James Burt, Executive Vice President EMENA, Accord Healthcare, asks whether Brexit will in fact present an opportunity for positive change in pharma and healthcare.
There has been much speculation about the fallout for the pharmaceutical industry
since the Brexit referendum in June 2016. Those fears deepened with the announcement that the European Medicines Agency (EMA) was moving its headquarters from London
to Amsterdam, taking with it 900 jobs.
The pessimists argue that the European Union (EU) will therefore take priority over the UK and new medicines could be launched up to two years after they have been launched in mainland Europe. That it will impact patients and clinical research. For example, if you haven’t launched your medicine in the UK, why would you want to go through additional regulatory hoops to set-up a clinical trial here?
However, I have a more optimistic outlook. Increasingly, political developments make a hard Brexit less likely, with more opportunity for mutual recognition and regulatory alignment post-Brexit. This becomes even more probable when you consider that, at present, around 40% of the testing that the EMA undertakes is through the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), considered to be a leading institution and centre of excellence upon which the rest of Europe depends. A viewpoint that the MHRA itself is acutely conscious of as illustrated by its five-year plan, which highlights how the agency intends to ‘become a real-world regulator’ and to ‘ensure a smooth EU exit under any scenario’.
There are multiple examples of where countries not part of the EU function perfectly well. Norway is fully aligned with the EMA process and bound by its regulations. Swissmedic has mostly seamless sharing agreements with the EMA, despite also not being part of the European Union.
We have already seen evidence of mutual recognition planning for post-Brexit. In May 2018, the General Data Protection Regulation (GDPR) was implemented across Europe. The UK has also adopted this, and the Data Protection Bill fully adopts GDPR with additional requirements. This almost certainly means that the data protection standards of the UK will be considered adequate post-Brexit and so data can continue to be shared in Europe and the UK.
Moreover, we have seen a global trend within medicine regulation where leading agencies such as the Food and Drugs Administration (FDA) are working more collaboratively with their international counterparts, mutually recognising activities and approaches.
Fit for purpose?
While we fully anticipate that it will be business as usual post-Brexit from a drug regulation standpoint, there is also a huge opportunity for modernisation of our present antiquated system and to further increase the UK’s leadership position in Europe.
The current system of drug regulation was developed in the 1960s in the aftermath of the thalidomide crisis. The drugs then were mainly chemicals but now all the important drugs are biologics, built on the understanding of human genomes. These drugs are revolutionising difficult-to-treat diseases such as cancer and infection. Naturally, the demand from healthcare professionals and patients is to secure these drugs much earlier than possible under the present long period of regulatory approval. A new framework might give us more opportunity to accelerate drug approvals.
We have got a chance now to seize the regulatory system, and re-examine whether it is fit for the purpose for approving the new drugs that are coming on the scene and which are going to be even more important in the future.
The UK has one of the highest uses of generic medicines in the world with generics accounting for 84% of the volume of pharmaceuticals sold in the UK and the lowest pricing levels in Europe. Our move away from the EU could also pave the way for a better deal for UK manufacturers. Currently, manufacturers have to wait for the day of patent expiry before they are able to start production of a generic medicine. This regulation is not mirrored outside of Europe, which means non-European countries have an advantage in getting a generic medicine to market. There are current discussions taking place within Europe on how to counter this, but post-Brexit the UK could be in an excellent position to take their own stance and give UK manufacturers a commercial edge,
at least for domestic consumption.
Looking to the future
It will come as no surprise that Accord Healthcare is fully committed
to Europe and the UK. At Accord Healthcare we remain confident about the UK’s future by continuing to make significant investments that represent a vote of confidence in UK science and manufacturing.
For example, the acquisition of a major pharmaceutical business from Teva last year, including its plant in North Devon, which is the largest Indian foreign direct investment into UK post the Brexit referendum, totalling GBP 603 million (USD 806 million) and securing over 650 UK based jobs. In January this year, we purchased a disused pharmaceutical facility in Newcastle-Upon-Tyne and have invested in regaining regulatory approval and re-hiring staff. We have also purchased a distribution site in Oxfordshire due to be opened in 2019. Simply put, we believe now isn’t the time to shy away from the UK. Brexit shouldn’t mean exit for pharma companies.
The path to Brexit is by no means clear, but whatever the final ‘deal’, I believe that the UK will continue to be a beacon of scientific excellence and this will be a catalyst in setting up trade agreements with the US, Middle East and Asia, retaining the UK’s appeal as a key market for clinical research and drug development.