The UAE’s distinctive willingness to embrace innovation and the ‘can-do’ spirit of authorities marks the country out as worthy of attention as an initial product launch platform.
“Along with fellow GCC members, Kuwait and Saudi Arabia, the UAE is notable for its accelerated regulatory pathways. Due to these mechanisms, we often find ourselves able to launch products swiftly after approval is granted from the US FDA or the EMA,” explains Vishnu Kalra, Janssen’s managing director for the GCC block.
“As such, we possess an in-country portfolio that closely resembles our global offering of innovative therapies, and the Emirates ranks amongst the top two to three countries globally from a market access perspective for many of our product categories… in some cases, we have witnessed an adoption rate that is swifter than in many European markets,” reveals Kalra. “Naturally it makes sense for us to utilize the UAE as one of our go-to markets for building and gaining launch expertise, especially in instances of highly-focused therapies tailor made for consumption by Middle Eastern patient communities,” he elaborates.
“Some of the enlightened policy developments that we have witnessed being introduced in recent years include regulations pertaining to fast-track approval, international referencing models for pricing, as well as outcome-based reimbursement approaches,” enthuses Genpharm CEO, Karim Smaira. “The FDA and EMA are now automatically recognized as the benchmarks in terms of drug approvals so the region does not require any further clinical trials for approved products,” he points out.
Over and above the fast-track approval schemes, other insiders highlight the sheer approachability and pragmatism of the Emirati authorities when it comes to adopting and integrating the latest generation therapies. Dream Samir, secretary general of the Pharmaceutical Research and Manufacturers Association Gulf (PHRMAG) describes the situation thusly: “many of our members regard the UAE as one of the most favourable business environments to operate in worldwide because we feel the government genuinely understands the needs and the requirements of innovation right along the spectrum. This starts with the need to provide speedy registration, but also encompasses many other critical elements such as the establishment of fair pricing systems that attract early innovation.”
“The authorities’ sustained commitment to the industry is why companies like ours continue to invest so heavily in the country… time and time again they prove receptive of the needs of the drug developer when it comes to the market access process and crucially they remain open to the idea of making changes and adjustments as and when industry requires them,” reflects Rashed Assouma, CEO of Elis Pharmaceuticals, a specialty developer of urology and erectile dysfunction products originally hailing from the British Virgin Islands.
Myriam Hakim, general manager for the GCC cluster at Japanese rare disease outfit Kyowa Kirin very much concurs. “I believe that the dialogue between the national authorities and multinational companies is significantly more fluid than is often the case in other parts of the world, such as the rigidly imposed regulatory frameworks of Western Europe. In the UAE, industry and state are listening to one another and collaborating in positively shaping the future marketplace,” she ventures.
“What makes specific emirates such as Dubai rather special is there tends to be a concerted effort among all stakeholders, but led by the authorities, to set the enabling conditions to make the place attractive and competitive for the pharma industry. We consider this strong innovation mind-set to be a perfect match for what companies like us are striving to accomplish,” concedes Magdy Fahmy, CEO of integrated drug maker LIFEPharma.
Equally applauded is the timeliness with which decision-making can be taken and executed. “What really impresses me is, once a decision is made, the sheer speed and efficiency of subsequent implementation,” muses Expanscience’s managing director for the Middle East, Africa and India, Frédéric Le Moigne.
A case in point is perhaps the experience of Al Khayyat Investments (AKI), one of the leading distributors and service providers for the healthcare industry in the Middle East. “One particular client decided to entrust us with one of their most important products, a one-time gene therapy to restore functional vision for patients with an inherited eye mutation,” recalls Doaa Albarbari, head of AKI’s pharma division. “The treatment is expensive, coming in at around USD one million, and requires a complicated temperature-controlled supply chain strategy at minus 65 degrees Celsius… The Ministry of Health, led by Abdul Rahman Mohammed Al Owais, nevertheless immediately exhibited great interest in this breakthrough product. Registration was completed within two to three months, and the stock has already been delivered, with the first patients expecting to be treated imminently,” he proudly recounts.