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, market access, product liability, dispute resolution 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.
In 2024, Dan was awarded Regulatory Adviser of the Year in EMEA (Europe, Middle East and Africa), one of the most prestigious recognitions in the life sciences sector, being also nominated by the reputed legal directories LMG Life Sciences and Managing IP amongst the elite European lawyers in the Product Liability Lawyer of the Year and IP Practitioner of the Year categories.
Dan is a frequent lecturer on pharmaceutical, intellectual property and compliance matters and published numerous articles on these topics.
An association of international medicines manufacturers, on various enactments and initiatives concerning the social health insurance system and the national health programs, the pricing and reimbursement of medicinal products, including dispute resolution legal work related to the constitutionality and the legality of the clawback system implemented in Romania.
A major pharmaceutical company from France, in connection with various matters including market access, health technology assessment, the inclusion of medicines in the reimbursement list, pricing, the trade and distribution of medicinal products, the implementation of educational and promotional programs, the donation of medicines, the drafting and conclusion of logistic services agreements, services and supply agreements, as well as numerous other agreements with healthcare professionals and healthcare organizations, the sponsorship of physicians, medical institutions and scientific events. We have successfully represented the Romanian subsidiary of this company before the courts in numerous litigations having as object the challenging of clawback notifications for various quarters.
A major pharmaceutical company from Switzerland, on 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 cost-volume agreements, protocols and other agreements with the healthcare authorities, public institutions, healthcare professionals and healthcare associations, the supply of medicines under public procurement procedures.
A pharmaceutical company from the United States, on numerous pharmaceutical regulatory matters, including without limitation to the issuance of the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion of medicinal products in the national list of reimbursed medicines, the supply of medicines under public procurement proceedings, clinical trials, the conclusion of numerous agreements with healthcare professionals and various services providers and business partners.
A multinational pharmaceutical company from Denmark, on numerous pharma regulatory matters, including the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the implementation of educational programs for physicians and data protection matters; representation of the company before the competent courts in the clawback litigations, successfully.
A pharmaceutical company from Japan, with respect to the distribution and establishing the price of medicines, the pricing of medicines, the drafting and conclusion of various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
The largest retailer of FMCG in Romania, part of a major global retail group, with respect to the Competition Council’s investigation of potential anticompetitive agreements concluded between several retail chains and their suppliers of food products. The investigation was closed without sanctions against our client.
An international pharmaceutical company, on the distribution agreements put in place in respect of Romania and the competition law aspects derived from the new structure of distribution, taking into account the recommendation of the Romanian Competition Council’s comprehensive sector inquiry report on the pharmaceutical sector.
The largest French pharmaceuticals producer and its Romanian subsidiary with day-to-day competition-related matters ranging from discounts and promotional activities to distribution agreements and including the setting up of an emergency stock system in such a manner as to comply with the competition law requirements.
A major European investment fund, on the EUR 300 million acquisition of the largest pharma distribution conglomerate in Romania by means of one of the biggest pharmacy chains in CEE owned by the fund. The competition component of the transaction implied assessment of the main distribution and supply agreements concluded by the pharma group companies, assessment of any other activity component involving competition law (not only vertical but also horizontal) implications and in complex merger control assessments of turnover and other eligibility conditions for the determination of the EU and/or national level notifications required to competition authorities. The challenge of merging the largest pharma distribution group in Romania with one of the largest pharmacy chains in Europe in the largest pharma transaction ever undertaken in Romania was uniquely well-suited for our team’s ability to investigate and identify not only immediate risks but also potential risks and to map for the minimization thereof on the medium and long term.
A leading pharmaceutical company, with respect to providing assessments on both the Preliminary and the Final Reports of the European Commission on the pharmaceuticals market, with special attention to its impact on the Romanian market, as well as in connection to sensitive competition law aspects of an envisaged protocol to be concluded with the Ministry of Health, so as to provide breakthrough medicines in one of the most important national health programs. Our work also covered providing legal assistance and representation in connection with a complaint against an alleged abuse of dominant position by the client, filed with the Competition Council by a generic company, and eventually dismissed by the Competition Council as ungrounded.
A leading private equity firm in Europe, in their acquisition of one of the biggest pharmaceutical producer in Romania, with a transaction value of more than EUR 300 million.
An international company, in relation to the sale of the business of the first producer of veterinary immunological preparations in Romania to a leading Asian investor (with a transaction value in excess of EUR 100 million).
An American multinational pharmaceutical and medical technologies corporation, on the corporate restructuring of its business. The mandate covered structuring the proposed restructuring, regulatory advice, preparing the corporate restructuring documentation, and obtaining relevant corporate and regulatory approvals.
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.
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.
An international manufacturer of electrical equipment and machinery in connection with the protection of the intellectual property rights in Romania, in the disputes concerning the online unauthorized use of the trademarks by third parties, developing the legal strategy to ensure that the IP rights of the trademark owner are observed at the national level.
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 authorizations, the distribution of medicines, the pharmacovigilance and other contractual and compliance aspects.
A research-driven pharma group in connection with numerous pharma regulatory, compliance and product liability matters, including without limitation to the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the reimbursement and promotion of medicinal products, on the conclusion of managed entry agreements for its key medicines and on the extension of its business operations in Romania.
An international IT company in connection with intellectual property, unfair competition and commercial aspects related to the structuring of its activities and the performance of the day to day operations in Romania.
An innovative pharmaceutical company in connection with the successful recovery of the clawback tax paid to the state budget for the medicines sold on the Romanian market, as well as on health technology assessments, pricing, reimbursement and other regulatory and compliance matters pertaining to its business operations.