Long-established as the Middle East and Africa’s leading country in terms of rapid access to biomedical innovation, the UAE is looking to bolster this positioning in the coming years. Indeed, allowing innovation to flourish – including through hosting greater numbers of clinical trials in the country and protecting intellectual property (IP) – was a key topic of discussion at this month’s Abu Dhabi Global Healthcare Week 2024. The panel discussion, ‘Innovation Enablers: Incentives, Regulatory Policies & IP Rights Protection’ brought together some of the leading institutional voices on the topics, who laid out what has been done so far and what the next steps need to be to truly incentivise innovation in the UAE.
Clinical Trial Framework
Clinical trials – whereby new medicines are tested in progressively larger groups of people – are the backbone of biomedical research and development. Countries able to host all phases of these trials benefit from trial participants having early access to medicines, healthcare professionals being exposed to cutting-edge new products, and industrial trial sponsors investing further in those geographies, including prioritising them for future launches.
Cognisant of this opportunity, Emirates like Abu Dhabi have moved to capitalise in recent years and expedite the application process for clinical trial sponsors. As Dr Asma Al Mannaei, executive director of the Research and Innovation Centre at the Abu Dhabi Department of Health explained during the panel discussion, “We wanted to ensure that Abu Dhabi would be welcoming and accessible for research. With that in mind, and in the pursuit of breakthroughs that will change lives, we have overhauled our regulatory framework, enabling less than 28 days (and an average of 14 days) from clinical trial submission to approval decision.”
This led to a staggering 484 percent increase in clinical trial numbers in Abu Dhabi between 2021 and 2022. Moreover, as Dr Al Mannaei explained, “This effort has been combined with a collaborative policy lab and a new health technology assessment framework that has been allowing us to build the future of Abu Dhabi healthcare sector together with our ecosystem partners. Today, thanks to those advances and opportunities, we stand at the bleeding edge of innovation in multiple novel areas, including CAR-T and stem cell research.”
Across the UAE, the newly-established Emirates Drug Establishment (EDE) will play a key role in enhancing the country’s position as a global and regional hub for the pharmaceutical and medical sectors. EDE Director General H.E. Dr Fatima Al Kaabi told the assembled audience that the institution would utilise a collaborative approach in building an R&D ecosystem.
“The UAE is not a one-man island,” she stated. “It’s based on partnerships…the first step is to create an A-Z ecosystem covering everything from R&D to pharmacovigilance, clinical trials, registering, licensing, authorisation, and post-marketing surveillance; everything under one scope.” She added “The EDE will follow the vision of the UAE being a knowledge-based economy rather than having a transactional approach.”
Intellectual Property and Innovation
Strong guarantees that innovators’ investments can be protected with robust intellectual property (IP) laws are also crucial to fostering this R&D ecosystem. As Eric Gaudiosi, deputy chief of the US Mission to the UAE noted in an opening address, “the journey from discovery to delivery is fraught with challenges, risks, and uncertainties. But this is tempered by the realisation that this is not just a question of cost, but ultimately of value. Along that way, IP protection serves as the very lone star, providing innovators with the necessary incentives and safeguards to expand the frontiers of science and medicine.”
To this end, in 2021 the UAE Ministry of Health and Prevention implemented an eight-year data exclusivity period from the date of marketing approval for originator pharmaceutical products, known as Decree 321. Generic companies can apply for marketing approval within the last two years of the data exclusivity period, but only if they can provide evidence of the lack of a valid patent protection for the original drug in the UAE. This system provides research-driven drug makers with a viable business environment conducive to introducing the latest therapies, but – as elsewhere in the world – there is always more that can be done.
For Aisha Y. Salem-Howey, intellectual property attaché for the Middle East & North Africa at the US Patent & Trademark Office, the IP winds are blowing in a very positive direction. “The government of the UAE, and specifically H.E. Dr Abdelrahman Almuaini [fellow panelist and assistant undersecretary of the Intellectual Property Sector at the UAE Ministry of Economy – Ed.], understands that IP is a critical component of driving the knowledge-based economy here.”
She continued, “The couple of recommendations that I would make are taking Decree 321 a step further and allowing for exclusivity period extensions. This applies not only to the pharmaceutical sector, but a lot of different industries and sectors would love to see a public review and comment period for draft legislation and regulations. Additionally, we will of course continue our partnership with the Ministry, and we have a lot of things in the works, including helping build the patent examination capabilities within Emiratisation [a strategy to increase the number of Emiratis in the job market and their contribution to the economy – Ed.].”
The Four Pillars of IP
In addition to protecting innovations of – and encouraging investment from – multinational companies, a robust IP framework will also eventually serve to boost Emirati companies. That at least is the plan of Dr Almuaini, who highlighted that the UAE has an extremely long-term vision up to 2071 (the country’s centenary year), by which time local start-ups will hopefully be consistently generating their own innovations.
To this end the MoE has launched an ‘IP Ecosystem’ based around four pillars. The first is an ‘IP Hub’ which covers everything from policy and strategy to infrastructure, finance, and training/education. As part of the IP Hub plan, the UAE is aiming to become global leader in IP management, innovation, and entrepreneurship. The second pillar is registration, with an Emiratisation for Patent Examination program, the third is utilsation of output from the IP hub, and the fourth is settlement, covering arbitration or mediation is necessary.
Already the regional innovation leader and 32nd in the Global Innovation Index, Dr Almuani feels that the foundations for an R&D ecosystem are already in place for the UAE. Now the question is whether it can create an innovation output to match it.
