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.

Pushing the envelope through the Global Financing Facility: potential impact of mobilising additional support to scale-up life-saving interventions for women, children and adolescents in 50 high-burden countries.

INTRODUCTION: The Global Financing Facility (GFF) was launched to accelerate progress towards the Sustainable Development Goals (SDGs) through scaled and sustainable financing for Reproductive, Maternal, Newborn, Child and Adolescent Health and Nutrition (RMNCAH-N) outcomes. Our objective was to estimate the potential impact of increased resources available to improve RMNCAH-N outcomes, from expanding and scaling up GFF support in 50 high-burden countries. METHODS: The potential impact of GFF was estimated for the period 2017-2030. First, two scenarios were constructed to reflect conservative and ambitious assumptions around resources that could be mobilised by the GFF model, based on GFF Trust Fund resources of US$2.6 billion. Next, GFF impact was estimated by scaling up coverage of prioritised RMNCAH-N interventions under these resource scenarios. Resource availability was projected using an Excel-based model and health impacts and costs were estimated using the Lives Saved Tool (V.5.69 b9). RESULTS: We estimate that the GFF partnership could collectively mobilise US$50-75 billion of additional funds for expanding delivery of life-saving health and nutrition interventions to reach coverage of at least 70% for most interventions by 2030. This could avert 34.7 million deaths-including preventable deaths of mothers, newborns, children and stillbirths-compared with flatlined coverage, or 12.4 million deaths compared with continuation of historic trends. Under-five and neonatal mortality rates are estimated to decrease by 35% and 34%, respectively, and stillbirths by 33%. CONCLUSION: The GFF partnership through country- contextualised prioritisation and innovative financing could go a long way in increasing spending on RMNCAH-N and closing the existing resource gap. Although not all countries will reach the SDGs by relying on gains from the GFF platform alone, the GFF provides countries with an opportunity to significantly improve RMNCAH-N outcomes through achievable, well-directed changes in resource allocation.

Stakeholders' perceptions of 10years of the Global Action Plan for Influenza Vaccines (GAP) - Results from a survey.

Ten years after the launch of the Global Action Plan for Influenza Vaccines (GAP), the World Health Organization (WHO) surveyed stakeholders to understand their perceptions of what the programme had achieved. This article provides a summary of the findings; the full report will be available on-line on the GAP website in November 2016 (http://www.who.int/influenza_vaccines_plan/en/). Seventy-seven responses were received from stakeholders including medical doctors, national influenza center officials, country immunization programme teams, surveillance and disease centers, policy-makers, researchers, vaccine manufacturers, and non-governmental organizations from 28 countries, representing all six WHO regions. Respondents cited GAP's biggest successes as capacity building in developing countries; raising international awareness of global needs in the event of a pandemic; and collaborative alignment of influenza stakeholders. The most commonly reported challenges were the limited progress in development of a broadly protective or universal vaccine and the perceived absence of a major increase in seasonal demand. These findings aligned with the perception that less global progress had been made under the third GAP objective, focused on research and development of better vaccines, than on increasing seasonal vaccine use (objective 1) and pandemic vaccine production capacity (objective 2). Respondents explained what they saw as the major challenges to development of better vaccines, including to development of a universal influenza vaccine. The majority of respondents agreed that the goal chosen at the GAP II consultation is still relevant. Results highlighted the importance of promoting research and development of better vaccines, both for facilitating uptake of seasonal vaccines and for ensuring timely vaccine availability in the event of a pandemic. As the GAP concludes its mandate this year, these findings will contribute to discussions on the impact of programme closure and how to address the key issues facing influenza stakeholders thereafter.