Healthcare

Healthcare

Our firm is widely known as having one of the leading Health Care and Life Sciences Practices in Greece. We have established and/or advised on a regular basis the subsidiaries of many of the world’s largest pharmaceutical and medical devices companies. Our assistance covers the whole range of matters arising in this highly regulated and demanding sector, with a particular focus on:   

  • Compliance and ethics by advising on the interaction of healthcare companies with healthcare professionals, auditing related internal policies and applicable practices and preparing codes of conduct and compliance programs and procedures;
  • Regulatory and licensing by ensuring compliance with regulations on authorization, marketing, pricing, labeling, advertising and promotion of medicines and health products;
  • Public procurement matters which may vary from support with the submission of tender offers to the preparation and hearing of challenges and judicial actions against tender processes and awards; 
  • Commercial arrangements by reviewing, drafting and negotiating different types of agreements like distribution, co-promotion and licensing agreements and by advising clients on how to restructure their business operations;
  • Competition by assessing compliance of unilateral or contractual conduct with the provisions of anti-trust law as they apply in a highly regulated sector and by representing clients in the ambit of anti-trust proceedings and investigations;
  • Data protection issues arising from the usual activities of pharmaceutical and medical companies, including pharmacovigilance, collection and processing of patients’ health data and HCP personal data including processing of data in the ambit of clinical trials, as well as disclosure of data related to interaction of HCPs with pharma companies;
  • M&A transactions by supporting clients on all corporate, commercial and regulatory aspects of the transaction including due diligence exercises, transfer of MAs, local sale agreements and transitional arrangements up to the final integration stage.

Accordingly, our firm has already developed a fast-growing expertise on the regulation and operation of the medicinal cannabis business and the importation and marketing of other cannabis related products. We also have significant experience in regard to other life sciences products such as, dermocosmetics, biocidal products and precursors.
      
Our full service and business approach allows us to be ideally positioned to provide ongoing regulatory and compliance counseling, assess compliance related risks, represent clients before competent authorities and administrative bodies, while we feel as an internal legal counsel of the company always attentive to act proactively for the client’s protection. 
 
Our clients include major pharmaceutical companies, multinational medical device manufacturers, cannabis producers, dermocosmetic companies and other entities 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. 

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
  • Roche Diagnostics Hellas SA, which we regularly advise on diversified legal matters covering compliance, regulatory affairs, commercial agreements, anti-trust and labor law issues, as well as participation to public tenders
  • Zimmer Inc., a multinational orthopedic medical devices company listed in NYSE, to which we provide extensive legal support on all corporate, regulatory, contractual and commercial matters
  • A leading Canadian group of companies in regard to all regulatory, corporate and contractual aspects of their business partnerships and entry into the Greek medicinal cannabis market
  • ICU with its acquisition of the Pfizer Infusion Unit, including corporate, regulatory and public procurement aspects, as well as the structuring of the marketing model for Greece
  • Baxalta Bioscience with the acquisition of the bioscience business of Baxter
  • Leo Pharma, a multinational pharma company to the Greek subsidiary of which we provide legal, tax and regulatory compliance advice on a regular basis 
  • Fosun Pharma, the leading Chinese generics manufacturer on M&A transactions in Greece
  • Aspen, on different regulatory, data protection and commercial matters
  • Teleflex Medical Hellas, a multinational medical devices company to the Greek subsidiary to which we provide on a regular basis services as to the full spectrum of legal and tax matters especially 
  • A large multinational on the importation and distribution of precursors in the national market
  • CSL Behring – on compliance issues
  • Novartis Hellas SACI, the Greek subsidiary of one of the largest multinational pharmaceutical companies in the world, which we regularly advised on diversified legal matters covering compliance, regulatory affairs, anti-trust and data privacy rules, commercial and labor law issues
  • Galderma Hellas, the Greek subsidiary of one major Swiss pharmaceutical company, which we regularly advise on almost all aspect of pharmaceutical law 
  • Haemonetics SA, a multinational blood management company which we regularly advise as to different matter related to its presence in the Greek market
  • Mylan on compliance matters
  • Menarini Diagnostics SA, with regard to restructuring of its business and its agreements with various distributors and tax advice on a regular basis
  • Philips Healthcare Division, which we advised on different legal matters related in particular to litigation on certain agency and distribution arrangement
  • Sanofi Pasteur France in its distribution and co-promotion agreements with local distributors
  • Shire – on the acquisition of Baxalta bioscience business 
  • Teva, on the corporate and regulatory matters relating to the divestment of certain businesses dictated by the commitments approved by the EU Commission decision on Teva’s acquisition of Allergan
  • Astellas, on general commercial matters
  • Medacta, a medical devices company, which we supported regarding its presence in the Greek market and professional ethics issues
  • Bausch & Lomb, the Greek subsidiary of a multinational ophthalmologic medical devices company, which we advised on a variety of legal matters
  • PRA International, a CRO company on all matters related to its activity in Greece
  • Servier France, with respect to regulatory issues related to the marketing of an innovative medical device
  • 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
  • Sandoz, a large multinational generic company, which we regularly support on regulatory, compliance, data privacy, anti-trust and tax law issues
  • 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
  • Agfa Geavert NV, as to the transfer of its healthcare sector
  • Pierre Fabre Group, a multinational dermocosmetics company, which we support on different issues, including the split up of its pharma activities
  • Medpace, a CRO company which we have established and support on corporate matters and questions on clinical trials.
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