How Will Brexit Impact The International Clinical Research Industry?

By Jacqueline Johnson North, IAOCR

Though the statement “we live in a global world” typically refers to healthcare and the environment, it truly applies to science, which spans country borders and languages. This is why the 2016 decision by the British electorate to leave the European Union (EU) was so significant for the international scientific community. Brexit doesn’t just apply to the U.K. and Europe; it needs to be considered for all international communities, including the clinical research industry.

The clinical research industry operates on a global level, with individual country nuances collectively working to build a comprehensive evaluation about a molecule, treatment, or device. Because of this, Brexit raises significant questions and uncertainties for the industry: How will the industry be impacted by Brexit? What will the implications be on data transfer? What are the workforce implications? How will the regulatory/legislative environment change? How will trials be conducted in key markets, including the United States, Europe, and the U.K.?

In an effort to begin to identify the range of challenges and understand how to mitigate them, a group of industry experts met at an Emergency Summit Meeting, “The U.K. Clinical Research Industry in a Pre-Brexit & Post-Brexit Britain,” in April to discuss the clinical research industry during this time of change. The following sections outline the key findings from the meeting.

Combatting Brexit Paralysis

For many, Brexit has brought about a sense of paralysis — people don’t know what Brexit will bring and feel they have no option but to wait and see. Many global clinical research organizations have yet to develop a strategy for leading through this uncertain period and beyond. A large number of clinical research companies simply aren’t discussing Brexit at an organizational level. While nobody can know what Brexit holds, it’s vital that all organizations take a proactive stance: considering what the potential opportunities and challenges may be, and devising strategies to mitigate risk and ensure that they are ready for opportunities that may arise.

 

Navigating Through Brexit

Uncertainties are unavoidable with change, which is why organizations need to develop concrete plans for the aspects they can control. Globally, the clinical research sector is risk averse compared with other industries. Decision making is slow, and there is generally a reluctance to be the first to try new approaches. In light of Brexit, the clinical research sector in the U.K. will need to look carefully at how to maximize efficiencies by investing in workforce quality, technology, and processes in order to raise quality and increase speed of clinical trials. A mindset change is needed in order to gain competitive advantage within the global marketplace.

Creating Opportunities

While change induces uncertainty, it also creates opportunities:

• Reviewing regulations: Industry leaders largely agree that the U.K. must continue to work closely with the EU. Brexit provides an opportune time to review our regulations. We should consider how we can meet EU requirements while looking more broadly for global best practices, and we should conduct benchmarking activities to devise a best-in-class framework for a low-bureaucracy, high-quality clinical research environment.
• Addressing the skills shortage: For several years, the industry has deliberated about a “war on talent” but has done nothing to address the issue in any meaningful sense. The U.K. sector is heavily reliant on non-U.K. EU nationals, with most organizations reporting that they account for 20 to 40 percent of their workforce. The implications of this can create new opportunities for how the industry views talent.

• Closing the good clinical practice (GCP) loophole to improve quality and efficiency: Current guidelines require that individuals are qualified by education, training, and experience. It’s sensible to assume the purpose of this requirement is to ensure that people are competent; however, these three things do not necessarily lead to competence. This presents a concerning loophole that is detrimental to the sector in a number of ways, such as:
  • Allowing potentially incompetent people to be employed in clinical research. Many people can think of examples of colleagues who have good qualifications and experience, and who have attended training courses, but still can’t perform their role to a satisfactory level.
  • Increasing risk and threatening quality and drug development timelines.
  • Preventing inexperienced, potentially competent people from entering the industry, thus fueling the global skills shortage.
  • Creating an employee-driven job market, which increases the costs of staffing and clinical research.

Proof of competence is a far more reliable indicator that someone can perform their role effectively. Brexit provides a unique opportunity for the U.K. to lead the way in this regard and benefit from the increased talent, improved quality, and efficiencies this approach brings. However, it also presents a global opportunity to actively

• Raising the profile of clinical research in U.K. parliamentary terms: There is very little reference to clinical research specifically in U.K. parliamentary documents and very little data about the value the sector brings to the U.K. in terms of the economy, healthcare, and employment contribution. It is vital that the profile of the sector is raised so that the U.K. government takes measures to provide an attractive environment for clinical research in the U.K.

During these uncertain times, it’s important that industry leaders take positive action to influence the future shape of the clinical research industry. Stakeholders need to look both outward and inward to ensure the sector and their organizations are future-ready and in a position of strength.

Rethinking The Clinical Research Paradigm

IAOCR, the accrediting organization for the international clinical research industry that hosted the Emergency Summit Meeting, is developing a positioning paper for parliamentary stakeholders outlining a proposed approach for the U.K. clinical research industry. They are doing this through consultation with meeting participants and other key stakeholders.

As the U.K. is a key market, Brexit provides the industry with a unique opportunity to address ongoing challenges to better the industry as a whole. Navigating challenges — such as the skills shortage — creates opportunities to rethink how the industry defines “skills,” and it’s important that this is optimized. To get involved in the positioning paper or to seek support on addressing these issues at an organizational level, please contact IAOCR at info@iaocr.com.

About The Author:

Jacqueline Johnson North is CEO and cofounder of IAOCR, the accrediting organization for the international clinical research industry. She began her career in accounting and finance prior to holding various operational roles in fast-moving, innovative companies and start-ups. Following a number of roles within the clinical research sector, she founded Dovetail Clinical and Dovetail Development Solutions in 2006, delivering bespoke services focused on organizational excellence to companies working within the clinical research industry and other sectors.

Jacqueline’s international consultancy experience spans countries as diverse as Argentina, the Democratic Republic of Congo, the United States, India, and Poland. She has worked intensively within the clinical research and pharmaceutical industries and also calls on her experience from other sectors to compare best practice across industries.