The multidisciplinary team of lawyers from STOICA & Asociații provides legal advice, assistance and representation to clients – medicine and medical equipment manufacturers, local and international companies – in an extended range of contentious and non-contentious matters, administrative and fiscal law, intellectual property or competition law.

The legal activities performed in this economic sector include a wide variety of contentious and non-contentious issues, in matters of administrative and fiscal law, intellectual property law or competition law.

Clawback tax

STOICA & Asociații is well-known for its comprehensive experience in clawback tax matters, acquired in various cases requiring an interdisciplinary approach. The lawyers from STOICA & Asociații provided legal assistance to clients – multinational companies and national manufacturers – with regard to the suspension of the notifications issued by the National Health Insurance House, as a result of strong illegality indications.

STOICA & Asociații achieved for its clients the cancellation of all notifications issued by the National Health Insurance House for the period 2010 -2015.

Intellectual Property

STOICA & Asociații provided legal assistance and representation to national and international pharmaceutical companies, in relation to an extensive range of contentious and non-contentious cases:

  • drafting and amending of various types of intellectual property related agreements: licensing or assignment arrangements;
  • representation during administrative/contentious proceedings before OSIM (Romania’s State Office for Inventions and Trademarks) and the competent courts in cases concerning the registration and protection of intellectual property rights: oppositions, infringements, cancellation or annulment/revocation claims, claims for the suspension of the commercial exploitation of a potentially infringing product, etc.;
  • assistance in connection with the protection of intellectual property rights and development of strategic management of intellectual property right portfolios;
  • preparing long-term strategies with regard to intellectual property litigations and in case of crimes specific to this area of law.

STOICA & Asociații provides assistance in all pharma regulatory matters, in particular in liaising with the competent authorities in this field: the National Agency of Medicines and Medical Devices, the Ministry of Health, the National Health Insurance House. As regards the production of medicines, STOICA & Asociații provides legal assistance in matters relating to price authorisation, subsidies, labelling and packaging.

Competition Law

Pharma industry is in the focus of competition authorities investigating anti-competitive practices: horizontal and vertical anti-competitive agreements, cartels, abuses of dominant position, economic concentration operations.

The lawyers from STOICA & Asociații assist and represent clients in the pharmaceutical industry before the competent competition authorities, but also before courts of law, conduct competition audits and corporate compliance programs for mergers and acquisition projects, joint-ventures, distribution structures, commercial agreements, pricing policies raising competition law issues.

Relevant experience

  • Assisting and representing various major pharmaceutical companies regarding the suspending or annulment of the notifications issued by the National Health Insurance Organisation pertaining to the computation of the clawback tax for various quarters
  • Assisting and representing of the top ten pharmaceutical international companies in developing a strategy for protecting its pricing levels taking into account the imminent market entry of the generic pharmaceutical products
  • Representing and assisting of one of the most important international manufacturers of pharmaceutical products in a litigation regarding the damage claims requested by one of its distributors
  • Assisting and representing a major pharmaceutical company in one of the most complex and important patent litigation as well as in pricing related matters
  • Representing and assisting an important producer of cosmetic products in fiscal-administrative procedures and in litigations arisen from the decision of the Romanian Customs Authority to impose additional custom taxes derived from levies and bonuses awarded to the exporting company
  • Legal assistance to a large pharmaceutical company in developing a comprehensive strategy to defend its patents, including intellectual property issues, customs duties, marketing authorizations, pricing
  • Assisting a major player from the pharmaceutical market in connection with an alleged anti-competition agreement regarding selling of pharmaceutical products
  • Assisting and representing a major distributor of pharmaceutical products in an investigation procedure initiated by the Competition Council pertaining to the existence of a potential understanding limiting the sale of medicines
  • Assisting and representing a major pharmaceutical producer in a litigation regarding an alleged abuse of a dominant position in the form of rescinding of an ongoing distribution contract
Legal 500, 2023 edition

Dispute resolution is a key focus for STOICA & Asociații, with practitioners described by one client as ‘real professionals in the science of the law‘.

Chambers Europe, 2023 edition

STOICA & Asociaţii has a well-regarded dispute resolution practice representing both domestic and international clients in criminal and civil litigation, as well as arbitration.