Availability of hormone replacement therapy products in Canada.

OBJECTIVES: To determine the availability in Canada of different types of hormone replacement therapy (HRT) products, and to compare the availability of HRT products in Canada to their availability in other countries. METHODS: A systematic review was conducted of the availability of products indicated for treatment of menopausal symptoms in Canada, the United States (US), the United Kingdom (UK), Sweden, and Australia. Products indicated for the treatment of menopausal symptoms were determined for each country by using on-line drug product databases. Products administered by injection and androgen products, unless combined with estrogens, were excluded from the analysis. RESULTS: There were 111 different brands identified in the 5 countries examined, with Canada having the lowest number of brands and active ingredients (28 and 22, respectively) compared to the other countries (Sweden and UK at 67 and 47 brands and 39 and 40 active ingredients, respectively). Not available in Canada are 34 active ingredients (either alone or in combination products) and 5 different types of formulations of HRT. There was a significant difference between the number of combination brand products available in Canada and in the UK (5 versus 29, P <.001, respectively). CONCLUSIONS: Canadian women have comparatively few options available to them for the management of menopausal symptoms. The wide range of HRT products available in other developed countries provides alternatives for managing side

Canadian access to hormonal contraceptive drug choices.

On October 29, 2002, Health Canada issued Guidance for Industry: Clinical Development of Steroidal Contraceptives Used by Women. The original draft of this guideline, published July 4, 2001, included recommendations for clinical trials in excess of those required in Europe and the United States. The proposed requirements, which reflected Health Canada's views, had the potential to discourage contraceptive research in Canada and to block registration of new products. To evaluate the impact of Canada's hormonal contraceptive regulation, a comparative analysis of the availability of products in various countries was performed, along with an evaluation of the time required from submission to approval of a new drug. Women in Canada have access to 35% of the contraceptive products available worldwide and to 37% of the hormonal contraceptives available worldwide, compared with 58% and 59% respectively, in the United States; 52% and 54% respectively, in the United Kingdom; 44% and 54%, respectively, in France; and 44% and 50% respectively, in Sweden. Regarding the more recent contraceptive products available worldwide, women in Denmark have the most choices (67% of available products), whereas women in Canada have the least (only 22% of available products). Eleven of 12 oral contraceptive products recently approved in other countries have either not been submitted for approval in Canada or remain in the Canadian regulatory process. Although the time-to-approval period in Canada, for drugs in general, is 6 months longer than in the United States, the mean lag time for 6 contraceptive products is 29.6 months as of January 1, 2004, and no oral contraceptives have been approved in Canada since 1997.