Chatham House Report: REGLAB Majlis: Healthcare and Pharma Sectors

Keynote Address by H.E Hanan Ahli, Director, Federal Competitiveness Statistics Centre, UAE

Presentation by Asma Nabouda, Director, UAE Regulations Lab at Ministry of Cabinet Affairs

Moderated by Sheikh Dr Majid Al Qassimi, Partner, Soma Mater, UAE 

Keynote address by Her Excellency Hanan Ahli, Director of the Federal Competitiveness Statistics Center, UAE.

H.E. Hanan Ahli expressed her gratitude to the organizers for providing a platform to exchange ideas and improve the healthcare and wellbeing of the UAE. “We are honoured to be surrounded by doctors and pharmacists who contribute greatly to the industry and thank you for your willingness to participate in the discussion.

Brief Presentation of RegLab by Asma Nabouda, Director, Reglab, UAE:

An elementary sandbox is a regulatory framework that offers a secure space for the private sector, small and medium-sized enterprises (SMEs), and innovators to test their solutions in a live environment within a specified time frame, typically six months to one year. During this period, the regulator provides oversight and supervision, evaluating the testing process and outcomes. The results gathered from these tests ultimately inform future policy and regulation developments.

The concept of sandboxes started in 2016 when the UK and Abu Dhabi launched their fintech sandboxes. These sandboxes allowed businesses and innovators to test and develop their products in a regulated environment.

Currently, there are 73 sandboxes across 57 countries, according to the World Bank Group. This evidence-based approach has proven to be cost-efficient and beneficial for both the government and businesses in adopting technology and regulating the environment.

What sets the UAE apart is the establishment of a sandbox curriculum that is linked to the government cabinet. This vision was initiated by His Highness and focuses not only on developing futuristic legislation for the UAE but also exporting it to the world for others to learn from.

In the UAE, a federal law was introduced to promote futuristic projects and provide solutions through a minimum viable license for innovators and businesses to test their ideas. In 2019, the UAE Cabinet established a club to handle the licensing process.

The approach focuses on three main principles: speed, co-creation, and scaling. The licensing process is efficient and quick due to the close connection with the cabinet, allowing for fast application review and decision making.

The main principle of importance regarding the process is speed. They have made it simple for anyone to access the cloud through our website. The registration process involves two quick steps, providing brief information about the company and the innovation itself.

Roundtable Participants

Healthcare Regulatory Systems 

There is a real need to understand where and how patients are treated, the availability of products and institutions, and the differences between Dubai and Abu Dhabi. The significance of accessing this information to make informed decisions and investments will support the well-being of the patients. The focus is on examining the granular elements of the healthcare system.

Is there a joint framework among the three ministries to collaborate for creating a larger population for the clinical trial?

There is a need for transparency in regulatory processes. Even without full integration of all entities, if there is more transparency about each stage, it would be beneficial.

Patents and University Collaborations

The government and private sector in the UAE are working together through public-private partnerships to move forward. However, there is a significant gap in the involvement of academia in the development of evidence-based policies and regulations. The healthcare market in the UAE is competitive and focused on revenue generation rather than research, development, and prevention.

The government actively collaborates with universities and engages students in various manufacturing and project development activities. For example, currently, the government is engrossed in developing a one-of-a-kind autonomous vehicle, and as part of this endeavour, they are carefully selecting students to join the team responsible for assembling the vehicle. These partnerships with universities play a crucial role in enabling the government to stay up to date with the most recent technologies and innovations.

The government has a close working relationship with the Ministry of Economy, collaborating on app development and analysing project requirements during the application process, and assists in creating awareness and streamlining the process. In addition, there is a closing working relationship with the Ministry of Industrial Manufacturing-related aspects for various types of registrations.

The government acknowledges the importance of understanding the role of universities and patents in intellectual property (IP). They recognize that there are gaps in the UAE’s IP and patent system, particularly in the medical and pharmaceutical fields. They express their eagerness to improve the system and seek perspectives from the participants who have experience with patent applications. What are the learnings or effective processes from other countries that could be implemented in the UAE?

The use of Artificial Intelligence and Blockchain Technology in Healthcare

The DHA is making significant advancements in this area, including genomics. However, the presence of telemedicine platforms in hospitals are not being utilized effectively.

With the help of AI, the UAE has an opportunity to become a leader in data-driven early diagnosis.

Investing in innovations and diagnostics are the key to closing the gap and creating a healthier population.

The Future of Medicine: Proactive or Preventive instead of Reactive Measures

There is a challenge, specifically in relation to insurance coverage, in dealing with chronic diseases like obesity.  The World Bank’s survey on the economic cost of chronic diseases in the GCC region is significant. There is a need to focus on running clinical trials to explore preventive medicine and potentially reduce the burden of chronic diseases.

Conducting clinical trials to compare prevention and treatment methods may convince insurance parties to provide support. For example, doctors cannot directly state that a child is obese, but must express it indirectly by mentioning related health indicators such as cholesterol and blood sugar levels. However, prevention is the key to combating obesity in children.

In countries like the UK, US, and Australia, general practitioners have the authority to treat and refer cases based on their training and expertise. However, in the UAE, general practitioners have limited capabilities due to restrictions that require specialists to handle many cases. While this ensures quality control, it also leads to missed opportunities for early prevention and treatment. The gap lies in the ability to treat conditions early, which can be easier than waiting for them to worsen and seeking help from a specialist.

There is a need to update children’s vaccines, specifically highlighting the Al Housn App as a major achievement in preventive medicine.

One way suggested was to have a proactive approach to healthcare, urging the government to involve insurance parties in creating a strategy to tackle chronic diseases. It is suggested that by doing so, chronic diseases will no longer be seen as something frightening for insurance.

Pharmaceutical Companies facing Barriers in conducting Clinical Trials in the UAE

There are challenges when trying to use clinical trial data from the US or Europe, as it may not be accepted due to the lack of representation of the Middle Eastern population. Local academia can help address this issue.

There is a need for transparency and information on centres willing to collaborate and capable of generating sufficient data in terms of technical and clinical expertise.

The pharmaceutical companies struggle to navigate the complexities of the region and are often overwhelmed. Without experts on the ground, these companies face difficulties investing in research and development. The speaker emphasizes the importance of being open to new approaches and collaborations to address these challenges effectively.

The importance of regulations in the pharmaceutical industry is highlighted. There is a significant barrier in registering products and medicines after the clinical trials programme. Adherence to the US FDA is essential in terms of selecting markets for clinical trials.

40 countries are automatically approved, allowing researchers to conduct trials without much difficulty. However, only one country from the Middle East – Israel, is included in this list, while Saudi Arabia, United Arab Emirates, and other countries in the Gulf region are notably absent. This omission of Middle Eastern countries is a significant problem.

The process of approving clinical trials in the Middle East is considered lengthy and complex, discouraging many research teams and labs from pursuing it. As a result, those based in the US mainly target US FDA approval and overlook the Middle East, except for Israel where they choose to invest. This situation is beyond our control and requires the cooperation of governments to address. Additionally, protecting intellectual property rights and extending patent protection for molecules and their steps is a concern for these research teams.

The development of sciences and research has primarily taken place in labs located in the US and various Middle Eastern countries. This geographical disparity poses a significant barrier to global progress in this field.

Additionally, another crucial obstacle that needs to be addressed is the ethical consideration of the participation of vulnerable subjects in clinical trials, along with the legal framework in place to protect these individuals. (Overall, this topic is extensive and cannot be fully summarized within the constraints of this short time.)

Experts from organizations such as the FDA or TI can be brought to the UAE for a short period to share their knowledge and build capacity through shadowing. This, in turn, would train a cohort of individuals who would become the future stars in the field for the next five to ten years.

The UAE can become an appealing market for clinical trials by improving data databanks and data sharing. The current population of 9 million people may not be considered a critical mass for clinical trials, except for rare diseases, these can be done here. The UAE has one of the highest rates of consanguinity in the world, making the region the right place for rare disease research. Furthermore, there is potential for cancer research in the UAE.

There are challenges in working with rare diseases, specifically in understanding the number of patients affected. While hospitals have this data, pharmaceutical companies and investors do not. This lack of accessible patient volume information hinders their ability to make informed decisions.

Beyond treatment options, it is crucial to understand the patient journey to effectively address rare diseases and bring about meaningful change.

Digital Healthcare Solutions and Data Privacy

The major challenge is the barrier posed by the digital privacy law in the Middle East.  Data cannot be transferred outside the country. However, there is a need for a worldwide search to find the right solutions.

The UAE has developed a specific data protection law for healthcare, making it the first country in the region to do so. The law focuses on protecting healthcare data and is part of the broader ICT law. This means that any data related to healthcare falls under the jurisdiction of the ICT law, rather than general data protection provisions. The government has also been working closely with the private sector on this issue and there have been discussions around the data residency requirement within the ICT law.

Overall, this development highlights the UAE’s commitment to safeguarding healthcare data. To address the challenges posed by data protection laws, a ministerial decision was made at the end of 2021. This decision grants exemptions for eight specific use cases. These use cases present a valuable opportunity for the Cabinet’s regulation lab to assess and certify pharmaceutical companies that are working on rare diseases and need to collect global data to achieve meaningful results. By obtaining certification from the regulation lab, these companies can ensure that their data collection practices comply with the exemptions provided by the decision.

There was a suggested solution for data privacy concerns – ‘Homomorphic Encryption’ – a relatively new technology that was made open source by MIT four to five years ago. This encryption allows for running neural network patterns on encrypted data, which can be useful in determining if a genetic disorder is present in a dataset without compromising privacy. By sharing encrypted data and running AI on top of it, it becomes possible to identify whether there is a problem or not, providing a potential solution to the issue.

Homomorphic encryption is proposed as a mathematical framework that can effectively address the problem of sharing data without violating any legal barriers. It is recommended as an important project to consider in a Reg Lab, as it provides a means to normalize data sharing while complying with legal regulations.

The proposal suggests creating a national data centre in the UAE linked to unique identification numbers. This centre would have an ethical review board overseeing access to the data. This solution is deemed necessary due to the complexity of laws and fragmentation within the country. By implementing this system with the support of the Border Control Committee, it would make the UAE an appealing place for clinical researchers and others seeking data for scientific and healthcare advancements.

There are certain codes being developed in the medical field, which if approved, would be explainable by physicians. This is considered a positive step towards the future.

Enquiry about genetic testing, specifically DNA tests, and how certain companies approach them. These companies need to have certain policies and licenses to work with them and approach individuals for testing. Data from these tests, which can predict diseases like cancer in the future, should be handled carefully. Concerns about what will happen in the world with such information.

The Challenges created by the Insurance Sector

One of the healthcare sector founders of a startup what offers free and impactful service finds that limitations on reimbursement hinder their ability to enter the market with their solution. Despite its ability to significantly improve medication adherence by 80%, the service faces challenges. Private hospitals have shown interest but are hesitant to implement it as it would affect their profits. On the other hand, government organizations prioritize their own services, leaving the creator feeling overlooked and disappointed.

It is noted that health insurers have a significant influence on how the system operates. Their alignment with the goals and direction of the system is deemed important to prevent similar issues in the future. Overall, the insurers’ impact on the system’s behaviours and their involvement in ensuring the right energy is emphasized.

While mandatory insurance ensures that everyone receives some level of health care, the current system is not equitable across different regions like Abu Dhabi, Dubai, and other Emirates. Moreover, access to healthcare services is also not consistent. Insurance and regulation play a significant role in addressing these challenges. Proposal for a solution of unifying regulation and reimbursement to make all the seven Emirates viable. At present the lack of regulation and insurance is hindering progress in the neglected emirates.

Insurance companies hold significant amounts of data through their work on claim platforms. The Dubai Health Authority’s initiative called the Dubai Health Insurance Corporation is a channel for utilizing this data.

The aim is to study the data and understand disease pathways to demonstrate to the insurance industry the need for improved quality. Insurance companies, like hospital groups, face pressure to be profitable. The role of insurance can be expanded in the reg lab, where they can share their concerns and bring in research with vast amounts of data. Transmitting the insurance industry’s pain points to the government would be valuable.

Those with mandatory insurance often face challenges when dealing with rare or expensive diseases. Despite having the means to pay for it, insurance companies are reluctant to cover these costs.

Many individuals have to go back to their home country for medical treatment due to cheaper costs. Although this may seem like a reasonable solution, it places a significant burden on the patients. They must endure the ordeal of flying hundreds of miles and may not even have a family home to return to. This situation needs better regulation to address the challenges it poses.

The healthcare services for the aging population, who are in their 60s and have the golden visa, will require more healthcare services as they age. But the cost of insurance for elderly individuals is very high, especially considering the likelihood of having chronic conditions. Therefore, it is important to find a way to address the needs of the aging population while also managing the financial aspect of providing care. One possible solution could be implementing capped policies or similar strategies to ensure coverage for private care, while making it more affordable and sustainable in the long run.

Health insurance companies are struggling to figure out how to properly handle women’s needs and are actively seeking assistance in doing so. However, this task is challenging due to the long-established systems that have classified women as the highest users of healthcare services. Women are seen as a burden to health insurance because they utilize the system the most, with numerous inquiries and claims. Therefore, it is crucial for health insurance companies to prioritize improving their relationship with women.

The importance of optimizing operating expenses (OpEx) to provide basic insurance coverage to employees. However, this limited coverage may prevent staff from benefiting from the best healthcare practices and services available in the industry. Since it is the employer’s responsibility to provide insurance, they may only offer the bare minimum, resulting in employees missing out on comprehensive insurance.

The suggestion is that the responsibility for obtaining insurance should be shared between employers and employees. They propose an amendment to ensure that employers cannot solely offload this responsibility. By increasing premiums and sharing the costs, both parties would benefit from better insurance policies. This would create a more conducive system, allowing employees to access specialized care directly rather than through a general practitioner.

Participant explained how that they can only afford insurance policies of AED 1000 to 1500 for their business. They mention that there are policies of AED 10,000 or 200,000 that would allow them to go to any medical centre or hospital.

One suggestion was to use Europe as a case study in implementing a compulsory health insurance system where contributions are made to the government. They believe that this type of insurance should be combined with the private sector. There is a need for a multi-level insurance system that would offer different levels of healthcare and involve different healthcare providers.

Retail Pharma Sector

Retail Pharma sector face challenges from technological advancements like Amazon and iherb in the retail pharmaceutical industry. They mentioned the difficulties in obtaining approvals for medicines and supplements through municipalities but are frustrated by the availability of products like melatonin through online platforms.

Pharmacists are not supposed to sell drugs without proper approval or authorization. They express concern over Amazon’s inclusion of non-approved medications, such as Otrovin, and how it can be purchased from unauthorized sellers. There is a need for a uniform selling policy for all platforms, including pharmacies, to address this challenge.

Many pharmaceutical companies viewed the market as a place to expand. However, they express a desire to change this perspective and transform the market into a place for research and development (R&D) opportunities. Recognizing the need for a gradual approach, they propose partnering with others to address the challenges and pain points in achieving this goal.

Healthcare Sector

About 5% of the country’s GDP is spent on managing chronic diseases, and 80% of it can be controlled or prevented with medications. The significance of this issue is acknowledged by health care strategies and vision documents, as well as the World Health Organization.

There is an urgent need for solutions to address the current healthcare market, where a significant number of hospitals and clinics are available for sale. Pricing guidelines should be changed to improve the profitability of these establishments and ensure their survival in the face of new insurance policies.

There is a need to maintain profitability at a lower cost margin to adapt to the changing market conditions. The overall situation is considered unhealthy from a macroeconomic standpoint due to the high number of healthcare facilities up for sale.

As a venture capital investor, one participant emphasized the importance of investing in companies with significant potential for revenue and profit. Additionally, they mention the discussions surrounding the small population and the various challenges faced in the health care industry.

They suggest that medical tourism could be a way to generate more revenue for hospitals and other companies in the industry. They believe that limiting revenue generation to the local population and healthcare prices is not sufficient and that exploring the broader market through medical tourism could be a solution.

There is a need for unified rules in product registration, doctor registration, and healthcare staff registration. Frustration expressed at inconsistencies when going through the process of registering 20 products, as each person they interacted with had a different perspective when reviewing the registration file.

There is a problem with the current state of healthcare in the UAE. The rules regarding medical practices should be unified and that human health is at stake. There is a lack of transparency when it comes to verifying a doctor’s credentials.

The challenge lies in effectively communicating changes in systems, regulations, and verification processes to the public and players. It is important that everyone remains informed about these updates to know where they stand. If someone is unaware of a particular system, it needs to be better understood and communicated to ensure broader awareness.