- Apprentice Lawyer
Equitable healthcare to address the CoVID-19 crisis requires a multilevel, multipronged approach, and it is important to achieve equitable healthcare because, as we've heard over and over again, no-one is safe till everyone is safe. Borders, whether drawn on maps or in minds, will not — cannot — guarantee the safety of those within their bounds. Not when one speaks of being safe from a virus such as this.
Intellectual property rights play a role in the process of achieving equitable healthcare although they are, by no means, the only factor. Ultimately, it is realpolitik which plays a decisive role in manufacturing, supply and demand chains. This write-up, however, focusses on intellectual property rights and strategies from a largely theoretical point of view because the information available in the public domain about pre-existing contractual relationships and other factors which affect the situation on the ground are not available in their entirety. Consequently, it is not a comprehensive overview of the legal position, but involves some speculation which hopefully leans more towards the informed than the inaccurate.
To begin with, pharmaceutical products are protected by a range of intellectual property rights, and it is not the case that a single right of one kind is the only right of that kind which protects a specific product. For example, vaccines are typically not protected by a single "vaccine patent" but by numerous patents acting in concert with each other.
The hope underlying the state grant of monopolies in intellectual property is that such grants spur further invention and creativity beneficial to society as a whole. However, the issue isn't entirely straightforward. There are clearly times when monopolies can, in fact, disincentivise creativity and, recognising this, some intellectual property laws contain explicit exceptions to infringement. At other times, creativity and invention rest on material which is either owned or funded by the public. Some of the research which spurs corporate R&D in the pharmaceutical sector, for example, may well be publicly funded. So, there is good reason to challenge the notion that the resultant product should be protected by unassailable intellectual property rights (even leaving aside ethical quandaries such as those which relate to profiteering off pandemics).
The fear — or threat, depending on one's point of view — is that loosening intellectual property protections (even in relation to essential pharmaceuticals for the duration of a pandemic) could disincentivise corporate investment in R&D. However, while it could indeed dampen corporate enthusiasm for pharma R&D, considering the extent to which publicly-funded research may be relied on by corporates, there's no certainty as to what the effect or extent of such "disincentivisation" would be.
Domestic Regulation in Public Interest
There are a number of provisions in Indian law which could potentially help to achieve healthcare equity including those which enable the National Pharmaceutical Pricing Authority to control the prices of drugs through Drug Price Control Orders, and Section 26B of the Drugs and Cosmetics Act which empowers the Central Government to regulate or restrict the manufacture, sale or distribution of drugs in public interest during an emergency arising due to epidemic or natural calamity, if it is necessary or expedient to do so.
Further, the Patents Act contains provisions relating to compulsory patent licenses, patent revocations, and access to pharmaceuticals. During the pandemic, compulsory licensing may be effected through Section 92 which could potentially bypass some of the stringent requirements of Section 84, the usual provision used to consider the grant of compulsory licenses. Also, the revocation of certain pharmaceutical patents may now be possible under Section 66 in public interest on account of their being prejudicial to the public, even though patents are usually revocable under Section 64, which is notoriously difficult to invoke successfully. And, apart from provisions relating to compulsory licensing and revocation, there are provisions in the Patents Act to facilitate government use of pharmaceuticals in Sections 47, 100, and 102. These provisions essentially allow for the distribution of pharmaceuticals in government facilities, extremely limited manufacture in some cases, and the government acquisition of patents.
However, simply stripping pharmaceutical products of their patent rights domestically may not be prudent. Patents are an obstacle to equitable healthcare but they are far from the only obstacle. As tempting as it may be to invoke provisions in the Patents Act that derogate from the rights of patent holders, the fact remains that doing so will not necessarily cut rights-owners out of the picture. It is often an extraordinary challenge to reverse engineer or replicate pharmaceuticals even if they are not protected by intellectual property rights and, so, to galvanize manufacture through IP law, it becomes essential not only to have the hurdles presented by patents removed but also to ensure that appropriate tech transfers are in place. The former without the latter could be meaningless as published patent specifications are simply not enough to realise production.
IPR Waivers v Unrestrained Enforcement
All of this brings one to the fraught issue of intellectual property rights waivers. Nobody who suggests that pharmaceutical patents be waived, or not enforced for the duration of the pandemic, has suggested that they be waived to the exclusion of tech transfers. In the context of the CoVID-19 pandemic, the argument, invariably made without pushing for tech transfers along with patent waivers, is that there is no point waiving patents because patent waivers are inadequate and tech transfers are not feasible because technology falls within the domain of trade secrets that are only shared if sharing is appropriately incentivised. After all, we are ultimately in the midst of a pandemic caused by a virus without an iota of respect for man-made borders or legalistic rights, and we will all likely sink or swim together. A few of us, to draw on a much-used figure of speech, have luxury yachts while most others are confined to handmade rafts but we're all still in the same storm, and no vessel is invincible against relentless assaults as vicious as those this virus seems inclined to unleash. Surely, at some point, if not anything else, a sense of self-preservation should make its presence felt.
There may be reasons not to want to waive pharmaceutical patents ranging from the self-centred to the altruistic. Hypothetically, rights-owners may not see global vaccine equity as being desirable since the emergence of new variants of the virus as it mutates in unvaccinated populations could potentially justify the sale of possibly-annual booster shots to richer vaccinated populations mainly in the Global North and to those able to afford vaccines in otherwise unvaccinated populations mainly in the Global South, often poorer, in no small measure, because of having been historically looted by colonisers usually from the Global North. At the other end of the spectrum, rights-owners may simply want to retain their rights to exercise some form of quality control in which case, if criteria to ensure quality are satisfied, they may proceed to ensure that necessary licences and tech transfers are freely granted to meet global demand.
International Consensus: Proposal and Pushback
Meeting global pharmaceutical demand to work towards healthcare equity could be facilitated by the waiver of various intellectual property rights at a global level as has been proposed at the WTO through what is widely being referred to as the TRIPS waiver, a proposal made in October 2020 to temporarily waive certain intellectual property rights so that they 'do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19'.
The proposal did not immediately receive unanimous support and, by the beginning of 2021, it came to be that if a map of once-colonised lands and historical colonisers had been superimposed over one of proponents and opponents of the proposed TRIPS waiver, they would have been an almost perfect match. What tentative support the proposal, now reportedly set to be revised, has received from erstwhile colonial and imperial states has been largely in relation to vaccine equity and not in relation to the broader proposal. Discounting that a vaccine may reduce the severity of illness, it is not clear how limiting support of the proposed TRIPS waiver to vaccine-related IPR would help people, particularly in the Global South, who become infected. Instead, doing so would likely perpetuate existing inequities.
There has been a deluge of opinions aired to the effect that it is not so much intellectual property and technology hurdles but the the lack of manufacturing capacity and export restrictions which stand in the way of healthcare equity. This, too, is not entirely incorrect although these opinions usually ignore the facts that IP, tech, and manufacturing hurdles must be removed simultaneously to achieve equity, and that a significant fraction of the world's pharmaceutical manufacturing capacity is already in the Global South. It stands to reason that with the appropriate support, including the removal of IP/tech barriers, global manufacturing capacity could be scaled to meet global requirements.
The arguments against the proposed TRIPS waiver are often either perfectly sound or diversionary gaslighting depending on one's point of view. The suggestion that releasing excess vaccine stocks in the possession of some states would be better than the waiver for immediate effect is, for example, entirely accurate although it fails to mention that releasing excess stocks would not obviate the need for the waiver.
A Possible Path Ahead
Focusing on vaccines alone: the relevant procurement contracts are not all publicly available but it looks like at least some of them prohibit vaccines from being simply given away across national borders — a clause pharmaceutical companies may have wanted to be inserted into agreements to limit their own liability, and which would explain reports of vaccine loans. Even if some of the excess stocks of vaccines can legally only be loaned, that immediately causes the question of how those stocks will be replenished without augmenting manufacturing capacity to arise. Without an excess stock replenishment requirement, too, should stocks of excess vaccines be released, the world's manufacturing capacity would still currently be inadequate to quickly vaccinate all of the world's people. The operative word is "currently" — an appropriate TRIPS waiver could help change that situation in months; scaling manufacturing is not an IP issue per se but becomes easier to achieve within a reasonable timeframe minus IP roadblocks.
Releasing excess vaccine stocks (which will anyway expire some time) would be a useful supplement to the proposed TRIPS waiver providing time to negotiate the fine print of the waiver itself. It would not, however, be an appropriate or adequate substitute for the waiver. Time is of the essence since the virus could mutate in unvaccinated populations ultimately lowering or neutralising the effect of existing vaccines. This is a possibility and not a prophecy, and increasing vaccination worldwide would help decrease the likelihood of such an eventuality, which could be catastrophic for everyone in both the Global North and the Global South. In the circumstances, even without taking into account healthcare that does not involve vaccines, gambling, even inadvertently, on the probability that it will be possible to programme or tweak existing vaccines to protect chosen populations, or at least a fraction of the world's population, comes across as being both unsafe and unethical.