Healthcare & Pharmaceuticals
The health care and life sciences sectors in Malta have grown exponentially over recent years and are major stakeholders in Malta’s advanced manufacturing industry. These sectors have proven to be resilient in the face of the catastrophic financial downturn experienced in the last years, and are expected to grow. IMS Health has estimated the global pharmaceutical market alone to be worth over $800 billion with an annual growth of 7% in 2009.
Home to the up-and-coming Life Sciences Park, Malta will soon boast a state-of-the-art 10,000 square metre location that include laboratories, offices and conference facilities, and an additional 3,500 square metre area for incubation facilities in the immediate vicinity to Mater Dei Hospital, the University of Malta and the offices of Fenech Farrugia Fiott Legal. The Life Science Park has been cited as the ideal setting for researchers and companies operating in all fields related to the biotechnology and medical sciences.
Employing nearly 2000 people in at least 19 companies, which include Actavis, Siegfried, Amino Chemicals and Baxter; the Health care and Life Sciences sectors in Malta benefit from a highly educated English speaking workforce, a modern operational infrastructure, EU membership and direct access to markets in mainland Europe and North Africa.
The first ever pharmaceutical patent directory registered in Malta was launched in July 2009 and the Seventh World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, which attracted around 1,500 scientists and academics worldwide, was held in the Mediterranean Conference Centre in Malta in March 2010.
The Legal and Regulatory Frameworks
The laws regulating medicinal products for human use, chemicals and medical devices in Malta are harmonised with the relevant EU legislative frameworks. Malta ensures good manufacturing and good distribution practices through its regulatory authorities and has fully implemented EU legislation relating to importation and parallel importation, licensing/marketing authorisation, packaging and labeling, wholesale distribution, clinical trials, pharmacological and advertising of medicinal products; classification, labeling and packaging of chemicals under REACH; and medical devices legislation and regulatory requirements.
The Maltese government is committed to supporting the healthcare and life sciences industries. A number of incentives have been introduced in recent years to attract pharmaceutical companies to set up their production and R&D bases on the island. These incentives include tax measures, the provision of custom-built industrial premises at low rates of rent, preferential loan financing, loan guarantees and assistance in training of employees.
Generic medicine manufacturers in Malta benefit from the Bolar Exemption. This allows pharmaceutical companies who are not the patent holders to carry out preparatory work, including development and licensing while the originator medicinal product is still under patent. The Bolar Exemption offers a significant competitive advantage as the generic medicine may be marketed immediately upon patent expiry.
Through a system of tax refunds, operations carried out by Maltese companies engaged in the health care, life sciences (particularly in the pharmaceutical industry) can produce attractive tax results. Further information about Tax Refunds is available in our Tax Consultancy section.
Companies engaged in qualifying activities are eligible to investment aid and tax incentives. Qualifying activities include:
- the production, manufacturing, processing of pharmaceuticals
- R&D activities and R&D related services
- IP development
- investment in health care services and medical equipment
Incentives for qualifying activities take the form of tax credits that are deductible from tax due on profits derived from such activities.
The supply of pharmaceutical goods qualify for an exemption with credit for VAT (zero-rated).
Set within the firm’s Corporate and Commercial Law unit, our Health and Pharmaceutical Law practice is well-positioned to assist health care and life sciences companies in setting up in Malta, and accessing all applicable grants and incentives. Our team offers legal consultancy in competition/antitrust law, consumer law and product liability, intellectual property rights, and all aspects of regulation governing industry and licensing, as well as post-licensing of products for manufacture, distribution and use in Malta and the EU.