Implications of empirical data: are pharmaceutical linkage regulations a success?*


Canada’s linkage regime for pharmaceuticals was brought in under intense political pressure specifically to balance effective patent enforcement over new and innovative drugs with the timely market entry of lower priced generic competitors. It has been almost two decades since the regulations were enacted and to date there has been little objective assessment as to whether the regulations have, in fact, stimulated innovation and timely generic entry. This chapter discusses the implications of the empirical data reviewed in Chapters 35 for the legal legitimacy of pharmaceutical linkage given the purpose and intent of this legislation noted above. ...

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