Pharma Industry powered by patent Law
Providing the right ingredients, Malta’s expanding reputation as a pharmaceutical manufacturing centre is attracting global attention.
A relatively new sector in Malta, pharmaceuticals is also one of the islands’ greatest success stories. Today’s thriving pharmaceutical industry is just over 5 years old, yet already employs well over 1,000 people and has attracted a number of pharmaceutical manufacturers to the country. Attracted primarily by the islands’ legal framework that allows the development ofgeneric drugs in advance of patent expiry, companies migrating to Malta also benefit from a well-stocked pool of qualified personnel, a modern infrastructure, ED membership and direct access to markets in mainland Europe and North Africa.
Pharmaceutical exports continued to grow in 2008, going up from 152 million euro in 2007 to 168 million euro in 2008. While the industry reported a decline in sales of around 12.5 per cent in 2009, to 147 million euro, this was mainly due to a shift in exporting trends, with manufacturers choosing to sell to domestic intermediaries outside the sector, who then exported the products themselves. Nevertheless, in 2009 the industry generated 96 million euro of gross value-added to the economy. In the first nine months of 2010, the pharmaceuticals sector embarked on a strong recovery and the value of exports topped 176 million euro, a 12 per cent increase on the previous year.
In the meantime, pharmaceutical companies have continued to set up facilities in Malta, with one of the most recent being India’s Aurobindo Group, while generics manufacturer, Actavis Ltd, announced in September 2010 that the company would be investing a further 12 million euro in new R&D facilities to complement its existing operations.
History in Healthcare
Malta claims a long tradition serving Europe’s health and pharmaceutical sectors. The Knights of St Iohn built a hospital in 1574 which was considered to be the most advanced in Europe in its time; the Maltese medical school is one of the oldest in the Commonwealth; and the School of Anatomy and Surgery, set up in 1676, is a historical reflection of the islands’ history of dedication to healthcare. This tradition continues today with the islands’ pharmaceutical industry, which is mainly composed of generics manufacturers, producers of active pharmaceutical ingredients and producers of health care products and services.
Favourable Legislative Provisions
Malta’s patent legislation is strong and the intellectual property environment provides all the necessary safeguards for the development of innovative medicines by pharmaceutical companies. However, because of the small size of the domestic market, Malta falls outside the patent jurisdiction of a number of pharmaceutical products. Malta’s patents and designs legislation incorporates the ‘Bolar’ provisions, which clearly define the circumstances in which the proprietors of a patent cannot prevent third parties from performing development work that would otherwise be protected under the patent legislation. Because of this legislation, generic manufacturers are able to develop their new drugs – conduct tests and trials on patented pharmaceuticals in support of filing applications for marketing authorisation – whilst the originator product is still under patent. They will then be ready to market it immediately when the patent expires, gaining up to a year on manufacturers in countries without the Bolar exemption.