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ILAP fast-track approval pathway for medicines – what are the risks?

Casualty
COVID 19 Coronavirus

May 24, 2021

A new streamlined regulatory pathway is set to make the UK a hub for developing innovative medicines. But with potential opportunity comes risk.

The new Innovative Licence and Access Pathway (ILAP)1 is intended to reduce the time to market for innovative medicines that fill unmet medical needs.

It is based on learnings from COVID-19, which proved that, if everything is aligned, new life-saving medicines can be developed in a fraction of the time previously thought possible.

The pandemic forced a rethink on clinical trial design with breakthroughs needed within months rather than years.

Using new thinking from the emerging discipline of translational medicine – which brings research and clinical development together to ‘translate’ lab findings into treatments – different models of trial were developed that offered the same rigour but with faster results.

With the UK setting its own regulatory framework post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) was free to adopt translational medicine approaches, such as accepting clinical trial data on a rolling basis, rather than waiting for trials to complete.

Now, with ILAP, the UK Government has formalised these advances in a new development pathway open to all medicines and drug treatments that have potentially transformative benefits.

The new framework clearly positions the UK as pro-innovation and is likely not only to boost new drug development within the UK, but also make the country a more attractive location for international pharma and biotech businesses to base their clinical trials.

What are the main features of the new pathway?

ILAP brings together the MHRA, the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (NICE), to break down barriers to innovation and support companies developing new medicines.

It brings the regulators into the product development process at a much earlier point – before rather than after clinical trials – reducing the potential for problems and delays at the approval stage.

Sponsor organisations must first apply for an ‘innovation passport’. If accepted, regulators will work with sponsors to develop a roadmap that details the support they will provide to smooth the path to market.

This can range from advising on design of clinical trials to help navigating licensing and market access routes.

Companies can receive immediate feedback on what a drug trial would need to demonstrate, and what data it would need to generate, to have the best chance of getting a positive assessment.

There is also a toolkit with a range of administrative resources and applications sponsors can use to support their entry.

Clinical trials will benefit from rolling data review, similar to COVID-19 vaccines.

And with NICE involved from an early stage, drugs approved on the ILAP pathway are more likely to be taken up quickly by the NHS and other healthcare providers.

What kind of medicines qualify for ILAP?

To qualify for the pathway, new medicines must offer significant benefits to patients with a life-threatening or seriously debilitating condition, or meet a significant patient or public health need. They can be:

  • New vaccines, advanced therapy products, biologic or chemical treatments or novel drug-device combinations.
  • Approved medicines being repurposed for another indication.
  • Medicines for rare diseases and special groups such as neonates, pregnant women or elderly people.1

What is the likely impact of the ILAP changes?

ILAP could mean big savings in both the time and cost of bringing a new product to market. If the example of COVID-19 vaccine development is replicated, this could potentially see years shaved off the process.

ILAP could mean big savings in both the time and cost of bringing a new product to market.”

Tracy Grant
Healthcare Industry Leader - Australasia
Willis Towers Watson

But fast-tracking may also increase risks, particularly long-tail exposures.

Any side-effects of a new medicine would normally become apparent within a traditional development timeframe over several years.

When the process is accelerated, there may be some residual risks, which might not be fully understood until further down the road.

How will ILAP affect insurance cover?

Although medicines will still go through the same evidence gathering and regulatory approval, sponsors will need to talk to their insurers to make sure they are comfortable with this new approach, avoiding any nervousness about unknown exposures and shortened processes.

We saw this during COVID-19 vaccine development, when some carriers refused to provide product liability cover for clinical trials. 

There may also be increased risk implications for directors and officers, for example, around their duty to communicate changes effectively to shareholders, and professional liability, related to their responsibility for clinical trial design.

There may also be increased risk implications for directors and officers, for example, around their duty to communicate changes effectively to shareholders.”

Tracy Grant | Healthcare Industry Leader - Australasia Willis Towers Watson

Clinical research organisations that run trials on behalf of large pharma and biotech companies may come under greater scrutiny, if new methods of processing and evaluating data increase potential exposures and change the nature of the risk.

What can businesses do to manage the risks of ILAP?

Pharma and biotech companies that use ILAP may need to check their existing insurance cover.

Where global clinical trials programmes exist, they should talk to their insurers to make sure that it will extend to cover medicines on the new fast-track pathway.

If not, they may need a standalone solution.

Life science businesses, including clinical research organisations should also consider whether they have enough protection against the unforeseen consequences of management decisions taken during a shortened regulatory process.

Any questions?

Get in touch if you’d like to find out more about ILAP and what it could mean for your business.

Sources

1 https://www.gov.uk/guidance/innovative-licensing-and-access-pathway

2 UK life sciences companies see £10.6 billion of deals in Q1 2021 | Cambridge Network

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Healthcare Industry Leader - Australasia

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