Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
When COVID-19 brought the world to a standstill, the Kingdom of Bahrain sought to adjust its current regulatory standing by adopting a set of measures aimed to expedite drug delivery, ensure pharmaceutical product safety during freight, and enable the adoption of tele-health solutions in light of social distancing. Furthermore, in September 2020, the Bahrain Medical Society (‘BMS’) took a quantum leap by adopting the World Health Organization’s Occupational Health Charter in order to safeguard the physical and mental well-being of the Kingdom’s key asset – the human resource.
This article considers the National Health Regulatory Authority of Bahrain (‘NHRA’) ‘mayday’ measures stemming from the broader provisions contained within Law 34 of 2018 promulgating the Public Health Law (the ‘PHL’). Furthermore, an introduction to Bahrain’s efforts towards institutionalising the provision of mental healthcare through regulating the functions and requirements of incorporating rehabilitation facilities will be briefly touched upon.
The flexibility of the PHL was most visible recently during the wake of the pandemic. Article 44 enables the Ministry of Health (‘MOH’) to exercise broad executive powers in combating the spread of all communicable diseases, by granting it a prerogative to establish adequate measures pertinent to each outbreak. This provision allows the MOH to tailor its policies on a case-by-case basis, depending on the nature of the pandemic.
Furthermore, the PHL vests the MOH with powers to install specific standards aimed both at preventing the transmission of infection across medical institutions, and the contamination of the environment. This protects the public from diseases that may originate from healthcare institutions, and offers security to patients who are hospitalised because of an unrelated condition, thereby safeguarding all members of the public irrespective of levels of vulnerability. Moreover, the elastic nature of the legislation governing public health allowed for the creation of mobile medical units across Bahrain to examine people in their homes.
The PHL dedicated key reporting mechanisms to illustrate the hierarchy of responsibility in relation to reporting an infected individual, ranging from the physician to the relatives of the patient. Further, Article 39 provides a list of all parties responsible for reporting a suspected case of a communicable disease to help prevent its spread. Moreover, any person who is infected or is suspected of being infected with a communicable disease must be isolated at a hospital or at a location as determined by the MOH.
In line with Resolution 32 of 2020 on Pharmaceutical Product Registration System and Prices, the NHRA swiftly issued Circular 41 of 2020 setting out the conditions and requirements of importing pharmaceutical products that are currently not registered. As the world witnesses a current hike in R&D activity attributed to the global call to ‘find the vaccine’, many inventive biologic and conventional drugs are expected to enter the local Bahraini market. Moreover, this modern pathway to import emergency drugs was highly commended by the international community as it offers a legitimate track to obtain vital interventions, thereby catering to distressed patients seeking a lifeline while combatting the logistical interruptions due to the current pandemic.
The following conditions are to be met inorder to import non-registered medicines and pharmaceutical products by Public and Private Medical Hospitals (‘PPMH’):
Upon the satisfaction of the abovementioned conditions, the NHRA requires the PPMH to append copies of the pharmaceutical product certificate (‘CPP’) and the good manufacturing practice (‘GMP’) certificate of the manufacturer prior to issuing an import permit. Furthermore, pharmaceutical agents in Bahrain are expected to comply with similar conditions for the importation of non-registered pharmaceutical products.
In line with the NHRA’s Medicines Barcoding and Serialization Guidelines, pharmaceutical manufacturers are now required to sign up to the NHRA-MVC Traceability Hub before January 2021 and obtain the adequate GS1 barcoding certificate no later than 1 October 2021 in order to comply with current importing standards. This landmark announcement places Bahrain on a par with the international community’s pharmaceutical surveillance effort by emulating the policies and functions of the European Medicines Verification System. As such, all drug manufacturers and distributors must commit to attaching the Global Trade Item Number (‘GTIN’) on their packages in an attempt combat the trade of counterfeit pharmaceutical products in Bahrain.
In 2020, the NHRA issued the first telemedicine licence in Bahrain to Doctori, a state-of-the-art telemedicine application aimed to serve a community at a time of distress. At the same time, it was announced that the NHRA would issue a guiding document aimed towards regulating drug- dispensing activity through mobile application.
Version (1) of the Telemedicine Guidelines was issued in July 2020, thereby allowing telemedicine consultations to take place thorough licensed medical practitioners in Bahrain. Substantial discretion has been given to Licensed Medical Practitioners (‘LMP’) in that if a medical condition requires a particular protocol to diagnose and prescribe, as in cases of in-person consultations, the same principle will be applicable to telemedicine consultations.
LMPs are thereby permitted to prescribe medicines via telemedicine if they are satisfied that they have adequate and relevant information about the patient’s medical condition, and that prescribed medicines are in the best interests of the patient. Henceforth, prescribing medicines in the absence of a suitable diagnosis report will amount to professional misconduct.
The NHRA categorised a list of medicines that may be prescribed following a virtual consultation. These have been divided into three categories: List P, List POM, and the Prohibited List.
List P comprises medicines that are safe for prescription through any mode of tele- consultation. In essence, these include:
List POM (prescription only medicines): These medications may be prescribed during the initial video consultation and by follow-up prescriptions such as: clotrimazole, mupirocin, calamine lotion, benzyl benzoate lotion, local ophthalmological prescriptions and hypertension prescriptions.
Prohibited List: Namely, narcotic and psychotropic items.
Furthermore, any prescription issued via electronic mediums must contain all the relevant information appearing on the MOH’s generic prescription sheet as well as containing the LMP stamp bearing his/her professional licence number.
On the margins of the virtual signing ceremony inducting Bahrain as an observer of the World Health Organization’s Occupational Health Charter, the general secretary of the BMS informed media outlets that “in addition to the physical risks, the pandemic has exposed health workers to extraordinary levels of psychological pressure as a result of working extended hours in demanding conditions, and living in constant fear of exposure to the virus while separated from family.”
With growing fears and apprehension towards the future of our mental wellbeing, NHRA introduced a governing framework aimed at institutionalising the treatment and delivery of mental care in Bahrain. This step entails embracing the importance of collective action aimed towards enhancing the current policy frameworks governing a key area of non- communicable diseases shrouded in taboo and gone astray. As such, Resolution 33 of 2020 extended a hand of support to the most vulnerable category of mental health patient – victims of addiction.
Applicants willing to obtain a commercial licence to run a rehabilitation facility are required to approbate their engineering sketches by the Healthcare Facilities Department – NHRA in addition to ensuring that day-to-day functions are supervised by a licensed medical consultant. Furthermore, rehabilitation facilities are required to follow modern diagnostic methods implemented internationally through a qualified medical cadre. As such, Article 10 sets out the minimum medical qualifications to be held by each member; namely:
The application of the PHL throughout COVID-19 tested the legislation, and demonstrated its flexibility and durability. The practical assessment of the PHL validated its success by corroborating the advantages of implementing harsh sanctions, as well as having flexible provisions to personalise each exposition reliant on it. The Kingdom of Bahrain is committed to the health and wellbeing of its citizens, and the government has adopted a modern trajectory by incorporating modern technology into everyday life with the chief aims of enhancing healthcare delivery, and the protection of potential new entrants into the local market.
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