MANAMA — A clinical research hub in Bahrain is committed to help more pharmaceutical manufacturers from around the world enter the Gulf market by contracting with companies to carry out clinical trials in the region to recognized international standards thanks to the proactive health regulators in the kingdom. The Royal College of Surgeons in Ireland (RCSI) Bahrain, a not-for-profit healthcare education and research institution, has established a clinical trials unit, and is supported by access to a strong ecosystem which includes, RCSI Ireland and Bahrain’s Ministry of Health (MOH) and National Health Regulatory Authority (NHRA). Through RCSI’s hub in Bahrain, approval for clinical trials which can take months in Europe may be given in weeks due to the NHRA being responsive to research trials that can then be carried out safely and to rigorous international standards. RCSI have recently completed two national clinical trials involving COVID patients, the first around the effectiveness of convalescent plasma from recovered patients, and the second a comparative trial of the effectiveness of the drug Favipiravir against hydroxychloroquine. A third trial in Bahrain worth around $1.7 million is currently under way. “There is a clear and growing opportunity for pharmaceutical companies to set up and trade in the Middle East region. But it’s not just about getting products into the market. You need a solid base to tap into the full potential the region has to offer. “We’ve found that it is much easier to access patients in Bahrain, despite its size, and the proactive approach to research by the NHRA is fostering a strong ecosystem that is encouraging more clinical researchers to work in Bahrain,” said Professor Stephen Atkin, head of School of Postgraduate Studies and Research, RCSI Bahrain. “There are four requirements needed to conduct clinical trials: facilities, access to patients, regulation, and research integrity. “Bahrain offers all of those at a fraction of the cost of Europe and America. It is also much faster to secure approvals in Bahrain due to the proactive nature of the NHRA. Approvals for trials in the Kingdom can take around five to six weeks. The same study in Ireland might take up to nine months and may not be feasible given costs.” The global market for pharma trials is valued at $1.2 trillion and the market in the Middle East and North Africa is valued at around $1.36 billion in 2020 and projected to rise to $1.95 billion by 2025. Yet only 2.5% of that is available in the GCC (Gulf Cooperation Council). While much of the Middle Eastern clinical trials market is currently dominated by non-member GCC countries, Bahrain has the necessary infrastructure in place to be the research hub of the Gulf, according to RCSI. Similarly, companies setting up trials in Bahrain will be able to more easily secure approvals by GCC regulators than those conducting trials in other regions. Ali Al Mudaifa, executive director - Investment Origination at Bahrain’s Economic Development Board, said: “The kingdom of Bahrain is focused on developing a regional base for international healthcare companies and a leading centre for modern medicine. “Against the backdrop of a global pandemic, RCSI has demonstrated through multiple clinical trials that Bahrain can be an internationally recognised leader in the pharma space.” With a growing regional population and a clear unmet need in many disease areas, pharmaceutical manufacturers can carry out rigorous clinical trials much more quickly, while still offering high-quality and financially sustainable healthcare.” While more than 80 percent of pharmaceutical products are imported from outside the region. The GCC offers a compelling case for the setup of in-market pharma production facilities and Bahrain offers healthcare manufacturers an excellent base to access the $20 billion GCC pharmaceutical industry. In recent years, the number of private healthcare facilities in Bahrain have grown. There are now some 800 private firms operating in the country’s healthcare space and investors have shown growing interest in specialist areas. — SG