Access to Life-Saving Medicines: Evoking Lawful Exemptions to Patent Rights
The fracas between NHS England and the BMJ is an instructive but unnecessary confrontation(1). The ultimate problem clearly lies in the pricing of sofosbuvir and other direct anti-viral agents. Patents ordinarily give exclusive rights of manufacture and sale to the patent holder. There are instances in which the privileges afforded by patents can be lawfully overridden. All 164 member states of the World Trade Organisation (WTO) are signatories to the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)(2,3). Article 31 allows for the abrogation of patent protection under certain circumstances, pertaining particularly to public health. Hence if these circumstances are met, governments can lawfully commission the manufacture of their own generic medication or import cheaper generics(4). Article 31 of TRIPS states that
“Where the law of a Member allows for…use of the subject matter of a patent without the authorization of the right holder,
(b) such use may only be permitted if,…the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public noncommercial use. “
In UK the power to manufacture and distribute a patented product without the patent holder’s authorisation is granted by the UK Patent Office’s comptroller under the provision of the Patents Act 1977ss48-54(5). Hence the £20billion estimated cost of treatment by NHS England(1) should not be a bone of contention but rather should be used to make a compelling and, in many ways, irrefragable case to the patent comptroller in the UK that authorisation could not be granted under “reasonable commercial terms” and hence Article 31 of TRIPS should be evoked. The conclusions of the US Senate Committee on Finance investigation are also admissible; given that it suggested that “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead”(6). The case is even stronger in light of the fact that sofosbuvir is listed among the World Health Organisation catalogue of essential medicines(7). In evoking Article 31 governments, however still are required to pay “adequate remuneration”.
Even if, in the unlikely event, current prices are considered “reasonable”, Article 31 explicitly allows the waiver of patent protection in cases of emergency or “public noncommercial use”. The current situation with hepatitis C treatment in the NHS, with delays literally costing lives; falls firmly into both categories. Article 31 is not a clandestine loophole. Indeed the WTO was so alarmed that this provision was not being evoked more frequently that it expressly reiterated the principles in the 2001 Doha Declaration(8). It explicitly stated that TRIPS should be construed “in a manner supportive of public health, by promoting both access to existing medicines research and development into new medicines”(8,9). It is clear that the WTO anticipated that “market equilibrium” would be achieved. If the cost of pharmaceuticals were excessive, nations would evoke Article 31 of TRIPS and the drug manufacturer would receive little return. Drug companies would thus be encouraged to engage in modest drug pricing. However this equilibrium remains elusive as Article 31 sits as a neglected provision. Clinical eristic may be cathartic but provides no real tangible benefits for patients suffering from hepatitis C. Evocation of lawful exemptions to patent rights provides one possible solution to this polemic.
(1) Gornall J, Hoey A, Ozieranski P. A pill too hard to swallow: how the NHS is limiting access to high priced drugs. BMJ. 2016 Jul 27;354:i4117
(6) McCarthy M. Hepatitis C drug maker puts profit ahead of patients, US Senate report charges BMJ 2015;351:h6573 (Published 03 December 2015)
Competing interests: No competing interests