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Welcome to the March 2017 edition of our newsletter. The EMEA Healthcare Industry Group Newsletter is your regular digest of legal developments affecting the life science and healthcare industries across the region.

In This Issue

Guest Feature: China

  • China’s New Two-Invoice System in Pharma Distribution Aims to Reduce Drug Prices and Compliance Risk

Guest Feature: Ireland

  • Irish Minister for Health proposes consultation paper on biosimilars

European Union

  • Anatomy of a Medtech carve-out
  • Teva/Allergan Generics: Portfolio power theory of harm
  • VAT exemption applicable on e-Health
  • Consolidated - and probably final - texts of EU medical device and in-vitro diagnostic regulations published - adoption expected in March


  • Recently published Belgian Sunshine Act establishes legal basis for transparency obligations


  • German government plans to limit royalty deductions as from 2018


  • The Decree on the new essential levels of care has been approved
  • The Italian Medicine Agency and the Ministry of Health sign the "Fast track" Memorandum of Understanding
  • The AIFA and the Antitrust Authority signed the Memorandum of Understanding to protect competition and the patients' health
  • A working group has been created to analyze the direct distribution of drugs


  • New regulation on distance selling of veterinary medicines
  • The Spanish Competition Authority ("CNMC") maintains its position: it is the Spanish legislation that obliges pharmaceutical companies to apply different prices according to the medicine's destination


  • Turkey tightens deadlines and revises fees for license applications in 2017


  • Reference pricing and reimbursement
  • Licensing of pharmaceutical activities
  • State registration of pharmaceuticals
  • State control over business activities
  • Public procurement
  • Pharmacovigilance
  • Anti-corruption
  • Implementation of the reference pricing for pharmaceuticals delayed until April 1, 2017
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