Our practice advises some of the largest global and domestic drug, pharmaceutical, biotechnology, healthcare, diagnostics and medical technology and devices companies.
We have exceptional experience in advising on licensing, research and development, marketing, advertising and pricing. We take a pro-active approach to managing risk in these highly regulated sectors where compliance failure comes with significant consequences for brand integrity.
Our team is experienced in developing compliance strategies, policies and monitoring programs and, if things do go wrong, crisis management. Product liability advice and representation in defective product disputes and consumer class actions are central components of our practice.
We advised an international law firm on the conditions that apply to the use of off- label medicinal products in the Greek market.
We are representing a market leading pharmaceutical company in preliminary proceedings relating to patent infringement of two biosimilar products.
We advised Hellenic Healthcare Sàrl, a company majority controlled by funds advised by CVC, on operating and medical equipment licenses, compliance with data protection regulations, cooperation and reimbursement agreements and other regulatory issues arising in the context of their entry into a binding agreement to acquire 97% of the share capital in IASO General SA from IASO SA.
We advised a pharmaceuticals company with respect to benefit related questions arising in the context of a transfer of an undertaking and share sale as well as on collective dismissals regulations and terms of employment.
We represented a global biopharmaceutical company in relation to the sale of pharmaceutical products, including the transfer of the market authorization, intellectual property rights, regulatory information and the physical transfer of the respective inventories.
We represented Glaxo Smith Kline in the implementation of the local part of their global joint venture with Novartis, with a matter value of $16bn for the Oncology business and $7.1bn for the Vaccine business, a transaction which had a significant effect on the entire pharmaceutical market and resulted in a major reorganization and integration of the sector.
We advised Bayer in relation to the corporate and commercial, tax and employment law aspects of the transfer by Bayer Hellas AG of its Bayer Material Science (BMS) business to the BMS Global Agency Hub (GAH), consisting of a carve-out of Bayer AG’s chemical business (Material Science) into a separate group, requiring a reorganisation of its business setup of the latter in a number of countries worldwide.
We are advising a global biopharmaceutical company on a wide range of matters arising in the course of their day to day business on an ongoing basis, including restructuring, termination of employment and related litigation, voluntary exits, litigation, implementation of policies, adoption of employment regulation, teleworking and data protection compliance.
We advised a pharmaceuticals company on the employment aspects of a proposed restructuring and option grants under portfolio share plan rules.
We advised an international pharmaceuticals company on the rights of former employees to access their personal data to support their claims against them.
We are advising a Greek and international pharmaceutical company in their appeals before the Council of State of decisions requiring them to pay claw backs to the Hellenic Organisation for the Provision of Healthcare Services. These cases are important as they involve a number of fundamental issues for pharmaceutical companies. A recent decision has been issued in another clawback dispute which is likely to set an unfavourable precedent for our case.
We acted on behalf of Fresenius – Kabi Hellas and Smith & Nephew Hellas in their participation in public supply tenders for pharmaceuticals.
We are advising the subsidiaries of international pharmaceutical companies on legislation and regulations on an ongoing basis.
We advised an international medical technology company on the legislation governing the supply of medical devices.
We advised a US-based international pharmaceutical company on the regulatory regime applicable to the conduct of non-interventional studies in Greece and the procedures followed by its Greek subsidiary.
We advise Bristol-Myers Squibb, a global biopharmaceutical company, on competition and antitrust issues as well as on regulatory issues related to pharmaceutical legislation.
We advised the subsidiary of a European-based food producer on the implementation of legislation governing food and beverages labelling.
We advised an international law firm on the update of marketing materials in line with legislation concerning the supply of medical devices in the Greek market.
We are advising a US pharmaceuticals company on the promotion and advertising of pharmaceutical products and international interactions with health care professionals.
We are advising Lundbeck Hellas on pharmaceuticals legislation and regulations on an ongoing basis.
We are advising an international law firm on the legislation governing the supply of medical devices.
We advised Barilla Hellas on the implementation of Greek legislation on the labelling of food and beverages.
We advised Servier on parallel trade issues and on an ad hoc basis on pharmaceutical legislation and regulations.
We advised an international manufacturer of healthcare devices on data protection issues.
We represented a US pharmaceutical company on the mutual recognition procedures for obtaining a marketing authorisation of a medicinal product procedure before the National Organisation of Pharmaceuticals.
We advised a Spanish pharmaceutical company on the compliance of promotional material for medicinal products with the regulations in place.
We advised an international law firm working on a German medical devices provider on the legal requirements for the sale of medical devices from a manufacturer directly to a consumer in Greece.
We advised a manufacturer of medical devices on the legislation governing comparative advertising.
We are advising a US health society in relation to data protection issues arising in the context of the provision of its certification services and the implementation of its accreditation program in Greece.
We advised an international health information technology provider in relation to issues and solutions arising from the transfer of personal data outside the EEA within the context of public procurement procedures.
We are advising an international pharmaceuticals company on human resources issues including notification of the operation of a whistleblowing hotline as well as data privacy issues arising in the context of a number of pharmaceutical related projects and programmes.
We advised an international pharmaceutical company on employee-related privacy issues and the monitoring of e-mails in the context of an internal investigation of its local subsidiary.
We advised an international pharmaceutical company on data protection issues arising from the provision of external online services.
We are advising a global pharmaceutical company on clinical trials and pharmacovigilance notifications, obtaining licences and undertaking in-house data privacy compliance training.