Whitepapers

Patient experience data (PED) is gaining ground with regulators. The EMA has published a draft reflection paper and the FDA has built out its Patient-Focused Drug Development framework. HTA bodies are less aligned: our review of nine markets found guidance on assessing PED uneven. For manufacturers, this creates uncertainty over which methods decision-makers will accept. Read on to find out how markets compare, which challenges keep coming up, and why your PED strategy matters

In this whitepaper, Partners4Access explores the market access trends that will define 2026, examining how evolving regulatory frameworks, policy reforms, and innovation pressures are reshaping pricing, reimbursement, and launch strategy across Europe and beyond. It offers a forward-looking perspective on how manufacturers, payers, regulators, and patients can navigate an increasingly complex access environment.

In this whitepaper, Partners4Access explores the market access trends that will define 2026, examining how evolving regulatory frameworks, policy reforms, and innovation pressures are reshaping pricing, reimbursement, and launch strategy across Europe and beyond. It offers a forward-looking perspective on how manufacturers, payers, regulators, and patients can navigate an increasingly complex access environment.

Executive Summary The introduction of the European Joint Clinical Assessment (JCA), a centralized EU process for the scientific analysis of clinical evidence on the relative

Introduction In many ways, healthcare is an industry built and sustained by women. According to the WHO, women account for around two-thirds (67%) of the

Introduction During 2023, we have seen revisions to pharmaceutical legislation, countdown to Jan 2025 and the EU Joint Clinical Assessment, patient experience data on the

By: Sophie Schmitz, Akshay Kumar, Joanna Fernandes, Chloe Sheppard, Srishti Gupta, Andrea Bernardini, Fisentzos Stylianou, Olivia Johns, Priyanka Kiritharan & Jodie Lyons Introduction In 2022

By: Sophie Schmitz, Akshay Kumar, Richard Wang, Fisentzos Stylianou, Adama Anozie, Chloe Sheppard, Nadia Al Lahiq, Andrea Bernardini & Sylwia Lach Introduction 2021 saw the

By: Richard Wang, Adama Anozie Akshay Kumar & Bruce Chin What is Hospital Exemption? In recent years, we have seen rapid commercial development of advanced