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.

The payback subject to the ruling is not among those expressly regulated by the Budget Law for the year 2018 (Law no. 205/2017), by the article 1, paragraph 394, letters a) and b)[2], but it is referred to the price reduction that pharmaceutical companies shall grant to the Regions in particular circumstances, in order to allow one of their pharmaceutical products not to be included in the C category, i.e. the category of products for which the National Health Service does not refund the expenditure incurred by the citizen. For this type of payback, the possibility of VAT recovery does not appear to be specifically regulated, either by positive law or by previous Italian tax authorities’ guidelines.

Read full post: https://blog.pwc-tls.it/en/2022/09/09/further-clarifications-provided-by-the-italian-tax-authorities-on-the-vat-deduction-related-to-the-pharmaceutical-payback/

Get in touch

Felice De Lillo, Partner, PwC Italy
felice.de.lillo@pwc.com

Davide Accorsi, Director, PwC Italy
davide.accorsi@pwc.com

Dr. Sandra Ragaz, Partner, PwC Switzerland
sandra.ragaz@pwc.ch

Sara Regales Alvarez, Manager, PwC Switzerland
sara.regales.alvarez@pwc.ch

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PwC’s 7. Schweizer MWST-Tagung

Die Mehrwertsteuer, insbesondere im Pharma Bereich für Konzerne, KMUs und Start-ups, ist im steten Wandel und immer transparenter.

Für Sie als Entscheidungsträger im Pharma & Life Sciences Bereich, wird es immer schwieriger all die gesetzlichen und behördlichen Vorgaben und Neuerungen effizient als auch kostengünstig einzuhalten. Dazu kommen die anhaltenden Auswirkungen der COVID-19-Pandemie sowie die Ukraine-Krise, welche umsatzsteuerliche Herausforderungen mit sich bringen und die es zu meistern gilt. Gleichzeitig spielt Industrie 4.0 und die umfassende Digitalisierung in der industriellen Produktion eine immer wichtigere Rolle. Dieser absehbare Wandel bringt neue Chancen zur Prozessoptimierung.

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Strategy&’s 2022 Global CDMO Study of Pharmaceutical Operations

How to gain a competitive advantage in a fast-changing pharmaceutical supply ecosystem.

The global Covid-19 pandemic as well as geopolitical tensions and trade restrictions have drawn attention to profound geographical, technical, and structural shifts in pharmaceutical supply chains. Treatments are increasingly produced by highly capable contract development and manufacturing organizations (CDMOs). As new, extraordinarily sophisticated, advanced therapies (ATx) emerge to complement traditional large and small molecule treatments, this trend looks set to deepen and accelerate. Today, CDMOs are targeting an increasingly attractive business segment, in which pure play CDMOs and other market participants are taking on a growing role.

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The Pharma Gamechanger

Happy to share the following Article of Chemie Pharma Innovation with you (German only): https://www.chemiepharma-innovation.ch/pharmaindustrie/der-pharma-gamechanger

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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.

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Indirect Tax virtual round table

24 November 2021 or 25 November 2021

Dear Pharma and Life Science Colleagues,

Thank you for your interest in our virtual round table on ESG, regulation and rebates in the health industry. This event will be held online on Wednesday 24 November 2021 from 15:00 to 16:00 CET, and again on Thursday 25 November 2021 from 09:00 to 10:00 CET.

Using environmental, social and governance (ESG) metrics to evaluate companies and countries on their progress towards sustainability has become a hot topic all around the world. Alongside these issues, the health sector is also facing major regulatory challenges. 

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PwC’s 6. Schweizer MWST-Tagung

Die Mehrwertsteuer, insbesondere im Pharma Bereich für Konzerne, KMUs und Start-ups, ist im steten Wandel und immer transparenter.

Für Sie als Entscheidungsträger im Pharma & Life Sciences Bereich, wird es immer schwieriger all die gesetzlichen und behördlichen Vorgaben / Neuerungen effizient und kostengünstig einzuhalten. Dazu kommt die anhaltende COVID-19-Situation, welche umsatzsteuerliche Herausforderungen mit sich bringt und die es zu meistern gilt. Gleichzeitig spielt Industrie 4.0 und die umfassende Digitalisierung in der industriellen Produktion eine immer wichtigere Rolle. Dieser absehbare Wandel bringt neue Chancen zur Prozessoptimierung.

Continue reading PwC’s 6. Schweizer MWST-Tagung

Webinar: How can ESG create value in the pharma industry?

ESG stands for ‘environmental, social and governance’ – without a doubt a global mega trend, and even more so in the post Covid-19 world.

During this webinar, we will look at how a strong ESG proposition can create value. In particular, we will illustrate the value creation process by providing a framework tailored to the pharma value chain to describe the various options.

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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.

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WEBINAR – Pharma news: German court decision – Sale of drugs from a Swiss company and new EU requirements

Dear pharma members

Germany has recently published a court decision with major impact on the pharma supply chain (commercial and clinical) in the EU Member States:

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