Europe Archives

Market Access Trends 2026

How Regulatory–HTA Convergence Is Reshaping European Market Access

March 24, 2026

Across Europe, 2025 accelerated a shift from sequential regulatory and access steps to more connected process through the Joint Clinical Assessment. Regulatory approvals, and clinical portion of HTA evaluation are now more tightly linked, which has the potential to bring the...

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Joint Clinical Assessment in the EU: What Life Sciences Companies Need to Know

June 13, 2025

March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by Trinity Life Sciences,...

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Pricing and Access in Germany: Innovation and Strong Evidence Rewarded

June 9, 2025

Germany’s Medical Research Act (Medizinforschungsgesetz or MFG), which came into force on October 30, 2024, is a major legislative reform aimed at strengthening Germany’s position as an attractive environment for medical innovation and pharmaceutical development. The act provides for confidential negotiated...

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Learnings to Kick-Start 2025: Joint Clinical Assessments and Health Technology Assessments

January 17, 2025

One trend Trinity Life Sciences has observed and that was reinforced by stakeholders at ISPOR EU is the importance of evidence in healthcare decision-making. This trend was highlighted particularly in the context of joint clinical assessments (JCA) and health technology assessments...

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Rise with the Waves: UK – Now and Beyond – Four Policy Trends That May Shape Pharma’s Future

May 23, 2024

Executive Summary The global payer landscape is rapidly evolving and is expected to continuously impact manufacturers’ decisions about new launches, portfolio management, trial design and importantly, pricing and market access strategy. In the UK, several policy reforms have been introduced which...

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Rise with the Waves: France – Accelerating Pricing and Market Access: Two Policies Shaping Pharma’s Future

April 22, 2024

Executive Summary The latest publication of new reimbursement regulations in the French Social Security Financing Act (PLFSS 2024), coupled with the recent approval of HEMGENIX® through the direct access scheme in France this past December, underline continued efforts in France to...

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Rise with the Waves: Italy – AIFA Restructuring and Budget Reforms – Stepping into a New (Uncertain) Future?

March 20, 2024

Executive Summary The Italian Medicines Agency (AIFA) underwent transformative changes on January 30, 2024, following a much-anticipated reorganization. AIFA’s restructuring has already faced challenges, with the recent resignation of the newly created Scientific and Economic Commission’s (CSE) chairman followed by the...

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Rise with the Waves: Germany – A Tale of Two High Impact Policies Shaping Pharma’s Future

February 26, 2024

Executive Summary Multiple cost-containment reforms, such as the introduction of a 20% rebate on brand-brand combinations and a temporary increase in the mandatory rebate on drugs to 12%, were implemented under Germany’s ‘Financial Stabilization of Statutory Health Insurance System’ Act (GKV-Finanzstabilisierungsgesetz)...

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Key Takeaways and Learnings from ISPOR Europe 2023

December 7, 2023

Trinity Life Sciences recently attended the ISPOR Europe 2023 conference in Copenhagen, Denmark. The main theme of the conference was “HEOR at the Nexus of Policy and Science,” and the event featured unique discussions and workshops across different stakeholders from both...

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Key Takeaways from the ISPOR Europe 2022 Conference

December 12, 2022

Last month, Trinity attended the ISPOR Europe 2022 conference in Vienna. The main theme of the conference was “Collaborating Across Borders: Building & Using Evidence to Enable Access”, which facilitated many interesting discussions amongst different stakeholders in life sciences, including...

From the ISPOR lobby - Welcome to ISPOR Europe 2022

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The German Financial Stabilization of Statutory Health Insurance System Act

October 31, 2022

Executive Summary: Key Policy Updates AMNOG Rebate Negotiations AMNOG* rebate negotiations will be modified to give the GKV-SV increased powers in the pricing negotiations. HIGH P&MA IMPACT: The new negotiation framework increases the threshold of added benefit required for therapies...

Pill with Germany flag on background and medical particles

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France Pilots Opportunity to Increase Speed to Reimbursement for Select Innovative Products

March 29, 2022

French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement [...]