Ishupal Singh Kang
“New vaccines for a safer world”, declares the homepage of The Coalition for Epidemic Preparedness Innovations (CEPI, in short). This aptly named international body, based on several accounts (here and here), is seemingly the omphalos of the vaccine development efforts for the Covid19 pandemic.
CEPI has been collaborating with “global health authorities and vaccine developers to support the development of vaccines against COVID-19”. Several countries, including Germany, Saudi Arabia, and UK among others, have pledged financial support, amounting to USD 2 billion, for the development and deployment of an effective vaccine.
Moreover, CEPI has provided crucial and substantive funding to a number of promising vaccine development projects. Considering this, CEPI and its role is likely to have some bearing on the important questions about producing an effective vaccine and – equally importantly – its access and affordability.
Launched in 2017 at the World Economic Forum in Davos, CEPI’s primary aim is to offer an innovative model for financing vaccine development for epidemics. This innovation is to be achieved, “through pooling resources from several investors”. It cuts across the spectrum and includes, public, private, philanthropic and non-governmental organisations and actors.
CEPI’s innovative model is aimed at addressing a longstanding global public health paradox around vaccine development. Vaccines are generally regarded as extremely crucial goods/resources that serve as effective medical countermeasures. Despite this, the currently dominant innovation regimes lead to substantial underinvestment in vaccine research and development. This paradox is mainly a product of the economics of the vaccine markets as well as certain particularities of vaccine in the form of biotechnology and the research ecosystem.
It is, of course, well established that the predominantly market-based biomedical and pharmaceutical research innovation systems lack the effective development and distribution of vaccines for epidemics. Ana Rutschman, a professor of health law and intellectual property, noted in a recently published article, “incentives regimes anchored predominantly in intellectual property fail to account for the specificities— and relatively limited prospects of revenue generation—of vaccines targeting infectious diseases that have very limited markets”.
Moreover, the R&D ecosystem in epidemic/vaccine research span several countries and various actors that range from academic research universities to small biomedical firms to Big Pharma. This feature contributes to the scattered and slow-progressing nature of vaccine development research.
On the basis of such a background, CEPI aims to take an end-to-end approach that ranges from discovery research to vaccine delivery. This approach entails two major functions – funding and coordination – that would enable CEPI to play the role of gap-filler for the inadequate R&D on vaccines targeting infectious diseases.
CEPI aims to step in to remedy the abovementioned twin market failures by “bringing together sustained long-term funding from governments and philanthropies to encourage collaboration” between relevant actors. As a collaborative global partnership, CEPI has taken lead in ensuring that research and development for Covid 19 vaccine can be facilitated. In pursuance of this, CEPI has disbursed substantive grants. This includes three of the most prominent vaccine candidates for which human trials are currently under way: ChAdOx1 nCoV-19 (Oxford Vaccine Group), Moderna’s mRNA-1273 and Inovio’s INO-4800 DNA vaccine.
CEPI and its supposed centrality, in the race for finding the cure of Covid 19, raises several important issues. First, talking specifically in context of epidemics, CEPI looks like an attractive development that builds upon the trend of collaborative cross-cutting partnerships to plug crucial gaps in the global public health architecture. This trend that started in early 2000s has resulted in collaborative partnership bodies like Gavi, TuBerculosis Vaccine Initiative, Innovative Medicines Initiative that now play critical role to “counter imperfect incentives to biopharmaceutical research”.
Secondly, it clearly demonstrates the idea that the innovation regulation perspective that considers markets as the foremost institutional paradigm for leading to beneficial and efficient social outcomes is, to put it mildly, off the mark.
Such innovation regulation perspectives have been a key aspect of the visions of globalization in last three decades. This has led to the prevalence of harmonized legal rules facilitating more reliance on market mechanisms for innovation, research and development.
With this in mind, it is important to realize that CEPI-backed vaccine development efforts are mostly supported by public money and, “should be considered as global public goods”.
Thirdly, and importantly, following up on this idea of global public goods, it is imperative that CEPI’s vaccine development efforts take into account consideration of global, equitable and affordable access. Prior experience with epidemics shows that a “zero-sum-game mind set” and nationalist postures resulted in concerns about poor and delayed access to vaccines in the global south. Furthermore, public funding, should not be utilized, as Mariana Mazzucato & Els Torreele point out, “like a handout or simple market-fixer.”
Equitable access, indeed, is a central tenet that grounds CEPI’s mission and work. CEPI has an Equitable Access Policy, according to which equitable access “means that appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay”.
Despite this, some serious concerns remain. CEPI, reportedly, doesn’t have “agreement yet on the principles or rules for a fair allocation system incorporated into contracts that can be consistently applied and enforced”.
Moreover, public health groups like MSF have expressed “concern and disappointment” over the revised Equitable Access Policy when it was released last year in 2019. According to MSF, the Policy “provides no basis for CEPI to be held accountable to its public and philanthropic investors in its agreements with development partners on the ownership and treatment of intellectual property or the pricing of CEPI-funded vaccines.”
This is quite significant because although there have been calls by world leaders about ensuring affordable access, the question of curtailment of intellectual property of vaccine related innovations have met with resistance despite the likelihood that they would have a bearing on issues of affordability.
Writing in context of the EU-led global funding pledge of which CEPI was a participant (that resulted in raising of 7.4 billion euro on May 4), Ellen’t Hoen notes that spending of such funds must come with a mandatory requirement that “intellectual property, knowledge, know-how and technologies whose development is supported by these funds are shared”.
In conclusion, CEPI represents a forward-looking solution to some enduring structural problems in the global health-related innovation paradigm. In the context of the race for the Covid 19 vaccine, it has emerged as a new locus for managing funding and coordination, functions that have been generally been associated with either state institutions or the market mechanism. Consequently, it is essential that reasonable and normal expectations of transparency and fairness hold the collaborative global governance model, as represented by CEPI accountable. In other words, while ensuring new vaccines for a safer world, it is equally worthwhile for CEPI to see that this safer world is inclusive and just.
Ishupal Singh Kang teaches at Jindal Global Law School. He mainly works on themes pertaining to Intellectual Property Globalisation, Access to Knowledge and Law and Development issues. @ishupalkang