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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. 

Application-accompanying data collection (anwendungsbegleitende Datenerhebung, AbD), is a post-launch evidence-generation mechanism used to reduce clinical uncertainty remaining after regulatory approval.

Germany’s structured early access route for medicines without marketing authorisation is compassionate use through cohort-based ‘hardship programmes’.

Recent reforms under the Medical Research Act (Medizinforschungsgesetz, MFG) are intended to strengthen Germany as a location for clinical research and early launches.

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 MHRA provides strict guidelines for importing unlicensed medicinal products (also known as "specials") into the UK. These guidelines ensure the safety and quality of unlicensed medicines and aim to meet the specific needs of individual patients when no suitable licensed options are available.

Individual Funding Requests (IFRs) are mechanisms within the UK's National Health Service (NHS) that allow for the consideration of funding treatments not routinely commissioned. These requests are typically made when a patient has unique clinical circumstances that may warrant access to a treatment outside standard protocols.

The Innovative Licensing and Access Pathway (ILAP) is a regulatory initiative led by the MHRA, designed to accelerate the development and approval of innovative medicines. It involves collaboration with the national health technology assessment bodies to coordinate the regulatory approval with technology assessment and allow faster patient access to new innovative treatments.

The Innovative Licensing and Access Pathway was launched in January 2021 by the MHRA to speed up the development and delivery of innovative medicines, and it is due to be relaunched in March 2025. It provides a collaborative framework among the MHRA, the national HTA bodies of the UK and, in the revised ILAP, the National Health Service (NHS). The scheme is designed to streamline access to new therapies that meet unmet medical needs, ensuring transformative treatments reach patients more swiftly.

The Innovative Medicines Fund (IMF) is a funding initiative established in England to provide patients with early access to promising new non-cancer medicines that are not yet routinely available through the National Health Service (NHS).

Managed access agreements are time-limited agreements implemented by the National Institute for Health and Care Excellence (NICE) to provide patients with early access to promising but uncertain treatments.

The Accelerated Aligned Pathway is a joint initiative of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE)s designed to align regulatory licensing and health technology assessment (HTA) for selected medicines, particularly those addressing unmet clinical needs, so that decisions on authorisation and value can be delivered in parallel rather than sequentially.

NICE operates a Managed Access Programme to provide patients with early access to promising new treatments while additional evidence is collected to address uncertainties about their clinical or cost-effectiveness. This approach is particularly beneficial for treatments that show potential but lack comprehensive data to support routine NHS use.