CERTAINTY AND RISK
A regulatory outlook from the MHRA'S recent board member, Professor Vincent Lawton CBE
In deciding where to locate your research-based biopharmaceutical company, the probability of success in developing your compounds and bringing them through to commercialisation is key. The regulatory framework of your chosen market plays a vital role in determining this success.
Post the UK referendum, increased uncertainty has entered the equation, challenging the confidence of potential investors in the UK. What will happen when the UK leaves the EU? Can the EMA remain in the UK?
At this stage it is uncertain. No one knows. The EU relies on the competence from within its member states. It is for this reason that the UK regulator, the MHRA, plays such a large role in the functioning of the EMA and globally. It is estimated that the MHRA does around 30% of work in and for the EU; two of the most important EMA committees are chaired by MHRA employees.
Because of the extensive contribution by the MHRA to EU processes it would make sense for it to stay as part of the centralised procedure. Both applicants for marketing authorisations and the regulators would benefit from the continuation of this relationship. Whether this will be possible is a matter of conjecture. Precedents include the UK becoming an EEA state like Norway, Liechtenstein and Iceland, enabling it to continue with certain MAs.
What can be certain is that the MHRA and UK science will continue to prosper. The MHRA can strengthen its already impressive global links with established markets like Singapore, Australia and Canada, and emerging markets such as India, South America and Mexico. MHRA is a pioneer with its Early Access to Medicine Scheme (EAMS). Its innovation office offers advice and support to individual innovators, academic institutions, registered SMEs and pharmaceutical companies. The UK Accelerated Access Review should further streamline product development to final adoption for use in patients.
To those considering entry into a currently uncertain UK market, is it a ‘risk’ worth taking? I think so. It presents important opportunities. Recent events are forcing the pillars of R&D and regulatory excellence to think differently and to explore new science/ business models. For example, I can envisage a regulatory ‘revolution’ in which drug appraisals can be risk based: the regulator can be involved at all stages of the product life-cycle, thereby adding considerable value to companies that choose to be in the ‘new’ UK market. A UK MA will still carry the reputation it has gathered over the past decades and it can continue to open doors to market access elsewhere.
The lead time for leaving the EU is sufficiently long to enable the development of greater certainty but this needs to benefit investors, research, and public health. The pharmaceutical industry remains a critical factor in decision making. An industry that employs >70,000 people and invests £11.5 million a day in research in the UK can offer a great deal to the planning process. Industry associations, particularly the ABPI and EFPIA, should be encouraged to talk to the UK Government and to the EU, respectively, to seek pragmatic and win-win approaches. Those European countries that have benefited from the UK regulators’ role in leading EMA committees and projects can consider a ‘pull’ position where the UK can continue to benefit from the centralised procedure.
The pharmaceutical and biotech industries thinking of entering the UK market should make their decision based on the ‘certainty’ of the UK scientific and regulatory excellence that marks its past, and will endure and develop in the uncertain future. I believe it is a risk worth calculating.
Professor Vincent Lawton CBE is Chairman of Addex Pharmaceuticals and former Sr VP Merck Europe, Board Member MHRA, and Strategy Advisor, Imperial College London.