The UK has long been renowned for its commitment to innovation and progressive regulatory approaches to pharmaceutical development.
There were concerns that separating from the European Union would hinder the UK. However, one welcome, if unexpected, consequence of Brexit has been the emergence of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as an invaluable source of independent scientific advice.
Encouraging innovation
The MHRA is providing a supportive and consultative approach to the developers of breakthrough products, particularly those aimed at addressing rare diseases. This was underscored with the UK Government’s 2021 Rare Diseases Framework, which, among other objectives, seeks to drive greater research, including with a £14 million investment to the UK Rare Disease Research Platform. Indeed, the MHRA has been explicitly tasked by the UK government to accelerate the approval of new medicines.
While the European Medicines Agency (EMA) provides extensive assistance to small innovative companies through SME status – a benefit we have been pointing out to our clients for many years – the MHRA expands that support to mid-sized and even larger companies through its Innovation Office.
The Innovation Office’s consultative approach allows sponsors to address the unique regulatory challenges presented by the novelty of their products. Moreover, MHRA’s fees for scientific advice, while not quite matching the discounted fees available to SMEs from the EMA, are substantially cheaper than the full fees that non-incentivised sponsors would have to pay in the EU.
In such instances, it may make more strategic sense to consider working with the MHRA before presenting a product to EMA. This is especially the case when access to incentives is not assured and scientific or protocol advice may be needed.
A wealth of experience
The MHRA is known for its widely respected regulators and advisors and as a highly responsive and agile agency. Not only was EMA headquartered in the UK until Brexit, but its regulators also provided significant scientific advice to companies seeking to initiate clinical trials and gain marketing authorisation in Europe.
The MHRA now leverages that experience and respect to provide a leaner, less burdened regulatory process for sponsors, benefiting from being a single market with one set of expectations and requirements.
One unique pathway that the MHRA offers to innovators is the Innovative Licensing and Access Pathway (ILAP). Unlike EMA’s PRIority MEdicines (PRIME) pathway, ILAP allows innovators to discuss specifics outside of their product. This might include conversations around the development of a platform for single-patient, personalised treatments and how best to regulate and validate such a platform.
These kinds of discussions, about how industry can contribute to the development of regulations and guidelines to support innovation for these kinds of products are encouraged by ILAP and underscore MHRA’s reputation as a forward-thinking regulator.
Easing the device journey
The UK may also offer an easier pathway with medical devices. This is because the UK has continued the processes established under the old EU Medical Devices Directive framework, which allows for a speedier route to market than the new EU Medical Devices Regulation (MDR).
This is particularly relevant as EU Notified Bodies deal with heavy workloads insufficient resources, resulting in long assessment delays. With a population of almost 70 million and a homogenous market, the UK offers a significant market opportunity for launching new medical devices while waiting to access the wider and more heterogeneous EU markets.
Fewer hurdles
By starting the development journey in the UK market first, the hope and expectation is that innovators can glean invaluable insights from MHRA scientific advisors while taking advantage of faster timelines for clinical trial applications compared to the EU’s Clinical Trials Information System (CTIS). This offers an opportunity to obtain experience with the regulatory process, hasten the development process in a progressive and innovative market, and start to earn revenue as they seek to enter other markets.
While there are inevitably hurdles that sponsors will need to overcome for the UK, as with any market, taking advantage of the expertise and paths to approval in the UK should not be overlooked in marketing plans or when considering trial site locations, key opinion leaders, advice procedures, and global regulatory strategy.
The MHRA is known for its widely respected regulators and advisors and as a highly responsive and agile agency.