We have extensive experience in dealing with diverse compliance and regulatory issues and with different government agencies and bodies vested with supervisory and enforcement authority, such as the National Organisation for Medicines (EOF) and the General Chemical State Laboratory.
Accordingly, our firm has a strong and fast-growing practice in various separate fields related to health and life sciences, such as regulation of biocidal products, detergents and food safety issues.
Our full service and business approach allows us to be ideally positioned, on the one hand, to provide ongoing compliance counseling, assess compliance-related risks, and represent clients before competent authorities and administrative bodies while, on the other hand, to advise our clients in the fields of competition, administrative, distribution and corporate law, business crimes, data protection, as well as taxation.
Our clients include major pharmaceutical companies, multinational medical device manufacturers, health care associations and other companies and enterprises active in related sectors. Apart from business enterprises, prominent foreign law firms often seek our advice on sophisticated health care law-related matters on behalf of their clients.
Indicatively, our practice advises clients on different regulatory and compliance matters, such as transfer of marketing authorisations of medicinal products, access to market, pricing and reimbursement questions, co-promotion, co-marketing and other arrangements relating to cooperation between pharmaceutical companies, clinical trial agreements, all types of interaction between health care companies and HCPs such as sponsorship and consulting services, implementation of patient assistance programs, evaluation of innovative projects involving both promotional and non-promotional activities, internet and social media related issues, pharmacovigilance obligations, interaction between health care companies and Social Security Funds, public awareness campaigns, placement into the market or recall of medical devices, procurement of medical devices to public hospitals and private entities, as well as different questions concerning conclusion, termination and transfer of distribution agreements regarding medical devices, authorisation and circulation of biocidal products and questions related to anti-bribery legislation.
By way of example we have advised the following:
- Novartis Hellas SACI, the Greek subsidiary of one of the largest multinational pharmaceutical companies in the world, which we regularly advise on diversified legal matters covering compliance, regulatory affairs, anti-trust and data privacy rules, commercial and labor law issues
- Sandoz, a large multinational generic company of the Novartis group, which we regularly support on regulatory, compliance, data privacy, anti-trust and tax law issues
- Alcon SA, the Greek subsidiary of a multinational company of ophthalmology products, which we advise in different matters, such as commercial agreements, public law and compliance
- Zimmer Inc., a multinational orthopaedic medical devices listed in NYSE, to which we provide extensive legal support on all corporate, regulatory, commercial and public law matters
- Fosun Pharma, the leading Chinese generics manufacturer, on M&A transactions in Greece
- Achaogen, a US-based company, in relation to its clinical trials into Greek hospitals
- Johnson & Johnson, in regard to regulatory and corporate law issues concerning the transfer of one of one of its business sectors
- Cook Medical with respect to its distribution arrangements in the local market and interaction with HCPs
- Bausch & Lomb, the Greek subsidiary of a multinational ophthalmologic medical devices company, which we advised on a variety of legal matters
- Leo Pharma, a multinational pharma company, to the Greek subsidiary of which we provide legal, tax and regulatory compliance advice on a regular basis
- Agfa Geavert NV as to the transfer of its healthcare sector
- Teleflex Medical Hellas, a multinational medical devices company, to the Greek subsidiary of which we provide legal, tax and regulatory compliance advice on a regular basis
- Philips Healthcare Division which we advised on different legal matters
- Haemonetics SA, a multinational blood management company, which we regularly advise as to different matters related to its presence in the Greek market
- Medacta, a medical devices company, which we supported regarding its presence in the Greek market and professional ethics issues
- PRA International, a CRO company, on all matters related to its activity in Greece
- Smith & Nephew, one of the largest orthopaedic medical devices company, which we advised regarding the compatibility of its promotional activities with the pertinent Greek legal framework
- Dentsply, a US-based dental plants company, which we represented for the acquisition of its local distributor
- Pierre Fabre Group, a multinational dermocosmetics company, which we support on different issues, including the split-up of its pharma activities
- Menarini Diagnostics SA with regard to restructuring of its business and its agreements with various distributors and tax advice on a regular basis.