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Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance. [ABSTRACT FROM AUTHOR]

The Canadian government recently sanctioned a supervised consumption site (SCS) that is currently in Vancouver, British Columbia. The government is open to sanctioning more sites across the country; however, by law the federal health minister must consider whether such facilities are supported by local governments representing the cities where the sites are proposed to be located. Until 2016, the government of Canada's largest city, Toronto, did not support SCSs. Drawing on Lenton cannabis policy research, this study analyses government documents, policy papers, scientific reports, and newspaper articles and secondary literature to identify some of the significant barriers that minimised the likelihood that Toronto's council would support SCSs between 2003 and 2016. The report compares conditions in Toronto to those of Vancouver where SCSs have enjoyed council support since 2001. This study find that three conditions play an important role in explaining why SCSs were supported in Vancouver 14 years before they were endorsed in Toronto: (1) Strong public support; (2) Favourable electoral conditions; and (3) Law enforcement support. Changes in Toronto surrounding these conditions help explain why its council endorsed SCSs in 2016. This study concludes that Lenton's research holds utility as a socio-legal theory of municipal drug policy change. [ABSTRACT FROM AUTHOR]

One of harm reduction's most salient features is its pragmatism. Harm reduction purports to distinguish itself from dominant prohibitionist and abstinence-based policy paradigms by being grounded in what is realistic, in contrast with the moralism or puritanism of prohibition and abstention. This is reflected in the meme "harm reduction works", popular both in institutional and grassroots settings. The idea that harm reduction is realistic and effective has meant different things among the main actors who seek to shape harm reduction policy. Drawing on scholarly literature about harm reduction, as well as examples from recent harm reduction advocacy efforts in relation to drug policy in Canada, this paper argues that harm reduction distinguishes itself through a unique "way of knowing". Grassroots harm reduction advocates, particularly as they argue through human rights frameworks, do more than simply make claims for the provision of particular services—like needle exchange, safe consumption sites, safe supply and the like—on the basis that these are realistic paths toward the health and well-being of people who use drugs. Rather, as they marshal lived experience in support of these policy changes through peer-driven initiatives in contexts of prohibition, they make particular claims about what constitute valid, methodologically rigorous evidence bases for action in contexts where policies to date have been driven by ideology and have developed in ways that have excluded and marginalized those most affected from policymaking. In doing so, they advocate for the centrality of people who use drugs not only in policy-making processes, but in evidence production itself. [ABSTRACT FROM AUTHOR]

Background: This paper provides a critical review of the decision‐making process of the Ontario Ministry of Health and Long‐Term Care (MOHLTC) regarding which migraine treatment drugs will be covered under the Ontario Drug Benefit Formulary (ODB). Main Text: Under MOHLTC policy, triptans and OnabotulinumtoxinA are available to patients only through the Exceptional Access Program (EAP). This policy, and justifications for it, are examined with reference to clinical guidelines, patient experiences, and health policy literature. The contexts and consequences of compromised access are outlined. Improvements in access to these treatments are suggested by highlighting how a country with similar healthcare infrastructure – Australia – employs policies that more adequately meet the needs of migraine patients as they secure treatments. Conclusions: Despite clinically significant gains in the discovery of safe and effective migraine‐specific treatments the ODB thus far has failed to align its practice with current clinical recommendations. This forces patients to rely heavily on medication that, while still effective for some, is potentially suboptimal. This review concludes it is prudent, at minimum, to follow clinical recommendations that advocate for the removal of triptans from EAP and recategorize them as Limited Use drugs. Ideally, moving them to a general benefit would further remove the barriers experienced by patients attempting to access this treatment. [ABSTRACT FROM AUTHOR]

In an era which marks an exceptional phase of growth in science and technology, the acute disparities in access to healthcare still persist. So where on one hand scientific advancement in medicine aims at increasing life expectancy, on the other hand there are millions who are denied access to existing medicines. Patents on medicines also pose a significant barrier to access new drugs, especially in low and middle income countries which already suffer from poor health financing mechanisms. The patent laws were built on the assumption of incentivizing the innovators by rewarding them with the exclusive right to produce, sell or market the innovation. The basic premise for granting patents was based on the thought that it would increase investment in research and development promoting dynamic gains through newer innovations. However, evidence found to support this justification is meager. So in a situation where the drug gap still persists and we aim to achieve sustainable development goals by 2030, this paper attempts to focus on understanding how compulsory licensing has been used in selected cases to alleviate the major legal and political barriers to access medicines. The methodology comprises of cross-country comparison of patent framework and compulsory licensing cases. The sample selected for study includes both developed as well as developing countries. The aim is to evaluate the policy approaches used by selected countries to grant compulsory licenses and to identify the best practices for evidence-based policy making on international issues related to pharmaceutical patents. In each case, a driving factor has been the international extension of patent laws through trade agreements; first bilaterally (US-Canada) and subsequently internationally (1995 Uruguay round, under which low- and middle-income countries were granted a grace period until 2005 to comply). [ABSTRACT FROM AUTHOR]

• First trends analysis of data from the national Canadian Cannabis Survey. • Past-year cannabis use increased since non-medical cannabis legalization in Canada. • The proportion of past-year consumers using cannabis frequently is unchanged. • Past-year use of edibles, drinks and vape pens/cartridges has increased. • Legal purchasing is displacing the illicit cannabis market in Canada. Cannabis use for non-medical purposes was legalized and regulated in Canada through the Cannabis Act in October 2018. This paper examined trends in use of cannabis for non-medical purposes and related indicators from pre- to post-legalization in Canada (2018–2022). Data from 5 years of the Canadian Cannabis Survey, an annual web-based survey administered to Canadians 16 years of age or older, were used in the analysis (n 2018 =12,952; n 2019 =11,922; n 2020 =10,821; n 2021 =10,733; n 2022 =10,048). Cannabis measures include questions about use, types of products, sources, risk perceptions and beliefs, and exposure to public education campaigns and health warnings. Adjusted logistic regression models tested differences in outcomes over time. Past 12-month cannabis consumption increased among Canadians from 22 % in 2018 to 27 % in 2022 (AOR=1.41;99 % CI:1.28–1.54). Similarly, daily/almost daily (DAD) consumption increased from 5 % in 2018 to 7 % in 2022 (AOR=1.36;99 % CI:1.16–1.59). Consumption of dried flower, hash/kief, and concentrates/extracts (e.g., wax, shatter, budder) decreased since 2018, whereas consumption of edibles, beverages and vape pens/cartridges increased (p < 0.001). Legal purchasing increased from 4 % in 2018 to 69 % in 2022, while accessing cannabis through social and illegal sources decreased over time (p < 0.001). More Canadians are reporting cannabis consumption since legalization and regulation of cannabis for non-medical purposes, continuing a pre-existing trend despite an increase in awareness of the risks of consuming cannabis. Trends in product use indicate a transition from dried flower and concentrates/extracts towards consumption of cannabis foods, drinks and vape pens/cartridges. The legal market is increasingly displacing the illicit cannabis market in Canada. [ABSTRACT FROM AUTHOR]

Background: In 2015, a new Liberal Government came to power in Canada, elected on a platform that included legalization and regulation of cannabis for recreational purposes. Their legislation, based on recommendations from a Federal Task Force on Marijuana Legalization and Regulation, is due in early April 2017.Methods: This commentary utilizes Canadian Federal policy papers, previous literature, and internal and international agreements to examine two key areas critical to the development of a nationwide regulated market for cannabis in Canada; the need to overcome restrictions to legalizing cannabis in United Nations' drug control treaties, and the unique challenges that non-medical cannabis creates for navigating interprovincial trade policies in Canada.Results: Irrespective of UN conventions that appear to prohibit legalization of cannabis the Government is preparing to bring forward legislation as this article goes to print. At the same time significant squabbles impede the selling of even beer and wine inter-provincially in Canada. This paper identifies the challenges facing Canadian legalization efforts, but also shows how the legalization legislation may provide opportunities to engender significant change beyond the simple legalization of a specific drug.Conclusion: This commentary does not argue for any specific course of action for Canada, but rather explores the nuance of legalization absent from the declaration in the Liberal party platform. The paper argues that Canada's efforts may hasten the dismantling of the UN drug control structure, and provide renewed opportunities for intern-provincial trade in Canada. [ABSTRACT FROM AUTHOR]

The article reports on a discussion paper released by the Patented Medicine Prices Review Board which asks Canadians, physicians, and pharmaceutical companies to review the drug-pricing system in Canada, with the aim of modernizing and simplifying the regulatory framework on patented drug pricing. It highlights statistics which compare the cost of medicines in the country with others. The discussion paper is said to be a part of a consultation process designed to focus drug-pricing problems.

The article reports on the proposal of Health Canada for a new regulatory regime for drugs. Under its paper, "The Progressive Licensing Framework Concept Paper for Discussion," Health Canada proposes to lower the threshold for initial market authorization licenses in exchange for more safety and efficacy studies as a condition for selling a drug. The institution's proposed regime involves the incorporation of post-market surveillance in its oversight of drugs.

Background: Canada has announced that it will legalize cannabis on October 17, 2018, and as a result of this impending drug law reform the need to develop prevention resources and drug education - in schools, in public health, and for parents - has emerged as a public concern and a policy priority. Set against this context, the aim of our paper is to amplify the parent perspective on preventing problematic adolescent cannabis use, but also to interrogate the idea of 'parents as the best prevention' that has taken hold in discussions about the potential consequences of legalization for youth.Methods: In 2016 we undertook an exploratory, qualitative interview study in Vancouver, British Columbia (n = 16) with parents of adolescents who had used cannabis. Building on our past research developing educator-led resources to support an open dialogue about cannabis in the classroom, in this study we asked parents about the supports and resources they needed to inform their discussions about cannabis with their adolescent children, as well the challenges they faced in responding to cannabis use when they believed it had become problematic.Findings: Across the interviews, parents mobilized discourses of risk and responsibility for preventing problematic cannabis use that appeared to reinstate individualizing accounts of substance use. Many echoed normative ideas about health, the risks of cannabis use, and 'good' parenting, sidestepping social inequities around drug use, and thus implicating parents and families as solely responsible for preventing adolescent drug use.Conclusion: Our analysis suggests how parents have been largely disempowered and unsupported when it comes to addressing adolescent drug use in the family context. Even as they expressed their awareness that formal supports and resources to assist them were lacking, parents also assigned blame to themselves - or to other parents - for 'failing' to prevent problematic cannabis use. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial stewardship programs (ASPs) have been shown to reduce inappropriate antimicrobial use and its consequences. However, these programs lack legislative requirements in many places and it can be difficult to determine what human resources are required for these programs and how to create a business case to present to hospital administrators for program funding. The objectives of the current paper were to review legislative requirements and outline human resource requirements for ASPs, and to create a base business case for ASPs. Methods: A working group of antimicrobial stewardship experts from across Canada met to discuss the necessary components for creation of a business case for antimicrobial stewardship. A narrative review of the literature of the regulatory requirements and human resource recommendations for ASPs was conducted. Informed by the review and using a consensus decision-making process, the expert working group developed human resource recommendations based on a 1000 bed acute care health care facility in Canada. A spreadsheet based business case model for ASPs was also created. Results: Legislative and /or regulatory requirements for ASPs were found in 2 countries and one state jurisdiction. The literature review and consensus development process recommended the following minimum human resources complement: 1 physician, 3 pharmacists, 0.5 program administrative and coordination support, and 0.4 data analyst support as full time equivalents (FTEs) per 1000 acute care beds. Necessary components for the business case model, including the human resource requirements, were determined to create a spreadsheet based model. Conclusions: There is evidence to support the negative outcomes of inappropriate antimicrobial use as well as the benefits of ASPs. Legislative and /or regulatory requirements for ASPs are not common. The available evidence for human resource recommendations for ASPs using a narrative review process was examined and a base business case modelling scenario was created. As regulatory requirements for ASPs increase, it will be necessary to create accurate business cases for ASPs in order to obtain the necessary funding to render these programs successful. [ABSTRACT FROM AUTHOR]

How far should the state go to prevent drug abuse? This paper rejects H.LA. Hart's paternalism, and even more strongly opposes Lord Devlin's case for the legal enforcement of morals. It adopts instead, J.S.Mill's argument that only public defence justifies state intervention or coercion. Canadian drug laws, which embody Devlin's position, are abusive of civil rights and ineffective despite their oppressiveness. In particular, the paper examines the violation of rights involved in school and employment drug detection plans, and also in compulsory treatment programs for illicit drug users. Basic legal reform is advocated. [ABSTRACT FROM AUTHOR]

Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement decision models and frameworks, such as managed access agreements (MAAs), may address this decision challenge. Here, we provide a comprehensive overview of the legal limitations, considerations, and implications for adopting MAAs in Canadian jurisdictions. We begin with an overview of current drug reimbursement processes in Canada, terminology and definitions of the different types of MAAs, and select international experiences with MAAs. We discuss the legal barriers to MAA governance frameworks, design and implementation considerations, and legal and policy implications of MAAs. Finally, we provide recommendations to guide policy development for implementing MAAs in Canada, based on existing literature, international experience, and our legal analysis. We conclude that legal and policy barriers likely prevent the adoption of a pan-Canadian MAA governance framework. More feasible is a quasi-federal or provincial approach, building on existing infrastructure. [ABSTRACT FROM AUTHOR]

There has been growing tension at the intersection of health and economic policy making as global governance has increased across sectors. This tension has been particularly evident between tobacco control and trade policy, as the international norms that frame them—particularly the Framework Convention on Tobacco Control and the World Trade Organization (WTO)—have continued to institutionalize. Using five case studies of major tobacco-related trade disputes from the principal multilateral system of trade govemance—the WTO/General Agreement on Tariffs and Trade—we trace the evolution of these interacting norms over nearly twenty-five years. Our analytic framework focuses on the actors that advance, defend, and challenge these norms. We find that an increasingly broad network, which includes govemments, intergovemmental organizations, nongovemmental organizations, and members of the epistemic community, is playing a more active role in seeking to resolve these tensions. Moreover, key economic actors are beginning to incorporate health more actively into their messaging and activities. We also demonstrate that the most recent resonant messages reflect a more nuanced integration of the two norms. The tobacco control example has direct relevance to related policy areas, including environment, safety, access to medicines, diet, and alcohol. [ABSTRACT FROM AUTHOR]

Background: Over the past several decades, there have been numerous peer-reviewed articles written about people who use drugs (PWUDs) from the Downtown Eastside neighborhood of Vancouver, Canada. While individual researchers have engaged and acknowledged this population as participants and community partners in their work, there has been comparatively little attention given to the role of PWUDs and drug user organizations in directing, influencing, and shaping research agendas.Methods: In this community-driven research, we examine 20 years of peer-reviewed studies, university theses, books, and reports that have been directed, influenced, and shaped by members of the activist organization the Vancouver Area Network of Drug Users (VANDU). In this paper, we have summarized VANDU's work based on different themes from each article.Results: After applying the inclusion criteria to over 400 articles, 59 items containing peer-reviewed studies, books, and reports were included and three themes of topics researched or discussed were identified. Theme 1: 'health needs' of marginalized groups was found in 39% of articles, Theme 2: 'evaluation of projects' related to harm reduction in 19%, and Theme 3: 'activism' related work in 42%. Ninety-four percent of co-authors were from British Columbia and 44% of research was qualitative. Works that have been co-authored by VANDU's members or acknowledged their participations created 628 citations. Moreover, their work has been accessed more than 149,600 times.Conclusions: Peer-based, democratic harm reduction organizations are important partners in facilitating groundbreaking health and social research, and through research can advocate for the improved health and wellbeing of PWUDs and other marginalized groups in their community. This article also recommends that PWUDs should be more respectfully engaged and given appropriate credit for their contributions. [ABSTRACT FROM AUTHOR]

This paper examines two recent examples of compulsory licensing legislation: one globally embraced regime and one internationally controversial regime operating under the same WTO rules. In particular, we consider Canadian legislation and the use of compulsory licensing for HIV/AIDS drugs destined for a developing country. This is then contrasted with the conditions under which Thai authorities are pursuing compulsory licenses, the outcomes of their compulsory licenses, as well as the likely impact of the Thai policy. Finally, we construct a rubric to evaluate characteristics of a successful regime. This is used to analyze the Canadian and Thai regimes and frame the expected implications of each national policy. It is hoped that the assessment will guide changes to compulsory licensing design to ensure that legitimate regimes are embraced while illegitimate ones are disallowed. [ABSTRACT FROM AUTHOR]

Copyright of Deviance et Societe is the property of Medecine et Hygiene and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

North America's overdose crisis is an urgent public health issue that has resulted in thousands of deaths. As the crisis began to take hold across Canada in 2016, bereaved parents, mainly mothers, emerged as vocal advocates for drug policy reform and harm reduction, using their stories to challenge the stigma of drug-related death. In 2017, we launched a qualitative research partnership with leading family organizations in Canada, conducting interviews with 43 mothers whose children had died from substance use, to understand their experiences of drug policy advocacy. Our findings showed that participants' motivations for engaging in advocacy were rooted in their experiences of grief, and that advocacy led to feelings of empowerment and connection to others. Our research suggests that advocacy can be cathartic and associated with healing from grief, but that "going public" in sharing a family story of substance use death can also have a considerable personal cost. [ABSTRACT FROM AUTHOR]

Canada's drug laws originated and developed in response to racial and political factors rather than reasoned analysis. After tracing the history of the legislation, this paper outlines the current drug offences and enforcement powers. The impact of the Canadian Charter of Rights and Freedoms on drug legislation and enforcement is also considered. [ABSTRACT FROM AUTHOR]

Background: Choice of minimum legal age (MLA) for cannabis use is a critical and contentious issue in legalization of non-medical cannabis. In Canada where non-medical cannabis was recently legalized in October 2018, the federal government recommended age 18, the medical community argued for 21 or even 25, while public consultations led most Canadian provinces to adopt age 19. However, no research has compared later life outcomes of first using cannabis at these different ages to assess their merits as MLAs.Methods: We used doubly robust regression techniques and data from nationally representative Canadian surveys to compare educational attainment, cigarette smoking, self-reported general and mental health associated with different ages of first cannabis use.Results: We found different MLAs for different outcomes: 21 for educational attainment, 19 for cigarette smoking and mental health and 18 for general health. Assuming equal weight for these individual outcomes, the 'overall' MLA for cannabis use was estimated to be 19 years. Our results were robust to various robustness checks.Conclusion: Our study indicated that there is merit in setting 19 years as MLA for non-medical cannabis. [ABSTRACT FROM AUTHOR]

Reports on the proposal of Health Canada to eliminate statutory barriers against direct-to-consumer advertising of the purported health benefits from using natural health products (NHP) and non-prescription drugs to treat serious diseases. Claims of the proposal's proponents on its impact; Discussion on issues governing its regulatory amendments; Coverage of the licensing regime for NHP and non-prescription drugs.

Purpose: New regulations are in place at the federal and provincial levels in Canada regarding the way medical cannabis is to be controlled. We present them together with guidance for the safe use of medical cannabis and recent clinical trials on cannabis and pain.Source: The new Canadian regulations on the use of medical cannabis, the provincial regulations, and the various cannabis products available from the Canadian Licensed Producers were reviewed from Health Canada, provincial licensing authorities, and the licensed producers website, respectively. Recent clinical trials on cannabis and pain were reviewed from the existing literature.Principal Findings: Health Canada has approved a new regulation on medical marijuana/cannabis, the Marihuana for Medical Purposes Regulations: The production of medical cannabis by individuals is illegal. Health Canada, however, has licensed authorized producers across the country, limiting the production to specific licenses of certain cannabis products. There are currently 26 authorized licensed producers from seven Canadian provinces offering more than 200 strains of marijuana. We provide guidance for the safe use of medical cannabis. The recent literature indicates that currently available cannabinoids are modestly effective analgesics that provide a safe, reasonable therapeutic option for managing chronic non-cancer-related pain.Conclusion: The science of medical cannabis and the need for education of healthcare professionals and patients require continued effort. Although cannabinoids work to decrease pain, there is still a need to confirm these beneficial effects clinically and to exploit them with acceptable benefit-to-risk ratios. [ABSTRACT FROM AUTHOR]

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. [ABSTRACT FROM AUTHOR]

The article discusses Bill C-7 or Protecting Canadians From Unsafe Drugs Act, a legislation introduced into the Canadian Parliament in December 2013 to regulate prescription drugs for patient safety. Elements in the proposed regulation include the power to recall drugs, the power to overcome information asymmetries and the power to enforce conditions on market authorizations and compel changes to product labels.

To enhance public understanding of the outcomes of cannabis legalization in Canada and avoid this skewed situation, provincial and territorial governments must become more transparent with their cannabis data. Despite the many potential impacts of the legalization of cannabis in Canada, provincial and territorial governments' poor disclosure of data about their recreational sales hinders researchers' efforts to study the the medical and social effects of legalization. [Extracted from the article]

The Canadian constitution divides the responsibility for Pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified. [ABSTRACT FROM AUTHOR]

The article offers news briefs on various issues. The Australian Cricketers' Association and Cricket Australia (CA) are considering 12-month trial of hair testing of players. Canadian provinces are likely to remove OxyContin and OxyNEO from the publicly funded drugs list. FIFA has insisted Brazil government to give the right to sell beer at the Brazil World Cup which is going to be held in 2014. Otto Perez, the Guatemala's new President has joined together with Latin American presidents over the issue of legalizing drugs.

ABSTRACT Aims Decisions on whether and how to 'schedule' drugs (i.e. to determine their legal status and penalties to be applied for sale or possession) are often heavily criticized. We sought to assess more comprehensively the results of such decisions for newly emerging drugs. Methods Through analysis of legislation and secondary sources, we identified 63 substances that have emerged since 1971, including all that have been added to the most restrictive schedule by the United Nations, United States, United Kingdom, Canada, Australia and/or New Zealand. Measurements For each jurisdiction we recorded whether, when, and how the substance was scheduled and note what decisions engendered substantial criticism or controversy within the international treaties' framework of balancing medical benefits with risk of abuse. Findings (i) The rate of emergence of new drugs has been fairly steady. (ii) There is broad cross-national agreement on what should be scheduled. (iii) The United States often acts first. (iv) Temporary bans that delay final decisions by 12-18 months can sometimes allow final decisions to be grounded on a substantially expanded research base. (v) It appears that no more than seven of the decisions reached by the United States with respect to the 63 substances are candidates for being considered errors, and arguably the United States has committed at most one serious Type I and one serious Type II error. Results for other countries are broadly similar. Conclusions The process for determining the legal status of new psychoactive substances appears to function reasonably well, within the framework of international treaty obligations. Most criticisms relate to one or a few substances (e.g. 3,4-methylenedioxymethamphetamine) and/or complaints that the decisions discount benefits that are not recognized by the treaties (e.g. recreational or religious use). [ABSTRACT FROM AUTHOR]

Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific recommendations for regulating promotion for drugs that may have a high abuse potential. [ABSTRACT FROM AUTHOR]

The article presents a reprint of the article "Policy alternatives for treatments for rare diseases," by Abbas H. Panju and Chaim M. Bell, which appeared in www.cmaj.ca. It mentions that partnership among pharmaceutical companies, clinical community, and federal government are factors needed for the development of drugs used for treating rare diseases. It adds that Canada's legislators passed Bill M-426 for the development of a national strategy to finance drugs to cure rare diseases.

Background: In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process. Methods: We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives. Results: The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media. Conclusions: Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects. [ABSTRACT FROM AUTHOR]

Reports on the plan of the Canadian government to reintroduce legislation amending the Patent Act to allow cheaper production of HIV/AIDS drugs for developing countries. Benefits of the proposed amendments for generic drug companies; Cost of antiretroviral drugs under the plan; Supporters of the legislation.

Background: It is mandatory for drug manufacturers requesting formulary inclusion under the British Columbia (BC) provincial drug plan to submit a pharmacoeconomic analysis according to published guidelines. These submissions are reviewed by the Pharmacoeconomic Initiative (PI) of BC.Objective: To assess the compliance of submitted studies with specific criteria outlined in the guidelines, to assess the methodological quality of individual submissions, and to demonstrate the importance of submitting guidelines-compliant pharmacoeconomic analyses.Data and Methods: All submissions between January 1996 and April 1999 assessed by the PI of BC were included. Submissions were reviewed according to a checklist to establish compliance with respect to choice of comparator drug, study perspective, sensitivity analysis, analytical horizon and discounting. Submissions were examined for association between analytical technique and author, and between source of submission and compliance. Association between compliance and recommendation for approval was also examined.Results: 95 applications were reviewed. Seven submitted no analyses. There were 25 cost-comparison/consequence, 14 cost-effectiveness, 11 cost-minimisation, 9 cost-utility/benefit and 29 budget-impact analyses. 65 of these 88 submissions failed to comply with guidelines. Of these, 45% used an inappropriate comparator drug, 61% lacked a sensitivity analysis, 73% used a third-party payer and excluded a societal perspective, 66% did not provide a long term evaluation and 25% did not specify any time horizon. 80% of noncompliant studies were cost-comparison/consequence or budget-impact analyses (p < 0.001, Fisher's Exact). Of 25 cost-comparison/consequence and 29 budget-impact analyses, 19 (76%) and 24 (83%), respectively, were industry-conducted, whereas cost-effectiveness (11 of 14) and cost-utility/benefit (6 of 9) analyses were mostly subcontracted to private consultants or academics (p < 0.001, Fisher's Exact). 74% of all submissions (compliant and noncompliant) were not recommended by the PI for listing as a provincial drug plan benefit, 16% received approval for restricted benefit and 9% were recommended as full benefit. 80% of the noncompliant submissions were not recommended (p = 0.06, Fisher's Exact test). Moreover, a strong association between type of analysis and type of recommendation was found (p = 0.03, Fisher's Exact test). Cost-comparison/consequence and budget-impact analyses were less likely to be recommended. IMPLICATIONS OF FINDINGS: Our findings show poor compliance with guidelines, especially among industry-conducted studies. Possible explanations are lack of expertise in pharmacoeconomics and/or scepticism regarding the importance of guidelines and submission quality in decision making. As corroborated by the strong associations between type of recommendation and compliance, and between type of recommendation and type of analysis, these 2 characteristics have a significant impact on decision making. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Sociology is the property of Canadian Journal of Sociology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The article focuses on a debate concerning the harmful effects of cannabis and how to address the mental health consequences of cannabis in Canada. It is stated that the acute effects of cannabis-used include accidents with motor vehicles and adverse reactions. It is added that cannabis has been associated with cognitive impairment and psychosis and direct causality is difficult to establish than for acute effects. The debate discusses the origins and effectiveness of prohibition and argues that people should apply the lessons from alcohol or tobacco control to cannabis.

The article reports on the plan of Health Canada to increase transparency into its regulatory process for drugs and medical devices by releasing clinical information submitted by drug and medical devices companies that receive market authorization. It mentions how access to clinical information submitted by companies will help people make informed decisions about their health, and increase public confidence; and plan to disclose information if the drug or medical device is approved for sale.

Reports on the changes that are underway in Canada's drug regulatory system which will have significant implications for how new drugs are approved and how well Health Canada monitors the safety of drugs already on the market. New direction in regulatory activities enunciated by the Throne Speech that opened the parliamentary session at the end of September 2002; Budget committed to improve the timeliness of Health Canada's regulatory processes with respect to human drugs; Percentage of new active substances marketed in Canada that qualify as either breakthrough products or significant therapeutic improvements.

The article discusses the issue on the application of tobacco and alcohol control to cannabis in Canada. The agreement on the issue and the association of cannabis with psychosis, reliance on a single legal remedy have been ineffective, and education should play a greater role in strategies to tackle cannabis use. It is suggested that the community should be investing in a range of measures including prevention, treatment and research. It is added that the approach to cannabis control may reduce the illegal market and associated crime, violence and corruption.

The author reflects on the need for close examination on the progressive licensing of drugs by regulatory agencies in Canada. The author comments that pharmaceutical products cannot be easily approved and cannot be driven by profit. He points out that regulatory agencies must focus on a transparent, patient-centered regulatory system which ensures drugs are safe and efficacious before and after their release.

Reports on the enactment of a Canadian legislation designed to provide developing countries with cheaper drugs to treat HIV/AIDS on May 14, 2004. Laws amended in the legislation; Provisions of the legislation; Other pre-election changes related to the Canadian health care system.