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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]

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]

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]

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]

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]

Since 2011, the misuse or abuse of etomidate has gradually increased when propofol was designated a controlled drug under the Narcotics Control Act in Korea. Accordingly, the Ministry of Food and Drug Safety announced that etomidate would be under the 'Regulation on the designation of drugs that may cause concerns of misuse or abuse' rule in June 2020, which is less stringent than the Narcotics Control Act. Therefore, this review investigates potential misuse or abuse cases of etomidate to consider strengthening its management. A literature search was conducted to compare etomidate with other sedatives in their efficacy and side effects, as well as identify the adverse health outcomes, abuse cases, and analytical methods of etomidate. Etomidate has an equal or higher sedative efficacy and lower risk of adverse cardiopulmonary events than propofol. However, major adverse effects of etomidate include adrenocortical suppression and unproven associated deaths, as well as myoclonus requiring pre-treatment. Although the issue of abuse and misuse of etomidate is emerging in recent years, there are few academic reports on these issues and analytical methods in the forensic field. In order to effectively manage the misuse or abuse of etomidate, it is necessary to continuously monitor related cases with great interest and to be more intensively studied on its abuse potential. [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]

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]

Pharmaceutical residues can harm the environment. Therefore any Marketing Authorisation Application (MAA) for a medicinal product for human use shall be accompanied by an "indication of any potential risks presented by the medicinal product for the environment" according to Article 8(3)(g) of the Directive 2001/83/EC. Since 2006 a guideline document from the European Medicines Agency (EMA, formerly EMEA) is available for this task, which is now called the "Environmental Risk Assessment" (ERA). Recently the EMA released a draft revision of an updated ERA guideline. The present paper provides a summary of the intended innovation. A number of options have been discontinued, but some of them cannot be easily recognised, even though they are potentially affecting the MAA and its costs in a relevant way. A new specifically tailored experimental testing course for antibiotics and a secondary poisoning assessment is introduced. The selection of required study types is altered and the environmental fate evaluation is adapted to the scientific progress. In the recent situation it is suggested that marketing authorisation applicants may reconsider the conduct of water/sediment studies for substances not requiring these according to the guideline revision. The new tailored testing approach for antibiotics avoids any vertebrate use, because it demands no fish study, therefore it may be applied henceforth. If the new prescriptions are not yet in force at the point in time of the MAA submission, appropriate waivers should be stated in the ERA. No further HPLC-study types and acute earthworm toxicity tests should be performed, since the guideline update draft does not accept them. In preclinical toxicity and pharmacokinetic studies, additional data gathering on metabolites should be considered in order to avoid unnecessary leaflet warnings. The cost for ERA may change significantly, with a tendency to increase for generic pharmaceutical MAA, but with a possible reduction for substances of low environmental concern. Earlier consideration of ERA in the drug development process is recommended. [ABSTRACT FROM AUTHOR]

The term 'off-label drug use' refers to drugs that have not yet acquired 'approved' status or drugs that have acquired 'approved' status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996 and the common law, which require that off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions. [ABSTRACT FROM AUTHOR]

Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana ('soft drugs') and other drugs ('hard drugs'). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow the sale of soft drugs at 'coffee shops'. However, they did little to control the activities of coffee shop operators, whereas the supply of soft drugs to the shops remained illegal. In this paper, we review the ongoing debate on the soft drug policy in the Netherlands and analyze it from the perspective of the regulation of illegal markets. [ABSTRACT FROM AUTHOR]

New European Union (EU) pharmacovigilance legislation, effective from July 2012, introduced new concepts and procedures to optimise the way medicines are regulated within the Union and provided new channels for public health interventions. Triggered by the EU legislation, the work done by the International Conference on Harmonisation (ICH) has provided a common standard for periodic benefit-risk evaluation reporting within the ICH regions. The present paper provides a review of the concepts behind the use of periodic benefit-risk evaluation reports (PBRER) in supporting safety evaluation and assessment of benefit-risk balance and covers essential points in the documentation of safety information, risk evaluation and benefit-risk assessment. The review incorporates the experience to-date with the PBRER at EU level led by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. The scope of the PBRER, the main content topics and the challenges relevant to the different stakeholders are highlighted together with key success factors for the report to deliver its objectives and maximise the use of the regulatory assessment procedure. It is clear that the PBRER extends beyond new ways of data presentation and analysis and reflects a further shift in pharmacovigilance in the EU towards more integrated benefit-risk assessment of marketed medicines. [ABSTRACT FROM AUTHOR]

The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets. [ABSTRACT FROM AUTHOR]

Background: The regulatory environment is one of the key factors in successfully bringing an innovative medical product, like a drug-device combination product, to market. This paper offers insight into the experiences of those involved in obtaining regulatory approval of drug-device combination products in the European Union and the United States. Methods: The research consisted of two phases, qualitative data collection (through semi-structured interviews) and analysis, followed by quantitative data collection (through an online survey) and analysis. Results: A conceptual model was developed that depicted the facilitating factors for obtaining regulatory approval of a drug-device combination product, relevant to the European Union and United States systems, respectively. Conclusions: This model provides, for the first time, a comprehensive understanding of these factors, providing a foundation that could be adapted to reflect specific drug-device combination products. This research demonstrated originality of approach in interviewing thought leaders in the life sciences sector as well as conducting a survey that spans two of the largest jurisdictions for drug-device combination products in the world. [ABSTRACT FROM AUTHOR]

Background: Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating economic development. Methods: To facilitate the implementation of a new national access to medicines policy, the national government and the Mexican medicines regulatory agency instituted a multifaceted series of regulatory and legal reforms, which are described in this paper. These reforms encompassed multiple aspects of the regulatory oversight of medicines: administrative processes, clinical trials oversight, reliance on market authorization information and reports (ie, “work products”) of other trusted regulators, and validation of activities by both Pan American Health Organization (PAHO) and WHO. Findings: These reforms have resulted in a marked positive impact on the availability of safe, effective, quality medicines at lower costs for Mexicans, both in the private and public sectors, while simultaneously facilitating expansion of the Mexican pharmaceutical industry. Interpretation: The regulatory optimization approach undertaken by Mexico could be a useful model for other countries that are trying to provide appropriate public health protection to their citizens, facilitate access to needed quality medicines, and encourage local economic development. [ABSTRACT FROM AUTHOR]

Background: The rapid expansion and anticipated U.S Food and Drug Administration regulation of 3D printing at the point-of-care necessitates the creation of robust quality management systems. A critical component of any quality management system is a document control system for the organization, tracking, signature collection, and distribution of manufacturing documentation. While off-the-shelf solutions for document control exist, external programs are costly and come with network security concerns. Here, we present our internally developed, cost-effective solution for an electronic document control system for 3D printing at the point-of-care. Methods: We created a hybrid document control system by linking two commercially available platforms, Microsoft SharePoint and Adobe Sign, using a customized document approval workflow. Results: Our platform meets all Code of Federal Regulations Title 21, Part 11 guidances. Conclusion: Our hybrid solution for document control provides an affordable system for users to sort, manage, store, edit, and sign documents. The system can serve as a framework for other 3D printing programs to prepare for future U.S Food and Drug Administration regulation, improve the efficiency of 3D printing at the point-of-care, and enhance the quality of work produced by their respective program. [ABSTRACT FROM AUTHOR]

Trafficking in drugs is a global problem. The legal response to the challenge of trafficking in drugs is found in harsh penalties usually founded in direct imprisonment for extended periods of time. The worldwide trend towards imprisoning drug traffickers, and indeed drug users, is mimicked in South Africa. This submission examines the sentencing or penal effects of the drug Nyaope, which was included in Schedule I and II of the South African Drugs and Drug Trafficking Act 140 of 1992 (Hereinafter the Drugs and Drug Trafficking Act.), in 2014. The effect of the inclusion is that Nyaope users and traffickers are now punished in the same manner as any other traffickers namely, through direct imprisonment. This submission argues that the inclusion of Nyaope and the resultant effect on sentencing is an example of net widening and results all too often in a one size fits all (The phrase 'One size fits all' literally describes commercial products tailored for suitability in all instances. It has since extended to describing effects of methods and measures upon applications, hence its adoption in several fields interpretations including law. As a legal term it differentiates general understanding of the application of particular principles to specific practical application. For example, in multilateral trade, it is used to analyse a perspective inscribing commonness in an uncommon or uncompetitive circumstance such as in the rationale behind the imposition of limitations on special and differential treatment principles for developing and least developed countries against developed countries. This article uses this phrase to argue that although the traditionally harsh sentences fit drug traffickers this is not always the case, especially where perpetrators are victims of drug abuse. For literal interpretation, see and . For multilateral trade legal perspective, refer to M.M.M. Monyakane, Special and Differential Treatment under the World Trade Organisation (WTO) with Specific Reference to the Application of the WTO Agreement on Agriculture, Dissertation in partial fulfillment of the LLM degree in Mercantile Law, University of the Free State South Africa 2005,75; as well as S. Michael, 'One Size Fits All' An Idea Whose Time Has Come and Gone Proceedings of the 21st International Conference on Data Engineering (ICDE 2005) 1084-4627, who explains this concept from a different professional perspective.) approach to the sentencing of drug users and traffickers. This submission uses the previous American practice of using a grid system of sentencing to demonstrate that the inclusion of Nyaope in the Schedules of the Drugs and Drug Trafficking Act has reduced sentencing discretion in a manner not conducive with the limitation clause. The paper argues that the South African approach at present faces the same challenges faced by American courts under the previous grid system of sentencing. The submission argues that the South African approach to sentencing Nyaope users should reflect the principle of fairness and not use an approach which treats all drug traffickers as one and the same for purposes of sentencing. [ABSTRACT FROM AUTHOR]

The GAIN Act, combined with previous US FDA regulations and in the setting of new guidance and related advisory committee recommendations, provides a path forward to expedite development of new anti-infective products that fulfill unmet need related to treatment of antibiotic-resistant organisms. Unresolved issues include the role of superiority versus non-inferiority trials in the approval of new drugs and the nature of the data package that could support the approval of a drug active against resistant organisms. This paper discusses both these issues and suggests paths forward, while acknowledging the concerns that expedited development will lead to greater uncertainty in efficacy and safety. [ABSTRACT FROM AUTHOR]

Introduction: TETRAXIM™ (Sanofi), a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in South Korea since 2009. In accordance with the Ministry of Food and Drug Safety regulations, this post-marketing surveillance (PMS) study evaluated the safety of the DTaP-IPV vaccine in real-world clinical practice in infants and children who received it as either a part of the three-dose primary series dose at 2, 4, and 6 months or school entry booster between 4 and 6 years of age. Methods: This multicenter, observational, PMS study was conducted in real-world practice in South Korea for 6 years (2009–2015) in participants aged between 2 months and 6 years. The study outcomes included solicited reactions, unsolicited adverse events (AEs)/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious AEs (SAEs)/ADRs. Results: Data from 647 participants was included in the safety analysis. Overall, 268 AEs were reported by 181 (28%) participants: 47 (17.5%) solicited reactions, 220 (82.1%) unsolicited AEs, and 1 (0.4%) unsolicited ADR. A total of 48 AEs (including 47 solicited reactions) were reported to have a causal relationship with the DTaP-IPV vaccine and were reported by 36 (5.6%) participants. A total of 212 unexpected AEs were reported by 152 (23.5%) participants, none of which had a causal relationship with the DTaP-IPV vaccine. Neither immediate AEs nor SAEs were reported during the study. Among the participants who reported AEs, 220 (34%) were on concomitant medications. Most AEs were of mild intensity, and all participants recovered. Conclusion: No safety concerns related to the DTaP-IPV vaccine in a real-world setting were raised in participants aged 2–6 months for the primary series and 4–6 years for the school-entry booster dose in the Korean population. The DTaP-IPV vaccine was well tolerated and can be continued as part of routine immunization programs in infants and children. Trial Registration: NCT01437423. [ABSTRACT FROM AUTHOR]

Enforcement intensity towards drug law offences in Denmark has increased since 2004, making Denmark one of the few Western countries that is heading towards a more repressive drug control approach. The aim of this study is to examine patterns and correlates of drug enforcement intensity over time. Policy documents and criminal statistics on drug law offences, from 1996 to 2017, are analysed in the context of the rationality perspective and the theory of policy coherence. Time series analyses and bivariate tests of statistical significance are used to examine enforcement intensity over time, between seasons, and in the gender and ethnic composition of convictions. Three periods are identified, delineated by documents that set forth drug policy aims. From 1996 to 2003, a series of qualitative changes to the legal framework was introduced, followed by a quantitative increase in enforcement pressure from 2004 to 2010 with a focus on Copenhagen. From 2011 to 2017, other regions of the country also increased enforcement. The increased intensity in drug control followed a period of increasing cannabis prevalence rates. The increase in reported minor drug law offences correlated with increased seasonal variations and increased disparity in the gender and ethnicity of convicted individuals. [ABSTRACT FROM AUTHOR]

Purpose: Various incentives are provided by the European Medicines Agency (EMA) to facilitate the development and marketing of orphan drugs. A 10-year period of market exclusivity is reserved to an orphan medicinal product. Sometimes, the sponsor renounces the designation before the expiration of that standard period. Our aim was to focus on these premature withdrawals. Methods: We retrieved all the molecules included in the Community Register of Orphan Medicinal Products for Human Use from 2000 to November 2020. We considered the active substance, therapeutic indication, sponsor, year of designation, year of approval of the corresponding medicinal product, and that of the withdrawal of the orphan designation, if occurred. Results: Overall, 2350 orphan designations were approved from 2000 to November 2020. Of these, 141 have been marketed. Premature withdrawal of orphan designation concerned 23 drugs (20 being antineoplastic agents), corresponding to 16 medicinal products. These withdrawals occurred after almost 2 years (range <1–7 years). Conclusions: A not negligible fraction of marketed orphan medicinal products underwent premature removal of their orphan designation. No motivation is requested by the EMA for this renouncement, although the peculiarity of the orphan medicinal products would need a greater transparency. We can only speculate about possible compensations in support of this decision, for instance in terms of commercial agreements between pharmaceutical companies, giving way to alternative products, as a couple of examples suggest. An open debate on this topic among members of academia, regulatory bodies, price and reimbursements committees, and pharmaceutical industry representatives will be welcome. [ABSTRACT FROM AUTHOR]

Purpose: To examine the impact of new controlled drugs legislation introduced in May 2017 on benzodiazepine receptor agonist (BZRA) prescribing in Ireland. Methods: A repeated cross-sectional analysis was conducted using publically available monthly pharmacy claims data from the General Medical Services (GMS) database. The study population comprised all GMS-eligible individuals aged ≥ 16 years from January 2016 to September 2019. Monthly prevalence rates of individuals receiving BZRA prescriptions per 10,000 eligible population were calculated and trends examined over time. Segmented linear regression of prevalence rates was used to examine changes before and after introduction of the legislation stratified by gender and age groups. Regression coefficients (β) and 95% confidence intervals (CIs) for monthly change were calculated. Results: Pre-legislation (January 2016 to April 2017), there was a significant monthly decline in benzodiazepine prevalence rate (β = − 1.18; 95% CI − 1.84, − 0.51; p < 0.001) but no significant change in Z-drug prescribing. Post-legislation (May 2017 to September 2019), increases in prevalence rates were observed for benzodiazepines (β = 1.04; 95% CI 0.17, 1.92; p = 0.021) and Z-drugs (β = 1.04; 95% CI 0.26, 1.83; p = 0.010). Post-legislation trends showed increases in BZRA prevalence rates among the youngest subgroup (16–44 years), with variable changes in the middle-aged subgroup (45–64 years) and no changes in the oldest subgroup (≥ 65 years). Conclusions: This study indicates that introduction of new legislation had limited impact on BZRA prescribing on the main public health scheme in Ireland. Interventions targeting specific population subgroups may be required to achieve sustained reductions in prescribing. [ABSTRACT FROM AUTHOR]

Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article. [ABSTRACT FROM AUTHOR]

The illicit supply of new psychoactive substances (NPS) in and from China has become a global concern. In line with the international prohibitionist regime, China has instituted a "zero tolerance" supply reduction policy, enacted various laws to regulate controlled substances, and punished related criminal behaviors severely. However, how the NPS supply is organized and how the national laws are interpreted and implemented at the local level have rarely been addressed. Data from qualitative interviews with governmental and judicial actors are used to investigate the experiences concerning the illicit supply of methcathinone and the dynamic ways in which drug policy and laws are implemented practically. Findings show the significance of Changzhi city as a distribution center for illicit supply of methcathinone, the fixed supply patterns, the prioritized measures for controlling methcathinone supply and demand, and the personal strategies used by individual actors to cope with political pressures and job requirements. This study concludes that the unbalanced coexistence of campaign-style and conventional governance results in active institutional arrangements and passive personal strategies in implementing the drug policy and further contributes to a discrepancy between policy formulation and its implementation in practice. [ABSTRACT FROM AUTHOR]

Purpose: To review the marketing authorization of biosimilars and provide a critical analysis of the pivotal trials supporting their approval by the European Medicines Agency (EMA). Methods: EMA website to identify the biosimilars approved up to July 2019 and the European Public Assessment Report for information on pivotal trial design, duration, intervention and control, primary outcome, data on immunogenicity, and comparability margins. Results: The EMA has approved 55 biosimilars (62% in 2017–2019) of 16 biologic products, used in several clinical indications. Some biosimilars were licensed as multiple products, with different commercial names, by the same or different companies. The comparability exercise and subsequent approval of 49/55 (89%) biosimilars were based on one or more pivotal phase III trials testing their clinical efficacy. In all, biosimilars were approved on the basis of 55 trials, mostly phase III (42/55, 76%) assessing clinical efficacy; these were mainly equivalence trials (31/55, 56%). The pivotal phase III trials assessed surrogate measures of clinical effect, and 71% reported immunogenicity data. Conclusion: Analysis of the approval of biosimilars in Europe depicts a complex and heterogeneous scenario. The requirement for showing similarity in terms of clinical efficacy and safety provides a robust demonstration of comparable clinical outcomes but lays a burden on biosimilar manufacturers and may delay the introduction of the drugs. The development, licensing, and monitoring of biosimilars would benefit from new strategies to accelerate access to these drugs while reducing uncertainties about their use in practice. [ABSTRACT FROM AUTHOR]

We assessed the association of state legislation with adolescent human papillomavirus (HPV) vaccination rates in states that legislated information dissemination or administration of HPV vaccination. Using insurance claims, we calculated monthly HPV vaccination rates (November 2009–December 2017) among adolescents in states that passed HPV vaccination legislation during that period: Missouri (July 2010), Kentucky (February 2012), Indiana (March 2013), Oregon (June 2013). We used segmented regression to estimate levels and trends of HPV vaccination rates, comparing pre-legislation to post-legislation segments, adjusting for seasonal vaccination patterns and changes to the vaccination recommendation among males during the study period. Indiana's legislation allowed pharmacists to administer HPV vaccination; legislation in Kentucky, Missouri, and Oregon included provisions HPV and cervical cancer education. No statistically significant increases in HPV vaccination levels or trends were observed in the post-legislation segments among adolescents overall; however, a significant post-legislation increase in vaccination trends was observed among boys in Missouri (β = 0.16, p = 0.03). Evidence for a positive impact of legislation on HPV vaccination rates is limited. The scarcity of policies that directly facilitate or promote HPV vaccination, and the breadth of exemptions to school vaccination requirements, may limit the effectiveness of these policies. Continuing efforts to introduce and pass legislation that directly facilitates HPV vaccination, combined with promoting existing evidence-based interventions, can provide opportunities to identify the most effective strategies to increase adolescent HPV vaccination rates. [ABSTRACT FROM AUTHOR]

Quack medicines were prepackaged, commercially marketed medicinal concoctions brewed from "secret recipes" that often contained powerful drugs. Governmental regulation of them in late nineteenth-century England is heralded as a landmark of public health policy. We argue that it's instead a landmark of medicinal rent-seeking. We develop a theory of quack medicine regulation in Victorian England according to which health professionals faced growing competition from close substitutes: quack medicine vendors. To protect their rents, health professionals organized, lobbied, and won laws granting them a monopoly over the sale of "poisonous" medicaments, most notably, quack medicines. [ABSTRACT FROM AUTHOR]

As US states move toward various forms of adult access to cannabis, there has been a great interest in measuring the impact of such changes on adolescent cannabis use. Two recent prominent analyses have used Monitoring the Future (MTF), a nationally representative survey of students, to examine the effects. We compared MTF data for California and for Washington State with other survey data on use by adolescents in those states. In both studies, findings based on MTF were different from those using other larger, state-representative surveys. The discrepancy reflects the high within-state variation in prevalence rates and the small number of schools in MTF state samples. Using the Washington Health Youth Survey, we estimate that after recreational cannabis legalization past 30-day cannabis use prevalence in grade 8 decreased by 22.0%, in grade 10 prevalence decreased by 12.7%, and no effect in grade 12. These trends are consistent with those in states without recreational cannabis laws, suggesting that legalization did not impact adolescent use prevalence. Long-term trends in MTF are consistent with other data, but year-to-year volatility in state-level series undermines the survey's suitability for evaluation of state cannabis policy changes. Survey-based analyses at the state level need to be cross-validated with findings from other data sources. When findings are disparate and methodological rigor is equivalent, analyses of data sources specifically designed to describe state-level phenomena are more credible. [ABSTRACT FROM AUTHOR]

This study examined one key element of drug supply-reduction policies – drug interdiction – in the Central and Eastern European country of Poland. Poland is a nation that has experienced significant social, political, and cultural changes since the fall of communism, resulting in multiple reforms to their national policing model and drug laws. Poland is also uniquely situated in Europe as a consumer nation, a transit country for drugs, and a significant source of amphetamines. These factors place additional strain on agencies responsible for drug interdiction. To-date, however, the efficacy of police-driven interdiction efforts or factors that might impact the success of such policies (e.g., funding, strength of the police force, the number of drug-related crimes detected) have not been empirically examined in this setting. Thus, this study examined officially reported data in Poland over a 15-year time period (2001 to 2015) to determine how these factors were related to the seized amounts of heroin, cocaine, amphetamine, and herbal cannabis, given the historic national context. The main findings indicated that the cannabis and amphetamine markets were strongly linked, while user-based arrests related to particular drug-types (e.g., amphetamines) were found to be significantly related to seizures of different drug-types (e.g., heroin), suggesting possible market integration. Further, government expenditures for public safety were not found to be significantly associated with interdiction efforts. [ABSTRACT FROM AUTHOR]

This essay argues that race and class influence drug laws through politicized means. Crack-cocaine and methamphetamine production, sales, and use were met with criminalizing efforts because of their respective association with African Americans and poor Whites, two groups that have been differentially identified as threatening to hegemonic power. Despite some similarities in criminalizing outcomes, specific reactions differed. Crack-cocaine's publicized connection to violence resulted in extensive surveillance, arrest, and imprisonment. Attention surrounding methamphetamine, however, often linked the drug to safety hazards, including property explosions, physical distortions of users, and the pathology of un(der)employment. As a result, policing the methamphetamine problem increased detentions but not to the same extent as crack-cocaine. I contend that the current opioid "epidemic" has received more medicalized reactions due to opiate's association to middle- and upper-class Whites—social groups that are traditionally protected. I conclude by proposing that despite nuanced and unique consequences of criminalizing and medicalizing responses, each reflects a neoliberalist agenda that seeks to diffuse social threat and reinforce prevailing inequalities. [ABSTRACT FROM AUTHOR]

Background: Non-medical use of benzodiazepines and Z-drugs is common; however, there is limited information available on the extent of harm related to this in Europe, as well as the relationship between misuse and availability.Aim: To describe presentations to the emergency department in Europe related to the recreational use of benzodiazepines and Z-drugs and compare regional differences in these presentations with legal drug sales of benzodiazepines and Z-drugs within each country.Methods: Emergency department presentations with recreational misuse of benzodiazepines and Z-drugs were obtained from the Euro-DEN dataset for the period from October 2013 to September 2015; data extracted included demographics, clinical features, reported coused drugs, and outcome data. Sales figures obtained by QuintilesIMS™ (Atlanta, Georgia) were used to compare regional differences in the proportion of benzodiazepines and Z-drugs in the emergency department presentations and legal drug sales across Europe.Results: Over the 2 years, there were 2119 presentations to the Euro-DEN project associated with recreational use of benzodiazepines and/or Z-drugs (19.3% of all Euro-DEN presentations). Presentations with 25 different benzodiazepines and Z-drugs were registered in all countries, most (1809/2340 registered benzodiazepines and Z-drugs, 77.3%) of which were prescription drugs. In 24.9%, the benzodiazepine was not specified. Where the benzodiazepine/Z-drug was known, the most frequently used benzodiazepines and Z-drugs were respectively clonazepam (29.5% of presentations), diazepam (19.9%), alprazolam (11.7%), and zopiclone (9.4%). The proportions of types of benzodiazepines/Z-drugs related to ED-presentations varied between countries. There was a moderate (Spain, UK, Switzerland) to high (France, Ireland, Norway) positive correlation between ED presentations and sales data (Spearman Row's correlation 0.66-0.80, p < 0.005), with higher correlation in countries with higher ED presentation rates.Conclusion: Presentations to the emergency department associated with the non-medical use of benzodiazepines and/or Z-drugs are common, with variation in the benzodiazepines and/or Z-drugs between countries. There was a moderate to high correlation with sales data, with higher correlation in countries with higher ED presentation rates. However, this is not the only explanation for the variation in non-medical use and in the harm associated with the non-medical use of benzodiazepines/Z-drugs. [ABSTRACT FROM AUTHOR]

An editorial is presented to the article special issue of Health Care Analysis has part of effort to engage philosophers and political theorists in the study of Harm Reduction (HR) and to encourage scholars and front-line workers. Topics include culminated in workshops and panel discussions in the United Kingdom at the University of Manchester, England, and in Canada; and public health advocates argue a moralistic, all-or-nothing approach to the Coronavirus.

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines. [ABSTRACT FROM AUTHOR]

U.S. drug policy has sometimes implicitly — and incorrectly — assumed that all drug-related harm is caused by drug use, so reducing drug use necessarily reduces drug harm proportionately. Instead, drug policy should try to reduce the sum of both harms incident to drug consumption — including harms to users as well as harms to others — and policy-generated harm in the form of illicit markets, enforcement costs, and increased harmfulness of drug-taking due to controls. A strict prohibition can meet these criteria when it succeeds in keeping illicit markets “thin” and consumption very low. However, promulgating wise policies toward “thick” markets with widespread consumption necessarily involves trade-offs among competing objectives. Recent U.S. history illustrates both the futility of trying to control already “thick” markets using very long prison sentences for dealers (as in the cocaine market) and the risks of allowing “thin” markets to “thicken” by neglecting regulatory and enforcement efforts as prevalence starts to rise (as in the market for prescription opioids). [ABSTRACT FROM AUTHOR]

Our drug policy has been widely deemed a failure because the criminalization of drug use has not succeeded in reducing prevalence rates. I contend that the most promising basis to defend the justifiability of drug offenses is to construe them as proxy crimes: offenses designed to prevent the commission of other, more serious crimes. I make a case that many law enforcement officials use drug proscriptions for this purpose in the real world. When construed as proxy crimes, drug prohibitions are less vulnerable to some of the familiar objections brought against their legitimacy. Nonetheless, the justification for punishing those who violate drug proscriptions remains unpersuasive. [ABSTRACT FROM AUTHOR]

Background: Over the past two decades, state and local governments across the U.S. have been increasingly reforming marijuana laws. Despite growing support for marijuana as a medical treatment, little is known about medical students' perceptions of marijuana use.Objective: To assess Colorado medical students' personal and professional opinions on current and future marijuana use in a healthcare setting.Design: A voluntary, anonymous, online cross-sectional survey.Participants: Medical students (n = 624) at the University of Colorado School of Medicine between January and February 2014 were invited to participate.Main Measures: Numerical responses were quantified using counts and percentages, and Likert scale responses were collapsed for bivariate analysis. Items were gathered thematically and additively scored for each subscale. Internal consistency reliability statistics were calculated for each subscale to ensure that items were assessing similar constructs. Unadjusted t tests and one-way analysis of variance (ANOVA) were used to calculate mean differences in subscale scores between subgroups.Key Results: We received 236 responses (37%). Students indicated support for marijuana legalization (64%), and few believed that physicians should be penalized for recommending marijuana to patients (6%). Nearly all (97%) believed that further marijuana research should be conducted, and believed marijuana could play a role in the treatment of various medical conditions. Seventy-seven percent reported that they believed marijuana use had the potential for psychological harm, and 68% indicated concern for potential physical harm. Only a minority of students would recommend marijuana to a patient under current law (29%), or if it were legally available (45%). Acceptability of marijuana for treatment of approved conditions was not correlated with age or gender, but was positively correlated with living in Colorado prior to medical school (p < 0.001) and with prior marijuana use (p < 0.001).Conclusions: Medical students support marijuana legal reform, medicinal uses of marijuana, and increased research, but have concerns regarding risks of marijuana use, and appear hesitant to recommend marijuana to patients. [ABSTRACT FROM AUTHOR]

Background: The AMNOG regulation, introduced in 2011 in Germany, changed the game for new drugs. Now, the industry is required to submit a dossier to the GBA (the central decision body in the German sickness fund system) to show additional benefit. After granting the magnitude of the additional benefit by the GBA, the manufacturer is entitled to negotiate the reimbursement price with the GKV-SV (National Association of Statutory Health Insurance Funds). The reimbursement price is defined as a discount on the drug price at launch. As the price or discount negotiations between the manufacturers and the GKV-SV takes place behind closed doors, the factors influencing the results of the negotiation are not known. Objectives: The aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process. Methods: The analysis was based on a dataset containing detailed information on all assessments until the end of 2015. A descriptive analysis was followed by an econometric analysis of various potential factors (benefit rating, size of target population, deviating from appropriate comparative therapy and incorporation of HRQoL-data). Results: Until December 2015, manufacturers and the GKV-SV finalized 96 negotiations in 193 therapeutic areas, based on assessment conducted by the GBA. The GBA has granted an additional benefit to 100/193 drug innovations. Negotiated discount was significantly higher for those drugs without additional benefit ( p = 0.030) and non-orphan drugs ( p = 0.015). Smaller population size, no deviation from recommended appropriate comparative therapy and the incorporation of HRQoL-data were associated with a lower discount on the price at launch. However, neither a uni- nor the multivariate linear regression showed enough power to predict the final discount. Conclusions: Although the AMNOG regulation implemented binding and strict rules for the benefit assessment itself, the outcome of the discount negotiations are still unpredictable. Obviously, negotiation tactics, the current political situation and soft factors seem to play a more influential role for the outcome of the negotiations than the five hard and known factors analyzed in this study. Further research is needed to evaluate additional factors. [ABSTRACT FROM AUTHOR]

The authors discuss the implications of the 2015 proposed revision of the Cancer Drugs Fund (CDF), established to provide a means by which National Health Service (NHS) patients could get cancer drugs that are not available on the NHS in Great Britain. They argues against the threats of the revised scheme on public health. They describe how the revised CDF could maximize the value of the benefit to cancer patients while minimizing its negative impact on the equity and efficiency of the NHS.

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

Colombian laypersons' perspectives regarding actual and potential drug policies were examined. Adults ( N = 395) aged 18-68 and living in Bogota were presented with 24 vignettes that were composed according to two within-subject orthogonal factor designs: (a) Demand for drugs in the country × Current government policy regarding soft and hard drugs (from 'laissez faire' policy for all drugs to complete prohibition of all drugs) and (b) Information campaigns regarding the dangerousness of drugs × Current policy. Participants rated the level of acceptability of each policy. Seven different perspectives were identified that can be grouped into five broad views. The first one (50 % of participants) was called 'radical constructionists' because participants considered that all policies were unacceptable. The second one (19 %) was called 'cultural conservatives' because only one drug policy was considered fully acceptable: complete prohibition (although half of the members of this group were willing to allow soft drugs to be sold freely). The third one (14 %) was called 'progressive prohibitionists' because the preferred policies in this group were either complete prohibition or complete regulation by the government. The fourth one (8 %) was called 'free trade libertarians' because the dominant opinion was that the drug market should be free. The last one (5 %) was called 'progressive advocates of legalization' because the preferred policy in this group was complete regulation of all substances. In most cases, the presence of information campaigns was highly valued. Methodological implications and implications for decision-makers are discussed. [ABSTRACT FROM AUTHOR]

Incorporation rates of the enantiomers of 3,4-methylenedioxymethamphetamine (MDMA) and its metabolite 3,4-methylenedioxyamphetamine (MDA) into hair and nails were investigated after controlled administration. Fifteen subjects without MDMA use received two doses of 125 mg of MDMA. Hair, nail scrapings, and nail clippings were collected 9-77 days after the last administration (median 20 days). Hair samples were analyzed in segments of 1- to 2-cm length. After chiral derivatization with N-(2,4-dinitro-5-fluorophenyl)- l-valinamide, MDMA and MDA diastereomers were analyzed by liquid chromatography-tandem mass spectrometry. Highest concentrations in hair segments corresponded to the time of MDMA intake. They ranged from 101 to 3200 pg/mg and 71 to 860 pg/mg for R- and S-MDMA, and from 3.2 to 116 pg/mg and 4.4 to 108 pg/mg for R- and S-MDA, respectively. MDMA and MDA concentrations in nail scrapings and clippings were significantly lower than in hair samples. There was no significant difference between enantiomeric ratios of R/ S-MDMA and R/ S-MDA in hair and nail samples (medians 2.2-2.4 for MDMA and 0.85-0.95 for MDA). Metabolite ratios of MDA to MDMA were in the same range in hair and nail samples (medians 0.044-0.055). Our study demonstrates that administration of two representative doses of MDMA was detected in the hair segments corresponding to the time of intake based on average hair growth rates. MDMA was detected in all nail samples regardless of time passed after intake. Comparable R/ S ratios in hair and nail samples may indicate that incorporation mechanisms into both matrices are comparable. [ABSTRACT FROM AUTHOR]

Recent social and legal responses to novel psychoactive drugs (NPDs) have been attributed to media panics rather than these substance's actual harms. NPDs, including botanical substances new to Western markets such as Salvia divinorum, newly synthesized analogues such as synthetic cannabinoids and 'bath salts,' and new ways of administering drugs, such as combining prescription cough syrup with soda ('purple drank') have been the target of various forms of legislation at the state and/or federal level. We systematically examine print media coverage of NPDs in the U. S. between 2005 and 2013 to determine whether media attention was temporally associated with legislative change. Results indicate that each drug had a brief window during which it was the focus of sensationalistic reporting. In addition, federal legislation banning synthetic cannabinoids and 'bath salts' appear to be closely linked to media reporting as spikes in coverage both preceded and followed the bans. [ABSTRACT FROM AUTHOR]

An analytical review of widely discussed issues on the classification of drugs based on the methods/sources of their preparation and the complexity of their structures is presented. According to the classification, drugs are divided into three types: (A) low-molecular-weight synthetic 'conventional' drugs that are completely characterized chemically; (B) biological complex drugs that are not fully characterized chemically (BCD); and (C) non-biological/synthetic complex drugs that are not fully characterized chemically (NBCD). This classification has both scientific and practical significance due to the fact that NBCDs (liposomal drugs, complex iron-carbohydrate complexes, glatiramoids, low-molecular-weight heparins) are similar to BCDs with respect to both structure (a mixture of strongly bound macromolecular fragments not amenable to isolation and complete identification) and biological/pharmacological effects (immunogenicity, insufficient information about the mechanism of action). Recent practice shows that NBCD generic versions in addition to biosimilar drugs are actually not identical to the original drugs because of differences in the manufacturing technology. For this reason, the expedited review and registration of these drugs, which is analogous to that used for conventional low-molecular-weight drugs, seems to be insufficient. [ABSTRACT FROM AUTHOR]

This article investigates the nature and potential trajectories of global disputes. Conventional accounts of global disputes often see them as inherently open-ended so that actors can always roll back previous defeats; alternatively, path-dependent accounts emphasize the likelihood of those who prevail in early struggles to reproduce their advantaged position. Like path-dependent accounts, I argue that disputes are nested, so that the goals and possible outcomes of new disputes are bounded by the results of earlier disputes-but rather than enlarging the gap between the parties to the dispute by reproducing advantages, nested disputes, on the contrary, lead to the narrowing of positions and to lower stakes. I illustrate this argument by describing two constitutive moments in the debate over intellectual property rights in Kenya: first, the debate around the Industrial Property Act over the exceptions to intellectual property rights; second, the debate around the Anti-Counterfeit Act over whether anti-counterfeit measures should apply to medicines. [ABSTRACT FROM AUTHOR]

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

Objectives: Competition from 'follow-on' drugs has been a highly controversial issue. Manufacturers launching new molecules in existing drug classes have often been criticized for inflating health systems' expenses, but it has been argued that such drugs increase therapeutic options. Economic theory suggests that follow-on drugs induce price competition. We contribute to this discussion by addressing the topic of pricing at market entry and price development in the German market. Methods: We measure determinants of price strategies of follow-on drugs using regression analyses, considering all new molecules launched in the German market from 1993 to 2008. Prices of products are standardized on defined daily dosages controlling for sales volumes based on data from the IMS Health DPM database and for the therapeutic quality of a new product using ratings by Fricke/Klaus as a proxy for innovation. Results: We identify prices correlating with therapeutic value at market entry. While the first two molecules engage in quality competition, price discounts below the market price can be observed from the third entrant on. Price discounts are even more distinct in development races with several drugs entering the market within 2 years and in classes with a low degree of therapeutic differentiation. Prices remain relatively constant over time. Conclusion: This study contributes to assessments of competition in pharmaceutical markets focusing on price strategies of new market entrants. After an initial phase of market building, further follow-on products induce price competition. Largely unchanged prices after 4 years may be interpreted as quality competition and can be attributed to prices in Germany being anchor points for international price referencing. [ABSTRACT FROM AUTHOR]

New regulatory guidance documents from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways for preclinical safety testing. The US and the European Union appear to be moving in a similar direction focussing and refining preclinical safety data requirements for both radiodiagnostics and radiotherapeutics. We here summarize these recent documents from both the US and European perspective. [ABSTRACT FROM AUTHOR]

This section offers news briefs. These include the restart of Phase 1 trials of an experimental Ebola drug after restrictions by U.S. regulators were modified, California's launch of a statewide 3 million U.S. dollars precision-medicine initiative on April 14, 2015 to study how genomic, socio-economic and other forms of patient data can be combined for the development of drugs and the creation of the African Centres for Disease Control and Prevention by the African Union and the U.S.

The author reflects on the adoption of the right to try legislation in the five U.S. states for having access to Investigational drugs that could save lives of seriously ill patients who cannot take part in clinical trials. Topics discussed include approval for access to investigational drugs by the US Food and Drug Administration (FDA), efforts of Texas Senator Michael McCaul, in implementing a legislation to increase transparency of compassionate drug and role of social media in the issue.