Governments step up: policy tailwinds for faster patient access

2025 brought something life sciences has long been waiting for: a sense that access is inching in the right direction, fueled by a new era of transparency and the rapid connection and integration of previously fragmented data available across stakeholders. Equitable access remains a distant goal, but the year showed signs of alignment that could lay the foundations for achieving it. From regulators to HTA bodies, policymakers to patients, we saw steps to shorten the distance between breakthrough science and the people who depend on it. Small steps, but a promising shift.

Europe raises tempo

The clearest structural progress came from Europe, where Joint Clinical Assessments (JCAs) finally became operational. By producing a single, centralised clinical-evidence assessment for selected medicines, JCAs address a long-standing source of delay: fragmented, duplicated evaluation across Member States. Pricing and reimbursement remain national decisions, but a shared evidence-base allows countries to enter those processes with greater clarity and predictability. JCAs cannot deliver faster access alone, but they create the structural conditions that make it possible.

The UK also signalled a shift toward access acceleration with a wave of reforms. The trial introduction of the Accelerated Aligned Pathway between NICE and the MHRA allows regulatory licensing and value assessments to run in parallel, removing the entrenched 90-day gap between marketing authorisation and NICE guidance. There’s hope that early joint scientific advice, coordinated scheduling and clearer evidence expectations will shorten approval times, potentially bringing NHS availability forward by three to six months.

Alongside this, the updated Innovative Licensing and Access Pathway extended earlier into development, giving high-impact medicines a more coordinated route toward availability. Its Innovation Passport brings MHRA, NICE and the NHS into structured early engagement, helping anticipate evidence needs and avoid delays that traditionally limit access.

The MHRA’s recent proposal to update how it evaluates rare disease treatments added further momentum. By proposing clearer guidance, more flexible evidentiary pathways and more collaborative value assessment, the MHRA acknowledged what rare disease communities have argued for years: speed matters, and rigid processes disproportionately disadvantage those with the smallest patient pools. The framework is unlikely to take effect until late 2026, but it’s a statement of intent to build access pathways that reflect modern scientific reality.

Transparency doesn’t fix the system on its own, but it removes a core barrier to progress: the hidden incentives that inflate cost and delay access.

Global powerhouses move

This direction of travel was echoed in the US. In November, the FDA introduced its Plausible Mechanism Pathway, giving ultra-rare treatments a clearer and more efficient route through evaluation while maintaining standards for safety and evidence. The pathway is narrow in scope but notable in intent: a signal that regulators are beginning to align review processes with the pace of modern innovation, not the constraints of legacy frameworks.

Broader US reforms also nudged access in a more positive direction. PBM transparency advanced sharply at the state level, with states passing laws to expose pricing practices, rebate flows and spread pricing – opaque mechanisms that have long distorted patient costs and restricted availability. Transparency doesn’t fix the system on its own, but it removes a core barrier to progress: the hidden incentives that inflate cost and delay access.

Elsewhere, CMS began reshaping its value-based payment model portfolio. Its Medicare Advantage VBID model will end after 2025 due to excess costs, while several value-based and cost-control models will continue as the agency recalibrates the mix. These moves signal a system slowly reorienting itself toward fairness, predictability and patient benefit, the essential ingredients of faster, more dependable access.

There was progress in Asia too. Japan continued its effort to reduce long-standing drug lag, strengthening regulatory science and aligning review expectations more closely with global norms – foundational steps toward smoother future access. China expanded pilot programmes designed to shorten review timelines in paediatrics and rare diseases, improving the regulatory infrastructure required for timely availability. These reforms represent essential groundwork for access advances in markets where regulatory readiness has historically limited speed.

For the first time in a long while, the policy environment feels in step with the scientific moment, and that alignment is the strongest basis for faster, fairer access in the years ahead.

Momentum meets 2026

All these developments mark a change in trajectory. Regulators are striving to keep pace with scientific progress, HTA bodies are aligning around clearer evidence standards, and transparency is slowly increasing. Significantly, early collaboration is becoming part of the fabric of how systems operate.

Together, these moves have created the foundation for progress. What happens in 2026 will show whether that groundwork can translate into tangible access gains. Certainly, momentum does seem to be gathering. For the first time in a long while, the policy environment feels in step with the scientific moment, and that alignment is the strongest basis for faster, fairer access in the years ahead.

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