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Policy Points In 2012, Colorado and Washington were the first states to legalize recreational marijuana through voter-initiated ballots. In these states, counties could restrict or ban local marijuana facilities through a variety of regulatory methods such as ordinances and zoning. County-level recreational marijuana policies in Washington and Colorado vary substantially, with 69.2% of Washington counties and 23.4% of Colorado counties allowing all types of recreational marijuana facilities as of April 1, 2019. After Colorado and Washington legalized recreational marijuana, many counties modified their marijuana policies over time, with shifts in county policy often preceded by advocacy and information-seeking activities., Context: In 2012, Colorado and Washington were the first states to legalize recreational marijuana. Both allowed local governments to further regulate the availability of marijuana facilities in their jurisdictions. As early adopters, these states are important quasi-natural experiments to examine local marijuana policy and policy change processes, including key stakeholders and arguments., Methods: We conducted a policy scan of county-level recreational marijuana ordinances and regulations in Colorado and Washington. Data collected included policy documents from counties in both states and newspaper articles. We used a mixed-methods approach to describe the types of county-level recreational marijuana policies enacted by April 1, 2019; identify key policy stakeholders involved in local policy debates; and explore arguments used in support or opposition of county policies. We also selected four counties that represent three county policy environments (all marijuana facility types allowed, some marijuana facility types allowed, all marijuana facility types prohibited) and described the policy changes within these counties since recreational marijuana was legalized., Findings: By April 1, 2019, Colorado counties were less likely than Washington counties to allow marijuana facilities-48.4% of Colorado counties prohibited recreational marijuana facilities in their jurisdiction compared to 23.1% of Washington counties. Since state legalization, several counties in both states have made substantial marijuana facility policy modifications, often preceded by information-seeking activities. Primary stakeholders involved in policy debates included elected officials, law enforcement, individual growers/farmers, marijuana business license applicants, parents, and residents. Proponents referenced local economic gain, reduced crime, and potential health benefits of marijuana as arguments in favor of permitting local facilities, whereas opponents pointed to economic loss, negative health and public health issues, public safety concerns, and existing federal law. Both sides referenced local public opinion data to support their position., Conclusions: By early 2019, a patchwork of local marijuana policies was in place in Colorado and Washington. We identify key areas of policy and public health research needed to inform future local marijuana policy decisions, including the impact of legalization on public health outcomes (particularly for youth) and public safety., (© 2021 The Authors. The Milbank Quarterly published by Wiley Periodicals LLC on behalf of The Millbank Memorial Fund.)

Background: The Canadian government legalized non-medical cannabis use by adults in October 2018 to minimize associated harms and redirect profits from criminals. In October 2019, a wider array of products, including edibles, was legalized, with entry into the legal market beginning in December., Data and Methods: Three quarters (the first quarters of 2018 and 2019 and the fourth quarter of 2020) of the National Cannabis Survey were used to examine changes in cannabis use (overall use and daily or almost daily (DAD) use), consumption methods, products and sources., Results: Cannabis use in the past three months was higher in late 2020 (20.0%) than in 2019 (17.5%) and 2018 (14.0%), and this was particularly the case among: females (for whom rates rose to equal male rates for the first time), adults aged 25 and older, and some provinces. Similarly, DAD use, at 7.9% also increased. Higher percentages of Canadians reported getting at least some of their cannabis from legal sources or growing it, and fewer were relying on friends and family or illegal sources in 2020., Discussion: This study spans three years-from before legalization to about two years after. It provides a more complete picture of the law's impact on cannabis use and related behaviours, given the more established legal cannabis industry better equipped to compete with the black market on price, convenience and selection. Findings demonstrate that change is continuing, and, as before, some cautions and assurances remain. The impact of the COVID-19 pandemic on cannabis use continues to be difficult to measure. Monitoring remains important, given the ever-changing provincial retail landscapes; the introduction of new products; and the pressure by the industry to remove or adjust potency limits, and allow widespread delivery, farm-gate sales and cannabis lounges.

This brief report covers recent advances in cannabis and cannabinoid regulation and drug approval. The popularity of cannabis and cannabinoid products continues to rise, and these products are available for the majority of the population in the United States to purchase as easily as alcohol. Although many states have approved programs and research licenses, these activities and products all remain federally illegal. The solution may be for the United States to offer multiple pathways for product approval that adapt to the diversity of the products and the needs of the consumer. Multiple pathways for market approval would protect public health, whether the public is using cannabis and cannabinoids as a medicine, a wellness product, or as a recreational substance.
., (© 2020, AICHServier GroupCopyright © 2020 AICH Servier Group. All rights reserved.)

Cannabidiol (CBD) is the second most abundant cannabinoid present in Cannabis sativa L. It is not associated with psychotropic activity and is capable to mitigate the psychotomimetic effects produced by tetrahydrocannabinol (THC). The latest cannabis decriminalization policies and the high applicability in therapeutic and technologic-industrial fields, have determined an exponential marketing growth of foods, cosmetics and in particularly medicinal products containing CBD, which are easily available for consumers. Most importantly, on 2018 United States Food and Drug Administration approved CBD oral solution with the trade name of Epidiolex® for the treatment of two rare and severe forms of epilepsy, "Lennox-Gastaut syndrome" and "Dravet syndrome", in pediatric patients. The aim of this review was to focus on pharmacology and on legal status of CBD, to highlight the lack of harmonization of international regulatory laws over the marketing authorization of CBD-based products.

Introduction: In October 2018, Canada legalized the nonmedical use of cannabis for adults. The aim of our study was to present a more recent temporal pattern of cannabis-related injuries and poisonings found in the electronic Canadian Hospitals Injury Reporting and Prevention Program (eCHIRPP) database and provide a descriptive summary of the injury characteristics of cannabis-related cases captured in a nine-year period., Methods: We conducted a search for cannabis-related cases in the eCHIRPP database reported between April 2011 and August 2019. The study population consisted of patients between the ages of 0 and 79 years presenting to the 19 selected emergency departments across Canada participating in the eCHIRPP program. We calculated descriptive estimates examining the intentionality, external cause, type and severity of cannabis-related cases to better understand the contextual factors of such cases. We also conducted time trend analyses using Joinpoint software establishing the directionality of cannabis-related cases over the years among both children and adults., Results: Between 1 April 2011, and 9 August, 2019, there were 2823 cannabis-related cases reported in eCHIRPP, representing 252.3 cases/100 000 eCHIRPP cases. Of the 2823 cannabis-related cases, a majority involved cannabis use in combination with one or more substances (63.1%; 1780 cases). There were 885 (31.3%) cases that involved only cannabis, and 158 cases (5.6%) that related to cannabis edibles. The leading external cause of injury among children and adults was poisoning. A large proportion of cannabis-related cases were unintentional in nature, and time trend analyses revealed that cannabis-related cases have recently been increasing among both children and adults. Overall, 15.1% of cases involved serious injuries requiring admission to hospital., Conclusion: Cannabis-related cases in the eCHIRPP database are relatively rate, a finding that may point to the fact that mental and behavioural disorders resulting from cannabis exposure are not generally captured in this surveillance system and the limited number of sites found across Canada. With Canada's recent amendments to cannabis regulations, ongoing surveillance of the health impacts of cannabis will be imperative to help advance evidence to protect the health of Canadians., Competing Interests: The authors have no conflicts of interest to declare.

Background: The trend of non-communicable diseases is alarmingly increasing and tobacco consumption and exposure to its smoke have been playing the leading role. Thirty-seven Ethiopians deaths per day are attributable to tobacco. Unless appropriately mitigated, this has social, economic and political impacts. Implementation of the appropriate policy is a good remedy; however, the policy process has never been straight forward and always successful. The involvement of different actors makes policy process complex hence agenda setting, policy formulation, implementation, and evaluations have been full of chaos and even may fail at any of these levels. Thus the aim of this review was retrospectively analyzing tobacco-related policies in Ethiopia that are relevant to control tobacco use and mitigate its impacts., Methods: Systematically, we searched in pub-med, Scopus, Web of Science and Embase. Additionally, we did hand search on Google scholar and national websites. The terms "tobacco", "cigar", "cigarette", "control", "prevention", "policy" and "Ethiopia" were used. Eleven of 128 records met the inclusion criteria and then included. For data analysis, we applied the health policy analysis framework developed by Walt and Gilson., Result: Lately, Ethiopia enacted and started to implement tobacco control policies and programs, but its implementation is problematic and consumption rate is increasing., Conclusion: Despite the early involvement in tobacco control initiatives and enactment of legal frameworks, Ethiopia's journey and current stand to prevent and control the devastating consequences of tobacco is very limited and unsatisfactory. Therefore, we strongly call for further action, strong involvement of private sector and non-governmental organizations., (© 2020 Teshome Tesfaye Habebo, et al.)

Objective: To determine the association of medical marijuana legalization with prescription opioid utilization., Methods: A 10% sample of a nationally representative database of commercially insured population was used to gather information on opioid use, chronic opioid use, and high-risk opioid use for the years 2006-2014. Adults with pharmacy and medical benefits for the entire calendar year were included in the population for that year. Multilevel logistic regression analysis, controlling for patient, person-year, and state-level factors, were used to determine the impact of medical marijuana legalization on the three opioid use measures. Sub-group analysis among cancer-free adults and cancer-free adults with at least one chronic non-cancer pain condition in the particular year were conducted. Alternate regression models were used to test the robustness of our results including a fixed effects model, an alternate definition for start date for medical marijuana legalization, a person-level analysis, and a falsification test., Results: The final sample included a total of 4,840,562 persons translating into 15,705,562 person years. Medical marijuana legalization was found to be associated with a lower odds of any opioid use: OR = 0.95 (0.94-0.96), chronic opioid use: OR = 0.93 (0.91-0.95), and high-risk opioid use: OR = 0.96 (0.94-0.98). The findings were similar in both the sub-group analyses and all the sensitivity analyses. The falsification tests showed no association between medical marijuana legalization and prescriptions for antihyperlipidemics (OR = 1.00; CI 0.99-1.01) or antihypertensives (OR = 1.00; CI 0.99-1.01)., Conclusions: In states where marijuana is available through medical channels, a modestly lower rate of opioid and high-risk opioid prescribing was observed. Policy makers could consider medical marijuana legalization as a tool that may modestly reduce chronic and high-risk opioid use. However, further research assessing risk versus benefits of medical marijuana legalization and head to head comparisons of marijuana versus opioids for pain management is required.

Objectives: To examine the effect of cannabis policy liberalisation (decriminalisation and legalisation) levels of use in adolescents and young adults., Design: Systematic review and meta-analysis., Inclusion Criteria: Included studies were conducted among individuals younger than 25 years and quantitatively assessing consequences of cannabis policy change. We excluded articles: (A) exclusively based on participants older than 25 years; (B) only reporting changes in perceptions of cannabis use; (C) not including at least two measures of cannabis use; (D) not including quantitative data; and (E) reviews, letters, opinions and policy papers. PubMed, PsycINFO, Embase and Web of Science were searched through 1 March 2018., Data Extraction and Synthesis: Two independent readers reviewed the eligibility of titles and abstracts and read eligible articles, and four authors assessed the risk of bias (Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies). Extracted data were meta-analysed. The protocol was registered with PROSPERO., Results: 3438 records were identified via search terms and four via citation lists; 2312 were retained after removal of duplicates, 99 were assessed for eligibility and 41 were included in our systematic review. 13 articles examined cannabis decriminalisation, 20 examined legalisation for medical purposes and 8 examined legalisation for recreational purposes. Findings regarding the consequences of cannabis decriminalisation or legalisation for medical purposes were too heterogeneous to be meta-analysed. Our systematic review and meta-analysis suggest a small increase in cannabis use among adolescents and young adults following legalisation of cannabis for recreational purposes (standardised mean difference of 0.03, 95% CI -0.01 to -0.07). Nevertheless, studies characterised by a very low/low risk of bias showed no evidence of changes in cannabis use following policy modifications., Conclusions: Cannabis policy liberalisation does not appear to result in significant changes in youths' use, with the possible exception of legalisation for recreational purposes that requires monitoring., Trial Registration Number: CRD42018083950., Competing Interests: Competing interests: None declared., (© 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.)

After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of any patient customization and intended for large-scale distribution. Accordingly, the resulting regulatory framework is hardly reconcilable with the concept of sustainable phage therapy, involving tailor-made medicinal products in the global perspective of both evolutionary and personalized medicine. The repeated appeal for a dedicated regulatory framework has not been heard by the European legislature, which, in this matter, features a strong resistance to change despite the precedent of the unhindered implementation of advanced therapy medicinal product (ATMPs) regulation. It is acknowledged that in many aspects, phage therapy medicinal products are quite unconventional pharmaceuticals and likely this lack of conformity to the canonical model hampered the development of a suitable regulatory pathway. However, the regulatory approaches of countries where phage therapy traditions and practice have never been abandoned are now being revisited by some Western countries, opening new avenues for phage therapy regulation. As a next step, supranational and international organizations are urged to take over the initiatives originally launched by national regulatory authorities.

Background: As of May 2017, the United States federal government renewed its prioritization for the enforcement of mandatory minimum sentences for illicit drug offenses. While the effect of such policies on racial disparities in incarceration is well-documented, less is known about the extent to which these laws are associated with decreased drug use. This study aims to identify changes in cocaine use associated with mandatory minimum sentencing policies by examining differential sentences for powder and crack cocaine set by the Anti-Drug Abuse Act (ADAA) (100:1) and the Fair Sentencing Act (FSA), which reduced the disparate sentencing to 18:1., Methods: Using data from National Survey on Drug Use and Health, we examined past-year cocaine use before and after implementation of the ADAA (1985-1990, N = 21,296) and FSA (2009-2013, N = 130,574). We used weighted logistic regressions and Z-tests across models to identify differential change in use between crack and powder cocaine. Prescription drug misuse, or use outside prescribed indication or dose, was modeled as a negative control to identify underlying drug trends not related to sentencing policies., Results: Despite harsher ADAA penalties for crack compared to powder cocaine, there was no decrease in crack use following implementation of sentencing policies (odds ratio (OR): 0.72, p = 0.13), although both powder cocaine use and misuse of prescription drugs (the negative control) decreased (OR: 0.59, p < 0.01; OR: 0.42, p < 0.01 respectively). Furthermore, there was no change in crack use following the FSA, but powder cocaine use decreased, despite no changes to powder cocaine sentences (OR: 0.81, p = 0.02), suggesting that drug use is driven by factors not associated with sentencing policy., Conclusions: Despite harsher penalties for crack versus powder cocaine, crack use declined less than powder cocaine and even less than drugs not included in sentencing policies. These findings suggest that mandatory minimum sentencing may not be an effective method of deterring cocaine use.

We review recent findings on medical aspects of marijuana use in order to identify those who are at greatest risk of marijuana-related medical problems. We analyze the impact of medical marijuana laws on health, in particular the disproportionate effects on adolescents and children. Chronic marijuana use predominantly affects certain areas of the brain that overlap the default mode network, linked hubs in the brain that play a supervisory role in critical thought processes such as attention, memory, and social interactions. Disruption of the default mode network areas has been documented in schizophrenia and Alzheimer's disease, illnesses with symptoms and brain changes that parallel findings in marijuana abusers. These findings counter the claim that marijuana is a harmless drug and are a cause for alarm in persons with cannabis dependence.

Objectives: To analyze how value-based pricing (VBP), which grounds the price paid for pharmaceuticals in their value, can manage "affordability" challenges, defined as drugs that meet cost-effectiveness thresholds but are "unaffordable" within the short-run budget., Methods: Three specific contexts are examined, drawing on recent experience. First, an effective new treatment for a chronic, progressive disease, such as hepatitis C, creates a budget spike that is transitory because initial prevalence is high, relative to current incidence. Second, "cures" that potentially provide lifetime benefits may claim abnormally high VBP prices, with high immediate budget impact potentially/partially offset by deferred cost savings. Third, although orphan drugs in principle target rare diseases, in aggregate they pose affordability concerns because of the growing number of orphan indications and increasingly high prices., Results: For mass diseases, the transitory budget impact of treating the accumulated patient stock can be managed by stratified rollout that delays treatment of stable patients and prioritizes patients at high risk of deterioration. Delay spreads the budget impact and permits potential savings from launch of competing treatments. For cures, installment payments contingent on outcomes could align payment flows and appropriately shift risk to producers. This approach, however, entails high administrative and incentive costs, especially if applied across multiple payers in the United States. For orphan drugs, the available evidence on research and development trends and returns argues against the need for a higher VBP threshold to incentivize research and development in orphan drugs, given existing statutory benefits under orphan drug legislation., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

According to the Organization for Economic Co-operation and Development (OECD), drug expenditures account for about 20 % of all health expenditures in high-income countries. The increase of these drug expenditures which has been observed in all these countries over a long period is due to the combination of aging populations, changes in medical practices and the dynamics of the pharmaceutical market, in particular the hospital market. France is no exception. Its consumption of drugs (which accounted for 17.5 % of health expenditures in 2014), historically among the highest in volume, has grown slower in the last decade than in other OECD countries. However, the particularly rapid and wide adoption of pharmaceutical innovations, which has always characterized France, has had in recent years a very significant effect on the soaring drug expenditures covered by the social protection system (plus 1.1 billion in 2014, a year marked by the introduction of new therapies against hepatitis C). This significant effect should continue with the introduction of new and very expensive therapies, particularly in oncology., (© 2018 médecine/sciences – Inserm.)

After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand., (© 2016 The British Pharmacological Society.)

The main objective of this study was to assess the practice at retail pharmacies in Pakistan and to compare the same in rural and urban areas. The maintenance of pharmacy and drug inspectors' visit was also assessed. This cross sectional study was conducted in Abbottabad, Pakistan during October-November, 2012. A sample of 215 drug sellers or drug stores was selected by employing convenient sampling method. With a response rate of 91.6%, 197 drug sellers participated in this study. All the drug sellers were male. Overall, 35% (n = 197) of the drug sellers did not have any professional qualification. A majority of the drug sellers were involved in various malpractices like selling of medicines without prescription (80.7%), prescribing practice (60.9%), prescription intervention (62.4%) and selling of controlled substances (66%) without a license for selling it. These malpractices were significantly higher in rural area than that in urban area.

Objectives: To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled "House Bill 1" (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012., Design: A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame., Results: The incidence of intraspinal abscess increased 1.56-fold in 2011 (n = 26) and 2012 (n = 25) relative to 2010 (n = 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold (n = 38) and then 4.19-fold (n = 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 (n = 3) and 2012 (n = 3). However, it increased twofold (n = 7) in 2013 and then ninefold (n = 27) in 2014. A correlation coefficient (rSAD ) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse., Conclusions: The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account., (Wiley Periodicals, Inc.)

According to the European Medicine Agency, a "biosimilar" is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference or innovative medicinal product) that has been authorized in the European Economic Area. The similarity to the reference medicinal product in terms of quality, biological activity, safety and efficacy needs to be set on a comprehensive comparability basis. The generic standard approach (demonstration of bioequivalence with a reference medicinal product by appropriate bioavailability studies), which is applicable to a wide range of chemically derived medicinal products, is not sufficient to prove the similarity of biotechnology derived products due to their structural complexity. Furthermore, these biopharmaceuticals products, in comparison with the conventional ones, show a greater ability to activate the immune response. The evaluation of biosimilar medicines for authorisation purposes by the European Medicine Agency does not include recommendations on whether a biosimilar should be used interchangeably with its reference medicine. Substitution policies are, therefore, within the remit of the EU member states. In order to support pharmacovigilance monitoring, all appropriate measures should be taken to clearly identify any biological medicinal product with due regard to its brand name and batch number. The situation of the European Community and the regulatory framework have been developed since the first applications (growth hormone), almost a decade ago, until the recent advent (monoclonal antibodies). The introduction to the market of biosimilars have positive effects on competition by improving access to biological therapies., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Background: Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries., Methods: We used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly available data from the state agencies, and directly contacted drug manufacturers and wholesalers., Results: National plan for rare diseases was developed and approved in 2013. Although there are no official designated centers of expertise as well as no specific register for rare diseases. Newborns are screened for only two disorders: phenylketonuria and congenital hypothyroidism. Currently 34 orphan drugs are available on Latvian market. Three medicines (8.8%) are included in the reimbursement drug list, all indicated for Ph + CML. 15 drugs (44.1%) were reimbursed within the framework of individual reimbursement system, and five drugs (14.7%) were provided within the program of medicinal treatment of rare diseases in children., Conclusions: Majority of orphan drugs authorized in the EU are not available in Latvia, moreover those drugs that are available are often not accessible because they are insufficiently reimbursed. Besides, approval of the national plan might be an important step towards improving situation in the field of rare diseases.

Many, if not most, commercially available diabetes treatment products are protected by some form of intellectual property. This article discusses the development and commercialization of products in view of the state of intellectual property for the diabetes treatment market, with respect to possible discouragement, for some, from seeking patent protection or commercializing a new product under the belief that patent protection is either unavailable or difficult to come by, or for fear of infringing existing patents. Upon closer investigation, the evolution of technology almost always creates opportunities for new improvements, which likely can be patent protected. Furthermore, while avoiding the claims of existing patents is sometimes challenging and opinion based, and thus not a guarantee of avoiding a patent litigation, patent litigation may be delayed and is often settled early on., (© 2013 Diabetes Technology Society.)

During the relatively short history of class proceedings in Canada, developers and manufacturers of medical devices and pharmaceuticals ("medical products"), including medical products designed for patients with diabetes, have found themselves at the receiving end of a significant number of class action claims. As a result, medical products litigation has become the battleground for some of the most significant developments in Canadian class actions law. This article provides a broad overview of some of the most significant developments. The authors pay particular attention to developments regarding the test for class action certification and consider whether high-profile dismissals of certification motions represent a trend toward raising the threshold for plaintiffs seeking to obtain certification of a proposed class action. The authors also consider a decision arising out of a lengthy class action common issues trial in which the medical device company was victorious. In the authors' view, the class action pendulum in Canada, particularly as it relates to medical products claims, remains in motion. It behooves all affected players to keep their eye on this ball with rapt attention to see where it may move next., (© 2013 Diabetes Technology Society.)

Problem: During the 1980s, Spain had very strict laws limiting access to opioid agonist maintenance treatment (OAMT). Because of this, mortality among people who used illicit opioids and other illicit drugs was high. Spain was also the European country with the highest number of cases of acquired immunodeficiency syndrome transmitted through illicit drug injection., Approach: The rapid spread of human immunodeficiency virus (HIV) infection among people using heroin led to a shift from a drug-free approach to the treatment of opioid dependence to one focused on harm reduction. A substantial change in legislation made it possible to meet public health needs and offer OAMT as part of harm reduction programmes in the public health system, including prisons., Local Setting: Legislative changes were made throughout the country, although at a different pace in different regions., Relevant Changes: Legal changes facilitated the expansion of OAMT, which has achieved a coverage of 60%. A parallel reduction in the annual incidence of HIV infection has been reported. Reductions in morbidity and mortality and improved health-related quality of life have been described in patients undergoing OAMT., Lessons Learnt: The treatment of opioid dependence has been more heavily influenced by moral concepts and prejudices that hinder legislation and interfere with the implementation of OAMT than by scientific evidence. To fulfil public health needs, OAMT should be integrated in harm reduction programmes offered primarily in public facilities, including prisons. Longitudinal studies are needed to detect unmet needs and evaluate programme impact and suitability.

Background: It is now a decade since the World Trade Organization (WTO) adopted the "Declaration on the TRIPS Agreement and Public Health" at its 4th Ministerial Conference in Doha. Many anticipated that these actions would lead nations to claim compulsory licenses (CLs) for pharmaceutical products with greater regularity. A CL is the use of a patented innovation that has been licensed by a state without the permission of the patent title holder. Skeptics doubted that many CLs would occur, given political pressure against CL activity and continued health system weakness in poor countries. The subsequent decade has seen little systematic assessment of the Doha Declaration's impact., Methods and Findings: We assembled a database of all episodes in which a CL was publically entertained or announced by a WTO member state since 1995. Broad searches of CL activity were conducted using media, academic, and legal databases, yielding 34 potential CL episodes in 26 countries. Country- and product-specific searches were used to verify government participation, resulting in a final database of 24 verified CLs in 17 nations. We coded CL episodes in terms of outcome, national income, and disease group over three distinct periods of CL activity. Most CL episodes occurred between 2003 and 2005, involved drugs for HIV/AIDS, and occurred in upper-middle-income countries (UMICs). Aside from HIV/AIDS, few CL episodes involved communicable disease, and none occurred in least-developed or low-income countries., Conclusions: Given skepticism about the Doha Declaration's likely impact, we note the relatively high occurrence of CLs, yet CL activity has diminished markedly since 2006. While UMICs have high CL activity and strong incentives to use CLs compared to other countries, we note considerable countervailing pressures against CL use even in UMICs. We conclude that there is a low probability of continued CL activity. We highlight the need for further systematic evaluation of global health governance actions. Please see later in the article for the Editors' Summary.

There has been considerable progress identifying pathophysiologic mechanisms of neuropathic pain, but analgesic medications with improved efficacy, safety, and tolerability still represent an unmet public health need. Numerous treatments examined in recent randomized clinical trials (RCTs) have failed to show efficacy for neuropathic pain, including treatments that had previously demonstrated efficacy. This suggests that at least some negative results reflect limited assay sensitivity of RCTs to distinguish efficacious treatments from placebo. Patient characteristics, clinical trial research designs and methods, outcome measures, approaches to data analysis, and statistical power may all play a role in accounting for difficulties in demonstrating the benefits of efficacious analgesic treatments vs placebo. The identification of specific clinical trial characteristics associated with assay sensitivity in existing data has the potential to provide an evidence-based approach to the design of analgesic clinical trials. The US Food and Drug Administration recently launched the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) public-private partnership, which is designed to facilitate the discovery and development of analgesics with improved efficacy, safety, and tolerability for acute and chronic pain conditions. ACTION will establish a collaborative effort to prioritize research objectives, develop a standardized analgesic database platform, and conduct methodologically focused studies to increase the assay sensitivity and efficiency of analgesic clinical trials. The results of these activities have the potential to inform and accelerate the development of improved pain management interventions of all types, not just pharmacologic treatments., (Wiley Periodicals, Inc.)

We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.