We recently had a catch-up with Marta Garcia from Servier who shared her perspective on the potential impact of the Brexit decision on the Clinical Research Industry. Having worked in Medical Affairs and Clinical Research for over 25 years, across a number of European countries Marta’s current role as Clinical Research Director for the UK and Ireland puts her at the heart for the imminent changes. Beyond this professional perspective, Marta is clearly passionate about healthcare as she is currently working on comparing the UK healthcare offering with other EU countries.
An evolving industry
Having worked in the Clinical Research industry for over 10 years, Marta has experienced a number of significant changes as the industry has become increasingly complex from a medical perspective, and products have become more technically complex. Furthermore, there has been an increased focus and need for personalized medicine alongside an increase in transparency. In brief, the rise in complexity has been met with a similar rise in transparency.
While this presents a more challenging environment operationally, ultimately the outcomes are positive; better treatments brought to market through improved, transparent processes. However, Marta surmises, “15 years ago if someone had described the current operating world it might have felt incomprehensible, but in fact I think we’re working in a much better environment and there are a lot of positives we can take from these changes. I’m excited to see what the next 15 years will bring.”
Change is on the horizon again…
The UK’s decision to choose Brexit has not had an immediate impact however it has raised a lot of uncertainties and Marta believes the real impact is yet to be seen. She explains, “We’re currently in limbo. The decision has posed lots of questions but we don’t yet have answers. The Clinical Research industry is truly global, so one country’s decision has the potential to have wider repercussions. For example, what will the European agency’s role be for the UK? What will happen with registration of new drugs?”
Marta continues: “Initially, the decision was not well received and there was a concern for other European countries. However, once the information was processed, conversations continue, but the biggest concern will be for the UK more than for the rest of Europe.”
What will the UK’s future role be in the Global Clinical Research Industry?
As the Clinical Research Director for the UK and Ireland, Marta’s perspective was encouragingly optimistic: “The decision hasn’t made the UK less attractive for business; but the UK does need to seize the opportunity. We need to focus on what the UK does well in Clinical Research. It has a good reputation, good universities and hospitals, and excellent academic research but we are often challenged on recruitment rates.”
“The UK is an experienced, valued member of the Clinical Research Industry but it’s not the largest. On a Global scale, we will need to avoid that a sponsor could choose to rule out the UK and re-focus on other European countries and concentrate of what makes the UK desirable as a center for Clinical Research?” explained Marta.
How the UK chooses to present this offering could have a huge impact on the future. Marta continues, “The UK has some strong assets such as the NHS, NICE and NIHR. It is very transparent in the way contracts and approvals are processed. Patient groups are well organized and a bit more in advance than other countries. These are all positive attributes but what we need to decide is what will be our USP? Why should a trial include the UK? How can our independence from the European regulation make the UK a strong market?”
The biggest challenges of Brexit on the Industry?
For companies with their headquarters in the UK there will be big challenges that will only become apparent further down the line. Labor regulation, freedom of movement, and the impact the value of people moving are very real concerns that cannot be addressed until the UK’s discussions with Europe have begun. “As an industry, we need this freedom of movement but we just don’t know when and where decisions will be taken. This leaves a challenging question mark over a fundamental concern,” Marta commented.
“At Servier, we’ve not taken any particular actions yet, but we are focused on ensuring we deliver strong project work in the interim. That’s all we can do for the time being. We’re working to avoid any delays and continuing ‘business as usual’”, explained Marta. “Pragmatically, the UK is a very good country with strong connections with big data, and e-medical records and e-prescriptions are very well developed. There is good understanding of some rare diseases, and the UK has well developed patient groups with a strong patient centric approach. My objective is to focus on these attributes and build the operations around the projects while things remain uncertain.”
What do you think is the UK’s USP for Clinical Research? What are you most concerned about? Let us know in the comments below.
IAOCR recently met with the British Prime Minister, Theresa May, to highlight opportunities for the clinical research sector and discuss IAOCR’s positioning paper on “Actions Needed to Support Significant Growth Opportunity for the UK Clinical Research Sector Pre-Brexit and Beyond” (click to download).
Mrs May expressed significant interest and asked a number of questions about the paper. She stated that she saw benefit in asking industrial strategy officials from the Department for Business, Energy and Industrial Strategy to sit down and spend some time with the IAOCR team.
The paper was written following wide-spread consultation with professionals from across the clinical research sector and interviews with IAOCR’s Industry Leaders Group.