Paulina Kieszkowska-Knapik leads the team dedicated to pharmaceutical issues. She has advised pharmaceutical companies and the industry's associations in all areas covered by the Pharmaceutical and Healthcare Law, in particular in issues regarding clinical trials, marketing authorisation, advertising, pharmacovigilance, as well as pricing, reimbursement and compliance. She has been consulting the industry's associations in their legislative initiatives as to the Pharmaceutical Law and Healthcare Law. Paulina Kieszkowska-Knapik has also extensive experience in intellectual property issues regarding patents, data exclusivity, and copyright. She is repeatedly listed by Legal 500, Chambers Europe and PLC Which Lawyer? as a leading expert in the life sciences.

Practice Focus

Ms. Kieszkowska-Knapik advises pharmaceutical companies and associations on areas related to pharmaceutical law and healthcare law. Her practice pays particular focus on registration, advertising, clinical trials, product liability as well as pricing and reimbursement issues. Ms. Kieszkowska-Knapik also handles IP-related matters, including patent and data exclusivity protection.

Representative Legal Matters

• Assisting major innovative pharmaceutical companies in day-to-day regulatory and competition law issues connected with distribution, reimbursement, advertising, legislative changes, compliance etc.
• Advising clients on the conduct of clinical trials in Poland including drafting of the clinical trial agreements, structuring relations between the entities conducting clinical trials (including financial arrangements) and assisting clients in the cases of occurrence of adverse events during clinical trials.
• Advising clients on pricing and reimbursement issues including assistance in pricing and reimbursement proceedings i.e. preparation of motions for establishment of official price and for reimbursement of a product, representation of pharmaceutical companies in disputes concerning the deletion of medicinal products from reimbursement lists, the establishment of official prices for products purchased by hospitals, reimbursement of generics authorized in breach of patent/data exclusivity protection.
• Participation in the legislative activity concerning Pharmaceutical Law and pricing and reimbursement law.
• Advising clients on unfair competition and advertising including assessment of loyalty and education programs, assessment of legality of various advertising actions, assistance to the companies in proceedings before Head Pharmaceutical Inspector.
• Advising clients on the distribution of medicinal products including advice as to the structure of distribution of medicinal products, wholesale of medicinal products via internet, importation of medicinal products, issues regarding employment of a qualified person, recognition of manufacturing authorizations granted in third countries, direct wholesale distribution, and withdrawal of wholesale licenses.
• Advising clients on patents, data exclusivity issues.

Professional Associations and Memberships

• Warsaw Bar of Advocates
• Polish Legislative Association

Admission

Poland (2002)

Education

Jagiellonian University  (Diploma Intellectual Property) (1998)
University of Warsaw  (Master's degree International Relations) (1998)
University of Warsaw  (Master's degree Law) (1996)