The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study.

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.

The Legal and Empirical Case for Firearm Purchaser Licensing.

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.

Drug prices and trends before and after requesting compulsory licenses: the Ecuadorian experience.

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.

Evaluation of Sex Distribution of Industry Payments Among Radiation Oncologists.

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.

Tobacco Retail Licensing and Youth Product Use.

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.

Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP).

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.

Evidence Europe 2017. London, UK - February 22-23, 2017.

As the political backdrop changes in both the U.S. and Europe, volatility in the pharma industry is beginning to be felt as the sector becomes sensitive to the uncertainty. U.S. President Trump has stated he will pursue an agenda against high U.S. drug prices and is expected to seek to repeal the Affordable Care Act, while in Europe, Brexit casts further unknowns in regulatory authorization procedures, trade and external reference pricing. With these factors in mind, Terrapin's Evidence Europe meeting provided for a very topical discussion on the use of evidence to define and communicate value in healthcare. With a particular focus on real-world evidence, the conference used presentations, panel briefings and roundtable discussions to foster debate on the challenges faced by industry as it negotiates the current fragile environment.

Expanding the geriatric mental health workforce through utilization of non-licensed providers.

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.

Challenges to driver licensing participation for Aboriginal people in Australia: a systematic review of the literature.

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.