Joanna Krakowiak

How long before generic drugs can be marketed?

Generics are substitutes for an original drug. May they be marketed as soon as the 10-year regulatory protection period for the original (innovative) drug ends?

Yes. On 1 May 2011 the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) dated 18 March 2011 goes into force. The act includes an amendment to the Polish Pharmaceutical Law extending the regulatory protection period. Instead of 6 years, as before, in line with Directive 2001/83 on the Community code relating to medicinal products for human use, the period will now be 10 years, and may be extended to 11 years in some cases.

Data exclusivity is the right of the producer of an innovative drug to protection of the results of research on the new drug and the dossier prepared in order to register the drug. A generic manufacturer may rely on the research conducted by the producer of the original drug, but only after the end of the data exclusivity period. Waiting until the end of the data exclusivity period makes life easier for producers of generic medicines because the documentation they must present in order to register a generic drug is much shorter and simpler to compile than the dossier that must be presented by a producer planning to introduce an innovative drug.

A manufacturer of generics may not rely on the original research until at least 8 years after the initial registration of the original drug in the EU, and may not market the generic until at least 10 years following the initial registration in the EU. The period between 8 and 10 years may be used by a manufacturer of generics to carry out the registration procedure in Poland before the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. If the generic manufacturer obtains consent from the owner of the innovative drug, however, it may use the results of the research without waiting until the end of the data exclusivity period.

Joanna Krakowiak, Life Science & Regulatory Law practice, Wardyński & Partners

This text was published on 29 April 2011 in Dziennik Gazeta Prawna daily, in the “Commercial Law Academy” series