Canada's Trans-Pacific Partnership (TPP) Entry: BIO Submits Comments to USTR

I. Agricultural and Animal Biotechnology

The Government of Canada has long been a trusted ally to the United States on agricultural biotechnology. Canada has been a like minded partner in various international fora, including joining the United States government in a successful World Trade Organization (WTO) challenge of the European Union‟s moratorium on product approvals; coordinating in global environmental negotiations such as the negotiations of the Cartagena Protocol on Biosafety, and has recently emerged as a leader on establishing low-level presence policies to facilitate trade of products derived from agricultural biotechnology. To further the utilization of technology and lessen any potential trade barriers in animal production, the Canadian government should complete and publish its risk-assessment for animal cloning. We encourage the United States government to utilize the TPP as an opportunity to reduce barriers to trade of agricultural biotechnology products, and to do so in partnership with the Government of Canada.

II. Transparency in Pricing and Reimbursement of Pharmaceuticals

BIO supports USTR‟s TPP proposal to include specific commitments on transparency in the purchase and reimbursement of pharmaceutical and related products by government bodies. It is important that such processes are transparent, follow clear criteria and timelines, that reasons are given for decisions, and that some form of external appeal to such decisions is possible. BIO will be interested to provide further input on how these transparency disciplines should apply in Canada.

III. IP Protections in Canada

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Eligibility and enforcement challenges related to patent utility, lack of an equitable right of appeal, lack of patent term restoration and lack of data package exclusivity for drugs not marketed in Canada have led BIO to request that these issues be raised by the U.S. during negotiations of the TPP Agreement. Canada needs to adhere to international norms in this area and commit through the TPP process to providing full patent protections for pharmaceuticals.