Faster access to medicines: What the NICE and MHRA partnership means for pharma, medtech, and the NHS

In a significant move for the UK's life sciences sector, NICE and the MHRA have announced a new streamlined process that promises to get new medicines to patients in England 3-6 months faster. This development, a key part of the government's 10-Year Health Plan, signals a significant shift in the regulatory landscape. But what does this accelerated pathway mean for the pharmaceutical and medtech industries, and for the NHS professionals on the front line?

This blog post unpacks the announcement and places this change within the broader context of the NHS's long-term strategy.

The new fast track

The core of the announcement is a new joint agreement between the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE). This will allow for parallel decision-making on a drug's licensing and its value to the NHS. In essence, pharmaceutical companies can now register their products with both bodies simultaneously, triggering a coordinated assessment process.

The goal is to have more medicines approved for use in the NHS at the same time as they receive their UK licence. This enhanced coordination is designed to be a win-win: patients get earlier access to innovative treatments, and the government aims to cut administrative costs for businesses by 25%.

Insights for the pharmaceutical and medtech industry

For pharmaceutical and medtech companies, this new pathway presents both a significant opportunity and a call to adapt. Here are the key takeaways:

• Early engagement: The new process hinges on early registration on UK PharmaScan, the national horizon scanning database. Companies are now encouraged to register their products at least three years before their expected marketing authorisation. This means a shift towards more proactive, long-range planning in your regulatory and market access strategies.

• An integrated approach: The integrated advice service offered by the joint MHRA-NICE initiative will require a more holistic approach to evidence generation. Companies will need to think about both regulatory and Health Technology Assessment (HTA) requirements from the outset. This could mean designing clinical trials that not only demonstrate safety and efficacy for licensing but also generate the real-world evidence and cost-effectiveness data that NICE requires.

• The rise of innovative commercial models: This move is part of a broader trend towards more innovative "pay for impact" commercial models, as we've seen with the introduction of the Innovative Medicines Fund (IMF). As medicines get to market faster, there will be an increased focus on demonstrating value and outcomes in the real world. Companies should be prepared for more flexible and outcomes-based commercial discussions with the NHS. ‍

• A new dynamic for biosimilars: The announcement specifically supports the earlier launch of new biosimilar medicines, a move set to intensify the competitive landscape. In many cases, the high cost-effectiveness of biosimilars may not just create competition but effectively eradicate it, making it commercially untenable for some products to launch or remain in the UK market.

Taken together, these points signal an acceleration of the entire competitive landscape. With competitors also reaching the market faster than before, launch excellence and strategic agility become critical. This new paradigm also requires companies to think beyond the product itself and engage with the whole patient pathway earlier. Ensuring that the system is set up optimally to enable a new medicine to be administered is a shared challenge, and this is where proactive, well-structured NHS-Industry Partnerships can be so valuable.

Implications for NHS professionals

For those working within the NHS, faster access to medicines is welcome news, but it also brings a new set of considerations:

• Keeping pace with innovation: The accelerated approval of new drugs will require clinicians to stay abreast of the latest treatments and be ready to adopt them into practice more quickly. This emphasises the need for continuous professional development and systems capable of disseminating new information and guidance.

• The National Formulary and prescribing: The 10-Year Health Plan also includes the development of a single national formulary. While this aims to reduce the "postcode lottery" of access and streamline prescribing, this national guidance will need to be balanced with the clinical autonomy required to treat individual patients.

• Workforce and service redesign: The rapid introduction of new medicines, particularly those that require new diagnostic or delivery methods, will have a knock-on effect on workforce planning and service design. For example, a new diagnostic test accompanying a novel therapy will require investment in training and equipment. With care shifting towards the community, this upskilling will need to cover a broader workforce than before, including community pharmacists who are increasingly responsible for managing long-term conditions.

Connecting the dots: The NHS 10-Year Plan

This announcement is a key component of the wider NHS 10-Year Health Plan, which, as we have explored in our previous blog posts, is driving a fundamental shift in the delivery of healthcare in England. This move towards faster access to medicines aligns with the plan's three core pillars:

• From analogue to digital: The emphasis on data sharing and a single national formulary is part of the broader digitisation of the NHS.

• From sickness to prevention: By getting preventative medicines and treatments to patients sooner, this new pathway supports the shift towards a more proactive model of care.

• From hospital to community-based care: The ability to get new medicines into the community faster will be essential for the success of the new Neighbourhood Health Centres and the expanded role of community pharmacy.

A new landscape for UK life sciences

The collaboration between NICE and the MHRA represents a significant step towards a more agile and responsive UK healthcare system. For the pharmaceutical and medtech industries, it presents a clear opportunity to bring innovative treatments to patients faster, but it also demands a more integrated and forward-thinking approach. If implemented successfully, this should also help make the UK a more compelling market for global launches; a welcome development for industry executives vying for resource and attention from European management. For the NHS, it is a chance to deliver better outcomes for patients, but one that will require a commitment to continuous learning and service adaptation.

By understanding the implications of these changes, we can all play a role in navigating this new landscape and building a healthcare system that is truly fit for the future.