Malta Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in malta, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
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Medical Equipment/Healthcare/Pharmaceuticals
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Overview

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 began promoting public-private partnerships in the healthcare sector to establish Malta as a Mediterranean hub for medical tourism and to manage part of its public health care system.  The government allocates a substantial portion of its budget to health, including investments in healthcare infrastructure.

The Maltese healthcare manufacturing sector currently focuses 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.  More than 30 established international brand names operate in Malta, including several U.S. companies.  Companies must meet EU requirements for manufacturing practices and most also receive U.S. Food and Drug Administration accreditation.

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.

In 2018, Malta enacted the ‘Production of Cannabis for Medicinal and Research Purposes Act’, which regulates the cultivation, processing, production, and trade of cannabis for medicinal and research purposes.  This law allows operators the use of medical marijuana locally to produce and export cannabis to global markets provided that they comply with all necessary regulations including obtaining a letter of intent from Malta Enterprise and a license from the Malta Medical Authority. 

Leading Sub-Sectors

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 fully recognizes the research exemption of the Patent Cooperation Treaty and European Patent Convention, by which generic companies can undertake development but not commercialization of drugs prior to patent expiry.  Therefore, under the Maltese Patent and Designs Act, 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.  Maltese laws incorporate all obligations arising from the Convention, ensuring that property rights registered in Malta automatically extend to the territories of all other signatories.

Opportunities

The Government of Malta is investing heavily to develop the life sciences sector in support of the larger healthcare industry.  The Life Sciences Park, a project supported by the government, aims to enable the creation of a research, development, and innovation cluster on the islands.  To launch this project, which is managed by Malta Enterprise in collaboration with the University of Malta and Mater Dei (the national hospital), the government invested around $47 million.  It continues to support the project with fiscal and financial incentives and training aids to attract companies that are active within the industry.

The life sciences sector expects to build on anticipated synergies with other sectors, such as information and communications technology (ICT) and health research.  There are also incentives for feasibility studies, as well as collaborative research projects under EU programs, including Eureka, LIFE program for the period 2021-2027, and Eurostars. 

With the legalization of marijuana, there are opportunities for entities to cultivate, import, process, and produce cannabis intended for medical and research purposes under a controlled and supervised environment.

Several large public health sector projects are also in the pipeline.  Opportunities exist for equipment manufacturers, pharmaceutical companies, medical service providers, and health care infrastructure developers.

Resources

Life Sciences Park

Medicines Authority:  www.medicinesauthority.gov.mt

 

 

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