Grzegorz Mączyński
of counsel

Attorney who specializes in the legal aspects of reimbursement of medicine and other medical products, matters pertaining to distribution, marketing and advertisement of drugs, medical devices and consumer goods in the food industry, compliance matters in the health market, regulations that relate to providing health/medical services as well as their financing, the functioning of medical entities, communication and cooperation stakeholders on the above-mentioned market, the tasks of public authorities in the health-care sector, as well as the legal aspects of research and development activities and the cooperation between representatives of the science world/medical profession and business.

He gained his current experience through several years of working with law firms in Poland that lead when it comes to counsel for the health care industry as well as his own law firm he ran from 2011. Prior, Grzegorz worked for Ministry of Health from 2002 to 2008 (including the Department of Drug Policy and Pharmacology). He provided support as an expert for the Minister of Health, the Polish representative regarding “Innovative Medicines Initiative”.

He is the author of specialized publications about pharmaceutical law and functioning processes of hospitals amongst others. From 2007 he as been acting as speaker during scientific and business conferences. He is preparing a doctoral dissertation titled “Risk management in research and developmental activities of pharmaceutical companies”. He is history enthusiast, with particular emphasis on economic history and scientific discoveries, and is also interested in crowdfunding and crowdsourcing.

Selected experiences:

Reimbursement of medication and medical devices:

  • Advising on several dozen reimbursement proceedings conducted based on drug and medical devices reimbursement provisions (preparing or verification of documents, preparing of positions, applications and other documents used in the proceedings);
  • Participating in negotiations with the Economic Commission and many meetings with representatives of the Minister of Health;
  • Advising on numerous different projects regarding the implementation the applicable reimbursement decision for drugs and medical devices (for example, settlement of risk sharing distribution and product promotion)

Financing of health services:

  • Adjusting and implementing action strategies in order to obtain the right financing from public funds, drug-coated balloons (DEB) – probably one of the first projects of this nature in Poland (2010/11);
  • Advising regarding preparing and implementing strategy of action for medical products used in the field of cardiology – for financing within homogenous patient groups;
  • Conducting an audit for a group of medical entities regarding the implementation of contracts with the National Health Fund and settlements of provided health services;
  • Implementation of over a dozen projects to ensure patients’ access to specialized healthcare services;
  • Leading the Polish part of the pan-European “market access” project regarding perception and financing possibilities of medical products used as part of intensive care

Other, selected projects:

  • Advising on several projects related to the development and implementation of the distribution structure of reimbursed products;
  • Co-creating complex strategy and rules of distribution on the health market regarding refundable and non-refundable products – in close cooperation with tax advisors (transfer pricing matters);
  • Advising on the restructuring of several hospitals under the Marshal of the Voivodeship;
  • Advising on notifications pertaining to medical products directed to the Office for Registration od Medical Products, Medical devices and Biocidal products (including thermometers, anti-varicose medical devices, bandages). With medical devices applications to the above-mentioned Office, advising on formal and legal matters and cooperating with medical and substantive experts;
  • Advising with numerous projects or cases regarding conducting advertisement and promoting medication as well as medical products (both regarding advertisement targeted at patients and medical professionals) – including “re-classification,” “borderline products” and “umbrella brands” related issues;
  • Developing a large number of marketing and compliance procedures on the healthcare market and supporting throughout their implementation (pharmaceutical, med-tech companies, medical entities);
  • Conducting numerous trainings, workshops or conference appearances, starting with matters pertaining to advertisement on the healthcare market, through compliance matter, up until reimbursement and financing of medical services;
  • Grzegorz Maczynski co-created the digital “Signovis Platform” which holds dedicated, legal and IT tools when it comes to supporting specialists and “market-access” teams.