Lessons for a pandemic preparedness treaty from previous successes and failures with treaty-based technology transfer.

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1.      Introduction

Scaling-up production of new vaccines to provide many billions of doses on a time-scale of one or two years has never been undertaken before. It is understandable that there have been problems to be faced at every stage of the Covid-19 vaccine manufacturing and distribution process. Nevertheless, given the magnitude of the need, the lack of progress in 2020 and 2021 on scaling-up domestic production of these vaccines in Low and Middle Income Countries (LMICs) is painfully evident. Increased LMIC production could assist with closing the existing gap between global supply and global need as well as with increasing the robustness and autonomy of regional LMIC supply. A key element has been the unwillingness of the pharmaceutical firms producing the Covid-19 vaccines to share their technology beyond the limited networks of their manufacturing partners. Initiatives that might have helped, such as the World Health Organization (WHO) hosted Covid-19 Technology Access Pool (C-TAP), have so far been neglected. In the context of discussions about a new international treaty to better prepare for future pandemic outbreaks (and perhaps yet improve the response to the present Covid-19 pandemic) it is therefore important to consider how adequate capacity building and technology transfer can best be effected. There is a substantial theoretical literature on technology transfer to inform any such discussions; unfortunately, a rather smaller one on successful instances in the real world. This briefing note focuses on one unsuccessful example and one successful example – experiences with technology transfer provisions in the 1982 United Nations Law of the Sea Convention (section 2) and the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer (section 3) – to examine  whether useful lessons might be learned for forthcoming discussions about a pandemic preparedness treaty. Issues identified for discussion include overarching international law principles, institutional architecture supplemented by a supportive financial mechanism, mandatory technology transfer in the case of severe threat and the importance of political leadership (section 4).

2.      Deep seabed mining and the 1982 United Nations Law of the Sea Convention

2.1       The policy problem.

About 50% of the Earth’s surface is covered by the deep seabed, at depths of between 200 and 10,000 m below sea level. It is rich in valuable mineral resources. These include fields of potato-sized metallic nodules on the abyssal plains (flat regions along the deep ocean floor) (Fig. 1) and metallic crusts on seamounts (underwater mountains), both of which have precipitated from seawater over millions of years. These mineral resources are largely located beyond the territorial jurisdiction of any individual coastal state. By the 1960’s, once the necessary technology had developed sufficiently for their mining to become a practical possibility, international discussions began to take place regarding their ownership. On the basis of so-called ‘high seas’ freedom, they could have been regarded as available to be exploited by anyone who was able, on a ‘first come, first served’ basis. Since the technology in question had been developed by only a few wealthy and technically sophisticated nations, however, this would effectively mean that they would likely reap the benefits of that exploitation to the exclusion of everyone else. In the political context of the time, the prospect of a new ‘gold rush’ benefiting only these few nations was not acceptable to many, especially developing nations. There were also concerns that unregulated competition could lead to an increase in Cold War tensions. A very different policy position was proposed by the Maltese Ambassador to the United Nations, Arvid Parvo, in 1967. He suggested that the deep seabed and its resources should instead be treated as the so-called ‘Common Heritage of Mankind’ (CHM; see Box 1) such that those resources could not be appropriated by individual states (and their mining companies) but could only be jointly exploited to the benefit of all mankind.

Fig. 1. A (poly) metallic nodule retrieved from the deep seabed. Image copyright ‘The Metals Company’ (https://metals.co/nodules/).

Reducing such high principle to legal, political and economic practice in the context of deep-sea mining took a good deal of time. (See e.g. Baslar (1998) for a broad ranging review of the CHM principle and its application in this and other areas). In fact, in the context of international discussions to reach a new convention on a range of issues relating to the law of the sea, it took fifteen years to reach broad (although, as will be seen, not unanimous) agreement on the inclusion of the CHM principle and settle on a particular implementation model. Art. 136 of the 1982 United Nations Convention on the Law of the Sea (‘Law of the Sea Convention’ or ‘UNCLOS’) provides that: “The Area [the deep seabed] and its resources are the common heritage of mankind.” Art. 137 (2) UNCLOS further provides that: “All rights in the resources of the Area are vested in mankind as a whole, on behalf of which the Authority [a new international organisation] shall act.” Art. 133 UNCLOS defines these ‘resources’ to be “all solid, liquid or gaseous mineral resources in situ in the Area at or beneath the sea-bed, including polymetallic nodules.”

Details of the mining regime to be established were spelled out in Part XI and Annex III UNCLOS. With the support of the Carter administration in the United States, a ‘parallel’ system had been adopted. So long as they obtained the necessary licence from the Authority, mining companies would be permitted to undertake their own mining activities. However, the Authority had also been tasked with establishing its own operational mining arm (the ‘Enterprise’). To help the Enterprise get up and running and able to undertake the technically difficult task of deep seabed mining in parallel with the mining companies, obligations would be placed on those companies via their licence agreements to engage in, for example, the identification of suitable mining sites for the Enterprise (the ‘site banking’ system) and technology transfer to the Enterprise (and to associated developing countries).

Box 1. The Common Heritage of Mankind (CHM) principle.

The Common Heritage of Mankind (CHM) principle can be characterised in terms of key elements, including: (a) non-appropriation by public or private parties; (b) management by an international authority to the benefit of all; (c) equitable sharing of any benefits among all; (d) peaceful use; and (e) free and open scientific research. Since ‘all’ is typically regarded as including future humanity too, the management of any spaces or resources subject to the CHM principle must look to a responsible and sustainable stewardship.

The application of the CHM principle to the mineral resources of the deep seabed is now uncontroversial. The leading maritime nations, with the exception of the United States, are parties to the 1982 United Nations Convention on the Law of the Sea and the explicit implementation of the CHM principle in its deep seabed mining regime. Even the United States has not acted on deep seabed mining in a manner inconsistent with the CHM principle, though, and the equivalent domestic American legislation (the 1980 Deep Seabed Hard Minerals Resources Act) recognises its provisional application. It is therefore arguable that aspects of the CHM principle as reflected in the Law of the Sea Convention have ‘freed themselves’ from its text and have become regarded as binding obligations under international customary law (Dingwall 2020).

To take another example from the same time period, though, Art. 11 (1) of the 1979 Agreement governing the Activities of States on the Moon and Other Celestial Bodies (‘Moon Agreement’) states that “The moon and its natural resources are the common heritage of mankind”; Art. 11 (5) accordingly calls for the establishment of “…an international regime…to govern the exploitation of the natural resources of the moon as such exploitation is about to become feasible.” In this case, none of the major spacefaring nations have ratified it and only eighteen other states have yet done so. The ownership and management of space-based resources is a pressing issue, with plans maturing for the establishment of permanent settlements on the Moon and Mars and proposals to begin near-Earth asteroid mining, but the chances of agreement on the application of the CHM principle in this context and, for example, an International Space Authority being put in charge (akin to the International Seabed Authority) seem slim. Its application in other treaty contexts, for example, regarding the marine genetic resources of the deep sea (see Box 2), is also strongly contested.

2.2       Technology transfer provisions of the Law of the Sea Convention

The Law of the Sea Convention contains provisions on technology transfer relating to both deep seabed mining and scientific research. As to the former, Art. 144 UNCLOS treats technology transfer in broad terms as follows:

“1. The Authority shall take measures in accordance with this Convention:

(a) to acquire technology and scientific knowledge relating to activities in the Area; and

(b) to promote and encourage the transfer to developing States of such technology and scientific knowledge so that all States Parties benefit therefrom.

  1. To this end the Authority and States Parties shall cooperate in promoting the transfer of technology and scientific knowledge relating to activities in the Area so that the Enterprise and all States Parties may benefit therefrom. In particular they shall initiate and promote:

(a) programmes for the transfer of technology to the Enterprise and to developing States with regard to activities in the Area, including, inter alia, facilitating the access of the Enterprise and of developing States to the relevant technology, under fair and reasonable terms and conditions; …”.

Important detail is provided in Annex III, UNCLOS. The term ‘technology’ is here defined as “…the specialised equipment and technical know-how…necessary to assemble, maintain and operate a viable system and the legal right to use these items for that purpose on a non-exclusive basis” (Art. 5 (8) Annex III, UNCLOS). A wide range of sophisticated technologies were therefore potentially involved including bathymetric profiling (to map the seabed), submersibles (to visit the seabed and, for example, undertake sampling), geological analysis, deep sea (probably robotic) mining equipment and associated processing facilities at the sea surface. Crucially, Art. 5 (3) Annex III, UNCLOS (‘Transfer of Technology’) provides that:

“Every contract for carrying out activities in the Area shall contain the following undertakings by the contractor: (a) to make available to the Enterprise on fair and reasonable commercial terms and conditions, whenever the Authority so requests, the technology which he uses in carrying out activities in Area under the contract, which the contractor is legally entitled to transfer…This undertaking may be invoked only if the Enterprise finds that it is unable to obtain the same or equally efficient and useful technology on the open market on fair and reasonable commercial terms and conditions.”

A mining company could not therefore expect to obtain a mining licence for a site in the Area without undertaking to transfer its technology to the Enterprise on ‘fair and reasonable commercial terms and conditions’, should the Authority so request. In other words, granting or denying the right to mine in the Area could be used by the Authority as the quid pro quo to effect technology transfer on request. An informal working paper which was provided by the American delegation to the Law of the Sea conference gave some guidance on how ‘fair and reasonable commercial terms and conditions’ was expected to be understood (reproduced as Annex I to this note).

In addition, Art. 5 (5) Annex III, UNCLOS provides that:

“If the Enterprise is unable to obtain on fair and reasonable commercial terms and conditions appropriate technology to enable it to commence in a timely manner the recovery and processing of minerals from the Area, either the Council or the Assembly [organs of the Authority] may convene a group of States Parties composed of those which are engaged in activities in the Area, those which have sponsored entities which are engaged in activities in the Area and other States Parties having access to such technology. This group shall consult together and shall take effective measures to ensure that such technology is made available to the Enterprise on fair and reasonable commercial terms and conditions. Each such State party shall take all feasible measures to this end within its own legal system.” (emphasis added)

A backstop was therefore provided that, if the necessary technology transfer to the Enterprise did not take place via licensing at a mining company level, the Authority could call on the States Parties (i.e. governments) to take ‘all feasible measures’ within their own national legal systems to ‘ensure’ that it is transferred to the Enterprise by other means. The scope of this provision has been debated and it has been argued that measures such as tax incentives or other financial incentives, including compensation, may be sufficient (Li 1994). However, it is not difficult to argue that ‘all feasible measures’ would also support non-voluntary measures, such as compulsory licensing of patents and equivalent measures for other intellectual property rights.

As it turned out, this conceptualisation of the Enterprise was hugely over ambitious. Although the Carter administration had been sympathetic to the idea of technology transfer to the Enterprise, the successor Reagan administration was not, and neither were many European governments. The leading marine mining companies which were based in these countries had no desire to share technologies which were of high importance to them. It also appears that they had a high degree of political influence. Further, there were national security concerns about the transfer of ‘dual use’ technologies which could give adversaries an advantage. Accordingly, despite sufficient agreement on the rest of the negotiated Law of the Sea Convention package, the United States, United Kingdom, France, Germany, Italy and Japan all declined to ratify it.

This stand-off continued for twelve years. Having achieved the necessary number of ratifications from other states, the Law of the Sea Convention was due to enter into force in late 1994. To do so without these important maritime states would have been a blow to the credibility of the Law of the Sea system, however, so a last-ditch effort was mounted to bring them on board. This resulted in the Agreement on the Implementation of Part XI of UNCLOS (the ‘1994 Agreement’). Its name is something of a misnomer since it was not so much concerned with implementing Part XI as amending it. Although the application of the CHM principle to the resources of the deep seabed was re-affirmed, the plans for the Enterprise were substantially scaled back. Instead of independent operation, the 1994 Agreement provides that the: “…Enterprise shall conduct its initial deep seabed mining operations through joint ventures” (Annex, Section 2.2, 1994 Agreement). Regarding the technology transfer obligations, it provides (Annex, Section 5, 1994 Agreement) that:

“1.       In addition to the provisions of article 144 of the Convention, transfer of technology for the purposes of Part XI shall be governed by the following principles:

(a) the Enterprise, and developing States wishing to obtain deep seabed mining technology, shall seek to obtain such technology on fair and reasonable commercial terms and conditions on the open market, or through joint-venture agreements;

(b) if the Enterprise or developing States are unable to obtain deep seabed mining technology, the Authority may request all or any of the contractors and their respective sponsoring State or States to cooperate with it in facilitating the acquisition of deep seabed mining technology by the Enterprise or its joint venture, or by a developing State or States seeking to acquire such technology on fair and reasonable terms and conditions, consistent with the effective protection of intellectual property rights. States Parties undertake to cooperate fully and effectively with the Authority for this purpose and to ensure that contractors sponsored by them also cooperate fully with the Authority;

(c) […]

  1. The provisions of Annex III, article 5, of the Convention shall not apply.” (emphasis added)

Art. 5, Annex III, UNCLOS and the 1994 Agreement can effectively be seen as artefacts of two different ages: the former springing from the idealistic New International Economic Order thinking of the 1960’s and the latter from the market economy philosophy of Reagan and Thatcher in the 1980’s. In this case, the former did not survive contact with the latter and the non-voluntary (‘mandatory’) technology transfer mechanism in Art 5, Annex III, UNCLOS, was therefore abandoned.

This and related changes in other areas were sufficient to persuade the United Kingdom, France, Germany, Italy and Japan to ratify the Law of the Sea Convention. They remained insufficient for the United States, however, which has still not ratified it. 

2.3       Has any technology transfer taken place?

With the entry into force of the Law of the Sea Convention, the Authority became operational, as the International Seabed Authority (ISA), based in Kingston, Jamaica (https://www.isa.org.jm). Even in its scaled-back form, it is still a striking experiment in the collaborative (or indeed ‘communal’) management of our planetary resources. At the present time, it has granted thirty licences to permit exploration by mining companies (whether private companies sponsored by a State or State bodies), although since earlier expectations about the likely ease and rewards of deep seabed mining proved overly optimistic no full-scale commercial activity has yet actually begun.

Although operational, it is not clear that the ISA has managed to bring about any meaningful deep seabed mining technology transfer. A recent study assessing the impact of the remnant provisions stated that the: “…ISA has paid more attention to training activities for personnel of the Authority as well as of developing States and has ignored the transfer of technology itself in practice, especially the patented mining technology which is the key technology in exploration and exploitation of the Area.” (Ning 2021). It may be charitably suggested that the ISA has had other policy issues to contend with first or that the training activities may assist better planning for technology transfer in due course. Nevertheless, progress is painfully slow. The study recommends that instead of passively waiting for technology transfer to occur (especially if it expects that it will happen on preferential terms, such as the ‘reduced rate or free of charge’ anticipated by the Intergovernmental Oceanic Commission (IOC) Guidelines, see: https://ioc.unesco.org/our-work/marine-policy), the ISA instead needs to begin planning proactively to use what remaining leverage it does have (for example, through the ‘reserved’ sites in the site-banking system) in order to aid the acquisition of the necessary technology in the context of commercial conditions and consistent with the protection of intellectual property rights (Ning 2021).

 2.4       Epilogue

The inclusion of the Common Heritage of Mankind (CHM) principle in the Law of the Sea Convention was a remarkable achievement, despite the 1994 Agreement reducing the scope of its practical consequences, for example, regarding technology transfer. However, the future impact of the CHM principle, and its application in other domains, remains somewhat uncertain (see Box 1).

The subject of deep seabed mining has again become a hot topic in international circles due to its linkages with climate change and biodiversity. On the one hand, it has turned out that many of the metals in which the deep seabed resources are rich, such as copper, nickel, cobalt and the Rare Earth Elements (REEs), are precisely those which are important in the transition from a hydrocarbon to a renewable energy-based infrastructure, for example, in terms of electric vehicle batteries. Deep seabed mining may therefore support efforts to move to a lower carbon future. On the other hand, such activity will have a severe impact on deep sea environments which have now been found to be rich in life, thriving in the unusual conditions. Ironically, this deep-sea life is itself now regarded as an independently exploitable resource. There is excitement among ‘bioprospectors’ that previously unknown molecules could be discovered in organisms here which may lead to the development of valuable new medicinal products. A new treaty, with its own technology transfer provisions, has been proposed to protect the biodiversity of the deep-sea zone and regulate its exploitation (Box 2). It has been suggested that this treaty could be based on the Common Concern of Humankind (CCH) principle (Box 3). It is likely to feature a so-called ‘clearing house’ architecture (Box 4). In addition, it is possible that deep seabed mining could have a further reaching impact in terms, for example, of releasing carbon stored in deep sea environments or reducing their ability to absorb it. An increasingly public debate is therefore now taking place about whether plans for deep seabed mining should now be slowed or stopped (see e.g.: Scales (2021) or https://www.seabedminingsciencestatement.org).

Box 2. Proposed treaty on ‘Marine Biological Diversity of areas beyond National Jurisdiction’ (BBNJ).

Previously unknown communities of life in the deep-sea zone have been discovered in recent decades, for example, those located around ‘hydrothermal vent’ systems. Such hydrothermal vent systems are produced along tectonic plate boundaries where magma interacts with seawater below the seabed such that superheated mineral rich fluids become injected through these vents into the deep sea. As metal sulphides precipitate out from the fluids, they form natural chimney-like structures up to 60m tall. On and around these chimneys, ecosystems have been found which rely on chemosynthesis (deriving energy from chemical reactions) instead of the photosynthesis (deriving energy from sunlight) on which the more familiar ecosystems rely at the Earth’s surface. This and other differences mean that organisms in these communities represent a rich new field for bioprospecting. Scientists and biopharmaceutical companies have therefore become involved in screening deep sea organisms for novel marine bioactive substances that may form the basis of new medicinal products, for example, antibiotics that may prove useful in combating antimicrobial resistance (see e.g. Tortorella et al 2018). A recent study examining patents associated with marine genetic resources (MGRs) reported that they already included genetic sequences associated with 91 deep sea and hydrothermal vent species (Blasiak et al 2018).

Unfortunately, and notwithstanding the richness, interest and potential value of these communities from a scientific and biopharmaceutical perspective, the fact remains that the chimney-structures are built of metal sulphides. As such, they and the metal sulphide deposits formed by associated but now extinct hydrothermal vent systems, represent a third type of deep seabed mineral resource over which the ISA has jurisdiction. Controversy has arisen, for example, over the ‘Lost City’ hydrothermal vent system on the mid-Atlantic ridge which lies within an area which is the subject of an active exploration licence granted by the ISA but which is of such scientific interest that it has been noted by UNESCO as a site potentially warranting World Heritage status (Johnson 2019). Following initial preparatory work, formal discussions began in 2017 about a new treaty (‘Marine Biological Diversity of areas beyond National Jurisdiction’ (BBNJ)) to protect the biodiversity of the deep-sea zone as well as to regulate access to and exploitation of its associated MGRs. Some framework is provided by, for example, Parts XIII (‘Marine Scientific Research’) and XIV (‘Development and Transfer of Marine Technology’) UNCLOS as well as the 1992 Convention on Biological Diversity (CBD) framework. Since the Common Heritage of Mankind (CHM) principle (see Box 1) presently only explicitly applies to the mineral resources of the Area, however, it is not clear whether it could be extended to embrace these MGRs too. The Common Concern of Humankind (CCH, see Box 3) principle, which was first explicitly expressed in the CBD, has been suggested as an alternative (Bowling et al 2016). Although less ambitious that the CHM principle, the CCH principle nevertheless obliges States, for example, to cooperate closely in their decision making to the good of all humankind and to share burdens and / or benefits (see Box 3). For a broad ranging review of the CCM principle and its application in a number of areas see e.g. Cottier & Ahmad (2021). In the absence of agreement, the default position might instead fall back to a ‘high seas’ freedom regime (and a ‘first come, first served’ approach).

Transfer of technology is again therefore an important issue for discussion in the context of trying to ensure that all States can participate in the scientific study of the biodiversity of the Area as well as taking part in, and benefiting from, exploitation of its associated MGRs. Detailed discussions are ongoing (see e.g, Harden-Davies & Snelgrove 2020) but it seems that even basic questions of approach to technology transfer have yet to be agreed. In the latest (2019) version of the draft treaty text (A/CONF.232/2020/3), for example, Art. 44 (draft BBNJ) (‘Modalities for capacity-building and the transfer of marine technology’) indicates that:

  1. States Parties, recognizing that capacity-building, access to and the transfer of marine technology, including biotechnology, among States Parties are essential elements for the attainment of the objectives of this Agreement, [undertake to provide or facilitate] [shall promote] [shall ensure] access to and the transfer of marine technology to, and capacity-building for, developing States Parties, in particular least developed countries, landlocked developing countries, geographically disadvantaged States, small island developing States, coastal African States and developing middle – income countries.
  2. Capacity-building and the transfer of marine technology [shall] [may] be provided on a [mandatory and voluntary] [voluntary] [bilateral, regional, subregional and multilateral] basis.


and Art. 45 (draft BBNJ) (‘Additional modalities for the transfer of marine technology’) indicates that:

  1. The [development and] transfer of marine technology shall be carried out [on fair and most favourable terms, including on concessional and preferential terms] [according to mutually agreed terms and conditions].

[2. Alt. 1. The transfer of marine technology shall [take into account the need to protect intellectual property rights] [be carried out with due regard for all legitimate interests, including the rights and duties of holders, suppliers and recipients of marine technology].]

[2. Alt. 2. States Parties shall [protect] [respect the protection of] intellectual property rights.]

[2. Alt. 3. Intellectual property rights [related to resources of areas beyond national jurisdiction] shall [not preclude the transfer of marine technology] [be subject to specific limitations in the furtherance of technology transfer related to marine technology] under this Agreement.]


Annex II (draft BBNJ) lists two pages of different types of capacity building and technology transfer that are contemplated for inclusion.

One element on which there may be more agreement is the institutional choice of a clearing-house mechanism (Box 4).  Art. 51 (draft BBNJ) (‘Clearing-house mechanism’) provides:

  1. A clearing-house mechanism is hereby established.
  2. The clearing-house mechanism shall consist primarily of an open-access web-based platform. [It shall also include a network of experts and practitioners in relevant fields.] The specific modalities for the operation of the clearing-house mechanism shall be determined by the Conference of the Parties.
  3. The clearing-house mechanism shall serve as a centralized platform to enable States Parties to have access to [, collect] [, evaluate] [, make public] and disseminate information with respect to:


[(e) Opportunities for capacity-building and the transfer of marine technology, such as activities, programmes and projects being conducted in areas beyond national jurisdiction, including those relevant to building capacity for skills development in activities covered in this Agreement [, as well as availability of funding];]

[(f) Requests for capacity-building and the transfer of marine technology on a case-by-case basis;]


[(h) Information on sources and availability of technological information and data for the transfer of marine technology and opportunities for facilitated access to marine technology.]

Box 3. The Common Concern of Humankind (CCH) principle.

The consequences of restricting the freedom of public and private parties to access and exploit resources subject to the Common Heritage of Mankind principle are not just legal but intensely political too. It is perhaps for this reason that the newer Common Concern of Humankind (CCH) principle retreats somewhat from the ambition of the CHM principle. It stakes a claim for the involvement of the international community in, for example, managing a resource but does not go so far as to usurp traditional national sovereignty over it. It is perhaps even more easily conceptualised in terms of addressing common threats. Although still evolving, key elements of the CCH principle include: (a) shared decision making and accountability; (b) shared benefits and burdens; (c) common but differentiated responsibilities (i.e. all states are responsible but not equally so); and (d) intergenerational equity.

The application of the CCH principle in several environmental treaties addressing classic examples of ‘collective action problems’ is now uncontroversial. The 1992 Convention on Biological Diversity (CBD) affirms that “…conservation of biological diversity is a common concern of humankind”. The 1992 United Nations Framework Convention on Climate Change (UNFCCC) acknowledges that “…change in the Earth’s climate and its adverse effects are a common concern for humankind…” and the related 2015 Paris Agreement acknowledges that “…climate change is a common concern of humankind…”. Nevertheless, significant questions remain as to whether it will become more broadly accepted as a valuable principle in international law (or whether it, like the CHM principle before it, runs the risk of being cast as ‘cosmopolitan daydreaming’) and, if so, how best to understand, develop and operationalise it (Cottier & Ahmad 2021).

Box 4. Clearing-houses.

A clearing-house provides a hub where those providing goods, services and information can be matched with those needing the same as well as providing a focal point for related activities. Such clearing-houses have already been implemented under several treaties, for example, under the CBD (https://www.cbd.int/chm/) and the United Nations Framework Convention on Climate Change (https://www.ctc-n.org). In the context of the proposed Marine Biological Diversity of areas beyond National Jurisdiction’ (BBNJ) treaty (see Box 3), a clearing-house is anticipated to support data and information exchange as well as technology transfer.


3.      The Ozone hole and the 1987 Montreal Protocol

3.1       The policy problem.

The previous example related to how a valuable resource (deep sea minerals) is to be shared in common. This example instead relates to how a common threat (weakening of the protective effect of the ozone layer) is to be faced. Chloroflurocarbons (CFCs) were invented for use in refrigeration systems in the 1920’s. They were intended to replace previously used refrigerants, such as ammonia (NH3) and sulphur dioxide (SO2), which were hazardous to humans if the system ruptured and they were released into the air. However, later on in the twentieth century it became clear that two of the properties which made CFCs such good refrigerants, being volatile and inert, caused an unanticipated problem. When the CFCs were released into the air, they became relatively easily transported into the stratosphere. At that altitude, solar ultraviolet (UV) radiation disassociates the CFC molecules, yielding chlorine atoms which in turn catalyse the transformation of ozone (O3) into oxygen (O2). A single chlorine atom can remain in the stratosphere long enough to transform as many as 100,000 ozone molecules into oxygen. The dynamics of the interaction of UV radiation with ozone molecules (the ‘ozone-oxygen’ cycle) are such that the ‘ozone layer’ (at an altitude between about fifteen and forty km) significantly reduces the intensity of particular wavelengths of UV radiation at the Earth’s surface which could cause genetic damage and other harm in humans, for example, sunburn, skin cancers and cataracts. Similar harm would also be caused to animals (including plankton) and plants. Accordingly, if naturally occurring levels of ozone were to be reduced through the presence of CFCs and other ozone depleting substances (ODSs), so too would the effectiveness of this ‘shield’.

Although concern about this threat had begun to rise in the 1970’s and early 1980’s, a particularly concrete example of the magnitude of the problem caused by CFCs came with the discovery in the mid 1980’s of a ‘hole’ in the ozone layer (not, in fact, an absence of ozone but a severe depletion) over Antarctica (Fig. 2). The state of the stratosphere in the Antarctic spring provides favourable conditions for CFC catalysed ozone destruction to occur. However, much smaller magnitude depletions at more densely populated latitudes could still have grave consequences for human, animal and plant health.

Fig.2. Antarctic ozone hole in October 2017. Image credit: NASA Goddard Space Flight Center (https://www.nasa.gov/feature/goddard/2020nasa-data-aids-ozone-hole-s-journey-to-recovery).

Even though the science took some time to become adequately understood, international negotiations first led to the 1985 Vienna Convention for the Protection of the Ozone Layer and subsequently to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer (‘Montreal Protocol’ or ‘MP’). Whilst the Vienna Convention encourages research, information sharing, and cooperation to reduce the environmental and human impact of the depleting ozone layer, it was the Montreal Protocol which provided the essential mechanism to ban the production and use of ODSs. It is notable, in the light of the confrontational policy position that the Reagan administration took on deep seabed mining, that it ended up playing a very much more positive policy role here. Whitesides (2020) provides an interesting analysis of the complex inter-relations between the scientific community, the chemical industry, the policy making community and others that caused it to do so. The Montreal Protocol subsequently entered into force in 1989. It is to-date the only UN treaty ever ratified by all 198 UN Member States.

The Montreal Protocol includes a list of ODSs which must be phased out as well as timetables for doing so. The list mechanism is a flexible one which is subject to change in the light of improved scientific information. As the ODSs are phased out, technology transfer has an important role to play regarding the deployment of their replacements. By way of encouragement, a meeting of the States Parties in London in 1990 amended the Montreal Protocol to provide for a financial mechanism (‘Multilateral Fund’ (MLF), see: http://www.multilateralfund.org/default.aspx) to support such technology transfer. The initial size of the MLF was set at USD 160 million for the period 1991-1993. The 2017 replenishment of the MLF raised this sum to USD 500 million for the period 2018-2020.

3.2       Technology transfer provisions of the Montreal Protocol.

The Montreal Protocol adopts a differential approach to the obligations of ‘developed’ and ‘developing’ countries, with the latter identified as Art 5(1) MP parties.

Arts. 10 (1) and (2) MP (‘Financial Mechanism’) respectively provide that:

“The Parties shall establish a mechanism for the purposes of providing financial and technical co-operation, including the transfer of technologies, to Parties operating under paragraph 1 of Article 5 of this Protocol to enable their compliance with the control measures set out in Articles 2A to 2E of the Protocol. The mechanism, contributions to which shall be additional to other financial transfers to Parties operating under that paragraph, shall meet all agreed incremental costs of such Parties in order to enable their compliance with the control measures of the Protocol. An indicative list of the categories of incremental costs shall be decided by the meeting of the Parties.” (emphasis added)

“The mechanism established under paragraph 1 shall include a Multilateral Fund. It may also include other means of multilateral, regional and bilateral co-operation.”

Art. 10A MP (‘Transfer of Technology’) provides that:

“Each Party shall take every practicable step, consistent with the programmes supported by the financial mechanism, to ensure:

(a) that the best available, environmentally safe substitutes and related technologies are expeditiously transferred to Parties operating under paragraph 1 of Article 5; and

(b) that the transfers referred to in subparagraph (a) occur under fair and most favourable conditions.” (emphasis added)

The indicative list of incremental costs that the financial mechanism will pay for (Art. 10 (1) MP) includes the “…cost of patents and designs and incremental cost of royalties…” associated with converting existing manufacturing facilities and / or building new ones (Annex VIII MP).

3.3       Has any technology transfer taken place?

The Montreal Protocol framework, supported by the MLF, has proved remarkably successful in delivering high impact technology transfer:

“It [the technology transfer] is an extraordinary deviation from the situation reported in other case studies of technology transfer, and many readers may find the truth too good to believe. It is possible that that Montreal Protocol experience is the only occasion so far when public and private stakeholders considered technology cooperation a matter of human survival, stepped out of their narrow self-interests and promoted actions that allowed humanity to survive on Earth.” (Andersen et al 2007).

The technologies transferred ranged across many industrial sectors including foams, refrigeration and air-conditioning, aerosol products, fire protection, solvents and pest control (Andersen et al 2007). One helpful contributory factor has been that intellectual property has not (yet) posed significant problems: “…this was because the best technology available generally had more than one supplier, but also because many technologies were cooperatively developed and administratively delivered to the public domain for unrestricted global use” (Andersen et al 2007). It also appears that some of the replacement substances were sufficiently old to have fallen out of patent protection and / or were not subject to patent protection in relevant countries (Seidel & Ye 2015; United Nations Environment Program (UNEP) Ozone Secretariat 2016). Where companies did own pertinent intellectual property, it has also been helpful that some of them voluntarily opted to disclose the relevant know-how and / or permitted non-exclusive royalty free use of their patents (Andersen et al 2007). Crucially, though, where companies were not prepared to offer their technology on these terms, it seems that in the vast majority of cases they were content with some form of (royalty) payment. The MLF has either explicitly paid for these associated incremental costs, including discrete (lump) sums for one-off transactions as well as ongoing royalties per unit of production, or has implicitly paid for them where the intellectual property related costs have not been split out (Seidel & Ye 2015; UNEP Ozone Secretariat 2016).

3.4       Epilogue

The Montreal Protocol is rightly acclaimed as a triumph. (For a very brief recap see, for example, this short film: https://ozone.unep.org/hole-film-montreal-protocol-narrated-sir-david-attenborough). The damage to the ozone layer caused by CFCs and other ODSs has already begun to recover.  Rather than collapsing by around the middle of the twenty-first century, it is anticipated that by then ozone levels should have recovered to those of the 1980s. CFCs and other ODSs also turned out to be potent greenhouse gases, so the dangerously accelerated warming which they would otherwise produced has also been avoided. Work under the Montreal Protocol is far from over, however, and there may be more complex challenges to address in the future. In fact, it has only been later appreciated that the hydrofluorocarbons (‘HFCs’) introduced to replace CFCs and other ODSs are themselves also potent greenhouse gases. Accordingly, under the recent Kigali amendment to the Montreal Protocol, those HFCs with a high Global Warming Potential (‘high-GWP’) are being phased out. There are concerns that possible substitutes, such as hydrofluoroolefins (‘HFOs’), may be more likely to be protected by intellectual property. Accordingly, it may become necessary to more explicitly address intellectual property issues within the Montreal Protocol framework including, for example, in terms of the development of patent information databases and potentially even patent pools (Seidel & Ye 2015; UNEP Ozone Secretariat 2016). 

4.      Conclusions

This briefing note has focussed on two examples – experiences with technology transfer provisions in the 1982 United Nations Law of the Sea Convention and the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer – which have illustrated successes and failures in their handling of technology transfer. Some initial issues and features can immediately be identified for discussion in the context of a pandemic preparedness treaty. If they prove of interest, it may be appropriate to draw on experts in those areas to develop them – or other issues and features – further. In particular, since experiences with treaty-based technology transfer do typically appear to be very disappointing (see, for example, McInerney 2014), a deeper dive with experts on successful experiences with the Montreal Protocol may be useful.

4.1.      Foundations and international legal principles.

A pandemic preparedness treaty might look to an overarching international law principle, for example, the Common Concern of Humankind (CCH) (see Box 3), to ground and support its provisions. Given the free-for-all that has occurred during Covid-19, with inadequate support for international mechanisms such as the Covax facility or the Covid-19 Technology Access Pool (C-TAP) and many countries instead resorting to ‘vaccine nationalism’, it would certainly be helpful for States to be more predictably guided as to decision making and common burden sharing. Alternatively, if the principle is regarded as having unambiguous normative effect, it may be that it ties the hands of negotiators to too great an extent and that a sui generis approach (i.e. a unique approach crafted for those particular circumstances) may lead to a more nuanced and suitable outcome.

4.2.      Justifying the inclusion of technology transfer provisions

Is technology transfer necessary to solve a particular policy problem? If so, what type and how is it to be done? In theory, a pandemic related medical product could be manufactured at a single site for distribution to the rest of the world. However, as flagged in the introduction, considerations of robustness (resilience) and regional or national health autonomy suggest that a much more distributed manufacturing system is appropriate. Technology transfer will likely therefore be required. Thought could be given to how different scales and types of technology transfer could be justified regarding, for example, longer term capacity building or operationalising shorter term surge capacity. Given the continuous updating process built into the Montreal Protocol (section 3.1), what might a desirable ‘end state’ look like in terms of optimal pandemic preparedness and might some equivalent updating process be suitable? In some cases, it may also be necessary to address sensitivities regarding the transfer of ‘dual use’ technologies regarding national security (section 2.2).

4.3.      Institutional architecture for technology transfer

A clearing-house mechanism is now commonly chosen in other treaties as a preferred institutional architecture for technology transfer (see Box 4). More complex institutions, such as patent pools, have now been discussed in the context of the Montreal Protocol (section 3.4). In the field of public health, a pandemic preparedness treaty could already draw on institutional architecture such as the Medicines Patent Pool (MPP) and, subject to its further development, C-TAP (see Box 5). There are also promising new developments regarding technology transfer ‘Hubs’ (see Box 5). However, the Multilateral Fund (MLF) established under the Montreal Protocol provides a model for another potentially very helpful element of architecture (section 3.2). The MLF has proved very successful in supporting technology transfer through paying for, for example, royalty costs (section 3.3). Thought could be given to how different funding models could be justified regarding longer term capacity building or operationalising shorter term surge capacity.

Box 5. The Medicines Patent Pool, Covid-19 Technology Access Pool, and technology transfer ‘Hubs’

There are several existing and promising new institutions that could be drawn on to facilitate technology transfer in the context of a pandemic preparedness treaty. They include:

The Medicines Patent Pool (MPP): The MPP is a UN-backed organisation that works to increase access to affordable medicines by negotiating non-exclusive, transparent licences to use patents on key medical technologies in low- and middle-income countries. Importantly, MPP licences can also include provisions to facilitate the registration and supply of generic medicines, including waiving regulatory data exclusivity. The MPP’s mandate currently includes patented medicines on the WHO’s Essential Medicines List, potential essential medicines, as well as technologies to combat Covid-19. See: https://medicinespatentpool.org/

The Covid-19 Technology Access Pool (C-TAP): C-TAP was launched on 29 May 2020 as a way to share intellectual property, including know-how, data, technology, and biological materials needed to expand and speed product development and manufacturing related to the pandemic. It expressly intended to facilitate technology transfer in order to aid in the creation of local and regional manufacture of tools to fight Covid-19.  See: https://www.who.int/initiatives/covid-19-technology-access-pool

Technology Transfer ‘Hubs’: The WHO has recently been working to set up ‘hubs’ that will transfer technology, know-how and provide training necessary to build manufacturing capacity on specific Covid-19 related vaccine technologies in Low and Middle Income Countries. The project is initially prioritizing mRNA-vaccine technology; the first regional hub will be in South Africa, with others planned to follow. MPP is aiding the transfer hubs with licensing expertise. See: https://www.who.int/news/item/21-06-2021-who-supporting-south-african-consortium-to-establish-first-covid-mrna-vaccine-technology-transfer-hub

4.4.      Incentives for voluntary technology transfer

A variety of direct and indirect incentives to encourage companies to transfer their technology are well-known including financial and tax incentives. Some of these could be provided by an MLF-like fund. An obvious difficulty is being able to make the incentives sufficiently attractive that the companies with the requisite technology are motivated to engage. The size of the MLF fund is currently of the order of USD 500 million (section 3.2) whereas Pfizer have announced that their Covid-19 vaccine sales are expected to exceed USD 33 billion in 2021 alone. (It can obviously be argued that the sums paid by States accounting for these sales should have been regarded as a supra-normal incentive and should have included ‘strings attached’ provisions on technology transfer; see https://left.eu/content/uploads/2021/07/Advanced-purchase-agreements-1.pdf.) Attractive incentives will therefore be more easily crafted for small and medium sized companies or other entities. Although other issues were very relevant too in their choice of partners (for example, the management of clinical trials), it is interesting to speculate on how different the development paths chosen by, for example, the Jenner Institute and BioNTech might have been had a substantial and supportive MLF-like fund been available, which might not have led to partnering with multi-national pharmaceutical companies (see ML&P’s briefing note on the Jenner Institute’s vaccine here: https://medicineslawandpolicy.org/2020/10/how-the-oxford-covid-19-vaccine-became-the-astrazeneca-covid-19-vaccine/).

4.5.      Mandatory technology transfer

An attempt to mandate technology transfer as a quid pro quo for being permitted to undertake deep seabed mining was a failure (sections 2.2 and 2.3). However, it is important to understand the context in which it failed and to note that such provisions may be viewed differently in different contexts. The threat posed by a pandemic could be even more severe than that posed by CFCs (and other ODSs) depleting the ozone layer (section 3.1). Pandemics are commonly regarded as being near the top of lists of existential threats to humanity due to the likelihood of their occurrence (inevitable) and their impact (the potential to lead to unrecoverable civilisational collapse in months). Worst-case scenarios must therefore be anticipated and planning not left until they occur. In this context, it is obvious that mandatory technology transfer may have to take place and must therefore be provided for in any pandemic preparedness treaty. This point is underlined by the recent use of ‘war powers’ by the United States in the context of Covid-19 (see, for example: https://www.cfr.org/in-brief/what-defense-production-act). Big Pharma firms could not be exempt from this. Accordingly, thought should be given to a pandemic preparedness treaty obliging States Parties to act in concert using all of the powers at their disposal to ensure that, even only if in extremis, vital technology transfer can take place effectively and rapidly (akin to the provisions discussed in section 2.2). The problem of accessing critical know-how kept in confidence by a company has been touched on in another MLP briefing note (“What is the ‘know-how gap’ problem and how might it impact scaling up production”, see: https://medicineslawandpolicy.org/2020/12/what-is-the-know-how-gap-problem-and-how-might-it-impact-scaling-up-production-of-covid-19-related-diagnostics-therapies-and-vaccines/). To obviate this problem, those States Parties with a close nexus to the company or companies in question would have a special duty to ensure its disclosure to the appropriate third parties (again, akin to the provisions discussed in section 2.2). In such circumstances, it may also be sensible to give some thought to ancillary obligations regarding, for example, States acting in concert to support the supply of the necessary raw materials and other inputs.

4.6.      Political leadership

The remarkable achievement of the Montreal Protocol in preventing and repairing anthropogenic damage to the ozone layer demonstrates that political leadership is important in bringing about technology transfer (section 3). Passively sitting back and expecting companies to offer their technology for transfer is unlikely to be successful unless overwhelmingly attractive incentives are available. Instead, so long as a treaty framework provides suitable institutional architecture and suitable funding, proactive political leadership and engagement efforts may be the key to success. The recent United Nations Secretary General report ‘Our Common Agenda’ (https://www.un.org/en/content/common-agenda-report/#download) may provide timely impetus for that leadership and engagement.


5.      References

Andersen, S.O., Sarma, K.M. and Taddonio, K.N., 2012. Technology transfer for the ozone layer: Lessons for climate change. Routledge.

Baslar, K., 1998. The concept of the common heritage of mankind in international law (Vol. 30). Martinus Nijhoff Publishers.

Blasiak, R., Jouffray, J.B., Wabnitz, C.C., Sundström, E. and Österblom, H., 2018. Corporate control and global governance of marine genetic resources. Science advances, 4(6), p.eaar5237.

Bowling, C., Pierson, E. and Ratté, S., 2016. The common concern of humankind: a potential framework for a new international legally binding instrument on the conservation and sustainable use of marine biological diversity in the high seas. Prepcom White Paper, pp.1-15. (https://www.un.org/depts/los/biodiversity/prepcom_files/BowlingPiersonandRatte_Common_Concern.pdf)

Cottier, T. and Ahmad, Z. eds., 2021. The Prospects of Common Concern of Humankind in International Law. Cambridge University Press.

Harden-Davies, H. and Snelgrove, P., 2020. Science collaboration for capacity building: advancing technology transfer through a treaty for biodiversity beyond national jurisdiction. Frontiers in Marine Science, 7, p.40.

Johnson, D.E., 2019. Protecting the lost city hydrothermal vent system: All is not lost, or is it?. Marine Policy107, p.103593.

Li, Y., 1994. Transfer of technology for deep sea-bed mining: The 1982 law of the sea convention and beyond (Vol. 25). Martinus Nijhoff Publishers.

McInerney, T.F., 2014. Experience involving technology transfer, capacity building, and information exchange for the International Treaty on Plant Genetic Resources for Agriculture. Food and Agriculture Organization of the United Nations. (http://www.fao.org/3/bq488e/bq488e.pdf)

Ning, Y., 2021. Assessment of the Mechanism for Mining Technology Transfer in the Area: Loopholes in ISA Practice and Its Mining Code. Sustainability, 13(13), p.7005

Scales, H., 2021, The Brilliant Abyss: True Tales of Exploring the Deep Sea, Discovering Hidden Life and Selling the Seabed, Bloomsbury Sigma.

Seidel, S. and Ye, J., 2015. Patents and the role of the multilateral fund. Center for Climate and Energy Solution. (http://www.igsd.org/wp-content/uploads/2014/10/patents-role-multilateral-fund.pdf)

Tortorella, E., Tedesco, P., Palma Esposito, F., January, G.G., Fani, R., Jaspars, M. and De Pascale, D., 2018. Antibiotics from deep-sea microorganisms: current discoveries and perspectives. Marine drugs, 16(10), p.355.

UNEP Ozone Secretariat, 2016. Briefing Note on Intellectual Property Rights and the Montreal Protocol: past practices and current challenges, 37OEWG. (https://ozone.unep.org/node/4044)

Whitesides, G., Learning from Success: Lessons in Science and Diplomacy from the Montreal Protocol, Science & Diplomacy, Vol. 9, No. 2 (June 2020). https://www.sciencediplomacy. org/article/2020/learning-success-lessons-in-science-and-diplomacy-montreal-protocol

6.      Annex I.

United States delegation to the United Nations Law of the Sea Conference: informal working paper (26 March 1979).

“Technology Transfer: Fair and Reasonable Commercial Terms and Conditions.

During the Intersessional period the United States delegation undertook to ascertain with a greater degree of clarity what was meant by the phrase “fair and reasonable commercial terms and conditions”. Although it was not possible to come up with a precise definition of this terminology, the United States delegation was able to compile a number of examples of terms which would in general be regarded in commercial terms as fair and reasonable. These examples have been drawn from practices firmly established in commercial licensing agreements and transactions involving technology transfers…the list compiled here represents examples which, in light of commercial practices in relevant trades, are generally considered fair and reasonable measures to protect the technology being transferred, to ensure fair compensation to its owner and to protect the recipient of the technology. These provisions include terms that:

(1)        establish a price – in specie, in kind or in other appropriate form – which provides a fair return to the owner for the transfer of technology and any related services provided and which may be based on factors such as the cost of developing the technology (including direct research and development costs, overhead and other indirect costs, and taking into account the cost of the total development effort including unsuccessful projects), the risk to which the owner was exposed in developing the technology, the profit or benefits to be derived or passed on by the Enterprise and a reasonable profit to the owner;

(2)        provide security for payments by means of letters of credit or other devices;

(3)        limit the use of the technology by the Enterprise to exploration and exploitation of the deep seabed;

(4)        provide for termination of the agreement in the event of substantial breach of the agreement;

(5)        require that the Enterprise provide to the owner, on an exclusive or non-exclusive basis and without royalties, any improvements which it makes in the technology transferred to it (known as “grantbacks”);

(6)        ensure adequate protection and proper handling of leased equipment;

(7)        protect the secrecy of the technology, including restrictions on sub-licensing or assigning the technology to third parties;

(8)        require indemnification by the Enterprise to the owner in the event the Enterprise causes damage to others by misuse of the technology and the owner is held liable;

(9)        make appropriate provisions for the protection of the Enterprise in its use of the technology, such as warranties as to the validity of any patent;

(10)      ensure that if there are any warranties of new technology, they take into account the untested nature of the technology; and

(11)      provide for a commercial arbitration mechanism to adjudicate any disputes arising within the scope of the contract for the transfer of technology including questions of financial or other damages to be awarded.

(Reproduced in “Impediments to U.S. Involvement in Deep Ocean Mining Can be Overcome”, General Accounting Office, United States, 1982, available via Google Books).


We need a Global Vaccines Taskforce, not just a British or European one

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. 

What is the ‘know-how gap’ problem and how might it impact scaling up production of Covid-19 related diagnostics, therapies and vaccines?

This entire article is also available as a PDF by clicking here.

1. Introduction.

How relevant are concerns about intellectual property rights causing problems for scaling up production of Covid-19 related diagnostics, therapies and vaccines? Haven’t some important pharmaceutical companies announced that they won’t enforce their patents during the pandemic? Even if others do decide to enforce their patents, won’t the availability of compulsory patent licences solve the problem?

Patents are indeed a concern but they are not the only form of intellectual property right which is relevant in thinking about access to diagnostics, therapies and vaccines. A patent provides its owner with the right to stop others from, for example, making or using their invention. It is a ‘negative’ right. If the owner decides not to enforce their patent, however, or if a compulsory licence to the patent is granted, that does not necessarily mean that others positively can make or use the invention. There might be other intellectual property rights blocking the way. In fact, the patent owner may themselves own two other types of intellectual property right based on ‘undisclosed information’ which, leaving aside the patent, could still prevent others from making or using the invention.

This note starts with a ‘back to basics’ look at what information does and doesn’t have to be disclosed by a patent applicant and examines how undisclosed information (including ‘know-how’ and ‘test data’) is treated under the World Trade Organisation (WTO) Agreement on Trade Related Aspects of Intellectual Property (‘TRIPS Agreement’). It shows how three corresponding types of intellectual property rights – patents, know-how and ‘data exclusivity’ – form a ‘stack’ and how the ability or failure of third parties to adequately access all three elements of that stack (whether in a voluntary way, with the consent and collaboration of the rights holder, or in a non-voluntary way) will impact scaling up production of Covid-19 related diagnostics, therapies and vaccines. It concludes that trying to obtain access to the know-how element in non-voluntary cases will likely be the most challenging problem and looks at how that ‘know-how gap’ might begin to be bridged.

2. Background.

2.1 What must an applicant for a patent explain to the public?

Art. 29.1 TRIPS provides that:

“Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.”

An essential element of the ‘patent bargain’ between a patent applicant and the public is that the applicant must explain to the public (speaking to a competent worker in the field of the invention – a ‘person skilled in the art’) how to practically carry out the invention. If the invention relates to a product, this includes how to make and use the invention. It is this information, increasing the stock of public knowledge, which is supposed to be the quid pro quo for the time-limited exclusive rights which a patent confers.

Informed by different historical practice in different states, Art. 29.1 TRIPS permits a WTO Member (‘Member’) to choose between requiring an applicant to explain a way of carrying out the invention (even a poor way, so long as it is sufficient) and the best way (‘best mode’) known to the inventor. The distinction between the two choices has important practical consequences. If a best mode disclosure is not required and, for example, if a patent applicant knew two ways of carrying out the invention, a poor but sufficient way and a better way, they would be permitted to disclose only the poor way whilst keeping the details of the better way secret as ‘undisclosed information’. If a best mode disclosure is required, then the applicant must increase the scope of the disclosure to describe this better way.

In a spirited defence of best mode disclosure in the United States and elsewhere, Carlson, Przychodzen and Scamborava (2005) argue that:

“Absent the best mode disclosure obligation, the primary purpose of the patent system would be frustrated because the inventor would be permitted to retain the details of the invention as trade secrets while gaining the benefit of the patent monopoly. Such a result would allow inventors to effectively “have their cake and eat it too”…After the patent’s expiration, the inventor would be able to continue to maintain the “heart” of the invention as a trade secret…In short, without the best mode requirement, the entire foundation of the patent system is weakened, and the patent system itself is placed at risk.” (p. 93)

This being the case, it is perhaps surprising that a best mode disclosure requirement has not been adopted by all Members. For example, a sufficient disclosure rather than a best mode disclosure is all that is required in Europe (under Art. 83 of the European Patent Convention (EPC) (1973, as last amended 2000)).

2.2. When must an applicant for a patent disclose the best mode? 

Even if a Member does decide to choose a best mode disclosure requirement, all that is required under Art. 29.1 TRIPS is the best mode known to the inventor at the filing (or priority) date. In many cases involving pharmaceutical inventions, it is likely that the inventor will be employed by a pharmaceutical company and (through the contract of employment) the pharmaceutical company will therefore be the patent applicant. The Art. 29.1 TRIPS requirement applies to the best mode known to the inventor rather than, in this case, that known to their pharmaceutical company employer. The pharmaceutical company may employ different teams, with different expertise, to make inventions and to develop and commercialise inventions that have been made.

Further, a patent application passes through a number of important administrative stages on its way from filing (at the filing date or, if priority is claimed, at the priority date, up to one year beforehand), through publication (typically eighteen months after the filing or priority date) and examination (by an examiner in a patent office) to eventual grant or refusal. The filing (or priority) date is therefore located right at the beginning of the patent application process.

This means that if the patent applicant (pharmaceutical company) happens to find a much better way of carrying out the invention on the day after the filing date, they can keep it to themselves as ‘undisclosed information’. The same is true all the way through the patent application process to grant or refusal. Even more likely perhaps, in the case of an invention which was proving to be a success, if the patent owner (pharmaceutical company) finds a much better way of carrying out the invention during the years of patent lifetime following its grant, they can likewise keep it to themselves as undisclosed information. Given Carlson, Przychodzen and Scamborava (2005)’s strongly expressed arguments, it is sobering to note that this is so even if it is only with such an improved method that the invention can be carried out effectively and in a commercially viable fashion. Figure 1 illustrates such cases where (left hand column) a best mode disclosure was not required and (middle column) where a best mode disclosure was required.

There are, of course, good reasons for viewing the patent bargain as a ‘one-off’ transaction which is complete at the filing date. One is legal certainty. The scope of the exclusive rights which can be properly claimed in a patent are based on its description of the invention. If that description were permitted to change over time then the scope of the corresponding claims might change over time too. There are also, of course, good reasons for wanting to encourage patent owners to continue investing time and resources in improving their methods for carrying out their invention after the filing date.  Nevertheless, again following in the sense of Carlson, Przychodzen and Scamborava (2005)’s arguments, if the public exchanges what may only be an early and bare snapshot of information about the best way (or at least a ‘sufficient way’) of carrying out an invention for twenty years of exclusive rights (potentially permitting very valuable monopoly market positions to be constructed and exploited) but the public then still fails to have access to an effective and commercially viable method of carrying it out, even after the patent has expired, that could easily look like the patent owner again ‘having their cake and eating it too’.

2.3. What is undisclosed information and how is it protected?

2.3.1. Undisclosed information.

In the above example, it might be that the improved method developed by the patent applicant or owner is itself potentially patentable and a second patent application might then be filed. Otherwise, the patent applicant or owner can keep the details of the improved method a secret as ‘undisclosed information’. The protection of undisclosed information is an independent type of intellectual property right. It rests on the foundation of the earlier Paris Convention (1883, as last amended in 1979). Art. 10 bis of the Paris Convention provides protection against acts of ‘unfair competition’, including any “…act of competition contrary to honest practices in industrial or commercial matters…”. Art. 39 TRIPS extends the ambit of this protection beyond the two types of undisclosed information commonly recognised before the TRIPS Agreement (‘trade secrets’ and ‘know-how’) to cover another, newly recognised type (‘test data’).

2.3.2. Trade secrets and know-how.

Trade secrets have long been recognised as specific bodies of undisclosed information with commercial value. A particular formula, for example, to make a soft drink, may be kept as a trade secret. Know-how is perhaps a less well-defined idea, understood as a broader body of undisclosed information which, taken in aggregate, is also commercially valuable. It can range from trade secrets down to, for example, technical designs and specifications, instruction manuals, process controls and monitoring, quality control procedures, technical training, working practices and other elements which, although individually not necessarily ‘groundbreaking’, might together nevertheless be difficult for a third party to reproduce.

Art. 39.2 TRIPS requires that:

Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices (footnote) so long as such information:

(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;

(b) has commercial value because it is secret; and

(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

The footnote provides that ‘a manner contrary to honest commercial practices’ includes, for example, breach of contract, breach of confidence and inducement to breach.

The broader term ‘know-how’ can reasonably be understood to include the more narrow term ‘trade secret’ but not vice versa. For the sake of brevity this paper will therefore use know-how as a catch-all term for both. However, it is only know-how which exhibits these characteristics (a) – (c) which will be protected.

Such ‘know-how’ protection is favoured by intellectual property owners as it is independent of patent protection and will therefore continue even if the associated patent protecting the underlying product expires or is revoked. This independence has important consequences. Consider an example where a pharmaceutical company owns both a patent, which discloses a poor but sufficient method for making the invention, and know-how, which permits the effective and commercially viable production of the invention. Art. 31 TRIPS permits compulsory patent licences to be granted, as confirmed by the Doha Declaration on TRIPS and Public Health. Even if a third party obtains a compulsory patent licence, without access to the know-how they will not be able to produce the invention in an efficient and commercially viable way. Practically speaking, the exploitation of the compulsory patent licence would therefore be frustrated. Even if, for example, an employee of the owner of the patent and know-how believed it unconscionable not to permit the third party to make and sell the product under a compulsory licence lawfully granted on public health grounds, they would be restrained from disclosing the know-how through the threat of legal actions against them for breach of contract and / or breach of confidence.

This relationship between patents and know-how is, of course, well known in intellectual property circles:

A very striking case about the importance of proprietary know-how comes from Brazil. Brazilian officials learned a quick and startling lesson when they decided, some years ago, to translate important patents that issued in developed countries into Portuguese for the benefit of Brazilian industry. They believed that this was all that was necessary to enable their industries to practice these foreign inventions without paying royalties for licenses. Needless to say, without access to the necessary know-how, this scheme was an utter failure.” (Jorda 2007)

and, therefore, in terms of advice:

If an invention has been fully described so as to enable a person skilled in the art to make and use it, and if the best mode for carrying out the invention, if available, has been disclosed (as is required in a patent application), all associated or collateral know-how not divulged can, and should, be retained as a trade secret. All of the massive R&D data—including data pertaining to better modes developed after filing, whether or not inventive—should also be maintained as trade secrets, if the data is not disclosed in subsequent applications. Complementary patenting and padlocking is tantamount to having the best of both worlds, especially when technologies are complex and consist of many patentable inventions and volumes of associated know-how.” (Jorda 2007)

Having the best of both worlds’ does sound rather similar to ‘having their cake and eating it too’ does it not?

One important feature of the protection provided under Art. 39.2 TRIPS is that it prevents a third party from improperly acquiring or using know-how generated by another but it does not prevent that third party from trying to re-create that (or equivalent) know-how independently. A lesser degree of protection is therefore provided vis-à-vis patent rights which prevent a third party from, for example, making and selling an invention even if they have independently generated itself.

2.3.3. Test data.

Test data is data which has been generated in pre-clinical and clinical trials (and in other tests) which has to be submitted to regulatory authorities in order to demonstrate that the corresponding medical product meets the necessary efficacy, safety and quality requirements such that it can obtain marketing approval.

Art. 39.3 TRIPS requires that:

Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

A number of different TRIPS-compliant models exist for the implementation of this obligation. Consider that a pharmaceutical company generates the necessary test data in order to obtain marketing approval. One model permits third parties to obtain marketing approval by relying on that test data and demonstrating that their product is equivalent. It would be unethical for the third party to have to repeat (unnecessary) clinical trials. It is important to note that this model does not require the test data to be disclosed to the third party but remains in the hands of the regulatory authorities. Such reliance could come with an obligation to compensate the owner of the test data (‘data compensation’) to offset the cost of undertaking the pre-clinical and clinical trials (and other tests). Some Members, especially High Income Country (HIC) Members, tend to favour another model, which instead forbids third parties from obtaining marketing approval by relying on that test data for a defined period of time. Although not required by the TRIPS Agreement (‘TRIPS-plus’), this model effectively creates a new intellectual property right: ‘data exclusivity’.     

Data exclusivity is favoured by intellectual property owners in the pharmaceutical field as it is (again) independent of patent protection and will therefore continue for the defined period of time even if the patent protecting the underlying product expires or is revoked. This independence (again) has important consequences in that even if a third party obtains a compulsory patent licence, without being able to rely on the test data they won’t be able to obtain regulatory approval. Practically speaking, the exploitation of the compulsory patent licence would (again) be frustrated. If Members do implement the data exclusivity model, they should therefore provide for a corresponding public health waiver (c.f. ‘where necessary to protect the public’), for example, to permit regulatory approval to be obtained for a product produced by a third party under a compulsory licence. (See here for an ML&P briefing document on data exclusivity and waivers.)

3. The know-how gap problem.

3.1 The ‘intellectual property stack’.

In many cases the information that is disclosed by a patent publication– a ‘sufficient’ description of how to carry out the invention or even the ‘best’ description known to the inventor at the patent filing (priority) date – will be inadequate to permit its effective and commercially viable production (Figure 1). This is especially likely to be true regarding some of the more technologically sophisticated Covid-19 related products, such as monoclonal antibody (mAb) therapies and mRNA-based vaccines. In order to enable commercially viable production (at scale), supplementary know-how will almost certainly be needed. In addition, though, reliance on test data will also be needed in order to obtain regulatory approval for the product eventually produced, and that may be forbidden if a data exclusivity implementation of Art. 39.3 TRIPS has been chosen. In those Members where they occur, the three rights – patents, know-how and data exclusivity – therefore form an ‘intellectual property stack’ (Figure 2). In order to make and supply the product, simultaneous access to all three elements of the stack will be required.

3.2 Voluntary access to the ‘intellectual property stack’.

In order to urgently scale up production of Covid-19 related products, the optimal mechanism will therefore likely be voluntary licensing and technology transfer. In this case, the owner of the ‘intellectual property stack’ will voluntarily provide appropriate third parties with a voluntary patent licence, the corresponding know-how and permission to rely on their test data (Figure 2, column 1). This could be done on a case-by-case basis, for example, the voluntary licensing programs such as that undertaken by Oxford University / AstraZeneca with their partners (see, for example, here).

Alternatively, voluntary licensing could be done in a more systematic way via the WHO-hosted Covid-19 Technology Access Pool (C-TAP) (and the Medicines Patent Pool (MPP)). In fact, there are two different C-TAP related mechanisms that could be considered. Firstly, a particular package of (‘foreground’) know-how for a particular product could be transferred via C-TAP. It is important, though, that partners have sufficient technical capability to be able to ‘absorb’ and use that know-how. Secondly, then, a range of packages of more general (‘background’) know-how could also be transferred via C-TAP, depending on the technical capability of the partner in question, to bring them all up to a level where they could absorb and use the particular (‘foreground’) packages of know-how.

3.3. Non-voluntary access to the ‘intellectual property stack’?

However, it is reasonable to observe that progress to date on voluntary measures has varied between patchy and deeply disappointing. In order to urgently scale up production of Covid-19 related products, Members are therefore entitled to consider non-voluntary options for accessing the ‘intellectual property stack’.

There is a clear danger that compulsory patent licences may be frustrated through lack of access to the know-how (Figure 2, columns 2 and 4) or test data (data exclusivity) elements (Figure 2, columns 2 and 3) of the stack. The relevant test data will at least have been provided to the regulatory authorities so long as regulatory approval is sought (an additional problem, not discussed here, will occur in a Member where regulatory approval is not sought and the test data has not therefore been provided). If a Member has chosen to provide for data exclusivity, then access can perhaps at least be provided via a corresponding waiver. Access to the know-how element is more challenging for a government to achieve as it is kept secret in the hands of its owner. The presently discussed proposal for a multilaterally agreed waiver of the need to enforce TRIPS obligations for Covid-19 related intellectual property rights will not solve this problem either. Even if agreed, such a waiver could not force the disclosure of know-how by its owners (Figure 2, column 5).

In practice, this danger is heightened by the fact that different elements of the stack are likely to be located in different Members. Even if a Member has granted a compulsory patent licence and granted a data exclusivity waiver, the know-how needed may be owned by a firm in another Member. Relevant know-how might be aggregated by a multinational pharmaceutical company from partners in several Members. It was recently reported, for example, that the scaling up of the Pfizer-BioNTech vaccine relies in part on know-how owned by Polymun, a small lipid nanoparticle manufacturer in Austria (“A key ingredient in what could be the first U.S.-approved Covid-19 vaccine comes from a family-owned company with 90 employees in the Austrian countryside, underscoring the fragility of the potential treatment’s supply chain.” (Wall Street Journal, 6th November 2020)). In order to help scale up production, Polymun have now agreed to transfer some of their know-how to Pfizer’s manufacturing facilities in Europe and the United States. It is easy to see how the effective exploitation of a corresponding compulsory patent license in, for example, a Low and Middle Income Country (LMIC) Member, might be difficult in such a case.

Unfortunately, even this does not exhaust all the ways in which the exploitation of a compulsory patent licence might be frustrated. Although not shown, the ‘stack’ can easily be extended to include a fourth ‘manufacturing capacity’ element. Even a compulsory patent licence granted by a Member with hypothetical access to the patent, know-how and test data elements of the ‘intellectual property / business stack’ could be frustrated if the necessary (end-to-end) manufacturing capacity element cannot be accessed, for example, if an essential element of the manufacturing process has been outsourced to another Member. (We have previously discussed the problem of the HIC opt-out to the Art. 31bis system in the context of Active Pharmaceutical Ingredient (API) production being outsourced to China and India).

3.4 Thinking about non-voluntary bridging of the ‘know-how gap’ problem

Bearing in mind that it is the know-how element of the stack which will likely often represent the most difficult problem to address in non-voluntary cases, how might this ‘know-how gap’ be bridged?

LMIC Members have long been advised to adopt a ‘best mode’ requirement under Art. 29.1 TRIPS. It is also sensible for them to think hard, for example, about how they should most appropriately define ‘person skilled in the art’. However, as illustrated in Figure 1, this may only mitigate the problem to a small extent. It is perhaps helpful to begin by framing a hypothetical solution to the problem with which to compare existing or proposed solutions.

Imagine how different the situation would be with an enduring best mode requirement: instead of just having to pay an annual renewal fee, an updated disclosure of the best mode of carrying out the invention known to the patent owner would have to be submitted as a free-standing annex each year in order to keep their granted patent in force. If a pharmaceutical firm (patent owner) had devised an improved method of carrying out their invention which permitted effective and commercially viable production (at scale), they would therefore have to disclose it at the next available (annual) opportunity if they wished to continue to benefit from the exclusive rights conferred by their patent. Figure 1 figuratively illustrates such a mechanism (right hand column).  Figure 2, column 6 figuratively illustrates the outcome. Bearing in mind the TRIPS Agreement states its objective as follows (Art. 7 TRIPS):

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.” (underlining added).

might such a maintenance requirement not seem reasonable in terms of the better balance this revised patent bargain would strike? From a public perspective, it would markedly reduce the likelihood that a compulsory patent licence would be frustrated since the corresponding know-how would necessarily be available. It would support the human right to health (c.f United Nations Committee on Economic, Social and Cultural Rights, General Comment No. 14 (2000)) and the human right to benefit from scientific progress (c.f United Nations Committee on Economic, Social and Cultural Rights, General Comment No. 25 (2020)).

Of course, patent owners would likely argue that this would be too heavy a burden for them to endure – they would prefer to stick with the ‘one-off’ bargain struck at the filing date. It could easily be argued, though, that the imposition of exclusive patent rights, with potentially life and death consequences in the pharmaceutical / medical field, is often too heavy a burden for the public to endure too. Other patent owners might argue that it would cause them not to undertake more development of the invention than the bare minimum required for the patent, but then there might be no commercial product at all, or that it would cause them to rely on know-how (trade secret) protection instead of patents, but then there would be no exclusive patent rights to deal with. Notwithstanding the long and complex history of the intellectual property system to date, there is still room for substantial debate about where the optimal balance between innovation, dissemination and access lies.

Against the background of such a hypothetical solution, though, how else might the know-how gap problem be addressed in a non-voluntary way in the urgent circumstances of the Covid-19 pandemic? Perhaps the most straightforward suggestion is that of a compulsory know-how licence, especially if considered as an ancillary order to accompany a compulsory patent licence. It is arguable that such a suggestion is TRIPS-compliant (Wang 2014). Helpful parallels can be made with equivalent mechanisms in Antitrust law. However, there still remains, for example, the practical problem of one Member enforcing such a compulsory know-how licence against a firm in another Member (Figure 2, column 7). A future note will examine this suggestion further. Another suggestion might involve a collaborative R&D program to reverse engineer, recreate and share the necessary know-how independently of its original owner. Even if this were possible, though, any such program would likely represent a diversion of important resources at a critical time.

3.5 The immediate future.

Although it is vital that Members are able to make use of effective non-voluntary measures, the most certain and quick way to solve the know-how gap problem, especially for the more technologically sophisticated Covid-19 related products, will likely be through voluntary licensing and technology transfer. Given the huge sums of public money being committed to underwrite the development of Covid-19 related products, it is entirely appropriate for Members to use the leverage that funding provides to encourage intellectual property rights holders’ to engage in voluntary licensing and technology transfer, especially through platforms such as C-TAP (and the MPP).  It is to be hoped that such encouragement soon begins to bear fruit.


Carlson, D.L., Przychodzen, K. and Scamborava, P., 2005, Patent Linchpin for the 21st Century – Best Mode Revisited, 87 J. Pat. & Trademark Off. Soc’y 89. Available, via hosting at www.wiggin.com, at: https://www.wiggin.com/wp-content/uploads/2019/09/best-mode-article-2005-carlson.pdf

Jorda, K.F., 2007, Trade Secrets and Trade-Secret Licensing, Chapter 11.5 in MIHR / PIPRA IP Handbook of Best Practices, available at: http://www.iphandbook.org/handbook/ch11/p05/

Wang, L.R., 2014, Ancillary Orders of Compulsory Licensing and Their Compatability with the TRIPS Agreement, 18 Marq. Intellectual Property L. Rev. 87. Available at: http://scholarship.law.marquette.edu/iplr/vol18/iss1/3


This briefing paper has been prepared by Christopher Garrison with the assistance of other members of Medicines Law & Policy: Dr Ellen ’t Hoen, Pascale Boulet, Dr Katrina Perehudoff, and Kaitlin Mara. Any questions or requests for further information should be directed to info@medicineslawandpolicy.net.

How the ‘Oxford’ Covid-19 vaccine became the ‘AstraZeneca’ Covid-19 vaccine

The ‘Oxford / AstraZeneca’ vaccine is one of the world’s leading hopes in the race to end the Covid-19 pandemic. Its history is not as clear, though, as it may first seem. The media reporting about the vaccine tends to focus either on the very small (non-profit, academic) Jenner Institute at Oxford University, where the vaccine was first invented, or the very large (‘Big Pharma’ firm) AstraZeneca, which is now responsible for organising its (non-profit) world-wide development, manufacture and distribution. However, examining the intellectual property (IP) path of the vaccine from invention to manufacture and distribution reveals a more complex picture that involves other important actors (with for-profit perspectives).

Mindful of the very large sums of public money being used to support Covid-19 vaccine development, Medicines Law & Policy has written a new technical briefing note that contextualises the respective roles of the Jenner Institute, AstraZeneca and these other actors, so that their share of risk and (potential) reward in the project can be better understood. It also provides comments as well as raises some important questions about what might yet be done better and what lessons can be learned for the future.

To access the briefing paper, click here or on the picture below.

How the ‘Oxford’ Covid-19 vaccine became the ‘AstraZeneca’ Covid-19 vaccine

Price, profit and the Covid-19 health technology pool: The example of remdesivir

We cannot yet know the precise trajectory of the Covid-19 pandemic, nor which therapies or vaccines will eventually prove most effective in its treatment or prevention. Nevertheless, decisions may have to be taken soon about scaling up the manufacture and deployment of some of those that are already available, depending on the outcome of large- scale clinical trials such as the Solidarity trial being undertaken by the World Health Organization (WHO). Price will be an important factor in this scale up.

Let’s take the example of remdesivir, an antiviral medicine developed by the American biopharmaceutical firm Gilead Sciences. Based on the outcome of a small clinical trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) in the United States, the American Federal Drug Administration (FDA) has granted emergency approval for remdesivir in the treatment of Covid-19. Gilead owns IP rights covering remdesivir in most high-, middle- and low-income countries and so, at least at first, it will be for Gilead to decide how it is to be marketed. Following the expiry of an initial donation programme, it seems likely that Gilead will broadly pursue a ‘higher price’ for high- and middle-income countries and one or more ‘lower prices’ for low-income countries.

If Gilead were to follow the same ‘higher price’ approach it took with earlier blockbuster medicines such as sofosbuvir (Sovaldi, a hepatitis C treatment), it will price remdesivir not on the basis of the cost of its manufacture or its development, but instead in terms of the ‘value’ that it is perceived to bring in the treatment of Covid-19. The NIAID clinical trial suggests that a 10-day course of remdesivir, administered intravenously, yields a 31% reduction in recovery time for Covid-19 patients. Treating this modestly positive outcome in terms of a ‘value-based’ pricing model, an analysis by the Institute for Clinical and Economic Review (ICER) suggests that $4,500 per treatment course would be reasonable. Other pharmaceutical analysts have suggested a price of $10,000. Given that Gilead is anticipating it will supply at least a million courses of treatment of remdesivir by the end of this year, this approach suggests that remdesivir could become another of the firm’s multi-billion dollar blockbuster medicines.

Gilead will be taking a different approach to ‘lower prices’ for remdesivir in low-income countries, building on its experience with voluntary licensing programs, for example, those undertaken in conjunction with the Medicines Patent Pool (MPP). Gilead has announced the agreement of non-exclusive voluntary licences with Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences and Mylan, manufacturers based in India and Pakistan, permitting the production of ‘authorised’ generic versions of remdesivir. These licences will be royalty-free until either the WHO declares that the Public Health Emergency of International Concern (PHEIC) is over (signalling the end of the pandemic) or another medicine or vaccine is approved to treat or prevent Covid-19. These licences permit the generic manufacturers to set their own prices, although none of these generic prices have yet been announced. One problem, though, is that these licences restrict export to a list of 127 predominantly low- and lower-middle income countries. The limited economies of scale that follow from this market partitioning therefore constrain how low these generic prices can go.

An indication of where they could start is provided by Beximco Pharmaceuticals Ltd. (a manufacturer in Bangladesh, part owned by Norges Bank, the Norwegian Central Bank), which has announced the independent development of a generic version of remdesivir. WTO Members agreed in 2015 that Least Developed Countries (LDCs) are not required to provide IP rights covering pharmaceutical products until 2033. Gilead has no relevant IP rights in Bangladesh and its permission is not therefore required to manufacture there (this will also be true in countries where Gilead lose all their IP rights: actions have been launched to revoke its patent(s) in India). Beximco’s generic version of remdesivir will be donated to the public sector in Bangladesh. It will be supplied to the private sector in Bangladesh, and presumably to other LDCs, at a price likely varying between $295 and $781, depending on the length of the course of treatment required. Independent analysis suggests that the lowest possible theoretical price for generic remdesivir, taking account of both reasonable profit and tax, should be significantly lower still, at about $10 per 10-day course of treatment.

Prices currently discussed for one 10-day course of treatment with remdesivir therefore range over three orders of magnitude: from $10,000 to $10. Such a range is painfully familiar to those who worked on getting adequate access to HIV medicines after the entry into force of the WTO TRIPS Agreement, where treatment prices for one patient for one year began at $10,000 in 2000 but fell by 99% to around $100 in 2006 due to generic competition. On the basis of these prices for remdesivir, decision makers could theoretically choose to treat either one patient or one thousand patients per $10,000 of health budget.

If remdesivir does prove to be sufficiently effective in the treatment of Covid-19 and if Gilead decides to adopt a blockbuster strategy and to set the price of remdesivir at the higher end of the spectrum, governments will have to decide whether this price can be justified. They will also have to decide whether it is affordable. A transparent accounting of the costs incurred by Gilead during development is unavailable. A significant portion of these costs will already have been covered by the estimated $60 billion earned from its Hepatitis C virus (HCV) R&D programme, from which both sofosbuvir (Solvadi) and remdesivir came. The subsequent development of remdesivir for use in the treatment of Covid-19 has been something of an accident from Gilead’s perspective and would not have taken place at all were it not for the pre-clinical and clinical trials undertaken by various agencies of the U.S. government, who tested remdesivir for use in the West African Ebola outbreak of 2014 – 2016. This vital public support has led to claims that the U.S. government ought to be able to influence Gilead’s pricing decisions for remdesivir, or that U.S. government scientists ought to have been listed as co-inventors on remdesivir-related patent applications.

If governments cannot agree with Gilead on a justifiable and / or affordable price, they are free to grant compulsory licences (as provided for in Art. 31 WTO TRIPS Agreement and as expressly confirmed in the 2001 Doha Declaration on the TRIPS Agreement and Public Health), authorising the manufacture, importation and/or sale of generic remdesivir without Gilead’s permission. A coordinated set of compulsory licences in a significant number of high- or middle- income countries could permit the price of generic remdesivir to be brought sharply down towards the lower end of the spectrum. It is true that many of the wealthiest High-Income Countries (HICs) have unilaterally opted-out as importers from the Art. 31bis mechanism agreed by WTO Members to facilitate compulsory licensing for export, which will constrain the size of the market that can be served via compulsory licences for export in other countries. Nevertheless, with political will, it is possible that they will reconsider and find a solution to this opt-out problem. Compulsory licensing would represent a reputational catastrophe for Gilead, and by association the whole pharmaceutical industry. Given the context of Covid-19, though, it may be more likely than ever before.

A more positive alternative to blockbuster strategies and compulsory licensing can readily be suggested. Prompted by the government of Costa Rica, the World Health Organisation (WHO) will soon be launching a Covid-19 health technology pool, supported by UNITAID and the Medicines Patent Pool. The WHO will call for an open and collaborative approach to battling Covid-19 which, as recognised in a strongly worded editorial in the leading journal Nature (“Coronavirus: everyone wins when patents are pooled”), is needed more than ever now. This initiative should encourage pharmaceutical firms to pool potentially vital scientific information about their therapies, including relevant pre-clinical and clinical trial data, such that the development of optimal formulations and combinations of therapies can be driven forward as quickly as possible. Gilead has excellent technical skills and resources but so too do many others around the world. The use of remdesivir in the treatment of Covid-19 (and perhaps its potentially advantageous precursor compound GS-441524) might be more quickly improved in collaboration with others than if Gilead tries to do it alone.

Further, this initiative should encourage pharmaceutical firms to abandon their market partitioning and expand existing voluntary licensing programmes to permit worldwide generic production, harnessing maximum economies of scale to drive the prices of those optimised therapies down as quickly as possible for everyone. This would require pharmaceutical firms to cede their monopoly control over who is, and who is not, permitted to produce. Many people will be astonished that companies were in a position to exert such monopoly control in the first place. It would not, however, require them to waive their IP altogether and they could still be remunerated with fair and reasonable royalties for the production that does take place.

A positive engagement by Gilead and other pharmaceutical firms with the Covid-19 health technology pool would reflect their recognition that a business-as-usual maximisation of individual profit is not the appropriate response to the pandemic. Instead, what needs to be maximised is the chance that the best possible versions of their therapies, vaccines and other health technologies can be deployed as quickly, cheaply and effectively as our combined planetary resources allow. Governments have already had a change of heart about business-as-usual and have announced a much more public health focussed ‘global public good’ approach to developing therapies, vaccines and other health technologies for use against Covid-19. It is up to Gilead and the rest of the pharmaceutical industry to follow their lead. As they must be acutely aware, the whole world is watching.

Never say never – Why the High Income Countries that opted-out from the Art. 31bis WTO TRIPS system must urgently reconsider their decision in the face of the Covid-19 pandemic

WTO building in Geneva, Switzerland by E. Murray; used under Creative Commons.

To limit the ability of patent owners to charge excessive prices for patented medicines, countries can grant compulsory licences which permit others to produce or import (competing) generic versions of the patented medicine. Even the suggestion that a compulsory licence might be granted will impact patent holders’ pricing decisions. The Financial Times (of London) recently said that: ‘[Facing the Covid-19 pandemic emergency] The world has an overwhelming interest in ensuring [drugs and vaccines effective against the virus] will be universally and cheaply available. Fortunately, trade rules allow compulsory licensing. If necessary, it must be used.’ It is therefore worthwhile to take a moment to understand how compulsory licensing has become complicated by the ‘outsourcing’ of Active Pharmaceutical Ingredient (API) manufacture to a small number of countries, notably India and China, and why it means that the High Income Countries that opted-out from the ‘Art. 31bis system’, which is now a part of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, must urgently reconsider their decision in the face of the Covid-19 pandemic.

What does ‘outsourcing’ API manufacture mean? There are at least two key steps in the production of a finished medicine product. Firstly, the manufacture of the necessary Active Pharmaceutical Ingredient (API) from raw materials. Secondly, the appropriate formulation of the API to make the particular medicine product. These two steps can either be completed by a single company or by two different companies. Although there are many companies in the world capable of formulating APIs into finished medicine products, there are far fewer who specialise in manufacturing APIs and many of these are now located in India and China. Following the entry into force of the TRIPS Agreement, patent holders are able to obtain the most far-reaching types of patents, which cover the Active Pharmaceutical Ingredient (API) (new chemical entity) itself, in both India and China. Major pharmaceutical companies wishing to increase their organisational flexibility and drive down costs therefore now routinely outsource the production of their APIs (under patent licence) to lower cost Contract Manufacturing Organisations (CMOs) in these countries. Although such outsourcing was already occurring before the entry into force of the TRIPS Agreement, its pace increased and carried on increasing afterwards. To take just one illustrative example,  following ‘the general trend within the pharma sector’, AstraZeneca, announced their intention in 2007 to begin withdrawing from API manufacture and outsource it instead to CMOs in China. It is now often suggested that up to 80% of the APIs used in the US come from India and China (see, for example, US Senate Finance Committee Chairman Chuck Grassley’s letter to the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA)) but, given the lack of transparency often associated with outsourced API manufacture, it is difficult to be certain.

To see how this affects the use of compulsory licensing, let’s take the example of a (WTO Member) country that wants to make use of compulsory licensing to supply its population with a generic version of a patented medicine (Art. 31 TRIPS) but that lacks domestic API manufacturing capability. This country could use compulsory licensing to import a finished medicine product, probably from a country where the API is manufactured. Or it could use compulsory licensing to import the necessary API from a country where the API is manufactured so that one of its own domestic generic manufacturers could formulate and finish the medicine product. The problem is that, whilst a country can grant a compulsory licence which permits the import of the medicine / API, it cannot command the medicine / API producing country to permit its export. If there is a patent in the medicine / API producing country, which is now likely for any commercially important new medicine, then a compulsory licence to permit the manufacture and export of that medicine / API will have to be granted in that country too. Here the TRIPS Agreement raises a significant problem. Art. 31 (f) TRIPS requires that any compulsory licences granted by WTO Members must be ‘predominantly for the supply of the domestic market of the Member authorizing such use’. This is not an inherent limitation of compulsory licensing but is an imposed constraint. It presents a severe limitation on the ability of medicine / API producing countries, including India and China, to grant a compulsory licence permitting the export of the medicine / API to other countries. Even though India and China have very large domestic markets, the ‘non-predominant’ portion of the medicine / API production will be insufficient to supply many other countries, much less the rest of the world. Thus, even though the (WTO Member) country in our example has granted a compulsory licence to supply its population with a generic version of a patented medicine, the Art. 31(f) export restriction may prevent it from having any practical effect.

This problem was just one of a number of concerns about the impact of the TRIPS Agreement on public health which continued to simmer in the late 1990’s. Addressing at least some of them, a WTO Ministerial Conference agreed the ‘Doha Declaration on the TRIPS Agreement and Public Health’ in 2001. Paragraph 6 of the Declaration addressed the Art. 31(f) problem by promising that an ‘expeditious solution’ would be found to permit ‘WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector’ to make effective use of compulsory licensing under the TRIPS Agreement. A partial waiver of Art. 31(f) was subsequently agreed under the ‘Decision of the General Council of 30 August 2003’ which was formalised in 2017 with the Art. 31bis amendment to the TRIPS Agreement. The system established under the waiver / Art. 31bis amendment permits WTO Members to grant a ‘special’ compulsory licence for export without the Art. 31(f) limitation to ‘predominant’ domestic supply. However, the core provision is hedged with potentially cumbersome procedures and it can only be regarded as a limited solution to the Art. 31(f) at best. There has only been a single example of the use of the system so far (under the waiver) and the slow pace at which it occurred has been strongly criticised. Nevertheless, Art. 31bis is now the only attempt to address the Art. 31(f) problem yet agreed and there is perhaps room, with political will, to make it work more effectively. The remarkable thing is that several HICs (‘Australia, Canada, the European Communities with…its member States, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States’) unilaterally committed that they would not make use of the system as importers (General Council Decision Art, 1(b), footnote 3; Art. 31bis, Annex, Art. 1(b), footnote 3). This not only impacts access to affordable generic medicines in these opt-out HICs but, since the economies of scale that could have been harnessed by exporting to these comparatively wealthy HICs are curtailed, the price of the generic medicines that could be produced for other WTO Members may well be higher than it could have been. Even more remarkably, this opt-out extends even to ‘situations of national emergency or other circumstances of extreme urgency’. So even in these situations, the opt-out HICs are stuck with reliance on only the ‘non-predominant’ portion of ‘ordinary’ compulsory licensed medicine / API production in India and China. This is entirely unsatisfactory.

The opt-out HICs should have provided themselves with a way to opt-back into the Art 31bis system if they needed to, even if just in ‘situations of national emergency or other circumstances of extreme urgency’. The system is framed in terms of ‘WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector’. Whether or not such manufacturing capacities are sufficient must be regarded as a dynamic question, the answer to which may change over time (Art. 31bis, Appendix to the Annex: ‘Member has some manufacturing capacity…found that…currently insufficient for the purposes of meeting its needs…’). If the pharmaceutical manufacturing capacity of the opt-out HICs has become heavily reliant on the importation of API from countries such as India and China then it arguably no longer represents the ‘sufficient (end-to-end) manufacturing capacity’ which supports the effective independent use of compulsory licensing. For these purposes, and even if only in some key sub-sectors, it may have become ‘insufficient’.

This consideration is given urgent force by the present Covid-19 pandemic emergency. It is not clear which medicines (or diagnostics, vaccines or medical devices) will prove to be most potent in combatting Covid-19. Whichever they are, they will hopefully be swiftly available at the necessary scale and affordable price either via the intellectual property right holders themselves or in ‘non-conflictual’ generic versions (whether through the licensing of rights, perhaps via a Covid-19 intellectual property pool, the waiving of rights or where there are no rights existing at all). However, if not, governments must have practically effective compulsory licensing powers at their immediate disposal. Take the example of remdesivir, one of the medicines in clinical trials for use in the treatment of Covid-19. Gilead’s instinctive response to the outbreak has been to try to reinforce their exclusive rights over remdesivir by persuading the FDA to grant them an orphan drug designation in the United States (now hastily relinquished), rather than reassure about universal access. Who knows what their commercial strategy will be if remdesivir proves effective? Gilead are currently trying to increase their manufacturing capacity (in conjunction with their licensed CMOs) but have recently struggled to maintain patient access to remdesivir even through their compassionate use program. Whilst other API manufacturers will be technically capable of manufacturing the remdesivir API, they will be prevented from supplying it in the absence of either a voluntary licence (from Gilead) or, if necessary, a compulsory licence (for example, in India or China), in which latter case the Art. 31(f) problem immediately presents itself.

Governments should therefore be urgently reviewing their ability to use their compulsory licensing powers, in practice not just on paper. National compulsory licensing systems (including ‘public non-commercial use’ powers for the government itself) should be scrutinised and, if necessary, action taken to remove potential roadblocks, as has already now happened in Germany, Canada, Chile and Ecuador. Israel has already used its compulsory licensing powers. At the international compulsory licensing level, the Art. 31(f) problem remains the elephant in the room. By ruling out the use of the Art. 31bis system for importation in all circumstances, even in ‘situations of national emergency or other circumstances of extreme urgency’, the opt-out HICs have left themselves dangerously exposed to the Art. 31(f) problem and, in the face of the Covid-19 pandemic emergency, such a dangerous exposure could not have come at a worse time.

The broader (and, it has to be said, long-standing) concerns about the vulnerability of international medicine manufacturing supply chains will have to wait for another time. Commercial API production cannot be turned on and off at the flick of a switch. The Covid-19 outbreak in China has already caused significant interruptions to the international supply of APIs, not least to India. Facing knock-on shortages, India responded by restricting the export of more than twenty essential APIs (and formulations made from them). The US President, Donald Trump, had to call the Indian President, Narendra Modi, to ask in person if the particular restriction on hydroxychloroquine (another of the medicines in clinical trials for use in the treatment of Covid-19) could be lifted to permit supply to the US. Hydroxychloroquine is a comparatively old medicine, however, and there appear to be no patent barriers to its manufacture and export. Remdesivir would be different.

At the instant moment, the opt-out HICs will just have to deal with the threat posed by the Covid-19 pandemic emergency as best they can. It is in their vital interests to make sure that they have a workable solution to the Art. 31(f) problem. Following the call in a widely supported open letter, the opt-out HICs should therefore urgently change course and work with other WTO Members to find a way to opt back into the Art. 31bis system, even if limited to ‘situations of national emergency or other circumstances of extreme urgency’. If that fails, they must work with other WTO Members to find a different solution, whether looking to previously suggested alternatives (for example, based on Art. 30 TRIPS) or supervening emergency powers at national and international levels (for example, based on Art. 73 (b) TRIPS). International cooperation, rather than division, will be key. The scale and seriousness of the threat posed by the Covid-19 pandemic emergency means that all governments, including those of the presently opted-out HICs, must have practically effective compulsory licensing powers ready and able to be used should they need them.

Urgent collective action to meet the challenge of this pandemic crisis: a coronavirus related intellectual property pool

Image by Scientific Animations; used under Creative Commons.

The Director-General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, first described the present coronavirus (COVID-19) outbreak as a pandemic on the 11th March 2020. The threat of such a pandemic has been discussed for decades. It is nevertheless clear that pandemic preparedness planning, at least at national level, has fallen far short of adequate. Countries have already been forced into almost unthinkable competition for resources to support their individual health systems, such as personal protective equipment (PPE) for medical professionals and ventilators.

Even if the immediate emergency can be confronted without national health systems being overwhelmed, the threat will likely continue for some time. The very nature of a pandemic suggests the possibility of successive waves of infections. It should therefore be obvious to decision makers everywhere that looking within their national borders will not be enough and that all countries, rich and poor, must overcome the pandemic together. Time is not on our side. It is not clear how long the social distancing and quarantine measures that have been implemented in so many countries will be able to be maintained. There is a very real danger that either the pandemic itself or the dislocation caused by the measures to combat it will produce cascading crises in other areas and that, at some point, social, economic or (geo-) political thresholds will be crossed from which there is no straightforward return.

The scientific community has responded admirably to the pandemic, sharing data and research findings rapidly and openly. The early sharing of genomic data has been particularly important. They have been supported by the decision of many scientific journals and publishers to move to an open-access model for all coronavirus related publications. The response from the holders of intellectual property rights over potential therapies has been more mixed. AbbVie has now waived the patent rights they own to one candidate therapy for coronavirus, a combination of the antivirals lopinavir and ritonavir (marketed under the trade name Kaletra), removing a barrier to this combination therapy being manufactured by qualified producers everywhere. In stark contrast, the response of Gilead has been to try to strengthen their proprietary rights over another candidate therapy for coronavirus, the antiviral remdesivir. Taking an approach which relied on the letter of the law, rather than its very obvious spirit, they managed to persuade the Food and Drug Administration (FDA) that the early coronavirus infections in the USA should be regarded as a rare disease for the purposes of the Orphan Drug Act, so that remdesivir could enjoy the considerable benefits provided under the Act, including seven years of (post-approval) market exclusivity. Following outcry over this improper use of the legislation, Gilead has now withdrawn its remdesivir orphan drug designation.

It is not yet known which particular therapies (or combinations of therapies) are going to be most helpful in the treatment of coronavirus patients. Rigorous clinical trial data needs to be shared quickly and openly as never before. Public funding of clinical trials, for both candidate therapies and vaccines, has been significantly increased. The WHO has just launched its SOLIDARITY trial, comparing the safety and effectiveness of four different candidate coronavirus medicines, including remdesivir and lopinavir/ritonavir (Kaletra), across forty-five countries. Once decisions have been made to deploy whichever therapies are most helpful at scale, unprecedented efforts from both intellectual property right holders and qualified generic manufacturers may be needed to rapidly scale up production and provide timely and affordable access to all those in need. Valuable time cannot be wasted in engaging in protracted negotiations with those intellectual property rights holders or campaigns to persuade them to co-operate. The same is true regarding the diagnostics which will be vital in improving our epidemiological understanding, the equipment which will protect medical professionals or, absent effective therapy, the ventilators that will help keep alive the most compromised of those infected and, in due course, the vaccines which could help bring an end to the pandemic. The urgency of the situation cannot be better underlined than by President Trump invoking the provisions of the Defence Production Act against General Motors in order to compel them to make ventilators in larger numbers, at a lower price and more quickly than they had seemingly been willing to contemplate. Wherever necessary, intellectual property right holders will therefore hopefully move swiftly to offer licences to coronavirus related rights (or waive them) on a voluntary basis. If not, then compulsory licences will have to be used. Countries that have compromised their own ability to make swift and effective use of compulsory licensing, including those high-income countries that decided to opt-out of the system established under the August 30th 2003 Decision of the World Trade Organization (WTO) which in 2017 became an amendment to the TRIPS Agreement, should now be urgently questioning whether that was a good idea.

If efficient access to all the intellectual property rights necessary to overcome the pandemic worldwide is to be co-ordinated and administered, a proactive rather than a reactive solution is vital. This is why the suggestion of the government of Costa Rica, calling for the WHO to create a voluntary pool of coronavirus related intellectual property rights (including patents, regulatory test data, know-how, copyrights and design rights), is of such central importance. The tried-and-trusted example of the Medicines Patent Pool (MPP) is already there to draw on. There will be important challenges to be faced and operational details to agree in due course but that must not let the initial work be delayed. Medical professionals everywhere are making heroic efforts (risking and losing their own lives) to treat as many coronavirus patients as possible. They are rapidly and often ingeniously reconfiguring equipment and hospital spaces to increase capacity as they go. In weeks rather than months, engineering companies have combined their expertise with medical equipment experts to design, test and already produce (3D print) new PPE and assistive breathing devices. Let’s show the same speed and ingenuity in operationalising this pool and so help to bring medical professionals more of the tools they need – including affordable and effective diagnostics, medicines, medical equipment and vaccines – as quickly as possible. There is no time to lose.