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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
Recommendations
Managing Indirect tax in a complex regulatory landscape
Indirect taxes in the Life Sciences industry