Healthcare Resource Guide: Macedonia

 

Macedonia Statistics

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Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Barriers
Registration Process

Reimbursement

Barriers

CS Contact

Demographics

Capital: Skopje

Population: 2 million
GDP:
USD 11.342 (2017)
Currency:
Denar (MKD)
Language
: Macedonian, Albanian

Summary             

Macedonia is undertaking a series of major health sector reforms. The Ministry of Health has set five core policy areas to improve: health expenditures, health revenues, payment mechanisms, information systems, and advocacy and public awareness strategies.

The main contributors to health system reform in Macedonia, other than the World Health Organization (WHO), are: The World Bank, UN agencies, and the Government of Macedonia. Their broad-based efforts focus on several components: health finance reform and management, basic health services, fostering public-private partnerships in the health sector, and pharmaceutical policy.

Macedonia spends between 1.0-1.3% of its GDP on the healthcare sector. The disease prevalence pattern is similar to other European countries, with cardiovascular and circulatory disease, neoplasms, metabolic and nutritional diseases, and respiratory diseases as the most prominent causes of morbidity and mortality. Diseases like HIV and TB are less prevalent.                                          

Market Entry

There are no legal barriers to foreign businesses entering Macedonia. However, serious challenges to doing business in Macedonia remain, including the country’s opaque tendering process, weak judicial system and significant levels of corruption.

According to import regulations, all medical equipment entering Macedonia is free of import duties, but subject to 18% value added tax (VAT). Accessories and spare parts are subject to 8, 10, and 15% customs import duty.

The CE marking is mandatory, as is compliance with ISO standards. 

Current Market Trends

In parallel to health sector restructuring efforts, the health sector management project will continue to be an important focus. The objectives of this project are to upgrade the Ministry of Health; the Health Insurance Fund; and the capacity of local health facilities to formulate and effectively implement health policies, health insurance, financial management, and provider contracting.

In addition, there is a goal to develop and implement efficient schemes to restructure hospital services, with an emphasis on developing day care services and shifting to quality primary care.

Main Competitors

European companies remain the main competitors to U.S.-produced medical equipment and pharmacies. Consumers in Macedonia are highly receptive to U.S. products, but are also very sensitive to prices. Siemens and Philips are present in the market, as are Hitachi and Toshiba.

Current Demand

Macedonia’s healthcare sector lacks sufficient medical materials, including pharmaceutical drugs, disposable products, and medical equipment due to low funding levels.

Invasive and non-invasive surgery equipment, cardiology equipment, EKG and ultrasound machines, defibrillators, vascular stents, pacemakers, oncology equipment, and urology, laboratory, and other testing equipment remain in high demand as do computer tomography imaging systems, magnetic resonance imaging, and sophisticated digitalized x-ray equipment.

Registration Process

In order to harmonize legislation with European Commission recommendations, the Assembly of the Republic of Macedonia has adopted extensive amendments to the Law on Medicinal Products and Medical Devices which came into force on February 1, 2012.

According to this law, all medical devices marketed in Macedonia must be labeled according with the provisions of this law on the outer and inner packing in Macedonian and English language, and must enclose instructions for use.

A packaged medical device must contain at least the following: information on the manufacturer and supplier, information necessary to identify the medical device and contents of the packing, different specialty labels to include: sterile, custom-made, single use, for clinical trials, identification codes, expiry period, storage conditions, special method of use, warnings or precautions, purpose and other information related to proper use of the device.

Medical devices and pharmaceutical products must be registered at the Bureau for Medicine and Medical Devices.

Reimbursement

The Government determines a Positive List of prescribed drugs, which are sold to patients for a 20% copayment. When drugs on the Positive List are unavailable (for any number of reasons), patients may purchase the drugs and full price and apply to be reimbursed for 80% of the cost.

This leaves the system vulnerable to misuse and abuse, but may benefit the Health Insurance Fund, as many do not apply for the reimbursement because the system is slow and inefficient. 

Barriers

There are no significant trade barriers or limitations on U.S.-produced medical devices.

Procurement & Tenders

Foreign companies participating in public tenders in Macedonia can expect to face delays in the preparation of technical specifications, and beginning and concluding the bid evaluation process, as well as delays during the approval process, and delays caused by bidder challenges to the procurement process.

More information available here:

 

U.S. Commercial Service Contact Information

 

Name: Arben Gega              

Position: Commercial Specialist          

Email: gegaa@state.gov              

Phone: +389 2 310 2403   

Demographics: as of 31 December 2017 estimates

Population

2,075,301

Life expectancy men/women

70.3 years/males 74.7 years/females

Infant mortality

9.2 infant deaths per 1000 inhabitants

Percent of population older than 65

13.1 %

Annual deaths

20 318 deaths in 2017


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