Kalha is the IFPMA's Associate Director, Intellectual Property & Trade Policy: and has been tracking the IP COVID-19 waiver ever since it was proposed in October 2020. With COVID-19 vaccine supplies on track to outstrip global demand and collaborations set to change Africa’s vaccine manufacturing landscape, initiatives such as the proposed Intellectual Property TRIPS waiver are a distraction to the real challenges of getting shots in arms, she says.
She'll be exploring the topic in-depth during BioPharma-Reporter's Manufacture of Vaccines webinar this Thursday, October 28: register here for the free event.
Ahead of the webinar, we ask Kalha to explain the key issues around the waiver.
BPR: What, in a nutshell, is the COVID-19 IP waiver proposal; and what problem does it seek to address?
KK: The proposed Intellectual Property TRIPS waiver was tabled to help address an assumed shortage of vaccines as the solution to vaccine equity. While we are fully aligned with the goal to ensure COVID-19 vaccines are quickly and equitably shared around the world, we have consistently stated, that a waiver is a solution in search of a problem.
At present, there are two proposals being considered by the TRIPS Council. One proposal tabled by India and South Africa a year ago seeks a very broad waiver on all COVID-19 technologies on different types of IP. This includes patents, trade secrets, and designs for all products, including healthcare technologies and products dealing with the prevention, treatment and containment of COVID-19. The India and South Africa proposal aims to last for a minimum of three years and automatic extension until such time the TRIPS Council agrees by consensus to end it.
The other proposal has been put forward is by the EU member states, and seeks to expand the current flexibilities, in particular compulsory licensing provisions.
According to proponents of these proposals, a waiver or an expansion of current flexibilities would enable greater production.
BPR: What is the IFPMA’s position on IP waivers?
KK: To quote one of the official statements made at TRIPS Council by one government official, it is an “extreme measure trying to address an unproven problem”.
To our knowledge, there has been no single incidence where IP has been a barrier to COVID-19 vaccines or treatments; to the contrary, IP has been an enabler.
It is because of the investment in R&D and a predictable IP system that we were able to bring to market more than one viable vaccine is less than a year as well as 127 vaccines that are currently in clinical trials.
We were able to enter into unencumbered voluntary licenses and technology transfer arrangements with trusted partners across the world.
If the aim is to address production capacity, then industry is already meeting the projected numbers for this year (12 billion doses) and next (24 billion by June 2022), which is enough to vaccinate the adult population.
Since May, the biopharmaceutical industry is committed to working with governments to support dose sharing efforts to urgently address vaccine equity. This month COVID-19 vaccine manufacturing output will pass the 9.3 billion dose mark.
Waiving intellectual property rights for COVID-19 technologies will not increase production nor provide practical solutions needed to battle this global health crisis. Neither will it address the issue of vaccination in countries. It will also not produce a single dose more, than already is.
On the contrary, it is likely to lead to disruption; while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally.
BPR: Why have IP waiver proposals prompted so many reactions - from industry to governments to NGOs - and why has it become such a polarising topic?
KK: The IP Waiver is an extreme proposal. Such a substantial waiver of a treaty has not been attempted. That in itself raises questions.
'Waiving IP is not the silver bullet that will solve everything. Each country and region has unique challenges that need to be addressed'
As for differing view points, this is an old political debate, where some have put forth that IP is the barrier and the waiver would solve all problems of access, pricing, infrastructure – in short, the entire healthcare system. Industry on the other hand has stated time and again, that in order to bring innovative products to market, you need a stable, predictable IP framework.
The reason we were able to respond to this pandemic in a relatively short time was because of a robust IP system that is in place. IP rules and laws are not barriers, but rather that they are core to a sustainable innovation ecosystem and enable technology transfers. Waiving IP is not the silver bullet that will solve everything. Each country and region has unique challenges that need to be addressed, universal health coverage and healthcare system strengthening being the primary ones.
During this COVID crisis, industry writ large, both innovative biopharmaceutical companies, as well as biotechs and developing world manufacturers have all demonstrated their resolve to make the most powerful contribution they can. Lest we forget, China and India are together with the USA and the EU the largest producers of COVID-19 vaccines. None of this would have been possible without the incentive framework we have place.
We have put science first and worked to bring to market safe and effective healthcare products to fight and end this pandemic. In order to overcome future pandemics and strengthen healthcare systems, industry has to be seen as a solution partner rather than an adversary
BPR: The IP waiver was initially proposed a year ago in October 2020. How has the vaccine manufacturing landscape changed since then?
KK: The vaccine manufacturing landscape has changed since the beginning of the pandemic and continues to evolve. Today, we have 14 vaccine candidates, with production taking place in every continent. According to Airfinity, by the end of 2021, the production will be at 12 billion doses, and, by June 2022, we will be at 24 billion, provided no new restrictions are put in place. Modelling by Airfinity indicates that even if the G7 countries vaccinate teenagers and adults and decide to give boosters to at-risk populations, there would still be over 1.2 billion doses available for redistribution in 2021 alone.
This means that each month for the foreseeable year, over 200 million doses would be, with effective planning, available for low- and lower-middle-income countries (LMICs). This has been achieved by industry entering into collaborations: 390 voluntary arrangements with over 220 including technology transfer for vaccine alone. As for therapeutics, our companies have already taken the lead and entered into voluntary licenses, 109 collaborations with 92 licensee companies, despite of their being a handful of therapeutics approved.
Dismantling IP, the very system that has allowed for this number of collaborations and R&D to take place, would be extremely unfortunate and negatively impact innovation across sectors in future.
The historic COVID-19 manufacturing scale up should now urgently shift attention to delivering vaccine equity including dose sharing. In May 2021, the innovative biopharmaceutical industry publicly committed to expend every effort to make additional uncommitted COVID-19 doses available to LMICs and to support governments that have significant domestic supplies of COVID-19 vaccine doses to share a meaningful proportion of their doses with LMICs in a responsible and timely way through COVAX or other efficient established mechanisms.
BPR: What, in your opinion, is one of the biggest challenges in getting shots in arms?
KK: We all share the same goal of getting people vaccinated and to end the pandemic. Manufacturing scale up is taking place, however it is only part of the solution, getting shots into arms and bringing therapeutics to market are other pieces to the puzzle. To this end, industry in its 5 step plan to advance vaccine equity, have listed factors that can achieve this goal.
- Dose sharing between countries: Vaccines have a limited shelf life and to see them go waste rather than them being sent to countries that need the shots, is deeply troubling. Especially, when we are dealing with vaccines made from raw materials that are in limited supply. We urge countries to increase dose sharing, to send the excess doses to countries that need them.
- Country readiness: Countries need adequate resourcing, the right infrastructure, a strong cold supply chain, and trained staff to effectively store, distribute and administer vaccines. If a country does not use existing systems of vaccination or does not have a roll out plan, the vaccine will just sit there and not reach the people that need them.
- Removal of Trade Restrictions: During this pandemic we have seen several countries put in export restrictions. If these are in place for upstream raw materials, it delays production. If they are downstream, then it delays delivery, in simple terms. Neither of these options help getting shots into arms.
- Continuous focus on for Innovation: . As variants of concern emerge and for future diseases, it is critical that innovation is not stifled by diluting policies that promote innovation.
- Vaccine manufacturing scale up: which as I mentioned has trebled in a year and we are well on our way to meet the goals that have been set.
BPR: What are the key takeaways you want to leave us with?
Industry has indicated that the problem is no longer the lack of supply but the distribution of the supply. If we are to end this pandemic, we cannot afford to throw away doses when they can get to people who need them. Nor should we get caught up in old political debates.
We understand that the issue is complex but with collective effort, planning and political will, we, together, can achieve the goal to get shots into arms and end the crisis.
