Monika Duszyńska is a Polish-qualified advocate and a Partner in the Commercial & Regulatory Department of CMS Cameron McKenna in Warsaw.
Monika specialises in pharmaceutical law and in providing legal services to the healthcare sector. She has assisted clients from the Lifesciences sector since 2001. Her experience in Lifesciences includes regulatory issues such as registration of medicinal products (in national, decentralised, MRP and centralised procedures, including orphan drugs), the regulatory data protection (data exclusivity), the advertising and marketing of medicinal products and medical devices, manufacturing and distribution. She assists the clients with respect to relationships with healthcare professionals, patients’ organisations and with respect to sponsorship. She has expertise in unfair competition and public procurement matters.
Monika Duszyńska also advises the clients in proceedings before the Minister of Health in relation to pricing and reimbursement of medicinal products and medical devices. She has also represented clients in proceedings before the Chief Pharmaceutical Inspector. As an attorney, she represented clients before the courts, and in particular before the administrative court in reimbursement matters. Monika also specialises in providing legal assistance to clients from the healthcare sector, with a particular focus on the transformation of public hospitals into commercial entities, and on models of cooperation between public and private operators of healthcare institutions, including public-private partnership.
Monika also has significant experience in advising on corporate matters. She has participated in various M&A transactions, including conducting due diligence. She also has a wide-range of experience in contract matters, having negotiated and drafted lease contracts, distribution and other commercial contracts and service agreements (including outsourcing agreements, among others outsourcing of management of the programme for patients and healthcare professionals). She has also negotiated licence agreements concerning intellectual property rights relating to medicinal products and the registration dossiers of such medicinal products.
She speaks fluent English and also provides legal services in French, Italian and Spanish