Medicines Law & Policy has recently proposed a provision for inclusion in the draft WHO pandemic instrument currently being discussed in Geneva (here and here, in the Financial Times). The provision is important since it would facilitate access to know-how and trade secrets essential to making complex medical products, including vaccines and therapeutics, during a pandemic emergency. Since the issues involved in sharing know-how/trade secrets are complex and nuanced, it is perhaps helpful to expand a little here on our reasoning explaining why it is vital that this problem we identify is tackled if we are to prepare as adequately as possible for a future pandemic, as well as how to do it.
The Covid-19 pandemic confronted the world with a terrible shock. At least seven million people died and perhaps ten times this number continue to suffer with a variety of ‘long’ Covid symptoms. Societies and economies will continue to feel its impact for some time to come. It remains unclear whether the pandemic was more likely the result of a natural spillover from animals to humans or the result of a laboratory accident. Terrible as it was, however, this pandemic was far from the worst that we could have been confronted with. Perhaps the most worrying future pandemic scenario relates to the deliberate or accidental release of an engineered bioweapon. We mentioned the democratisation of technologies such as synthetic biology and machine learning in our proposal, suggesting that they could contribute to the development of new pandemic countermeasures. However, if used with malign intent, they could instead contribute to the development of new and unprecedentedly harmful pathogens. Indeed, those who think about the most likely sources of existential threat facing humanity tend to place a pandemic caused by an engineered bioweapon near the top of their lists. Thinking about how to prepare for future pandemics and debates about which powers should and should not be included in the WHO instrument must therefore not only bear in mind experiences during the Covid-19 pandemic but also the extent to which others in the future could be very considerably worse.
Thinking about preparations must include the treatment of intellectual property rights too; not least, the treatment of know-how/trade secrets. Pharmaceutical products have extended beyond the traditional ‘small molecule’ medicines to include more complex ‘biological’ medicines which are grown rather than synthesised. It can be very difficult to produce such biological medicines at scale without more information than is provided in published patent specifications. The key additional information is typically kept secret by the patent owner as one type of ‘undisclosed information’ (Art. 39.2 TRIPS), more commonly referred to as know-how/trade secrets. It is important to appreciate that the grant of a compulsory patent licence does not, by itself, include any obligation for the patent owner to share any such additional know-how/trade secrets, even if the patented medicine cannot be made at scale without it.
In preparing for a future pandemic, it is therefore vital to consider how pharmaceutical firms can be expected to deal with their know-how/trade secrets in such circumstances. A recent report prepared by advocates of industry-focussed intellectual property protection, based on interviews with pharmaceutical firms (‘Trade Secrecy and Covid-19’), relates key findings on their treatment of know-how/trade secrets during the Covid-19 pandemic. One is that the protection of know-how/trade secrets played an important role in firms being able to establish the necessary trust with each other when sharing them, so that they could enter into mutually beneficial manufacturing collaborations. Given the nature of the processes involved in producing the more complex medicines, such as vaccines, and given that such sharing was not typical behaviour, it was often challenging to undertake. The report describes the example of the giant pharmaceutical firm Pfizer having had a team who were “…among a relatively small number of professionals with the rare skill set to enable other companies to produce the shots.”
Some of the collaborations that were set up, in a record time albeit with unprecedented financial support from governments, made decisive contributions in combating Covid-19, such as those for the development and production of adenovirus and mRNA vaccines. The report also suggests, however, that the forced sharing of know-how/trade secrets with manufacturers outside the collaborations would have been regarded as an unhelpful and impractical distraction which, at a large-scale, could also have had the effect of discouraging future investment in pharmaceutical firms.
It is perhaps helpful to take a step back here to reflect on this last comment. Very many talented scientists, technologists and other professionals choose to join pharmaceutical firms, at least in part, due to a strong desire to improve human health and wellbeing. However, pharmaceutical firms are businesses rather than not-for-profit foundations. It is an inescapable ‘law of gravity’ for these firms that they must make money. The incentive environment in which they operate means that they must deliver medicines to the market which are sufficiently profitable such that their investors and shareholders are attractively rewarded. They must continue to be attractive to capital investments if they are to continue to develop new medicines. We can therefore perhaps characterise the guiding aim of these collaborations as balancing public health benefits with the limits of acceptable commercial considerations.
A telling example illustrating these limits is provided by the launch of the WHO ‘mRNA Technology Transfer Hub’ in South Africa. Beginning to take steps to avoid the inequity of vaccine supply which marked the Covid-19 pandemic, the Hub is intended to show how sustainable vaccine manufacturing capacity can be boosted in Low- and Middle-Income Countries (LMICs). However, despite being able to make a vital contribution to the operationalisation of the Hub, neither Pfizer nor Moderna agreed to share their know-how/trade secrets relating to the manufacture of mRNA vaccines. Indeed, this lack of cooperation may have gone further. Consequently, it has taken Afrigen, the lead South African pharmaceutical firm involved, two years to progress to develop its own equivalent know-how. In the abstract, activities such as inventing ‘around’ a patent or independently developing know-how can themselves lead to valuable contributions to research and development. However, even if it were possible, there will be no luxury of time to spare in a future pandemic.
So how would pharmaceutical firms be expected to behave in a future pandemic? Presumably, in a very similar way. They would again perhaps share know-how/trade secrets in voluntary collaborations which would aim to balance public health benefit with the limits of acceptable commercial considerations. Of course, as they did during Covid-19, governments would be expected to intervene to try to shift those limits to improve the outcome whether in terms of public health or, perhaps, political necessity. One intervention, which has become institutionalised through, for example, the international COVAX (Covid-19 Vaccines Global Access) facility, is to enter into ‘market making’ commitments for guaranteed future purchases of pandemic products. The vaccines supplied by the collaborations led by Pfizer and Moderna have now become legendary commercial successes, with cumulative profits estimated to be at least thirty five and twenty billion dollars respectively. Despite an enormous funding contribution amounting to thirty billion dollars in the United States alone, however, governments made no demands for the sharing of know-how/trade secrets. In the future, an alternative intervention to consider could be for a government to ‘buy-out’ a firm’s know-how/trade secrets such that they were then able to be shared as necessary.
Alternatively, governments can try to shift the limits by pressuring or compelling firms to act in particular ways. It appears that some of the voluntary collaboration among pharmaceutical firms in the United States was, in fact, not so voluntary and that it was the implicitly threatened use of emergency powers under the Defence Production Act (1950) which forced the rival firms to work together and to share necessary know-how/trade secrets. The European Commission has proposed a similar solution in its scheme for EU wide compulsory patent licensing in an emergency. The proposal includes new powers which, in the event that a compulsory patent licence is granted during an emergency, would require patent owners to share with the holders of those licences any additional ‘indispensable information’ which is necessary for production to be carried out efficiently and effectively.
However, whilst such American and European powers can be used to pressure pharmaceutical firms based (or perhaps with significant assets in) the United States and Europe, they may have little impact on firms elsewhere. The same will be true of equivalent government powers everywhere, whether in China, India, South Africa or Brazil. Governments are therefore exposing themselves to a significant degree of risk if they assume it is ‘their’ firms which will necessarily hold the key technology: ten or twenty years from now, who can say where the vital products and associated know-how/trade secrets will be developed? Further, from an international perspective, to the extent that governments can successfully pressure firms, experience during the Covid-19 pandemic suggests that they would do so to favour production which would most directly benefit themselves.
In the face of the threat posed everywhere and to everyone by future pandemics, which could indeed be existential in nature, it is in all our interests to do better. We should certainly acknowledge what was achieved through voluntary agreements between pharmaceutical firms during Covid-19 and we should assume that they should be given a chance to make such agreements in any future pandemic. However, we cannot afford to have what may require an all-out planetary mobilisation in the future unnecessarily constrained in any way. So, in case a voluntary response proves insufficient, or looks like it is going to prove insufficient in the necessary time, we should have a transparent international ‘plan B’, which would not be limited by commercial or, indeed, political considerations.
Many of the elements of an ‘intellectual property plan B’ are already in place in the TRIPS Agreement itself, supported by the Doha Declaration on TRIPS and Public Health. An additional option for a time-bound intellectual property waiver is being discussed under Art.11 of the draft WHO instrument. However, these elements do not extend far enough to deal adequately with the problem of sharing know-how/trade secrets we identify in our proposal. They cannot guarantee that the production of the more complex ‘biological’ medicines can be enabled during a pandemic. We have accordingly proposed the following additional provision for inclusion in the draft WHO instrument:
Where the Director-General of the World Health Organization has determined that: (i) a pandemic outbreak, or the threat of a pandemic outbreak, represents a public health emergency of international concern (PHEIC); (ii) the urgent production by qualified third parties of a pharmaceutical product is necessary to respond to the pandemic outbreak, or the threat of the pandemic outbreak; and (iii) the manufacture is prevented or hindered through lack of access to undisclosed information as defined in Art. 39.2 TRIPS possessed by one or more entities located in one or more Parties, that or those Parties shall compel that or those entities to share the undisclosed information with the third parties.
Elements (i) and (ii) are consistent with pharmaceutical firms being able to make as many voluntary agreements as they choose to in order to expand production. If by doing so, they enable all available manufacturing resources to be used, then this provision will not be triggered. If, however, it is determined that there are realistically additional manufacturing resources which could also be enabled if they were provided with the necessary know-how/trade secrets (element (iii)), then the provision could be invoked to require the countries in which the pharmaceutical firm(s) holding the know-how/trade secrets are located to compel the firm(s) to share them with the additional manufacturers.
In terms of available manufacturing resources, it is important to bear in mind that, as part of a comprehensive plan to prepare for future pandemics, not only must existing resources be fully enabled but sustainable vaccine manufacturing capacity must also be boosted around the world including through initiatives such as the above-mentioned Hub. Kate Bingham, who very successfully led the UK Vaccine Task Force during the Covid-19 pandemic, has recently stated that:
“It is essential that the UK, and maybe the G20 and other motivated countries, invest in building vaccine manufacturing facilities around the world, especially in Africa…We need to build the skills, infrastructure and capabilities to make safe, approved vaccines, and to do so quickly in a pandemic.”
A key practical issue is that, even in the most favourable circumstances, the sharing of know-how/trade secrets is not necessarily an easy thing to do. Know-how/trade secrets may subsist in written and unwritten (‘tacit’ knowledge) forms. If there is to be a credible plan B, though, a workable mechanism must be found. We suggest that thinking now about how to avoid the types of transfer and scaling problems that pharmaceutical firms faced in sharing know-how/trade secrets during Covid-19 could be of vital importance in a future pandemic, whether such sharing is voluntary or compulsory. It is possible that: (i) pharmaceutical firms could agree (or be placed under a regulatory obligation) to systematise the treatment of know-how/trade secrets and the resourcing of associated teams in ways which could assist with urgent and efficient sharing in an emergency; and/or that (ii) ‘bottlenecks’ in sharing could be ameliorated by teams using architectures such as the Medicines Patent Pool (MPP) or the WHO Covid-19 Technology Access Pool (C-TAP).
It is understood that pharmaceutical firms are likely to look sceptically on the idea of the compulsory sharing of know-how/trade secrets. They will very likely suggest that even thinking about such an idea could have an impact on their business model through, for example, discouraging future investment. However, if there truly is a conflict between a particular business model and a robust plan to combat a future pandemic which, at worst, could be existential in nature, it seems sensible to suggest that it is the business model which should be re-examined rather than the plan. We are reminded of a darkly amusing cartoon in the New Yorker (Tom Toro, 2012) which depicts a suited survivor saying to other survivors around a campfire: “Yes, the planet got destroyed. But for a beautiful moment in time we created a lot of value for shareholders”.
It is interesting that similar reflections about the need for access to corporate know-how/trade secrets in the context of a potentially existential threat are also now occurring in relation to the possible development of artificial (general) intelligence (AI) in the near to medium future. Ahead of an international summit on AI safety to be held at Bletchley Park, the site of the Allied code breaking effort led by Alan Turing during World War Two, the British government has reportedly been in discussions with firms such as OpenAI and DeepMind for deeper (‘unprecedented’) access to their AI models, on the grounds that it has not been possible to adequately assess potential risks on the basis of the limited access conceded by the firms so far. In both cases, private businesses should be celebrated for their remarkable achievements but we must nevertheless retain a clear-sighted perspective that they operate in a public context and, through government regulation, to public ends, not the other way around.
Both in the context of the discussions on the WHO instrument and elsewhere, there is still a great deal of work to do if workable plans are to be put in place, and rehearsed, to prepare for and hopefully successfully combat future pandemics. We hope that our proposed provision stimulates an overdue conversation about the role of sharing know-how/trade secrets in such plans.
