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