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Time to repair the drug patent process in Canada

Longer drug pat ent s will not at t ract new research
A version of this commentary appeared in the Windsor Star and the Huffington Post Last week the f ederal government signalled that, to reach a new trade agreement with Europe, it might extend pharmaceutical patents. T he move could cost Canadians up to $2 billion per year. Supporters argue that it will attract research investment and generate jobs. But longer drug patents will not attract new research to Canada. Pharmaceutical f irms locate research investments on the basis of the quality of local scientists and the cost of running clinical trials. If we want industry to invest in Canada, we need to invest in our capacity to conduct research. One way would be to double the budgets of the Canadian Institutes of Health Research which would cost less than extending pharmaceutical patents. But if Canada must change drug patents to win a trade deal, lets at least f ix our broken intellectual property system while we are at it. T he patents that apply to other technologies f ail the pharmaceutical sector. T hey f ail f or a number reasons. First, most patented medicines must be studied in clinical trials to establish that they are saf e and ef f ective enough to be sold to Canadians. T his can take years af ter f irms f ile their initial patents, which reduces the time they can charge monopoly prices (the carrot that patents create to give f irms incentive to develop new drugs). T he proposal to give f irms a guaranteed period of market exclusivity (i.e., a guaranteed length of monopoly sales) af ter regulatory approval would not only benef it f irms, it would also allow regulators to demand better pre-market drug trials and to take more time to evaluate trial data. T he current rush to approve medicines while manuf acturers patent clocks are ticking means that some medicines make it to market that later must be recalled because of harms they cause to patients harms that could be detected with more thorough pre-market evaluation. T he second f ailing of the patent system f or pharmaceuticals is that, although disclosure of scientif ic inf ormation is a key benef it of the patent system, the inf ormation of greatest value to society is not publicly disclosed when a patent is f iled. T his is because data about the saf ety and ef f ectiveness of most medicines is gathered af ter patents are granted. Few Canadians realize that pharmaceutical companies can and do keep regulatory data about saf ety and ef f ectiveness secret. T his secrecy should end. And it can be ended by making f ull public disclosure of regulatory data a condition of extended pharmaceutical patents. Finally, the patent system f ails in the pharmaceutical sector because nobody appears to know when generic

competitors can enter the market. T his is because pharmaceutical companies of ten f ile multiple, overlapping patents on the same drug and use these of ten-bogus patent claims to block regulatory approval of generics. T his generates a lot of income f or patent lawyers and consultants but provides no value to society as a whole. If the International Trade Minister wants to extend drug patents, the Health Minister should use the opportunity to improve our regulatory system too: Provide a clear and unambiguous period of market exclusivity af ter a drug has met high standards of pre-market regulatory approval; Require that all data considered by that regulatory process be made available to the public; And allow all generic competition as soon as the period of market exclusivity has expired. Such a system would be a windf all f or truly innovative pharmaceutical companies, would dramatically improve regulatory transparency, and would likely mitigate the aggregate cost-impact of conceding pharmaceutical patents as part of our trade negotiations. But simply granting longer drug patents under the guise of attracting research investment is patent nonsense. Steve Morgan is an expert advisor with EvidenceNetwork.ca and Associate Professor and Associate Director of the Centre for Health Services and Policy Research at the University of British Columbia.