Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
U.S. Commercial Service Contact Information
Executive Summary
The healthcare system in Albania is mostly public, although private healthcare has become increasingly popular. The public healthcare service is organized at the primary, secondary, and tertiary service levels. Approximately 413 public healthcare clinics offer primary and secondary healthcare services and 42 public hospitals offer tertiary healthcare services. Pharmaceutical and dental services are almost entirely private. The share of private healthcare services has experienced impressive growth in the last decade. The number of specialized private diagnostic clinics, labs, and hospitals has been growing at a fast pace, especially in major urban areas. The 13 private hospitals, as well as dozens of private multi-disciplinary diagnostic clinics and labs, offer a full range of medical services.
Estimates put the current health expenditure for 2018 between 6-7% of the GDP, or more than $1 billion, out of which almost 60% is paid privately. According to the Albanian Ministry of Health (MoH), public healthcare spending in 2018 reached 48.6 billion leke ($450 million). Experts argue that healthcare spending in Albania is even higher considering the sizable informal economy.
Public healthcare spending is partially financed by compulsory health insurance contributions by employees and employers (a 3.4 % health insurance contribution, divided evenly between employer and employee, is imposed on salaries) and subsidized by the state budget. The Compulsory Health Insurance Fund (ISKSH), funded by the health insurance contributions and subsidized by the state budget, reimburses the prescription drugs for the insured and pays for the public healthcare services as well as some approved hospital healthcare services provided by the private healthcare providers. The ISKSH budget for 2018 was $374 million, out of which $97 million was earmarked for the reimbursement of 1,175 prescription drugs, $73 million for financing primary healthcare services, and $196 million for the financing of hospital care services. In 2018, ISKSH had earmarked close to $30 million to pay for services provided under the Public Private Partnership (PPP) contracts the government has signed in the healthcare sector. The number of reimbursable drugs for 2019 is 1,050. For a list of reimbursable drugs for 2019, please visit https://www.fsdksh.com.al/lista-e-barnave .
The National Agency of Drugs and Medical Equipment oversees registering drugs entering Albania. Since 2016, the Agency is also in charge of registering medical equipment. The MoH develops healthcare policies, proposes the national healthcare budget, and monitors state-owned health institutions.
In 2013, the Albanian government pledged to implement universal healthcare coverage and has since undertaken a series of steps toward implementation of this model. Since January 2016, roughly 600,000 uninsured Albanians benefit annually from free family doctor visits and reimbursable drugs, and close to one million Albanians aged between 35-70 years old, both insured and uninsured, are entitled to benefit from free medical check-ups provided under a PPP contract.
Over the last few years, the government has also granted several other PPP contracts in the healthcare sector, including hemodialysis treatments, sterilization of surgical equipment and surgery theaters, and treatment of dangerous medical waste. Most recently, the government signed a PPP for hospital laboratory services. The 2016-2020 healthcare sector strategy foresees other PPP contracts within the healthcare sector, including online control and monitoring of drug inventories at pharmaceutical warehouses and drug stores in coordination with the Drug Agency. In addition, the government has initiated a reform effort to digitize medical records of all patients, implement e-prescriptions throughout the country, track and trace e-prescriptions, establish a National Center for healthcare information and develop, pilot, and implement e-visits, e-examinations, and e-referrals.
Albania imports all medical equipment and devices and around 90% of drugs.
All major pharmaceutical and medical equipment and device manufacturers are present in the market, mostly through distributors.
Market Entry
It is advisable for companies from the United States (U.S.) interested in entering the Albanian pharmaceutical and medical equipment and devices market to partner with local companies. U.S. companies should carefully select a potential distributors or agents and consider training local and after-sale service staff as an important component of their business plan.
Public sector purchases, including those in the healthcare sector, are conducted electronically and notifications can be found on the Agency of Public Procurement website at www.app.gov.al . The amount of government procurement in the healthcare sector may shrink significantly in the future, as the government moves to outsource many health services as PPPs.
Customs tariffs depend on the Harmonized Tariff Schedule (HS) code. For medical equipment and devices, the tariffs vary from 0-2% for the following HS codes: all codes under 9018-9019-9020-9021-9022 incur a 0% customs tariff, except for 90200000, which incurs a 2% customs tariff. Medical equipment currently incurs a 20% value added tax (VAT) except for Active Implantable Medical Devices, which incur a 0% VAT. For pharmaceuticals, the tariff rates for chapter 30 are 0% except for 30061030 and 30069100, which incur a 6% customs tariff. There is no VAT on pharmaceutical drugs.
In July 2014, the Albanian government approved a new law on medical devices aiming to align Albanian and European Union (EU) regulations. In August 2016, several provisions regarding the registration and labeling of medical equipment foreseen in the 2014 law on medical equipment entered into force. The new law requires CE marking for all medical equipment entering the country. The law also requires medical device manufacturers, domestic or foreign, which have registered their business in Albania, as well as all wholesalers and retailers that operate in the market, to apply with the MoH to receive authorizations to operate in the market. According to the law, all medical equipment should register with the National Register of Medical Equipment, maintained by the National Agency of Drug Control and Medical Equipment. Additionally, all medical equipment should have Albanian language labels.
The number of local companies that sell medical equipment is limited due to the size of the market. U.S. companies interested in exporting to Albania should consult with their distributors or representatives on the requirements and procedures needed for export to Albania.
Regarding pharmaceuticals, the Albanian law on drugs requires that all drugs marketed in the Albanian market be registered with the National Agency of Drug Control and Medical Equipment.
Current Market Trends
Medical Equipment and Devices:
The ongoing modernization of the private and public healthcare sectors provides opportunities for U.S. exporters. As the sector modernizes, Albanians increasingly are demanding modern, western medical devices and treatments. Wealthy Albanians who have previously traveled overseas for medical treatment increasingly opt to stay in Albania and seek services at private hospitals and clinics. Medical tourism into Albania, especially in dentistry, is small but growing. Imports of Medical Equipment in Albania
2014
U.S. Share
2015
U.S. Share
2016
U.S. Share
2017
U.S. Share
2018
U.S. Share
Total Imports HS Codes*
$43mil
9.2%
$46mil
7.9%
$50mil
9.4%
$58mil
10.5%
$69mil
8.7%
* The data is based on the following HS Codes: 300510, 300590, 300610, 300640, 300650, 300680, 300691, 300692, 340700, 382100, 382200, 401511, 401519, 420600, 420610, 611510, 611512, 611519, 611592, 611593, 630720, 630790, 650610, 681250, 681280, 681291, 841920, 841990, 854370, 854380, 854389, 871310, 871390, 871420, 901811, 901812, 901813, 901814, 901819, 901820, 901831, 901832, 901839, 901841, 901849, 901850, 901890, 901910, 901920, 902000, 902110, 902111, 902119, 902121, 902129, 902130, 902131, 902139, 902140, 902150, 902190, 902211, 902212, 902213, 902214, 902219, 902221, 902229, 902230, 902290, 902511, 902519, 940210, 981000.
The presence of U.S. brands in the medical equipment and devices sector is likely much higher than customs data reflect, as the importing country listed in the customs reports does not necessarily reflect the brand.
Pharmaceuticals
2014
U.S. Share
2015
U.S. Share
2016
U.S. Share
2017
U.S. Share
2018
U.S. Share
Total Imports HS Codes*
$183mil
3.9%
$154mil
4%
$171mil
5.8%
$207mil
4.7%
$220mil
4.8%
*The data is based on all HS codes under Chapter 30
Although U.S. exports account for a small market share, it should be noted that the share might be larger because U.S. products are often imported from their European offices.
Generic drugs are popular in the market due to lower prices.
Best Prospects
Best prospects include equipment and medical devices in the categories of medical imaging, ultrasound, monitors and anesthesia, dental, diagnostic and surgical microscopes, endoscopes, and blood diagnostics. Additionally, better management of information in the healthcare system and the introduction of e-services should create opportunities for exports of U.S. goods and services to Albania.
Market Size
Healthcare Spending (Including Investment)
…as percent of GDP
6-7%
… of which spent on inpatient services (including long-term care)
N/A
… of which spent on pharmaceuticals/consumables
N/A
… of which spent on investments
N/A
… of which spent on outpatient services
N/A
Hospitals, Procedures, Healthcare Professionals (Source: Albanian Institute of Statistics)
Number of Hospitals
55
… Public
42
… Private
13
Number of Hospital Beds
8,885 (8169 are in public hospitals)
… available beds per 1000
3
… of which in general hospitals
N/A
… of which in specialized clinics and rehab centers
N/A
Number of Surgical Procedures
57,475 (at public hospitals)
Physicians
1.29 physicians per 1,000 habitants (2013)
Demographics (Source: Albanian Institute of Statistics)
Population
2,862,427 (January 2019)
Life expectancy men/women
77.4/80.5 (2018)
Infant mortality
8.9 (2018)
Percent of population older than 65
14 (January 2019)
…projection, 2030
20.8 - 21.7 (projection 2030)
Annual Deaths
21,804 (2018)
…caused by [highest disease burden]
Ischemic heart disease
…caused by [second highest]
Cerebrovascular disease
Prevalence of [fastest growing disease burden]
Alzheimer disease
Main Competitors
Medical equipment and devices:
The complete list of registered medical equipment in Albania can be found at this link: http://www.akbpm.gov.al/dokumenta/Pajisje%20Mjekesore.xlsx .
Medical Imaging, Ultrasound, Monitors & Anesthesia
Dental
Diagnostic & Surgical Microscopes
Endoscopes
Blood Diagnostic
The major competitors of U.S. manufactured medical equipment are European companies. U.S. brands sell very well in Albania, but after-sales service remains a challenge. As such, it is highly advisable that U.S. companies aiming to enter the market consider a local partner who can provide after- sales service.
Pharmaceuticals:
All major international pharmaceutical companies are present in the Albanian market, with their products mostly sold through distributors. Based on data from the Drug Agency, as of July 2019, 3,678 drugs have been registered in Albania, of which 1,150 are on the reimbursable drug list. The budget earmarked for the latter was around $100 million (2018).
The complete list of registered drugs in Albania can be found at this link: http://www.akbpm.gov.al/dokumenta/21%20SHKURT.xlsx . The document has an up-to-date list of all registered drugs in Albania along with the manufacturer and the authorized trading company.
Current Demand
Demand for medical equipment will likely continue to grow in Albania. The Albanian government has pledged to modernize and increase spending in the health sector, which will lead to new investments in public hospitals. The private sector is also investing in and diversifying services, which should increase demand for further capital investments. The public private partnership contracts in healthcare would also increase prospects for U.S. exports.
Market demand for medical equipment, including but not limited to computer tomography imaging systems, magnetic resonance imaging, sophisticated digitized x-ray equipment, invasive and non-invasive surgery equipment, cardiology equipment, EKG and ultrasound, defibrillators, vascular stents, pacemakers, oncology equipment, urology, dentistry, and laboratory and testing equipment will continue to grow as Albania modernizes its healthcare system.
The ten most common causes of death in Albania in order of incidence are: heart disease, stroke, lung cancer, Alzheimer’s disease, cardiomyopathy, other cardiovascular conditions, chronic obstructive pulmonary disease, stomach cancer, lower respiratory infections, and chronic kidney disease. As such, drugs addressing these health issues are in high demand.
Registration Process
Pharmaceuticals:
To market a drug in the Albanian market, interested parties should apply with the National Agency of Drugs and Medical Equipment to receive a Drug Marketing Authorization. The Marketing Authorization is valid for five years and can be renewed for five-year increments following a request by the Marketing Authorization Holder. Licensed domestic drug manufacturers and/or the holders of the right to trade/represent drugs, even if they are not the drug manufacturers, should file the request with the agency to receive the Marketing Authorization. According to Albanian Drug Law No. 105/2014 (approved in 2014 and amended in 2015), the agency grants Marketing Authorization to the following categories of drugs:
Drugs manufactured in Albania
Drugs that have received marketing authorization and circulate in the United States, EU, Canada, Switzerland, Israel, Australia, Japan, or Turkey
Drugs manufactured in at least one Balkan country, and which have received a marketing authorization and circulates in that country
Drugs that have received a marketing authorization from the EMA and FDA
For more information, including the documents required to register a drug in Albania, please refer to registration regulations published by the National Agency of Drugs and Medical Equipment at http://www.akbpm.gov.al .
Medical Equipment and Devices:
Albanian legislation requires that all medical equipment must carry the CE marking. Importers, authorized dealers, and manufacturers in Albania should register medical equipment with the National Agency of Drugs and Medical Equipment. Foreign and domestic manufacturers of medical equipment which have registered their activity in Albania, or wholesale and retail traders of medical equipment, should apply for authorization to trade such equipment. U.S. companies interested in exporting to Albania should consult with distributors or representatives on the requirements and procedures needed to export to Albania.
Reimbursement
A decision of the Council of Ministers in February 2017 paved the way for the Compulsory Health Insurance Fund to initiate the process of preparing and approving the list of reimbursable medical devices for the first time. Once approved, the list would be published on the page of the Fund, at http://www.fsdksh.com.al .
Barriers
There are no significant market-entry barriers in Albania.
Procurement & Tenders
Please visit the online public procurement portal for procurement opportunities in the healthcare sector: www.app.gov.al .
In addition, please monitor the World Bank procurement site for healthcare procurement opportunities financed by World Bank loans and grants.
U.S. Commercial Service Contact Information
Name: Edi Jacellari jacellarie@state.gov
