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The Canadian National Association of Pharmacy Regulatory Authorities (NAPRA), Canada's voluntary umbrella association of provincial and territorial pharmacy licensing bodies, has asked the Canadian government to legislate against the export of drug products to the United States. In a press release issued by NAPRA November 13, the organization noted that such exports are creating a challenge for those pledged to protecting Canadian public safety, and placed much of the blame for the problem on American agencies' failure to enforce U.S. laws. “The [Canadian] federal and provincial regulatory systems … were not originally designed to regulate the export of prescription drugs. Provincial self-regulation of the profession of pharmacy and the distribution of drugs is intended to protect Canadians. Similarly, the federal drug approval process is designed so that Canadians will have safe and effective access to drugs,” the release stated.
NAPRA criticized other, unnamed, Canadian government agencies – presumably governmental bodies in those provinces that are taking the greatest advantage of the demand – that encourage the export of drugs to other countries for the purpose of increasing regional economic growth. This practice, NAPRA claims, conflicts with the national public policy of providing Canadians with access to pharmaceutical products. NAPRA's statement warns that because of the conflict resulting from these competing objectives, those government agencies responsible for promoting export of Canadian drugs in order to boost local economies “must also be responsible for the consequences.” These consequences so far have included moves by pharmaceutical companies to raise prices in Canada, as well as to cut off or limit sales to Canadian pharmaceutical distributors.
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.