinal products.
- Advising Berlin-Chemie/Menarini on multiple ongoing issues, including a distribution agreement concerning Daiichi Sankyo’s medicinal product Efient, as well as on the transfer of marketing authorisation for the medicinal product Viklaren.
Clifford Chance
With disputes expert Marcin Ciemiński at its helm, the offering at Clifford Chance is well placed to represent key players from the pharmaceutical, healthcare and life sciences sectors in strategic cross-border litigation, including white-collar cases relating to technology, services and products. Paweł Pogorzelski and Justyna Błazejczyk-Kuwał left the firm in early 2023.
Practice head(s):
Marcin Ciemiński
CMS Cameron McKenna Nabarro Olswang Posniak i Bejm sp.k.
Under the guidance of counsel Agnieszka Starzyńska, CMS Cameron McKenna Nabarro Olswang Posniak i Bejm sp.k.'s Warsaw-based team operates as part of the firm's global life sciences group, which consists of sector specialists located in over 30 countries across the world. The group is able to advise on issues arising throughout the life cycle of its clients, from the fulfilment of regulatory obligations connected with launching on the market, through to development of marketing procedures.
Practice head(s):
Agnieszka Starzyńska
Other key lawyers:
Katarzyna Łoś
Key clients
Becton Dickinson
PZ Cussons
Coopervision Poland
Medtronic
Partner in Pet Food
Labocan
PRA HealthSciences Polska
Cytiva
Work highlights
- Advising Beckton Dickinson on issues relating to medical devices, including clinical trials and sales contracts.
- Advised Partner in Pet Food on the acquisition of G-Mart and Zakład Przetwórstwa Rolniczego.
- Advising PZ Cussons, a UK-based cosmetics producer, on regulatory issues related to placing products on the Polish market.
DBS Law Firm
Boutique firm DBS Law Firm fields a ‘deeply knowledgeable‘ team, which has a proven track record advising on the gamut of issues relating to the pharmaceutical, medical devices, and cosmetics sub-sectors. Regulatory, reimbursement, advertising, distribution, and manufacturing matters all make up part of the team’s typical workload. Agata Bzymek-Waśniewska and Marta Sroka-Maleta bring ‘seasoned expertise‘ to their roles as co-chairs. Counsel Andrzej Siwiec is another highly regarded member of the group.
Practice head(s):
Agata Bzymek-Waśniewska; Marta Sroka-Maleta
Other key lawyers:
Joanna Mączko-Forgiel; Andrzej Siwiec
Testimonials
‘DBS team has extensive experience in the healthcare category, and reacts very quickly to all legal changes. The team anticipates the potential risks associated with the upcoming changes – and thus stays ahead of the competition.’
‘The people I work with are distinguished by flexibility and speed of response to my needs.’
‘Deeply knowledgeable in the area of pharmaceutical law. Great customer service.’
Key clients
Alpen Pharma Polska
Avanzanite Bioscience B.V.
Dirk Rossmann GmbH
GOFARM
Plich Advisory & Investments B.V.
Polski Lek (MASPEX group)
Foundation – Centre of Medical Charity
ResMed Polska
Teva Operations Poland
Teva Pharmaceuticals Polska
Your Health Medical Centre
Work highlights
- Advised a foreign pharmaceutical company on the negotiation of an agreement concerning the distribution of a medicinal product for a rare disease across eight European countries.
- Represented a foreign cosmetics producer and its Polish subsidiary in a declaratory action concerning non-infringement of a top international drug producer’s second medical use patent.
Fairfield
Boutique firm Fairfield is differentiated by its focus on work relating to medical and in-vitro devices; the team counts POLMED (the Medical Devices Trade Association) as one of its core clients. 'High-class specialist' Oskar Luty, 'outstanding' Marcin Flak, and distribution and reimbursement expert Karol Korszuń are the key senior practitioners to note. Senior associate Oskar Platta is also recognised as 'a lawyer of the first choice'.
Practice head(s):
Oskar Luty; Marcin Flak; Karol Korszuń
Other key lawyers:
Oskar Platta
Testimonials
‘Fairfield is providing a very reliable legal service in the field of medical law and public procurement law. The staff are high-level specialists. They prioritise every inquiry, and the answers to questions are always provided in a transparent, understandable manner and are of very high quality.’
‘The qualities that I appreciate are, above all, the reliability of the information provided, the response time to the questions asked, as well as the possibility of consultation outside of office hours.’
‘Oskar Luty is a high-class specialist in medical device law, pharmaceutical law and public procurement law. He is also a great trainer during workshops and lectures.’
Key clients
Zwiazek Pracodawcow Producentow Przemyslu Spirytusowego (Spirit Producers’ Association)
INFARMA (Association of Innovative Pharma Firms)
Polish Hypertension Medical Society (Polskie Towarzystwo Nadciśnienia Tętniczego)
Aristo Pharma
Adamed
Diabetyk24
Stryker
FM Logistic
Aspironix
POLMED (Medical Devices Trade Association)
Zentiva
Boston Scientific
Zentiva
BBraun
Moelnlycke
Resmed
Stada
Merck
Magnapharm
Accord Healthcare
Angelini
Olympus
Brass
Avon
Spark&Mortar (US Pharmacia Group)
Polpharma
Biocodex
Amplifon
Alcon
Douglas
Kochanski & Partners
Kochanski & Partners‘ practice spans a wide range of issues affecting clients from the pharmaceutical and life sciences sectors, with a particular focus on marketing and advertising, medical technology, distribution, product liability, reimbursement and telemedicine. The firm’s broad outlook ensures that it is also well placed to advise on more general matters relating to employment, tax, intellectual property and corporate law. Krzysztof Zieba leads the team.
Practice head(s):
Krzysztof Zięba
Key clients
Techdow Pharma Poland sp. Z o.o.
Hasco TM
nOvum Fertility Clinic
Krynica Vitamin S.A.
Natural Pharmaceuticals
Ringier Axel Springer Polska
Molecule One sp. Z o.o.
Reckitt Benckiser
Shenzhen Hepalink Pharmaceutical Group Co. Ltd
Corza Medical
Work highlights
- Advising Reckitt Benckiser on issues related to distribution of pharmaceutical products and medical devices.
- Successfully represented HASCO Lek against its competitor Swiss Pharma International in numerous trade mark infringement cases.
- Advising Molecule One on contractual and regulatory issues.
Taylor Wessing Poland
Taylor Wessing Poland's client base ranges from small innovative manufacturers of pharmaceuticals and medical devices to large hospital companies and global enterprises. The firm's key areas of expertise are manufacturing and distribution agreements; licensing and collaboration; contentious mandates, particularly in relation to patents and product liability; data protection and intellectual property; and regulatory issues. In January 2022, practice head Przemyslaw Walasek welcomed senior associate Bartosz Świdrak from Fairfield, thus strengthening the bench further.
Practice head(s):
Przemysław Walasek
Other key lawyers:
Bartosz Świdrak
Testimonials
‘Availability, wide range of knowledge, trustworthiness.’
‘Good customer service approach.’
‘Bartosz Świdrak is a distinguished lawyer specialising in medical devices. On all occasions, he provided quick, correct and clear answers to the questions asked.’
Key clients
mBank
Hauck & Aufhäuser Privatbankiers
BioMaxima S.A.
InspireMD
HAMMERmed Medical Polska
BTL Polska
Align Technology
Adare Pharmaceuticals
Sight Sciences
Theramex
Apotex Inc.
Fresenius Kabi
Perrigo Group
Work highlights
- Advised BioMaxima on the transfer of its listing from NewConnect to the main trading floor of the Warsaw Stock Exchange.
- Assisting InspireMD with the launch of clinical trials for medical devices, including drafting and negotiating clinical trial agreements with research sites and investigators in Poland.
- Providing ongoing advice to BTL Polska, including assisting with issues relating to new EU regulations and advertising regulations.
Wardynski & Partners
Since the beginning of 2022, the dedicated life sciences offering at Wardynski & Partners has been under the leadership of counsel Joanna Krakowiak, and has focused particularly on matters relating to biotechnology and medical devices. The team has also recently assisted with multiple mandates concerning clinical trials, including pioneering projects financed from EU funds, and regularly advises both public and private service providers in the healthcare sector. Transactional work is another strength of the group.
Practice head(s):
Joanna Krakowiak
Other key lawyers:
Katarzyna Wójcik-Bąkowska; Ewa Butkiewicz
Key clients
Moleculin Biotech Inc.
CNS Pharmaceuticals Inc
Mabion S.A
QIAGEN N.V
Eight Roads Ventures
Orifarm Group A/S
Atlantic Labs V GmbH & Co. KG
Urban Technology GmbH – DrSmile
HTL-STREFA S.A.
Work highlights
- Advised Moleculin Biotech on the establishment of a consortium with the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, and the implementation of the Anna-Sarc Project in Poland.
- Advised US-based CNS Pharmaceuticals on issues relating to the co-ordination of the EU Berubicine Project.
- Advised Qiagen on the acquisition of over 95% of the shares in Blirt, a manufacturer of recombinant enzymes.