Understanding Post-Brexit British Pharmacovigilance

On 26 April 2017, professionals from across the pharmaceutical, drug safety and legal sectors gathered to discuss the future of the British pharma industry in light of leaving the European Union.

The announcement that Theresa May was officially beginning the two-year countdown to our departure from the EU sent shockwaves through the industry, giving way to uncertainty. While it can be concluded that the implications of the nation’s decision will be felt keenly by healthcare professionals, the extent and direction of these changes remains largely unknown.

One of the biggest questions on the lips of healthcare professionals is where the European Medicines Agency (EMA) is going to relocate, now that the UK is no longer a viable location. This decision alone will affect the industry at all levels, with implications for the market, for researchers, and for patients.

We explore some of the predictions for post-Brexit big pharma, and life after the European Medicines Agency.

What is the European Medicines Agency?

The EMA is an organisation dedicated to maintaining a standard of scientific excellence in the evaluation and supervision of medicines across the EU.

This responsibility includes assuring timely patient access to new medicines, by regulating and supporting research and protocols for getting drugs on the market.

The EMA is also responsible for providing independent evaluations and recommendations on medicines for human and animal use. This offers a centralised procedure by which medicines can be authorised for marketing within EU countries.

Safety is another priority of the agency, and it is committed to continuously monitoring and supervising the safety of authorised medicines, ensuring that their benefits ongoingly outweigh adverse side-effects.

Based on their monitoring work, the EMA also publish clear and impartial information on medicines for the use of both healthcare professionals and patients. Written in easy-to-understand lay language, these guides are intended to build confidence and ensure adherence to approved uses.

As a decentralised agency of the European Union, the EMA is governed by an independent Management Board. Its day-to-day operations are carried out in London, overseen by an Executive Director.

While this location has previously made the UK a key player in European healthcare decisions, the impending relocation of the agency has implications for the pharmaceutical industry in the UK and in Europe alike.

What will happen when it leaves the UK?

Depending on the EMA’s new location, up to 50% of its 850 staff members could end up leaving. With 20% of the agency’s resources coming from the UK, central members from across the EU are already stepping down.

While nobody can say where the agency will relocate at this stage, one thing that is certain is that the moving process will result in a severe slowing down of procedures. Thomas Lönngren, the former executive director of the EMA, is concerned that this disruption will have a particularly negative impact on public health, safety, and the quality of medicines in the UK.

Not only will British pharma no longer be monitored and evaluated by the agency - it is also likely that the UK will miss out on the top pharmaceutical talent that had previously flocked to the country as a result of its affiliation with the EMA.

Talent is one of the primary concerns for the Association of the British Pharmacy Industry (ABPI), and it needs to maintain access to top international pharmaceutical talent in order to maintain its position amongst the top three economies for biotechnology.

Currently, the vast majority of European Qualified Persons in Pharmacovigilance (QPPV) are based in the UK. In response to Brexit, these experts must choose to relocate along with the EMA, lend their expertise to an alternative position in the UK, or be made redundant. As a result, Britain could lose a significant number of experts - a loss that will be felt all the more as the country works its way through its own pharmaceutical disruption.

Comparatively, the UK is making it known that talented healthcare professionals from across Europe are still welcome here, with the Minister for Universities and Science stating “We remain fully open to scientists and researchers from across the EU. We hugely value the contribution of EU and international staff and there are no immediate changes to their rights to live and work in the UK.”

What will this mean for pharmacovigilance regulations?

Talent aside, the UK’s Drug Safety Research Unit is facing the concern that pharmacovigilance research conducted in the UK may no longer be accepted elsewhere in the EU, resulting in timely and costly repetitions conducted in another country.

Furthermore, EU-based pharmaceutical companies will no longer be obliged by EMA guidelines to carry out pharmacovigilance in the UK, meaning that the country will lose access to important ongoing monitoring of medicines from around Europe.

The departure of the EMA from the UK could also result in the loss of significant databases that are currently based in the country, meaning that British pharmacovigilance professionals will need to report adverse reactions on scientifically inferior systems from outside of the UK.

One option is the EMA outsourcing some regulatory work to the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, meaning that the country could retain access to important information, top talent, and its reputation for pharmacovigilance. However, discussions are still in place between both agencies as to how viable this could be.

How will this affect patients?

While the industry works its way through the implications of Brexit, it’s important to consider how these changes will affect those who need pharmaceutical stability the most.

In the case of patients, the greatest concern is that the UK’s impending status as a “third country” will cause it to require separate approval to those decided by the EMA. This will delay important medicines reaching the UK market, meaning that British patients will not enjoy the same healthcare benefits as patients in the European system.

This will need to be taken into account as the MHRA, DRSU and other regulatory bodies work to create patient-centric alternatives to current pharmacovigilance practices.

What’s the long-term prognosis?

Despite the overall climate of uncertainty, there are still those who believe that in long-term, Brexit could be a catalyst for growth in the pharmaceutical industry.

Former secretary of state for health, Stephen Dorrell MP, suggested a future in which "Britain expands collaborations and partnerships outside Europe. It is an opportunity to develop an agenda which pushes the UK forward as a location that welcomes and invests in pharmaceutical related research."

In order to realise this vision, the UK will need to work hard to quickly develop appropriate and attractive regulatory codes of their own, drawing professionals from around the world regardless of nationality.

British pharma professionals such as Jamie Martin, science policy adviser for Scientists for Britain, are pushing for continued access to funding from the European research framework Horizon 2020, which could even increase depending on the outcome of negotiations.

While hopes and concerns abound in the build-up to the UK’s departure, one thing is certain: it is now more vital than ever for British healthcare innovators to work together and present a united voice at the negotiating table.

What’s your ideal outcome for post-Brexit healthcare in the UK? Let us know on LinkedIn.