LiSAH News

The Accelerated Access Collaborative (AAC) is a partnership established in England to expedite the development and adoption of innovative health technologies within the National Health Service (NHS).

The Access Consortium is a collaboration of five national regulatory agencies (MHRA, TGA, Health Canada, HSA, and Swissmedic) that work together to align regulatory processes and reduce duplication in drug evaluations. Its purpose is to enhance international cooperation, ensuring timely access to high-quality, safe, and effective therapeutic products across member countries.

Recommendations for a flexible approach to archetypes for making sense of the diversity of national access approaches.

The All Wales Medicines Strategy Group conducts health technology assessments to evaluate new and existing medicines for use in NHS Wales. The main aim of this process is to ensure that patients in Wales have timely access to safe, effective, and cost-efficient medicines. This briefing describes the AWMSG appraisal process, which typically follows a structured procedure that involves submission, evaluation, and final recommendations.

The French National Agency for Medicines and Health Products Safety, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), offers a scientific advice service to assist pharmaceutical companies in the development of health products. This service provides guidance on scientific, technical, regulatory, and legal aspects, aiming to facilitate the development and market access of innovative health products.

The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) plays a role in improving patient access to new therapies in France. By implementing regulatory procedures and offering scientific support, the agency aims to ensure timely access to treatments while maintaining safety and efficacy standards.

The Cancer Drugs Fund (CDF) is a funding mechanism established in England to provide patients with access to cancer treatments that are not routinely available through the National Health Service (NHS).

France has implemented early access programmes to provide patients with innovative medicines before full marketing authorisation or reimbursement. These programmes include the Early Access Authorisation (AAP), Compassionate Access Authorisation (AAC), and Compassionate Prescription Framework (CPC). They are designed to address serious, rare, or disabling diseases lacking appropriate treatment options, ensuring timely access to potentially life-saving therapies.

The Early Access to Medicines Scheme (EAMS) is a UK initiative established by the Medicines and Healthcare products Regulatory Agency (MHRA) to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation but address unmet medical needs. 

The HAS’s structured approach to economic evaluation follows a robust process to ensure transparency, efficiency, and equity in healthcare decision-making. By integrating rigorous analyses with stakeholder engagement, the process balances cost-effectiveness with patient access to innovative treatments. This comprehensive methodology supports the long-term sustainability of the healthcare system while maintaining its commitment to high-quality patient care.

The French government’s France 2030 plan is a national initiative to modernise health research, accelerate scientific discoveries, and improve patient care. It is led by the French Ministry of the Economy, Finance and Recovery (Ministère de l’Économie, des Finances et de la Relance, MEFR).

France's healthcare system is centrally coordinated and regionally administered through Agences Régionales de Santé (ARS), ensuring universal coverage and equitable access to services. The Haute Autorité de Santé (HAS) evaluates medical benefits and improvements, informing reimbursement decisions, while the Comité Économique des Produits de Santé (CEPS) negotiates medicine prices. France operates two main early access programmes, the Autorisation d’Accès Précoce (AAP) and Autorisation Compassionnelle (AC) pathways to expedite patient access to innovative treatments.

France's healthcare system is a hybrid model that combines public and private sectors to deliver comprehensive medical services to its residents. This overview addresses the main components of France's healthcare framework, focusing on the organisation of the healthcare system, funding mechanisms, service provision, medicines approvals, and pharmaceutical access.

The French National Authority for Health (Haute Autorité de Santé, HAS) has in place a structured action plan issued in 2020 to adopt evaluation processes for innovative medicines. The plan focuses on three core initiatives: issuing conditional opinions for early access, implementing real-world monitoring to confirm efficacy and safety, and streamlining assessments for high-value medicines.

The Haute Autorité de Santé (HAS, National Authority for Health) offers an Early Dialogue scientific advice service to guide pharmaceutical companies in designing pivotal clinical trials for innovative medicinal products. This voluntary and confidential service provides non-binding recommendations to optimise evidence generation for Health Technology Assessments, focusing on unmet medical needs and aligning with national requirements.

The Heads of Medicines Agencies (HMA) is a collaborative network comprising the heads of National Competent Authorities (NCAs) responsible for regulating medicinal products for human and veterinary use within the European Economic Area (EEA).

The Health Economics Methods Advisory (HEMA) is a collaborative initiative established to enhance the evaluation methods used in health technology assessments (HTAs). It brings together experts three health technology assessment agencies to critically assess and refine health economic methodologies.

The French Health Technology Assessment (HTA) process, overseen by the French National Authority for Health (Haute Autorité de Santé, HAS), is a comprehensive evaluation system designed to assess the medical, economic, and public health value of pharmaceuticals. This process informs decisions regarding the reimbursement and pricing of medications within the French healthcare system.