WKB Lawyers – Life Sciences

We advise on:

Clinical trials

Preparation and negotiation of clinical trial agreements on behalf of foreign sponsors with Polish sites and investigators.
Preparation of NDA agreements accompanying clinical trials.
Support in the establishment of clinical research centres in Poland.
Training on new clinical research regulations.
Ongoing legal advice on clinical trials.

Ongoing GDPR advice to healthcare entities, including healthcare entities, biobanks.
Drafting of GDPR procedures, information obligations, processing entrustment agreements.
Development of models for the flow of sensitive data between entities.
GDPR due diligence.
GDPR in the context of marketing activities in the healthcare sector.
Advice in the context of the planned EHDS regulation.

Advice and training on medical device advertising.
Creation of by-laws and internal procedures from medical device advertising rules.
Marketing cooperation agreements for medical devices.
Preparation of contracts for the sale of medical devices to medical personnel.

Advice on medical activities using new technology solutions in light of regulatory obligations.
Advice on Software as Medical Device, the use of AI in the provision of health services.
Protection of ownership of data and intellectual property created using new technologies.
Advising on the protection and further use of data using new technologies.

Placing medicines on the market, in particular as regards the admissibility of post-registration changes, MAH changes, sunset clause.
Parallel imports, including B2B disputes and regulatory issues.
Access to medicinal product dossiers maintained by the regulatory authority.
Borderline products (we have experience from the work of the Committee for Borderline Medicinal Products and Biocidal Products of the URPL).
Pointing out the correct way for URPL to deal with disputes.
Advising on the advertising and marketing of medicinal products.
Sale and storage of medicines by pharmacies, retail shops and commercial chains.
Duty to ensure availability of medicines.

Registration in the Register of Medical Institutions.
Drafting of organisational statutes of medical entities and other procedures, including provision of medical records.
Advice on contracts for the provision of health care services, including cooperation agreements between medical entities, B2B agreements in the context of occupational health services.
Inspections by registration authorities.
Ongoing general advice to healthcare entities.
Management of issues related to the interrupted cold chain storage of medicines.
Rules on the conduct of advertising and health promotion.

Comprehensive legal advice on establishing and operating a telemedicine business in Poland.
Assistance in selecting an appropriate telemedicine business model.
Preparation of articles of association and other necessary procedures.
Preparation of regulations for the provision of services by electronic means.
Preparation of the RODO procedure and all necessary information obligations and consent forms.

Representation of clients in proceedings before the Medical Incident Commission.
Representation of clients in pre-trial and trial proceedings in respect of medical errors.
Representation of the investigator and sponsor regarding clinical trial liability.

Labelling of cosmetic products, requirements for packaging and labelling of medicinal products.
Entrepreneurial status in the supply chain and regulatory obligations arising from such status.
Advice on marketing activities.

Managing trade mark portfolios on behalf of clients in the field of pharmaceuticals.
Representing clients before the Polish Patent and Trademark Office, EUIPO and WIPO in trademark and design disputes, including opposition, cancellation and revocation proceedings.
Representing clients in civil proceedings relating to trademark and design infringement and unfair competition.

Consultancy on brand protection.
Registration of trademarks and industrial designs in the national, EU and international system.
Advice on innovation transfer, including publicly funded projects.

Development of customised distribution systems.
Drafting of pharmacy franchise agreements.
Advice on dominance issues (including definition of relevant markets, assistance in estimating market shares, commercial policy of dominant companies).
Collaboration of competitors in R&D projects.
Ongoing antitrust advice, including assistance in preparing responses to requests for information and market surveys issued by the President of the OCCP.
Analysis of the compliance of the activities of trade associations with competition law.
Representing entrepreneurs in antitrust proceedings in merger cases.

Due diligence of therapeutic entities, entities in the cosmetic industry, medicinal products, medical devices, dietary supplements.
Transactional support, including preparation of transaction documentation in the acquisition of shares, life sciences portfolio.
Preparation of shareholder agreements, investment agreements, management contracts.
Preparation of collaboration agreements, including contract manufacturing agreement, transitional services agreement, etc.

Advising on the establishment of companies in order for them to carry out therapeutic activities.
Advising on the choice of the optimal form and structure for conducting medical activities.
Support in corporate reorganisations, including mergers, demergers and transformations of companies operating in the medical sector.
Corporate consultancy.

Advising on the regulations and T&Cs of insurance companies regarding life sciences insurance products, in particular regarding clinical trials, health benefits.
Representing the insurer in civil proceedings for medical malpractice and clinical trial errors with respect to sponsor and investigator insurance.
Representing the insurer in civil proceedings regarding product liability of the distributor of a medical device.

Supporting the client in tender proceedings for medicines and medical devices, including at the stage of enquiries to the CVS.
Representation of the client in appeal proceedings before the NAC.

Our competitive advantages:

Creating an interdisciplinary team of experts for a specific client.
Our experts combine knowledge and experience from different fields of law.
Finding business solutions for clients.
Knowledge of the Life Sciences sector.
Supporting clients in large, demanding business projects.
We support clients from the initial conception of their business plans through to their implementation and ongoing operation.
We have experts with extensive professional experience in regulatory matters, intellectual property, contract law, marketing activities, public procurement, insurance, transactions.
We have knowledge and experience from our work in the URPL and the Office of the Patient Ombudsman.