With the Ruling reply no. 440/2022 dated 29th August 2022, the Italian tax authorities provided clarifications with reference to a case submitted by a taxpayer related to the the possibility of recovering the VAT included in payback amount, according to the Law Decree no. 78/2015, on the procedures related to the years 2015 and 2020, for which, as a matter of prudence, the relevant VAT had not been deducted by the taxpayer.Continue reading Your VAT payback opportunity: Further clarifications provided by the Italian tax authorities on the VAT deduction related to the pharmaceutical payback
1) General background information
As a consequence of the failed MRA between CH and the EU, EU certificates (i.e., medicinal products with SQS certificate) which were issued by the respective Swiss body, shall no longer be recognized in the EU and an EU representative is required.
Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.
Switzerland and the EU did not reach a consensus on the negotiations of the Institutional Framework Agreement. As a consequence, the Mutual Recognition Agreement (MRA) between the EU and Switzerland and related provisions for medical devices were not updated and, therefore, ceased to apply on 26 May 2021. With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa. The following article shows what companies selling medical devices need to consider when exporting to the EU or Switzerland.Continue reading Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement
The Dutch Court of First Instance has found in favour of the taxpayer in a case involving indirect rebates paid to pharmaceutical companies. In essence, the court granted a refund of VAT to a pharmaceutical company based on the CJEU Boehringer case (C-462/16), although the pharmaceutical company was not obliged to grant the rebates under national law. Although the case was concerned with price arrangements with the Minister of Health, Welfare and Sport, it is possible that the same rationale could be applied to other rebate schemes, such as rebate arrangements between pharmaceutical companies and insurance companies.Continue reading VAT refund due to taxpayer on pharmaceutical rebates
The EU Commission has adopted a proposal, allowing the EU Member States to apply a zero rate VAT rate on Covid-19 vaccines and testing products. Currently, Member States can apply reduced VAT rates on sales of vaccines, but cannot apply a zero rate, while testing kits cannot benefit from reduced rates. As a consequence, different EU Member States might be adopting such a zero/reduced rate in the next coming months for these products (they are not obliged to).Continue reading EU Commission welcomes agreement on crucial VAT relief for COVID-19 vaccines and testing kits
Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls).Continue reading OFAC fined US subsidiary of Austrian ERBER Group after misinterpreting US Sanctions
As an effort to limit the impact of COVID-19, the Belgian government has introduced a temporary relief measure whereby certain goods imported into Belgium can benefit from a VAT and duty exemption.
A key condition to benefit from said exemption entails the importation by a so-called recognized healthcare institution (almost all Belgian hospitals qualify as such an institution).Continue reading Will you change your supply chain to benefit from a VAT and duty free importation into Belgium?
Medical devices suppliers conducting agreements for allowing hospitals to use free of charge their equipment might face both VAT and corporate tax adverse implications.Continue reading Cutting edge tax implications for medical devices suppliers in Europe
1. The background in a nutshell
- Until 25th May 2020 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
- However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
- In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.
Following the latest developments of the Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2020.Continue reading Swiss Medtech companies – action required for the sale of products in the EU as per May 2020 – Is your business ready for the upcoming changes?