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The Pandemic and the Path to Equitable Healthcare

Equitable healthcare to address the CoVID-19 crisis requires a multilevel, multipronged approach, and it is important to achieve equitable healthcare not least 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, and in supply and demand chains. This write-up, however, focusses on intellectual property rights and strategies from a largely theoretical point of view not least 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, and involves some speculation which hopefully leans more towards the informed than the inaccurate.

Incentivising Innovation

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 licences, patent revocations, and access to pharmaceuticals: now, 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 licences. Also, the revocation of certain pharmaceutical patents may now be possible under Section 66 of the statute 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: erasing all nuance, 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 galvanise 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 at all who has suggested that pharmaceutical patents be waived, or at least 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, that there is no point waiving patents because patent waivers are inadequate is just as hard to sustain as the argument that 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 consigned 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 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 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, actually occurring. 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. 

(This post, based on a Twitter thread, is by Nandita Saikia and was first published at IN Content Law. It was republished at Bar and Bench on 29 May 2021.)

[UPDATE: (1) A revised proposal was was submitted by 62 WTO members on 21 May 21. It did not appear to be immediately available at the WTO site although uploaded the document and posted a summary of it online.]


3 June 2021

A quick note on vaccines re indemnity and immunity:

They're not the same.

Indemnity does not mean that an individual suffering from vaccine injury cannot be compensated; immunity may sometimes mean that.

Indemnity is to evade payment.

Immunity may be to evade liability.

Immunity is not generally granted to pharma companies but it is a negotiable issue. The US granted ltd duration immunity under the PREP Act, AFAIK, but it also has programmes that could help individuals if things go wrong: and are US vaccine injury compensation programmes. How well they work is open to debate but they do exist.

A drug regulator cannot generally be sued for granting approval due to sovereign immunity. US employers mandating vaccination, too, may not be easily sued although there may be people who can legitimately claim exemptions (such as, possibly, on medical advice through disability law) and vaccine injury may be treated as an on-the-job injury enabling compensation claims.

India, thus far, AFAIK, has not granted any vaccine manufacturer immunity from liability for vaccine injury but that does not mean that it cannot do so. What India ultimately decides to do — either continue as is or change course — will be more a policy than a legal decision.

Recent reports suggest that India has chosen to consider granting indemnity, not immunity. All granting a vaccine manufacturer indemnity usually does is say that should a legal requirement to pay compensation for vaccine injury arise, the grantor of the indemnity will pay it / reimburse payment (depending on how the clause it structured).

An indemnity clause does not leave vaccine recipients unprotected although — importantly — it acts in tandem with a judicial determination that compensation/damages are due. The Indian system is not known to routinely award large damages for medical negligence/product liability.

Without being granted indemnity, a vaccine manufacturer would typically get insurance to pay damages, if required, which could be either third party insurance or self generated. Whichever option it were to choose, the costs of insurance would be passed on to the buyer.

So, not agreeing to indemnify vaccine manufacturers may (1) not benefit vaccine recipients, (2) raise vaccine prices. There is no major downside to (or cause to decry) agreeing to indemnification in the circumstances.

Once again, indemnity & immunity are entirely different. And the grant of indemnity doesn't justify the brouhaha that's being generated.

8 June 2021

So, how is copyright implicated in pharma intellectual property? (And why does a limited copyright waiver find mention in the proposed TRIPS waiver re pharmaceuticals to fight the pandemic?)

Packaging easily confused with the original licensed or patented product aside, spurious or infringing pharmaceutical products may well use the documentation of the original — fact sheets, specifications, trials... you name it — in which case, in addition to all the other violations involved, copyright infringement has also almost certainly been committed. 

Unlicensed pharmaceuticals are usually primarily dealt with through patent and trade mark law. Copyright law tends to be invoked only to the extent of the rights in artistic works which comprise packaging being infringed. However, not additionally invoking copyright law in respect of literary works comprising associated documentation is often something of a missed opportunity.

To avert the legitimate possibility of copyright law being used to assail pharmaceuticals made under the auspices of a patent waiver & tech transfer, a copyright waiver is also necessary.