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Enforcement 80(1)(b) and 81(1)(a) of the Patent Act, the patentees are required to submit pricing information to the PMRPB. If a price is found to be excessive, the PMPRB has the authority to order a reduction and repayment of excessive revenues under s. 83(1) of the Patent Act.21 Secondly, the PMPRB is responsible for reporting trends in pharmaceutical sales and in R&D spending by patentees.22 The Health Canada Special Access Programme Health Canada's Special Access Programme (SAP) permits the sale of unauthorized drugs to Canadian practitioners for medical emergencies.23 Ordinarily, a drug cannot be sold in Canada until Health Canada issues a market authorization (i.e., notice of compliance) having been satisfied of the drug's safety, effectiveness and quality of manufacture.24 However, in rare circumstances a drug may be made available to medical practitioners through SAP prior to market authorization. These rare situations are limited to "serious or life-threatening conditions where conventional therapies have failed, are unsuitable, or are unavailable either as marketed products or through enrolment in clinical trials".25 In order to access an unauthorized drug under SAP, practitioners must submit a request to Health Canada demonstrating that the use of the drug for the proposed treatment is supported by credible research evidence. It is incumbent on practitioners to inform patients of the possible risks and benefits associated with the use of any unauthorized drug. Once the request is submitted, Health Canada retains the discretion to authorize or deny the request. If the request is granted, practitioners must report back to Health Canada on use of the drug and any adverse reactions observed. However, access under SAP does not suggest 32 Update November/December 2013 the drug is safe or efficacious, nor does it compel a manufacturer to sell the drug.26 The manufacturer is provided with complete discretion over whether it wishes to make the unauthorized drug available under the SAP and under what conditions, for example whether to charge for the unauthorized drug or provide it for free on compassionate grounds. Celgene was a New Jersey-based distributor of THALOMID. Until the Canadian marketing authorization was issued for THALOMID in 2010, Canadian healthcare professionals purchased THALOMID from Celgene only under the SAP. When Celgene obtained a Canadian patent for THALOMID in 2006, the PMPRB requested drug pricing information. Celgene refused, arguing that under commercial law principles THALOMID was not "sold in any market in Canada". Rather, they argued the drug was sold in New Jersey and remained outside the PMPRB's jurisdiction. Celgene Corp. v. Canada On January 20, 2011, the Supreme Court of Canada (SCC) rendered its first decision on the PMPRB's jurisdiction, since the Board's creation in 1987. The SCC held that the PMPRB had jurisdiction to regulate the price of patented medicines sold into Canada pursuant to the SAP, despite the fact that such medicines do not have market authorizations in Canada, and thus cannot be sold in Canada outside of the SAP. The SCC held that sales "in any market in Canada" should be interpreted to "include sales of medicines that are regulated by the public laws of Canada".27 Since THALOMID was sold through the SAP, a public law of Canada, the PMPRB's jurisdiction included Celgene's sales of the drug. The Court's finding was founded on the legislative context and the Board's consumer protection purpose outlined in ss. 80(1)(b) and 83(1) of the Patent Act.28 It is the PMPRB's "responsibility for ensuring that the monopoly that accompanies the granting of a patent is not abused to the financial detriment of Canadian patients and their insurers".29 As a result of the Court's support of the PMPRB's overarching consumer protection mandate, foreign drug manufacturers, such as New Jersey-based Celgene, are cautioned that they may be subject to Canada's federal pricing review board when making sales under the SAP for serious or life-threatening conditions prior to obtaining a marketing authorization in Canada. Data Protection Canada's Data Protection Regime Pursuant to section C.08.004.1 of Canada's Food and Drug Regulations, an "innovative drug" is entitled to an eight-year term of market exclusivity. An eligible "innovative drug" must contain a previously unapproved medicinal ingredient, that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. Other variations, such as metabolites and prodrugs, are considered on a case-by-case basis. A six-month extension to the eightyear term is available where qualifying pediatric studies are submitted within the first five years of the term. Generic drug manufacturers are prohibited from filing abbreviated new drug submissions during the first six of eight years and cannot receive approval until the full eight-year term has expired. Given the relative infancy of Canada's current data protection regime, which has only been in effect since 2006, there has been little jurisprudence interpreting the data protection provisions to date. A case involving THALOMID has been www.fdli.org http://www.fdli.org

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