04 th Aug What does the future hold for the MHRA?
What does the future hold for the MHRA?
The recent decision by the UK to leave the European Union (EU) is likely to have major political and economic implications on many industries within the UK and Europe. Whilst there has been extensive media coverage following Brexit, the UK pharmaceutical industry is one topic which has not been at the forefront of the campaign. This is surprising when the National Health Service is the fifth largest employer globally and the UK is one of the top five Countries in the world for Research and Development.
The UK will remain a full member of the European Union until Article 50 of the Lisbon Treaty has been invoked. Following this, there will be a negotiation period of at least two years. There is very little precedent regarding the exit of the UK from the EU; the only precedent is Greenland which undertook three years of negotiation once they decided to leave the European Community. Greenland were only negotiating terms of the fishing industry; it is therefore likely that negotiation of terms around the UK leaving the EU will be a lengthy process.
In the short term, existing legislation will remain in place and the UK will continue to implement EU directives until a full exit of the EU. The lack of precedent and the lengthy negotiation process creates a level of long term uncertainty for the pharmaceutical industry who favour long term planning. The Medicines and Healthcare Products Regulatory Agency (MHRA) are currently, in association with European and Global networks, discussing three scenarios for their long term position within the pharmaceutical industry.
The first model follows Norway which is part of the European Economic Area (EEA) but not the EU. The Norway Model would allow the UK to continue to operate within EU regulatory frameworks and have an existing level of access to the single market. This may be the preferred option of trade bodies as it would provide continuity to the UK pharmaceutical industry. Norway, however, is the tenth largest contributor to the EU budget and must maintain free movement of people which may contradict what many people voted in support of during the UK referendum.
The second scenario considers the MHRA as an independent regulator but following regulatory frameworks which have been previously established elsewhere, e.g. Switzerland. The Swiss pharmaceutical industry has a very positive relationship with the European Medicines Agency (EMA) including a mutual recognition agreement; they must however maintain complicity with EU restrictions.
In the final scenario, the UK has full independence whereby the MHRA would be required to provide a full regulatory service capable of reviewing every medicine application independently.
If the UK were to follow the route of becoming part of the EEA (the Norway Model), market authorisations may continue to be granted in the UK via the centralised authorisation procedure. If the UK were to choose to not become part of the EEA, the MHRA would be responsible for all new medicines in the UK which would be required to go through a national procedure. Whilst this may generate greater income for the MHRA, it may also result in a slower authorisation process due to an increase in workload.
Following Brexit, many questions have been raised regarding the future of the UK pharmaceutical industry and the MHRA. During September, the MHRA will hold a Medicines Industry Liaison Group meeting to discuss Brexit with more clarity following the change of government. Whilst in the short-term, very few changes are likely and regulations will remain the same; the long term implications of Brexit are not clear and may take many years to resolve.
With so much uncertainty, GSK’s £275 million, post-Brexit investment into the UK economy gave welcome, light relief. Through our own business at TRAC, we have also seen evidence of progressive companies adapting websites to include translations aimed at more global markets as well as the launch of marketing campaigns with a stronger focus on European markets to take advantage of exchange rates. What remains certain, is that the UK pharmaceutical industry must continue to engage at the frontline of these conversations for any potential longer term post Brexit value to be realised as we navigate the maze of uncertainty.
Edited 5th August 2016
Lucy Rafferty, Regulatory Executive with The Regulatory Affairs Consultancy (TRAC)