While the development of vaccines has given the world hope, success will depend upon closer global cooperation and the waiving of intellectual property protections
With six Covid-19 vaccines fully approved for use, six others approved for early/limited use, and at least 70 in clinical trials, there is light at the end of the pandemic-shaped tunnel. But faced with the daunting challenge of vaccinating billions of people against the background of the continuous ‘cat and mouse’ game between a mutating virus and vaccine developers, fears about this light being a mirage are understandable. It has been estimated, for instance, that there won’t be enough vaccines to inoculate everyone until 2023/4 and this doesn’t necessarily take into account the emergence of new variants that would require tweaked vaccines.
Doubts intensify the more one looks into how the challenge of vaccinating the world is currently being (mis)handled: a piecemeal approach predominantly cobbled together by national governments and private companies at the expense of a cooperative and globally coordinated approach commensurate to the social and economic scale of the pandemic. Current vaccine dose purchases confirm this approach: nearly 4.6 billion doses – enough to inoculate the majority of the world’s adult population – have been purchased by high-income countries that, using a combination of public investment on domestic vaccine R&D capacity and/or leveraging their purchasing power, were the first to secure large advance market commitments from private companies. Trailing at a distance are upper/middle income countries leveraging what they could: manufacturing capacities (e.g. India, Brazil) or clinical trials infrastructure (e.g. Peru). The rest have not fared well. Here, forms of pooling finance and procurement have emerged (e.g. through the African Union) and reliance on nominally global mechanisms such as the COVAX facility is strongest.
Our not-so-distant history of dealing with other infectious diseases globally, most notably smallpox and polio, offers some salutary reminders about what can be achieved through investment and cooperation. These diseases are different to the present one, of course, and success was achieved over decades; technological advances today can speed up R&D processes and outcomes, but they cannot replace the need for strong leadership and cooperation at the global level. Indeed, the ongoing HIV pandemic has clearly illustrated that the piecemeal approach that predominated early on had tragic consequences: almost 33 million people with HIV have died so far. That around 67% of people with HIV (who know their status) now receive antiretroviral therapy (ART) is a bittersweet reminder of the importance of decisive global cooperation which has been slow in the case of the HIV pandemic and hard-won over years of political struggle, notably over access to and affordability of ART drugs in the developing world where most HIV cases are also located. Largely because of patents, the price of a triple ART drug cocktail was over US$10,000 per person per year around twenty years ago; over the next decade, the price would drop by around 99% as a result of lengthy legal and political battles that ultimately opened up generic production and competition in this drug segment.
It is perhaps unsurprising that countries at the forefront of battles over access to ART drugs should also propose a waiver to certain elements of the WTO TRIPS Agreement in October last year. Tabled by South Africa and India, the proposed waiver would allow countries to neither grant nor enforce patents and, importantly, other forms of intellectual property (e.g. industrial designs, copyright, data exclusivity) related to Covid-19 therapies, diagnostics, vaccines and other technologies for the duration of the pandemic. Around 100 countries have supported the idea, but prominent high-income countries like the US, Canada, Switzerland, the UK, Australia, Japan and the EU remain against it, arguing that there are no indications that intellectual property (IP) poses barriers to accessing Covid-19 therapies and vaccines (a rebuttal of these points can be found here).
As the debate drags on at the WTO, the C-TAP – a ‘public good’ mechanism created by WHO in May last year to pool IP-protected Covid-19 technologies, information, know-how, and clinical trial data with the aim of allowing qualified manufacturers to produce and supply the world without fear of prosecution – has yet to attract contribution from private companies so far; indeed, Pfizer’s CEO said the mechanism was dangerous. Missing from the long list of supporters are also most of the high-income countries that oppose the TRIPS waiver, countries that are home to large pharmaceutical companies and/or have invested millions on Covid-19 research, e.g. the US, the UK, Switzerland, France and Germany. Notably, the considerable public funds these governments have invested on Covid-19 therapeutics, diagnostics and vaccines R&D – the US Warp Speed operation alone appears to have directed over US$15 billion – have been characterised not only by a minimal level of global coordination, but also by a baffling timidity of exerting public interest and government rights. In other words, these funders have not generally used the considerable public funding investment that has gone into Covid-19 vaccine R&D to demand receiving firms to share their technology, for instance, or even to claim for themselves rights to the IP and data arising from publicly-funded research as their own national laws permit.
Instead, as is widely known, many of these recipient firms appear to have retained control over the more relevant IP and over manufacturing schedules, the latter largely through entering into voluntary but restrictive/exclusive licensing agreements with select manufacturers around the world. This state of affairs will undoubtedly delay expanding manufacturing capacities to the order of magnitude needed, a challenge that would have been serious even in the complete absence of IP. Indeed, it is often argued that the problem with manufacturing modern vaccines, as with biologics in general, rests less with IP and more with the peculiarities of their manufacturing process, especially the precise and complex manufacturing know-how and complementary technologies and capabilities. This is certainly true, but this argument does not take fully into account the extent to which IP have become deeply entangled not just with R&D processes/outcomes, but also with manufacturing processes. As the head of the WHO’s Technology Transfer Initiative disclosed recently, while previously IP was not a key hindrance for vaccines – although, notably, neither Jenner nor Salk patented their smallpox and polio vaccines – during the last 20 years some 10,000 patent applications for vaccines have been submitted. The mRNA technologies used in some of the current Covid-19 vaccines, for instance, are widely patented and litigated.
Indeed, the close entanglement of IP with R&D and manufacturing is especially visible in the case of vaccines and biologics where the final product, unlike the simpler vaccines and chemically-synthesised ‘small molecule’ drugs of the past, is sensitive to the production pathway and even minor alterations can alter the final product’s effectiveness and safety. Although this process is unlikely to be fully known at the time of filing the relevant (process) patent at the patent office, it is fully known and fully disclosed to health authorities at the marketing approval stage. In other words, the manufacturing know-how, although considered a trade secret, is not tacit but generally well codified in these cases. While undoubtedly not an easy task, states can use or amend existing laws and/or devise incentives for private companies to share this knowledge widely (but, if impossible, even more narrowly as a ‘club good’), especially in light of enormous public funding invested so far and, more broadly, in light of public interest arguments during a pandemic. It is disappointing that several important departures in vaccine R&D funding and manufacturing spurred by the urgency of the pandemic were not accompanied by overdue and needed changes in the business-as-usual IP model that has come to underpin it.
Some of these points seem to be the basis for the time-limited waiver proposed at the WTO and why it is meant to apply not only to patents, but to all relevant IP, including those specified in TRIPS over trade secrets and originator’s data of the kind submitted to regulatory agencies. It is simplistic to assume that the waiver, were it approved, would, on its own or alongside some pooling mechanism of the C-TAP kind, immediately resolve the enormous challenge of manufacturing enough doses fast enough to vaccinate everyone. It would, however, be the right step in the only possible direction. Nothing short of a robust structure for widely sharing knowledge across production platforms and products during the pandemic would help vaccinate the world. In the process of saving lives and livelihoods, it would also help generate more innovation and manufacturing capabilities; the world will need them in the next pandemic.