For those involved in the industry, June 2016 could go down as a momentous month for UK clinical research. The source of intense debate, the EU referendum - and the subsequent Brexit vote - was significant in many respects in that it could have far-reaching implications for the industry as a whole.
But for all the political and economic instability Brexit has caused, the impact of the vote on UK clinical research may take years to unfold.
CTA caught up with experts from both the pharma and medical device industries to get their input on what the Brexit result means to them.
Sorin Popa (CEO, Stent Tek) (on the impact Brexit could have for medical devices): I think the UK needs to accept the CE marking standard for medical devices, and I hope nothing changes in that respect. If the UK decides it wants to create its own regulatory body that could have a detrimental impact on medical device innovation. Currently, companies like mine (Stent Tek) have to factor between which route to take as far as CE marking and FDA approval is concerned.
In some respects, gaining a CE marking first is more beneficial because the European market is closer and once the device is established in the EU it lays the groundwork for FDA approval. But if the UK comes into the mix with its own regulatory approval process that could be harmful to the UK because, from a purely business point of view, I don't see companies prioritising the UK over Europe or the US. That's not to say the UK won't get innovation, but it might take longer than it once did, but that's assuming if things change with the CE mark.
If things don't change, I can't see anything that would be detrimental to the UK; companies could still develop devices and run trials according to the same EU standards. There are obviously concerns over how taxes and tariffs would be applied if, say, the UK no longer had access to the common market and had to negotiate its own trade deals. How such a scenario would play out remains to be seen.
One clinical trial professional from a start-up biotech company: From an industry standpoint, the damage could be immense, but I hope it's more a case of Brexit looking bad on paper when in reality it doesn't actually change much.
In the short term, nothing is going to happen for at least five years, you can be sure of that. But this is the crux of the matter - when you're conducting a clinical trial, you have to take an eight to 10 year view on it. So why take the risk of running a trial in the UK when you don't know what the landscape will look like in five years' time?
If you're a full EMA member, or you're seeking FDA approval, you won't have an issue. It's simple as that - so why take the extra risk? Brexit may well end up being a major deterrent for sponsor companies looking to conduct trials in the UK.
David Collier (Joint Clinical Director, William Harvey Clinical Research Centre, QMUL): While I was strongly anti-Brexit, I know patient experts who were positive about it and thought we could run our affairs better outside the EU, but I disagreed. As someone who runs a team of people from around the world, I can say over the years we recruited strictly on merit and find ourselves with an extremely international team.
A lot of the European players within that team who have settled in the UK, married Britons and established families, don't have British passports, naturally because they never thought it was necessary. Now they face substantial expense as well as the slightly humiliating process of having to apply for UK citizenship, and as a result feel destabilised. I'm quite horrified and surprised by what a strong message this sends to some of our best and longest serving staff that actually they might not be welcome anymore. It's unthinkable, especially in a city like London that has such a diverse population. We wouldn't be able represent the patients we look after who are largely international in perspective.
Generally, the UK's position in the clinical trials space has been improving with NIHR (National Institute for Health Research) support and much greater NHS commitment to clinical trials. There has been a concerted change in attitude toward clinical trials being relevant to activity of the NHS as well as the medical schools, which have always been interested in terms of trials. I think ultimately it would be a disaster if things like Brexit damaged that growth against our European competitors.
Nathan Nagel (Managing Director, Sanyal Bio LLC, Managing Partner - Nagel and Partners Ltd.) - Macro environmental market forces are always changing and the BREXIT means significant PESTLE changes to the UK LifeScience and healthcare ecosystems. However, I use the word 'change' not end, as the nation's competitiveness depends on the capacity of its backbone industries to adapt to change through innovation. So what should the UK do after BREXIT, the obvious but easy option is to focus on what a Switzerland-like deal would mean, with Britain obtaining associated country status.
HOWEVER, the UK could explore how change can create an opportunity to innovate and create a differentiation strategy for the UK's healthcare and LifeScience ecosystems. I am talking about taking a forced change and adapting it into a national competitive advantage. Implicit in the oft-repeated Japanese statement, "We are an island nation with no natural resources," is the understanding that these deficiencies have only served to spur Japan's competitive innovation. In other words, they converted factor disadvantages into competitive advantage.
The UK should take note of where it holds a sustainable competitive advantage in the value chain of the life science industry; University spin outs, NHS spin outs, SME's and clinical trials up-to phase 1-2. Granted when companies want to undertake phase 2 and 3 they may wish to undertake the studies in the EU across multiple sites. The UK, like any competing body, has three options: cost leadership, differentiation or focus. Given that the UK now won't be able to achieve cost leadership, its options are focus or differentiation. Focus in healthcare and LifeScience might stifle talent coming out of universities so it is best that a broad spectrum of medical and LifeScience disciples are maintained so the UK is left to create a differentiation strategy. Now is the time to take the bull by the horns and create a globally leading synergistic biotech and medtech ecosystem integrated with the NHS by not just copying EU policies and laws but by adapting and improving on them to differentiate the UK. As laws and policies only provide infrastructure, it is leadership that provides a competitive advantage as people are impossible to duplicate or replicate.
The major players, as a team, who I see can grab the raging bull are George Freeman (MP), Harriet Fear (One Nucleus), Simon Stevens (NHS) the MHRA, and very importantly the HMRC. Together as a team, one option would be to implement a long term differentiation strategy to actively promote UK biotechnology and medtech entrepreneurship from grass roots level with the objective of home grown companies moving through to an LSE IPO. The UK has all the ingredients to create a thriving domestic market that with UK ownership creates a long term UK revenue strategy. Or the UK could carry on looking for foreign firms to spend their money in the UK, but this is simply transactional revenue flow and not an economic strategy. Us British are world class moaners, however, the whole world knows that when it to comes to healthcare and LifeScience innovation, Britain's got talent!