Cases

Gün & Partners’ cases in Biotech & Life Sciences

• Assisting a global pharmaceutical company in the Turkish leg of merger with a local pharmaceutical company, providing the client legal advice in relation to pre merger issues, such as lifting the companies from technical bankruptcy position, handling the complex transfer of shares matters and making the necessary changes to be able to follow up fast track merger;
• Advising and representing the Turkish subsidiary of a multinational pharmaceutical company in relation to various tax disputes with regard to distribution of hidden profit by transfer pricing where pharmaceutical law, criminal law, administrative law, customs law and competition law as well as comparative and international law matters are discussed. The cases have recently been closed with success.
• Advising leading suppliers in various industries, including pharmaceuticals, medical devices and fertilizers on exclusive and non-exclusive distribution networks and on the discriminatory aspects of discounts schemes, joint distribution and subcontracting arrangements.
• Advising pharmaceutical companies on the compliance aspects of their co-marketing, co-promotion, sub-contracting and licensing agreements concluded with generic or original drug producers. Handling the notification of the TCA of the co-marketing agreement between a multinational research-based pharmaceutical company and a local generic pharmaceutical company.
• Advised and represented trade organisations in the pharmaceutical and medical device sectors in relation to all local and international aspects of their field of activity and member interests, their relations with governmental organisations and peers, as well as establishing regulatory policies, position papers and the like. Below are the important medical device industry policy issues we advised in the recent past:

• Drafting the Code of Ethics on Interactions with Health Care Professionals and Good Practice in line with EUCOMED standards.
• Drafting “Competition Law Compliance Guidelines”.
• Drafting consultation documents on the MoH’s draft Regulation on Advertising and Promotion of Medical Devices
• Providing policy consultation on Clinical Trials Regulation and guidelines specific to medical devices
• Advising on the European benchmark studies on electronic instructions for use of medical devices, then consultation on the draft Communiqué on the same
• Advising on a proposed regulation on online retail sales of contact lenses
• Advising on the proposed revisions to “Regulation on Market Surveillance of the Products”
• Advised on compatibility of the MoH off-set regulation.