Healthcare & Pharma

Practice Highlights. A selection of our deal highlights includes advising:

• Penta Investments and Dr. Max, on the regulatory and contractual aspects pertaining to the successful acquisition of the largest wholesale distributor of medicines in Romania (Mediplus) and a pharmacy chain of 600 pharmacies (Sensiblu), including on the distribution of medicines, medical devices, cosmetics, and food supplements.
• Abbott Laboratories, on the structuring and implementation of the separation of its operations in Romania into two different companies: AbbVie, acting in the research based pharmaceutical area, and Abbott, acting in the medical devices field, as well as in connection with the spin-off of the generic medicines business operations to a joint-venture vehicle established together with Mylan.
• Roche Diagnostics International Ltd., in connection with the EUR 17,500,000 successful acquisition of several assets of Top Diagnostics S.R.L., one of the most important companies on the Romanian diagnostics and diabetes care market.
• Baxter, Baxalta and Shire, on the transfer of the marketing authorizations for the medicines traded in Romania and the related changes to the pharmacovigilance system and to the regulatory activities.
• Novartis, on the implementation of complex programs for supporting the access of patients to the prescribed treatment, and the conclusion of cost-volume agreements and protocols with the healthcare authorities.
• Eli Lilly, in relation to the price, distribution and reimbursement of medicines and medical devices, the promotion of medicinal products, and the performance of clinical trials on innovative products.
• A research-based biopharmaceutical company, in connection with the protection of its IP rights in the context of the requests for compulsory patent licenses submitted by third parties in relation to the company’s best-selling drug.
• GlaxoSmithKline, during the investigations initiated by the Competition Council on the dialysis and oncology products’ market, as well as in relation to their alleged abuse of dominant position in the beginning of the European Commission practice and jurisprudence of the European Court of Justice.
• ARPIM (the Romanian 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.
• Servier, 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 Servier before the courts in numerous litigations having as object the challenging of clawback notifications for various quarters.
• Roche, 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.
• Pfizer, in connection with price authorization procedures, health technology assessment and the reimbursement of certain medicines.

Other representative mandates. A selection of mandates of our practice includes advising:

• AbbVie Inc., 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.
• Eli Lilly, in relation the implementation of complex education programs for healthcare professionals, the conclusion of protocols with the authorities, the sponsorship of scientific events, the clawback tax applicable to medicinal products traded in Romania, employment matters, as well as numerous data protection matters.
• Novo Nordisk, 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; our mandates included representation of Novo Nordisk before the competent courts in the clawback litigations, where we successfully challenged numerous clawback notifications issued by the healthcare authorities.
• Novartis, in relation to a wide range of matters, including market access, health technology assessment, the pricing and reimbursement of medicines, the supply of samples and the donation of medicines.
• Abbott, for the drafting and implementation of complex compliance policies, the drafting and conclusion of various agreements with HCPs, professional associations and other business partners.
• Astellas Pharma, 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.
• Biotest A.G., in relation to the distribution of its medicinal products in Romania, the payment of the clawback tax and the conclusion of wholesale distribution agreements with Romanian business partners.
• Ferring Pharmaceuticals, on the implementation of complex projects designed for improving the medical education of healthcare professionals, as well as on promotional related aspects.
• Genesis Pharma, in relation to the pricing and reimbursement of medicinal products, the conclusion of various agreements and protocols with healthcare professionals, healthcare organizations and regulatory authorities, the clawback tax and the donation of medicines to hospitals.
• Ipsen Pharma, in connection with day-to-day legal assistance on healthcare, regulatory, corporate and commercial-related matters and various competition aspects regarding distribution operations performed in Romania.
• Janssen (part of Johnson & Johnson), in connection with the marketing authorization, pricing, distribution, supply and donation of medicinal products in Romania and on specific authorization procedures.
• Kedrion, in connection with the pricing and reimbursement of the medicinal products traded in Romania, including in the litigations concerning the clawback tax.
• Mundipharma, in connection with the health technology assessment, reimbursement, pricing and distribution of the medicines placed on the Romanian market, and various other regulatory matters.
• Octapharma, in connection with regulatory, contractual and compliance aspects related to the supply of medicines on the Romanian market, including on aspects regarding price establishment, reimbursement and promotion of medicines.
• Quintiles, Covance, PSI, Ergomed and Synexus, on the regulatory, contractual and compliance aspects related to the performance of clinical trials in Romania.
• Roivant Sciences, on the health technology assessment, pricing, reimbursement and other regulatory matters related to the supply of certain innovative medicines for the patients in Romania.
• ARPIM, Abbott Laboratories, Servier, Roche, Eli Lilly, with respect to the Competition Council’s sector inquiry on the wholesale pharmaceuticals distribution market in Romania, including training programs, designing and implementing specific compliance programs and representation before the Competition Council.
• Roche, Eli Lilly, Servier and Astellas Pharma, in connection with the distribution system implemented in Romania for medicinal products and potential changes to such systems, such as the direct-to-pharmacy distribution and the setting up emergency supply systems, to comply with the competition law requirements.
• Belupo Pharmaceuticals and Cosmetics, in respect of an investigation conducted by the Romanian Competition Council related to an alleged infringement of competition rules at both national and EU level, via the impairment of parallel trade of products.
• Roche, in connection with the first investigation in Romania dealing with an alleged abuse of dominance in the pharma industry, as well as in relation to the sector inquiry launched by the Romanian Competition Council with respect to the pharma sector, and also in connection with various other competition, corporate, commercial and IP matters.
• AbbVie, in connection with numerous IP matters, including the protection of its patents in the context of the threats concerning the launch in Romania of a generic version of AbbVie’s top selling medicines, more than 5 years before the expiry of the patent protection thereof.
• Bayer, during a dispute resolution procedure concerning the protection of intellectual property rights, in the context of promoting certain Bayer products.
• Millennium Pharma, in connection with the protection of its industrial property rights, against the launching of certain generic medicines before patent expiry.
• H Lundbeck A/S, in connection with the whole range of IP-related matters, including protection of its IP rights over innovative drugs and the enforcement of its patent rights in Romania.
• Otsuka, in connection with the protection of its IP rights over innovative drugs, the assignment and the enforcement of its patent rights in Romania.
• GlaxoSmithKline, in connection with one of the first pharmaceutical patent-related infringement proceedings in Romania.
• Ipsen Pharma, in connection with IP protection and regulatory matters related to the parallel import of certain pharmaceutical products.
• Merz Pharmaceuticals and Biogenerix A.G., in connection with the legal protection of certain innovative medicinal products in Romania and other IP-related matters.
• Baxter and Baxalta, in connection with the spin-off of Baxter’s BioScience business, including the corporate, employment, tax and regulatory aspects related to the transfer of the BioScience business between two of their Romanian affiliates.
• Eli Lilly, on the structuring and implementation of the transfer of the business related to the supply of medicinal products for veterinary use in Romania, between two of its affiliates, and also in connection with various other corporate matters.
• Pfizer, in connection with the procedures conducted in view of obtaining the requisite antitrust and merger control clearances arisen from the worldwide acquisition of Pharmacia Corporation USA by Pfizer Inc. USA.
• Sanofi-Aventis, on the mandatory public tender offer on Zentiva Romania for a total offer value of approximately EUR 17,400,000.
• Messer Medical, on the regulatory and contractual matters pertaining to the transfer of its medical division in Romania, including on the transfer of the reimbursement agreements concluded with 42 health insurance houses across Romania.
• GHD Gesundheits GmbH, in connection with the regulatory and employment matters related to the implementation of an educational program for nurses in Romania.
• New Life Drugstore, a Romanian pharmacy chain, with respect to an insolvency procedure undertaken against the company by several of its creditors.
• B. Braun, for day-to-day legal assistance on regulatory, competition, mergers & acquisitions, corporate and commercial-related matters.
• Clinicco, a leading privately-owned hospital located in Brasov, in connection with the full spectrum of authorizations related to opening a new clinic specializing in cardiovascular diseases.
• Rhea Medical, in connection with the development of a new medical center in Bucharest.
• Synexus, for obtaining the required authorizations for performing medical activities and clinical trials in their medical center in Bucharest.
• Târgoviște Emergency Hospital, in connection with the full range of legal work, including advice on restructuring its activities, refinancing schemes, complex employment issues, as well as regulatory, data protection and compliance matters.
• Ovidius Clinical Hospital, in connection with organizing training programmes for physicians and other employees on different areas of interest, including compliance related aspects, competition, malpractice, as well as other regulatory aspects, and day-to-day legal assistance in connection with the performance of medical activities.