Areas of practice: Healthcare & Pharma, Corporate & Commercial Law, Competition & Antitrust, Intellectual Property, Consumer Protection
Phone: +40 21 202 59 16
Fax: +40 21 223 04 95
Address: 43 Aviatorilor Boulevard, 1st District, Code 011853, Bucharest, Romania
Dan Minoiu has over 13 years experience advising clients active in highly regulated fields, including pharmaceutical and medical devices companies, private clinics and hospitals, as well as companies in the IT, FMCG, insurance and agriculture sectors. Clients appreciate Dan for his in-depth knowledge of the intricacies of the regulatory environment of these fields and for his business oriented advice.
Dan advised numerous international and domestic companies on mergers & acquisitions, business transfers, as well as on regulatory, commercial, contractual and compliance matters related to the supply and promotion of products and services on the Romanian market. Dan represented clients in landmark cases before the regulatory authorities and the competent courts.
Dan is an active member of leading business associations assisting the main associations and the national authorities to revise and improve the legislation in important business fields. Dan is a frequent lecturer on pharmaceutical, medical and compliance matters and published numerous articles on these topics.
Career & Qualifications
- LL.B – Faculty of Law – University of Bucharest, Bucharest (2003-2007)
- Legal experience: 13 years
- Experience within Muşat & Asociaţii: 10 years
- Partner, Mușat & Asociații: 2020 to date
- Managing Associate, Mușat & Asociații: 2015 – 2019
- Senior Associate, Mușat & Asociații: 2010 – 2015
- Associate, Dentons, White & Case: 2008 – 2010
- English, German and Romanian
A selection of Dan Minoiu’s notable mandates include advising/representing:
- Advising one of the largest pharmacy chains in Central Europe on the regulatory and contractual aspects pertaining to the successful acquisition of the biggest wholesale distributor of medicines and of chain of +600 pharmacies in Romania, including on the matters concerning the distribution, supply and/or reimbursement of medicines, medical devices, cosmetics and food supplements.
- Advising a leading US based pharmaceutical company in connection with various regulatory, commercial and contractual matters, such as the pricing, distribution and reimbursement of medicines and medical devices, the public service obligation, the promotion of medicinal products, the clawback tax, the performance of clinical trials and the revising of clinical trials agreements concluded with investigators and institutions, the implementation of complex education programs for healthcare professionals, the sponsorship of scientific events;
- Advising a leading European pharmaceutical group in connection with numerous legal matters, such as market access, health technology assessment, the medicines’ pricing and reimbursement, the implementation of educational and of promotional programs, the drafting and conclusion of various agreements with healthcare professionals, healthcare organizations/professional associations and other business partners, the sponsorship of healthcare professionals, medical institutions and of scientific/educational events, the implementation of international industry codes, compliance trainings for employees;
- Advising a major IT company in connection with an unfair competition claim related to the use of company trade secrets by a competitor to solicit the company’s clients; the court ordered the competitor to cease the use of the trade secrets and to suspend the performance of the agreements concluded by the competitor with the company’s clients;
- Advising a major pharmaceutical research-driven company in connection with the issuance of the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion in the lists of reimbursed medicines, the supply of medicines under public procurement proceedings, in the context of the potential launch of certain medicines breaching its patents;
- Advising a global healthcare company in connection with the corporate, regulatory and contractual matters pertaining to the separation of its operations in Romania into two different companies: one acting in the research based pharmaceutical area, and the other acting in the diversified medicinal products field, including with respect to the issuance of the required authorisations and licenses, the performance of the registrations and filings with the competent authorities, the transfer of numerous clinical trials agreements, the variations to the marketing authorisations etc.;
- Advising the world’s biggest biopharma company in connection with numerous regulatory and commercial legal matters, such as the distribution and trade of medicinal products and of medical devices, the clawback tax, the conclusion of various agreements with healthcare professionals and healthcare organizations, the supply of medicines under public procurement procedures;
- Advising the leading business association in the plant protection field in connection with the revising and the update of the main regulations in this highly specialized field, in line with the European legislation and the latest practices of the EU authorities;
- Advising a major global healthcare company in connection with the spin-off of its Romanian operations related to generic medicines to a joint-venture vehicle, including with respect to the authorisations, licenses and registrations required for the new pharma company, the transfer of the marketing authorisations, the changes to the pharmacovigilance system, the payment of the clawback contribution, etc.;
- Advising the wholesale distributor affiliated to an international pharma group, in connection with the trade, distribution and supply of medicinal products, the conclusion of logistic services agreements, the authorisation for the wholesale distribution of medicinal products, the clawback tax, the public procurement proceedings organized by hospitals for the acquisition of medicines, the donation of medicines, the fulfillment of the public service obligation and dealing with Romanian distributors’ oversized orders;
- Advising a leading international company in the crop sciences field in connection with obtaining the necessary authorizations for trade activities and other operations in Romania, the revising of the commercial agreements concluded with its customers and other regulatory matters;
- Advising an innovative pharmaceutical company in connection with health technology assessments, pricing, reimbursement and other regulatory matters related to the supply of medicinal products on the Romanian market;
- Advising a global healthcare company in relation to a wide range of legal issues, including without limitation to market access, the supply of samples and the donation of medicines, the implementation of complex programs for facilitating the patients’ patients to the prescribed treatment;
- Advising two global pharmaceutical companies in connection with the spin-off of the BioScience business, covering the regulatory matters related to the transfer of the marketing authorisations, the distribution of medicines, the pharmacovigilance and other contractual and compliance aspects;
- Advising a research-driven pharma group in connection with numerous pharma regulatory matters, including without limitation to the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the implementation of educational programs for healthcare professionals;
- Advising an international IT company in connection with the corporate, contractual and commercial aspects related to the structuring of its activities and the performance of the day to day operations in Romania.
- Romanian Bar Association (Admitted 2008)
- Coauthor of the “Pharma Legal Handbook for Romania”, the 2019 edition, published by Pharma Boardroom;
- Coauthor of the “Medicinal product regulation and product liability in Romania” guideline, the 2018, 2017 and 2016 editions, published by Thomson Reuters (Practical Law UK) & Westlaw;
- Coauthor of the “Pharmaceutical IP and competition law in Romania: overview” guideline, the 2018 edition, published by Thomson Reuters;
- Coauthor of “Medicinal Product Reimbursement in Romania”, 2015, International Journal of Law and Medicines, Yorkhill Law Publishing;
- Contributor to guidelines and newsletters for various directories and law guides.