By: Dr Owain Williams
Simon Rushton and I had our blog published on the SPERI site today, and although the blog format is good for getting it out there, it does limit the depth that you can go into a given problem. I’ve written in the past about market failure and medicines, and probably will again. The essence of the SPERI piece is that we have generated a system that creates profound problems in terms of upstream R&D and downstream access and equity issues for medicines. A COVID vaccine will be pretty exceptional if it avoids a number of pitfalls.
The present R&D response to the crisis seems to be on a different footing to the normal state of affairs with unprecedented collaborations, data sharing, and coordination by are range of national and international institutions such as CEPI and the WHO. The giant Pharma firms are also entering into collaborations and partnerships, committing to the common project that is now defining a great deal of global life sciences work. It is also significant that vaccines themselves are the subject of so much focus, having been a moribund area for so long, at least in commercial terms. We are not in the usual territory of missing markets here, whereby drugs are not developed in the absence of effective economic demand – or put simply, re not developed for diseases affecting populations that are too poor to warrant investment in R&D by firms. There are a catalogue of such infectious diseases that have remained neglected because they are diseases of the poor and poorer regions of the world.
Downstream, however, we might face more significant problems if a vaccine is developed at all. In the context of ever-increasing national bans on the export of medical technologies, what will happen if a firm in an originator country manages to produce a COVID vaccine? Epidemics of recent decades have witnessed stockpiling and prioritisation of supply to certain countries, and the de-prioritisation of others. Unseemly scrambles for these vaccines have had political fallout. So the question is who will get what, at what price and and when? It will also take time, with a many months (if not a year) of lead time for mass production hindered limited plant capacities to produce. Most manufacturing capacity lies with 4 big player multinationals. What will they charge faced with universal demand? Also, how will we produce the other essential vaccines that we rely upon for measles, polio, diphtheria and so on. Without continued access to these vaccines we will create a myriad of other outbreaks, while perhaps getting COVID under control until a possible new ‘seasonal’ strain emerges.
Who also will hold the intellectual property on the drug? Will the IP holder assert this aggressively and will they be allowed to? If it it is a US firm, does that make IP an non-negotiable issue? Even if shared altruistically, this is still going to cost a great deal to produce at such huge volumes. The vaccine will need storage and distribution on a massive scale. Someone will have to pay for all of this if coverage is to be fair and equitable.
Of course, this is just one area of global life that the virus has exposed fundamental flaws in the way we do things and have done things. The vaccine R&D system is not completely broken, at least in terms of very committed scientists who have worked under-funded on what has become a niche commercial area, notwithstanding the inevitable surges in largesse that have followed the odd epidemic event or two. Like many areas of medicines and healthcare, the interaction with the market with vaccines has mainly served produce neglect and fragility. We have derived a system skewed from what is a health 101, prophylaxis against disease and prevention.
Funding vaccine R&D, platforms and capacity can be represented as a classic ‘inverted hockey stick’ curve in economics. The short end of the stick (the blade???) represents an initial spiked up-front cost, and ostensibly it looks like a huge investment. In the case of 1 vaccine many hundreds of millions upwards to the billion mark. But the trail down of costs on the long handle (the stick I guess???) is significant in both economic and health terms. The handle trailing down represents costs saved from disease prevented; from the dramatically reduced burden on health systems from infections prevented; the avoided costs of closing economies and borders; and the important gains in terms of human lives saved. When observed from either health or economic terms, or both, investment in medicines or vaccines that prevent infection or onward transmission (as is the case with ARVs) is a slam dunk case. But because they have been left to the market for so long, we are simply not prepared and do not have the finances and systems in place to replicate the hockey stick curve.
Something radical needs to change in this one vital area of science, production and consumption. This is exactly why we have tried to work around the market, creating all these publicly and philanthropically funded product development partnerships. But it is not enough and is not systemic, and we cannot really afford to tinker around the edges of this problem any longer. We certainly need to start treating R&D, basic research, manufacturing capacity, pricing and access to medicines as they should have been treated for so long, as public goods that are free from rationing and economic demand and supply drivers. We should both nationally and globally fund the whole area by means of progressive taxation and create a publicly owned and supported infrastructure for training, research and data sharing, all toward drug development. Access to final products should not be dependent on price and disease focus should not be dependent on effective demand. The mechanisms to incentivize research should also be taken out of the broken patent system. R&D efforts where they are undertaken as enterprise and not in the public domain should be rewarded by health impact, unless we want to continue to pump research money into dandruff or male patterned baldness. We need prizes to pull and funding to push research; and let us try out impact funds and other mechanisms all talked about endlessly for the decades after the HIV crisis saw $10,000 price tags on a year’s supply of ARVs. As COVID has proven, none of these considerations are niche any longer (if they ever truly were) and demand more than just committee resolutions and endless debate with obdurate politicians who are bank rolled by Pharma. We need a new and well-funded system to cater to supply medical technologies.
And finally, in a pub one day in the future I will be able to talk about all this without people glazing over.