A Proposed Global Medicines Agency (GMA) to Make Biological Drugs Accessible: Starting with the League of Arab States

Abstract

Medical anthropology teaches us of historical disparity in the accessibility of medicines in the developing world due to their lack of availability and affordability, more particularly of biological drugs, including therapeutic proteins, gene therapy, CRISPR-Cas9, mRNA therapeutics, CART therapy, and many more. This challenge can be resolved by establishing an independent regulatory agency, proposed as the Global Medicines Agency (GMA), with a charter to allow originators from the Stringent Regulatory Agency (SRA) countries to receive immediate registrations applicable to all member states, expanding the market potential as an incentive. For non-SRA countries, it will be limited to biological drugs that are allowed their copies to be made, only biosimilars. A transparent approval process will involve using a rapporteur, a third-party product-related current Good Manufacturing Practice (cGMP), and assurance of the integrity of samples tested for analytical similarity and clinical pharmacology testing. GMA membership will be open to all countries. Still, it is suggested that the League of Arab States, representing 22 states with a population of 400 million, takes the lead due to their cultural and language homogeneity, which is likely to provide a concurrence among the member states. However, some states, like the Gulf Cooperative Council, are already accustomed to this approach, albeit with a different perspective. The target drugs are biotechnology and gene therapy pharmaceuticals, and their scope can be expanded to any drug.

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“…It is crucial for policymakers responsible for the approval and regulation of biosimilars to understand the distinctions between generic small molecules and biosimilars. The Gulf Cooperation Council (GCC) comprises six countries: Bahrain, KSA, Kuwait, Oman, Qatar, and the UAE, with a population of more than 54 million people [ 22 , 23 ]. However, because of the heterogeneity of biosimilar regulatory approval processes in the Gulf, the availability of biosimilars varies significantly across the region (Table 1 ) [ 13 ].…”

“…However, because of the heterogeneity of biosimilar regulatory approval processes in the Gulf, the availability of biosimilars varies significantly across the region (Table 1 ) [ 13 ]. Although the GCC Central Committee for Drug Registration oversees drug evaluation, registration, and post-marketing surveillance across the GCC [ 23 ], local authorities within the local markets in individual countries vary. For example, the Saudi Food and Drug Authority and the UAE regulatory authorities adapted their guidance from the FDA and EMA, with adaptations to the local and GCC requirements [ 13 , 23 , 24 ].…”

“…Although the GCC Central Committee for Drug Registration oversees drug evaluation, registration, and post-marketing surveillance across the GCC [ 23 ], local authorities within the local markets in individual countries vary. For example, the Saudi Food and Drug Authority and the UAE regulatory authorities adapted their guidance from the FDA and EMA, with adaptations to the local and GCC requirements [ 13 , 23 , 24 ]. However, the availability of biosimilars depends on regulations by local markets and authorities’ regulations.…”