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Twenty genetic therapies have been approved by the US Food and Drug Administration to date, a number that now includes the first CRISPR genome-editing therapy for sickle cell disease-CASGEVY (exagamglogene autotemcel, Vertex Pharmaceuticals). This extraordinary milestone is widely celebrated owing to the promise for future genome-editing treatments of previously intractable genetic disorders and cancers. At the same time, such genetic therapies are the most expensive drugs on the market, with list prices exceeding US$4 million per patient. Although all approved cell and gene therapies trace their origins to academic or government research institutions, reliance on for-profit pharmaceutical companies for subsequent development and commercialization results in prices that prioritize recouping investments, paying for candidate product failures and meeting investor and shareholder expectations. To increase affordability and access, sustainable discovery-to-market alternatives are needed that address system-wide deficiencies. Here we present recommendations of a multidisciplinary task force assembled to chart such a path. We describe a pricing structure that, once implemented, could reduce per-patient cost tenfold and propose a business model that distributes responsibilities while leveraging diverse funding sources. We also outline how academic licensing provisions, manufacturing innovation and supportive regulations can reduce cost and enable broader patient treatment., (© 2024. Springer Nature Limited.)

Background: Non-exclusive voluntary licensing that is access-oriented has been suggested as an option to increase access to medicines to address the COVID-19 pandemic. To date, there has been little research on the effect of licensing, mainly focused on economic and supply chain considerations, and not on the benefits in terms of health outcomes. We aimed to study the economic and health effect of voluntary licensing for medicines for HIV and hepatitis C virus (HCV) in low-income and middle-income countries (LMICs)., Methods: A robust modelling framework was created to examine the difference between scenarios, with (factual) and without (counterfactual) a Medicines Patent Pool (MPP) licence for two medicines, dolutegravir and daclatasvir. Data were obtained from MPP licensees, as well as a large number of external sources. The primary outcomes were the cost savings and health impact between scenarios with and without MPP licences across all LMICs. Through its licences, MPP had access to the volumes and prices of licensed generic products sold in all covered countries on a quarterly basis. These data informed the volumes, prices, and uptake for the past factual scenarios and were the basis for modelling the future factual scenarios. These scenarios were then compared with a set of counterfactual scenarios in the absence of the studied licences., Findings: Cumulatively, between 2017 and 2032, the model's central assumptions predicted an additional uptake of 15·494 (range 14·406-15·494) million patient-years of dolutegravir-based HIV treatments, 151 839 (34 575-312 973) deaths averted, and US$3·074 (1·837-5·617) billion saved through the MPP licence compared with the counterfactual scenario. For daclatasvir-based HCV treatments, the cumulative effect from 2015 to 2026 was predicted to be an additional uptake of 428 244 (127 584-636 270) patients treated with daclatasvir, 4070 (225-6323) deaths averted, and $107·593 (30·377-121·284) million saved with the licence compared with the counterfactual scenario., Interpretation: The chain of effects linking upstream licensing to downstream outcomes can be modelled. Accordingly, credible quantitative estimates of economic and health effects arising from access-oriented voluntary licensing were obtained based on assumptions that early generic competition leads to price reductions that influence procurement decisions and enable the faster and broader uptake of recommended medicines, with beneficial economic and health effects., Funding: Unitaid., Competing Interests: Declaration of interests SM is an employee of the MPP and reports grants from Unitaid. HBM is an employee of MPP and reports grants from Unitaid. EB is an employee of MPP and reports grants from Unitaid. OB-H has acted as a consultant for MPP for this work. CvD has acted as a consultant for MPP for this work. JVL has acted as a consultant for MPP for this work., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

This article argues that state government actors concerned about gun violence prevention should prioritize enactment of robust firearm purchaser regimes at the state level. First, the article outlines the empirical evidence base for purchaser licensing. Then, the article describes how state governments can design this policy. Next, the article assesses the likelihood that purchaser licensing legislation will continue to be upheld by federal courts. Finally, the article addresses the implications of this policy, aimed at curbing gun deaths, for equally important racial justice priorities. Taken together, these various considerations indicate that purchaser licensing policies are among the most effective firearm-focused laws state governments can enact to reduce gun deaths within the existing federal legislative and legal frameworks.

Introduction : The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. Areas covered : The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. Expert opinion : The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.

Background: Restricting youth access to tobacco is a central feature of US tobacco regulatory policy, but impact of local tobacco retail licensing (TRL) regulation on cigarette smoking rates remains uncertain. Effects of TRL on other tobacco product use and use as adolescents reach the age to legally purchase tobacco products has not been investigated., Methods: Prevalences of ever and past 30-day cigarette, electronic cigarette (e-cigarette), cigar, and hookah use were assessed in a survey of a cohort of 1553 11th- and 12th-grade adolescents (mean age: 17.3 years); rates of initiation were evaluated 1.5 years later. An American Lung Association (2014) youth access grade was assigned to each of 14 political jurisdictions in which participants lived on the basis of the strength of the local TRL ordinance., Results: At baseline, participants living in 4 jurisdictions with "A" grades (ie, with most restrictive ordinances) had lower odds of ever cigarette use (odds ratio [OR] 0.61; 95% confidence interval [CI] 0.41-0.90) and of past 30-day use (OR 0.51; 95% CI 0.29-0.89) than participants in 10 D- to F-grade jurisdictions. At follow-up at legal age of purchase, lower odds of cigarette use initiation (OR 0.67; 95% CI 0.45-0.99) occurred in jurisdictions with stronger TRL policy. Lower odds of e-cigarette initiation at follow-up (OR 0.74; 95% CI 0.55-0.99) and of initiation with past 30-day use (OR 0.45; 95% CI 0.23-0.90) were also associated with better regulation., Conclusions: Strong local TRL ordinance may lower rates of cigarette and e-cigarette use among youth and young adults., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)

Importance: Industry relationships are an important measure of professional advancement; however, the association between physician sex and industry payments in radiation oncology has not been described., Objective: To update the trends in the sex distribution of industry payments in radiation oncology., Design, Setting, and Participants: This retrospective cross-sectional study was conducted between July 1, 2018, and August 31, 2018. It used the publicly available Centers for Medicare & Medicaid Services (CMS) Open Payments program and CMS Physician and Other Supplier Public Use File databases to obtain 2016 industry payment data for US radiation oncologists who reported receiving industry funding in that year (n = 3052). Total monetary value, number of payments, and median payment amounts were determined for each sex in the following categories: research, consulting, honoraria, industry grants, royalty or license, and services other than consulting., Main Outcomes and Measures: Industry payment amounts among 3052 radiation oncologists who reported receiving payments in 2016; association of median payment with the types of payment by sex., Results: Of the total 4483 radiation oncologists who practiced in 2016, 1164 (25.9%) were female and 3319 (74.0%) were male. Industry payments were distributed among 3052 radiation oncologists (68.1%), of whom 715 (23.4%) were female and 2337 (76.6%) were male. The proportion of female radiation oncologists who received at least 1 industry payment was 61.4% (715 of 1164), whereas the proportion of their male counterparts was 70.4% (2337 of 3319). Across all payment types, female radiation oncologists received a smaller percentage of total industry funding than the percentage of female physicians represented in each category. The median payment value was smaller for female radiation oncologists in consulting (-$1000; 95% CI, -$1966.67 to $100.63; P = .005) and honoraria (-$500; 95% CI, -$1071.43 to $0; P = .007). This trend was also observed in research payments, but was not statistically significant (-$135.02; 95% CI, -$476.93 to $6.88; P = .08). Of the $1 347 509 royalty or license payments made to 72 physicians, none was for female radiation oncologists., Conclusions and Relevance: Distribution of industry payments appears to show sex disparity in industry relationships among radiation oncologists; this observation warrants further investigation to determine the underlying reasons and provide avenues for increased parity.

Objectives: We evaluate policy and practice strategies for bolstering the geriatric mental healthcare workforce and describe costs and considerations of implementing one approach., Method: Narrative overview of the literature and policy retrieved from searches of databases, hand searches, and authoritative texts. We identified three proposed strategies to increase the geriatric mental healthcare workforce: (1) production of more geriatric mental health providers; (2) team-based care; and (3) non-licensed providers. We evaluate each in terms of challenges and potential and provide estimates of costs, policy, and practice considerations for training, employing, and supervising non-licensed mental health providers., Results: Use of non-licensed providers is key to reforms needed to allow a more older adults to access necessary mental healthcare. Licensed and non-licensed providers have achieved similar improvements for generalized anxiety disorder among patients, although non-licensed providers did so at a lower cost., Conclusion: Supervised non-licensed providers can extend the reach of licensed providers for specific mental health conditions, resulting in lower costs and increased number of patients treated. Although several barriers to implementation exist, policy and infrastructure changes that may support this type of care delivery model are emerging from reforms in financing and associated delivery initiatives created by the Affordable Care Act.

The Medicines Patent Pool (MPP) was established in 2010 to ensure timely access to low-cost generic versions of patented antiretroviral (ARV) medicines in low- and middle-income countries (LMICs) through the negotiation of voluntary licences with patent holders. While robust data on the savings generated by MPP and other major global public health initiatives is important, it is also difficult to quantify. In this study, we estimate the savings generated by licences negotiated by the MPP for ARV medicines to treat HIV/AIDS in LMICs for the period 2010-2028 and generate a cost-benefit ratio-based on people living with HIV (PLHIVs) in any new countries which gain access to an ARV due to MPP licences and the price differential between originator's tiered price and generics price, within the period where that ARV is patented. We found that the direct savings generated by the MPP are estimated to be USD 2.3 billion (net present value) by 2028, representing an estimated cost-benefit ratio of 1:43, which means for every USD 1 spent on MPP, the global public health community saves USD 43. The saving of USD 2.3 billion is equivalent to more than 24 million PLHIV receiving first-line ART in LMICs for 1 year at average prices today.

Introduction: Aboriginal and Torres Strait Islander people are overrepresented in transport-related morbidity and mortality. Low rates of licensure in Aboriginal communities and households have been identified as a contributor to high rates of unlicensed driving. There is increasing recognition that Aboriginal people experience challenges and adversity in attaining a licence. This systematic review aims to identify the barriers to licence participation among Aboriginal people in Australia., Method: A systematic search of electronic databases and purposive sampling of grey literature was conducted, two authors independently assessed publications for eligibility for inclusion., Results: Twelve publications were included in this review, of which there were 11 reporting primary research (qualitative and mixed methods) and a practitioner report. Barriers identified were categorised as individual and family barriers or systemic barriers relating to the justice system, graduated driver licensing (GDL) and service provision. A model is presented that depicts the barriers within a cycle of licensing adversity., Discussion: There is an endemic lack of licensing access for Aboriginal people that relates to financial hardship, unmet cultural needs and an inequitable system. This review recommends targeting change at the systemic level, including a review of proof of identification and fines enforcement policy, diversionary programs and increased provision for people experiencing financial hardship., Conclusion: This review positions licensing within the context of barriers to social inclusion that Aboriginal people frequently encounter. Equitable access to licensing urgently requires policy reform and service provision that is inclusive, responsive to the cultural needs of Aboriginal people and accessible to regional and remote communities.

Importance: Women in ophthalmology are growing in number and have made strides in traditional metrics of professional achievement. Professional ties to industry represent another potential means of career advancement, recognition, and income., Objective: To report the representation of women among ophthalmologists receiving industry remuneration for research, consulting, honoraria, grants, royalties, and faculty/speaker roles., Design, Setting, and Participants: In this observational, retrospective study, the Centers for Medicare and Medicaid Services Open Payments database for payments to ophthalmologists by biomedical companies was reviewed for representation, median payments, and mean payments by women and men for industry relationships in 2013 and 2014. The analysis was performed from July 2015 to November 2015., Main Outcomes and Measures: The primary outcome measures were percentage representation of women vs men overall and in industry research, consulting, speaking roles, royalties and licenses, grants, services other than consulting, and honoraria. Secondary outcome measures included mean and median payments from industry to female vs male ophthalmologists., Results: In 2013, 4164 of 21 380 (19.5%) ophthalmologists were women, and of 1204 ophthalmologists analyzed for industry payments, 176 (4.2%) women had industry ties compared with 1028 (6%) men (P < .001). Mean payments to women were $11 419 compared with $20 957 for men (P = .001), and median payments to women were $3000 compared with $4787 for men (P = .007). In 2013, women were underrepresented among ophthalmologists receiving industry payments for research (49 of 462 [10.6%]), consulting (96 of 610 [15.7%]), honoraria (3 of 47 [6.4%]), industry grants (1 of 7 [14.3%]), royalties and licenses (1 of 13 [7.7%]), and faculty/speaker roles (2 of 48 [4.2%]). In 2014, 4352 of 21 531 (20.2%) of ophthalmologists were women. Of 1518 ophthalmologists analyzed for industry payments, 255 (6%) women had industry ties compared with 1263 (7.4%) men (P < .001). Mean payments to women were $14 848 compared with $30 513 for men (P = .004), and median payments to women were $3750 compared with $5000 for men (P = .005). Women remained underrepresented among ophthalmologists receiving industry payments for research (25 of 241 [10.4%]), consulting (145 of 921 [15.7%]), honoraria (14 of 11 [12.6%]), industry grants (3 of 25 [12.0%]), royalties and licenses (1 of 22 [4.6%]), and faculty/speaker roles (21 of 189 [11.1%]) in 2014., Conclusions and Relevance: Women make up a minority of ophthalmologists with professional industry relationships, and the average woman partnering with industry earns less than her male colleagues. The reasons for differences are multifactorial and could not be determined by this study.

Background: Excessive alcohol consumption at licensed alcohol establishments (i.e., bars and restaurants) has been directly linked to alcohol-related problems such as traffic crashes and violence. Historically, alcohol establishments have had a high likelihood of selling alcohol to obviously intoxicated patrons (also referred to as "overservice") despite laws prohibiting these sales. Given the risks associated with overservice and the need for up-to-date data, it is critical that we monitor the likelihood of sales to obviously intoxicated patrons., Methods: To assess the current likelihood of a licensed alcohol establishment selling alcohol to an obviously intoxicated patron, we conducted pseudo-intoxicated purchase attempts (i.e., actors attempt to purchase alcohol while acting out obvious signs of intoxication) at 340 establishments in 1 Midwestern metropolitan area. We also measured characteristics of the establishments, the pseudo-intoxicated patrons, the servers, the managers, and the neighborhoods to assess whether these characteristics were associated with likelihood of sales of obviously intoxicated patrons. We assessed these associations with bivariate and multivariate regression models., Results: Pseudo-intoxicated buyers were able to purchase alcohol at 82% of the establishments. In the fully adjusted multivariate regression model, only 1 of the characteristics we assessed was significantly associated with likelihood of selling to intoxicated patrons-establishments owned by a corporate entity had 3.6 greater odds of selling alcohol to a pseudo-intoxicated buyer compared to independently owned establishments., Conclusions: Given the risks associated with overservice of alcohol, more resources should be devoted first to identify effective interventions for decreasing overservice of alcohol and then to educate practitioners who are working in their communities to address this public health problem., (Copyright © 2016 by the Research Society on Alcoholism.)

Aims: Few studies have examined the role of gender and both area-level and individual socio-economic status (SES) as independent predictors of alcohol-related aggression (ARA) in and around licensed venues., Methods: The aim of the present study was to investigate the relationship between gender, area-level SES and individual SES (operationalised as occupational category) and ARA in and around licensed venues. The sample comprised 697 men and 649 women aged 16-47, who completed a patron intercept survey as part of a larger study assessing trends in harm and stakeholders' views surrounding local community level interventions in dealing with alcohol-related problems in the night-time economy., Results: Binary logistic regression analyses showed that age, gender, occupational category, area-level SES and level of intoxication at time of interview were all significant predictors of involvement in ARA. Being male doubled the odds of involvement in ARA, while age was a protective factor. Blue collar workers had more than double the odds of ARA involvement of professionals, while those living in the most socio-economically disadvantaged areas were over twice as likely to report experiencing ARA compared to those living in the most advantaged areas. However, assessment of the predictive model by gender revealed that effects of age, occupational category and area-level SES were restricted to male participants, with greater intoxication no longer predictive., Conclusions: ARA among patrons was significantly more likely to occur among men, those in blue collar occupations, and individuals living in low SES areas, suggesting both individual and area-level disadvantage may play a role in ARA., (© The Author 2015. Medical Council on Alcohol and Oxford University Press. All rights reserved.)

Purpose: To use the Centers for Medicare and Medicaid Services Open Payments database to characterize payments made to radiation oncologists and compare their payment profile with that of medical and surgical oncologists., Methods and Materials: The June 2015 release of the Open Payments database was accessed, containing all payments made to physicians in 2014. The general payments dataset was used for analysis. Data on payments made to medical, surgical, and radiation oncologists was obtained and compared. Within radiation oncology, data regarding payment category, sponsorship, and geographic distribution were identified. Basic statistics including mean, median, range, and sum were calculated by provider and by transaction., Results: Among the 3 oncologic specialties, radiation oncology had the smallest proportion (58%) of compensated physicians and the lowest mean ($1620) and median ($112) payment per provider. Surgical oncology had the highest proportion (84%) of compensated physicians, whereas medical oncology had the highest mean ($6371) and median ($448) payment per physician. Within radiation oncology, nonconsulting services accounted for the most money to physicians ($1,042,556), whereas the majority of the sponsors were medical device companies (52%). Radiation oncologists in the West accepted the most money ($2,041,603) of any US Census region., Conclusions: Radiation oncologists in 2014 received a large number of payments from industry, although less than their medical or surgical counterparts. As the Open Payments database continues to be improved, it remains to be seen whether this information will be used by patients to inform choice of providers or by lawmakers to enact policy regulating physician-industry relationships., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Compulsory licensing has been widely suggested as a legal mechanism for bypassing patents to introduce lower-cost generic antiretrovirals for HIV/AIDS in developing countries. Previous studies found that compulsory licensing can reduce procurement prices for drugs, but it is unknown how the resulting prices compare to procurements through the Global Fund to Fight AIDS, Tuberculosis, and Malaria; UNICEF; and other international channels. For this study we systematically constructed a case-study database of compulsory licensing activity for antiretrovirals and compared compulsory license prices to those in the World Health Organization's (WHO's) Global Price Reporting Mechanism and the Global Fund's Price and Quality Reporting Tool. Thirty compulsory license cases were analyzed with 673 comparable procurements from WHO and Global Fund data. Compulsory license prices exceeded the median international procurement prices in nineteen of the thirty case studies, often with a price gap of more than 25 percent. Compulsory licensing often delivered suboptimal value when compared to the alternative of international procurement, especially when used by low-income countries to manufacture medicines locally. There is an ongoing need for multilateral and charitable actors to work collectively with governments and medicine suppliers on policy options., (Project HOPE—The People-to-People Health Foundation, Inc.)

High-tech businesses are the driving force behind global knowledge-based economies. Academic institutions have positioned themselves to serve the high-tech industry through consulting, licensing, and university spinoffs. The awareness of commercialization strategies and building an entrepreneurial culture can help academics to efficiently transfer their inventions to the market to achieve the maximum value. Here, the concept of high-tech entrepreneurship is discussed from lab to market in technology-intensive sectors such as nanotechnology, photonics, and biotechnology, specifically in the context of lab-on-a-chip devices. This article provides strategies for choosing a commercialization approach, financing a startup, marketing a product, and planning an exit. Common reasons for startup company failures are discussed and guidelines to overcome these challenges are suggested. The discussion is supplemented with case studies of successful and failed companies. Identifying a market need, assembling a motivated management team, managing resources, and obtaining experienced mentors lead to a successful exit.

Health Information Technology (Health IT) constitutes an integral component of the operations of most academic dental institutions nowadays. However, the expenses associated with the acquisition and the ongoing maintenance of these complex systems have often been buried among costs for other electronic infrastructure systems, distributed across various cost centers including unmeasured central campus support, covered centrally and therefore difficult to quantify, and spread over years, denying school administrators a clear understanding of the resources that have been dedicated to Health IT. The aim of this study was to understand the financial impact of Health IT at four similar U.S. dental schools: two schools using a purchased Electronic Health Record (EHR), and two schools that developed their own EHR. For these schools, the costs of creating ($2.5 million) and sustaining ($174,000) custom EHR software were significantly higher than acquiring ($500,000) and sustaining ($121,000) purchased software. These results are based on historical data and should not be regarded as a gold standard for what a complete Health IT suite should cost. The presented data are intended to inform school administrators about the myriad of costs associated with Health IT and give them a point of reference when comparing costs or making estimates for implementation projects.

Objective: To measure the impact of a 15-fold licence fee increase on tobacco retailer licence renewals., Methods: The regulatory change increasing tobacco licence fees (from $A12.90 to $A200 per annum) took effect on 1 January 2007. Government Tobacco Licence records (n=7093) were audited for 1 year prior to, and 2 years after the change. An interrupted time series analysis using ARIMA modelling was conducted to examine the impact of fee increases on the number of active licences., Results: The total number of tobacco licences decreased by 23.7% from December 2007 to December 2009. The increased tobacco licence fee implemented on 1 January 2007, was associated with a significant reduction in the number of tobacco licences purchased or renewed in subsequent years. Of the 1144 entertainment licensees holding valid licences in December 2007, 30.9% no longer held a licence by December 2009, and 19.9% had reduced the number of points of sale within the same venue., Conclusions: Licensing of tobacco retailers has received little attention in tobacco control in Australia and internationally. Our data add to the growing body of evidence supporting further regulation of retail sale of tobacco. The results demonstrate that a tobacco licence price increase off a low base is a potentially effective method of reducing tobacco points of sale when consumer demand for cigarette products is low. However, further research is needed to identify additional measures that may be necessary to reduce the availability of tobacco products in areas where consumer demand for cigarettes is high.