OBJECTIVES: The main objective of this descriptive study analysis was to assess the access regulations applied in the MENA countries and examine how Managed Entry Agreement projects are implemented in the MENA these recent years.  METHODS: To provide a comprehensive description of Pricing and Reimbursement regulation used in MENA region: We focused on the pharmaceutical policy in six countries: Algeria, Lebanon, UAE, KSA, Jordan, and Egypt. The analysis involved reviewing the literature in each country:

• First we reviewed the pricing and reimbursement procedures for the innovative drugs
• Secondly, we focused the review on the use in the regulatory process of MEA.
• Third we examined the agreements achieved in these region.

RESULTS:

• We noticed that there are a lot of similarities and differences in principles of pricing and reimbursement of pharmaceuticals in the six countries studied are similar.
• The Pricing decision is taken at national level by a reimbursement committee within an institutional context (Ministry); most countries take into account the price levels prevailing in other countries, external price referencing) e.g. KSA, UAE, Algeria, or for alternative therapies (internal reference pricing) e.g. Egypt, Lebanon, Algeria.
• The Reimbursement is an administrative negotiation between the relevant committee and the manufacturer.
• In the regulatory process we didn’t find explicitly the possibilities for MEA.
• Based on the case studies, it appears that some countries practice the MEA especially in KSA, Egypt, and Lebanon.

CONCLUSIONS: In the MENA region, there are still important legal and structural obstacles for the implementation of risk sharing agreement and only few agreements have been implemented.  Mainly financial-based, and the scientific literature on such schemes in the MENA countries is still sparse.  However, as a response to uncertainty associated with new high cost of innovative drugs, we believe that the Managed Entry Agreement will increase in the MENA regions.