The European Commission has been heavily criticised for its performance over Covid-19 vaccine supply to European Union Member States. Despite the urgency of the situation, the impression has been given that the European Commission approached the negotiations with potential suppliers of Covid-19 vaccines in the summer of 2020 in much the same way as other contract negotiations, taking time to finesse issues such as price and liability provisions. Whether or not this is wholly fair, it is evident that the European Commission did place a great deal of reliance on pharmaceutical companies to be able to deliver on the agreed vaccine supply schedules. In fact, the difficulty involved in scaling-up such ‘biological’ vaccine manufacture has been described as “…like trying to go from making a loaf of sourdough in your kitchen to making 100,000 sourdough pizzas.” Or, indeed, a billion sourdough pizzas. It appears to have been unanticipated manufacturing process-related problems in vaccine manufacturing plants which recently led, for example, to the politically explosive row between AstraZeneca and the European Union.
To try to improve its response to the Covid-19 pandemic, including preparing for the emergence of new variants of SARS-CoV-2, the European Commission has proposed a new bio-defence preparedness plan: the European Health Emergency Preparedness and Response Authority (HERA) Incubator. It marks another stage in the road for the European Commission to acquire competence from European Union Member States in public health matters.
The proposed HERA Incubator heralds a new approach to industrial policy:
“…the past weeks have shown how challenging it is for the scale-up of industrial vaccine production to keep pace. In order to boost production capacity in Europe, we need a much closer, more integrated and more strategic public-private partnership with industry.”
In addition to calling for urgent new approaches to, for example, surveillance of new variants, new clinical trial infrastructure and faster-tracked regulatory approval, it is important that:
“…the Commission has set-up a Task Force for Industrial Scale-up of COVID-19 vaccines to detect and help respond to issues in real-time.”
In particular, regarding issues such as addressing bottlenecks in production and supply of raw materials for vaccine production and the re-purposing of suitable pharmaceutical capacity toward vaccine production, it is indicated that:
“…one of the responsibilities of the Task Force for Industrial Scale-up is to act as a one stop shop helpdesk for any queries and operational support”.
It is also recognised that:
“…vaccine development and production require highly specialised and skilled professionals. To that end, the Commission will continue building strong skills partnerships under its Pact for Skills.”
In fact, it is likely that this new approach to industrial policy has been influenced by recent experience in the United Kingdom. Recognising that the earlier stages of the pandemic had not been well handled, with hurried and often ineffective plans being put in place, for example, to supply Personal Protective Equipment or to implement a ‘track and trace’ programme, the British government set up a ‘Vaccines Taskforce’ in May 2020. Crucially, its membership included pharmaceutical industry and military figures as well as civil servants in order to ensure that it “has access to the deep, specialist expertise in vaccine preclinical and clinical development, regulatory issues, manufacturing and project management necessary to deliver its objectives.” Underlining its hybrid nature, Boris Johnson, the British Prime Minister, asked Kate Bingham, a well-known venture capitalist in the life-sciences field, to be its Chair. As of November 2020, it had “just under 200 staff”. Its primary objective is to “Secure access to promising vaccine/s for the UK population” and it has already been remarkably successful at doing so (see, for example, here and here), enabling the surprising speed and scale of the UK Covid-19 vaccination programme.
A significant element in its success has been the close support offered by the British government in efforts to scale-up vaccine manufacture. For example, AstraZeneca have said that:
“At the time of signing the agreement with Oxford University in mid-May 2020 AstraZeneca entered into a binding agreement to supply the vaccine to the U.K. government, allowing for the development of a dedicated supply chain for the U.K.”
Oxford BioMedica (Oxford, UK) was identified as a key resource for this supply chain and, accordingly, the British government “…effectively commandeered the manufacturing plant.” The Wockhardt ‘fill and finish’ facility (Wrexham, Wales, UK) was likewise identified and, accordingly, the British government reserved eighteen months of exclusive use. Not co-incidentally, due to the speed with which the agreement with AstraZeneca was thus able to be concluded, Pascal Soriot (CEO AstraZeneca) indicated that there had been three extra months to resolve any unanticipated problems in the vaccine manufacturing plants for the UK supply chain.
It is not quite clear what level of close support the European Commission would be able to provide under the HERA Incubator and to what extent it would still need to draw on European Union Member States. Nevertheless, the enhanced public / private cooperation approach that it foresees should make a positive contribution to the development, manufacture and supply of Covid-19 vaccines in the European Union. An obvious criticism, though, in addition to the length of time that has elapsed before the European Commission proposed something like the HERA Incubator, is that it is heavily focussed on the European Union.
Even the most inward-looking of European Union politicians and policy officials should by now be aware that “This pandemic is not over anywhere until it is over everywhere”. The Communication explicitly recognises the danger of the emergence of vaccine resistant SARS-CoV-2 variants and this is just as much a concern regarding the, as yet, comparatively unvaccinated populations of Low and Middle Income Countries as with the European population. It is in everyone’s interest that every element of manufacturing capacity in Low and Middle Income Countries that could usefully be brought to bear on the manufacture of Covid-19 vaccines (as well as diagnostics and therapies) is prepared for scaling-up, if that has not already taken place, and that new manufacturing capacity is created if that is insufficient. It is completely inadequate for the Communication to lamely suggest that: “In the medium and long-term, the EU should cooperate with lower and middle- income countries, in particular in Africa to help scale up local manufacturing and production capacities.”
The Communication also appears to betray an inward-looking focus on intellectual property. It recognises that “Increasing manufacturing and ‘fill and finish’ capacities can mean sharing the technological know-how and intellectual property behind the vaccines and their corresponding technology”. Public health advocates have been calling for the urgent ‘pooling’ of Covid-19 related intellectual property rights in order to facilitate global ‘scaling-up’, not least in support of the WHO Covid-19 Technology Access Pool (C-TAP), which was launched in May 2020. Either in collaboration with C-TAP or independently, the Medicines Patent Pool has indicated that it stands ready to help with Covid-19 related intellectual property licensing. After more than ten years in operation, voluntary licences agreed via the Medicines Patent Pool have already resulted in the delivery of more than 14 billion doses of treatment for diseases such as HIV and TB.
Further, though, the Communication suggests that:
“The Commission will foster the creation, if need be, of a voluntary dedicated licensing mechanism, which would allow technology owners to retain a continued control over their rights whilst guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers.”
No further detail is given and no explanation as to what is meant by such a ‘voluntary dedicated licensing mechanism’ or why it might be necessary. The Medicines Patent Pool already has huge experience with voluntary licensing for public health purposes and a track record of working with many different pharmaceutical companies. It is not therefore difficult to suggest that, instead of devoting more precious time to ‘re-inventing the wheel’, the European Commission would be better served by looking to draw on the international Medicines Patent Pool for voluntary licensing expertise and infrastructure. This would also have the benefit, should the European Commission justify atypical voluntary licence features, that they could immediately be made available for worldwide use and ‘scaling-up’ efforts in Low and Middle Income Countries too.
It is likely that the enhanced public / private cooperation approach foreseen in the proposed HERA Incubator should make a positive contribution to the development, manufacture and supply of Covid-19 vaccines in the European Union, not least as a similar approach already appears to have been a success in the UK. It is not difficult to see why the European Commission suggests that it should acquire the necessary competence to be able to carry it out. It may yet be a challenge, though, to manage the competing interests of individual European Union Members and any temptation to ‘go it alone’ (It is sobering to reflect that, in classical Greek mythology, Hera gave birth not only to Hephaestus, creator of ‘technological’ marvels, but also to Eris, goddess of discord and even Ares, god of War.) In the very obvious circumstances of the Covid-19 pandemic, though, the European Commission should look beyond its borders and include immediate support for scaling-up, in particular, in Low and Middle Income Countries, as well as making use of the existing international voluntary licensing expertise and infrastructure of the Medicines Patent Pool and the possibilities afforded by C-TAP. There’s no time to lose in designing a Global pandemic preparedness plan and infrastructure – and a Global Vaccines Taskforce – not just a British or European one.