In Canada's pharmaceutical industry, strategic decisions on how to best launch a drug and how to best maintain a drug’s market exclusivity are influenced heavily by the regulatory framework. The pricing of patented drugs is regulated both federally and provincially.
In the United States, strategic decisions on issues relating to the termination of distributors of alcoholic beverages are heavily influenced by the United States Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), as well as by individual state laws.
We advise clients on regulatory and pricing issues, as well as on drafting and negotiating agreements. We also advise on consents for the use of data or biological materials in conducting research; consents for clinical trials; agreements relating to such research and clinical trials; privacy issues associated with such research and clinical trials; and coordination of regulatory compliance, product approvals and product launches.
Our advice in this area includes
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submissions and approvals (NDS, SNDS, IND, DIN and other license submissions)
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representation of clients before the Therapeutic Products Directorate of Health Canada (TPD), the U.S. Food and Drug Administration (FDA) and other Canadian and U.S. governmental committees
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representing clients on advertising matters before PAAB, ASC and other organizations
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the impact of proposed regulations
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compliance, recalls, cross-border issues and inspections
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protecting and accessing information
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packaging, labeling and advertising
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patent listings in Canada and the United States
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the pricing of medicines and medical devices
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Patented Medicines Prices Review Board (PMPRB) hearings and negotiations with PMPRB staff in Canada
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formulary listings and strategy
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grey marketing and the impact of spillover of differentially priced products (province-to-province and cross-border)
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research, grant, clinical, funding, confidentiality, consulting, packaging, marketing, supply, distribution and other agreements