Bahrain’s Healthcare Evolution: From Pioneering Genome Sequencing to Legislative Reform
Healthcare & Life Sciences Focus
Shouq Al MajaliSenior Associate,Dispute Resolution
Hiba Abid Trainee Solicitor,Dispute Resolution
In line with Bahrain’s Vision 2030 for Bahrain to become a leading center for modern medicine, the country has recently made significant progress in the healthcare sector by enhancing its medical infrastructure and services through several transformative developments. Bahrain is setting new standards in healthcare excellence by improving the quality and accessibility of healthcare services and adopting advanced technologies, such as the acquisition of the human genome sequencing machine. These advancements will evidently lead to improved health outcomes and position Bahrain as a frontrunner in international medical care.
The Bahrain Genome Project (“Project”) is a collaborative effort involving the Bahrain Ministry of Health, Brigham and Women’s Hospital, and the Broad Institute of MIT and Harvard. As part of the Project, the National Genome Centre was launched in 2018. More recently, the Ministry of Health has inaugurated NovaseqTM X Plus machine, a human genome sequencing machine, which can generate more than 20,000 whole genomes on an annual basis.
This makes Bahrain the first country in the Middle East to utilize this state-of-the-art technology for human genome sequencing. The Bahrain National Genome Project demonstrates a key advancement in genomics that will significantly improve health and well-being in the GCC region and on an international level.
Genome sequencing provides insights for diagnostics, personalised treatment, and disease risk predictions.
Genome sequencing has emerged as a transformative technology in the field of medicine, offering unprecedented insights into the genetic underpinnings of health and disease. This process involves analysing an individual's complete DNA sequence, which can provide diagnostic information, treatment personalisation, and disease risk predictions. The Bahrain National Genome Project and other initiatives are spearheading this movement, positioning Bahrain as a leader in genomic research and personalized medicine.
Data Privacy and Protection - One of the primary legal concerns surrounding genome sequencing is the privacy and protection of genetic data. Given the sensitivity of genetic information, stringent measures are required to safeguard this data from unauthorized access or misuse, as well as ensuring the data is being transferred, processed, and collected in line with conditions for processing sensitive personal data as per the Personal Data Protection Law No. 30 of 2018 (“PDPL”), which is the main piece of legislation governing data protection in Bahrain. Although the PDPL provides a foundation for data privacy, there may be a need to expand to specifically address genetic information.
Informed Consent - Informed consent is a critical issue in genome sequencing. Patients must be fully informed about the potential risks, benefits, and implications of undergoing genetic testing. Legal requirements for obtaining and documenting informed consent needs to be clearly defined to ensure ethical practices.
Collaboration and Research - As genome sequencing drives research and innovation, intellectual property rights related to genetic discoveries become crucial. Bahrain’s legal framework must balance the interests of researchers, patients, and commercial entities. Policies need to be implemented that support innovation while ensuring equitable access to genetic advancements. Genome sequencing may lead to discoveries that can be patented, such as novel genetic markers, diagnostic methods, or therapeutic targets. It is essential to ensure that the patent system effectively protects these innovations while promoting further research and development. Given the nature of these novel healthcare solutions, researchers would need access to genetic data and tools to drive innovation. Accordingly, policies needed to be implemented to support open access to fundamental research tools and data, while protecting technologies developed through such open access. Genome sequencing can promote collaborative models between academic institutions, commercial entities, and public organisations. These models can facilitate shared access to genetic data and resources, fostering innovation while ensuring broad benefits from discoveries. The Project has attempted to foster such collaboration by sending a team of specialists from the National Genome Centre to undergo advanced training at Harvard University. This training covered the latest techniques in genome sequencing, biological data classification, clinical analysis, scientific data evaluation, and genetic data management.
In addition to genome sequencing, Bahrain has made other significant strides in the healthcare sector, showcasing its commitment to adopting cutting-edge medical technologies and treatments.
Stem Cell Therapy In another groundbreaking development, Bahrain became the first country in the Middle East and the second in the world to approve CASGEVY (exagamglogene autotemcel) a one-time gene-editing therapy for treating patients with sickle cell disease and transfusion-dependent beta-thalassemia – shortly thereafter, the USA and KSA also approved the treatment. Following the UK MHRA’s authorization of this treatment, Bahrain’s decision marks a significant milestone in regional healthcare. This groundbreaking development not only paves the way for innovative medical advancements, but also underscores Bahrain's dedication to leading healthcare solution.
Private Health Institutions LawBahrain continues to invest in upgrading its healthcare infrastructure, including the expansion of hospitals and clinics, and the adoption of advanced medical technologies. In addition to technological and therapeutic advancements, Bahrain is also focusing on legislative reforms to enhance its healthcare system. Recent developments include the proposed amendments to Bahrain Decree Law No. 21 of 2015 on private health institutions (“Private Health Institutions Law”), which were reviewed by Shura Council’s Services Committee. Currently, specialist medical institutions are established by Bahraini doctors licensed to practice medicine or dentistry within Bahrain only, with the exception of a few medical facilities. However, the proposed amendment to Private Health Institutions Law will allow individuals, companies, and foreign medical institutions to obtain licenses for establishing hospitals, instead of restricting such right to Bahraini doctors licensed to practice medicine or dentistry in Bahrain only.
Furthermore, the proposed amendments to Private Health Institutions Law aims to maintain high standards in quality care by making it a requirement for individuals establishing a health institution, along with their partners, to have a clean criminal record. However, exceptions are allowed for those who have been rehabilitated or pardoned. Additionally, the law permits heirs of a licensee to continue operating the institution, provided it is managed by a Bahraini general physician or consultant. These professionals will handle all technical and administrative duties, and the institution’s name can remain the same if it includes the deceased founder’s name.
In addition, the legislative developments to Private Health Institutions Law grants authority to the National Authority for Regulating Health Professions and Services to launch a national accreditation programme for health institutions. The committee has also reviewed the possibility of implementing fines outlined in the law.
Bahrain has implemented new regulations regarding the transfer and transplantation of human organs, detailed in the recently published executive by-laws for the Transfer and Transplantation of Human Organs Law (“By-Laws on Organ Transplantation”). The by-laws prohibit the buying and selling of organs and explicitly forbid any form of compensation to donors, whether directly or indirectly, through family members, or other associated beneficiaries. The by-laws establish a national centralised committee that will oversee all procedures to ensure compliance with the law and maintain health and safety standards. The National Health Regulatory Authority (“NHRA”) will monitor authorised health facilities, which must follow specific protocols before any transplant can take place. A list has been issued identifying the authorised health facilities permitted to perform human organ transplantation, and no other hospitals are allowed to conduct such procedures. Additionally, both the living donor and recipient must be informed about the procedure through two face-to-face sessions, with details provided both verbally and in writing. These comprehensive By-Laws on Organ Transplantation aim to promote transparency and uphold ethical standards in organ transplantation in Bahrain.
In conclusion, Bahrain's recent strides in healthcare demonstrate the country's commitment to enhancing healthcare services and improving the quality of life for its citizens. These initiatives position Bahrain at the forefront of medical innovation in the region, paving the way for a healthier future that integrates advanced technology and regulatory reform to enhance medical services and infrastructure. The implementation of stringent regulations for organ transplantation underscores this dedication to ethical standards and patient safety. By prioritising quality of life for its citizens and ethical practices, Bahrain is not only improving healthcare outcomes but also fostering trust within its communities, ultimately contributing to a more robust and resilient healthcare system.
For further information,please contact Shouq Al Majali and Hiba Abid.
Published in January 2025
