Pandemic Influenza Preparedness Framework Research Articles

Distressed setting and profound challenges: Pandemic influenza preparedness plans in the Eastern Mediterranean Region.

Influenza pandemics are unpredictable and can have severe health and economic implications. Preparedness for pandemic influenza as advised by the World Health Organization (WHO) is key in minimizing the potential impacts. Pandemic Influenza Preparedness (PIP) Framework is a global public-private initiative to strengthen the preparedness. A total of 43 countries receive funds through Partnership Contribution (PC) component of PIP Framework to enhance preparedness; seven of these fall in the WHO's Eastern Mediterranean Region. We report findings of a desk review of preparedness plans of six such countries from the Region. The assessment was done using a standardized checklist containing five criteria and 68 indicators. The checklist was developed using the latest WHO guidelines, in consultation with influenza experts from the Region. The criteria included preparation, surveillance, prevention and containment, case investigation and treatment, and risk communication. Two evaluators independently examined and scored the plans. Pandemic preparedness plan of only one country scored above 70% on aggregate and above 50% on all individual criteria. Plans from rest of the countries scored below satisfactory on aggregate, as well as on individual preparedness criteria. Among the individual criteria, prevention and containment scored highest while case investigation and treatment, the lowest for majority of the countries. In general, surveillance also scored low while it was absent altogether, in one of the plans. This was a desk review of the plans and not the actual assessment of the influenza preparedness. Moreover, only plans of countries facilitated through funds provided under the PC implementation plan were included. The preparedness scores of majority of reviewed plans were not satisfactory. This warrants a larger study of a representative sample from the Region and also calls for immediate policy action to improve the pandemic influenza preparedness plans and thereby enhance pandemic preparedness in the Region.

The Pandemic Influenza Preparedness Framework: A viable procurement option for developing states?

In this article, I argue that the Pandemic Influenza Preparedness (PIP) Framework is unlikely to have a significant impact on procurement of pandemic influenza vaccines by developing states during the next pandemic. I argue this on the basis that the vaccine stockpile that the Framework has created is not sufficiently large to meet the demand from developing states. I also argue that the fact that so few pandemic influenza vaccine manufacturers have committed to supply the PIP stockpile, and those that have, have given commitments lower than those initially proposed by the World Health Organization in the Framework, implies that the overall impact the PIP stockpile will have on procurement of pandemic influenza vaccines is even lower than initially anticipated within the literature.

Law as a fixture between the One Health interfaces of emerging diseases.

A One Health approach calls for multisectoral and multi-institutional cooperation and partnership across the interfaces of human, animal and ecosystem health risks. Without strong governance, these interfaces risk detaching, leaving gaps in capacities to prevent, detect and respond to emerging and persisting public health threats. As a crucial component of governance, law can act as the fixture between interfaces. We examine some of the many forms and foci of law and propose that the process of law-making, implementation and evaluation can provide a benefit for strengthening law as a fixture between One Health interfaces. To demonstrate this, we discuss three current examples of international legal instruments for emerging infectious diseases: the International Health Regulations, the Pandemic Influenza Preparedness Framework and the Global Action Plan on Antimicrobial Resistance.

The global health law trilogy: towards a safer, healthier, and fairer world

Global health advocates often turn to medicine and science for solutions to enduring health risks, but law is also a powerful tool. No state acting alone can ward off health threats that span borders, requiring international solutions. A trilogy of global health law—the Framework Convention on Tobacco Control, International Health Regulations (2005), and Pandemic Influenza Preparedness Framework—strives for a safer, healthier, and fairer world. Yet, these international agreements are not well understood, and contain gaps in scope and enforceability. Moreover, major health concerns remain largely unregulated at the international level, such as non-communicable diseases, mental health, and injuries. Here, we offer reforms for this global health law trilogy.

La sécurité sanitaire mondiale à l’heure de Nagoya

RÉSUMÉLe Règlement Sanitaire International est le principal instrument légal pour la prévention de la propagation internationale des maladies, en particulier liées à des agents infectieux. Il incite en particulier à des échanges de prélèvements entre pays. Ces échanges sont aujourd’hui influencés par l’attente exprimée, par de nombreux pays, d’un partage des bénéfices résultant des échanges de prélèvements. Dans le domaine des virus influenza, l’Accord international de 2011 sur la préparation à une pandémie grippale y apporte une réponse. Le contexte de ces échanges est aussi modifié par les progrès en génétique.Le Protocole de Nagoya entré en vigueur en 2014 constitue le nouveau cadre international de l’utilisation des ressources génétiques, y compris touchant les pathogènes. Il aura un impact favorable en termes de santé publique s’il facilite les échanges et permet un partage international des avantages découlant des ressources génétiques liées aux pathogènes. Une telle évolution est possible si la mise en œuvre du Protocole prend appui et modèle sur l’Accord-cadre pour la préparation à une pandémie grippale.

Open Access DNA, Rna and Amino Acid Sequences: The Consequences and Solutions for the International Regulation of Access and Benefit Sharing

This article addresses how open access to DNA, RNA and amino acid sequences might be reconciled with the benefit-sharing obligations under the United Nations’ Convention on Biological Diversity and its Nagoya Protocol, the Food and Agriculture Organization of the United Nations’ International Treaty on Plant Genetic Resources for Food and Agriculture, and the World Health Organization’s Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. Tracing the evolution of open access databases, the article posits models for reconciling open access and benefit sharing; the article concludes, however, that none of the proposed solutions – monitoring and tracing, the contract model, and the copyright and database right model – provides a perfect solution. Each model does, however, suggest that open access to these sequences might be at least partially reconciled with benefit sharing.

A decade of adaptation: Regulatory contributions of the World Health Organization to the Global Action Plan for Influenza Vaccines (2006–2016)

The Global Action Plan (GAP) for Influenza Vaccines is a decade-long initiative that brings together a diverse range of stakeholders to work towards reducing anticipated global shortage of influenza vaccines and ensuring more equitable access to vaccines during the next influenza pandemic. Since its inception in 2006, significant progress has been made towards all the main objectives of GAP, namely: (1) an increase in seasonal vaccine use, (2) an increase in vaccine production, and (3) progress in research and development of more effective vaccines. The Technology Transfer Initiative (TTI), conceived and managed by WHO under the GAP, contributed to increasing regional influenza vaccine production capacity. This was achieved by facilitating technology transfer in 14 low- and middle-income countries, through grants to manufacturers to establish or strengthen influenza vaccine production capacity and support to their national regulatory authorities. Five of the countries subsequently licensed locally produced influenza vaccines; two pandemic and three seasonal vaccines received WHO prequalification. The success of GAP can be largely attributed to the regulatory support provided by WHO to both manufacturers and regulators. This support had two components: (1) direct regulatory support to GAP/TTI, and (2) support to GAP-related WHO programmes, such as the Pandemic Influenza Vaccine Deployment Initiative in 2010 and the Pandemic Influenza Preparedness Framework since 2013, especially in non-vaccine-producing countries. Temporary adaptation of the assessment process for influenza vaccines in the WHO Vaccine Prequalification Programme to the A(H1N1) pandemic situation in 2009 was instrumental to the success of the WHO Pandemic Influenza Vaccine Deployment Initiative in its attempt to meet the demand for pandemic vaccines in countries that received donated vaccines.

Contribution of laboratories in the WHO Eastern Mediterranean Region to the selection of candidate seasonal influenza vaccine, 2010-2015.

The World Health Organization (WHO) formulates recommendations for viruses to be included in vaccines for the influenza seasons in the northern and southern hemispheres on the basis of analyses by its collaborating centres (CCs). This report describes the contribution of influenza laboratories and national influenza centres in countries in the WHO Region for the Eastern Mediterranean to the selection process of seasonal and pre-pandemic influenza virus subtypes. Data submitted by 22 countries to FluNet and FluID between September 2010 and June 2015 were analysed. National Influenza Centres (NICs) in 12 countries (55%) reported data, 5 (23%) to both FluNet and FluID and 7 (32%) only to FluNet. The WHO CC in London characterized 78% of the samples, and the CC in Atlanta, characterized 21%. The contribution of influenza laboratories and NICs from this Region to global influenza surveillance is appreciable. However, enhancing the contribution through initiatives such as the Pandemic Influenza Preparedness Framework is still needed.

The International Health Regulations: The Governing Framework for Global Health Security.

Policy Points: The International Health Regulations (IHR) are the governing framework for global health security yet require textual and operational reforms to remain effective, particularly as parallel initiatives are developed. The World Health Organization (WHO) is the agency charged with oversight of the IHR, and its leadership and efficient functioning are prerequisites for the effective implementation of the IHR. We reviewed the historical origins of the IHR and their performance over the past 10 years and analyzed all of the ongoing reform panel efforts to provide a series of politically feasible recommendations for fundamental reform. This article offers proposals for fundamental reform—with politically feasible pathways—of the IHR, their operations and implementation, WHO oversight, and State Party conformance. Context The International Health Regulations (IHR) have been the governing framework for global health security for the past decade and are a nearly universally recognized World Health Organization (WHO) treaty, with 196 States Parties. In the wake of the Ebola epidemic, major global commissions have cast doubt on the future effectiveness of the IHR and the leadership of the WHO. Methods We conducted a review of the historical origins of the IHR and their performance over the past 10 years and analyzed all of the ongoing reform panel efforts to provide a series of politically feasible recommendations for fundamental reform. Findings We propose a series of recommendations with realistic pathways for change. These recommendations focus on the development and strengthening of IHR core capacities; independently assessed metrics; new financing mechanisms; harmonization with the Global Health Security Agenda, Performance of Veterinary Services (PVS) Pathways, the Pandemic Influenza Preparedness Framework, and One Health strategies; public health and clinical workforce development; Emergency Committee transparency and governance; tiered public health emergency of international concern (PHEIC) processes; enhanced compliance mechanisms; and an enhanced role for civil society. Conclusions Empowering the WHO and realizing the IHR's potential will shore up global health security—a vital investment in human and animal health—while reducing the vast economic consequences of the next global health emergency.

Vaccine procurement during an influenza pandemic and the role of Advance Purchase Agreements: Lessons from 2009-H1N1

Vaccines are hugely important tools in minimising the effect pandemic influenza could have on a population. The reforms introduced by the Pandemic Influenza Preparedness Framework are ill-suited to providing sufficient levels of access to vaccines to meet the needs of developing states, and as such developing states will continue to be reliant upon the traditional methods of vaccine procurement to procure the majority of the vaccines they required. Using procurement during 2009-H1N1 as a case study, this paper examines the methods of procurement utilised by states in order to determine if the procurement tools available to developing states are sufficient to procure adequate levels of pandemic influenza vaccines. Particular focus is given to the role Advance Purchase Agreements (APAs) play in the procurement process. By exploring this case study it is possible to argue that these procurement methods are ineffective for developing states, and when the next influenza pandemic occurs, demand will once again outstrip supply globally, due to supply of vaccines being dominated by the developed states with APAs in place.

Virus sharing, genetic sequencing, and global health security.

This Perspective focuses on the future of the Pandemic Influenza Preparedness (PIP) Framework, which was initially established to promote the fair sharing of public health-related pandemic influenza samples between countries. We examine the changes that need to be made to address the growing likelihood that genetic sequence data might be shared instead of physical virus samples, as well as the need to expand the PIP framework's scope and to improve its fairness.

Global health diplomacy: five years on

Global health diplomacy: five years on

Asian Contributions to Three Instruments of Global Health Governance

AbstractIt is widely recognised that the adverse impacts that transnational forces are having on health determinants and outcomes require more effective collective action. The Asian region has been among the most acutely affected by the health impacts of globalisation, while many health issues in the region have potentially far reaching consequences. The rapidly rising economic status of many Asian countries, coupled with their vulnerability to global health, points to the need to better understand their contributions to Global Health Governance (GHG). This article analyses Asian contributions to three key instruments underpinning GHG – the International Health Regulations (IHR), Pandemic Influenza Preparedness Framework (PIPF), and Framework Convention on Tobacco Control (FCTC). It finds that, if Asian countries are to move, from rule takers to rule makers, there is a need to address weak capacity in the region, to go beyond traditional notions of sovereignty, and to build trust and policy processes across the region.Policy implications The impacts of globalisation on health within the region, and the potential for health issues in the region to have global consequences, suggest that strengthening GHG requires increased Asian engagement commensurate with the region’s growing economic strength. Emergent forms of GHG have been shaped to date by a small number of high income countries. Asian state and nonstate actors have been increasingly inclined to challenge existing institutional arrangements and rules. Without stronger technical capacity and political processes to enable meaningful participation in global health governance negotiations, Asian countries will remain rule takers rather than rule makers.

WHO concerned that new H5N1 influenza research could undermine the 2011 pandemic influenza preparedness framework

WHO concerned that new H5N1 influenza research could undermine the 2011 pandemic influenza preparedness framework

The 2011 Pandemic Influenza Preparedness Framework: Global Health Secured or a Missed Opportunity?

In early 2007 the Indonesian government announced that it would cease sharing H5N1 influenza virus samples with the World Health Organization's Global Influenza Surveillance Network. At the heart of the government's complaint was the fact that samples were being passed by the WHO to pharmaceutical companies which developed, and patented, influenza vaccines that the Indonesian authorities could not purchase. The decision gained widespread support among advocates of greater equity of access to medicines, and in response the WHO established an intergovernmental process to agree a framework for influenza virus sharing. The process officially concluded in April 2011 and a new Pandemic Influenza Preparedness Framework (PIPF) was agreed at the 64th World Health Assembly in May 2011. This article investigates the events that prompted the re-examination of a technical cooperation system that has provided effective global health security on influenza for 60 years, and evaluates the framework that has now been agreed. Drawing the distinction between functional and moral-political benefits, the article argues that PIPF more accurately represents a diplomatic stand-off – one that has now been effectively sidelined with the passage of the agreement – rather than genuine reform. In fact, the PIPF papers over fundamental disagreements regarding authority in global health governance, the relationship between the WHO and governments, and the role of private industry. The article concludes by examining an alternative mechanism that would arguably better address the inherent tensions between national and collective interests, and accomplish the functional and moral-political benefits that the negotiations set out to achieve.

The WHO Pandemic Influenza Preparedness Framework

AFTER YEARS OF NEGOTIATIONS, THE WORLD HEALTH Organization (WHO) reached agreement on a pandemic influenza preparedness (PIP) framework for the sharing of influenza viruses and access to vaccines and other benefits in April 2011. The framework addresses a troubling controversy—should lowand middleincome countries share influenza virus specimens with WHO without assurances that benefits derived from sharing will be equitably distributed? During the avian influenza A(H5N1) outbreaks in late 2006, Indonesia refused to share virus specimens with WHO, claiming it was unfair to give pharmaceutical companies access. Industry would use viruses to patent vaccines and antiviral medications that Indonesia could not afford. Indonesia asserted sovereignty over viruses isolated within its territory, grounded on the Convention on Biological Diversity. Indonesia also argued that the 2005 International Health Regulations did not require states to share H5N1 viruses. The international community feared that Indonesia’s refusal to share would impede surveillance and response, particularly because Asia was the epicenter of the global H5N1 outbreak. Serious health and political repercussions could result if states failed to cooperate when confronting a common threat. In May 2007, WHO member states commenced negotiations on virus and benefit sharing to strengthen influenza surveillance and response. Negotiations in intergovernmental meetings and an open-ended working group proved difficult—the problems were complex and states had divergent interests, particularly on intellectual property rights. The 2009 influenza A(H1N1) pandemic deepened developing-country mistrust because vaccines were not equitably shared. In October 2010, Convention on Biological Diversity parties reasserted state sovereignty over biological materials within their territories. Finally, after nearly 4 years of arduous negotiations, WHO’s director-general announced the WHO pandemic framework on April 16, and the World Health Assembly approved it in May. PIP Framework

Preliminary Remarks on the Envisaged World Health Organization Pandemic Influenza Preparedness Framework for the Sharing of Viruses and Access to Vaccines and Other Benefits

Over the last few decades, the World Health Organization (WHO) has played a significant role in the prevention and control of new strains of influenza virus in the human population. Beginning in the 1950s, it has coordinated a network of WHO‐linked laboratories, charged with monitoring the changes in influenza viruses and favouring the timely sharing of virus samples, which is necessary for the development and production of vaccines. In December 2006, the said system was brought into question by Indonesia, according to which it was unfair and in conflict with the principle of state sovereignty over biological and genetic resources. Although very controversial, the Indonesian decision to interrupt the supply of candidate influenza vaccine strains boosted intergovernmental negotiation, until then not achieved, aimed at establishing a new WHO framework. This article examines the outcome of such a negotiation, as well as the aspects of the framework still under discussion. It emphasizes the innovative nature of the proposed benefit‐sharing mechanism, which would promote access to vaccines mainly through the multilateralization of intellectual property rights governance. Similarities and differences between the envisaged framework and the benefit‐sharing mechanism established by the Food and Agricultural Organization International Treaty on Plant Genetic Resources for Food and Agriculture in the field of access to plant genetic resources are analysed.