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Healthcare Resource Guide: Malta

Malta Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Barriers

Trade Events

Best Prospects

CS Contacts

Capital: Valletta

Population: 419,531

GDP*: $9.7 million ($34,700 per capita)

Currency: Euro

Language: Maltese, English

Summary:

Over the past several years, the healthcare industry has emerged as one of Malta's fastest growing sectors. Healthcare is an important priority for Malta; in 2014 the Government of Malta began promoting public-private partnerships in the healthcare sector to establish Malta as a Mediterranean hub for medical tourism. The Government allocates a substantial portion of its budget to health, including investments in healthcare infrastructure.

The Maltese healthcare manufacturing sector currently focused on the production of pharmaceuticals, pharmaceutical ingredients, and medical devices; this industry represents an important part of the country’s industrial sector, generating significant economic activity and employment. Over 30 established international brand names operate in Malta, including several American companies. Companies meet European Union requirements for manufacturing practices and most companies are also accredited by the U.S. Food and Drug Administration.

Over the years, Malta has become an important jurisdiction for the establishment of pharmaceutical companies and the filing of patent applications. Several leading pharmaceutical companies have relocated to Malta because they have identified a vast array of opportunities. The Maltese pharmaceutical industry has been and continues to be a thriving sector.

Market Entry

The Maltese government provides comprehensive health care that is free at the point of delivery for all Maltese residents. State funds cover most medical services, including specialist treatment, hospitalization, prescriptions, pregnancy, childbirth, and rehabilitation. Consequently, the Maltese government is the primary purchaser of medical equipment. Public hospitals account for over 75 percent of medical device sales. Nevertheless, the country has a steadily growing private healthcare system which is expanding with medical tourism opportunities. Developing public-private partnerships for the healthcare industry remain high on the government’s agenda.

Current Market Trends

Despite a considerable local manufacturing industry, the domestic market for medical equipment is heavily dependent on imports. The manufacturing sector employs 2,118 full time employees (1,464 employees directly in pharmaceutical production) and has an annual global export turnover of over €295 million.

In 2014, the total expenditure on health amounted to 10 percent of GDP. Of this, the government accounted for approximately 70 percent of expenditures. The total share of government spending allocated to health reached 16 percent. In 2014, Malta spent over $1.1 billion on healthcare, equal to $2,471 per capita.

Source: WHO, Health system financing country profile: Malta, 2014

Main Competitors

Established international brand names include Amino Chemicals, Combino Pharm, Actavis, Pharmacare, Starpharma, Siegfried, Solea Pharma, Sterling Pharmaceutical Services, Medichem, Baxter, and Cardinal Health.

Malta succeeded in attracting renowned industry players, particularly in medical device manufacturing (Baxter, Cardinal Health), pharmaceuticals (Actavis/Watsons), and related ancillary services including the production of active pharmaceutical ingredients (Amino Chemicals, Sterling), product development and technologies, formulations and improvements, laboratory testing, batch release for the EU market, repackaging activities, specialized packaging and printing (including blister lines), and logistics.

All of these companies are export-oriented, and do not manufacture for the local market. Most choose to operate from Malta due to a number of strategic advantages, including a strategic geographic location, EU and Eurozone membership, an attractive tax system, the authorization of registered products mutually recognized in the EU, a highly skilled, qualified, dedicated and multilingual workforce, and the recognition of a research exemption for generic pharmaceutical development.

Registration Process

Some medical devices in Malta need to be registered with the Malta Competition and Consumer Affairs Authority (MCCAA), depending on their classification. Only Class I medical devices that will be placed on the EU market for the first time through Malta have to be registered with MCCAA. Nonetheless, custom made medical devices and low-risk in-vitro medical devices also have to be registered with MCCAA. The EU’s three Medical Device Directives require that a non-EU manufacturer must appoint an “Authorised Representative,” which must be established in the European Union, to act on the manufacturer’s behalf in carrying out certain tasks.  The official form to register Class I medical devices is available at http://mccaa.org.mt/en/medicaldevices  and registration costs €40. Once registered with the local authority, the medical device is then included in the European Databank on Medical Devices (EUDAMED), which is a secure web-based portal which serves as an information exchange between EU countries.

The languages of all labelling and instructions for use of medical devices placed on the Maltese market have to be in at least English or Maltese. The instructions for use must be included in the packaging for every device; however, no such instructions for use are needed in Class I or Class IIa products if they can be used safely without any such instructions.

More detailed information can be found in the Medical Devices Regulation applicable for Malta at http://justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=10781&l=1.

Barriers

There are no other significant trade barriers or limitations on imports of U.S. goods. Technical specifications are essentially those established by the EU, which have been incorporated into Maltese law.

Trade Events

No international trade events are held in Malta.

Local Associations

Malta Chamber of Commerce and Industry: http://www.maltachamber.org.mt/

Medical Association of Malta: http://www.mam.org.mt/

Association of Medical Representatives: http://www.amrmalta.com/index.htm

Government Links:

Healthcare Procurement:

http://health.gov.mt/en/cpsu/Pages/Procurment/Published-Calls.aspx

https://www.etenders.gov.mt/epps/home.do

http://contracts.gov.mt/en/Pages/Home-DepartmentOfContracts.aspx

Government Health Plans: http://health.gov.mt/en/Pages/health.aspx


Best Prospects

The Government of Malta is investing heavily to create develop the life sciences sector in support of the larger healthcare industry. The Life Sciences Park aims to enable the creation of a research, development, and innovation cluster on the islands. The project, managed by Malta Enterprise in collaboration with the University of Malta and Mater Dei (the national hospital), consists of an investment of around €38 million. The project is strongly supported by fiscal and financial incentives and training aids to attract companies that are active within the industry.

The life sciences sector is hoping to build on anticipated synergies with other sectors, such as information and communications technology (ICT) and health research. Furthermore, this industry is supported by incentives specifically for projects undertaken in industrial or experimental research. There are also incentives for feasibility studies, as well as collaborative research projects under EU programs, including Eureka, Horizon 2020, and Eurostars.

Pharmaceutical firms setting up in Malta benefit from the Maltese legal framework which allows for the development of generic drugs in advance of patent expiry. Malta is one of the few EU member states that in 2003 fully recognized the research exemption, by which generic companies are allowed to undertake development work prior to patent expiry – held by originators – but excluding any product commercialization. The manner in which the Maltese Patent and Designs Act has been adopted allows generics companies to carry out testing and trials needed for regulatory approvals prior to the expiration of the patent in question. Therefore, a generic pharmaceutical company in Malta may manufacture a drug, complete all the mandatory testing requirements to obtain the necessary approvals, and, upon expiration of the competitor’s patent, release their product onto the market without undue delay. All obligations arising from the Patent Cooperation Treaty and European Patent Convention are also incorporated into Maltese legislation, ensuring that property rights registered in Malta are automatically extended to the territories of all other signatories.

U.S. Commercial Service Contact Information

Name: Maria Cassar

Position: Commercial/Economic Specialist

Email: cassarm@state.gov

Phone: (356) 2561 4120


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