Malta is the only EU country which allows for the testing, production and stockpiling of Generic pharmaceutical products prior to that product’s EU patent expiry.
How is this possible?
Firstly Malta’s Patents and Designs legislation incorporate within them the “Bolar” Provisions which allows a company to develop and stockpile a particular generic prior to its patent expiration.
Secondly because of its size, Malta has seen very few patents being registered as most international firms do no bother to register locally thus giving other companies the time to develop, license and stockpile a particular product prior to patent expiry enabling the flooding of the market as soon as a particular patent expires.
Malta’s entry into the EU has further strengthened Malta’s position by enabling companies to market their generics in North Africa and beyond especially to the rest of the African continent, as well as to South America,thanks to the authorization of the Maltese regulatory body as an EU member state.
Thirdly Malta embraces the inward processing relief (IPR) mechanism on imports. This mechanism provides an exemption or reduction in import duties of raw materials utilised for the export out of the EU of the final product.
Fourthly this Industry benefits from very attractive investment incentives such as investment tax creditsamounting from anything from 30% to 50% of
A. The amount invested in qualifying expenditure
B. The cost of wages
The percentage of tax credits being dependent on the size of the company.
There are also very attractive additional tax credits on / or Grants on R&D varying from 35% to as much as 80%
Another advantage is a tax exemption in income from patents registered in Malta. Moreover patents moved to Malta can benefit from a top up provision.
Finally Malta’s extremely attractive general tax refund system, complete with a ready pool of professional
English Speaking Graduates makes the package complete and hard to beat for pharmaceutical generics industry.