Irina Macovei LLB

Counsel

Head of Intellectual Property and Technology

Emailirina.macovei@akd.partners

Call+40 732 222 109

Bucharest

About

Irina has extended experience in working with companies in the life sciences sector, in various areas such as regulatory matters, change of business models, interaction with HCPs, clinical trials, claw back and taxation, advertising and promotion, ethics and compliance etc. Irina has been seconded to several leading international pharmaceutical producers in Romania.

In addition to being a Life Sciences regulatory lawyer, Irina is also a data privacy lawyer, regularly advising clients on data privacy compliance matters, ranging from privacy assessments, compliance programs, trainings, structuring of projects, data processing agreements, cookie policies etc.

In the past, Irina has been involved in various corporate transactions, with an emphasis on mergers and acquisitions transactions for foreign and domestic clients. Irina’s experience also covers extensive regulatory assistance in areas such as employment, insurance and consumer protection.

Irina is a regular speaker at AKD Partners or external events.

Areas of FocusConsumer Goods, Food and Retail Energy and Natural Resources Financial Services Industrials Infrastructure, Construction and Transport Insurance Life Sciences Media, Sport and Entertainment Real Estate Corporate Technology

Professional QualificationsAvocat registered with the Baroul Bucuresti

EXPERIENCE

Assisting an international toy producer in a complex competition law review project of its activities for all products and for all channels (brick and mortar as well as online).
Advising a global, research and development-driven pharmaceutical company with respect to an investigation of the Romanian Competition Council for an alleged cartel of producers of immunoglobulin suspected to have adopted a coordinated strategy for limiting and disrupting the supply of immunoglobulin on the Romanian market.
Representing global healthcare company that conducts innovative research and manufactures products for human health in arbitration against one of the largest Romanian distributors of pharmaceutical products in order to collect money which was illegally transferred to another entity from the group.
Assising a multinational pharmaceutical company in relation to developing compliance with the GDPR, while also offering advice on complex projects such as CRM software and patient support projects.
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.
Assisting a leading biotechnology company in the implementation of a limited direct-to-pharmacy business model and assessing the competition-related implications.
Assisting a local association of medicine manufacturers during meetings with the European Commission on potential State aid implications and at the meetings with the Romanian Competition Council meant to obtain the support of the competition authority on various topics with competition law impact.
Advising an international healthcare company on all its distribution arrangements with third party distributors in Romania covering the medicines portfolio and the medical devices.
Assisting a Romanian online retailer with the implementation of the GDPR within their company and on their online store/marketplace.
Assisting a highly innovative pharmaceutical company with legal advice for ensuring compliance of revolutionary software solutions with the applicable legislation, generally as part of complex patient support programmes.