This month, after years of discussion, Canada signed a Canada-EU Free Trade deal. The Comprehensive Economic Trade Agreement (CETA) is testing the waters for dropping import tariffs on everything from cars to food in trade between Canada and the European Union’s member states. Part of the agreement includes pharmaceutical imports, which is, understandably, a game changer for the industry.
At this stage in negotiations, this includes establishing working groups to resolve differences in Canadian and European standards, not necessarily topics such as pharmaceutical quality assurance, which is already more or less in sync, but to help facilitate negotiations of the ownership of ideas and their use. Further extension of CETA may even tackle the intellectual property law differences, to make them mirror each other.
To be exact: Although formally, patents last the same span of twenty years in each jurisdiction, the finer points of patent law varies between Canada and Europe, based on the different circumstances both legal entities developed their rules, but there is a great deal of parallel evolution. For example, both include different measures to allow the extension of patent lifespan to facilitate clinical research, albeit this selective favouritism is not applied evenly. For example, Canada awards an extra six months on the eight-year exclusive use of data, if it’s for paediatric purposes, while Europe encourages investment in rare diseases and conditions by allowing for additional extensions on patent terms. Other compensatory measures affect the process. For instance, in Europe patent lifespans have protective padding to help with delays in processing approval for commercialization.
Impact of the CETA on the Canadian Pharmaceutical Industry
At this point and time it is difficult to judge whether this will be a net negative or positive to the Canadian pharmaceutical industry. For example, CETA gives Canada access to the largest market in the world, but is balanced by Europe’s productive capacity. One of the most commonly discussed subjects surrounding CETA’s influence on the pharmaceutical industry is the effect on the price of generics. At the moment, shorter intellectual property restrictions make the time it takes to get access to the information needed to develop generic drugs shorter in Canada. This gives Canadian generic manufacturers an advantage that, should regulations be brought more in line with each other, will mean a price raise for the end consumer.
Wondering how this will affect you as a part of the industry? While the deal has been signed now, it’s not going to come into effect until 2015. Thus, regardless of whether you’re in regulatory affairs or pharmaceutical sales, now is the time to chart a career and choose the pharmaceutical courses that will help you navigate industry changes.
For the pharmaceutical industry, do you agree with the implementation of CETA?