The past few weeks have been turbulent, both politically and economically, as the UK takes in the results of the General Election, the Queen’s speech.
In light of recent events, where does the healthcare and especially the pharma industry stand?
The results of the General Election, along with the Government’s recent concessions (albeit that they have been heavily criticised) for EU migrants, increasingly point to support for a softer Brexit, shifting away from the “no deal is a bad deal” rhetoric. Yet the UK Government’s direction of travel in Brexit is unclear and the Queen’s speech, which sets out bills required by Brexit, offered little clarity for the pharmaceutical industry and the UK’s regulator, the MHRA.
In a hard Brexit scenario the MHRA will have to assume for the UK market the responsibilities undertaken by the EMA for the EU. This transfer of authority creates challenges for the MHRA in terms of resources whereas the UK pharma industry’s taskforce and other lobbying have repeatedly emphasised that the industry does not want to bear the related costs if the MHRA becomes an independent authority.
Within the context of the EMA, the MHRA plays a fundamental role as the single largest contributor, taking charge of approximately 20% of assessments within the EMA’s centralised procedure for medicines approval. As one of the larger Member State regulators, the MHRA also takes actively part in oversight activities such as pharmacovigilance. However, unless an alternative solution is implemented, once the UK leaves the EU , the MHRA will need to take on the remaining 80% of the work load currently dealt with by counterparts in other Member States. The same applies to products authorised through mutual recognition and decentralised procedures for which other Member States act as reference Member State.
The MHRA announced that it still needs to determine its “future relationship and engagement with our European counterparts in a post-Brexit context, including the potential for ongoing co-operation in EU regulatory procedures.” This should not be a surprise given the wider political uncertainty around Brexit. The historic close collaboration between the MHRA and EMA, would allow for greater collaboration than with other regulators, such as the FDA in the United States. However, to which extent collaboration will be possible and what form it would take as part of a wider Brexit deal remains uncertain for now.
Not being part of the EU network also means that the MHRA will need to negotiate its own reciprocal arrangements with regulators from outside the EU in which the EMA has existing collaboration agreements with, for instance, ICH, FDA, Health Canada and the Japanese PMDA. Within this context and pending the uncertainty, the MHRA made developing its international strategy and engagement with key partners a priority.
Eudravigilance and other IT systems
Eudravigilance is the EU’s system for managing and analysing information on suspected adverse reactions to medicines authorised within the EEA. The UK will need to determine whether it wants to retain access to the database post-Brexit or develop its own. Given the complexity and unique architecture of Eudravigilance and the significant cost implications, it is less likely the UK would want to establish its own, separate system. There would be duplication of effort as marketing authorisation holders would need to submit data to both the EU and the UK equivalent. It may be possible for the UK to continue to use Eudravigilance as well as other systems (e.g. EudraCT) for a transitional period as it continues to search for a longer term solution or altogether, permanently pay for access.
The recent UK elections and the Queen’s speech did not bring clarity regarding the future relationship between the UK and the EU-27 and how it may impact on the pharmaceutical industry, the MHRA and ultimately the EU regulatory system.
With Brexit due in 2019, there is only a short period to secure a mutually beneficial outcome which makes the need for an interim solution more apparent. A key question to be answered for the pharma industry is if an EEA model is feasible as -an interim- solution. Such model is readily available and would represent little disruption to business while carefully planning for more significant changes but needs political support.
We expect the current environment of uncertainty to continue for some time and will continue to closely follow developments in this space and on Baker McKenzie’s Brexit blog.