Michaela Merz


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PwC’s Pharma & Life Sciences Regulatory Radar


Increasing regulatory challenges

The pharmaceutical & life sciences industry, a long-standing, innovative and successful industry, needs to function in an increasingly challenging market environment. Regulation is one of the main reasons for this. In an increasingly interconnected world where more and more sophisticated pharmaceutical (e.g. genetically engineered, and biologicals, orphan drugs), Medtech as well as nutrition products are being developed, public scrutiny and ultimately legal frameworks are tightening. Governments and regulators are adopting more regulations in order to meet the requirements of technological advancement and changing social conditions (e.g EU GMP/GDP Annex 21, Annex 6 and 16 for clinical trials and the new Swiss “Arzneimittelverordnung”). Given the vast quantity of regulations, there is an inherent risk of missing out on critical topics or taking the required action too late. Therefore, the pharmaceutical & life sciences sector will have to be vigilant and adapt to the constantly changing regulatory landscape. Continue reading


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EU: Clinical Trials in Europe and VAT – a complex topic with 28 different local VAT regulations


In 2018, PwC Switzerland collected the data and organised for the set up of the PwC “VAT Guide to Clinical Trials in Europe”.

 The Guide to VAT for Clinical Trials in Europe aims at: 

• providing you a first high level overview of the regulations in 28 EU Member States
• helping you assess the VAT implications and reporting obligations (e.g. VAT registration obligation, VAT return, EC Sales Listing and Intrastat reporting)
• assisting you answering some questions related to the trends in the pharma sector for clinical trials and precision medicines. Continue reading


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PHARMA WEBINAR: Brexit and its impact on pharma and life sciences industry


The continued complexities in agreeing the form of the UK’s exit from the EU, can make planning for Brexit difficult for businesses. However, the pharma and life sciences industry has been one of the more prepared industry sectors given its unique challenges around Brexit.

I would like to invite you to join our webinar to discuss this topic together with PwC’s international indirect tax experts, as well experts in the wider regulatory and supply chain issues that will impact the pharma and life sciences industry. During this digital presentation our panel of experts will give you an overview of the indirect tax implications within the pharma and life sciences sector both in the UK and in other EU member states, as well as an overview of the wider implications.

Date:  25 February 2019 from 1.30pm to 2.30pm (CET).

I’m looking forward to welcoming you to our “Brexit and its impact on the pharma and life sciences industry” webinar! Please klick the link which will guide you to your personal registration page and further event information.

 

Image source: unsplash.com


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Pharma & Life Science – Get together


PwC_fl_30mmh_cAs a tax specialist within a pharmaceutical company, you face complex sector specific challenges each and every day. You have to do more with less resource and find efficient and pragmatic solutions in line with local law. Your job is interesting and exciting but very demanding. Exchange and information what is best in class in your industry can support you and inspire you in your daily business.

Therefore, we would like to invite you to our Pharma & Life Science – Get together to discuss with us and other professionals from your industry. We will talk about VAT, Customs, Direct Tax and Regulatory issues in the pharmaceutical and life science business concentrating on Risks and Opportunities, which impact national and international sale of drugs, Technology, BEPS / UCC and Contract Clauses. Continue reading


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Biotechnica 2013, 8 – 10 October: Europe’s No.1 Event for Life Sciences


BIOTECHNICA 2013 in Hannover will once again serve as the central hub for Europe’s entire Life Sciences sector and its clientele by featuring new topics and innovative marketplaces. It is already the twentieth time that BIOTECHNICA brings together exhibitors and trade visitors to do business. One of the keynotes of this year will be bio-economics. An important focus of attention of this year’s trade fair will be the participation of Switzerland as the first Partner Country. Continue reading