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Background The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law. Discussion We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments -- average income and burden of disease -- to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. Summary An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments' human rights obligation to provide medicines and governments' trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights. [ABSTRACT FROM AUTHOR]

Despite the widespread use of the drug court model, standardized performance measures for drug courts are not uniformly utilized, and rarely include process measures. To ensure that drug courts are being implemented in the most effective manner, the use of performance measurement tools should be considered for wide scale adoption. Drug court effectiveness is moderated by participant characteristics, and is most effective for individuals with the highest substance use needs. Therefore, having quality clinical screening processes is crucial to ensuring that drug courts are serving the population for which they are effective. This paper examines clinical screening in drug courts, to answer the following 1) what is the current state of screening, 2) what works, and 3) why measurement matters. It also proposes a clinical screening performance measure to improve fidelity and ensure appropriate participant enrollment. The creation of a performance measure would create opportunities to improve drug court outcomes, and leverage pay-for-performance models. [ABSTRACT FROM AUTHOR]

Background: In Belgium, Cannabis Social Clubs (CSCs) collectively organize the cultivation and distribution of cannabis for the personal use of their members. In this paper we seek to improve understanding of the motivations and practices of cannabis growers operating within CSCs, shedding light on the cultivation process.Methods: We draw on data gathered through face-to-face semi-structured interviews with the directors of seven active Belgian CSCs (n = 21) and CSC growers (n = 23). These data are complemented by additional fieldwork and a review of policies relating to CSCs', including bylaws and growing protocols.Findings: The Belgian CSCs rely on single and multiple in-house grower arrangements. Most CSC growers had been cultivating cannabis prior to joining their current CSC, albeit growing in different contexts (non-commercial and commercial). The CSC growers discussed both ideological and pragmatic motives for operating within a CSC. Cultivation took place indoors and followed organic practices. Despite their small-scale (20 plants on average), the grow sites used specialized equipment. The growers reported receiving financial compensation to cover production costs.Conclusion: This paper offers new insights into a particular sector of domestic cannabis cultivation - CSC growers and their practices within those collectives - which has not been studied previously. The Belgian CSCs have decentralized production among small-scale grow sites, at a size comparable to that found in other small-scale cultivation studies. In terms of motivations and practices, CSC growers share some features typically ascribed to small-scale cannabis cultivators. At the same time, CSC growers seemed particularly engaged with the CSC model and willing to adhere to the (self-)regulated practices developed by the organizations. This had implications for the way cultivation was organized and for the role of the grower within the CSC. [ABSTRACT FROM AUTHOR]

Introduction: This paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.Objectives: To investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.Materials and Methods: We retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004-2006 and 2012-2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.Results: In 2004-2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012-2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004-2006 and seven in 2012-2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012-2014 compared with 2004-2006.Conclusions: The entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information. [ABSTRACT FROM AUTHOR]

This paper highlights a significant gender disparity within Ireland’s illicit drug landscape, which is predominantly composed of men. Irish men’s historical gender invisibility contributed to their predominance as drug users being overlooked. Thus, this paper focuses a masculinities lens on Irish men’s recreational use of illicit drugs, making their drug taking visible as a gendered activity. The study utilised a qualitative methodology, with masculinities theory forming the primary theoretical and analytical lens. Nine focus groups were conducted with Irish men exploring their views on illicit drugs. Twenty in-depth interviews were completed with men who identified as illicit recreational drug users, exploring their drug-taking histories and experiences. Findings demonstrate how the use of illicit drugs can symbolically communicate messages about the drug taker. The study reveals masculinities are an interpretative lens employed by men when trying to understand their own or other men’s drug taking. It is argued that men’s drug taking and masculinities intersect. In homosocial contexts, men’s recreational use of illicit drugs can contribute to them demonstrating masculinities to other drug-taking men; however, outside of these contexts, the same behaviours can be viewed by non-drug takers as emasculating. [ABSTRACT FROM AUTHOR]

Aims: The indicator of availability has been used in the risk assessment (RA) of new psychoactive substances (NPS). This paper aims to examine the pre- and post-control availability of 25I-NBOMe, AH-7921, MDPV and MXE, which were assessed by the EMCDDA.Methods: Data were collected by a semi-automated software tool (I-TREND SASF) on e-shops in national languages (Czech, French, Dutch, Polish and English) that offered shipping of these compounds into the respective countries; frequency analysis was used.Findings: The number of e-shops selling these substances decreased between III/2014 and XII/2015 (except for AH-7921). Both increases and decreases were found on the country-level for all the compounds (except for an overall decrease for MXE). In one instance an NPS disappeared from this market in 2015 (25I-NBOMe in NL); 25I-NBOMe and AH-7921 in France and AH-7921 in Poland appeared for the first time in 2015 after they were put under control. The e-shops listing AH-7921, 25I-NBOMe and MDPV in XII/2015 ranked higher in terms of “popularity” than in III/2014. The IP addresses were more likely to be outside the EU in 2015 than in 2014.Conclusions: We found no evidence that national-level compound bans contributed to the changes in online NPS markets. Indicators of the accessibility, availability, popularity, and IP origin should be considered in RA. Data triangulation with street markets and the darknet is needed as well as more research into the “displacement” and “replacement” effects of control laws. [ABSTRACT FROM PUBLISHER]

Aims: Studying the characteristics of the science-policy nexus in the field of drugs emerged in parallel with an interest in the principles of good governance. Centre-stage is the processes through which policy is informed, especially with regard to the role of non-government actors, contrasting with the widely accepted view that drug policymaking is a prerogative of governments. Through the lens of what is defined as good governance in drug policy, this article examines the processes underpinning the drug-policy change in Belgium between 1996 and 2003. Methods: The paper is based on an analysis of 164 policy documents and 1067 newspaper articles, and 55 interviews with a range of stakeholders including policymakers, professionals, scientists and journalists. Findings: Some distinctive features were found relating to the mechanisms through which evidence was mobilised and eventually informed policy change in Belgium. Evidence-imbued leadership, evaluation, coordination, the engagement of different stakeholders and the role of the parliament played key roles. Conclusions: Several characteristics of good governance make the use of evidence more likely. However, governance processes seem to be challenged in highly sensitive discussions (e.g. on cannabis policy). Another challenge may be how the principles of good governance can be consolidated in the long term. [ABSTRACT FROM AUTHOR]

Background: Psychiatric research in the 1950s and 1960s showed potential for psychedelic medications to markedly alleviate depression and suffering associated with terminal illness. More recent published studies have demonstrated the safety and efficacy of psilocybin, MDMA, and ketamine when administered in a medically supervised and monitored approach. A single or brief series of sessions often results in substantial and sustained improvement among people with treatment-resistant depression and anxiety, including those with serious medical conditions. Need and Clinical Considerations: Palliative care clinicians occasionally encounter patients with emotional, existential, or spiritual suffering, which persists despite optimal existing treatments. Such suffering may rob people of a sense that life is worth living. Data from Oregon show that most terminally people who obtain prescriptions to intentionally end their lives are motivated by non-physical suffering. This paper overviews the history of this class of drugs and their therapeutic potential. Clinical cautions, adverse reactions, and important steps related to safe administration of psychedelics are presented, emphasizing careful patient screening, preparation, setting and supervision. Conclusion: Even with an expanding evidence base confirming safety and benefits, political, regulatory, and industry issues impose challenges to the legitimate use of psychedelics. The federal expanded access program and right-to-try laws in multiple states provide precendents for giving terminally ill patients access to medications that have not yet earned FDA approval. Given the prevalence of persistent suffering and growing acceptance of physician-hastened death as a medical response, it is time to revisit the legitimate therapeutic use of psychedelics. [ABSTRACT FROM AUTHOR]

Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China’s current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects’ rights and interests. The paper compares the status quo in China in this area to that of other countries and discusses ways China might enhance the protection of rights and interests of trial subjects, such as enhancing the ethical awareness of investigators through training, improving laws and regulations, and strengthening the communication between investigators and ethics committees. [ABSTRACT FROM AUTHOR]

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

There have been several recent commentaries which have highlighted the relevance of the postcolonial perspective to drug prohibition and called for the decolonisation of drug policy (Daniels et al., 2021 ; Hillier, Winkler & Lavallée, 2020 ; Lasco, 2022 ; Mills, 2019). While these are significant interventions in the field, sparse drugs scholarship has engaged more directly with well-developed literature and concepts from Critical Indigenous Studies (Moreton-Robinson, 2016) and Indigenous Standpoint Theory (Moreton-Robinson, 2013 ; Nakata, 2007) and reflected on its applicability to the drug and alcohol field. In contrast to the postcolonial perspective, which understands colonisation as a historical event with contemporary impacts, Indigenous scholarship conceptualises colonisation as an active and ongoing part of how the settler-state continues to impose itself. From this vantage point I explore coloniality as a system of power and reflect on the way prohibition acts as a key arm of the settler-colonial state. The paper explores the way concepts like vulnerability, marginality, overrepresentation, disproportionality and addiction involve colonial violence, knowledge practices and narratives which are central to the way coloniality is maintained and continues to assert itself in contemporary settler societies. [ABSTRACT FROM AUTHOR]

In Australia drug profiling had its formal beginnings during the early 2000s. Initially, this involved the development of a heroin signature program by the Australian Federal Police and the National Measurement Institute, which was then expanded to include cocaine, and by 2007 both programs had reached a mature state. From then, the focus switched to high volume synthetic drugs such as methylamphetamine. This paper describes the expansion of the Australian Illicit Drug Intelligence Program (AIDIP) to include a range of chemical signatures aimed at investigating the clandestine manufacturing methods and precursor chemicals used for synthetic drugs such as methylamphetamine. It also describes the commencement of the Enhanced National Intelligence Picture Illicit Drugs (ENIPID), which was designed to monitor domestic drug seizures in the Australian States and Territories with the goal of establishing links to drug trafficking into Australia. Examples of links between domestic, Border and international seizures are explored. Finally, the changing nature of drug trafficking into Australia during the last decade is considered in the context of how forensic chemistry laboratories need to be adaptable and willing to evolve as the threat from illicit drugs evolves. [ABSTRACT FROM PUBLISHER]

Background: Recent decades have seen substantial changes in the UK cannabis landscape, including increased domestic production, the ascendancy of stronger strains (namely 'skunk') and the drug's reclassification under the 1971 Misuse of Drugs Act. Resultantly, cannabis retains significance in the consciousness, priorities and policy agendas of communities, drug services and criminal justice agencies.Methods: This paper presents an empirical study, which examined both perceptions and impacts of cannabis cultivation and its control within a North-West English borough. It draws on qualitative research with samples of professionals, practitioners, resident groups, cannabis users, cannabis users' families and cannabis cultivators themselves.Findings: The findings suggest that cannabis cultivation was not a uniformly familiar concept to respondents, who had limited knowledge and experience of its production. Across all participant groups, the transmission of accurate information was lacking, with individuals instead drawing on the reductionist drug discourse (Taylor, 2016) to fill knowledge deficits. Consequently, some participants conflated cannabis cultivation with wider prohibitionist constructions of drug markets, resulting in the diffusion of misinformation and an amplification of anxieties. In contrast, other participants construed cultivation as making economic sense during austerity, justifying such tolerance through inverse adherence to the same narrow socio-cultural construction of drugs i.e. that cultivation carried comparatively less harms than real drug markets. Enforcement mechanisms also drew on generic prohibitionist conceptions, assuming cultivators to be unconstrained, autonomous actors in need of punishment; a belief which lacked nuanced understanding of the local terrain where vulnerable individuals cultivating under duress played a key role in the supply chain.Conclusion: The paper concludes with a call for the provision of accessible information/education; the need to challenge and reconceptualise the assumed autonomy and resultant punity directed at all cannabis cultivators; and a subsequent need to reassess established forms of legal (and increasingly social) enforcement. [ABSTRACT FROM AUTHOR]

Real world evidence (RWE) has the potential to inform drug discovery, development, and regulatory decision making. The emergence and availability of large population‐based datasets around the globe have stoked enthusiasm in the research community. However, much work remains to refine research methodologies, evolve the science, and define the place of RWE as a complementary source of evidence to randomized controlled trials. [ABSTRACT FROM AUTHOR]

This article tests the impact of deterrence and normative variables in the estimation of drug use among both detected drug users and university students. Consistent with perceptual deterrence research, we expect: (a) a stronger effect of normative variables on estimation of drug use compared to deterrence variables and (b) that any deterrent effect would be restricted to detected drug users. In Portugal, we conducted a cross-sectional survey with detected drug users (N = 147) and with a sample of university students (N = 247). The main results show that normative variables outperform deterrent variables as predictors of intention to use drugs. Descriptive norms have a greater influence on the estimation of drug use in both groups, and proximal social norms have robust effects among university students. Core elements of the deterrence model are not related to the intention to use drugs. Personal certainty of being caught has even an unexpected positive correlation with this intention. A small deterrent effect is limited to the general certainty variable and only among more law-abiding people. The overall findings are consistent with a normative perspective on law compliance and highlight the importance of including all different normative and deterrent variables in models estimating drug use. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [ABSTRACT FROM AUTHOR]

The precise assessment of treatment efficacy in clinical trials requires scientific instruments that are not only relevant to the target population and treatment, but have been shown to be reliable, valid, and sensitive to change within the intended context of use. This paper describes the background, procedures, and current status of 2 patient-reported outcome (PRO) instruments developed for use in clinical trials of chronic obstructive pulmonary disease (COPD). The first measure, the EXAcerbations of Chronic pulmonary disease Tool (EXACT), was developed under the EXACT-PRO Initiative, a multi-year, multi-sponsor project involving experts in pulmonary medicine, instrument development, and drug development regulatory issues, dedicated to the development of a single, standardized instrument for evaluating the effects of treatment on acute exacerbations of COPD. The second measure, the EXACT-Respiratory Symptoms (E-RS) scale, is a derivative instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD. The EXACT-PRO Initiative was the first PRO instrument development consortia, and the EXACT and E-RS are the first PRO measures to undergo qualification review by the United States Food and Drug Administration (FDA). [ABSTRACT FROM AUTHOR]

This article tracks the development of opium use in present day Iran. Investigating how opium use is influenced by ideological change within the country, this paper intimately attempts to understand how Iranian intellectual, religious and national movements affected and still affect opium use. Working from an historicist approach, this paper furthermore investigates the changing response of the state to this opiate addiction. Analyzing the Islamic Republic's response to opiate-drug use is key in understanding how state policy decisions are influenced by and embedded within these ideological movements of a nation, and, specifically, how the Islamic Republic's constitutional policy of maslahat allows for flexible legal strategies to combat drug control. Such an investigation is important, not only in understanding the etiology of Iranian policies of drug control and criminalization, but also in understanding how ideological movements affect an individual's choice to use illegal substances. [ABSTRACT FROM AUTHOR]

The article offers information on Georgia's Senate Bill (SB) 36. The Bill authorizes the Georgia Drugs and Narcotics Agency to establish a program to monitor the prescription and dispensing of Schedule II, III, IV, and V controlled substances. The Bill became effective on July 1, 2011. Details on the history of the Bill are also highlighted.

Purpose – The purpose of this paper is to assess the social impact, i.e. the estimated return to the Australian community, of Australian Federal Police (AFP) drug law enforcement effort in general and the relative success of specific policy initiatives. Design/methodology/approach – Benefit-cost analysis (BCA) was employed in the assessment of 2,716 drug investigations that took place between 2000 and 2005. Costs associated with the Australian Customs Service, the legal process and prisons were included. Benefits related to the economic estimate of reduced harm in terms of death and injury, crime, reduced productivity, and pain and suffering associated with the use of illicit drugs. Findings – The results suggest that the Australian community receives $5.80 of benefit in terms of potential harm avoided for every dollar invested in drug law enforcement. Specific policy initiatives were found to result in higher than average returns: investigations involving domestic and international partners ($6.00 and $9.20 respectively), an emphasis on serious and complex crime ($9.20), and intelligence-led policing ($7.90). Research limitation/implications – The estimation of economic benefits is the most contentious area of the study. The AFP is undertaking a review of its estimation of benefits. Originality/value – The results suggest that AFP drug law enforcement provides a positive contribution to the wellbeing of the Australian community. Furthermore, the findings indicate that specific drug law enforcement initiatives enhance the relative effectiveness of drug law enforcement in Australia. The study also provides an example to other public sector agencies of the use of BCA to determine the social impact of their policies. [ABSTRACT FROM AUTHOR]

This paper reviews the impact of ten years of domestic incorporation of the European Convention on Human Rights (ECHR) on the evolution of the United Kingdom's primary piece of prohibitive drugs legislation, the Misuse of Drugs Act 1971. The significant cases where traditional interpretation of this Act has been challenged in the courts using the Convention are discussed. Structured thematically, this paper looks at the interplay between drug prohibition and human rights in addressing complex issues, such as our right to self-medicate, to practice our religion(s) freely, and to explore our own consciousness. The intention is to expose the untapped potential of the ECHR as a tool with which to fundamentally challenge the (discriminatory) drug policy of the United Kingdom. [ABSTRACT FROM AUTHOR]

The article discusses the paper "The Bermuda Triangle of Pharmaceutical Law—Is Data Protection a Lost Ship?," by Dinca Razvan, which appeared in the 2005 issue of "The Journal of World Intellectual Property." The paper discusses the ways to implement Article 39.3 of the Trade-Related Aspects of Intellectual Property Systems Agreement pertaining to protection of marketing approval data.

Since the 1980s, the pharmaceutical industry has benefited substantially from a series of policy changes that have strengthened the patent protection for brand-name drugs as a result of the industry's political influence. This paper incorporates special interest politics into a quality-ladder model to analyze the policy-makers' tradeoff between the socially optimal patent length and campaign contributions. The welfare analysis suggests that the presence of a pharmaceutical lobby distorting patent protection is socially undesirable in a closed-economy setting but may improve social welfare in a multi-country setting, which features an additional efficiency tradeoff between monopolistic distortion and international free riding on innovations. [ABSTRACT FROM AUTHOR]

This paper examines the reorganization of Finnish drug policy in the light of recent major changes. The analysis is inspired by writings of criminologist David Garland on crime control and governmental control strategies (Garland, 1996, 2000, 2001), and by the British drug debate on the normalization of drug use (Parker, 2005; Parker et al., 1998; Shiner & Newburn, 1999; South, 1999). Garland distinguishes between adaptive and non-adaptive social responses to crime. Adaptive responses generally lower the objectives of public policy because the goals seem unrealistic. If you cannot get the best, you can always strive for the good. Non-adaptive or repressive responses are needed to justify the image of the State as an efficient and competent actor. The conclusion of the paper is that, after a somewhat stormy debate in Finland around the turn of the century, the adaptive and non-adaptive responses have peacefully aligned with each other. This dual-track model has become the new paradigm in Finnish drug policy: Both harm reduction and criminal control approaches are now well established and expansive. Related trends are recognized also in other countries. [ABSTRACT FROM AUTHOR]

Windows of opportunity for changing drug laws open infrequently and they often close without legislative change being affected. In this paper the author, who has been intimately involved in the process, describes how evidence-based recommendations to 'decriminalize' cannabis have recently been progressed through public debate and the political process to become law in Western Australia (WA). The Cannabis Control Bill 2003 passed the WA Parliament on 23 September. The Bill, the legislative backing behind the Cannabis Infringement Notice (CIN) Scheme, came into effect on 22 March 2004. This made WA the fourth Australian jurisdiction, after South Australia, the Australian Capital Territory and the Northern Territory, to adopt a prohibition with civil penalties scheme for minor cannabis offences. This paper describes some of the background to the scheme, the process by which it has become law, the main provisions of the scheme and its evaluation. It includes reflections on the role of politics and the press in the process. The process of implementation and evaluation are outlined by the author, foreshadowing an ongoing opportunity to understand the impact of the change in legislation. GUEST EDITOR: RICHARD MATTICK [ABSTRACT FROM AUTHOR]

Treatment service provision for problem drug users in the Republic of Ireland until the mid-1980s was centralized, specialist and ideologically tending towards abstinence models of intervention. However, in the context of continuing heroin use and its accompanying public health risks, all these features of policy and service provision changed gradually over the next decade. This paper looks in detail at the evolution of the methadone protocol of 1998, which institutionalized and regulated methadone prescribing by general medical practitioners in Ireland. It discusses the main stakeholders, lists the sequence of events and looks analytically at the policy process. It is concluded that the introduction of the methadone protocol was a pragmatic success, albeit one which departed significantly from conventional beliefs about policy transparency in democratic societies. [ABSTRACT FROM AUTHOR]

Background and aims Prohibitions on producing, distributing and selling cannabis are loosening in various jurisdictions around the world. This paper describes the diversification of cannabis supply laws and discusses the challenges to and opportunities for learning from these changes. Methods We document changes in cannabis supply laws that de jure legalized cannabis production for medical and/or non-medical purposes (excluding industrial hemp) in Australasia, Europe, North America and South America. We also highlight challenges to evaluating these legal changes based on our experiences studying cannabis laws and policies in the United States. Findings As of August 2016, two countries have passed laws to legalize large-scale cannabis production for non-medical purposes at the national (Uruguay) or subnational level (four US states). At least nine other countries legally allow (or will soon allow) cannabis to be supplied for medicinal purposes. Most of the changes in cannabis supply laws have occurred since 2010. The data available in most countries are inadequate for rigorously evaluating the changes in cannabis supply laws. Conclusion The evidence base for assessing changes in cannabis supply laws remains weak. Efforts should focus upon collecting information about quantities consumed and market transactions as well as validating self-report surveys. [ABSTRACT FROM AUTHOR]

Title II, the Controlled Substances Act (CSA), of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CDAPCA) created the present system of drug scheduling and regulation. This paper illustrates how the CSA created the incentives for induced 'malnovation' (innovation intended to circumvent legislation, and thus foil policymakers' intended ends) into drug markets, namely 'designer drugs.' As a result of this induced malnovation, drug markets have not only increased in the variance of products available that are often sold under similar street names, but there is also a tendency towards creating more dangerous drugs in an attempt to stay outside of the regulation. [ABSTRACT FROM AUTHOR]

Classic theories of comparative advantage point to factor productivity and factor abundance as determinants of specialization and trade. Likewise, geography and topography can determine trade patterns. Institutions, however, are increasingly seen as important sources of comparative advantage. A global drug prohibition regime implies that institutional quality matters more than traditional sources in the drug trade. This paper theoretically models trade patterns of illicit goods and confirms the role of institutions empirically with respect to the drug trade. In particular, illicit enterprises gain force in countries where resources are scarce, drug enforcement is uncertain, and institutions are weak in absolute terms and relative to neighboring countries. I propose several policy alternatives that emphasize economic opportunity for the poor and institutional quality that complement drug prohibition. [ABSTRACT FROM AUTHOR]

Background: Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country's income status.Methods: A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status.Results: Pharmaceutical policies are linked to a country's socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price-cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure.Conclusions: There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries. [ABSTRACT FROM AUTHOR]

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Objective With growing access to the Internet, people who use drugs and traffickers started to obtain information about novel psychoactive substances (NPS) via online platforms. This paper aims to analyze whether a decreasing Web interest in formerly banned substances-cocaine, heroin , and MDMA-and the legislative status of mephedrone predict Web interest about this NPS. Methods Google Trends was used to measure changes of Web interest on cocaine, heroin, MDMA, and mephedrone. Google search results for mephedrone within the same time frame were analyzed and categorized. Results Web interest about classic drugs found to be more persistent. Regarding geographical distribution, location of Web searches for heroin and cocaine was less centralized. Illicit status of mephedrone was a negative predictor of its Web search query rates. The connection between mephedrone-related Web search rates and legislative status of this substance was significantly mediated by ecstasy-related Web search queries, the number of documentaries, and forum/blog entries about mephedrone. Conclusions The results might provide support for the hypothesis that mephedrone's popularity was highly correlated with its legal status as well as it functioned as a potential substitute for MDMA. Google Trends was found to be a useful tool for testing theoretical assumptions about NPS. [ABSTRACT FROM AUTHOR]

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

Research on the impact of European integration focuses on the external relations of national agencies. This has neglected the impact that Europeanization has on the internal operations of agencies and the way in which coordination is practiced. This article researches the impact of European integration on national agencies with regard to three dimensions: their recruitment schemes, their internal organization, and their external coordination arrangements. The paper presents a 20-year historical review of highly Europeanised agencies – the German pharmaceutical and chemical regulators. This allows us to explore whether different roles in the policy process mediate the effects of Europeanisation. As a result, the article shows that Europeanisation has impacted comprehensively on the recruitment schemes, organizational structure, and coordination arrangements of the two agencies. Both agencies have gained highly qualified personnel for their tasks related to European decision-making and have reorganized their structure to adapt to the requirements of this decision-making. [ABSTRACT FROM AUTHOR]

Drawing from data obtained in a comparative study of US district courts' criminal justice practices, this paper examines adjudication processing responses at the intersection of immigration and drug offences in a Southwestern federal district court, where the logic of immigration enforcement subsumes more traditional federal drug law enforcement. I demonstrate how characteristics of 'drug cases' are constructed at this intersection in such a manner that they stand apart from the prototypical federal drug case, and more closely resemble criminal immigration cases. I argue that in this border jurisdiction, the prevailing adjudicatory logic is concerned with defendants' status as unauthorized outsiders such that these defendants are barely distinguishable from immigration defendants in how their sentences are calculated and rhetorically justified. [ABSTRACT FROM AUTHOR]

• The Norwegian government proposed a drug decriminalization reform. • The shift from the justice sector to the health sector would only be partial. • The police would retain their role in drug law enforcement after the reform. • Illicit drug use continued to be fundamentally pathologized in the proposed reform. • The most profound aspect of the reform was its emphasis on consent in interventions. In 2018 the Norwegian government appointed a committee to prepare the implementation of a drug decriminalization reform. The overall goal of the committee was to propose a model where responsibility for society's response to the use and possession of illegal drugs for personal use would be transferred from the justice sector to the health service, under the catchphrase 'from punishment to help'. While the proposal ultimately did not get the necessary backing in parliament, the proposed reform still constitutes a very comprehensive and recent proposal for reforming national drug policy and it provides an ideal case for studying contemporary discourses on 'drug decriminalization'. The analysis of this reform proposal is guided by the post-structuralist "What's the Problem Represented to be" (WPR) approach, which is used for investigating the problem representation(s) in the proposal, as well as the rationalities, practices and deep-seated assumptions underpinning these. In doing this, the paper explores how the strategy represents both changes and continuities in discourses around illicit drugs and the people who use them. Based on the WPR approach, two problem representations in the proposal are identified: the 'problem of illicit drug use' and the 'problem of criminalization'. However, the 'problem of illicit drug use' is argued to be the authoritative representation, that takes precedence over the other. In that regard, the paper points to how the proposed shift from the justice sector to the health sector would only be partial, given that the role of the police and drug law enforcement would be retained in the reform. Furthermore, the paper points to how illicit drug use continued to be fundamentally pathologized in the proposed reform. The paper concludes with a discussion about the overall ambition of shifting from a crime-centered to a health-centered approach to people who use drugs and some reflections on the potential of an additional rights-based approach is provided. [ABSTRACT FROM AUTHOR]

• Random drug testing in schools has been part of Philippine policies since the 2000s. • During Duterte's drug war, it was implemented and scaled up by education agencies. • It has impacted students by placing them at risk of stigma and fatal violence. • It has impacted schools by necessitating human and financial resources. • Drug testing in schools has political and social efficacy amid a drug-free paradigm. With the stated aims of promoting "drug-free" campuses and "instilling in the minds of students" that drugs are harmful, drug testing in schools has been a feature of the Philippines' punitive drug regime for two decades, gaining prominence during the Duterte administration's war on drugs (2016-2022). Drawing on key informant interviews and a desk review of news articles and official documents, this paper presents a historical overview of this policy as well as its impacts on students, educational institutions, and Philippine society. The paper finds that the group most affected by drug testing in schools are the students themselves, who are placed at risk of discrimination and alienation. Schools are also affected by the policy, as it requires expending their human and financial resources. More broadly, the policy perpetuates longstanding popular notions on drugs, children, and the overall idea that individuals carry the "burden of proof" to demonstrate their worthiness for societal inclusion. Drug testing in Philippine schools is ineffective and misguided in its objectives, but it has received widespread support because of its social and political efficacies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Over the past two decades, there has been growing concern over the lack of proper medication for children. This review attempts to evaluate the current progress of EU Pediatric Regulation made since 2007. The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. The drugs that were used in the past were often not properly evaluated, and dosage was arbitrarily calculated. Therefore, it was necessary to establish the Pediatric Regulation (EC no. 1901/2006) in the EU which would mandate research for pediatric drugs. Current legislations in place not only require mandatory research by pharma industry but also have guidelines to direct the quality of pediatric research performed. The main aim of this regulation was to advance high-quality research and development of pediatric drugs, thereby increasing the availability of safe and effective drugs for children. It also aimed to improve the information available on existing pediatric drugs. It has been 9 years since the pediatric regulation was framed. The pharma industry now sees pediatric research as an integral process of development. Drug companies which develop plans for a new drug, new form of drug, new indication, or new route of administration for adults are obliged to integrate in their development plan similar research for pediatric populations as well.Conclusion: It is hoped that the implementation of the current legislation will be reflected better in the future by the marketing of better and safer drugs for the pediatric population. The upcoming assessment to the European Commission in 2017 will further inform us on the impact after 10 years implementation of the legislation. What is Known: • The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. • Therefore, it was necessary to establish the EU Pediatric Regulation which would mandate research for pediatric drugs. What is New: • It has been 9 years since the pediatric regulation was framed, and the teething problems are slowly being overcome and the regulation is being used with increasing confidence. • As the Regulation is due for revision in 2017, this paper gives a current perspective on the impact of the regulation on availability and access to medicine for children. [ABSTRACT FROM AUTHOR]