(2003; 82 pages)
2.6 North America
Anderson M, Auld C, Bolton C, Gregory A, McBride J. The economic impact of Bill C-91 on the cost of pharmaceuticals in Canada. Kingston, Canada, Queen's Health Policy Research Unit, Queen's University, January 1997.
Compulsory licensing for drug patents was introduced in Canada in 1923. However, in 1987, Bill C-22 was passed to provide the patent holding firm with a 7-10 year period of market exclusivity before the entry of generic drug competition. In 1993, after the passage of Bill C-91, the compulsory licensing provision was eliminated and patent protection of brand-name drugs was extended to at least 20 years. This study focuses on the economic impact of Bill C-91 on the cost of pharmaceuticals in Canada. Three different scenarios are modelled using the cases of 7 or 10 years of patent protection from launch date, as provided under Bill C-22, compared to a 5-year extension of current patent protection (total 25 years). The authors conclude that in each model consumers would incur substantial costs because of the extended patent protection on new drugs, estimated at between $ 3.7 and $ 9.4 billion.
Congressional Budget Office. How increased competition from generic drugs has affected prices and returns in the pharmaceutical industry. July 1998. Available on the web at: http://www.cbo.gov
In 1984, the United States Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act) created an abbreviated approval process for generic drugs and, at the same time, extended patent terms for innovator drugs. This study examines the price competition among manufacturers in the pharmaceutical market, including the impact of the dramatic growth in the generic drug industry since 1984. Such competition comes in three main forms: between brand-name drugs in the same therapeutic class, between brand-name drugs and their generic counterparts, and between different generic versions of the same drug. This study also analyses the changes in patent protection for brand-name drugs as well as supply-side factors that have boosted generic market share, in order to assess how that competition has affected the returns from developing a drug.
Hunt MI. Prescription drugs and intellectual property protection: finding the right balance between access and innovation. Washington, D.C., National Institute for Health Care Management Research and Educational Foundation, August 2000.
This report is devoted to the examination of the most important law pieces related to IPP for pharmaceuticals approved in the United States of America during the last two decades, from the 1983 Orphan Drug Act to the 2000 Pipeline Drug Proposals with mention of the Uruguay Round Agreements Act and the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman). It also takes into account the effects of this enhanced protection on technological innovation and the market for prescription drugs. The report asserts the critical impact of current patent laws on the price of prescription drugs and general public health costs. It pays close attention to some of the reported benefits of IPP, such as the support for technological innovation, showing in contrast the major role played by IPP, not only in protecting pharmaceutical industry profits but also in delaying the entry of affordable generic drugs onto the market and shielding brand-name drugs from price competition. The report concludes by asking for greater vigilance on the part of public authorities on the use by private companies of public funds devoted to R&D while signalling that, within the period 2000-2005, some of the most lucrative brand-name drugs will go off patent, leaving the way open for their replacement by generic drugs in prescription schemes.
Kanavos P. Health policy versus industrial policy in the pharmaceutical sector: the case of Canada. Health Policy, 1997, 41, 241-260.
All governments face the dilemma of balancing a dual role of encouraging the pharmaceutical industry while at the same time attempting to contain the costs of pharmaceutical products. This paper analyses the trade-off between health policy and industrial policy objectives in the Canadian setting. It provides a brief overview of the Canadian health system and the domestic pharmaceutical industry. It examines pharmaceutical policies at the federal and provincial level, and discusses the impact of federal health and industrial policies on the provincial objectives for pharmaceutical cost control.
Prime Institute. The cost of Bill C-91: An economic impact analysis of the elimination of compulsory licensing of pharmaceuticals in Canada. Prime Institute, College of Pharmacy, University of Minnesota, January 1993.
This study was reported in 1993 before the promulgation of Bill C-91, to show the possible impact if the compulsory licensing of pharmaceuticals were eliminated as the result of this legislation. The author argues that, although the passage of this Bill may have a number of positive effects for some sectors, there would also be major costs in terms of increased pharmaceutical expenditures throughout Canada. The author claims that the magnitude of direct costs due to Bill C-91 over the subsequent 15 to 20 years, $ 3.6 to $ 7.3 billion, would far outweigh the direct benefits, $ 500 million, in increased R&D spending in Canada.
Rhein R. Patent passions run high in Canada. Scrip Magazine, April 1998, 37-39.
Since the passage of the controversial Bill C-91, the Canadian generics industry has been campaigning for the repeal of at least some of its provisions, such as the link between a drug's notice of compliance and its patent status. However, the Government revisions have not lived up to the industry's expectations.
Torremans P. Compulsory licensing of pharmaceutical products in Canada. International Review of Industrial Property and Copyright Law (IIC), 1996, 27(3): 316-331.
Canada had always stood out for its special policy in relation to pharmaceutical patents until important changes took place at international level with the negotiation of the NAFTA and the TRIPS Agreement. Compulsory licences were at the centre of all these debates and they have attracted attention in Europe. This article investigates what pattern is to be found in all these developments and what are the advantages and disadvantages of the various regimes. It seeks to demonstrate that the new system, while perfectly acceptable in principle, can be improved on a series of points, and that experience under European law can be of assistance.
Wilcox PR. Pharmaceutical patent litigation in Canada. Patent World, May 1996, 26-30.
Pharmaceutical patent litigation in Canada is a burgeoning field. Since 1993, when compulsory licences as of right were abolished and the patented medicines (notice of compliance (NOC)) regulations were enacted, the opportunities for pharmaceutical patentees to enforce their rights have dramatically improved. As a result, a number of legal proceedings have been initiated by pharmaceutical patentees since 1993, including actions for patent infringement and court applications pursuant to NOC reglations.