Medical Law

Pharmaceutical Law and Medical Devices Law

The law firm is specialized in the field of pharmaceutical and medical devices. Our legal advice covers all problem areas in connection with pharmaceuticals, medical devices, food supplements, groceries and cosmetic products. We provide legal advice:

• in marketing and in misleading advertisement
• in pre-marketing (including sponsoring)
• in trade-marks at medical devices
• in pricing and reimbursements
• in withdrawing pharmaceutical products and medical devices from the market
• in registration and licences proceedings (the EU, Poland, and Austria)
• in merger and acquisitions, restructuring, and privatization in the pharmaceutical and medical sector
• in tenders concerning delivery of pharmaceutical products to pharmacies
• in online pharmacies and mail-ordered sales of pharmaceuticals
• in on-going matters like changes in registers and organizations of shareholders
• in GMP
• in off-label use
• in compassionate use programmes
• in advertisements in social media and on the Internet
• in clinical trials, including drafting agreements, applications, and correspondence with supervisory authorities

Dr Wolińska-Umschaden is highly specialized in the field of pharmaceutical law and medical law. She has a perfect understanding of the pharmaceutical sector and of rules governing the market in which the clients operate. She has extensive experience in providing legal advice to international clients in different European and US legal systems.

Dr Wolińska-Umschaden advises on problems associated with pharmaceutical products, medical devices, food, dietary supplements, food for special nutritional purposes, cosmetics and mergers and acquisitions between entities operating in the pharmaceutical and food markets.

She is an author of numerous publications about pharmaceuticals and medical devices, such as: Czy Legal Highs można interpretować jako produkty lecznicze w oparciu o Dyrektywę 2001/83/WE?, MIDA (2015); Arzneimittel- und Medizinproduktewerbung, doctoral dissertation (2015); Promoting Medical Products in Europe & North America, Bilingual 3rd edition Baker & McKenzie (2012); Pricing and Reimbursement Handbook, Pharmaceuticals & Healthcare Europe, Bilingual 1st edition Baker & McKenzie (2011) and runs training sessions in Pre-Marketing; Promoting pharmaceutical products and medical devices; Liability of pharmaceutical products; Pharma Social Media; Compliance in Medical Law; etc.

Medical Law

We provide full-range advice to entities carrying out medical activities and to external firms directly or indirectly involved in this area.

Our advice covers:

• advice on patient rights
• assistance with social benefits and communication with the Social Insurance Institution and the Austrian Health Insurance Fund
• compensation for damages, in particular for medical malpractice
• compliance in the healthcare sector
• preparation of standard operating procedures for medical facilities – the so-called SOPs
• training for doctors and nurses (including medical malpractice, contact with patients, prevention of corruption, prescription of reimbursed drugs)
• substantive support and legal representation of both health care representatives and patients in compensation proceedings both in court and arbitration proceedings in Poland and Austria
• assistance in carrying out inspections or obtaining administrative decisions, as well as in arbitration proceedings before the Medical Chamber
• comprehensive support for proceedings with the National Health Fund (NFZ)
• representation in civil, criminal and disciplinary proceedings in Poland and Austria