We recently conducted an interview with Dr Mahmoud El Shabrawy, the General Manager of a leading distribution service provider in the Sultanate of Oman, to explore key considerations for international manufacturers looking to launch their new products in the Middle East in general and Oman in particular.
See below to learn about everything he shared with us.

Pharma BP: In general, how does partnership with local distributors work in Oman?
Dr El Shabrawy: Usually, when an international manufacturer does not have local presence in Oman, they would appoint a local representative who must be a locally authorized distributor. Both parties would then progress to signing a Distribution Service Agreement which is both exclusive and non-exclusive. It is exclusive in the sense that the manufacturer is not allowed to have a separate agreement with another distributor for the same product. However, the agreement between both parties is also non-exclusive as the manufacturer can have agreements with other distributors for other products.

Pharma BP: What is the typical duration of these Distribution Service Agreements?
Dr El Shabrawy: The contracts are usually valid for three years. To terminate this agreement, either party must inform the other, 3 – 6 months in advance. Even where there is no termination before the end of the third year, each party is also expected to declare their intent before an existing contract comes to an end – similarly, this declaration of intent is expected 3 – 6 months in advance.

Pharma BP: Are there any interesting trends you have noticed in the last few years with respect to pharmaceutical distribution in the Middle East and in Oman?
Dr El Shabrawy: Apart from the fact that the Middle East is attracting more and more interest from international manufacturers, we are seeing clear patterns in patient demand and expectations. Often we can see patient preference for products that are either manufactured, or imported from, outside the country; for example those from either the US or Europe. However, patient preference is not the only factor in play, as there is also the influence of institutional preference for locally vs. internationally manufactured products – this varies by institution and is usually driven by the budget of the respective institutions. It is important for manufacturers to tailor their tender strategy in line with the product and institution they are dealing with. Importantly, during the tender rounds, there is often the option between European, US and local brands, thus allowing each institution to make a choice that meets their individual situation and one that fits with their budget.

Pharma BP: These are interesting trends with regards to medications that are seeking authorization. Are there scenarios where access to unlicensed medicines is allowed in Oman?
Dr El Shabrawy: Yes, there are such opportunities for certain diseases, particularly where such medicines have already been licensed in other markets. It is important to remember that permission from the Ministry of Health is required before the product can be accessed. There is typically a requirement that access to the unlicensed medicine is linked to a commitment to generate evidence around the efficacy and safety of the product. Furthermore, the Ministry of Health would only approve access to such unlicensed medicines if both the prescription and the associated evidence generation applies to a specific individual and/or institution. It is on a named patient basis.

Pharma BP: What advice would you give to international manufacturers who want to succeed in Oman?
Dr El Shabrawy: Timing and proper pre-planning is super important. First of all, manufacturers must familiarise themselves with applicable timelines very early in advance of launch, to avoid unnecessary delays. In Oman, there are fixed timelines and dates in the market for tender submission - although there can be fluctuations, but typically, tenders are announced in Q3, while first order is expected in Q1 the following year. It is therefore important to know what these dates are in advance and factor these into the overall launch plan. This should also be done before going into Distribution Service Agreements as this allows the chosen distributor to plan towards, and support, the manufacturer’s tender submission efforts.

Acknowledgement: We thank Dr Mahmoud El Shabrawy, General Manager at Al Razi Pharmacy, Oman, for his insight and contributions to this blog.