In preparations for Brexit, the EMA has redistributed the UK’s product portfolio to other EU members and is not allocating any centralised marketing authorisation applications to the MHRA. We take a closer look at this and the consequences it may have…
Brexit
Over the weekend, The Guardian reported on the end of Britain’s role in evaluating new medicines for sale across the European Union as a result of Brexit. Although, this is not necessarily completely unexpected in terms of the potential impact of Brexit on healthcare, it has still been seen as a huge blow by industry and its ramifications potentially highly costly.
Authorisation and the centralised procedure
All medicines for human and veterinary use must be authorised to be marketed and made available to patients. In the European Union this authorisation can be done via a centralised route or a national route. The centralised procedure means that companies need only submit a single application to the European Medicines Agency (EMA) and once approved the product can be marketed across the whole of the EU.
In order to come to an approval, however, the medicine needs to be scientifically assessed. For this, the EMA calls on experts from various national competent authorities to form a committee. From these a rapporteur (and in some instances a co-rapporteur) is appointed to prepare an assessment report, which is used as part of the scientific opinion or recommendation. Committees established by a rapporteur may be multinational.
The role of the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has been significantly involved in the assessment of medicines for the European Union and has taken the lead on multiple assignments. As reported in The Guardian’s piece, proportionally the MHRA was involved in around 20–30% of all assessments.
However, after the UK submitted the notification of its intention to withdraw from the EU in March 2017, the agency commenced preparations for the withdrawal, including the redistribution of the product portfolio.
“The MHRA still participates in EMA activities and will continue to do so until the UK withdraws from the EU,” confirmed a spokesperson from the EMA. “However, in order to protect animal and public health we have to prepare for the scenario that as of 30 March 2019 the UK will be a third country and may no longer participate in the work of the Agency. EMA is working with the 27 Member States to ensure that the resources and capacity required are available to guarantee an orderly redistribution of the work.”
Redistribution of portfolio
In April this year (2018), this redistribution of the UK’s portfolio was completed, meaning that more than 370 centrally authorised products were allocated to other rapporteurs and co-rapporteurs from the 27 countries in the EU, as well as Norway and Iceland.
Further to this, the EMA has then stopped allocating any centralised marketing applications to the MHRA as the length of time for the full evaluation may go beyond 30 March 2019 when the UK may no longer be a part of the EU.
“Rapporteurs for initial centralised marketing authorisation applications are appointed on the basis of objective criteria, which aim to make sure that the best and available expertise in the EU in the relevant scientific area can be used. In the current context, ‘available’ means also being available beyond 30 March 2019,” added the EMA spokesperson. “As the average length of a centralised evaluation for initial marketing authorisation applications is more than one year, UK representatives can no longer be considered for appointment as rapporteurs or co-rapporteurs.”
No surprise but still a shock!
“The news that EMA has announced it will discontinue awarding contracts to the MHRA, is no surprise. It is, nonetheless, a shocking blow to MHRA, which will create a massive hole that is unlikely to be filled by way of demand from national applications or UK government funding (especially noting current fiscal pressures),” stated Martin MacLean, life sciences partner at intellectual property firm, Mathys & Squire. “As a result, our current wealth of regulatory expertise will likely be forced to find new roles, else retrain or migrate.”
In speaking to The Guardian, the head of the Association of the British Pharmaceutical Industry, Mike Thompson said: “Clearly we’ve all been incredibly proud of the MHRA’s role over the last few years. They’d established themselves as one of the most respected regulators across all of Europe and industry. It’s been a British success story.
“Companies are having to build extra laboratories to try to prepare to batch-release medicines made in the UK on the continent. That’s a huge cost for us. Hundreds of millions of pounds that we’re having to spend that frankly we’d rather spend on researching new medicines…”
The best or worst outcome?
Earlier in the year, we spoke with some leaders from industry about the potential impact of Brexit as we passed the six month point for the relocation of the EMA to Amsterdam.
“The best outcome is that a mutual recognition agreement is maintained between the EU and UK, meaning there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages, which is extremely concerning,” noted Thomas Beck, senior vice president, Quality Management, Recipharm. “Treating the UK as a ‘third country’ post-Brexit also has the potential to create additional layers of complexity that manufacturers will have to adapt to if they are not already familiar with third-party importation practices.
“The challenge needs to be faced in a pragmatic way and details need to be confirmed and communicated as a matter of priority or patients across the UK and EU could suffer.”
“There is a lot of uncertainty surrounding the full impact of Brexit,” added Colin Newbould, director of regulatory affairs and QP services, Wasdell Group. “The most obvious implication would be the requirement for EU and UK batch certification. For a product to be certified for the EU market it would potentially need to be retested on importation from the UK, unless the relevant regulatory bodies agree to grant mutual recognition agreements. Likewise, the UK may need to grant licenses for exported products. Implementing any additional measures to incorporate these requirements could have a noticeable effect on lead times, necessary resource and as a result overall cost.”
Significant uncertainty
In a post-Brexit strategy vote, however, the UK government were in favour of keeping the UK in the EMA, with the vote swinging 305 for to 301 against.
“The pharmaceutical industry is in a state of significant uncertainty. We are now less than a year away from the official exit yet there is still ambiguity and important negotiations to take place. However, MPs have now voted for the UK taking ‘all necessary steps’ to participate in the regulatory network operated by the EMA after it leaves the EU which is likely to instil some confidence within the industry,” stated Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS). “Of course, EMA has yet to determine the terms on which the UK could remain part of the agency post-Brexit.
“There have been many warnings from experts within the industry that Brexit could affect access for all Europeans to the most effective, affordable, safe and innovative healthcare products. As negotiations continue, new legislation must protect the links between the UK and the EMA to ensure the smooth flow of medicines and new drugs for British patients after Brexit.”
It is in the negotiations that the MHRA is hopeful that a relationship may be salvageable. As reported in The Guardian, an MHRA statement said: “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. This involves us making sure our regulators continue to work together, as they do with regulators internationally, and we would like to explore with the EU the terms on which the UK could