Achieving Clinical Equality in an Influenza Pandemic: Patent Realities

ArticleinSeton Hall law review 39(4):1137-72 · October 2009with5 Reads
Source: PubMed
A twenty-first century novel influenza A (H1N1) pandemic is currently unfolding, and the eventual scope of this public health crisis is not clear. In addition, ongoing surveillance of the avian influenza A (H5N1) virus reveals outbreaks of human-to-human transmission of the virus, with significant mortality. Effective pandemic management depends on pharmaceutical intervention with two different clinical objectives: the generation of an immune response to specific viral strains (vaccination) and the reduction of viral replication in an infected individual (antiviral administration). The ability to offer pharmaceutical interventions for a public health crisis depends on three factors: development, capacity, and access. Pharmaceutical measures must be developed, capacity must be established, and access must be ensured. The article discusses the three nodes of patenting that influence the availability of pharmaceutical countermeasures in an influenza pandemic. Identification of the causative influenza virus is the first step in pandemic management and precedes vaccine design, and the virus and its RNA sequence are both knowledge assets and inputs for vaccine design. Vaccine development, therefore, will be influenced by any patents on the genetic sequences or proteins of the pandemic virus, as well as on novel methods for vaccine production, the actual vaccine or adjuvant technology, all of which are relevant to the assembly of a working vaccine on short notice. Pharmaceutical treatment of influenza infection during a pandemic could also rely on use of patented antiviral drugs, whose efficacy may be revealed as the pandemic unfolds. Unlike vaccines, these are not generally developed de novo for a pandemic, but their availability could be dependent on the exercise of patent rights by market incumbents. Patent rights could control capacity, which may determine access. Pandemic planning must consider how patenting can influence development, capacity and access to pharmaceutical interventions. The national and international public health authorities are slowly integrating intellectual property considerations into pandemic planning. Further integration will anticipate the emergence of patent claims, identify any relevant patents, encourage access norms, and consider the use of legal mechanisms that could alleviate patent-mediated obstacles to the availability of critical products and methods that may be patented. Pandemic management must also co-exist with existing efforts to control seasonal influenza outbreaks. The article analyzes the intersection of patent nodes relevant to vaccine development and to antiviral distribution during a global influenza pandemic, identifying where such patents may facilitate or inhibit the availability of pharmaceutical countermeasures, and offers preliminary observations on the emerging novel H1N1 pandemic. The goal of international clinical equality is essential for the eradication of an influenza pandemic, and strategies for its achievement can also be applied to other diseases.
    • "For example, operating under public emergency legislation or the international Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement would plausibly allow respective governments to meet some national needs. The benefits of a dormant, but extant right to compulsory license is the threat of activation, and indeed, this has shown to be its strength in persuading patent holders to voluntarily transfer generic licenses (Kane, 2009). "
    [Show abstract] [Hide abstract] ABSTRACT: Equitable access to vaccines in the event of an influenza pandemic has been debated for a number of years, particularly since the H1N1 pandemic. With the discovery of new avian H7H9 strain (along with other “odd” subtypes; see Capua 2013), and the prospect of another pandemic looming, it is critical that our planning creates the best conditions for responding to a public health emergency. It is our opinion that these debates and the proposed solutions have so far failed to achieve what would be expected of an ethical pandemic plan in respect to vaccine production. In the most recent analysis of influenza vaccine production, it was concluded that: Currently ... global capacity will be far from able to meet even the essential needs for a monovalent vaccine in the event of a severe influenza pandemic. In this article, we propose a reorientation of the debate from one that looks to accommodate current vaccine production, to an analysis of what might be achieved by a paradigm shift. Political solutions addressing these concerns to date have not been far reaching, and have only scratched the surface of deeper problems in vaccine production (WHO 2010b). So, after a brief account of the H1N1 pandemic and concerns we have about shortfalls in vaccine development and production, we offer three scenarios in respect to future vaccine planning. The first scenario is one in which planning remains within existing procurement contracts. In light of 2009, we see this as a problematic option given the premise that economic interests of the vaccine manufacturing industry entailed slow and inadequate delivery of a vaccine due to protracted negotiations between governments and corporations.1 The next two scenarios suggest a more radical approach to pandemic planning based on a particular typology of rights. During an emerging influenza pandemic, civil rights are likely to be curtailed by public health measures, which may include prohibitions on public gatherings, quarantine and forced treatment. The mandate for the state to act in such circumstances derives from the belief that coordinated action benefits the community as a whole and that uninformed or irresponsible actions could risk the entire population. The purpose is to create a favourable outcome defined in terms of reaching the recovery phase with as little damage as possible to persons, social networks, institutional frameworks and economic systems. In terms of ethics, this action is defined by the justification to mobilise an effective response to protect public health in spite of civil rights. Without this explanation, it would be inexcusable for democratic governments to withhold certain freedoms from its citizens. However, the seriousness of a global influenza pandemic prompts us to question how public health ought to relate to other kinds of entities, such as pharmaceutical corporations that are responsible for the expedient development and production of an effective vaccine. During the Influenza A (H1N1-2009) pandemic (hereafter, H1N1-2009), “preparedness plans” were activated that curtailed civil rights. Yet even though problems beset the production of an effective and safe vaccine, the pharmaceutical industry escaped the same state mandates that were used to organise the public into an effective response. The second scenario then builds on this premise to assess the possibility of vaccine production takeover. However, such an option could be too shortsighted despite the moral rhetoric of providing essential drugs to those who need them. Our last proposal considers building a national vaccine infrastructure. This is our preferred solution; one that moves away from industry dependence and towards an (inter)national infrastructure by reasserting the ethical responsibility for state-led public health responses. Fortuitously, the 2009 pandemic turned out to be far less destructive than was initially expected, and providence allows assessment of pandemic preparedness plans. Our intention is to thus raise the prospect of reform and demonstrate why, based on current systematic failures, alternatives models of global vaccine production should be considered. While much has been written about the escalation of events during 2009, the responsibilities of the vaccine industry have not been a significant focus of post analysis.2 The logic of pandemic planning portends to “the immediate and crucial need to plan for a mass...
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  • [Show abstract] [Hide abstract] ABSTRACT: Compulsory licensing is a well-recognized institution for striking a balance between patent and copyright protection and social or economic goals in general. For a compulsory license to work effectively, three conditions must be met at first: competent licensees with sufficient capacities, adequate market size, and access to necessary know-how. If the third condition is missing, the authority granting such licenses may issue a know-how transfer order to fill in the gap. Ancillary orders may also direct non-voluntary licensees to address specific harms to public interest, ensuring the attainment of their policy goals. In addition, the granting authority can issue a side-effect averting order to alleviate unnecessary impact that the license may impose on the patent or copyright holders. Given that no exception to the protection of undisclosed information is expressly acknowledged in the TRIPS Agreement, there are some doubts about the TRIPS compatibility with know-how transfer orders. These doubts are not well founded. On the other hand, orders requiring local manufacturing are likely to violate the principle of non-discrimination between imports and local production as enshrined in Article 27.1 of the TRIPS Agreement.
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