Drug Regulation

Pricing on the other side of the globe: Drug Manufaturers speak up in Canada.


If developing countries, thought that the problem with strict regulations, generic drugs and pricing only affected one side of the globe, latest developments in Canada definitely prove them wrong.

Canadian generic drug manufacturers are urging their Parliament (and even considering going to Court) to forfeit the idea of new regulations that if implemented, would delay their ability to reproduce drugs, including Viagra and Lipitor. Previously, a manufacturer could (through a Court order) block Health Canada’s approval of the generic competitor for two years. However, the new regulations in effect overturn the intention of several judicial pronouncements. The regulations may also cost Canadian citizens much more as per the statements by the Canadian Generic Pharmaceutical Association.

Under the new rules, patents that have been removed from drugs that were on the market prior to June 17, 2006, could be reinstated which essentially could allow brand names to extend their monopoly on drugs that are priced on the higher end of the market and/or on those that are in demand (such as Liptor). Regular SpicyIP readers will remember that we have blogged extensively on the pricing debate across several countries. With manufcturers even in developed countries facing the brunt of drug monopoly, it is time to for Government’s to understand the consequences of patent reforms encouraging monopoly. While on one hand, there is a strong lobby for building a strong R&D base and long term investment in a country with extensive capital from drug manufacturers, on the other hand, as a State responsible for making decisions that affect several groups of people (not just the poor, or the rich), extending monopoly of drug manufacturers especially on generic drugs especially those priced on the higher end of the market increase expenditure, and in several cases (if extremely essential in the health care system of the country) are out of reach of the common man.

This post like the one on the ban on varities of rice with GI protection is sure to generate debate of similar nature. But these are just some ideas that must be considered and if necessary, thrashed about to understand them in their entirety.

Read the full report here.

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