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Health Canada is proposing to update its accelerated review pathways to get important new drugs into the market more quickly. To date, the two pathways that Health Canada uses have not demonstrated that they can identify therapeutically valuable new drugs. Drugs approved under the two pathways also have a greater likelihood of acquiring a serious safety warning post-marketing compared with drugs approved through the standard review pathway. The new proposals from Health Canada will not go far in rectifying this situation, and major changes are needed. Health Canada needs to present evidence that the changes it is proposing will actually allow these pathways to fulfill the set objectives and support health benefits for Canadians., (Copyright © 2020 Longwoods Publishing.)

Background: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials' funding sources, and none reported trial authors' financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate the extent to which pharmaceutical industry funding and author-industry FCOIs and employment from included drug trials are reported in meta-analyses published in high-impact journals and (2) compare current reporting with results from 2009., Methods: We searched PubMed (January 2017-October 2018) for systematic reviews with meta-analyses including ≥ 2 randomized controlled trials (RCTs) of patented drugs. We included 3 meta-analyses published January 2017-October 2018 from each of 4 high-impact general medicine journals, high-impact journals from 5 specialty areas, and the Cochrane Database of Systematic Reviews, as in the previous study., Results: Among 29 meta-analyses reviewed, 13 of 29 (44.8%) reported the funding source of included trials compared to 2 of 29 (6.9%) in 2009, a difference of 37.9% (95% confidence interval, 15.7 to 56.3%); this included 7 of 11 (63.6%) from general medicine journals, 3 of 15 (20.0%) from specialty medicine journals, and 3 of 3 (100%) Cochrane reviews. Only 2 of 29 meta-analyses (6.9%) reported trial author FCOIs, and none reported trial author-industry employment., Protocol Publication: A protocol was uploaded to the Open Science Framework prior to initiating the study. https://osf.io/8xt5p/ LIMITATIONS: We examined only a relatively small number of meta-analyses from selected high-impact journals and compared results to a similarly small sample from an earlier time period., Conclusions: Reporting of drug trial sponsorship and author FCOIs in meta-analyses published in high-impact journals has increased since 2009 but is still suboptimal. Standards on reporting of trial funding described in the forthcoming revised PRISMA statement should be adapted and enforced by journals to improve reporting.

Background: Because not all medicines are equally safe, effective, and affordable, health systems often use formularies to define explicitly which medicines will be included and excluded from coverage., Objective: We sought to synthesize methods and findings from published studies of formulary variation across health systems in high-income countries., Methods: We conducted a systematic review of peer-reviewed research papers published from 2000 to 2017, inclusively. Because of the heterogeneous nature of the literature, we used an inductive approach to summarize methods and findings., Results: Nine studies met our study inclusion criteria. Included studies used a variety of methods for selecting medicines for analysis, for measuring coverage levels, and for measuring concordance between formularies. Studies assessing variations in coverage of all licensed medicines and found lower rates of cross-national coverage variation than studies of coverage for selected specialty drugs and indications. The one study that focused on coverage of high-volume medicines found the most complete and consistent levels of formulary listings across countries., Conclusion: Although published studies contain interesting findings that likely have prompted discussions about their policy implications, the literature can be improved with greater transparency concerning the overarching objective of work in this area and more rigor concerning the selection, analysis, and reporting of data., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: In 2016-19, JL was a paid consultant on two projects: one developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief for a lawyer in a case about side effects of a drug, and from the Canadian Institutes of Health Research for presenting at a workshop on conflict of interest in clinical practice guidelines. He is a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer for books he has written. HM and FG work for The BMJ. Peer review and editing of the article was managed and overseen by editors who were not involved as authors.

Background: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways., Results: An analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways., Conclusions: The analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations.

Objectives: This study examines financial conflict of interest (FCOI) of clinicians who made submissions to the pan-Canadian Oncology Drug Review (pCODR), the arm of the Canadian Agency for Drugs and Technology in Health that recommends whether oncology drug indications should be publicly funded. Final reports from pCODR published between October 2016 and February 2019 were examined., Design: Descriptive study., Data Sources: Website of pCODR., Interventions: None., Primary and Secondary Outcomes: The primary outcome is the number of submissions declaring FCOI. Secondary outcomes are the number of times where clinicians agreed and disagreed with preliminary recommendation from pCODR and the association between the distribution of individual clinicians' FCOI and pCODR's funding recommendations., Results: There were 46 drug indication reports from pCODR. Clinicians made 261 submissions. Clinicians declared they received payments from companies 323 times and named 38 different companies making those payments a total of 500 times. Financial conflicts with drug companies were declared in 176 (66.3%) of all submissions. In 21 (45.7%) of the 46 drug indications, 50% or more of the clinicians had a conflict with the company making the drug. Clinicians commented on 37 preliminary recommendations. In all 25 where pCODR recommended funding or conditional funding, the clinicians either agreed or agreed in part. pCODR recommended that the drug indication not be funded 12 times and 9 times clinicians disagreed with that recommendation. The distribution of clinician responses was statistically significantly different depending on whether pCODR recommended funding/conditional funding or do not fund p<0.0001 (Fisher exact test). The distribution of clinicians' FCOI differed depending on whether the recommendation was fund/conditional fund or do not fund p=0.027 (Fisher exact test)., Conclusion: Financial conflicts with pharmaceutical companies are widespread among experts making submissions to the pCODR., Competing Interests: Competing interests: In 2016–2019, JL was a paid consultant on two projects: one looking at developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief for a law firm and from the Canadian Institutes of Health Research for presenting at a workshop on conflict of interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Conflicts of interest: Michael D. Elfassy, Sharef Danho, and Alexander Adibfar have no conflicts of interest to disclose. In 2015-2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation), and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payments for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization), a panel at the American Diabetes Association and for a talk at the Toronto Reference Library. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare.

The government of New Zealand is currently considering a new Therapeutic Products Regulatory Scheme that includes how direct-to-consumer advertising (DTCA) of prescription drugs should be regulated. This article reviews three different types of possible regulation of DTCA: government regulation, industry self-regulation and a mixture of the two. Recent studies demonstrate that DTC ads in the US continue to be misleading and contain minimal if any educational value, despite governmental regulatory efforts by the Food and Drug Administration. Other regulatory models are equally unsuccessful at controlling DTCA. Available evidence suggests that DTC ads are commonly misinterpreted as trusted public health messages and are more likely to affect vulnerable subgroups of New Zealanders. Taken together with the international evidence that regulation has consistently failed to prevent the inappropriate promotion of prescription medicines, these findings suggest that DTCA is more likely to cause harm than benefit and should be banned., Competing Interests: In 2015–2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organisation), a panel at the American Diabetes Association, for a talk at the Toronto Reference Library and for writing a brief for a law firm. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. David Menkes serves on two New Zealand Government committees relevant to pharmacotherapy, and has been active in the International Society of Drug Bulletins (ISDB).

Background: Health Canada supplements its in-house expertise on pharmacotherapy and pharmaceutical policy through the use of scientific/expert advisory committees and scientific/expert advisory panels. This study was undertaken to examine the interests of the members of these Health Canada advisory bodies., Methods: This was an observational study of the financial and intellectual interests of members of Health Canada's scientific/expert advisory committees and panels. The following information was extracted from Health Canada websites in December 2018: member's name, name of committee/panel, direct and indirect financial interests, and intellectual interests. Information extracted about the committees and panels included the number of meetings for which a record of proceedings was available and the topics discussed at the meetings., Results: Of 81 unique committee and panel members, 12 declared a direct financial interest, 56 an indirect financial interest and 65 an intellectual interest. Five of 11 committees and panels had people who declared a direct financial interest. All 11 advisory bodies had members who declared indirect financial interests ( n = 62) and intellectual interests ( n = 81). Six of the 11 committees and panels had a majority of members who declared a direct or indirect financial interest. In the 10 advisory body meetings for which information was available, individual products were rarely discussed but recommendations from all but 1 of the meetings could potentially have affected sales., Interpretation: Only a minority of members of Health Canada's advisory committees and panels declared direct financial interests but the majority of members of a majority of the advisory bodies declared indirect financial and intellectual interests. Because of the lack of individual voting records it was not possible to determine if financial or intellectual interests influenced voting patterns., Competing Interests: Competing interests: In 2015–2018, Joel Lexchin was a paid consultant on 3 projects: one looking at indication-based prescribing (US Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Strategy for Patient-Oriented Research Support Unit and the St. Michael’s Hospital Foundation). He also received payments for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization), being on a panel at the American Diabetes Association, giving a talk at the Toronto Reference Library and writing a brief for a law firm on the effects of promotion on prescribing. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare., (Copyright 2019, Joule Inc. or its licensors.)

Portals to allow patients to access their primary care medical records are necessary to achieve true collaborative care between doctors and patients. In this article, we outline a practical approach to achieving this goal that involves Ministries of Health, electronic medical record vendors, physicians and patients. Patient portals to primary care records could make possible an entirely new world of on-the-spot, customized learning. Patient portals ideally should be designed with the goal of optimizing patients' to better their ability to help themselves. Delaying implementation of these portals exacts a continued financial and personal hardship on patients and their families., (Copyright © 2019 Longwoods Publishing.)

Health Canada has developed its Notice of Compliance with conditions (NOC/c) policy to get promising new drugs for serious diseases to market faster than would be possible through its standard approval process. Companies can receive an NOC/c for a new drug or a new indication based on incomplete evidence in return for agreeing to conduct post-market studies. This paper investigates the additional therapeutic gain from drugs approved under this policy, the percent of drugs that have fulfilled their conditions, and the length of time for fulfillment. From the inception of the policy in 1998 to the end of 2017, 89 new drugs and new indications for existing drugs received an NOC/c. Therapeutic evaluations were available for 78 of the drugs, and 54 offered only minimal or no gains over existing products. Fifty NOC/c were fulfilled, 31 were not fulfilled, and 8 were withdrawn. The median time to fulfillment was 1,040 days. Twelve NOC/c took more than 5 years to fulfill their conditions. The unfulfilled NOC/c had been issued for a median of 1,161 days, and 10 had been issued more than 5 years. The value of the NOC/c policy to patients is uncertain.

Purpose: There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian "direct health professional communications" (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA)., Methods: We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow-up freedom-of-information (FOI) request to the TGA., Results: Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality; the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful., Conclusions: Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases., (© 2019 John Wiley & Sons, Ltd.)

Background: Patient groups represent the interest of their members when it comes to drug funding. Many patient groups receive grants from pharmaceutical companies that make products being considered for funding. This research examines whether there is an association between the positions that Canadian groups take about the products and conflicts of interest with the companies., Methods: The Common Drug Review (CDR) and panCanadian Oncology Drug Review (pCODR) make recommendations to Canadian provincial and federal drug plans about funding particular drug-indications. Both utilize input from patient groups in making their recommendations. Patient group submissions are available from both organizations and these submissions contain statements about conflicts of interest. Views of the patient groups, with and without a conflict with the company making the drug under consideration and without any conflicts at all, were assessed and then compared with the recommendations from CDR and pCODR., Results: There was a total of 222 reports for drug-indications. There were 372 submissions from 93 different patient groups. Groups declared a total of 1896 conflicts with drug companies in 324 (87.1%) individual submissions. There were 268 submissions where groups declared a conflict with the company making the product or said they had no conflict. Irrespective of whether there was a conflict, the views of patient groups about the drug-indications under consideration were the same. There was no statistically significant difference between views of patient groups and the recommendations from CDR and/or pCODR., Conclusions: The large majority of patient groups making submissions about funding of particular drug-indications had conflicts with the companies making the products and their views about the products were almost always positive. This association between funding and views needs to be further investigated to determine if a true cause and effect exists., Competing Interests: In 2015-2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. This does not alter my adherence to PLOS ONE policies on sharing data and materials.

Objectives The aim of the study was to estimate the potential savings to the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) in 2015-16 if biosimilar versions of selected biologic medicines (biologics) had been available and listed on the PBS. Methods The research involved retrospective analysis of Australian Medicare expenditure data and PBS price data from 2015-16 for biologics, for which biosimilar competition may be available in future, listed on the PBS. Results Australian Government expenditure on biologics on the PBS and RPBS was estimated at A$2.29 billion dollars in 2015-16. If biosimilar versions of these medicines had been listed on the PBS in 2015-16, at least A$367million dollars would have been saved in PBS and RPBS subsidies. Modelling based on price decreases following listing of biosimilars on the PBS suggests that annual PBS outlays on biologics could be reduced by as much as 24% through the timely introduction of biosimilars. Conclusions Biologic medicines represent a large proportion of government expenditure on pharmaceuticals. Reducing the length of monopoly protections on these medicines could generate savings of hundreds of millions of dollars per year. What is known about the topic? Biologics take up an increasing share of pharmaceutical expenditure, but no previous published studies have examined Australian Government expenditure on biologics or the potential savings from reducing the duration of monopoly protection. What does this paper add? This paper provides new evidence about Australian Government expenditure on biologics and potential savings for selected medicines that are still subject to monopoly protection and thus are not yet subject to biosimilar competition. In 2015-16 Australian Government expenditure on biologics through the PBS and RPBS was estimated at A$2.29 billion dollars. If biosimilar versions of these medicines had been listed on the PBS at that time, at least A$367million dollars would have been saved. What are the implications for practitioners? Reducing the duration of monopoly protection on biologic medicines could save hundreds of millions of dollars annually that could be redirected to other areas of the healthcare system.

Introduction: Biologics are currently protected from competition by eight years of data protection. The renegotiated North American Free Trade Agreement (NAFTA) increases data protection from 8 to 10 years. This study investigates the effect of such an extension on drug spending in Canada., Methods: A list of currently available biologics eligible for data protection along with their 2017 sales was compiled. Two years were added to the current expiration date of data protection to see if it exceeded patent protection, and any theoretical change in spending due to delayed competition was calculated. The number of biologics approved after January 1, 1995, that have competition and the time until competition started was analyzed. Theoretical competition due to increased data protection for biologics where data protection has already expired was examined., Results: Depending on how much of the market is captured by biologic competitors and how strong the patents are, lost savings from data protection extension could range from $0 to $305.8 million. One biologic competitor currently on the market could theoretically have been affected by an increase in data protection. Increased data protection would have had minor effects on products that have already lost data protection., Discussion: The potential impact on drug expenditures of a two-year extension in data protection is highly variable. Possible increases in spending on biologics strengthen the rationale for a national pharmacare plan where monopsony buying power would help to control drug prices overall and offset increased spending on biologics., (Copyright © 2019 Longwoods Publishing.)

Nursing home (NH) residents are increasingly in need of timely and frequent medical care, presupposing not only available but perhaps also continual medical care provision in NHs. The provision of this medical care is organized differently both within and across countries, which may in turn profoundly affect the overall quality of care provided to NH residents. Data were collected from official legislations and regulations, academic publications, and statistical databases. Based on this set of data, we describe and compare the policies and practices guiding how medical care is provided across Canada (2 provinces), Germany, Norway, and the United States. Our findings disclose that there is a considerable difference to find among jurisdictions regarding specificity and scope of regulations regarding medical care in NHs. Based on our data, we construct 2 general models of medical care: (1) more regulations-fee-for-service payment-open staffing models and (2) less regulation-salaried positions-closed staffing models. Some evidence indicates that model 1 can lead to less available medical care provision and to medical care provision being less integrated into the overall care services. As such, we argue that the service models discussed can significantly influence continuity of medical care in NH., Competing Interests: Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: In 1995, Health Canada started collecting fees from pharmaceutical companies for various drug regulatory activities. This study investigated whether this change in the source of revenue affected the postmarket safety of drugs., Methods: A list of all new active substances approved in the 5 years before (1990-1994) and after (1995-1999) the introduction of cost recovery was compiled. Drug safety warnings and market withdrawals due to safety reasons were identified from the Health Canada Web site and other sources. Information about total funding for Health Canada's drug regulatory program came from a report by KPMG, a global professional service company providing financial audit, tax and advisory services. Time-series analyses and Kaplan-Meier curves were used to determine whether cost recovery affected postmarket safety., Results: The introduction of cost recovery made no difference in the proportion of new active substances that received a safety warning, the number of safety warnings per new active substance or the time until the first safety warning or the likelihood that a drug would have a safety problem. Median drug review times decreased significantly after cost recovery was implemented ( p = 0.02)., Interpretation: The introduction of cost recovery and the associated reduction in review times did not affect the postmarket safety of drugs. Further changes to cost recovery, as are currently being proposed by Health Canada, need to be evaluated for any potential effects on the approval process that might influence decisions that Health Canada makes about the safety and efficacy of new drugs., Competing Interests: Competing interests: In 2015–2018, Joel Lexchin was a paid consultant on 3 projects: 1 looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Strategy for Patient-Oriented Research in Ontario – the Ontario SPOR SUPPORT Unit and St. Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare., (Copyright 2018, Joule Inc. or its licensors.)

Canada has strengthened intellectual property (IP) protections for pharmaceutical drugs several times over the last 3 decades. This study investigates whether the IP changes had an effect on the market exclusivity time of brand products on the Ontario Drug Benefit (ODB) formulary. We constructed a database that included the first brand approval date for drugs launched between 1974 and 2012, the first ODB listing date of the brand drug, and the first ODB listing date of the generic form of the drug. We then calculated the time of formulary exclusivity to detect any changes in market exclusivity times associated with changes to Canada's IP regimen. There were 595 drugs launched between 1974 and 2012 that were available for analysis. Exclusivity gradually declined from the late 1970s to 1990. Drugs approved in 2004 received 7.6 years of exclusivity, and drugs approved in 2005 received 5 years of exclusivity. Over the time period we analyzed, market exclusivity time of brand drugs experienced marked changes, but we did not detect any systematic effects of Canada's stronger pharmaceutical IP laws on the market exclusivity.

Purpose: Clinical research is widely sponsored by drug and device companies. We investigated whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. This review is an update of a previous Cochrane review., Methods: In this update we searched MEDLINE and Embase (2010 to February 2015), Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). We included empirical studies that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. Two assessors included papers, extracted data and assessed risk of bias. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether conclusions agreed with results., Results: We included 27 additional papers in this update (review now includes 75 papers). Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI 1.17-1.37), no difference in harms results RR: 1.37 (95% CI 0.64-2.93) and more often favorable conclusions RR: 1.34 (95% CI 1.19-1.51) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in reporting of data and heterogeneity of results. Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI 1.05-1.50), compared with non-industry sponsored studies., Conclusions: Drug and device studies sponsored by manufacturing companies have more favorable efficacy results and conclusions than studies sponsored by other sources.

Background: The independent French drug bulletin, La revue Prescrire (henceforth Prescrire ), annually releases a list of drugs to avoid. The aim of this analysis was to review the status of the 2017 list of drugs in Canada to determine whether they had been approved for marketing, their therapeutic status and whether they have been recommended for listing on public drug plans., Methods: This descriptive analysis reviewed a list of drugs compiled by Prescrire . The status of each drug in Canada was assessed through the Drug Product Database. Therapeutic ratings were obtained from the Patented Medicine Prices Review Board (PMPRB) and the formulary listing recommendation came from the Common Drug Review (CDR) or the pan-Canadian Oncology Drug Review (pCODR). For drugs without a formulary recommendation the Ontario Drug Benefit (ODB) Formulary was searched to see if the product was listed., Results: Prescrire recommended not using 92 drugs. The PMPRB evaluated 36 of these drugs; 2 were classed as substantial improvements or breakthroughs, 3 as moderate improvements and 31 as little or no therapeutic improvement. Nine of the remaining drugs that were approved in Canada were not assessed because they were approved before 1988 (the year the PMPRB was established), 4 were approved from December 2015 onward and had not yet been reviewed by the PMPRB, and for 1 the approval date was unknown. Twenty-six of the drugs were evaluated by CDR or pCODR, of which 13 were recommended for formulary listing. Sixteen additional drugs that were not evaluated were on the ODB Formulary., Interpretation: Many drugs that Prescrire recommended avoiding were available in Canada. The results also highlight the diversity of the conclusions that different expert panels have reached., Competing Interests: Competing interests: In 2015–2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Strategy for Patient-Oriented Research Support Unit and the St. Michael’s Hospital Foundation). He also received payments for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization) and a panel at the American Diabetes Association and for a talk at the Toronto Reference Library. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare., (Copyright 2018, Joule Inc. or its licensors.)

Invited Editorial.

Objectives: This study examines the use of expedited approval pathways by Health Canada over the period 1995 to 2016 inclusive and the relationship between the use of these pathways and the therapeutic gain offered by new products., Design: Cross-sectional study., Data Sources: Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, Notice of Compliance database, Notice of Compliance with conditions web site, Patented Medicine Prices Review Board, La revue Prescrire, WHO Anatomical Therapeutic Chemical classification system., Primary and Secondary Outcomes: Percent of new drugs evaluated by Health Canada that went through an expedited pathway between 1995 and 2016 inclusive. Kappa values comparing the review status with assessments of therapeutic value for individual drugs., Results: Of 623 drugs approved by Health Canada between 1995 and 2016, 438 (70.3%) drugs went through the standard pathway and 185 (29.7%) an expedited pathway. Therapeutic evaluations were available for 509 drugs. Health Canada used an expedited approval pathway for 159 of the 509 drugs, whereas only 55 were judged to be therapeutically innovative. Forty-two of the 55 therapeutically innovative drugs received an expedited review and 13 received a standard review. The Kappa value for the entire period for all 509 drugs was 0.276 (95% CI 0.194 to 0.359) indicating 'fair' agreement between Health Canada's use of expedited pathways and independent evaluations of therapeutic innovation., Conclusion: Health Canada's use of expedited approvals was stable over the entire time period. It was unable to reliably predict which drugs will offer major therapeutic gains. The findings in this study should provoke a discussion about whether Health Canada should continue to use these pathways and if so how their use can be improved., Competing Interests: Competing interests: In 2015–2017, Joel Lexchin received payment from two non-profit organisations for being a consultant on a project looking at indication-based prescribing and a second looking at which drugs should be distributed free of charge by general practitioners. In 2015, he received payment from a for-profit organisation for being on a panel that discussed expanding drug insurance in Canada. He is on the Foundation Board of Health Action International., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United States and Japan. In this paper we explore the manner in which state interdependence fosters the conditions for regulatory harmonization by tracing the underlying parallels between ICH and member state pharmacogovernance to clarify emergent patterns in regulatory policy convergence., Results: A shift to the life cycle approach to pharmaceutical regulation corresponded with international convergence in pre-market standards as emphasis shifted to post-market standards where convergence remains unresolved. Transnational pharmacogovernance was found to concentrate regulatory authority within a co-regulatory model of bilateral negotiation with pharmaceutical trade associations in defining safety and efficacy standards. Given a context of state interdependence, parallels were found between transnational and ICH member pharmacogovernance modes that guide policy development. Divergent modes of state regulatory governance that re-calibrate perceptions of risk and risk mitigation were found to coincide with post-market policy dissonance., Conclusion: Although interdependence fostered harmonization in pre-market standards and aligned with increased focus on post-market approaches, the confluence of divergent state governance modes and perceptions of risk may inspire improvisation in post-market standards. As the ICH expands to an ensemble with a greater global reach, further research is needed to clarify the manner in which interdependence shapes transnational pharmacogovernance and the conditions that foster policy convergence in the public interest.

Competing Interests: Competing interests: As the principal investigator and founder of PrimeHealth Clinical Research, Iris Gorfinkel reports receiving grants for research from many major pharmaceutical companies during her participation in more than 50 clinical research trials. In addition, she has participated in speaking engagements for pharmaceutical companies. She has sat on the advisory board for GlaxoSmithKline’s Shingrix vaccination. Joel Lexchin reports acting as a paid consultant on projects for the US Agency for Healthcare Research and Quality, the Gordon and Betty Moore Foundation, and the Ontario Strategy for Patient-Oriented Research Support Unit and the St. Michael’s Hospital Foundation. He also reports receiving payments for participating in a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization), a panel at the American Diabetes Association and giving a talk at the Toronto Reference Library. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare.

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

ABSTRACTDespite the increasing complexity of nursing home care, the role of physicians caring for residents is largely unexplored. This international, exploratory study sought to learn about physicians' roles, responsibilities, and tasks as well as investigate the unique qualities of medical practice in nursing homes. We conducted interviews with 18 physicians, who reported making important contributions to the quality of resident care, including clarifying the goals of care, working to reduce unnecessary medication and hospitalization, as well as contributing to staff education. Nursing home practice involved physicians in networks of relations that were instrumental to the quality of medical care and physicians' job satisfaction. The importance of these relationships disrupts the oft-drawn boundary between the medical and the social, suggesting that good medical practice depends on good social practice. Reflecting the exploratory nature of the study, we recommend research to better understand and support the relational dimensions of nursing home medicine.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: JL has received payments from non-profits for consulting on projects that investigated indication based prescribing and which drugs should be distributed free of charge by general practitioners. He received payment from a for-profit for being on a panel that discussed expanding drug insurance in Canada. This proposal has been endorsed by Physicians for a National Health Program and Canadian Doctors for Medicare; authors and working group members are active in both organizations. Physicians for a National Health Program is not-for-profit organization that advocates for a single-payer healthcare system for the United States. Canadian Doctors for Medicare is a not-for-profit organization that advocates on behalf of Canada’s public single-payer system.

Objectives: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017., Design: Cohort study., Data Sources: Journal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies., Interventions: None., Primary and Secondary Outcome Measures: Characteristics of studies-study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women., Results: Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44-61). The median number of men per study/trial was 184 (IQR 58-514) versus women 141 (IQR 46-263)., Conclusions: Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts., Competing Interests: Competing interests: In 2015-2017, JL received payment from two non-profit organisations for being a consultant on a project looking at indication-based prescribing and a second looking at which drugs should be distributed free of charge by general practitioners. In 2015, he received payment from a for-profit organisation for being on a panel that discussed expanding drug insurance in Canada. He is on the Foundation Board of Health Action International., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delaying the introduction of low-cost generics. While developing nations negotiated transition periods for implementing some obligations, all parties would have eventually been expected to meet the same standards had the TPP come into force. While the TPP has stalled following US withdrawal, there are moves by some of the remaining countries to reinvigorate the agreement without the United States. The proponents may seek to retain as much as possible of the original text in the hope that the United States will re-join the accord in future. This article presents a comparative analysis of the impact the final 2016 TPP intellectual property chapter could be expected to have (if implemented in its current form) on the intellectual property laws and regulatory regimes for medicines in the TPP countries. Drawing on the published literature, it traces the likely impact on access to medicines. It focuses particularly on the differential impact on regulatory frameworks for developed and developing nations (in terms of whether or not legislative action would have been required to implement the agreement). The article also explores the political and economic dynamics that contributed to these differential outcomes., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: D.G. often represents the Public Health Association of Australia on matters related to trade agreements and public health. The authors have no other conflicts of interest to declare.

Background: Competing claims are made about the amount of money that pharmaceutical companies spend on research and development (R&D) versus promotion. This study investigates this question in the Canadian context., Methods: Two methods for determining industry-wide figures for spending on promotion were employed. First, total industry spending on detailing and journal advertising for 2013-2016 was abstracted from reports from QuintilesIMS. Second, the mean total promotion spending for the years 2002-2005 was used to estimate total spending for 2013-2016. Total industry spending on R&D came from the Patented Medicine Prices Review Board (PMPRB). R&D to promotion spending using each method of determining the amount spent on promotion was compared for 2013-2016 inclusive. Data on the 50 top promoted drugs, the amounts spent, the companies marketing these products and their overall sales were abstracted from the QuintilesIMS reports. Spending on R&D and promotion as a percent of sales was compared for these companies., Results: Industry wide, the ratio of R&D to promotion spending went from 1.43 to 2.18 when promotion was defined as the amount spent on detailing and journal advertising for the 50 most promoted drugs. Calculating total promotion spending from the mean of the 2002-2005 figures the ratio was 0.88 to 1.32 for the 50 most promoted drugs. For individual companies marketing one or more of the 50 most promoted drugs, mean R&D spending ranged from 3.7% of sales to 4.1% compared to mean promotion spending that went from 1.7 to 1.9%. The ratio of spending on R&D to promotion varied from 2.11 to 2.32. Eight to 10 companies per year spent more on promotion than on R&D., Conclusions: Depending on the method used to determine promotion spending, industry-wide the ratio of R&D spending to promotion ranges from 1.45 to 2.18 (sales representatives and journal advertising only) or from 0.88 to 1.32 (total promotion spending estimated based 2003-2005 data.) For the individual companies promoting one or more of the 50 most promoted drugs, 2.11 to 2.32 times more is spent on R&D compared to promotion. However these results should be interpreted cautiously because of data limitations., Competing Interests: Not relevantNot relevant.In 2015-2017, Joel Lexchin was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is member of the Foundation Board of Health Action International.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Objectives: To examine and compare the experiences and attitudes of primary care physicians in three different regulatory environments (United States, Canada, and France) towards interactions with pharmaceutical sales representatives, particularly their perspectives on safety information provision and self-reported influences on prescribing., Methods: We recruited primary care physicians for 12 focus groups in Montreal, Sacramento, Toulouse and Vancouver. A thematic analysis of the interview data followed a five-stage framework analysis approach., Results: Fifty-seven family physicians (19 women, 38 men) participated. Physicians expected a commercial bias and generally considered themselves to be immune from influence. They also appreciated the exchange and the information on new drugs. Across all sites, physicians expressed concern about missing harm information; however, attitudes to increased regulation of sales visits in France and the US were generally negative. A common solution to inadequate harm information was to seek further commercially sourced information. Physicians at all sites also expressed sensitivity to critiques from medical students and residents about promotional interactions., Conclusions: Physicians have contradictory views on the inadequate harm information received from sales representatives, linked to their lack of awareness of the drugs' safety profiles. Commonly used strategies to mitigate information bias are unlikely to be effective. Alternate information sources to inform prescribing decisions, and changes in the way that physicians and sales representatives interact are needed., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Competing Interests: Competing interests: Iris Gorfinkel has received research grants from Astellas, Mundipharma, GSK, Serenity, Ferring and Romark, and has served on an advisory board for GSK. Joel Lexchin has received consultant fees from the US Agency for Healthcare Research and Quality for a project researching indication-based prescribing; and from the Government of Canada, the Ontario Supporting Patient-Oriented Research Support Unit and St. Michael’s Hospital Foundation for a project determining which drugs should be distributed free of charge by family physicians. He also received renumeration from The Canadian Institute for being on a panel that discussed a pharmacare plan for Canada. He is a member of the Foundation Board of Health Action International. No other competing interests were declared.

Aims: This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome., Methods: Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes., Results: There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001., Conclusions: Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators., (© 2017 The British Pharmacological Society.)

Objectives: Investigate if the recommendations by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial, territorial and federal drug plans about whether to list non-oncology and oncology drug-indication combinations on their formularies are associated with whether the drug-indication combination was approved via the standard evidence pathway or the Notice of Compliance with conditions (NOC/c-limited evidence) pathway., Design: Cohort study., Data Sources: Websites of the CDR and pCODR up to the end of 31 March 2017; journal articles evaluating drugs approved through the NOC/c pathway, the NOC database, the NOC/c website and the Summary Basis of Decision website., Interventions: Recommendations by the CDR and pCODR., Primary and Secondary Outcome Measures: Analysis of the percent of drugs receiving positive listing recommendations from CDR and pCODR depending on the pathway used to approve the drug., Results: There were 310 recommendations for drug-indication combinations from the CDR and 79 from the pCODR. There was a statistically significant difference in the number of drug-indication combinations that received a list versus do not list recommendation from the CDR for those approved through the standard pathway compared with those approved through the NOC/c pathway (p=0.0407). A similar analysis for recommendations from the pCODR was not statistically significant., Conclusion: For non-oncology drug-indication combinations, the type of review appears to influence the recommendation regarding listing on public formularies. This difference may reflect the level of evidence about the efficacy and safety of the drug indication at the time the recommendation was made., Competing Interests: Competing interests: In 2015-2017, JL received payment from two non-profit organisations for being a consultant on a project looking at indication-based prescribing and a second looking at which drugs should be distributed free of charge by general practitioners. In 2015, he received payment from a for-profit organisation for being on a panel that discussed expanding drug insurance in Canada. He is on the Foundation Board of Health Action International., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Whether drug promotion helps or hinders appropriate prescribing by physicians is debated. This study examines the most heavily promoted drugs and the therapeutic value of those drugs to help determine whether doctors should be using promotional material to inform themselves about drugs., Methods: Lists were constructed of the 50 most heavily promoted drugs (amount of money spent on journal advertisements and visits by sales representatives) and the 50 top-selling drugs (by dollar value) for 2013, 2014 and 2015. Therapeutic gain was determined by examining ratings from the Patented Medicine Prices Review Board and the French drug bulletin Prescrire International and was categorized as major, moderate or little to none. For each of the 3 years, the number of drugs in the 3 therapeutic categories for drugs in both groups was compared. The amount and proportion of money spent on promotion for drugs in each of the 3 therapeutic categories for the 3 years was also determined., Results: Therapeutic ratings were available for 42 of 79 of the most heavily promoted drugs over the 3 years and for 40 of 61 of the top-selling drugs. Nearly all the money spent on promotion in each of the 3 years went to drugs with little to no therapeutic gain. The distribution of therapeutic gain for drugs in both groups was statistically significantly different only in 2013 ( p = 0.04)., Interpretation: Most of the money spent on promotion went to drugs that offer little to no therapeutic gain. This result calls into question whether doctors should read journal advertisements or see sales representatives to acquire information about important medical therapies., Competing Interests: Competing interests: See the end of the article., (Copyright 2017, Joule Inc. or its licensors.)

Background: Clinicians are faced with a plethora of guidelines. To rate guidelines, they can select from a number of evaluation tools, most of which are long and difficult to apply. The goal of this project was to develop a simple, easy-to-use checklist for clinicians to use to identify trustworthy, relevant, and useful practice guidelines, the Guideline Trustworthiness, Relevance, and Utility Scoring Tool (G-TRUST)., Methods: A modified Delphi process was used to obtain consensus of experts and guideline developers regarding a checklist of items and their relative impact on guideline quality. We conducted 4 rounds of sampling to refine wording, add and subtract items, and develop a scoring system. Multiple attribute utility analysis was used to develop a weighted utility score for each item to determine scoring., Results: Twenty-two experts in evidence-based medicine, 17 developers of high-quality guidelines, and 1 consumer representative participated. In rounds 1 and 2, items were rewritten or dropped, and 2 items were added. In round 3, weighted scores were calculated from rankings and relative weights assigned by the expert panel. In the last round, more than 75% of experts indicated 3 of the 8 checklist items to be major indicators of guideline usefulness and, using the AGREE tool as a reference standard, a scoring system was developed to identify guidelines as useful, may not be useful, and not useful., Conclusion: The 8-item G-TRUST is potentially helpful as a tool for clinicians to identify useful guidelines. Further research will focus on its reliability when used by clinicians., Competing Interests: Conflicts of interest: A.F.S., J.L., and L.C. have published research evaluating clinical practice guidelines and a commentary advocating for more rigorous oversight of guideline development and dissemination., (© 2017 Annals of Family Medicine, Inc.)

Objectives: This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated., Methods: A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs., Results: A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017., Conclusions: Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims., (Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)