The Manufacture of Generic Pharmaceuticals in Malta: A First Step

Abstract

Malta, with a population of circa 400,000 and no natural resources, has had to exploit every niche business opportunity to enhance its economic prosperity since gaining independence in 1964. In this respect, current endeavours are focused on the generic pharmaceuticals industry. This sector should form the foundation upon which to build a Mediterranean healthcare centre of excellence. This paper explains why generic pharmaceuticals manufacturers locating in Malta within the next few years will have a distinct competitive advantage. Timing holds the key to success in this fiercely competitive industry. Malta offers a unique blend: the Bolar exemption incorporated into patent legislation; the negligible number of patents registered; and its location between Southern European and North African markets. Together, these bestow the desired timing and attractive marketing opportunities for generics manufacturers.

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References

Malta Medicines Act: Act III of 2003 Medicines Act, Chapter 458 of the Laws of Malta.

Ministry of Finance and Economic Affairs (2003) ‘Economic Survey’, January—September.

Patents and Designs Act, Chapter 417 of the Laws of Malta, para. 27(1).

Ibid; para. 27 (2).

Ibid; para. 27 (6).

Case (WT/OS114/R).

Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, Art. 28.1.

Ibid; Art. 30.

The acquis communitaire is the body of common rights and obligations which bind all member states together within the EU (available at europa.eu.int).

10.

The figure of 400 refers only to employment in the generics industry. Employment in the private healthcare production sector in Malta is around 3,000 people, representing 10 per cent of the working population in the production sector.

11.

The University of Malta is state funded. Its 40 faculties confer degrees that are recognised worldwide. The university is one of the oldest in the Mediterranean and is managed independently by a senate made up of leading academics, businessmen and students.

12.

The Malta College of Arts, Science and Technology (MCAST) comprises 11 institutes, focusing on vocational training up to tertiary level.

13.

The Business Promotion Act, in fact, regulates Malta's incentive package: Chapter 325 of the Laws of Malta and subsidiary legislation 325.06, dated 1st November, 2000.