scholarly journals Compulsory Licenses for Cancer Drugs: Does Circumventing Patent Rights Improve Access to Oncology Medications?

2016 ◽  
Vol 2 (5) ◽  
pp. 292-301 ◽  
Author(s):  
Cinthia Leite Frizzera Borges Bognar ◽  
Brittany L. Bychkovsky ◽  
Gilberto de Lima Lopes

Worldwide, there are enormous inequities in cancer control that cause poor outcomes among patients with cancer who live in low- and middle-income countries (LMICs). One of the biggest challenges that oncology faces today is how to increase patient access to expensive, but life-saving, therapies in LMICs. Access to cancer medications in LMICs is a major problem, especially in recent years, as the costs of these therapies continue to rise exponentially. One mechanism available to LMICs to improve access to cancer medications allows a country to pursue a compulsory license for a given drug. Here, we will review how the legal framework in the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights Agreement and the Doha Declaration supports countries to circumvent patent laws and acquire compulsory licenses for essential medicines. We will also discuss the current and future role of compulsory licenses in oncology and how compulsory licenses may improve access to cancer drugs in LMICs.

2018 ◽  
pp. 1-8 ◽  
Author(s):  
Yehoda M. Martei ◽  
Sebathu Chiyapo ◽  
Surbhi Grover ◽  
Christina Hanna ◽  
Scott Dryden-Peterson ◽  
...  

Purpose In low- and middle-income countries (LMICs), frequent outages of the stock of cancer drugs undermine cancer care delivery and are potentially fatal for patients with cancer. The aim of this study is to describe a methodologic approach to forecast chemotherapy volume and estimate cost that can be readily updated and applied in most LMICs. Methods Prerequisite data for forecasting are population-based incidence data and cost estimates per unit of drug to be ordered. We used the supplementary guidelines from the WHO list of essential medicines for cancer to predict treatment plans and ordering patterns. We used de-identified aggregate data from the Botswana National Cancer Registry to estimate incident cases. The WHO Management Sciences for Health International Price Indicator was used to estimate unit costs per drug. Results Chemotherapy volume required for incident cancer cases was estimated as the product of the standardized dose required to complete a full treatment regimen per patient, with a given cancer diagnosis and stage, multiplied by the total number of incident cancer cases with the respective diagnosis. The estimated chemotherapy costs to treat the 10 most common cancers in the public health care sector of Botswana is approximately 2.3 million US dollars. An estimated 66% of the budget is allocated to costs of rituximab and trastuzumab alone, which are used by approximately 10% of the cancer population. Conclusion This method provides a reproducible approach to forecast chemotherapy volume and cost in LMICs. The chemotherapy volume and cost outputs of this methodology provide key stakeholders with valuable information that can guide budget estimation, resource allocation, and drug-price negotiations for cancer treatment. Ultimately, this will minimize drug shortages or outages and reduce potential loss of lives that result from an erratic drug supply.


Author(s):  
Susan M. Henshall ◽  
Hugo V. Villar ◽  
Raul Doria ◽  
Danny A. Milner

Incidence and mortality from cancer is increasing in most countries in the world, with the highest burden in developing countries. City Cancer Challenge (C/Can), an initiative launched in 2017, aims to improve access to quality cancer care in metropolitan areas (1 million inhabitants or more) in low- and upper-middle income countries by transforming the way stakeholders at the city, regional, and national levels collectively design, plan, and implement local cancer solutions. The approach is built on the core principle that local leaders in cities define their own needs and craft solutions with the support of a network of global, regional, and local partners that reflect an understanding of the unique local context. C/Can aims to build a collective movement of cities that can together deliver quality, equitable, and sustainable cancer control solutions for all.


2016 ◽  
Vol 34 (1) ◽  
pp. 69-75 ◽  
Author(s):  
Lawrence N. Shulman ◽  
Claire M. Wagner ◽  
Ronald Barr ◽  
Gilberto Lopes ◽  
Giuseppe Longo ◽  
...  

Purpose A great proportion of the world's cancer burden resides in low- and middle-income countries where cancer care infrastructure is often weak or absent. Although treatment of cancer is multidisciplinary, involving surgery, radiation, systemic therapies, pathology, radiology, and other specialties, selection of medicines that have impact and are affordable has been particularly challenging in resource-constrained settings. In 2014, at the invitation of the WHO, the Union for International Cancer Control convened experts to develop an approach to propose essential cancer medicines to be included in the WHO Model Essential Medicines Lists (EML) for Adults and for Children, as well as a resulting new list of cancer medicines. Methods Experts identified 29 cancer types with potential for maximal treatment impact, on the basis of incidence and benefit of systemic therapies. More than 90 oncology experts from all continents drafted and reviewed disease-based documents outlining epidemiology, diagnostic needs, treatment options, and benefits and toxicities. Results Briefing documents were created for each disease, along with associated standard treatment regimens, resulting in a list of 52 cancer medicines. A comprehensive application was submitted as a revision to the existing cancer medicines on the WHO Model Lists. In May 2015, the WHO announced the addition of 16 medicines to the Adult EML and nine medicines to the Children's EML. Conclusion The list of medications proposed, and the ability to link each recommended medicine to specific diseases, should allow public officials to apply resources most effectively in developing and supporting nascent or growing cancer treatment programs.


2021 ◽  
Author(s):  
Abimbola Olaniran ◽  
Jane Briggs ◽  
Ami Pradhan ◽  
Erin Bogue ◽  
Benjamin Schreiber ◽  
...  

Abstract Background: This paper explores the extent of community-level stock-out of essential medicines among Community Health Workers (CHWs) in Low- and Middle-Income Countries (LMICs) and identifies the reasons for and consequences of essential medicine stock-outs. Methods: A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. Five electronic databases were searched with a prespecified strategy and the grey literature examined, January 2006 - March 2021. Papers containing information on (i) the percentage of CHWs stocked out or (ii) reasons for stock-outs along the supply chain and consequences of stock-out were included and appraised for risk of bias. Outcomes were quantitative data on the extent of stock-out, summarized using descriptive statistics, and qualitative data regarding reasons for and consequences of stock-outs, analyzed using thematic content analysis and narrative synthesis. Results: Two reviewers screened 1083 records; 78 evaluations were included. Over the last fifteen years, CHWs experienced stock-outs of essential medicines nearly one third of the time and at a significantly (p < 0.01) higher rate than the health centers to which they are affiliated (28.93% [CI 95%: 28.79 - 29.07] vs 9.17 % [CI 95%: 8.64 - 9.70], respectively). A comparison of the period 2006-2015 and 2016-2021 showed a significant (p < 0.01) increase in CHW stock-out level from 26.36% [CI 95%: 26.22 -26.50] to 48.65% [CI 95%: 48.02- 49.28] while that of health centers increased from 7.79% [95% CI: 7.16 - 8.42] to 14.28% [95% CI: 11.22- 17.34]. Distribution barriers were the most cited reasons for stock-outs. Ultimately, patients were the most affected: stock-outs resulted in out-of-pocket expenses to buy unavailable medicines, poor adherence to medicine regimes, dissatisfaction, and low service utilization. Conclusion: Community-level stock-out of essential medicines constitutes a serious threat to achieving universal health coverage and equitable improvement of health outcomes. This paper suggests stock-outs are getting worse, and that there are particular barriers at the last mile. There is an urgent need to address the health and non-health system constraints that prevent the essential medicines procured for LMICs by international and national stakeholders from reaching the people who need them the most.


2021 ◽  
Author(s):  
Anne Schuind

HPV is extremely common worldwide and mainly transmitted through sexual contact; most people are infected with HPV shortly after onset of sexual activity. There are >200 types of HPV, of which at least 12 are cancer-causing (oncogenic or high-risk types). HPV is a causal factor for several anogenital and a subset of oropharyngeal cancers with 2 HPV types (16 and 18) causing 72% of all HPV-associated cancers. Cervical cancer is the fourth most common cancer among women globally with nearly 90% of the deaths occurring in low- and middle-income countries. Comprehensive cervical cancer control includes primary prevention (vaccination against HPV), secondary prevention (screening and treatment of pre-cancerous lesions) as well as treatment of invasive cervical cancer. The currently licensed vaccines are L1 VLP-based and prophylactic; they have been shown to be safe and highly effective in preventing HPV infections and HPV-associated lesions, precancer and cancer. Neutralizing antibodies are the mechanism of protection for prophylactic HPV VLP-based vaccines. Therapeutic HPV vaccines targeting the oncoproteins E6 and E7 are in clinical development.


2019 ◽  
Vol 4 (2) ◽  
pp. e001248
Author(s):  
Helen Saxenian ◽  
Nahad Sadr-Azodi ◽  
Miloud Kaddar ◽  
Kamel Senouci

Immunisation is a cornerstone to primary health care and is an exceptionally good value. The 14 low-income and middle-income countries in the Middle East and North Africa region make up 88% of the region’s population and 92% of its births. Many of these countries have maintained high immunisation coverage even during periods of low or negative economic growth. However, coverage has sharply deteriorated in countries directly impacted by conflict and political unrest. Approximately 1.3 million children were not completely vaccinated in 2017, as measured by third dose of diphtheria–pertussis–tetanus vaccine. Most of the countries have been slow to adopt the newer, more expensive life-saving vaccines mainly because of financial constraints and the socioeconomic context. Apart from the three countries that have had long-standing assistance from Gavi, the Vaccine Alliance, most countries have not benefited appreciably from donor and partner activities in supporting their health sector and in achieving their national and subnational immunisation targets. Looking forward, development partners will have an important role in helping reconstruct health systems in conflict-affected countries. They can also help with generating evidence and strategic advocacy for high-priority and cost-effective services, including immunisation. Governments and ministries of health would ensure important benefits to their populations by investing further in their immunisation programmes. Where possible, the health system can create and expand fiscal space from efficiency gains in harmonising vaccine procurement mechanisms and service integration; broader revenue generation from economic growth; and reallocation of government budgets to health, and from within health, to immunization.


2020 ◽  
Vol 34 (2) ◽  
pp. 94-100
Author(s):  
Washington T. Samukange ◽  
Helga Gardarsdottir ◽  
Hubert G.M. Leufkens ◽  
Aukje K. Mantel-Teeuwisse

2018 ◽  
Vol 3 (6) ◽  
pp. e001077 ◽  
Author(s):  
Dorothy Lall ◽  
Nora Engel ◽  
Narayanan Devadasan ◽  
Klasien Horstman ◽  
Bart Criel

Management of chronic conditions is a challenge for healthcare delivery systems world over and especially for low/middle-income countries (LMIC). Redesigning primary care to deliver quality care for chronic conditions is a need of the hour. However, much of the literature is from the experience of high-income countries. We conducted a synthesis of qualitative findings regarding care for chronic conditions at primary care facilities in LMICs. The themes identified were used to adapt the existing chronic care model (CCM) for application in an LMIC using the ‘best fit’ framework synthesis methodology. Primary qualitative research studies were systematically searched and coded using themes of the CCM. The results that could not be coded were thematically analysed to generate themes to enrich the model. Search strategy keywords were: primary health care, diabetes mellitus type 2, hypertension, chronic disease, developing countries, low, middle-income countries and LMIC country names as classified by the World Bank. The search yielded 404 articles, 338 were excluded after reviewing abstracts. Further, 42 articles were excluded based on criteria. Twenty-four studies were included for analysis. All themes of the CCM, identified a priori, were represented in primary studies. Four additional themes for the model were identified: a focus on the quality of communication between health professionals and patients, availability of essential medicines, diagnostics and trained personnel at decentralised levels of healthcare, and mechanisms for coordination between healthcare providers. We recommend including these in the CCM to make it relevant for application in an LMIC.


2017 ◽  
Vol 4 ◽  
pp. 205566831770873 ◽  
Author(s):  
Michelle Jillian Johnson ◽  
Roshan Rai ◽  
Sarath Barathi ◽  
Rochelle Mendonca ◽  
Karla Bustamante-Valles

Affordable technology-assisted stroke rehabilitation approaches can improve access to rehabilitation for low-resource environments characterized by the limited availability of rehabilitation experts and poor rehabilitation infrastructure. This paper describes the evolution of an approach to the implementation of affordable, technology-assisted stroke rehabilitation which relies on low-cost mechatronic/robot devices integrated with off-the-shelf or custom games. Important lessons learned from the evolution and use of Theradrive in the USA and in Mexico are briefly described. We present how a stronger and more compact version of the Theradrive is leveraged in the development of a new low-cost, all-in-one robot gym with four exercise stations for upper and lower limb therapy called Rehab Community-based Affordable Robot Exercise System (Rehab C.A.R.E.S). Three of the exercise stations are designed to accommodate versions of the 1 DOF haptic Theradrive with different custom handles or off-the-shelf commercial motion machine. The fourth station leverages a unique configuration of Wii-boards. Overall, results from testing versions of Theradrive in USA and Mexico in a robot gym suggest that the resulting presentation of the Rehab C.A.R.E.S robot gym can be deployed as an affordable computer/robot-assisted solution for stroke rehabilitation in developed and developing countries.


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