Amalia Mu?at-Rusu

Counsel

Emailamalia.musat@akd.partners

Call+40 372 155 868

Bucharest

About

Amalia has been part of AKD Partners team since 2011 and having also experience as in-house lawyer and compliance counsel for a global pharmaceutical company dedicated to their regional pharmaceutical and consumer health business in Romania and Republic of Moldova, where she was in charge with advising in a wide array on matters specific for the pharmaceutical and self-care industries, handling independently a large variety of legal and compliance projects.

Amalia is an experienced lawyer is two regulated fields: life sciences and consumer protection. Amalia assisted clients in various sectors, such as FMCG, Retail, Automotive, Self-Care, Food.

Amalia is focused mainly on pharmaceutical and life sciences industries, providing general assistance and advice in relation to various regulatory and day-to-day business matters, from a legal and tax perspective. Amalia advised and assisted global clients in various contexts: HTA, market access, pricing, regulatory, contracts negotiations, promotion and advertising, litigation matters, competition and other daily business advice.

Amalia has significant experience in assisting clients in front of various Romanian authorities, handling also tax and administrative litigations and claims for the annulment of taxes and of other administrative acts. Her previous experience in various areas of practice contributed to a wider understanding and perspective over the dynamics of business.

She is an experienced lawyer in Consumer Protection legislation, having assisted clients on various topics such as: product claims, safety and safety requirements, marketing and promotion, advertising and unfair market practices, online trade, food law, other regulatory aspects and also assistance during various audits carried-out by the competent authorities.

Areas of FocusConsumer Goods, Food and Retail Life Sciences Media, Sport and Entertainment Corporate

EXPERIENCE

Advising a multinational pharmaceutical company in relation to a quota supply system for some of its medicines as well as way to improve the access of patients to its medicines, relationship with distributors in Romania, communication rules regarding biosimilars as well as various commercial schemes regarding discounts in case of tenders, a novel project on the Romanian market for its hepatitis C medicines, an intended change of its distribution system and competition law aspects pertaining to its commercial policies in several EU countries.
Assisted and represented a global, science-led, biopharmaceutical company in the preliminary administrative procedure and in a fiscal/administrative court case for the annulment of fiscal decisions unlawful issued by the fiscal authority for amounts representing penalties and interest in relation to the late payment of the clawback contribution.
Advised an international healthcare company on all its distribution arrangements with third party distributors in Romania covering the medicines portfolio and the medical devices.
Advising a multinational pharmaceutical and life sciences company in a recent investigation initiated by the Romanian Competition Council on the market for medicines released without medical prescription and food supplements.
Assisting an international manufacturer of branded chocolate and confectionery products during its negotiations with important international key accounts, including the drafting of the contractual documentation and the alignment of the contractual documentation with the client's own commercial terms, in particular in the context of the amendment of the Romanian food trade legislation.
Advising a key international manufacturers of consumer healthcare products with respect to a broad spectrum of competition and regulatory matters, including (i) contractual relationship with Romanian distributors, (ii) discount schemes and promotional campaigns, (iii) category management projects and merchandising.
Advising a key international manufacturers of consumer healthcare products on the change to a selective distribution model from the first direct-to-pharmacy scheme implemented in Romania, including the design of selection criteria for distributors and the organization of a tender, in cooperation with the Romanian Competition Council given the investigation for a potential abuse of dominance on which we also assisted.
Assistance and representation in front of the Bucharest Court of Appeal's claiming the partial annulment of the clawback notifications issued by National Health Insurance House ("NHIH") for the consumption of reimbursed medicines in 2014 and 2015. Administrative dispute for annulment of the claw-back notifications issued by NHHI and payment of the damages resulting from the inclusion of the trademarks within the consumption values.
Advised an international health, hygiene and home products company on a number of complex and challenging competition and regulatory matters, related mainly to commercial campaigns, advertising / promotions, category management projects and the commercial and discount policies applied for various products in their portfolio.
Advising a trade association with various regulatory aspects (implication in various projects at the client level, including aspects with respect to the promotion and advertising of supplements and OTCs, the new regime for commercialization of food supplements or other food products in Romania retail system, e-commerce legislation).

Languages

Education

University of Bucharest, Faculty of Law, Degree: LL.B., 2011

Prior Experience

October 2017 - to date: AKD Partners Romania, Managing Associate
September 2016 - September 2017, Bayer Romania, Bulgaria and Republic of Moldova, Legal and Compliance Counsel
May 2014 - September 2016: AKD Partners Romania, Associate
October 2011 - April 2014: AKD Partners Romania, Junior Associate
July - October 2010: AKD Partners Romania, Summer internship