The result of the EU Referendum meant that the UK was no longer a part of the European Union, and therefore, no longer directly involved in its regulatory system as it had been for the previous 35 years.
In the time since the referendum we have been working extensively with our members to guide them through this period of change, which has led to a process of increased collaboration and co-operation with the regulator and wider stakeholders, and will hopefully reinforce the UK and the MHRA as a leading global marketplace and regulator respectively.
Learning from Adversity
During the early stages of the COVID-19 pandemic, there was a desperate need for emergency ventilators, to ensure patients were cared for appropriately in hospital. In order to manufacturer the large numbers required, innovative methods of regulation had to be developed, which resulted in the ‘Ventilator Challenge’, where regulators, clinicians, conformity assessment bodies, and industry worked together to produce appropriate ventilators in short order. There was no doubt, that this co-operation and collaboration quickly and efficiently identified and resolved issues, leading to the manufacture of nearly 40,000 devices, without compromising patient safety.
These lessons are being well applied now that the initial challenge of the pandemic has subsided somewhat, with the MHRA keen to engage with those who they regulate, to develop a regulatory system which ultimately, will be world leading. Interactions with industry and wider stakeholders is seen as vital to the appropriateness of regulation for a number of reasons:
- To ensure that global strategies of manufacturers are compatible with the intention of the MHRA and UK plc, to be the place to innovate and research new technologies.
- To exploit what is seen as an increasingly diminishing pool of regulatory knowledge and capacity.
- To better serve the patient, particularly with aspects transparency and understanding of risk, vigilance and safety, as outlined within the Independent Medicines and Medical Devices Safety Review on safety.
- To curb the increasing cost and complexity of regulation that has resulted in manufacturers looking further afield than Europe for product development and place of ‘first market’.
These points are being no more firmly felt than in Europe, where transition from the Medical and In-vitro Diagnostic Device Directives to the new Regulations, is resulting in the need for a much higher degree of technical and legal compliance. Europe will therefore have to face the prospect of regulatory reform when it comes to reviewing the Medical Device and In-Vitro Diagnostics Regulations in the coming five years, as a further hike in technical compliance will finish many current medical technology activities.
Nimble and Fast Moving
So, outside of the European Union may well offer opportunities to the UK. Seeing these issues arising in the EU whilst being at the cross-roads of needing to define regulatory structures now, gives the UK government and the MHRA the chance to think again. ABHI are in that fortunate position of being able to offer that strong industrial experience through its 330+ members to government, not just to the MHRA but to other departments, such as those responsible for business and trade.
Members of the Association are regularly canvassed as to how the regulations should change. The abiding message back is one of non-divergence, but non-divergence of technical needs rather than regulatory process. Longer term and where the UK can be truly world-leading, is the prospect of regulatory practices such as ‘Outcome Based Collaborative Regulation’ as well as acceptance of Real-World Evidence and integration of digital practice.
All of these innovative practices are most effectively applied through collaboration and co-operation across stakeholders, and while it is recognised that separation is always needed between the regulator and industry, success requires a Trade Association, made up of a multi-faceted member base, input and expertise.
Regulatory innovation will therefore go hand-in-hand with product regulation, to ensure that the UK patient has access to new technologies faster and safer…