„STOICA & Asociaţii handles high-profile litigation pertaining to banking, environment, tax and insurance, as well as international arbitration. ”
The multidisciplinary team of lawyers from STOICA & Asociaţii 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.
Clawback tax
STOICA & Asociaţii is well-known for its comprehensive experience in clawback tax matters, acquired in various cases requiring an interdisciplinary approach. The lawyers from STOICA & Asociaţii 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 & Asociaţii achieved for its clients the cancellation of all notifications issued by the National Health Insurance House for the period 2010 -2015.
Intellectual Property
STOICA & Asociaţii 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.
Regulatory
STOICA & Asociaţii 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 & Asociaţii 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 & Asociaţii 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 the largest generic pharmaceutical company in Romania with regard to the annulment of the notifications issued by the National Health Insurance Organisation pertaining to the computation of the clawback tax for the fourth quarter of 2011 and the first quarter of 2012. The notifications were challenged in connection with the inclusion of the VAT in the calculation basis of the incumbent tax and other significant irregularities;
- Assisting and representing a major pharmaceutical company regarding the suspension of clawback duties determined following fiscal inspections based on clawback tax due under GEO no. 104/2009;
- Assisting and representing several pharmaceutical companies before the Constitutional Court with regard to challenging the constitutionality of the government ordinances enforcing the clawback taxation;
- Assisting and representing several pharmaceutical companies with regard to recovering the VAT inputted in the clawback tax, as a result of previous decisions issued by the Constitutional Court;
- Representing and assisting of one of the most important international manufacturers of pharmaceutical products in a litigation regarding the annulment of fraudulent acts concluded by one of its distributors
- Assisting a major pharmaceutical company regarding a compensation claim for breaching the patent rights;
- Assisting and representing a major distributor of pharmaceutical products in an investigation procedure pertaining to the existence of a potential understanding limiting the marketing of medicines;
- Assisting and representing major local medicine distributors in connection with a complaint regarding a potential anticompetitive distribution scheme imposed by one of the most important medicine producers;
- Assisting and representing a major distributor of pharmaceutical products in an investigation procedure pertaining to the existence of a potential understanding limiting the marketing of medicines;