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In Digital Health

The Healthcare Agenda of Germany’s New CDU/SPD Coalition Government – A Point-by-Point Analysis of Key Policies and Their Potential Implications for Pharma and Med-Tech Companies

by and 11 Mins Read

In brief The newly negotiated Coalition Agreement between Germany’s center-right CDU and center-left SPD political parties outlines a healthcare policy agenda with implications for pharma and med-tech companies. Key measures include reinforcing general practitioners as gatekeepers, expanding Hybrid-DRG hospital reimbursement aiming to shift care to outpatient settings, and reintroducing prompt payment “Skonto” discounts for Rx drugs granted to pharmacies. HTA (AMNOG) pricing rules will be maintained, though “guardrails” limiting reimbursement prices may possibly be reconsidered,…

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In Medical Devices

Switzerland’s Therapeutic Products Act Revision: Industry Stakeholders Show Positive Support

by , and 7 Mins Read

I. Overview of proposed key changes The Swiss Federal Act on Medicinal Products and Medical Devices (Swiss Therapeutic Products Act, TPA), which has been in force since 2002, is currently undergoing its third revision. The proposed changes are designed to improve the safety and quality of medicinal products and medical devices (therapeutic products). The changes will update the legal framework to match current scientific and technological standards, as well as international laws, especially those…

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In Medical Devices

The Impact of Tariffs on the Life Sciences Industry

by , , and 9 Mins Read

Import tariffs have become the priority trade issue since President Donald Trump took office on January 20, 2025, with a wide variety of measures announced and imposed. These tariffs have the potential to disrupt all industries; however, they pose unique challenges for the life sciences industry, in particular the pharmaceutical and medtech industry, whose products have typically not been subject to customs duty on cross-border movements. We have set out below i) a summary of…

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In Pharmaceuticals & Biotech

United Arab Emirates: Enacts New Medical Products Law to Boost Innovation in Pharmaceuticals and Medical Devices

by , , and 5 Mins Read

On 1 October 2024, the UAE Government has issued a new Federal Decree-Law No. 38 of 2024 to regulate medical products, the pharmacy profession and pharmaceutical establishments (the “Law”). The Law replaces Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments including its later amendments (hereafter, “Federal Law of 2019”). However, its implementing regulations remain in effect to the extent they do not contradict with the Law. The Law was first published on the UAE government website…

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In Pharmaceuticals & Biotech

“What can we learn from 2024’s biotech IPOs?” –  Adam Farlow chats to Fierce Biotech

by 1 Min Read

Is there renewed enthusiasm on the public markets for biotech companies following the uptick in IPOs seen at the start of 2024 and in the late summer and autumn? What advice would you give to biotechs considering an IPO listing? Are there key traits that define successful biotech IPOs, or red flags that signal less successful ones? How do biotech IPO trends fit in the broader IPO market context, and what can we expect to…

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In Medical Devices

The French Political Crisis Leads the Pharmaceutical and Medical Device Industries Towards A Leap Into the Unknown for 2025

by , and 2 Mins Read

On 5 December 2024, the French Government was forced to resign following the vote of non-confidence by the French National Assembly towards the Social Security Financing Bill (“PLFSS”). A new Government was then appointed on 23 December 2024. As a result, 2024 ended without a PLFSS for 2025, leaving the Pharma and MedTech industries in uncertainty, particularly regarding the safeguard clause mechanism.   A Special Law To Prevent From Any Shutdown The PLFSS is debated…

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In Pharmaceuticals & Biotech

Extended Producer Responsibility for Pharmaceutical and Cosmetics Companies: Adoption of the Recast Urban Wastewater Treatment Directive

by and 5 Mins Read

On 5 November 2024 the Council of the European Union adopted the recast Urban Wastewater Treatment Directive, following the European Parliament’s approval of the text earlier this year. Of particular relevance to pharmaceutical and cosmetic companies, the recast Directive will introduce new extended producer responsibility (“EPR”) [1] obligations in respect of micropollutants from their products that end up in the urban wastewater stream. Background The EU’s previous Urban Wastewater Treatment Directive has been in place since…

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In Pharmaceuticals & Biotech

ECJ Ruling: Pharma Payments to State Health Insurers Are Rebates, Not Taxes

by , and 2 Mins Read

Pharmaceutical companies can breathe a sigh of relief following the European Court of Justice’s recent ruling in the Novo Nordisk A/S case (C-248/23 ). This decision marks the third time the ECJ has softened the rules around deducting pharmaceutical subsidies from the VAT base. Previously, in the German and Hungarian Boehringer cases (C-462/16 and C-717/19), the ECJ allowed subsidies to be deducted if paid to private insurers and later extended this to public insurers under…

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In Pharmaceuticals & Biotech

Guest Feature: India Pharma Focus – 4 Key Industry Developments to Track

by and 4 Mins Read

The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch: 1. Patent (Amendment) Rules 2024: Beware shorter…

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In Pharmaceuticals & Biotech

Has the European Parliament Missed the Chance to Boost Orphan Drug Development?

by , , and 1 Min Read

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…

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