Malta - Generic Medicines as a Legal and Safer Alternative to C

Daniela Bartolo | Published on 25 Sep 2012

Chetcuti Cauchi Lawyers

While the debate on the ACTA Treaty has shed further light on the market share of generic products, the debate has also shed light on the stark difference between generic medicines and counterfeit products.

Generic drugs are medicines that contain the same active ingredients as a branded product and are thus comparable to a branded drug in terms of the dosage form, strength, administration mode, quality and intended use.  Counterfeit medicines, on the other hand, are medicines that are mislabelled and that are misleading with respect to the source of the producer. Unlike generics, counterfeit medicines may include ingredients that are harmful or may fail to have the active ingredients necessary to provide the desired therapeutic effect.

In the wake of the debate on ACTA, the Maltese government has launched a proposal for a discussion to secure the combating of counterfeit medicines. Its position is that while Malta is adamant at combating counterfeit medicines, Malta is one of the few EU countries that continues to fully embrace the nature of the so-called Bolar Provision

By virtue of this provision which is deemed as an exception to the restrictive exclusivity rights granted to patent holders, generic companies in Malta may carry out clinical trials and commercial testing for the purposes of obtaining regulatory approval or other commercial purposes prior to the expiration of the lifetime of the patent concerned. Upon the expiration of the patent concerned, generic companies may put their products on the market without undue delay.

This ensures that while Malta retains a firm stance against counterfeit products, the generics industry continues to thrive thus securing wider access to pharmaceutical products.

Chetcuti Cauchi has fully fledged IP & Tax Practise Groups that assist clients in protecting their inventions through domestic, direct registration, patent validation or international patent protection excercises. Our firm has also advised generic pharmaceutical companies in obtaining advice on their position within the local market and in setting up herein. We urge you to contact us for further detailed information on this matter. 



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