Generic pharmaceutical policies in the MENA region

Generics/Research | Posted 17/09/2021 post-comment0 Post your comment

Healthcare systems in the Middle East & North Africa (MENA) region face challenges in service funding and delivery with policy emphasis in the region currently focused on controlling pharmaceutical expenditure. A key component of pharmaceutical cost-containment is a strong policy for generics aiming to improve uptake and access.

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In this context, a study by researchers from the London School of Economics and Political Science [1] examined and critically appraised the key features of policies on generics in eleven MENA countries (Algeria, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Qatar, Saudi Arabia and United Arab Emirates). The aim of the study was to understand the strengths and weaknesses of existing policies and outline gaps that can be addressed in the future. The analysis covered both the supply- and the demand-side, focusing on pricing, reimbursement and procurement policies (supply-side) and generic prescribing, dispensing and substitution (demand-side). Both primary and secondary data was collected for these aspects of pharmaceutical policy across all eleven countries.

The results indicated that price capping with and without managed competition and external price referencing are the principal pricing policies for generics in the region. Price capping mechanisms are often coupled with reductions in originator prices post-patent expiry. Six of the MENA countries have set percentage decreases for off-patent originator prices at this stage, though no evidence of such practice was identified for the remaining countries. While this is done to reduce spending on pharmaceuticals, it continues to promote the off-patent originator by making it cheaper, especially to patients who pay out-of-pocket. Reimbursement and procurement of generics in the region rely principally on tendering. However, tendering may prove complex as many countries in the MENA region have fragmented reimbursement systems with multiple actors involved in the purchasing of pharmaceuticals, delivery of healthcare and reimbursement.

There are considerable opportunities for the study countries to tailor their generics policies more closely to their individual health system needs to improve efficiency and cost-effectiveness. While significant scope remains for both pricing and reimbursement policies in countries across the region to benefit from some refinement, it is crucial to note the MENA countries focus efforts predominantly on supply-side policies to contain cost. Demand-side policies, such as generic drug prescribing and substitution policies, are rarely in place, and where they are, often not mandatory. Therefore, while generics may be available in these markets, the lack of strong demand-side policies limits the subsequent ability of healthcare systems to ensure sufficient uptake of available generics. Any weakness arising from this issue is exacerbated by the region’s inherent mistrust in generics. Because of this, supply-side policies alone may be insufficient to achieve the efficiency and cost-effectiveness objectives seen across the healthcare systems in the region.

More focus should be placed on introducing effective demand-side legislation, policies or other measures to improve use of generics among physicians, pharmacists and patients, and improving public awareness around generics, including issues surrounding the quality of generics. Placing emphasis on demand-side action, which works in conjunction with improvements in supply-side policies, could create a more holistic approach to improving access to, and uptake of, generics and to pharmaceutical cost-containment more widely.

Conflict of interest
The authors of the research paper [1] declared that this research is in part based on a wider study, ‘Pharmaceutical pricing and reimbursement in the Middle East and North Africa region: a mapping of the current landscape and options for the future’, conducted by the authors. This wider study was funded by the Pharmaceutical Research and Manufacturers of America. The sponsor was not involved in the study design; collection, analysis and interpretation of data; or writing of the report and publication of the study results.

Abstracted by Bregtje W Kamphuis, Department of Health Policy, Medical Technology Research Group – LSE Health, London School of Economics and Political Science, UK.

Editor’s comment
Readers interested to learn more about policies for generics are invited to visit to view the following manuscript published in GaBI Journal:

Analysis of European policy towards generic medicines

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1. Kamphuis BW, Kanavos P. Assessing pricing and reimbursement policies for generic pharmaceuticals in the MENA region for improved efficiency, affordability and generic penetration. Health Policy OPEN. 2021;2:100045.

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