Mahmoud Elmahdawy, PharmD President, ISPOR Egypt Regional Chapter Director, Hospital Pharmacy Administration, Ministry of Health, Egypt

Population: 82,999 million residing in 28 governorates. 1969 private and governmental hospitals. 5034 primary health care units. Fragmented health care system with multiple sources of financing and providers. Spending on pharmaceuticals is 34% (OOP* and government) of total health care spending in the country! Share of OOP spending of total health spending has increased from 51% to 72% in the past 2 decades.
* Out-of-pocket

Egyptian Parliament and Cabinet Ministers

Jointly evaluate new health care legislations

National Organization for Research & Control of Biologicals (NORCB)

safety, quality and efficacy of all imported and domestic biological products generate reports on medical issues not on economic evaluations

National Organization for Drug Control And Research (NODCAR)

It is the empowered national quality control authority for locally marketed, manufactured, and imported pharmaceutical products It analyzes the samples of new products under registration and products that need reevaluation to ensure safety and efficacy

Currently there are 2 prices for each drug

The mandated government retail price The tender price

Pricing decisions are compliant with the pharmaceutical Egyptian price regulations. The pricing committee: initial decision maker of the retail price. CAPA either approves or rejects the decision. CAPA reevaluates pricing of drugs

every three years upon request of the drug manufacturers in case of changed costs. in case of new indications or changed exchange rate by 15%.

The price of product can be changed in case of appearance of any cheaper equivalent in any country.

For brand products, pricing is based on a reference pricing model

10% less than the lowest price referenced country.

Annual price reduction by 2% once the first generic is approved (10 generics per brand) For generic products, a reduction from the lowest price referenced country by:
30% if: Product certified by FDA, EMEA or TGA, or Manufacturer is accredited by WHO, or Manufacturer is a member in ICH. 40% if product is locally manufactured and licensed by CAPA. 60% for products manufactured in another manufactory (Toll).

Procurement department conducts a needs assessment and informs manufacturers about the quantities needed Drug manufacturers submit bids Procurement Technical Committee reviews all MOHP hospitals and primary care units needs of medications and makes a determination. The financial offer committee selects the lowest price for each active ingredient to be reimbursed. Procurement department publishes approved tender drug list

Reimbursement in Egypt :
Covers most drugs in the market. Accessible to a wide range of patients. Tests quality of drugs before providing to the patient.

Drug prices are stable over time is an important advantage to current pricing regulations in Egypt.

Limits innovation. Contains loopholes that allow pharmaceutical companies to circumvent the rules and obtain the highest possible price for their products regardless of their true cost. A gap exists between health technology assessment (HTA) research and actual reimbursement decision making. A Minister decree signed on establishment of Pharmacoeconomic Unit at CAPA !!

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