Pharmaceutical industry in Malta: The Bolar exemption and pharmaceutical innovation

The pharmaceutical industry in Malta is thriving, thanks in part to the early introduction of the Bolar provision. Companies wanting to become active in Malta can rely on numerous incentives. These range from loans and subsidies to facilitate access to finance and investment grants to the provision of industrial sites and regulations to promote research and development.

Malta’s strategic geographical position, coupled with the advantages it offers as a fully-fledged member of the European Union, has over the years attracted numerous businesses to the country. The pharmaceutical industry is one such industry which has thrived within Malta’s enhanced infrastructure to support biotechnology and the life sciences, as the Ecovis experts know.

The Bolar exemption

In particular, Malta was a pioneer in adopting the ‘Bolar provision’ in 2003, arising from the US case of Roche Products vs. Bolar Pharmaceuticals. As a result, Maltese legislation allows for the early development and testing of generic products even before the patent expires. This means that the generic product is in an advantageous position to hit the market without any undue delays as soon as the patent expires.

Do you want to expand your activities in the pharmaceutical industry? We will help you to obtain financing, investment grants or access to top-notch research facilities.

Dr Roberta Avellino Pulé, Senior Legal Consultant, ECOVIS Malta, Mosta, Malta

Promoting the development of generic drugs

The Bolar exemption aims to facilitate the development and regulatory approval of generic drugs by allowing manufacturers to conduct necessary research and testing without the risk of infringing on patent rights, which protect the patent holder for 20 years. The exemption strikes a balance between intellectual property rights and public health interests. It ensures that once the patent protection expires, generic drugs can be readily available in the market, enabling greater access to affordable medications.

Malta Medicines Authority

The Malta Medicines Authority licenses and regulates pharmaceutical companies, ensuring that they adhere to good manufacturing practices. This esteemed authority holds a strong reputation both within Malta and on an international level. Its responsibilities include reviewing and granting licenses and authorisations for all medicinal products, while also actively competing with other jurisdictions to attract pharmaceutical companies to register their products in Malta for batch release, testing, and validation.

For further information please contact:

Dr Roberta Avellino Pulé
Senior Legal Consultant
ECOVIS Malta, Mosta, Malta
Email: malta@ecovis.com