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In EU Pharmaceutical Package

Council Clears Path to Trilogue on Pharma Package with Reduced Market Protection and stepped up Access Obligations

by , , , and 7 Mins Read

Political compromise raises questions around feasibility implementation and EU’s innovation edge After nearly two years of negotiations, the Council of the EU has adopted its negotiating position on the proposed revision of the pharmaceutical legislation on 4 June 2025. This milestone reached under the Polish presidency follows intense debate and numerous concessions among Member States. The most divisive issues of access to medicines and incentives for pharmaceutical innovation are likely to remain a balancing act…

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In Pharmaceuticals & Biotech

External Control Arms Based on Real World Data: MHRA Consultation Opens

by , and 2 Mins Read

On International Clinical Trials Day, the UK’s MHRA unveiled a major shift: a consultation on using external control arms (ECAs) based on real-world data (RWD) for regulatory decisions. This move aims to leverage patient-level data collected outside clinical studies to compare the efficacy and safety of interventions in clinical trials. Stakeholders have until the end of June to weigh in. What’s the Focus? The guidelines target sponsors planning to use RWD ECAs in trials needing…

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In Pharmaceuticals & Biotech

New White House Executive Order to Establish “Most-Favored-Nation” Drug Pricing

by , , , , , , , , , and 7 Mins Read

On May 12, 2025, the White House issued a wide-reaching Executive Order (“EO”) titled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” for the stated purpose of ensuring that American patients will have access to the most-favored-nation (“MFN”) price for prescription drugs and biologics.1 This EO came out about one month after the release of EO No. 14273 titled “Lowering Drug Prices by Once Again Putting Americans First” (April 15, 2025) which outlined…

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In Medical Devices

US Tariffs and the Life Science industry – an update

by , , and 4 Mins Read

Following our previous post here, we provide an update on the current developments in this area. On April 2, 2025, the US administration announced reciprocal tariffs on all imports into the United States (see here). As it has been widely reported, pharmaceutical products were exempted from these tariffs whereas medical devices were not. Subsequently, on April 9, 2025, the administration announced a 90-day postponement of the reciprocal tariffs for most countries except for China. For…

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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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