Updated: September 2018
Validated by: (in process)
Egypt

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BACKGROUND

Population & Type of Government

With 100 million citizens, the semi-presidential Arab Republic of Egypt is the most populous country in the Arab world and the third most populous in Africa, according to the 2017 census [1]; with 10% of Egyptians living abroad. The country’s estimated 2017 population growth rate is 2.45%. Most Egyptians are 20 to 39 years old; 40% are under age 24. Egypt’s 1-million square kilometer area is divided into 27 governorates, with 90% of the population living along the Nile River.

Healthcare Market

Egypt has one of the largest healthcare markets in the Middle East and North Africa (MENA). Healthcare services are provided through the public and private sector. The government is considered the main provider of healthcare services in terms of expenditures, capacity, and the breadth of services.

Government Body Responsible for Healthcare

Formally, the Egyptian Ministry of Health and Population (MOHP) is responsible for ensuring healthcare services for all Egyptians. However, the healthcare system is fragmented with many public and private entities providing healthcare services without MOHP oversight or sovereignty. These issues are addressed in the universal health coverage law passed by Parliament in December 2017.

New Universal Healthcare Coverage

According to MOHP, universal healthcare coverage, one of Egypt’s sustainable development goals for 2030, will be implemented in stages with the first phase starting in late 2018 and covering the population of five governorates (Port Said, Suez, Ismailia, North Sinai, and South Sinai). Coverage will gradually expand to include the entire population by 2032. Currently, approximately 43% of the population does not have health insurance. Out-of-pocket health expenditure is at 60% of the total health expenditure. [2-3]

Subscription to the universal policy will be mandatory. This will spread the financial risk of illness across the entire population and will use funds from the government health budget, other ministries’ budgets, health insurance premiums, co-pays, and additional funds from other resources, such as international donations and nongovernmental organization (NGO) contributions. Premiums will be set at 4% of a citizen’s salary, with 3% paid by the employer and 1% paid by the employee. Employees will pay an additional 1% for each child and 3% for their spouse. Co-pays and deductibles will vary depending on income. Free coverage will be provided for those individuals with incomes below the minimum wage threshold, an estimated 30% of the population. Additional sources of funding include taxes on polluting industries, eg, cement producers and on tobacco users. [4]

Under the new Universal Health Care Coverage Law, payers and providers of healthcare services will be separated to reduce conflict of interest and potential corruption as well as improve accountability. Three separate entities will be instituted.

  1. The National Health Care Authority focuses on the regulations and control of the health sector and healthcare facilities and sets strategic plans and policies.
  2. The Social Health Insurance Agency (SHIO) funding body is legally independent with oversight by the prime minister. It covers the healthcare expenses for insurees and enrolls medical care facilities for the provision of healthcare services.
  3. The accrediting body, which oversees quality control, ensures that all healthcare services and facilities, whether private, public, or institution-affiliated, meet the international standard of quality services and infrastructure.

Healthcare Spending

In the 2016/2017 fiscal year budget, Egypt allocated 53.3 billion Egyptian pounds (EGP) to healthcare spending, which represents 5.7% of total government spending, or 1.6% of GDP, far below the recommended 3% of GDP as per the Constitution [5]. The World Health Organization’s (WHO) data on current health expenditure (CHE) as percentage of gross domestic product (GDP) indicated that CHE was 4.2% of GDP in 2015. [6]

For more details on healthcare expenditures, see the World Health Organization’s Global Health Observatory data repository.

Healthcare System Funding

While 5 of 28 governorates will operate under the universal healthcare system, the remaining 22 will continue to operate under Egypt’s current healthcare system. The financing sources include:

  • government spending directly from tax revenues
  • employer / employee premium payments
  • co-payments
  • donor assistance from charity organizations without any role in the decision-making process.

Healthcare Services

The current healthcare system is fragmented, with services provided by different entities that can be categorized mainly into:

Public and Governmental Sector

Public health services are offered free of charge at the MOHP’s large network of hospitals and primary care facilities. Egypt has around 5,000 primary healthcare units and more than 400 general and specialized MOHP hospitals. The MOHP is considered one of the main providers of public healthcare, along with the Health Insurance Organization (HIO) and the Curative Care Organization (CCO), which are quasi-governmental organizations.

The HIO, which covers government employees and school-age children, was created decades ago as the umbrella organization to provide all Egyptians with insurance and care. However, it was never implemented. Under the new universal health coverage, the plan is to re-institute the role of the HIO as the provider of insurance and care for all Egyptians. The increased premiums and co-payments for universal coverage take into account the employee’s salary range and the rise in healthcare services and prices. The CCO operates in specific governorates and contracts with other entities to provide care.

Other public sector and governmental entities— such as university hospitals and clinics, ministry-affiliated hospitals and clinics (e.g., military and railway hospitals), and institution-affiliated hospitals (Egypt Air hospitals and clinics)—provide healthcare services for their members and the population at large for a reduced fee. The Teaching Hospitals and Institutes Organization (THIO) provides primary, secondary, and tertiary services [7]. Both of these entities have self-governance but abide by the MOHP regulations.

Private Sector

The private sector includes several private insurance organizations as well as a network of outpatient clinics and hospitals. There are also health facilities run by religious entities and NGOs as a charity service. The private sector has its own set of regulations and standards. Some are the same as those for the public sector and some may differ. Private insurers and providers negotiate prices with drug manufacturers, but are not involved in the drug evaluation process.

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DECISION MAKERS AND INFLUENCERS

Egyptian Cabinet of Ministers
The executive authority of the Egyptian government

Ministry of Health & Population (MOHP)
Led by the Minister of Health, the MOHP executes the legal and regulatory framework for healthcare interventions, the Health Insurance Act, and overall health policy. Decrees are issued by the MOHP, and it has the responsibility for health system regulation.

Egyptian Drug Authority (EDA)
The Egyptian Drug Authority (EDA), which is made up of NODCAR, NORCB, and CAPA, is the pharmaceutical regulatory body of the Egyptian MOHP. It is responsible for regulating safety and quality of pharmaceutical products, pharmacy practice regulation and legislation, strategic planning and policymaking for the sector, setting standards of pharmaceutical services for both hospitals and the community, and ensuring availability of quality medicines at an affordable price.

National Organization for Drug Control and Research (NODCAR)
NODCAR is part of the MOHP and the empowered national quality control authority for locally manufactured and imported pharmaceutical products, medical devices, cosmetics, and insecticides. NODCAR evaluates the safety and efficacy of pharmaceuticals, analyzing samples of new products under registration and products that need re-evaluation by testing the quality of active constituents and formulation strength (quantitative assessment) and microbiological assay.

National Organization for Research & Control of Biologicals (NORCB)
NORCB is responsible for safety, quality, and efficacy of all imported and domestic biological products in compliance with WHO and International Organization for Standardization (ISO) requirements. It is responsible for clinical trials and post-marketing studies for biological products only. NORCB generates reports on clinical assessment, but not the economic evaluations, which are performed by CAPA’s Pharmacoeconomic Unit (PEU). NORCB evaluates and assesses clinical trials submitted after approval of protocol from the Ethical Committee at the MOHP (Decree 360/2010).

Central Administration for Pharmaceutical Affairs (CAPA)
CAPA has responsibility for price regulation and supervises therapeutic products, including market authorization and post-market surveillance. CAPA, a public service organization of the government, is responsible for licensing, registration, inspection, and importation and exportation of products. Its activities are based on the Egyptian law on therapeutic products. CAPA authorizes market access for pharmaceutical drugs after evaluating and ensuring their efficacy and safety based on bioequivalence studies, published clinical trials, and the recommendation of reference countries’ regulatory bodies. It requests post-marketing studies when necessary. CAPA is considered the final decision-making body for setting the mandatory public price of drugs. To fulfill its responsibilities, CAPA includes:

The Procurement Department
Within the Procurement Department, decisions are made through the Procurement Committee, while the department is responsible for logistics and administration. The Committee is composed of physicians, academic pharmacists, and legal affairs personnel from MOHP and the head of CAPA. The committee holds meetings when the tender drug list is renewed or on an as-needed basis for add-ons (eg, the second tender drug list when all MOHP hospitals and primary care units’ needs are not covered by the main or first tender drug list).

Efficacy, safety, and drug costs are taken into account for coverage by reviewing each application to ensure that medications have acceptable pharmacokinetics, pharmacodynamics, safety (no alerts), and efficacy. The tender drug list is renewed every 2 years, when all drugs go through the review committee again. All applicants have to follow this mandatory review.

The Pricing Unit
The Pricing Unit is part of CAPA’s Policy and Planning Department. The Pricing Unit consists of approximately 10 members (medical, commercial and pharmaceutical academy, physicians, pharmacists, Ministries of Commerce & Social Solidarity representatives, and the head of CAPA). It evaluates new drugs for pricing. The Pricing Unit regulates not only the ex-factory price, but also the distribution margin to be shared between wholesalers and pharmacies in payment for logistic and capital costs of distribution. The committee is responsible for publication of the only authorized mandatory public price of the drug (mandatory for all pharmacies).

Pharmacoeconomic Unit (PEU)
Similar to the Procurement Department and Pricing Unit, decisions are made through the Pharmacoeconomics Unit. It is composed of physicians, pharmacists, health economists, academic advisors, and statisticians. The PEU fosters advancement in the understanding of costs and outcomes of pharmaceutical products, pharmacy services, and medication use policy. Its vision is to provide technical and scientific guidance regarding the value of drugs in delivering expected outcomes to decision makers, health professionals, and the public.

PEU’s four main missions:

  1. Evaluate economic studies of both new and existing pharmaceutical products and ensure best outcome for the patient by adhering to the Egyptian Pharmacoeconomic Guidelines; for more information see: https://tools.ispor.org/PEguidelines/countrydet.asp?c=39&t=1
  2. Conduct economic studies for drugs selected in the tender drug list, Essential Medicine List, and Hospital Formulary.
  3. Study the use of pharmaceuticals in the population to support the cost-effective and rational use of drugs.
  4. Provide education and training programs to build capacities and facilitate advancement in understanding the clinical, humanistic, and economic impact of pharmaceutical products on health policies.

Health Insurance Organization (HIO)
The HIO administers a fragmented set of social health insurance programs, established under different laws that cover different population groups with separate rules for payment of premiums and management of benefits. Benefits packages are broad and generous, while copayment rates are low. Benefits include inpatient care, plastic surgery, and treatment abroad.

The last major expansion of health insurance in Egypt was the introduction of the School Health Insurance Program in the mid-1990s. The HIO continues to have gaps between revenues and expenditures for several reasons:

  1. a fragmented set of social health insurance programs, leading to inefficiencies;
  2. broad and generous benefits packages; and
  3. employers are able to opt out.

Beneficiaries in low-income regions bear a larger cost burden than those in high-income regions. The cost to buy insurance is higher for females, those living in rural areas, and those in the lowest income quintile. The lowest income population is less likely to use HIO facilities because they are less likely to be insured.

Medical Supply Department
The Medical Supply Department at the HIO is complementary to the Procurement Committee at MOHP. It covers drugs not covered on tender drug list. Since 2013, there has been one tender drug list for MOHP and one for the HIO. The Medical Supply Department follows the Procurement Committee regulation at CAPA.

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DECISION-MAKING PROCESS SCHEME FOR HEALTH TECHNOLOGY APPROVAL & REIMBURSEMENT

The Procurement Committee in the MOHP, as well as in other ministry-affiliated health facilities (eg, military hospitals and facilities operated by the ministries of the interior and electricity for their employees and their families) are the initial reimbursement decision makers. Not all market-authorized drugs are reimbursed by MOHP or listed in the tender drug list. The tender drug list is a list of approved medications for reimbursement based on requests by all MOHP hospitals and primary care units. It includes all essential drugs and biologics that need to be covered for patients.

There are three tender drug lists:

  1. The first tender drug list is used at the MOHP and HIO facilities;
  2. The add-on tender drug list is for MOHP hospitals and primary care units’ whose needs are not covered by the main or First tender drug list;
  3. The HIO tender drug list is used when additional drugs are needed and are not listed in the first two tender drug lists. The Medical Supply Department at HIO covers the drugs on this list; it differs each year according on HIO local needs.

The Procurement Technical Committee reviews all MOHP hospitals and primary care units’ needs for medications and applications submitted by drug manufacturers and then decides, based on pharmacokinetics, pharmacodynamics, safety, and efficacy, whether a medication will be listed.

The MOHP makes the final decision on reimbursement based on the Procurement Technical Committee recommendation for the public sector. Other ministries are parallel final reimbursement decision makers for the healthcare services they provide.

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PRICING AND REIMBURSEMENT PROCESS

Pricing
Currently, each drug has 2 prices. The first is the mandated price for the Egyptian market, which is based on international reference pricing (IRP); the second is the price on the tender drug list. Both prices are set by CAPA, one by its pricing unit and the second price by its procurement department.

Pricing Process

For the mandated market price, the drug manufacturers recommend prices for new medicines. These prices are reviewed by the pricing committee. The recommended price is approved or reduced according to the lowest price-referenced country for the referenced product. The referenced product is then applied to the branded drug.

The pricing committee’s IRP model is based on a list of 36 countries, and a cost-plus model that examines the cost of raw materials, industrial expenses, distribution expenses, as well as company and pharmacy profits. The set price is reviewed every 5 years or upon request by the drug manufacturers. In addition, prices are re-evaluated in the case of a new indication or if foreign exchange rates change by 15%.

A pharmacoeconomic study, based on data from several studies conducted by the CAPA’s PEU, is conducted upon request for high-technology products, such as biologics and chemotherapy drugs. The pharmaceutical company can choose to do its own study; the MOHP can use that study or do its own. The study’s recommendations are considered advisory, not mandatory.

In the case of generic products, the rule is to set the price lower than the referenced product by the following percentages:

  • 35% for the first 5 generic products based on the pricing application date
  • 40% for the rest of generic products

This price includes a profit margin for importers, wholesalers, and pharmacists.

The price of the product can be reduced when a lower price for the same product is set in another country.

Reimbursement process

The reimbursement process in the MOHP applies to MOHP facilities, as well as HIO. Other institution or ministry-affiliated public facilities follow MOHP regulation, but have their own budget and autonomy. As for private sector entities, while they have to abide by the MOHP’s healthcare standards and regulatory rules, they do not have to follow the same reimbursement regulations as the MOHP. They may follow their own set of regulations and negotiation processes for reimbursement.

The Procurement Department is responsible for setting the tender drug list and reimbursement price, which is published and distributed to all MOHP facilities. Each hospital or primary care facility with a plausible budget can purchase their directly from drug manufacturers or wholesalers according to the price specified in the tender drug list (no negotiations).

Procurement Process

Each year, the Procurement Department requests that all MOHP hospitals and primary care units submit the needed list of medications and the quantities consumed per year to build the tender drug list. The department then calculates the average amount of medications needed to be covered and forms a new list. The drug manufacturers or wholesalers are informed of the total amounts of medications needed to be covered in the new list, to which the drug manufacturers or wholesalers submit bids.

However, many pharmaceutical companies do not submit bids for the first tender drug list to secure a higher price for a drug and to protect themselves against manufacturing issues that may arise.

After drug manufacturers and wholesalers submit an application, the Procurement Technical Committee meets and decides, based on safety, efficacy, and medical need, whether the medication should be listed. The application then goes to the MOHP Committee for Financial Offers reviews the financial issues to ensure the offered price by is lower than the mandatory market price and doesn't exceed an estimated value (estimated value not regulated by any law) calculated by the Procurement Department for each medication.

The lowest price for each medication is selected for reimbursement. Reimbursement prices are based on acceptable technical offers and the lowest price provided by the drug manufacturers or wholesalers. After the price is set, it is valid on the tender drug list for 2 years. This reimbursement process includes all drugs whether locally manufactured or imported and utilized by the MOHP and HIO facilities.

The procurement committee selects drug manufacturers and wholesalers that have presented the lowest price for the medication with the same active pharmaceutical ingredient (API) to receive reimbursement. Reimbursement is split equally between those manufacturers and wholesalers.

To be listed on the tender drug list, the drug must be effective and safe. The implementation of cost-effectiveness is not mandatory. The time frame to get reimbursed depends on the Procurement Technical Committee’s meeting schedule. Normally, it takes 8 months from the reimbursement dossier application to the official reimbursement status. After a final decision on reimbursement is made, random batches from each product must be tested at NODCAR or NORCB to ensure quality.

In cases of a projected negative reimbursement decision, the Procurement Technical Committee informs the applicant about the negative decision. The applicant may then apply for re-evaluation before the official reimbursement decision has been issued by the committee. Examples of arguments for re-evaluation include price adjustments at the final stage or additional data.

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DATA REQUIREMENTS

Data Requirements for Pricing for All Egyptian Facilities
(Mandatory public price):

  • Preliminary market authorization by CAPA
  • Cost study for the product (list of all costs)
  • Statement of product composition ingredients
  • Importing price (in case of imported drug only)
  • Original product pack & pamphlet (in case of imported drug only)
  • List of imported public product prices in countries where the drug is being traded or the origin country; including distribution margin to be shared between wholesaler and pharmacy, and value-added taxes (VAT)
  • Certificate of pharmaceutical product traded in origin country (in case of imported drug only)
  • Copy of manufacturing contract (in case of domestic product only)

Data Requirements for Reimbursement of MOHP and HIO: Three Tender Drug Lists

  • Final market authorization by CAPA
  • Final pricing certificate by pricing committee
  • Quality and appropriateness certificate by NODCAR or NORCB before and after final decision
  • Certificate of pharmaceutical product traded in the Egyptian market

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ACRONYMS

MOHP: Ministry of Health & Populationوزارة الصحة والسكان 
HIO: Health Insurance Organizationالهيئة العامة للتأمين الصحى  
GDP: Gross domestic product

PEU: Pharmacoeconomic unit وحدة أقتصاديات الدواء
PTES: Program for Treatment at the Expense of the State العلاج على نفقة الدولة
CAPA: Central Administration For Pharmaceutical Affairsالادارة المركزية للشئون الصيدلية
NODCAR: National Organization for Drug Control and Research الهيئة القومية للرقابة و البحوث الدوائية
NORCB: National Organization For research & Control of Biological الهيئة القومية للبحوث و الرقابة على المستحضرات الحيوية
EDA: Egyptian Drug Authority
FDA: Food & Drug Administration
EMA: European Medicines Agency
MHLW: Ministry of Health, Labor and Welfare
TGA: Therapeutic Goods Administration

USEFUL LINKS

Egyptian Drug Authority. http://www.eda.mohealth.gov.eg/
Egyptian Pricing Decree no499/2012. Egyptian Drug Authority. In Arabic at: http://www.eda.mohp.gov.eg/Files/474_499.pdf

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REFERENCE

  1. The World Factbook. US Central Intelligence Agency. https://www.cia.gov/library/publications/the-world-factbook/geos/eg.html Accessed April 12, 2018.
  2. Mahmoud M. What you need to know about Egypt’s universal health insurance law? Egypt Today. December 19, 2017. https://www.egypttoday.com/Article/2/37507/What-you-need-to-know-about-Egypt%E2%80%99s-universal-health-insurance Accessed: April 12, 2018.
  3. Al-Youm A-M. Comprehensive health program to begin in 2018, says health minister. Egypt Independent. October 24, 2017. http://www.egyptindependent.com/comprehensive-health-care-program-begin-2018-says-health-minister/ Accessed: September 13, 2018.
  4. Devi S. Universal health coverage law approved in Egypt. Lancet. 2018;391(10117):194
  5. Egypt’s cabinet approves new national health insurance bill. Ahram Online. April 3, 2017. http://english.ahram.org.eg/NewsContent/1/64/262182/Egypt/Politics-/Egypts-cabinet-approves-new-national-health-insura.aspx Accessed: April 12, 2018.
  6. Global Health Observatory data repository. Health financing. World Health Organiztion. http://apps.who.int/gho/data/node.main.HEALTHFINANCING?lang=en Accessed April 12, 2018.
  7. Rashad AS, Sharaf MF. Who benefits from public healthcare subsidies in Egypt? Soc Sci. 2015;4(4):1162-76

ACKNOWLEDGEMENTS

Mahmoud Diaa Elmahdawy, PharmD, Patient Access Director, Novartis, Cairo, Egypt

AUTHORS & CONTRIBUTORS

Gihan Hamdy El-sisi, PhD, MSc, Managing Director, HTA Office, Middle East and North Africa, and Treasurer, ISPOR Egypt Regional Chapter, Cairo, Egypt

Randa Eldessouki MD, MSc, MBBCH, Assistant Professor, Faculty of Medicine, Public Health & Community Medicine, Fayoum University, Cairo, Egypt

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