02 February 2021 Brexit

2021: The strategic opportunities for global medicines innovators in the UK

Summary
We firmly believe the UK’s post-Brexit regulatory picture provides a wealth of strategic opportunities for medicines innovators to advance clinical programmes here from both a Global and European perspective. As we embark on a new era the MHRA, as a world-class regulator, will establish an even stronger influence in regulatory guidance for clinical development and the UK should always be an early strategic consideration.

In the article below we discuss:

  • The UK post Brexit: the significant opportunities
  • The MHRA post-Brexit: still delivering prompt, pragmatic and patient benefit-powered decisions that can be a strategic step in your clinical development


Where does the UK sit in a Global or European Clinical Development Plan? That is the question that many of our clients have been asking since the Brexit vote was announced. Clarity was provided by the EU when it stated from the outset that companies should prepare for the UK to become a third country – and this has been a consistent message throughout. Fast forward to January 2021 and the UK is in a strong position to offer opportunity for medicines development. We believe that the MHRA can be used strategically to advance clinical programmes from both a Global and European perspective.

The UK has long been highly regarded as a site for clinical development and regulatory engagement, providing a robust but pragmatic approach to technologies new and old. Seeking advice from the UK has always provided invaluable insight into the regulatory considerations for new products in development, providing access to opinions and guidance that set programmes on a sound course from an EU perspective. Of course, it is important to present and debate the development with EMA on route to MAA, but national advice and scrutiny during clinical development has always been a solid foundation from which to build a programme towards market.

Now that the UK has left the EU – why seek advice here?

We believe there are significant opportunities for engaging with the MHRA, and if 2020 is an indicator of future trends, our clients agree:

  • The MHRA contributed extensively to the existing EU medicines regulatory system and therefore has a closely aligned expectation and assessment philosophy to EMA. It can be used strategically, within the development timelines, to gain practical but robust assessment as a precursor to EMA advice
  • The UK provides a useful staging post for testing out regulatory ideas and concepts before building out to EMA and other national agencies
  • Clinical trials can be used strategically in the UK, ensuring that a robust and pragmatic assessment enables trial initiation
  • New programmes, like the Innovative Licensing and Access Pathway (ILAP), demonstrate that the UK will remain innovative and focused on driving new medicines to patients. New tools are being developed to facilitate the development of medicines via the Innovation Passport, facilitating interactions with stakeholders including NICE
  • The MHRA remains a global player interacting in numerous regulatory convergence programmes including the ACCESS scheme


It is clear to us that the UK and its MHRA now offer an efficient and effective means to progress clinical development programmes, offering a well-respected regulatory opinion and providing a stepping-stone into conversations with the EMA, FDA and others.

As the MHRA embarks on a new journey, as a fully sovereign regulator outside the EU, we believe the UK will establish a new era of influence in regulatory guidance for clinical development:

Opinion

The MHRA is already highly respected globally, its views are influential worldwide and it is still considered as an authority that will ‘punch above its weight’ post Brexit. It is globally recognised as having played an integral role in the design of the EU regulatory environment and its personnel will continue to be involved in the evolution of regulatory convergence and new technologies . The MHRA will be part of the new ACCESS consortium working groups and it is developing UK based initiatives and development tools within the Innovative Licensing and Access Pathway.

Resources

The UK remains a world-renowned centre for research and clinical development, pharma companies and innovation.

Motivation

As the MHRA is now a fully sovereign regulator it has control over the decisions it believes will most benefit UK citizens and will be keen to ensure the UK retains access to the latest available treatments. As has been evidenced most recently with the multiple Covid-19 UK vaccine approvals, it is clear that it will continue to work in an agile and pragmatic manner in the interest of National and Global Health concerns.

Promptness

The MHRA has a well-deserved reputation for making prompt, pragmatic and patient benefit-powered decisions, positioning it at the vanguard of global clinical development plans. If issues do arise, the MHRA’s high-quality responses may be a valuable form of ‘early warning’ to address these before speaking with other regulators in other territories.

Agility

Scheduling scientific advice meetings between key trials is often a complicated aspect of global development when trying to align the next trial protocols and regulatory expectations. The MHRA is renowned for its agility which allows companies to position and schedule its opinion efficiently between FDA and EMA meetings at key milestones during development. The MHRA also aims to remain pragmatic and avoid unnecessary bureaucracy and may take into account some global opinions to assist the access of novel and effective medicines to patients.

THE UPSHOT

We firmly believe the post-Brexit regulatory picture provides a wealth of strategic opportunities for medicines innovators to advance clinical programmes from both a Global and European perspective. As we embark on a new era the MHRA, as a world-class regulator, will establish an even stronger influence in regulatory guidance for clinical development and should always be a strategic consideration.