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LSHC Newsletter

Indirect tax

A newsletter to keep you informed about trending issues and regulations in the indirect tax area of the LSHC industry

First Quarter 2021

EMEA Customs & VAT updates
  • A new version of the EU Combined Nomenclature 2021
  • CJEU C-476/19 - Clarification of ‘goods that have been used’ in the context of the extinguishment of a customs debt
  • CJEU C-775/19 - Fee for Exclusive Distribution Agreement is part of the customs value
  • New guidelines of the VAT Committee on when VAT ID number is not indicated in case of intra-Community supply
  • Dutch Court confirmed that paid discounts to health insurance companies result in a VAT refund for the pharmaceutical company
  • The Belgian Act on medical devices 
  • German VAT rate will increase again to 19% and 7% as of January 2021
Brexit
  • UK-Japan Trade Agreement (CEPA)
  • UK-EU Trade and Cooperation Agreement (TCA)
  • EU Council adopts VAT Directive regarding the identification of taxable persons in Northern Ireland after the end of the transition period
COVID-19 updates
  • EU Commission prolongs customs and VAT relief for medical equipment, including vaccines and testing kits in response to the COVID-19 pandemic
  • EU Directive regards temporary measures in relation to value added tax applicable to COVID-19 vaccines and in vitro diagnostic medical devices in response to the COVID-19 pandemic

Fourth Quarter 2020

EMEA Customs & VAT updates
  • Newly in force FTA - EU-Vietnam (EVFTA)
  • Revision of the Pan-Euro-Mediterranean Rules of Origin
  • Exporting goods out of the European Union
  • Update on the application of the Registered Exporter System (REX) in the EU
  • Updated Guidance on Customs Valuation
  • Exceptions to the deemed intra-EU supply of own goods must be interpreted strictly
  • Reform to VAT refund rules for NHS bodies and other s.41 bodies
  • The Customs Action Plan
Brexit
  • Brexit – the latest state of play
  • Postponed Import VAT Accounting/Import VAT Recovery - HMRC Brief 15 (2020)
COVID-19 updates
  • The EU Commission prolonged the customs and VAT relief for medical equipment
  • Finland - Zero VAT rate implemented for goods used for testing and prevention
  • COVID-19 Vaccines Portfolio

Second Quarter 2020

Global updates
  • EU-Vietnam FTA (EVFTA)
  • EU-Mexico FTA
Trending topics and the impact on the LSHC industry:
  • CJEU C–182/19 - Pfizer ThermaCare
  • Medical Devices Regulation - Postponement of one-year
  • Harmonised System 2022
COVID-19 updates
  • Deloitte resources regarding COVID-19 measures
  • Brexit - State of negotiations
  • Import duty and VAT exemption for products that help combat COVID-19 (distributed freely)
  • The Entry Summary Declaration
  • France issues new guidelines for non-EU exporters

April 2019

Customs and VAT Regulatory updates in the LSHC industry
  • Newly in force FTA: EU-Japan 
  • Newly in force FTA: EU-Singapore
  • New directive for falsified medicines 
  • Ireland: Change in VAT treatment of food supplements
  • Finland: Detailed guidance regarding health care services updated by the tax authorities
  • Luxembourg: Potential extension of super-reduced VAT rate to health care products
Trending topics in the LSHC industry
  • Deloitte Publication: Increasing role of Export controls in LSHC
  • The e-Procurement Directive 
  • Solution Selling – Bringing the myth down to business reality: the taxman always finds you
  • 2019 Global life sciences outlook
Brexit Update
  • Commission intensifies “no-deal” customs preparedness outreach to EU businesses and publishes guidance for pharmaceutical companies
  • European Medicines Agency Update
  • Key points of European Medicine Agency and Commission advice regarding centralised procedure

October 2018

Customs and VAT Regulatory updates in the LSHC industry:
  • Extended collaboration on medicine manufacturer inspections between EU and Japan
  • The Netherlands: Increase of reduced VAT rate
Trending topics in the LSHC industry:
  • Blockchain - A leading pharmaceutical company engaged with Deloitte on a Blockchain Proof of Concept (POC)
  • EU Clinical Trial Regulation - Building a successful program
  • Second annual Real-World Evidence (RWE) Benchmarking Survey
  • Pharma.be releases Pharma Figures for 2017: “Now more than ever, Belgium is a pharma valley”

March 2018

European Court of Justice decisions related to the LSHC industry:
  • ECJ, C-51/16, Boehringer Ingelheim case
Indirect tax regulatory updates in the LSHC industry:
  • UAE VAT update specific to LSHC industry
  • New combined Nomenclature 2018
  • Classification of medical screws: Regulation (EU) 1212/2014 repealed
  • Update on EU-Japan Economic Partnership Agreement
Regulatory updates in the LSHC industry:
  • Brexit: EMA is moved to Amsterdam
  • Brexit: Regulatory guidance for pharmaceutical companies
  • Modified-release paracetamol-containing products to be suspended from EU market
Trending topics in the LSHC industry:
  • Poland:The evolving definition of fixed establishment for VAT purposes
  • Italy: Mandatory e-invoicing from 2019
  • 2018 Global health care outlook: The evolution of smart health care
  • The future awakens – Life sciences and health care predictions 2022
  • Measuring the return from pharmaceutical innovation 2017

October 2017

European Court of Justice decisions related to the LSHC industry:
  • ECJ, C-51/16, Boehringer Ingelheim case: Advocate-General opinion on rebates paid to insurers or health bodies
Indirect tax Regulatory updates in the LSHC industry:
  • Russia: Federal law on introduction of VAT exemption for lease of medical devices
  • Switzerland : possible decrease of Swiss VAT rates
  • GCC VAT update specific to LSHC industry
Regulatory updates in the LSHC industry:
  • EU-Japan FTA
Trending topics in the LSHC industry:
  • Managing Indirect tax in a complex regulatory landscape
  • The connected patient – How digital technology is enabling patient centricity
  • Russian Pharmaceutical Market Trends in 2017

June 2017

European Court of Justice decisions related to the LSHC industry:
  • ECJ, C-51/16, Stryker
  • ECJ, C-497/16, Juraj Sokáč
  • ECJ, C-412/15, TMD Gesellschaft für transfusionsmedizinische Dienste mbH
  • ECJ, C-573/15 Etat Belge vs Oxycure Belgium SA
Indirect tax Regulatory updates in the LSHC industry:
  • Pharmaceuticals and the 2017 Harmonised System reform
  • New amendment in Explanatory Notes for orthopaedic appliances
  • EU GMP Annex 21: Possible change of the importation of medicinal products in EEA
Regulatory updates in the LSHC industry:
  • Regulation (EU) 2017/746 and Regulation 2017/745 (EU) on medical and on in vitro diagnostic medical devices
Trending topics in the LSHC industry