Clinical trials provide a pathway to innovation for clinicians and patients in countries like Saudi Arabia and form a key element of the country’s Vision 2030 national plan. As Saudi transitions away from oil towards becoming a knowledge-based economy, it is hoping to attract ever more international pharma companies to situate research in the country.
“We want to highlight Saudi Arabia as a unique clinical trial destination,” Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Administration (SFDA), the agency that regulates, oversees, and controls food, drug, medical devices, recently told PharmaBoardroom.
For the industry, the effort seems so be custom made. “Innovative solutions that [Big Pharma] companies bring require smart investment. When countries start to focus on how to promote in-country clinical trials, they receive economic growth based on innovation and knowledge,” says Samir Khalil, executive director for PhRMA in the Middle East and Africa.
However, investing in clinical trials is far from straightforward. To succeed, a country requires a certain level of healthcare infrastructure, a clear regulatory framework, a strong academic ecosystem and qualified professionals, something that Saudi Arabia has been working on for over a decade.
When countries start to focus on how to promote in-country clinical trials, they receive economic growth based on innovation and knowledge
Samir Khalil, PhRMA
“It was very impactful to observe firsthand Saudi Arabia’s transformation… It is not easy for an oil-dependent country to take on this huge challenge, and we are working together as an industry to genuinely support the country in reaching a new era through its Vision 2030,” the general manager for AbbVie in Saudi Rabia, Ashraf Daoud, explained to Pharma Boardroom. According to Daoud, the Saudi pharma industry is maturing and increasingly willing to leverage the country’s healthcare infrastructure to bring in more clinical trials.
After all, Saudi Arabia does spend a significant percentage of its annual budget on healthcare, around 16 percent, and, according to a recent Gulf Cooperation Council (GCC) report, the region had made the largest healthcare infrastructure investments globally between 2010 and 2020. The number of hospitals almost doubled in most countries and at least 80 percent of the centers built were driven by government initiatives.
With the right infrastructure in place, Saudi Arabia needed a proven model to follow, and it found one in South Korea. Saudi authorities scanned several entities around the globe and found the Korea National Enterprise for Clinical Trials (KoNECT) to be particularly interesting. Because of it, South Korea has been able to jump to the top five in terms of clinical trial recruitment and investment.
To mimic the Asian country, Saudi established the Saudi Clinical Trial Enterprise (SCTE) which is composed of advisory boards from different health and regulatory stakeholders in the Kingdom and which focuses on improving the setup of clinical trials.
On the right path
The Kingdom’s efforts have not gone unnoticed by the general managers of research-based companies present in the Saudi market.
For Bayer’s pharma general manager, Hussein El Hakim, the authorities have taken “very good steps” in developing a system that can attract innovation and investment. “At the clinical trial level, we can see many research centres being developed and the Saudi FDA has created accelerated processes to enhance clinical trials.”
Several CROs are now present in Saudi Arabia, which gives Amgen more operational confidence to conduct world standard clinical trials
Mohammed Nasser, Amgen
To accompany the infrastructure, Saudi has also seen an increase in the number of contract research organizations (CROs). “Several CROs are now present in Saudi Arabia, which gives Amgen more operational confidence to conduct world standard clinical trials. Beyond clinical trials, I believe that logistics can be another interesting area for Saudi Arabia. The country’s location, between East and West, is enviable and it is already a big market,” Amgen’s Mohamed Nasser told us.
For Lilly’s Dimitri Livadas, the Kingdom has the essentials to succeed in clinical trials with its “skilled” clinical professionals and “strong” healthcare infrastructure which is why the American diabetes giant has worked with the Ministry of Investment to establish the Clinical Trials Coalition.
In his mind, clinical trials mean early access to innovation. After all, in 2019 there were 192 innovative medicines launched in Saudi Arabia compared to 270 in the UK, 275 in Germany and 309 in the Unites States, according to IQVIA.
However, “there is an opportunity to close that gap, but we have to look at a few things, there needs to be headroom to reward innovation, we need to accelerate access to patients in the public sector following Saudi FDA approval of medicines, and there needs to be an environment where intellectual property (IP) is fully protected,” said Livadas.
The challenges: better IP protection and regulatory approval
While the country seems to be moving in the right direction, a couple of hurdles remain. The first one is a better system to protect the intellectual property (IP) of innovators investing in clinical trials, the second, according to Bristol Myers-Squibb’s Oscar Delgado, is a regulatory framework that facilitates the approval of clinical trial applications and provides fast registration for the innovative medicines coming from the companies’ R&D efforts.
We welcome the commitment of Saudi authorities to improve the IP environment and recent work on IP protection
Oscar Delgado, BMS
“IP, in particular, is an area of concern for Bristol Myers Squibb and the industry in general. We welcome the commitment of Saudi authorities to improve the IP environment and recent work on IP protection, which is a good start, but there is still an opportunity to improve the regulatory data protection laws. Regulatory Data Protection (RDP) is not only about protecting against the disclosure of the innovator’s data, underpinning regulatory approval by the SFDA, but also preventing the reliance on it by generic manufacturers,” Delgado explained to PharmaBoardroom.
The issue appears to be that local manufacturers take advantage of the innovator’s clinical data which should have Regulatory data protection (RDP).
For Delgado, if all of these benchmarks are met, considering the country’s size, infrastructure and capabilities, there is “no doubt that Saudi Arabia can become a regional leader in life sciences R&D.”