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Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization
The Brexit referendum decision is a pivotal moment for the United Kingdom’s life-sciences economy. The UK consistently punches above its weight for research, with one-sixth of the most popular prescription medicines developed in the UK (1), and its status as the gateway into Europe is well known. The industry contributes to the country’s economy, provides high-value jobs and skills, benefits UK patients, and often allows earlier access to innovative medicines (2). Following the UK’s decision to leave the European Union, there are two areas that demand attention.
Conducting clinical trials that involve the UK may become more difficult
The average Phase III clinical trial involves approximately 600 patients across 34 countries (3) and is an essential step on the path to launch. Clinical trials account for a third of the total drug development cost. The new EU Clinical Trials Regulation aims to harmonize trials across its member states and make it easier for pharma companies to mobilize clinical trials across EU borders. In leaving the EU, the UK may not be a part of this harmonized process and the effect on the UK may be significant with companies prioritizing markets that are linked to the harmonized approach, rather than undergoing another separate regulatory process within the UK.
To remain competitive and minimize the potential burden, UK regulatory bodies must seize the opportunity to make clinical trial regulations as straightforward as possible. A full end-to-end process review should take place in the short to medium term, with the goal of further enhancing the UK’s already strong regulatory reputation. This should involve an optimized clinical trial process that repositions the UK as a world leader, while retaining the highest standards of drug and patient safety. Furthermore, a refreshed regulatory approach should look to the future and encompass the already increasing demands for “real world” data studies that involve a greater reliance on digital and virtual health solutions (4).
Gaining marketing authorization in the UK and across Europe may take longer
It is possible that the UK population may not be allowed access to new pharmaceutical products as quickly as their European neighbors if they no longer fall under the European Medicines Agency’s (EMA’s) centralized approval process.
In Europe, product licences successfully filed with EMA enable organizations to market their medicines across the EU. If the UK is, at the very least, unable to align with existing frameworks, the filing process is likely to be overhauled. This means companies will have to file separately with the Medicines and Healthcare products Regulatory Agency (MHRA) to market products in the UK. To account for a potentially greater burden, pharma companies should review their approval resource plans.
Getting drugs approved via EMA is a process that, as a recent study indicated, takes 366 days-approximately 40 days longer than its counterpart United States process via the Food and Drug Administration (5). This area presents UK regulators with an opportunity to speed up the approval process and offer a more streamlined process for sponsors. However, an assumption that a more efficient process will naturally be the outcome should not be made. Drug approval times outside of the EU often tend to be slower; for example, application approvals in Switzerland, which has a strong pharmaceutical sector, are known to take 420 days (6).
Pharma companies should lobby government to ensure there is a close alignment with the current approval system. Not only will this move safeguard them against disruption and additional burden but it will also ensure current research fund levels are honored and a highly skilled workforce is retained. And if, and when, any new regulations evolve, it is essential for pharmaceuticals to absorb new approval criteria and amend their policies and standard operating procedures proactively.
About the author: Glen McCracken is a life sciences expert at PA Consulting Group.
1. ABPI, Fact and Figures about the Pharmaceutical Industry in the UK, accessed Sept. 8, 2016.
2. LSE Health, Do International Launch Strategies of Pharmaceutical Corporations Respond to Changes in the Regulatory Environment?, accessed Sept. 8, 2016.
3. K. Getz, “Evolving Challenges and Opportunities for Clinical Trials,” presentation at the CTO 2014 Clinical Trials Conference (Toronto, February 2014).
4. ABPI, The Vision for Real World Data-Harnessing the Opportunities in the UK, accessed sept. 8, 2016.
5. Forbes, More Proof FDA is Faster than Other Drug Regulators, accessed Sept. 8, 2016.
6. Switzerland Regulatory and Funding Process Flowchart, accessed Sept. 8, 2016.