IP and COVID – part of the solution not part of the problem
Fostering a research eco-system that can deliver that innovation rather than undermining it through challenges to IP like compulsory licensing, is the best way to protect citizens across Europe and around the world
by Nathalie Moll, EFPIA Director-General
24.02.2021
Witnessing millions of Europeans getting their vaccines just 12 months on from the first discovery of COVID-19, is an incredible collaborative, scientific, manufacturing and logistical achievement involving the global research community working in lock-step with the research-based pharmaceutical industry, EU institutions, governments, regulators and health-systems.
Over 30 million doses have been delivered to the EU since the first COVID-19 vaccine approval by the EMA, just two months ago.
We understand and share the frustration caused by temporary reductions to the quantities of COVID-19 vaccines being delivered. Manufacturing billions of doses for people across Europe and around the world is an unprecedented challenge involving multiple partners, working around the clock without ever compromising on the quality or safety of the vaccines. Fluctuations in the supply of doses, however frustrating, is a feature of manufacturing such complex biological products.
This pandemic affects us all. We all want the same thing; to provide access to as many vaccines as possible in as short a time as possible. How we achieve that aim is understandably the focus of intense debate as companies, governments and the EU institutions work nonstop to protect citizens from COVID-19 as quickly as possible. When considering how to continue to increase the supply of vaccines to citizens across Europe and around the world, we have to avoid considerations, however well-intended they may be, that in practice would impede or delay the supply of COVID-19 vaccines.
One such consideration is to negate patents on COVID-19 vaccines and issue compulsory licenses.
First of all, it doesn’t fix the problem.
The World Health Organisation as well as the European Commission have publicly recognized that IP is not a barrier to increased capacity to produce COVID-19 vaccines. It is skills, infrastructure and technical know-how that are key to increasing capacity and producing the billions of doses needed. Just issuing a compulsory license, while the challenge is a lack of capacity, does not mean factories across Europe could suddenly start producing COVID-19 vaccines.
Establishing a new manufacturing plant requires significant financial investment ($500-700m), usually taking between 5 to 10 years to be built, validated and certified. Building new manufacturing sites is not a quick fix.
Currently, there are only 5 or 6 pharmaceutical groups capable of manufacturing COVID-19 vaccines at the pace, scale and quality needed. Globally, there are around 60 manufacturing sites equipped to produce COVID-19 vaccines.
The experience of the last months and weeks has shown us that increasing capacity requires the skills and technical know-how of the vaccine developer to bring on-board partner manufacturing organizations through tech-transfer agreements under voluntary licensing arrangements. Capacity extension is therefore mostly dependent on investments in upgrades or adaptations of existing facilities and through partnerships with CMOs and other companies.
This process has been moving ahead at an unprecedented pace, some examples announced in the last few weeks are:
- GSK working with CureVac to fill and finish up to 100 million doses in 2021 in Wavre, Belgium as well continued work to address variants
- Bayer working with CureVac to produce 160 million doses in 2022, in Wuppertal, Germany, first commercial product expected to be made available at the end of 2021; in addition, Bayer will aid in R&D, regulatory affairs, supply chain management and potential marketing operations
- Sanofi working with Pfizer/BioNTech to fill and finish 125 million doses starting summer 2021, in Frankfurt, Germany
- Rovi working with Moderna to fill and finish “hundreds of millions of doses”
- Novartis working with Pfizer/BioNTech to fill and finish doses starting Q2 2021 in Stein, Switzerland
- Moderna working with Lonza to produce capacity for 400 million doses a year – 300 million from three production lines in Visp, Switzerland, and 100 million in New Hampshire, US.
- Novavax working with Baxter – production in Halle/Westfalen, Germany
- AstraZeneca has built more than a dozen regional supply chains, collaborating with over 20 supply partners in more than 15 countries
You simply cannot achieve this kind of capacity expansion through compulsory licensing. It is only achievable through voluntary, collaborative partnerships between the innovators behind each vaccine and expert manufacturing partners. This reality was clearly articulated by Thierry Breton, European Commissioner for Internal Market, who when speaking to the media recently said. “It is not an intellectual property subject; it is a matter of having factories, (…) Just because I give a patent to a company in India for example it would not change anything.”
Secondly, the only reason we have vaccines and therapeutics to tackle COVID-19 is because of the intellectual property protection that has fostered innovation in recent years. Take messenger RNA, used in the first COVID-19 vaccine approved by EMA, mRNA has, in recent months, become the poster child for medical innovation. But the development of mRNA has spanned the last 20 years or more, long before companies like Moderna, BioNtech, Pfizer and CureVac began applying the science to COVID-19 vaccines. Its development relied on private investors supporting the research on the basis that their investment was protected by IP. These decisions, made over the past 20 years, help us to be agile and fast in the face of the COVID-19 crisis.
Stopping this pandemic, including new variants, will require a number of diagnostics, treatments and vaccines. Compulsory licensing negates any incentive to invest in medical innovation for COVID-19 at a time when citizens across Europe, across the world, are looking to the life-science community to find the answers to the coronavirus crisis. It is not just about COVID-19, compulsory licensing would remove any incentive for investing in new technologies that could be used to fight future pandemics.
So what can be done to continue to increase capacity and achieve what we all want – more doses to more people, more quickly?
We support the creation of a sustained high-level dialogue and collaboration between industry and the European Commission services to support efforts to increase manufacturing capacity in Europe.
Vaccines manufacturing involves dozens of ingredients and disposables. Access to sufficient quantities of both may create bottlenecks in the production of COVID-19 vaccines. With manufacturing sites running 24 hours a day, any shortage of raw material can halt production and greatly impact production. Today, there are signals that the lead time for procurement of some disposables is increasing, which could be an indicator for future shortages. The first priority is to support global, resilient vaccine supply chains, allowing the uninterrupted flow of raw materials, components, consumables, clinical trial samples, batches for testing and finished vaccines.
Like many health emergencies of the past, only medical innovation can stem the devastating human and economic cost of this pandemic. Fostering a research eco-system that can deliver that innovation rather than undermining it through challenges to IP like compulsory licensing, is the best way to protect citizens across Europe and around the world.
