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Switzerland has reached a Mutual Recognition Agreement with the US

Switzerland has reached a Mutual Recognition Agreement (MRA) with the United States for good manufacturing practice (GMP) inspections, which will facilitate and decrease administrative barriers in the exchange of pharmaceutical products between the two countries which will further strengthen the supply chain.

New Italian Decree Impacts MedTech Companies: What You Need to Know about MedTech Payback

We update you on legislation being approved that could impact the companies operating in the MedTech sector in Italy.

New public Clinical Trials database leads to increased tax & regulatory transparency – risk of supply chain disruption / recall

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Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact:

1. Management Summary:

• Starting 31 January 2023, all EU clinical trial applications must be submitted via the clinical trial data base CTIS, the single-entry point for submitting and assessing clinical trial data.

• Previously, sponsors had to submit applications separately to national competent authorities and ethics committees in each country. CTIS streamlines the process, allowing sponsors to apply for authorizations in up to 30 countries at once. The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS.

• The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing.

• Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Fantastic News – EU initiative: Extension of the transition period for medical devices

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR)¹ and (EU) 2017/746 (IVDR)².

Amendments to these regulations have been prompted by factors which include the insufficient operating capacity of conforming assessment bodies as well as the unpreparedness of many manufacturers to meet the strengthened requirements of the MDR by the end of the transition periods. Taken together, there is the risk of shortages of medical devices on the EU market.

Your VAT payback opportunity: Further clarifications provided by the Italian tax authorities on the VAT deduction related to the pharmaceutical payback

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[1], 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.

Update: Mutual Recognition Agreement CH-EU

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.

Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement

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.

Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?

Continue reading Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?

VAT refund due to taxpayer on pharmaceutical rebates

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.

EU Commission welcomes agreement on crucial VAT relief for COVID-19 vaccines and testing kits

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).