Voluntary Licensing Research Articles

Lenacapavir to prevent HIV infection: current prices versus estimated costs of production.

Despite improvements in treatment and oral pre-exposure prophylaxis (PrEP) access, 1.3 million people acquired HIV in 2022. Six-monthly lenacapavir PrEP could benefit tens of millions of people at high risk of infection. However, prices are currently up to $44 819 per person per year (pppy). We projected minimum lenacapavir pricing based on generic mass production and a Cost-Plus (Cost+) model. Current active pharmaceutical ingredient (API) and key starting materials (KSMs) costs were obtained from export databases. The routes of synthesis (ROS) were analysed to project a cost of goods (COGs). Formulation, vials and profit margin costs were included using standardized algorithms and Cost+ pricing. We estimated prices with scale-up to supply 1 million then 10 million treatment-years, comparing this with national list prices. The lenacapavir API is currently exported from India for $64 480/kg on 1 kg scale. Based on the ROS and KSMs, API COGs of $25 000/kg and $10 000/kg are achievable for a committed demand of 1 million (2 million tonnes/annum of API) and 10 million treatment-years, respectively. Including formulation steps, injectable lenacapavir could be mass produced for approximately $94 pppy for 1 million and $41 for 10 million treatment-years, if voluntary licences are in place and competition between generic suppliers substantially improves. Greater scale-up with improvements in manufacturers' ROS could reduce prices further. Currently lenacapavir costs $25 395-44 819 pppy. Lenacapavir could be mass produced for <$100 pppy at launch. Voluntary licensing and multiple suppliers are required to achieve these low prices. This mechanism is already in place for other antiretrovirals. To date, Gilead has not agreed lenacapavir voluntary licences with the Medicines Patent Pool.

Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries.

Monoclonal antibodies (mAbs) are revolutionizing management of non-communicable diseases in high-income countries and are increasingly being advanced for a range of infectious diseases (IDs). However, access to existing mAbs is limited in low- and middle-income countries (LMICs), and investment in developing fit-for-purpose mAbs for IDs that disproportionately affect LMICs has been limited. Underlying these access barriers are systemic challenges, including a lack of commercial incentives to target LMIC markets and complexity in manufacturing and regulatory processes. Novel strategies are needed to overcome systemic access barriers for mAbs. We outline key areas where new approaches could address these barriers, based on a multistakeholder consultation in March 2023. Three disease-market archetypes are identified to guide thinking about business models tailored to different contexts. New business models are needed to incentivize development and manufacturing of ID mAbs and to ensure mAbs are optimized with a target product profile and cost of goods that enable use in diverse LMIC settings. Lessons can be applied from voluntary licensing strategies and product development partnerships that have shown success in catalysing development and affordable supply for a range of infectious diseases. Technology transfer will be key to expand LMIC research and manufacturing capacity and to enable sustainable and diversified supply. Improved market intelligence, demand aggregation mechanisms, and portfolio-based manufacturing models could be used to de-risk commercial investment and establish a sustainable manufacturing ecosystem for affordable mAbs. Novel regulatory approaches and robust technology transfer may reduce data requirements and timelines for biosimilar approvals. Trailblazer products, with coordinated "end-to-end" support from funders, can demonstrate proof of concept for pathways to accessible mAbs across a broader range of LMICs. Research funders; local, regional, global health agencies; and, private sector partners should commit to implementing innovative partnerships and end-to-end strategies that enable equitable access to mAbs for infectious diseases in LMICs.

Ethical and Practical Considerations for an Agreement to Ensure Equitable Vaccine Access Comment on "More Pain, More Gain! The Delivery of COVID-19 Vaccines and the Pharmaceutical Industry's Role in Widening the Access Gap".

This paper discusses the potential of an international agreement to ensure equitable vaccine distribution, addressing the failures witnessed during the COVID-19 pandemic. COVAX was unable to prevent vaccine monopolization and unequal distribution, which led to significant disparities in vaccination rates and avoidable deaths. Any future agreement on equitable vaccine distribution must address ethical and practical issues to ensure global health equity and access. The proposed agreement should recognize healthcare as a human right and consider vaccines beyond mere commodities, emphasizing the social responsibility of pharmaceutical companies to prioritize affordability, availability, and accessibility, particularly for low-income countries (LICs). Voluntary licensing agreements are suggested as a means to enhance access to essential medicines. The paper also outlines the necessity of international cooperation, with robust compliance mechanisms, to effectively enforce such an agreement and mitigate future health crises.

Budget impact analysis of two treatment approaches for hepatitis C in Malaysia through the use of voluntary and compulsory licensing options.

A scaled-up treatment cascade with direct-acting antiviral (DAA) therapy is necessary to achieve global WHO targets for hepatitis C virus (HCV) elimination in Malaysia. Recently, limited access to sofosbuvir/daclatasvir (SOF/DAC) is available through compulsory licensing, with access to sofosbuvir/velpatasvir (SOF/VEL) expected through voluntary licensing due to recent agreements. SOF/VEL has superior clinical outcomes but has higher drug acquisition costs compared to SOF/DAC. A stratified treatment cascade might be the most cost-efficient approach for Malaysia whereby all HCV patients are treated with SOF/DAC except for patients with cirrhosis who are treated with SOF/VEL. This study aimed to conduct a 5-year budget impact analysis of the proposed stratified treatment cascade for HCV treatment in Malaysia. A disease progression model that was developed based on model-predicted HCV epidemiology data was used for the analysis, where all HCV patients in scenario A were treated with SOF/DAC for all disease stages while in scenario B, SOF/DAC was used only for non-cirrhotic patients and SOF/VEL was used for the cirrhotic patients. Healthcare costs associated with DAA therapy and disease stage monitoring were included to estimate the downstream cost implications. The stratified treatment cascade with 109 in Scenario B was found to be cost-saving compared to Scenario A. The cumulative savings for the stratified treatment cascade was USD 1.4 million over 5 years. A stratified treatment cascade with SOF/VEL was expected to be cost-saving and can result in a budget impact reduction in overall healthcare expenditure in Malaysia.

The WTO and the Covid‐19 “Vaccine Apartheid”: Big Pharma and the Minefield of Patents

&lt;p&gt;Unequal access to vaccines for the Covid-19 pandemic, also referred to as “vaccine apartheid,” has marginalized low-income countries again. In October 2020, India and South Africa proposed a temporary waiver from certain provisions of the TRIPS Agreement for the prevention of Covid-19&lt;em&gt; &lt;/em&gt;at the World Trade Organization (WTO). An agreement was later reached in Geneva on June 17, 2022. The objective of this article is to analyze the negotiation and agreement reached at the WTO. This article explores the difficulties of creating international public good in the field of public health within the milieu of powerful actors, namely big pharmaceutical companies with vested interests. The central argument of this article is that this agreement alone will not solve the vaccine access problem for low-income countries. It is too restrictive, does not cover trade secrets and know-how, production capacity, availability of raw materials, and even adds new limitations that did not exist before. The best option to promote the production of quality vaccines in low-income countries is to share technology and know-how on a voluntary basis through production agreements. One way to facilitate the cooperation of large pharmaceutical corporation is to make it easier for low-income countries to use compulsory licenses. Simplifying the use of this mechanism could help encourage pharmaceutical companies to enter into voluntary licensing agreements.&lt;/p&gt;

Time to Consider the Introduction of Mandatory Continuous Professional Development Training Programme for Registered Healthcare Workers Especially Nurses and Midwives in Sierra Leone

In developed countries like Australia, Canada, UK and USA, continuous professional development (CPD) is statutory or mandatory training for all regulated healthcare staff such as doctors, midwives, nurses, pharmacists and physiotherapists. All patients facing healthcare professionals are expected to attend stipulated programs of learning some with annual recall. These trainings are compulsory to attend. Staff employers would be in breach of statutory laws or regulatory requirements if they employ or allow staff to work with expired CPD competencies. In a low- or middle-income country (LMIC) like Sierra Leone, CPD is currently selective, and voluntary and registration licences are not revalidated. This can invariably put patients at risk as clinical skills/knowledge are not regularly verified. This paper discusses the rationale for the Government of Sierra Leone (GoSL) to consider introducing mandatory CPD training programmes, especially for nurses and midwives employed in healthcare settings in the country.

The Race for COVID-19 Vaccines: Accelerating Innovation, Fair Allocation and Distribution.

Racing to develop and distribute a vaccine against COVID-19 has proven to be a challenging endeavor. Not only has there been the enormous scientific-technical challenge of developing the world’s first vaccines against a coronavirus, the subsequent ethical issues involved in vaccine allocation have been equally complex. This contribution focuses on the policy and strategic aspects of accelerating innovation, fair allocation, and distribution. We take a holistic approach to describing the various tasks and how they are interconnected. Through comparative analysis we explore the issues through the lens of multiple stakeholders: i.e., public health authorities, governments of industrialized and developing countries, and industry. At each step of the consecutive process—from vaccine development to delivery—common ground has to be found between global community stakeholders, to move the project to the next stage, until completion: (1) accelerated innovation, (2) centralized purchasing, (3) selecting suppliers, (4) equitable allocation, (5) global access and affordability, (6) compulsory vs. voluntary licensing, and (7) a universal pandemic treaty. Conclusions: Public–private partnership is essential with regards to inventing and allocating new vaccines to fight infectious disease pandemics. The nature of pandemics requires collaboration at both the national and international levels. Seven important lessons have been identified that we can learn from based on the experience gathered during the COVID-19 pandemic. We trust that these findings will be helpful in drafting preparedness guidelines and a global pandemic treaty to manage future pandemics.

3D Printing, Intellectual Property Rights and Medical Emergencies: In Search of New Flexibilities

The COVID-19 pandemic has exponentially accelerated the use of 3D printing (3DP) technologies in healthcare. Surprisingly, though, we have seen hardly any public intellectual property right (IPR) disputes concerning the 3D-printed medical equipment produced to cope with this crisis. Yet it can be assumed that a great variety of IPRs could potentially have been enforced against the use of various items of equipment printed out without express consent from IP holders. Many reasons might have motivated IP owners not to enforce their rights during the pandemic, such as the fear of acquiring a bad reputation during a declared situation of national emergency. There is no internationally recognised general exception to IPR enforcement for health emergencies, while several − sometimes ineffective − tools, like compulsory licensing, voluntary licensing arrangements and potential TRIPS waivers, have been considered or used to facilitate access to and the distribution of innovations in critical situations. During the COVID-19 emergency, this has meant that the 3DP community has been operating in a state of relative uncertainty including with regard to the risks of IP infringement. This study contextualises these issues for pandemic-relevant 3DP. Building upon experience gathered during the COVID-19 pandemic, we look to the future to see what novel mechanisms within the IPR system could provide the additional flexibility required for dealing more smoothly, with the help and support of digital technologies, with situations such as global health emergencies.

Predicaments during a period of health emergency: Waiving patent protections or innovative public procurement? The example of advance purchase agreements (APA) for COVID-19 vaccines.

The health emergency provoked by the worldwide pandemic requires immediate action to achieve the immunization of the population and to stop further contagion. The systems of public procurement needed to adapt in a very short time to reach agreements with the pharmaceutical industry. Proposing options between the waiving of patent protections and innovative public procurement, principally the European Advance Purchase Agreements (APA). A description of the actual situation and the necessary regulatory reforms. The sources are scientific articles, legislative compendiums and opinion pieces and the current press. The debate over the waiving of patent protections at this time is both misleading and ineffective due to the economic and legal problems involved. The path of the APA has proven to be very effective, although some deficits should be corrected, principally regarding questions of transparency and confidentiality. Among the possible options for the acquisition of the COVID-19 vaccine and its universal access, agreements and cooperation between States and innovative industry are desirable. One successful path is that of the advance purchase agreements utilized by the European Union, another could be that of voluntary licensing. We propose following these routes as opposed to the waiving of patent protections.

Transforming or tinkering: the world remains unprepared for the next pandemic threat

Transforming or tinkering: the world remains unprepared for the next pandemic threat

Barriers to Worldwide Access for Paxlovid, a New Treatment for COVID-19.

Pfizer and the Medicines Patent Pool (MPP) have reached a voluntary licensing agreement for Paxlovid (nirmatrelvir+ritonavir), a novel antiviral for coronavirus disease 2019 (COVID-19) taken orally in the first 5 days from symptom onset. The Pfizer-MPP deal enables 95 low- and middle-income countries (L/MICs) to access affordable biosimilars. Generics are delayed awaiting bioequivalence testing and may be ineffective in L/MICs with reduced testing capacity, which comprise only 10% of global diagnoses. Thirty-nine percent of diagnoses originate in MICs forced to pay high prices due to exclusion from the Pfizer-MPP deal. The cost-effectiveness of Paxlovid could be limited compared with the creation of sustainable vaccine infrastructure in these nations, delaying socioeconomic pandemic recovery. Furthermore, Paxlovid may not be cost-effective in vaccinated populations, and concerns remain over ritonavir drug interactions with COVID-19 comorbidity medications. We call for expanded coverage by the Paxlovid-MPP deal and greater access to testing.

Proposals for copyright law and education during the COVID-19 pandemic

This article asks whether the catastrophic impact of the COVID-19 pandemic justifies new limitations or interventions in copyright law so that UK educational institutions can continue to serve the needs of their students. It describes the existing copyright landscape and suggests ways in which institutions can rely on exceptions in the Copyright, Designs and Patents Act 1988 (CDPA), including fair dealing and the exemption for lending by educational establishments. It then considers the viability of other solutions. It argues that issues caused by the pandemic would not enliven a public interest defence to copyright infringement (to the extent this still exists in UK law) but may be relevant to remedies. It also argues that compulsory licensing, while permissible under international copyright law, would not be a desirable intervention, but that legislative expansion to the existing exceptions, in order to encourage voluntary collective licensing, has a number of attractions. It concludes by observing that the pandemic highlights issues with the prevailing model for academic publishing and asks whether COVID may encourage universities to embrace in-house and open access publishing more swiftly and for an even greater body of material.

Ukrainian experience in implementation of the flexible provisions of the TRIPS Agreement in the context of European integration and the pandemic

Keywords: intellectual property, human rights, patients' rights, pharmaceutical nationalism,protectionism, vaccines, generics, COVID-19&#x0D; The article concerns the analysis of global trends in theparadigm of intellectual property rights on the objects used in the diagnosis, preventionand treatment of COVID-19. The experience of the implementation of pharmaceuticalnationalism policies provided by the EU, Canada and Israel are presented in the article.The authors provide the legal backgrounds of the need for Ukraine to be a co-sponsor ofthe IP waivers proposals, which are submitted to the TRIPS Council by some membersof the WTO. The authors stress the need for Ukraine to use the historic opportunity forthe development of the national pharmaceutical industry, which would contribute tothe interests of the domestic patient, and make proposals for the necessary changes tonational legislation.The authors also stressed the position of the governments of Germany and France.Thus, in Germany there is the Law on Governmental Use of Patented Inventions duringa Pandemic. The law provides, inter alia, for amendments to the Patent Law, accordingto which the Federal Ministry of Health has the right to authorize the use of relevantpatents to ensure the production and supply of pharmaceuticals or medical devices.In 2020, France adopted the Emergency Law № 2020-290 to combat theCOVID-19 epidemic, which introduced Article 3131 15 of the French Public HealthCode. This rule authorizes the Prime Minister to issue orders to recover or seize allgoods and services necessary to combat the disaster, to temporarily control the price ofproducts and, if necessary, to take any measures to ensure that patients are providedwith appropriate drugs to deal with the disaster, related to health. It is useful forUkraine to use the experience of Canada in terms of facilitating negotiations with majorvaccine manufacturers to establish national drug production and in terms of developinglegislation in the field of compulsory licensing.It is obviously, voluntary licences from patent owners, which provide for the fulltransfer of technology, and not just patent disclosure, are the most effective tool for thenational production of biosimilars. However, international experience shows that pharmaceuticalcompanies are holding back the issuance of compulsory licences. Therefore,our government's biosecurity portfolio should include an effective tool for compulsory licensingor emergency use of biosimilars and generic drugs by the Government.

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

BackgroundNon-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).MethodsA 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.FindingsCumulatively, 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.InterpretationThe 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.FundingUnitaid.

Capitalizing an epidemic: Does voluntary license stabilizes access to patented vaccines and public health crisis?

AbstractThe spread of SARS‐CoV‐2 has paused the entire commercial sector except for the pharmaceutical domain. This highly contagious virus has kept the pharmaceutical domain, and publicly funded research institutions dynamically occupied in the R&amp;D process to achieve the vaccine for the treatment and eradication of the COVID‐19 virus. The key issues are not the incentives for R&amp;D but the accessibility of such vaccines at the ground level amidst voluntary licensing, elliptically, the dilemma encompassing innovations, patent rights, accessibility, and public health emergencies amidst stakeholders with contrasting interests. The voluntary licensing approach promotes a balance between native generic manufactures and international groups yearning to protect their intellectual property (IP) rights while boosting goodwill via better accessibility of such medicine, and concurrently providing pharmaceutical giants a constructive business strategy to set foot in developing markets. Patent rights and more significantly voluntary licensing might have a consequential impact on the public healthcare niche as it would facilitate a grip of patent holders concerning private governance activities over IP‐protected technologies. This paper provides an overview of voluntary licensing and its implications on vaccines in the pandemic.

Application of Parallel Importation and Voluntary License in the Covid-19 Vaccines Patent as a Strategy for Handling the Health Emergency Situations in Indonesia

This article examines how the application of Parallel Importation and Voluntary License in the Application of the Covid-19 Vaccine Patent as a Strategy for Handling Health Emergency Situations in Indonesia. The problem of the Covid-19 vaccine happens in many countries around the world, including Indonesia whos trying to find a vaccine that can neutralize the Covid-19 Virus. As a consequence of the tremendous demand for vaccines, the world pharmaceutical industry is encouraged to provide Covid-19 vaccines for the needs of 7.8 billion. This article uses normative legal research with a statute, conceptual, and comparative law approach. The results showed that mechanisms such as parallel importation and voluntary licenses could be reached to procure the Covid-19 vaccine. If parallel importation and voluntary licenses are not successful, then the Government shall take a win-lose approach, such as Compulsory Licensing and Use of Patents by the Government, or initiate an anti-monopoly lawsuit.

Assessing Technical Assistance Needs among Recovery Residence Operators in the United States

ABSTRACT Recovery support services such as recovery housing assist individuals with increasing their access to social support, employment services, and systems of care. Lack of evidence-based practices and calls for increased oversight of these settings suggests a growing need for technical assistance and training for recovery residence owners and staff, yet little is known about their areas of greatest need for technical assistance. We developed and administered a survey to assess the technical assistance needs of recovery housing operators in the United States using a convenience sample of individuals who own or operate a recovery residence (N = 376). A total of 77 owners/operators completed the survey (20% response rate), representing urban, suburban, and rural communities. Differences were observed between number of owned residences: owners/operators of a single residence were interested in technical assistance on house-specific policies and linkage to established systems of care, whereas owners/operators of multiple residences were interested in technical assistance on building financial sustainability and incorporation of best practices into their recovery residences. As an increasing number of states move to implement voluntary certification or licensing for recovery residences, targeted training and technical assistance to owners/operators will facilitate the successful adoption of recovery residence best practices and quality standards.

COVID-19 AND INTELLECTUAL PROPERTY LAW: COMPULSORY LICENSING AND THE ACCESS TO COVID-19 TREATMENT

This essay concerns the problematic of the access to Covid-19 treatment at an international scale and the role of Intellectual Property Law. As in past outbreaks, one of the most raised questions is the possibility of patent holder’s rights being an obstacle to the access to treatment. Since the beginning of this pandemic, Compulsory Licensing has been presented as the mechanism capable to guaranteeing Covid-19 treatment globally and rapidly. We propose to analyse this figure and its possible alternatives - Voluntary Licensing, Patent Pools and the Proposal to waive TRIPS Intellectual Property provision. We will then assess which is the most effective solution to overcome this humanitarian crisis without compromising the balance between the right to health and intellectual property rights.

Affordable treatment and political commitment are crucial to eliminate hepatitis C globally

Affordable treatment and political commitment are crucial to eliminate hepatitis C globally

Proposals for copyright law and education during the COVID-19 pandemic

This article asks whether the catastrophic impact of the COVID-19 pandemic justifies new limitations or interventions in copyright law so that UK educational institutions can continue to serve the needs of their students. It describes the existing copyright landscape and suggests ways in which institutions can rely on exceptions in the Copyright, Designs and Patents Act 1988 (CDPA), including fair dealing and the exemption for lending by educational establishments. It then considers the viability of other solutions. It argues that issues caused by the pandemic would not enliven a public interest defence to copyright infringement (to the extent this still exists in UK law) but may be relevant to remedies. It also argues that compulsory licensing, while permissible under international copyright law, would not be a desirable intervention, but that legislative expansion to the existing exceptions, in order to encourage voluntary collective licensing, has a number of attractions. It concludes by observing that the pandemic highlights issues with the prevailing model for academic publishing and asks whether COVID may encourage universities to embrace in-house and open access publishing more swiftly and for an even greater body of material.