Waivers.

On 1st October 2015, the Coalition for Affordable T-DM1 (hereafter: ‘the Coalition’) issued a letter to the then Secretary of State for Health Jeremy Hunt, demanding that the UK government issued a compulsory license on a life-extending cancer medicine trastuzumab emtansine, trade name: Kadcyla (The Coalition for Affordable T-DM1 2015). The Coalition’s challenge addressed the problem of the prohibitive cost of Kadcyla by seeking to override the industry’s unfettered monopolistic prerogative—relying primarily on the instrument of Crown use provisions of Sect. 55 of the UK Patents Act 1977. The UK National Institute for Health and Care Excellence (NICE) and the UK Cancer Drug Fund had previously declared this treatment unaffordable at £5908 for a 3-week cycle, or £90,000 for a standard 14 months cycle of treatment (Triggle 2014).Footnote1 Kadcyla is “a next generation breast cancer drug”, combining a cancer-killing cytotoxic agent with a monoclonal antibody, trastuzumab (Staines 2017). This treatment has given hope to many, but in 2016 it was also “the most expensive breast cancer drug ever sold” (Boseley 2016).

This somewhat paradoxical situation, potentially pitting the sovereign of the UK against British health agencies, raises the question of the implications of this action beyond the immediate legal context: why did patients invoke this particular passage of law? Was this only an opportune strategic choice? This article provides a performative reading of rights activism, which foregrounds patients’ desire to be recognised as subjects that count in the delivery of healthcare, and are using this particular method to wield power in a process that usually excludes them entirely. The rights of the Crown are here effectively turned into somatic rights, which are claimed by ‘active’ patients—or biological citizens (Heath, Rapp, and Taussig 2004; Rose 2007). Furthermore, the choice of this particular legal strategy highlights the absence of any other avenues of challenge to the monopolistic position of the pharmaceutical industry created by the IP regime. In this context, the Coalition’s demand represents a clear declaration of sovereignty in the face of exclusion, re-asserting power in a field in which patients are usually entirely absent. It mobilises the conceptually unfettered rights of a sovereign, utilizing a very specific limited exception to the IP rights regime. This strategy provides a glimpse of the potential power of patients’ demands, but its necessarily limited remit does not seek to address the inbuilt absence of patients for instance within deliberations of price. Their absence in the IP regime has a deeper historic background and fundamental conceptual roots, as shown below.

The exclusion of patients from decisions affecting their lives and health is profound. The Coalition pointed out that de-listing Kadcyla would effectively make this medicine unavailable for patients in England, which would result in patients with HER2positive, metastatic breast cancer dying earlier than necessary. In particular cases this could lead to quite a significantly lessened life span, on average however amount to approximately six months of life (Boseley 2015a). In the face of these devastating consequences, the Coalition’s demand relied on a particular passage in British Patent Law: the Rights of the Crown. The Crown, as the sovereign ruler of Great Britain, retains power to override existing patents and intellectual property rights (IPRs) in cases of pressing need, such as for example “foreign defence purposes”, medicines and research (Yang 2015, p. 416).Footnote2 These rights apply especially to any areas of the state that are part of the “services of the Crown”, which originally covered “the civil and armed services and the Post Office” (Boehm and Silberston 1967, p. 120). In 1965, a landmark case on access to the antibiotic tetracycline confirmed “the treatment of patients in hospitals” as falling within the remit “of the functions of government”, but also pointed out that it only applied to patients as long as they were supplied by the hospital, not while they are receiving medication through a general practitioner or pharmacist (Ibid.; “Pfizer Corporation v. Ministry of Health” 1965). From its inception, Crown use thus referred to the needs of services provided by the Crown, not the needs of patients as recipients of this service. Since then, Crown use has been invoked in a very small number of cases. The Coalition argued that de-registering Kadcyla constituted a need for such a declaration—despite this emergency being co-produced by the British health agencies themselves.

A separate signature campaign for access to Kadcyla conducted by another group of breast cancer campaigners heightened public pressure further, delivering 42,000 signatures to Roche Pharmaceuticals on 28th October 2015 (Breast Cancer Now 2015). In response to these challenges, Roche decided to drop Kadcyla’s price to an undisclosed amount, to make it more affordable for the UK Cancer Drugs Fund (Boseley 2015b). While this made the drug available in England at least for the moment, even Roche’s offered discount “was not enough to bring the price within the NICE upper threshold of £50,000” thus causing a “post-code lottery” of access (Boseley 2015c). The Cancer Drugs Fund was subsequently restructured due to significant overspending, which triggered another reassessment of the affordability of medicines. After another de-listing and another signature campaign—this time delivering 115,000 signatures—Roche and NICE once again agreed on an undisclosed price for Kadcyla, thus taking it out of the Cancer Drugs Fund and making it once again available as a routine treatment within the NHS. The decision acknowledged “the comments received from patients” and the signature campaigns, and argued that this experience showed that companies “can offer good deals when it comes to pricing” (NICE 2017).

This struggle over access to medicines is not confined to the UK context alone—it rather reflects a global problem that plays out slightly differently in different local (legal) contexts. Next-generation molecular medicines have become notoriously expensive, triggering discussions about drug pricing for cancer treatments on the global level (WHO 2018), within the US government (Azar 2019) and in US Congress (Facher 2019). Other cases challenging the price of medicines include for example a March-in request for the prostate cancer drug enzalutamide, brand name Xtandi (Love 2016; Knowledge Ecology International and Union for Affordable Cancer Treatment 2016; Andrew Goldman 2017), backed up by demands for a public hearing on this issue (Silverman 2016); the price of the antibody Keytruda that “was an accidental acquisition, initially ignored by Merck and almost discarded but now its main blockbuster” (Gapper 2019); and the debate of the use of Crown use provisions for the drug Orkambi for cystic fibrosis (BBC News 2019; Cystic Fibrosis Trust 2018). Price hikes of other medicines, such as Martin Shkreli’s notorious 5000% price increase on Turing Pharmaceuticals’ Pyrimethamine (trade name: Daraprim) (Beck 2015), or the near doubling of the price of Insulin between 2012 and 2016 in the US (Respaut and Terhune 2019), further highlighted the exclusionary power of intellectual property rights at the heart of this issue. This global problem is met by an increasingly global response. In the case of the Coalition, some of the main actors were charities and international non-governmental organisations (NGOs), which were also involved in bringing similar proceedings in the USA and in Scotland (Knowledge Ecology International and Union for Affordable Cancer Treatment 2016).

These campaigns problematise the price of medicines set by the pharmaceutical industry. Molecular biomedical research has given rise to a vast new industry, undertaking exploratory research and developing new technologies and medicines that promise personalised treatment. This industry regularly transcends national boundaries. Kadcyla was developed and is owned by Genentech (a member of the Roche Group)—an international biotech company, which manufactures a number of high profile antibodies and antivirals, and considers itself “the founder of the industry” (Genentech 2019). The antibody–drug conjugate used in Kadcyla is produced by Lonza’s pharma and biotech unit, a Swiss multinational “speciality chemicals maker and life sciences group” (Reuters 2014). Lonza began working on mammalian cell cultures and monoclonal antibodies in 1996 after taking over Celltech Biologics (UK and USA), and in 2004 invested heavily in “three 20,000-L mammalian cell culture fermentation reactors in Portsmouth, NH (USA), the biggest single investment in its history” (Lonza 2019). The production of Kadcyla is located in this complicated geographical, legal, and institutional set up, showing the level of complexity involved in the organisation of the international biomedicine sector. This global distribution of production and an increasingly complex drug development pipeline add to high prices of final products, often including the purchase fees for start-up companies, which develop the actual treatment (Gapper 2019). This global complexity was one of the objects of the Kadcyla-challenge, as the Coalition pointed out in an online explanatory video: “at least one company has offered to manufacture a generic version of T-DM1 in England and there are at least four companies that have the capacity to make the drug for the NHS” (Love 2015).

The exclusionary power of intellectual property rights enables these production and pricing strategies to continue. They bestow a monopoly that effectively disallows other voices to influence the debate around price. The UK’s concept of Crown use overrides this exclusion, as it does not require any type of license: “[t]he Crown or the government has the power to use the patent without obtaining a licence from the patentee” (Yang 2015, p. 418). In this way, the Crown use provisions are more reminiscent of the original sovereign power of the executive or monarch, which can override any other determinations, including international standards or human rights. However, in many ways the Crown use section is usually effectively equated with a compulsory license (Ibid., 416). These are relatively rare, and also likely to anger the international pharmaceutical industry, as for instance in cases of previous campaigns for compulsory licenses for HIV/AIDS treatments in South Africa and Brazil (see for example Rosenberg 2014).

The sovereignty claimed on behalf of patients in England thus invokes the potential boundlessness of sovereign rights, and makes a powerful demand for inclusion in deliberations on price and access to treatments. It also needs to be understood as a global response to a global problem involving global actors. However, conceptually the rights of the sovereign work through the power of exclusion. They represent particularist rights that can override emerging democratic initiatives in the interest of national power and executive privilege. The specific legal remedy used by the Coalition thus limits the effects of the declaration to a particular local context and has to be replicated within each legal system—making even Scotland a different locality with different effects. This draws attention to the limitations of sovereignty as a challenge to a global issue. Claims to ‘genomic sovereignty’ can in fact add further layers of exclusion, as shown in other declarations of sovereignty that set out to challenge the globally operating biomedical sector.