The challenges of pharmaceutical law

What issues are addressed in the draft amendments to the pharmaceutical law ? 

The draft legislative Act – the Pharmaceutical Law, having as it does the objective of implementing European Union law in Poland, introduces a considerable number of changes to the Polish legal system. To dwell for a moment on the more important ones, we might begin with amendments to the catalogue of statutory definitions. The definition of medicinal minerals, for instance, was dropped from the Act in reflection of the fact that marketing of medicinal minerals no longer requires a permit (a development welcomed by spas).

The draft introduces a definition of mail-order sales of medicinal products; this is a topic which warrants separate discussion. The next proposed change comprises expanding the catalogue of products which may be marketed without a permit by introducing the concept of “advanced therapy medicinal products”, i.e. products prepared in Poland on a non-systematic basis in compliance with applicable quality standards for use by a medical facility in Poland for treatment of a specific patient at the sole responsibility of her/his attending physician. Other proposed changes concern the exclusivity of data covered by the proscription on referring to registration documentation of an original medicinal product, with the basic six-year exclusivity period now applied to be extended to eight years (with this basic period extendable by another two years, and by an additional year if the responsible entity receives approval for another treatment recommendation with respect to the given product).

It should be borne in mind that, as per the proposed interim solutions for reference medicinal products with respect to which an application for marketing authorisation has been filed prior to 1 November 2005, the previous regime shall apply. As a corollary, the new rules would apply to products with respect to which the application for marketing authorisation has been filed after 1 November 2005. The draft amendments also include considerable changes with respect to clinical testing and tweaks the rules regulating advertisement of medicinal products. It also proposes to repeal in its entirety the legislative Act of 27 July 2001 regarding the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which would be supplanted by a new statute, and also certain executory instruments to the Pharmaceutical Law. These, as it were, additional statutes are being drafted alongside the new Pharmaceutical Law.