Life Sciences & Healthcare

Our practice advises some of the largest global and domestic pharmaceutical, biotechnology, healthcare, diagnostics, medical technology and devices and consumer products companies.

We have exceptional experience in advising on licensing, research and development, marketing, advertising and pricing. We take a proactive 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.

Pharmaceuticals & Biotechnology
Our client base is made up of local and international pharmaceuticals, biotechnology and biopharmaceutical companies which develop, manufacture or distribute medicines, medical supplies, immune oncology, vaccines and allergens. We advise extensively on compliance, competition, licensing, distribution and clinical trial procedures, stock management plans for medicinal products, collaboration and research and development matters. We also advise on corporate and commercial transactions in the pharmaceutical and biotechnology sectors. Together with our Intellectual Property, Tax, Competition and Dispute Resolution teams, we provide an integrated service offering. We boast significant sector specific experience. The Firm has participated as counsel to the Hellenic Association of Pharmaceutical Industries (SFEE) in working parties of the European Federation of Pharmaceutical Industries’ Associations (EFPIA) on EU legislation and industrial property issues.
Healthcare Services
Our Firm has a long history of advising on a wide range of issues arising in the Healthcare industry, including health and safety, public policy and data privacy. Our Public Procurement and PPP teams have advised on numerous tenders for the supply of public hospitals and public private partnerships for the design, construction, financing and maintenance of healthcare facilities throughout Greece. We also have considerable experience advising on hospital supply, outsourcing, strategic licensing and employment agreements, as well as disputes arising from them.
Medical Devices & Technologies
Market leaders in the medical devices, software, diagnostic equipment and technologies fields turn to us to assist them in pivotal business operations, clinical trial procedures, product liability and competition and antitrust issues. We advise on brand protection and the regulatory framework governing emerging technology, advertising and marketing. We have experience of acting in commercial transactions, including licensing and distribution agreements, and in mergers, acquisitions and other corporate transactions in this sector. We have represented clients in investigations and litigation relating to product safety and liability, personal injury and comparative claims and public procurement disputes.
Consumer Products
Our team has extensive experience of advising on compliance with regulations governing the licensing, development, manufacture, packaging, labelling, composition, distribution and advertising in the tobacco, eCigarettes, vaping, food and beverages and cosmetic products sectors.
Recent Experience
Pricing, Rebates and Clawbacks
We are advising a multinational pharmaceutical company on matters relating to pricing, rebates and clawbacks in the context of the reimbursement process.
Digital Health Assistant Apps
We advised an international law firm with respect to digital health assistant applications.
Generics Regulatory Advice
We are advising an international law firm acting for a mainline pharmaceutical company on the regulatory aspects of the entry of a generic product into the market and compliance and filing obligations towards the authorities.
EU Patent Protection
We act for F. Hoffman-La Roche AG, a Swiss multinational healthcare company, in relation to patent enforcement actions against a biosimilar company.
BMS Advice
We advise Bristol-Myers Squibb, a global biopharmaceutical company, on competition and antitrust issues as well as on regulatory issues related to pharmaceutical legislation.
Compliance Advice to Lundbeck Hellas
We are advising Lundbeck Hellas on pharmaceuticals legislation and regulations on an ongoing basis.
Non-Interventional Studies in the Pharmaceuticals Sector
We are advising 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.
OTC Supply Chain Advice
We advised a leading OTC pharmaceutical company on the Greek law regulatory aspects of the manufacture and supply of medicinal products from the UK to the EEA in the context of a Europe-wide review of their supply chain.
Advice on Clinical Trials
We advised an international law firm on the regulatory aspects and obligatory requirements of informed consent forms for clinical trials.
Restrictions in the Use of Medicinal Products
We advised an international law firm on the conditions that apply to the use of off- label medicinal products in the Greek market.
Electronic Cigarette Regulatory Advice
We advised a tobacco company in relation to the regulatory framework for electronic cigarettes.
Medicinal Product Marketing Authorisations
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.
Comparative Advertising Advice
We advised a manufacturer of medical devices on the legislation governing comparative advertising.