Elaine Gemmell, head of regulatory affairs at InnoScot Health, considers the latest MHRA initiative, the Innovative Devices Access Pathway (IDAP).
The opening of applications for a pilot of the new Innovative Devices Access Pathway (IDAP) is undoubtedly a positive step forward for post-Brexit regulatory approval processes.
The wider regulatory framework may be proceeding more slowly than was originally expected – including an extension to the transitional arrangements for CE marked devices – but this is an important, progressive move that benefits all involved.
Applications for companies of all sizes to be part of the pilot were welcomed through a government portal with a deadline of 29 October to register interest before outcomes are analysed and eight technologies selected in December.
This pilot phase will test the main elements of the pathway and, according to the government, “provide informative learning and feedback that helps to build the future IDAP.”
Back in May, I watched with interest as the Medicines and Healthcare products Regulatory Agency (MHRA) announced that implementation of government plans to streamline and fast-track post-Brexit regulatory approval processes for medical technologies and medicines would be going ahead later in the year.
This included the introduction of the new Innovative Devices Access Pathway (IDAP), operated by the MHRA, National Institute for Health and Care Excellence (NICE), and other partners, including the devolved administrations.
The IDAP is essentially an initiative designed to bring new technologies and solutions to the NHS to help with medical needs that are not currently being met, including diagnostics and digital health solutions.
The aim of this product-specific roadmap is “to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers,” says the MHRA, with joined up advice from the IDAP partners.
In simple terms, the IDAP should provide tailored support and scientific advice throughout the product design and development process.
It will be open to UK and international commercial and non-commercial developers with new health technology solutions, supporting innovators to generate the evidence they need to achieve regulatory approval, heath technology assessment decisions, and patient access in the NHS.
Speaking about the rollout during a launch webinar, Ed Clifton, unit head of the Scottish Health Technologies Group (SHTG) said: “IDAP improves access to medical technologies across Scotland and the UK for the benefit of patients, delivery of services, and the life science sector itself.”
He stated that its collaborative approach is “uniquely placed to deliver the right regulatory and evidence support at the right time” and successes for the pilot “will hopefully translate into longer-term wins for the wider system.”
Clifton added that IDAP would help to support Scottish companies and that all medical devices are eligible, including software as a medical device.
“There are very specific opportunities,” he said. “We have a new accelerated national innovation adoption pipeline, and my hope is that absolutely anything that comes through the IDAP process will plug in quite neatly to that, and there’s an opportunity for funding and implementation across the health boards through that accelerated National Innovation Adoption (ANIA) process.”
The second stage of IDAP implementation is expected to include legislative changes that will mirror the Innovative Licensing and Access Pathway (ILAP) process for medicines, from which InnoScot Health’s own spinout Aurum Biosciences was granted an Innovation Passport – a gateway to accelerate innovative products to market, thereby improving patient access to important new treatments.
From my point of view, and no doubt others, it is worth noting particularly that the IDAP will focus only on newer technologies, building on experiences and learnings from the ILAP.
Furthermore, MHRA has stated that IDAP coordinators are expected to “coordinate with ILAP to identify synergies and efficiencies” and lead the IDAP from pilot phase to a “mature access pathway”.
It is part of a broader package of reforms to the medical devices regulatory framework that the government is planning to introduce in a phased approach.
Indeed, more substantive reforms are expected to be implemented in future including matters such as new alternative domestic routes to market and rules dealing with approved bodies, registration requirements, software as a medical device, clinical investigations, and implantable medical devices.
If the indicated timescales are adhered to and ILAP learnings are taken fully into account, then I believe that MHRA should be supported to progress and ultimately deliver an effective IDAP pathway with potentially very positive outcomes.
Changes to the regulatory pathways for medical devices, and technologies, are intended to enable forward-thinking, safe, effective, medical products to reach patients faster, whilst establishing the UK as a centre for medical innovation.
These developments are to be welcomed, but it is also understandable that this transitional period can be difficult for healthcare innovators to navigate and so it is even more important that they have access to high quality advice.