Now that the news headlines have moved away from the pandemic, is there still international will to make COVID-19 related innovations available to the public?
“The Good”: We finally have a draft text of a COVID Vaccine IP Waiver
In March, the United States, the European Union, India, and South Africa finally found some language they can agree upon as a compromise for a draft intellectual property (IP) waiver for COVID vaccines. Assuming the approved text holds, the agreement still needs to be accepted by the WTO member countries before it can be adopted. Call me a curmudgeon, but we are well into the third year of living with COVID…..there must be some way to respond a bit faster to future pandemics.
Instead of focusing on the negative, let us not lose sight of the many positive things that have come out of the global response to combat COVID-19. Significant public funds have been invested worldwide into the research, development, and manufacturing of medical tools and products.
WHO's COVID-19 Technology Access Pool was established in the early days of the pandemic as a voluntary initiative to support rapid collaborative research and development efforts aimed at sharing available knowledge by removing legal barriers. In the spirit of openness, unity, and global cooperation, the world truly stepped up and rallied under the banner of ‘global common good’ in search for solutions under the stress of a global pandemic.
For example, the rapid assessment and emergency approval of promising treatment options and the negotiation of advance purchase agreements to finance the upfront costs of manufacturing vaccines were all good indicators of what is possible when facing a common threat. The world witnessed what we can collectively achieve with open and collaborative efforts to accelerate the discovery of solutions.
The Bad: Does the draft IP waiver adequately address the IP related barriers?
As new innovations approached market readiness and commercial realities started to overshadow previously shared common good considerations, IP positions were taken and used to secure financial interests. These exclusive rights created a layer of complexity to gaining global access to much needed medical solutions, as we have seen with the need for the IP waiver.
Traditionally, IP rights have been justified in the pharmaceutical sector because of the need for financial incentives to balance against the significant time, cost, and risk that comes with developing new drugs.
However, if (a) the cost of research for COVID-19 related innovations have largely been subsidized by the public purse through public research grants; (b) the time for development has been significantly reduced through publicly funded initiatives, such as the Solidarity Trial; and (c) manufacturing has been de-risked through taxpayer funded advance purchase agreements, then why is it so hard to find ways to gain access to medical solutions that have largely already been paid for by the taxpayer?
Reportedly, many details of the draft IP waiver still need to be resolved in order for it to be effective. What we desperately need instead are proactive and legally supported mechanisms to ensure that worldwide access to much needed medical solutions that benefited from public funds and open collaborative research efforts will not be frustrated.
The Ugly: Will the agreement hold for the next pandemic?
Countless international voices have warned of the dangers of “vaccine nationalism” even before the news reported examples of countries leveraging their significant national resource to secure limited supplies of medical innovations at the expense of poorer countries.
As the WHO Director-General stated very poignantly, it is natural that countries want to protect and prioritize their own citizens first, but in order for vaccines to be effective, they must be “used effectively”, which means we need to “vaccinate some people in all countries rather than all people in some countries”.
If vaccine nationalism is allowed to fester into ‘haves and have-nots’, the concept of ‘global common good’ and ‘open collaborative efforts’ will forever be undermined. The trust, solidarity, and goodwill between nations and global citizens cannot be allowed to break because we failed to learn how to address the access and availability problem arising from the COVID pandemic.
As long as production capabilities and capacities are limited by proprietary rights, countries in need of access to vaccines will continue to rely on other countries to distribute doses to them. This cannot be an acceptable or sustainable way to achieve health equity and equality.
What is the alternative?
Because the current reactive solutions that attempt to achieve a better balance between public, private, and national interests are problematic and unlikely to be useful for future pandemics, there needs to be a framework that proactively ensures the benefit of publicly funded outcomes can ultimately reach the public.
This will require pharmaceutical companies to permit worldwide production if they are unable to produce sufficient quantities to meet global demand, while still being compensated and recognized for their innovation. Incorporating a licensing provision to a trusted centralized authority, triggered only under strict prescribed circumstances as a condition to receive public funding or to participate in publicly funded open and collaborative initiatives, will provide the legal basis to allow innovations supported by the public to reach the public.
In this model, the license to IP and proprietary know-how will be granted to a trusted centralized authority to authorize production by countries with manufacturing capabilities if and only if the IP holder is unable to produce sufficient quantities to meet global demand. If innovators want to take advantage of public funding and initiatives to accelerate R&D of new innovations in order to remain competitive with those who do take advantage of these public initiatives, then they must agree to this “compulsory voluntary license”.
Export restrictions should likewise be removed to ensure the medical solutions can be made available to countries without their own manufacturing infrastructure. The production capacity of the IP holder therefore cannot be held captive by national or private interest if mechanisms for alternative manufacturing are made available as a condition for having received public financial support, or expedited access to clinical trials, or accelerated regulatory approval.
IP holders will still be entitled to receive fair and reasonable royalties for production in markets they cannot service, administered by way of a trusted international organization that understands and will consider the market and economic realities of the pharmaceutical industry.
The Crux of the Matter
In response to a global pandemic, there must be legally supported mechanisms to ensure the pharmaceutical industry and national interests cannot be used to undermine the ability to rapidly and widely distribute essential medicines worldwide. While commercial interests of industry need to be recognized to incentivize innovation, private profits should not be subsidized by public funds that supported the development of essential medical solutions.
Nor should global public health be at the mercy of national interests and companies who refuse to give up manufacturing control if they are unable to produce sufficient quantities to meet global demand. If innovators want to remain competitive with rival companies who do take advantage of these public initiatives, they have a choice to make: work independently to maintain full control of the IP, or take advantage of the publicly funded tools and initiatives under conditions that reflect principles of responsibility and global common good.
The intent of the “voluntary compulsory license” is to incentivize and put some pressure on industry to take proactive steps to optimize their own manufacturing capacity and their licensing strategies if they do not want manufacturing control taken away from them.
This places some onus on industry to become an active and responsible participant in matters of global public health, should they wish to take advantage of publicly funded and supported efforts to accelerate their product development efforts. In the spirit of ‘global common good’, a key lesson we should learn from the COVID-19 pandemic is how we can use legal tools to proactively address the issue of access and availability to ensure innovations that benefited from public initiatives can reach the public.