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Background: In the past decades, economic sanctions imposed on Iran for its nuclear program. The embargo made difficulty in foreign trade and led to lack of timely access to medicines. As the internationally-led sanctions caused to the shortage of medicine there, healthcare systems need to applied the new policies for maintaining health service quality especially in pharmaceutical sector. Objectives: This paper is about policies applied in Iran health system during the crisis reached its peak in 2012 as a good experience for guarantying access to pharmaceutical products. Methods: Through interviewing experts and managers in pharmaceutical regulatory system, the implemented policies in targeted historical period were extracted, then quantitative data were analyzed to show the impact of the policies on the access and affordability of medicines before and after their implementation in Iran food and drug administration (IFDA). This paper tries to show strategies employed by to tackle the crisis caused by sanctions and to offer practical policies to make medicines more accessible at the time of crisis. Results: In order to reduce the harmful effects of this crisis, IFDA proposed some changes at different levels ranging from organizational procedures to parliament legislations. The main achievements of IFDA were making drugs easily available are as follows, significantly reducing prices, decreasing the share of market regarding the imported medicines, facilitating the manufacture of domestic medicines, encouraging foreign investment in manufacturing drugs domestically, controlling the shortage of drugs, and finally giving financial support to all patients in general and to those patients who had problem paying for drugs in particular. Conclusion: These experiences which made the Iran pharmaceutical sector survive during the international sanctions, can be considered as a good example of resilience strategies in similar situations. [ABSTRACT FROM AUTHOR]

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

This paper takes a critical look at progress and prospects regarding the sociology of pharmaceuticals over the years. Key themes examined include: (i) medicalisation and pharmaceuticalisation; (ii) regulation; (iii) consumption and consumerism; (iv) expectations and innovation. Papers in the monograph are also introduced and discussed in relation to these themes. The paper concludes with some further comments and reflections on progress and prospects in this field, emphasising the continuing importance of sociological engagement with these personal and political issues in the 21st century. [ABSTRACT FROM AUTHOR]

Public health advocates aim to maximise affordable access to good quality essential medicines. This goal often conflicts with the profitseeking ambitions of the pharmaceutical industry. Since the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights agreement, the extension and enforcement of intellectual property (IP) rights has become the dominant discourse in global medicines governance. Public health advocates operating within this framework face significant obstacles and challenges. This paper presents an historical perspective to the contemporary debate over medicines and patents by examining the evolution of international medicines governance between the 1940s and 1970s. This research indicates that debates around IP and medicines were more advanced in terms of equity and access in the 1960s and 1970s than they are today. While acknowledging the existence of obstacles and challenges for advocates, the paper argues that alternative frameworks can and should be reasserted in global debates about medicines governance. [ABSTRACT FROM AUTHOR]

We introduce this special issue firstly by tracing drugs from their traditional, cultural and religious uses through to their roles as commodities in colonial relations and now the global economy. We secondly explore the shifting nature of drugs and drug use in different places and times as shaped by politics, especially state regulation and the law. Thirdly, given the complexity as well as contingency of drugs, we survey a wide range of relevant theoretical approaches, but suggest that a critical analysis attend to their spatial framing and geography. Fourthly, and finally, we summarize the eight papers comprising this collection. [ABSTRACT FROM PUBLISHER]

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow. [ABSTRACT FROM AUTHOR]

Throughout history, medicinal and aromatic plants have been used extensively to cure a variety of ailments. This article provides a comprehensive overview of Cannabis sativa, specifically focusing on its legislative status, decriminalization, phytochemistry, antimicrobial activity, and safety. The study begins by briefly outlining the plant's history, including its cultivation, harvesting, and storage methods. The review analyzes extensively the antimicrobial properties of Cannabis sativa and its derivatives, specifically examining their reported antiviral, antibacterial, antifungal, and antiparasitic capabilities, which have been documented in databases such as Scopus, ScienceDirect, PubMed, and Web of Science. The paper also discusses trends in studies about the plant object of the study, the different bioactive compounds that were identified in the plant (phenolic acids, flavonoids, alkaloids, cannabinoids, and terpenes), and safe consumption in several cannabis-based products including candies, desserts, wine and as food flavoring. Furthermore, this study has reported information about the legalization and decriminalization of cannabis use across the globe with a specific focus on Morocco because it has the largest cultivated area of C. sativa plant. However, some substances with potential antimicrobial properties were not investigated in this review due to the lack of data on their activity. The authors hope that their efforts will inspire future studies on the therapeutic uses of Cannabis sativa and its derivatives, ultimately leading to improved health outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Access to medication for opioid use disorder (MOUD) varies across the rural-urban continuum. The Hub & Spoke Model (H&S) emerged to address these gaps in service whereby hubs with staff expertise in MOUD support delivery of specialized care to a network of spoke locations, often located in rural communities with workforce shortages. This paper presents a case study of efforts to implement the hub and spoke model in a frontier and rural (FAR) state: Montana. Methods: The primary data are structured interviews with 65 MOUD program staff in hub and spoke locations within Montana. Both inductive and deductive coding were used to analyze the transcripts. Findings: Using the H&S structure to expand access to MOUD in Montana led to mixed results. There were consistent themes identified in the interviews about the reasons why hubs struggled to successfully recruit spokes, including (1) geographic barriers, (2) a lack of interest among medical providers, (3) fears about excessive demand, (4) concerns about the financial viability of the model, and (5) a preference for informal technical assistance rather than a formal H&S relationship. In addition to these 5 themes, efforts to implement H&S across different medical systems were unsuccessful, whereas the H&S model worked more effectively when H&S locations were within the same organization. Conclusion: This case study identified limits to the H&S model utility in supporting states' abilities to expand access to MOUD treatment and offers suggestions for adapting it to accommodate variation across divergent rural contexts. We conclude with recommendations for strategies that may assist in expansion of MOUD in rural communities that are like those found in Montana. [ABSTRACT FROM AUTHOR]

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States. [ABSTRACT FROM AUTHOR]

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Purpose: The COVID-19 pandemic has devastated economies and public health systems across the globe, increasing the anticipation for the creation of an effective vaccine. With this comes the reinforcement of debates between the right to health and pharmaceutical patent rights. The purpose of this study is to illustrate how the Philippines could attempt to balance the right to health with pharmaceutical patent rights in the introduction of a potential COVID-19 vaccine into the country. Design/methodology/approach: This will be accomplished through an examination of the flexibilities allowed by international agreements and domestic patent laws. Findings: With the economic and health challenges brought about by the COVID-19 pandemic, the Philippine Government will have a strong justification to pursue parallel importation and compulsory licencing under the Agreement on Trade-Related Aspects of Intellectual Property Rights. This is exacerbated by the bold leadership of President Duterte, whose administration has so far shown a propensity to decide in favor of the right to health at the expense of other rights in dealing with the pandemic. Originality/value: While this paper focuses on the Philippines, it has a potential application in the least developed and developing countries which aim to gain access to a prospective COVID-19 vaccine. Moreover, while this study discusses the harmonization of laws on the right to health and patent laws as a solution to the COVID-19 pandemic and the lack of access to vaccines, it also calls for solutions that go beyond the application of the law. [ABSTRACT FROM AUTHOR]

Background: Antibiotics have played an essential role in decreasing morbidity and mortality from infectious diseases. However, indiscriminate use and unrestricted access is contributing to the emergence of bacterial resistance. This paper reports on a situational analysis of antimicrobial use and resistance in Ghana, with focus on policy and regulation.Methods: Relevant policy documents, reports, regulations and enactments were reviewed. PubMed and Google search engines were used to extract relevant published papers. Websites of stakeholders such as Ministry of Health (MOH) and its agencies were also reviewed. An interview guide was used to elicit responses from selected officials from these sectors.Results: Laws and guidelines to control the use of antimicrobials in humans were available but not for animals. There was no National Antimicrobial Policy (NAP). A health practice regulatory law mandates Physicians, Physician Assistants, Midwives and trained Nurses to prescribe antimicrobials. However, antibiotics are widely prescribed and dispensed by unauthorised persons, suggesting weak enforcement of the laws. Antibiotics were also supplied to and from unapproved medicine outlets. The Standard Treatment Guidelines (STG), Essential Medicines List (EML) and the National Health Insurance Scheme Medicines List (NHISML) provide restrictions regarding levels of prescribing of antimicrobials. However, existing guidelines on antibiotic use are mostly not adhered to. The use of Automatic Stop Orders to avoid wastage in the hospitals is also not practiced. Data on use of antibiotics for individuals are not readily available in most facilities. Again, there are no standards or guidelines on veterinary use of antibiotics. Surveillance systems for consumption of antibiotics and resistance monitoring were not in place in most health facilities. However, there is an ongoing national action to create awareness on bacteria resistance, strengthening knowledge through research and surveillance and development of NAP in line with global action plan on antimicrobial resistance.Conclusion: Absence of national antimicrobial policy, weak regulatory environment and non-adherence to practice standards may have contributed to increased and unregulated access to antimicrobials in Ghana, a catalyst for development and spread of antimicrobial resistance. [ABSTRACT FROM AUTHOR]

Using the 'war on drugs' in Colombia as its case study, this paper reflects on the recent findings and recommendations of Colombia's Truth Commission to make a case for a transformative approach to end ongoing cycles of drugs-related violence. In Colombia, the armed conflict and repressive prohibitionist drug policies are deeply entangled, and violence is ongoing. A peaceful future, we contend, requires thinking about a world in which we can live well with drugs. This would be a clear break from the goal of a 'drug free' world that has prevailed under the repressive prohibitionist regime. Legal regulation of drug markets is proposed here as a form of long-overdue reparations for victim groups in Colombia, which could address and repair past inequality and harms engendered by prohibition, and improve the living conditions of people involved in, and impacted by, illegal drug markets. Colombia, with its unique historical trajectory, has much to contribute towards future projections on the global legal regulation of drug markets. By positioning legal regulation of drug markets as reparation, this paper contributes to debates on drug policy reform and reparative justice, arguing that the two are very much connected. • The Colombian truth commission (CEV) concluded that the county's conflict has been transformed by the 'war on drugs'. • This chapter analyses the CEV's recommendation to transition towards a legally regulated drug market to end violence in Colombia. • Drug policy reform is not an end in itself; it should help to create a fairer and more inclusive world. • This chapter makes an important contribution from the Global South to debates about drug legalisation. [ABSTRACT FROM AUTHOR]

A lively drug policy debate is going on in the UK, and a central theme emerging is the punishment of drug offenders. The main contributing voices draw attention to the largely futile position of prosecuting offenders through the criminal justice system who are drug addicted and/or who are caught in possession of small quantities of drugs for personal use. This paper adds to this discussion by reporting findings from observations carried out in London Magistrates’ Courts. It notes the relatively high prevalence of small quantity drug possession cases that appeared before the courts over the study days, and questions the value of this type of crime arriving here in the first place. It examines the resultant financial penalties that are most commonly dispensed, and asks whether they can be reasonably justified. It states these are harsh and depriving given the already economically disadvantaged status of most defendants. In addition, case details revealed issues of policing approach involving ‘stop and search’ and the variable application of police discretion. The paper calls for thought to be given to the damage caused to peoples’ lives through pursuing criminalising drug policies, and to the time and economic cost to stretched policing and criminal justice resources. It suggests we learn lessons from other European jurisdictions who assign drug possession for personal use cases, to an arm of the prosecution service where they are processed as ‘out-of-court’, ‘administration offences’. [ABSTRACT FROM AUTHOR]

The recent benefit–risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit–risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit–risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators. [ABSTRACT FROM AUTHOR]

In both the United Kingdom and United States of America legislation has been proposed or enacted which claims to provide patients with a 'right' of access to experimental drugs and treatments where there is no other hope. In this paper we will explore this narrative and consider the steps taken in the United States to shift to a more rights driven legal framework. The paper will critically assess the United States model and the similarly framed 'Saatchi' model in the United Kingdom; demonstrating that, despite the rights-based narrative, these laws do not represent a significant change in access to treatment for patients. Rather, the reality is that this 'right to try' paradigm represents a patient advocate narrative that is deeply flawed. It fails to implement any meaningful change, exposes vulnerable patients to risk of harm and, potentially, delays safe development of potentially life-saving treatment regimes. [ABSTRACT FROM AUTHOR]

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

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

Context Until the last decade of the 20th century, France had no equivalent to the US Food and Drug Administration. In this paper we describe and interpret the complex series of events that led to the passage by the French Parliament in December 1992 of a law incorporating such an agency, the Agence du Médicament (literally, 'medicines agency'). The broad aim of this project was to learn how public health policy change comes about by detailed analysis of a specific instance. More specifically, we aimed to better understand the circumstances under which public health crisis leads to significant public health policy reform. Methods This paper is based on detailed analysis of primary documents (eg, archived French health ministry papers, recorded parliamentary debates, government reports, newspaper articles) and oral history interviews covering a period from 1988 to 1993. Thematic analysis of these materials was initially grounded in theories of organizational change, moving to constructs that emerged from the data themselves. Findings Policy entrepreneurs positioned to frame adverse events and seize opportunities are key to public health policy reform. However, whether these entrepreneurs will have the requisite institutional power is contingent both on political structure and on the power of competing institutional actors. Health crises may catalyze institutional reform, but our analysis suggests that whether reform occurs, or even whether adverse episodes are labeled as crises, is highly contingent on circumstances of history, political structure, and political ideology and is extremely difficult to predict or control. Conclusions Actors positioned to shape public health policy need to have a detailed understanding of the circumstances that facilitate or impede policy reform. Health crises are now more often global than not. Comparative, theoretically grounded, cross-national research that looks in detail at how different countries respond to similar health crises would be extremely valuable in informing both policymakers and researchers. [ABSTRACT FROM AUTHOR]

Under the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, individuals convicted of drug-related felonies were permanently banned from receiving welfare and food stamps. Since then, over 30 states have opted out of the federal ban. In this paper, I estimate the impact of public assistance eligibility on recidivism by exploiting both the adoption of the federal ban and subsequent passage of state laws that lifted the ban. Using administrative prison records on five million offenders and a triple-differences research design, I find that public assistance eligibility for drug offenders reduces one-year recidivism rates by 10 percent. [ABSTRACT FROM AUTHOR]

This article expands upon a session, titled "Implications of Pediatric Initiatives on CNS Drug Development for All Ages--2020 and Beyond," that was presented as part of a two-day meeting on pediatric drug development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs. The speakers wrote summaries of their talks, which are included here. The session's lead chair was Dr. Gahan Pandina, who wrote introductory and closing comments. Dr. Joseph Horrigan addressed the current landscape of pediatric development programs. Dr. Gahan Pandina addressed how the approach to research in pediatric populations affects the drug development process and vice versa. Dr. Alison Bateman-House discussed the ethical implications of research in the pediatric population. Dr. Luca Pani discussed some of the global regulatory issues and challenges concerning research in pediatric patients. Dr. Judith Kando served as a discussant and posed new questions about means of facilitating pediatric research. Finally, Dr. Gahan Pandina provided closing comments and tied together the presented issues. This paper should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and/or required, through regulations, to include children as part of the approval process. [ABSTRACT FROM AUTHOR]

The Controlled Substance Act ("CSA") of 1970 serves as a near midpoint for considering a century of drug regulation, dating to the Harrison Narcotic Tax Act (1914), the now-quaint first federal step in this field, i.e. of taxing the sale of (but not outright criminalizing) cocaine and opium. The early cases construing the Harrison Act are similarly anachronistic. Bundled as "public welfare cases" and including United States v. Balint, in those early days, the Supreme Court was willing to forego requiring the element of "criminal intent" to be read into general and novel statutes like the Harrison Narcotic Tax Act, and in Balint yielded to apparent congressional wisdom to punish controlled substance violations without an impediment of traditional mens rea. This logic would seem to have been explicitly "firewalled" to its bygone era by Morissette v. United States (1952),2 particularly in light of the modern, comprehensive CSA subsequently "clearing the field" in 1970. Convicted immigrants only wish they were so lucky. In a parallel track, use of the "categorical approach" in modern criminal3 and immigration4 law has evolved to require strict comparison of federal and state definitions of criminal offenses in order for those offenses to trigger sentencing or deportation consequences. This implies that both state drug offenses and drug definitions also require a literal federal analogue, under the CSA, to prompt collateral federal treatment. Again, convicted immigrants only wish it were so simple. The Board of Immigration Appeals (BIA), part of the U.S. Department of Justice, has repeatedly invoked the "public welfare cases" to justify removal of immigrants for drug offenses in the absence of proof of their criminal intent.5 In 2019, the BIA had further telegraphed reluctance to requiring strict uniformity in state drug definitions vis-à-vis the federal enumerated standard substance before permitting an immigration consequence to flow from a related offense. The author has written on, and litigated--both successfully and unsuccessfully, and in pending matters9--these issues as both primary counsel and for amici curiae. This article develops the interconnectedness of the above two topics, in order to comprehensively discuss the immigration consequences of drug convictions, particularly as evolved since 1996 and to attempt to reconcile 1) tracks of Supreme Court civil and criminal jurisprudence regarding mens rea and 2) the collision course of the "categorical approach" with the interpretive principles of Chevron.10 In doing so, the article makes recommendations for a more consistently principled, predictable, and uniform intersection of the CSA and the Immigration and Nationality Act (INA). While this paper mostly deals with highly technical explanations of legal theories11 in the criminal-immigration universe, it should not be lost on the reader just how out of touch the legalese gets from reality. In a way, it is a microcosm of the larger social problem. America's cultural duality is on display--with our aspirational decadence conflicting with our puritanical roots--and we struggle to balance these extreme polarities. If controlled substances were regulated from a holistic public health perspective, if our laws were not so dissonant with our culture's appetites, or even if drugs were taxed (not outright banned) as in 1914, we could avoid much of the technical jousting of the following pages. However, as it is, we have serious legal "apex" scenarios--criminal sentence enhancements and deportation--in which society's wrath bares down on individuals, typically with consequences disproportionate to the "harm" (if any) they inflicted upon society. With the stakes so raised, the esoteric legal analysis is the necessary antidote and justified defensive tool to a ludicrously over-punitive, unrealistic, and hypocritical criminal scheme. [ABSTRACT FROM AUTHOR]

While state drug law reform is moving apace, federal drug law reform has moved much more slowly. Many, including the Judicial Conference of the United States and the United States Sentencing Commission, have urged Congress to enact substantive federal drug law reform for years. But Congress has not acted. As a result, the federal system continues to single out drug offenses for harsh treatment at the bail stage and the sentencing stage--the front end and back end of the federal mass incarceration crisis. In this paper, we argue that federal judges have a critical role to play in future federal drug law reform in light of Congress' long-standing failures to meaningfully change the laws. At the front end, judges should encourage the release of more people on bail by closely scrutinizing prosecutors' motions for temporary detention and giving little weight to the Bail Reform Act's presumption of detention. Data shows that the statutory drug presumption is overbroad and does a poor job of determining who is a risk of flight or a danger to the community. At the back end, judges should issue categorical policy disagreements with the drug sentencing guidelines and the career offender sentencing guideline using the Supreme Court's blueprint in Kimbrough v. United States. Judges should issue sentences below these guidelines because they are not based on empirical evidence, over-punish drug offenses, and result in racial disparities. At both ends, judges should rest their decisions on the evidence that the drug presumption, the drug sentencing guidelines, and the career offender sentencing guideline are flawed. While judicial action is not a cure for Congressional inaction, it would send a clear message from one co-equal branch of government to another that substantive reform is urgently needed. [ABSTRACT FROM AUTHOR]

Collective efforts among governments and regional organizations is a vital part of the fight against piracy that represents a security threat to all nationstates with respect to freedom to navigate the high seas. This paper provides a concise overview of piracy, contemporary maritime drug laws, and cases among the circuit courts to illustrate the procedural concerns that affect fundamental constitutional principles of jurisdiction. A possible solution to existing substantive and procedural due process issues is establishment of a regional judicial institution with broad powers to preside over criminal prosecutions that include maritime crimes. The suggestion may be a viable means to resolve some concerns with respect to jurisdictional principles, regional stability, and the need for a comprehensive, coordinated response within the Western Hemisphere. Establishing a tribunal to preside over enforcement practices alleviates dependency on the existing legal framework that may not fully resolve jurisdictional issues associated with maritime drug trafficking. In addition, a regional tribunal minimizes the need for the United States to function as the only viable, sovereign nation-state in the Americas to ensure that pirates engaged in illicit trades are not roaming the high seas with impunity. [ABSTRACT FROM AUTHOR]

Eleven US States and the District of Columbia legally allow personal (i.e., recreational) cannabis use by adults, and an additional 22 states allow use of cannabis for medicinal purposes. Of these jurisdictions, only two do not have some form of legalized gambling available (https://www.casino.org/local/guide/). In contrast to this rapid increase in legally available marijuana is the limited knowledge about the intersection of cannabis use and gambling. This paper strives to define the current status of the relevant literatures and consider the implication for future gambling research. We describe the research literature on the prevalence of cannabis use and co-existing gambling problems and the effects of cannabis use on gambling-related cognitive functions and decision-making. We also discuss clinical considerations with treating problem gamblers with a cannabis use disorder. Finally, the potential implications for responsible gambling practices and policies and the most pressing gaps in the research literature are offered. [ABSTRACT FROM AUTHOR]

This paper explores events surrounding the US Food and Drug Administration's formal approval of the heart failure drug BiDil in 2005. BiDil is the first drug ever to be approved with a race-specific indication, in this case to treat heart failure in 'self-identified black patients'. BiDil has been cast by many as a step toward the promised land of individualized pharmacogenomic therapies. This paper argues, however, that when examined in context, the approval of BiDil emerges as a new model of how a pharmaceutical company may exploit race in the marketplace by literally capitalizing on the racial identity of minority populations and leveraging the disproportionate risk of adverse health outcomes they suffer into a cheaper, more efficient way to gain the US Food and Drug Administration's approval for drugs. Discussions of BiDil in both popular media and professional journals have repeatedly elided the difference between pharmacogenomic and race-based medicine. In fact, broad-based true pharmacogenomic therapies remain years—perhaps decades—in the future. The story of BiDil's development elucidates an alternative model to developing tailored therapies that promises to fill in the gap between the promise and reality of pharmacogenomic medicine. It is a model that exploits race to gain regulatory and commercial advantage, while ignoring its power to promote a regeneticization of racial categories in society at large. [ABSTRACT FROM AUTHOR]

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

This paper argues that the concept of resilience is a fruitful way of understanding the impact of repressive policies on illegal drug markets. For the purpose of this article, resilience is defined as the ability of market participants to preserve the existing levels of exchanges between buyers and sellers, despite external pressure aimed at disrupting the trade. The first part of the paper highlights how some of the core features of illegal drug markets, a decentralized structure and high prices, contribute to increasing their resilience to attacks. The second part develops a framework that can be used to compare markets on the basis of their resilient properties. Some of the empirical and policy implications of the framework are discussed in the conclusion. [ABSTRACT FROM AUTHOR]

This paper addresses three types of drug policies: drug laws, drug prevention strategies, and drug treatment strategies that might be used to improve drug policies. For each of these three categories, the paper discusses what criminological research tells us about the best practices. Research suggests that drug abuse prevention and treatment have statistically and clinically significant effects. The terms ‘prevention’ and ‘treatment’ are, however, often used indiscriminately and with reference to many different concepts. To assume that everything that is called prevention or treatment is effective would be foolish: not every drug prevention program is effective; not every treatment program has an effect in terms of reducing recidivism. Research has made it possible to identify successful prevention and treatment programs for drug abusers. However, the programs that research would suggest are not always those chosen by practitioners or widely funded by policymakers. [ABSTRACT FROM AUTHOR]

The Regulatory Department is sometimes unfairly seen as a bottleneck in the process of getting a new drug to market. Perhaps this is a natural response given their pivotal role in ensuring compliance of all manner of aspects of the drug compound discovery through to manufacture and distribution. However, it is reasonable, given the internal and external pressures upon this department to change, that the Regulatory Team has the potential to significantly change and improve their impact upon the whole approval process. The changes that they face can lead to an opening up of company knowledge and content. The following paper describes the situation that the Regulatory Departments currently face. It considers how the electronic Common Technical Document (eCTD) is causing change and offering the potential for process change, not just in the Regulatory Department but also in other departments of both Research & Development (R&D) and Manufacturing.Journal of Medical Marketing (2006) 6, 126–130. doi:10.1057/palgrave.jmm.5050021 [ABSTRACT FROM AUTHOR]

In 2004, Europe took the lead among regulated markets in creating a legal framework and a regulatory route for biogenerics. The EU has consequently established a competitive advantage over the USA and Japan in this sector. This paper covers the process of drafting and adopting the legal framework for biogenerics in the enlarged EU through the review process of the European pharmaceutical legislation and in parallel with the publication of the new Annex I of Directive 2001/83/EC, which delineates instructions for the presentation and content of the different types of application dossier in Europe. This paper describes the precise chronological order of the development of the legal framework, as well as the main actors in the process, and describes the background to the adoption of the final terminology used to designate biogenerics - that is, 'similar biological medicinal products'. [ABSTRACT FROM AUTHOR]

Social policies have evolved to address the associated concerns related to the public health crises of drug abuse and undertreated pain. Prescription monitoring programs (PMPs) have been used for many years in this effort but are undergoing re-evaluation and restructuring in light of changes in technology as well as changes in our understanding of the collateral impact of such programs. We reviewed the state of PMPs in the United States and highlighted recent changes in these programs that have occurred nationally. The current changes occurring in California, with the most physicians of any U.S. state as well as the oldest triplicate-based serialized prescription program, are reviewed, with focus on the transition to tamper-resistant prescriptions that use security paper forms. Future trends for PMPs are described, including the potential for widespread use of electronic prescribing, which is gaining favor with the Drug Enforcement Agency. [ABSTRACT FROM AUTHOR]

This paper presents a review of the recent economics literature in the area of illicit drug use. Particular attention is paid to the economics of addiction and the rational addiction model, the welfare economics framework for analysing the social costs of drug use, and the attempts that have been made by economists to evaluate recent or proposed policy interventions. A dominant theme in this review is the problem of poor data availability. This is particularly true when it comes to implementing the Rational Addiction model, but it is also apparent in the literature on estimating the costs of illicit drug use to society as a whole. One of the main conclusions of this review is that until recently public policy has not been particularly influenced by research carried out by economists. It is not clear whether this is because economists have had to grapple with inadequate data, and hence their conclusions are couched in uncertainty, or whether it is because drugs researchers have assumed a very limited role for economists in their analysis. [ABSTRACT FROM AUTHOR]

Synthetic cannabinoids (i.e. Spice) are a major public health problem in UK prisons, however, research in this area is limited. Here we aimed to draw comparisons between people with and without experience of using synthetic cannabinoids in prison, to characterise the features of, and motivations for use within this setting and evaluate support for different treatment interventions. Questionnaires were administered to 122 people in a category-B prison for adult males in England between July 2022 and March 2023. Participants were asked questions related to their sociodemographic and custodial characteristics, use of synthetic cannabinoids (and other drugs) inside and outside of prison and psychological distress was measured via the Brief Symptom Inventory (BSI-18). Those that had ever used synthetic cannabinoids in prison completed additional questions related to features of use, motivations for use and support for various interventions. In total 46.7 % (n = 57) of participants reported use of synthetic cannabinoids in prison and this group experienced significantly greater levels of psychological distress compared to those reporting no use (mean (± standard deviation) BSI-18 scores = 23.7 (±16.7) vs 12.8 (±13.6), p < 0.001). Participants mostly reported using paper-based preparations (77.4 %) and use via e-cigarettes (75.9 %). The most strongly endorsed motivations for use included to alleviate boredom (91.1 % strongly agree/agree), to make the sentence pass faster (89.3 % strongly agree/agree) and to cope with stress (80.4 % strongly agree/agree). The interventions that received most support were strategies to better manage time and medication to manage withdrawal. The use of synthetic cannabinoids in UK prisons typically involves the use of paper-based preparations via e-cigarettes, and use is associated with greater levels of psychological distress. Motivations for use were mostly pragmatic (e.g. to alleviate boredom or cope with stress) and interventions should prioritise increasing the time individuals spend out of cells and in meaningful activity. [ABSTRACT FROM AUTHOR]

Many nations and jurisdictions have legalized non-medical adult use of cannabis, or are considering doing so. This paper contributes to knowledge of adult use legalization's associations with cannabis use disorder (CUD) treatment utilization. This study collected data from a dataset of all publicly funded substance use disorder treatment delivered in California from 2010 to 2021 (1,460,066 episodes). A logistic regression model estimates adult use legalization's impacts on CUD treatment utilization using an individual-level pre-post time series model, including individual and county-level characteristics and county and year-fixed effects. Adult use legalization was associated with a significant decrease in the probability of admission to CUD treatment (average marginal effect (AME): −0.005, 95 % CI: −0.009, 0.000). Adult use legalization was also associated with a decrease in the probability of admission to CUD treatment for males (AME: −0.025, 95 % CI: −0.027, −0.023) Medi-Cal beneficiaries (AME: −0.025, 95 % CI: −0.027, −0.023) adults ages 21+ (AME: −0.011, 95 % CI: −0.014, −0.009) and Whites (AME: −0.012, 95 % CI: −0.015, −0.010), and an increase in the probability of admission to CUD treatment for patients referred from the criminal justice system (AME: 0.017, 95 % CI: 0.015, 0.020) and Blacks (AME: 0.004, 95 % CI: 0.000, 0.007) and Hispanics (AME: 0.009, 95 % CI: 0.006, 0.011). Adult use legalization is associated with declining CUD treatment admissions, even though cannabis-related problems are becoming more prevalent. Policies and practices that protect public health, and engage people with CUD in treatment are needed. • Pre-legalization, 19 % of SUD admissions were CUD, compared to 9 % post-legalization. • Adult use legalization was associated with a decrease in CUD treatment admissions. • Differences existed in legalization's associations on different demographic groups. [ABSTRACT FROM AUTHOR]

Global momentum for drug law reform is building. But how might such reform be achieved? Many argue that human rights offer a possible normative framework for guiding such reform. There has been very little research on whether human rights processes can actually achieve such aims, however. This paper responds to this knowledge gap. It explores how one human rights mechanism—the "parliamentary rights scrutiny process"—deals with alcohol and other drugs. We consider how four Australian parliaments scrutinized proposed new laws that would deal with alcohol and other drugs for their human rights "compatibility." We find that laws that would limit the rights of people who use alcohol and other drugs were routinely seen as justifiable on the basis that alcohol and other drugs were inherently "unsafe." Crucially, safety was conceptualized in a gender-neutral way, without regard to the potential role of gender, including specific masculinities, in the production of phenomena such as family violence and sexual violence and other public safety problems. Instead, such problems were regularly constituted as consequences, simply, of alcohol or other drug consumption. In making this argument, we build on the pioneering work of David Moore and colleagues (e.g., 2020). Their work asks important questions about how the causes of violence are constituted across different settings, including research and policy. Drawing on ideas from scholars such as Carol Bacchi and John Law, they identify "gendering practices" and "collateral realities" in research and policy on violence, in which the role of men and masculinities are routinely obscured, displaced or rendered invisible. We find similar problems underway within human rights law. In highlighting these gendering practices and collateral realities, we aim to draw attention to the limitations of some human rights processes and the need for more work in this area. [ABSTRACT FROM AUTHOR]

Model‐informed drug development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision‐making process. MIDD was formally recognized in Prescription Drug User Fee Act (PDUFA) VI. There have been many regulatory applications of MIDD to address a variety of drug development and regulatory questions. These applications can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, and informing policy. Case studies, literature papers, and published regulatory documents are reviewed in this article to highlight some common features of these applications in each category. In addition to the further development and investment in these established domains of application, new technology, and areas, such as more mechanistic models, neural network models, and real‐world data/evidence, are gaining attention, and more submissions and experiences are being accumulated to expand the application of model‐based analysis to a wider scope. [ABSTRACT FROM AUTHOR]

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines. [ABSTRACT FROM AUTHOR]

BACKGROUND: A number of studies show that an intensification of the policing of illicit drug markets has an impact on public health. The impacts are largely seen as negative. AIMS: The aim of this paper is to describe the basic characteristics of data collection and to review the aspects related to data collection and its context that might influence the law enforcement indicators (drug law offences and offenders). METHODS: This work is based on research on the literature and grey zone materials, which consisted of reviewing reports published by relevant institutions and by searching in specialized databases. RESULTS: Long-term indicators based on police statistics available for the Czech Republic come from the Crime Statistics System (ESSK) and from data collected by the National Drug Headquarters (NPC). The difference between the ESSK and NPC data lies in the reporting procedures and their changes and specificity as regards the substances involved in drug law offences. The review identified different aspects of data collection and its context that have the potential to influence the indicators. Nine events with such potential were identified in three areas: legislation, the reporting system, and the structure and priorities. The events that have the greatest potential to influence the time series are related to the reporting system, structure, and priorities. CONCLUSIONS: The review may assist and facilitate informed analysis and interpretation of drug-related law enforcement indicators individually or in combination with other indicators, using time series analysis as well as comparative approaches. [ABSTRACT FROM AUTHOR]

Little is known about the relationship between illegal firms and local economic activity. In this paper I study changes in satellite night lights across Mexican municipalities after the arrival of large drug trafficking organizations in the period 2000–2010. After accounting for state trends and differences in political regimes, results indicate no significant change in night lights after the arrival of these illegal firms. Estimated coefficients are precise, robust, and similar across different drug trafficking organizations. [ABSTRACT FROM AUTHOR]

Graphical abstract Highlights • The importance of adopting a risk-based approach has been tackled. • The analytical quality by design is thoroughly described in every step. • Recent papers regarding the application of a risk-based approach have been reviewed. Abstract Pharmaceutical regulatory bodies increasingly require the implementation of systematic approaches in pharmaceutical product development. Quality control methods play a key role in the control strategy of drugs manufacturing to assure their quality. A risk-based approach in the analytical method development is strongly recommended to ensure that the method performances fit the purpose of the method during its entire life-cycle. In the last decade, analytical quality by design (AQbD), as risk management oriented methodology, has been progressively integrated with method development for fulfilling this objective. This approach has successfully allowed the quality to be designed into the analytical processes by obtaining a deep understanding of the procedures. In this paper the AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed. Recent publications regarding how AQbD has been applied in separation techniques were reviewed. The different development strategies have been also showcased, highlighting their advantages and disadvantages, in order to give a useful overview. [ABSTRACT FROM AUTHOR]

Background and aims: The short‐lived regulated legal market for new psychoactive substances (NPS) in New Zealand marked a radical departure from the traditional prohibition‐based approach to drugs. This paper aimed to enhance understanding of this policy change using Punctuated Equilibrium Theory (PET). Methods: The analysis draws on 3 years of evaluative research, including interviews with key stakeholders, analysis of legislation and policy documents and academic and grey literature. Results: The reframing of the NPS issue from one of drug control to the need for stricter market regulation was achieved by the efforts of strategic policy entrepreneurs, including the legal high industry, drug law reform advocates, influential politicians and an independent legal advisory institution. This reframing was aided by the perceived saliency of the NPS problem and ineffectiveness of previous prohibition‐based responses. In the absence of any political opposition to the regulatory approach, the Psychoactive Substances Act rapidly progressed through the Parliament. However, once the interim legal market was established, portrayal of the issues shifted away from experts and lobbyists to critique from local communities, local government, animal rights activists and the media, who viewed the new regime as a source of social and health problems. The mobilization of criticism ('Schattschneider mobilization') drew on ideas of animal welfare and community safety. With a looming national election, the government responded by ending the interim market with the urgent passage of amendment legislation. Conclusions: Punctuated Equilibrium Theory (PET) helps explain how New Zealand's Psychoactive Substances Act (PSA) policy first emerged on the political agenda and how the initial positive tone of expert support for reform shifted to a tide of popular criticism during the interim regime. However, with its emphasis on explaining agenda‐setting, PET does not account for the legislative design shortcomings of the PSA. [ABSTRACT FROM AUTHOR]