IP, vaccine imperialism cause death and suffering, delay recovery

Anis Chowdhury and Jomo Kwame Sundaram

SYDNEY and KUALA LUMPUR: Vaccine developers’ refusal to share publicly funded vaccine research findings is stalling broader, affordable vaccinations which would more rapidly contain COVID-19 contagion. The pandemic had infected at least 109 million people worldwide, causing over 2.4 million deaths as of mid-February.

Avoidable delays in preventive vaccination are imposing terrible burdens on the world economy and human welfare, with economic disruption demanding more relief and recovery measures. They have cost US$28 trillion in lost output globally, with developed countries contracting by 7% in 2020.

Avoidable vaccination delays

National capacities to cope with the pandemic have been largely determined by means and power. Thus, access to COVID-19 tests, treatments, personal protective equipment and other pandemic supplies has been severely lacking in most African and other poor countries.

At current vaccination rates, it would take “not one or two years, but six years” to reach 75% global coverage, currently considered the minimum to achieve ‘herd immunity’ against COVID-19.

Patent protections, vaccine production constraints and the rich country scramble will deprive more than 85 poor countries of public access to vaccines before 2023. As of 5 February, not a single dose had been administered in 130 countries with 2.5 billion people.

Of the more than 131 million doses available by 8 February, the US, China, the EU and the UK had 78%, while Africa had 0.2%! Meanwhile, the African Union has only ordered less than half of what it needs to reach herd immunity, i.e., just 670 million doses. Meanwhile, besides Brazil, other Latin American countries only have 150 million doses for less than a quarter of their population.

Supply shortfalls

By the end of 2021, total global capacity of the 13 leading COVID-19 vaccine manufacturers would still be well short of the needs of the world’s almost 7.7 billion people. Even if they all produce at maximum capacity, a fifth of the world’s population would not have access until 2022.

Rich countries continue to oppose the South African-Indian proposal to temporarily suspend relevant provisions of the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to effectively block rapid scaling up of generic vaccine production.

The resulting “catastrophic moral failure” is thus mainly due to vaccine suppliers’ profit maximisation, also limiting supplies and access. Meanwhile, rich countries’ grossly excessive vaccine purchases can vaccinate their residents several times over.

The US will soon have enough to vaccinate its population twice over, while Canada and Australia have booked enough to protect residents several times over. Exceptionally, New Zealand – which has also ordered several times its population’s needs – plans to freely share vaccines with its Pacific island neighbours.

Manufactured scarcity and prices

Global needs now greatly exceed available supply. Middle-income countries have joined the scramble, making onerous direct deals with vaccine suppliers, typically on worse terms than if they had bargained collectively. Unsurprisingly, vaccine prices vary considerably, by more than 12-fold, from US$6 to US$74 per dose.

As countries have not published contract details, acceding to vaccine suppliers’ terms, lack of transparency has enabled abuses. And when forced to comply with Freedom of Information Act requests, documents are heavily redacted before release.

Such limited transparency enables ‘vaccine imperialism’ as big power ‘vaccine nationalism’ impairs others’ access. Thus, following its spat with AstraZeneca, the European Commission (EC) banned vaccine exports to most countries outside the EU.

Double standards rule

In fact, cross-border enforcement of intellectual property rights (IPRs) is relatively recent. Big Pharma successfully lobbied their governments for TRIPS inclusion in the 1994 WTO founding documents. This greatly strengthened and extended IPRs transnationally.

Now, as these non-transparent deals are disputed, European politicians are threatening ‘patent grabs’. EU President Charles Michel has warned of “urgent measures” demanding compulsory licensing, provided for by the European Treaty.

This would require vaccine developers to facilitate generic production, which the developing country-backed TRIPS temporary waiver proposal seeks for all countries. Nevertheless, the EU, other rich countries and their allies still oppose the request to enable rapid scaling-up of affordable vaccine supplies.

Publicly financed vaccine development

To accelerate vaccine development, expenses and risks have been mainly borne by governments, rather than by developers or private finance. The six top candidate vaccine developers have already received over US$12 billion of public money, sometimes with little to show for it.

Of the more successful, Moderna received US$955 million for research and development plus a premarket purchase commitment of US$1.53 billion. In Europe, Pfizer/BioNTech got €375 million from the German government and another €100 million for debt refinancing from the European Investment Bank. Yet, despite massive public financing, vaccine developers retain the IP monopoly right to profit. Thus, the prospect of huge gains from 2021 vaccine sales revenue of almost US$40 billion is delaying progress against COVID-19.

Greed kills, unless…

AstraZeneca promised Oxford University not to profit off any COVID-19 vaccines “for the duration of the pandemic”. However, its contracts allow it to declare the pandemic over as early as mid-2021. It could then charge higher prices for vaccines developed with public money for the university.

The AstraZeneca vaccine was ‘trialed’ on the South African population. Yet, it is paying 2.4 times more than the EU – US$5.25 compared to US$2.16. This makes a mockery of “benefit-sharing” and priority “post-trial access” promises. Meanwhile, turning ‘ability to pay’ on its head, Uganda is paying 20% more than South Africa!

Having the greatest vaccine manufacturing capacity in the world by far, the Serum Institute of India has several contracts to produce the Astra-Zeneca vaccine for different countries. In India, it will sell 90% to the government and 10% to the private sector at a higher price.

Waiver can end pandemic

Vaccines produced generically at greater scale will be far more affordable, enabling more rapid containment of the contagion, infections, deaths and disruptions. Until herd immunity is achieved nationally and globally, priority in allocation should be on the basis of urgent need, rather than ability to pay or political muscle.

The best way forward now is the TRIPS waiver proposal, still blocked by rich country governments at the WTO. It would enable all countries to affordably make or buy ‘generic’ vaccines. This would most effectively expedite containing the pandemic with the least loss of lives and livelihoods.

Intellectual property cause of death, genocide

Jomo Kwame Sundaram and Anis Chowdhury

KUALA LUMPUR and SYDNEY: Refusal to temporarily suspend several World Trade Organization (WTO) intellectual property (IP) provisions to enable much faster and broader progress in addressing the COVID-19 pandemic should be grounds for International Criminal Court prosecution for genocide.

Making life-saving vaccines, medicines and equipment available, freely or affordably, has been crucial for containing the spread of many infectious diseases such as tuberculosis, HIV-AIDS, polio and smallpox.

Jonas Salk, who developed the polio vaccine, insisted that it remain patent free. Asked who owned the patent 65 years ago, he replied, “The people I would say. There is no patent. You might as well ask, could you patent the sun?”

Intellectual property induced scarcity

However, cross-border enforcement of intellectual property rights (IPRs) is relatively recent. The 1994 WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) greatly strengthened and extended IP transnationally. IPRs have effectively denied access to patented formulas and processes except to the highest bidders.

Recognising the extent of the pandemic threat, vaccine developers expect to be very profitable, thanks to national and transnational IP laws. Thus, IP has distorted research priorities and discouraged cooperation and knowledge sharing, so essential to progress.

As COVID-19 infections and deaths continue to rise alarmingly, rich countries are falling out among themselves, fighting for access to vaccine supplies, as IP profits take precedence over lives and livelihoods.

‘Vaccine nationalism’ involves cut-throat contests responding to scarcity due to limited output. Facing vaccine wars, multilateral arrangements, such as Covax, have not adequately addressed current challenges.

Vaccine nationalism has also meant that among the rich, the powerful – Trump’s US – came first. Consequently, most developing countries and most of their people will have to wait longer than necessary for vaccines, while the powerful and better off secure prior access, regardless of need or urgency.

Lethal combination

This lethal combination of IP and vaccine warfare is responsible for more avoidable losses of both lives and livelihoods. Developing nations, especially the poorest and most vulnerable, have been left far behind, even in most programmes for COVID-19 prevention, containment, treatment and vaccination.

The deadly duo are unnecessarily delaying the end of the pandemic, causing avoidable infections, deaths and related setbacks. World Health Organization (WHO) Director-General (DG) Tedros warns “the world is on the brink of a catastrophic moral failure…the price of this failure will be paid with lives and livelihoods in the world’s poorest countries”.

He advises that “the international community cannot allow a handful of companies to dictate the terms or the timeframe for ending the pandemic”; “vaccine nationalism combined with a restrictive approach to vaccine production is in fact more likely to prolong the pandemic … tantamount to medical malpractice on a global scale”.

While over 39 million vaccine doses had been given in 49 richer countries, only 25 doses had reached one poor country! At current rates, more than 85 poor countries will not have significant access before the end of 2023! In 70 lower income countries, only one in ten will be vaccinated.

Of the 7.2 billion confirmed sales of COVID-19 vaccine doses, 4.2 billion have gone to the wealthiest nations. With only 16% of the world’s population, high income countries have secured 60% of available doses. Meanwhile, the African Union has only procured 670 million for the continent’s 1.3 billion people.

Public health exception

Following strong advocacy led by South African President Mandela, a 2001 WTO Declaration on TRIPS and Public Health affirmed countries’ right to protect public health by enabling access to medicines, even without a health emergency.

Although TRIPS now allows such government public health efforts, developing countries remain constrained by compulsory licensing’s complex rules, procedures and conditions. Threats and inducements by transnational corporations and their governments limit its use.

Hence, use of compulsory licensing by developing countries has been largely limited to several more independent middle-income countries and HIV/AIDS medicines.

TRIPS waiver

The TRIPS waiver proposal to the WTO – led by South Africa and India – seeks temporary suspension of several TRIPS provisions to greatly scale up production of and access to COVID-19 vaccines, medicines and equipment to contain the contagion.

The Trump administration, the European Union (EU) and their allies have so far blocked the waiver proposal, although its measures are allowed by their own national laws. Some rich countries even increased such provisions with the pandemic.

South African TRIPS negotiator Mustaqeem Da Gama has debunked the waiver opponents’ claim that even if “approved tomorrow, there are no companies in the developing world that can produce any number of products relevant to COVID-19, including mRNA vaccines”.

In fact, the Serum Institute of India is acknowledged as the only facility in the world with the mass vaccine production capacity to rapidly greatly scale up output. Furthermore, 72 of the 154 vaccines ‘pre-qualified’ by the WHO are already being manufactured in developing countries.

Such production in developing countries is subject to very restrictive IP regulations and licensing agreements with stringent conditions. Hence, existing capacity in India, China, Brazil, Cuba, Thailand, Senegal and Indonesia, among others, remains underutilised, primarily due to such legal barriers.

IP main barrier

Despite growing support for the waiver, the proposal was rejected by the TRIPS Council on 4th February. The EU insists that IP will “ensure the publication and dissemination of research results, when otherwise they will remain secret”.

But everyone knows the IP system discourages, rather than encourages cooperation and sharing, both essential for accelerating progress. Although IP requires sharing research results, no vaccine developer has done so yet. Nonetheless, waiver opponents insist the system is working well.

Rich countries opposing the waiver have quietly, even secretly bought up vaccines. Even as the EU has lost vaccine wars despite furthering pharmaceutical company interests, it has claimed the moral high ground as a major Covax donor. The recent EU export authorisation scheme, restricting exports, is bound to trigger retaliatory restrictions by others.

Incredibly, rich countries opposed to the TRIPS waiver proposal, particularly the EU, now want WTO members to instead accept its trade and health initiative for further trade liberalisation and removal of export restrictions –to address a problem of its own making!

Biden can still lead

The Biden administration has shown renewed commitment to multilateralism by rejoining the WHO, but still needs to offer leadership beyond funding the ineffective Covax scheme and lifting Trump’s embargo on exports of vaccines, vital medicines and equipment.

One ‘people’s vaccine’ proposal involves sharing research results in return for public financing. This can affordably, quickly and greatly scale up generic production, enabling ‘vaccines for all’ in the world at little additional cost.

As rich country governments have already spent to accelerate vaccine development, they can make this happen. As vaccine developers do not expect to profit much from the poor, this will benefit many at little added expense.

Depriving and delaying vaccines for those with less means has to be seen for what it is. Such avoidable behaviour is, frankly, nothing less than genocidal, for causing many people to die needlessly for IP profit.

At the forthcoming 23 February TRIPS Council meeting, US President Biden can secure consensus support for the waiver proposal, thus providing the Rooseveltian leadership internationally that he seems to be emulating in the US.

Related IPS commentaries:

“Intellectual Property Monopolies Block Vaccine Access”. 15 Dec. 2020. https://www.ipsnews.net/2020/12/intellectual-property-monopolies-block-vaccine-access/

“Caught in Tangled Web of Vaccine Nationalism”. 2 Feb. 2021. https://www.ipsnews.net/2021/02/caught-tangled-web-vaccine-nationalism/

“Road to Hell Paved with Good Intentions”. 3 Feb. 2021. https://www.ipsnews.net/2021/02/road-hell-paved-good-intentions/

“West First Policies Expose Myths”. 31 Mar. 2020. https://www.ipsnews.net/2020/03/west-first-policies-expose-myths/

Road to hell paved with good intentions

Jomo Kwame Sundaram

KUALA LUMPUR: Access to COVID-19 vaccines for many developing countries and most of their people will have to wait as the powerful and better off secure earlier access regardless of need or urgency. More profits, by manufacturing scarcity, will surely cause even more loss of both lives and livelihoods.

Good intentions not enough

To induce private efforts to develop and distribute vaccines, the WHO initiated COVAX to ensure more equitable access to COVID-19 vaccines. However, interest by vaccine companies has been limited, while some governments – especially from better-off upper middle-income countries – pursue other options.

COVAX has been co-led with GAVI, the Vaccine Alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI). Buoyed by their earlier success with advance market commitments (AMC), they have extended the same approach in very different circumstances.

AMC was originally conceived to induce the development of vaccines for ‘neglected diseases’. Such infectious diseases remain threats in poor countries and among poor people. Hence, prospective sales revenue was believed to be too small for needed investments by profit-seeking vaccine companies.

By guaranteeing and subsidising sales, the AMC effectively promises the vaccine developer to make the research and development effort profitable, typically with early payments and subsidies to enhance the inducement.

No one size fits all

In the Covid-19 pandemic context, however, the COVAX AMC is not a ‘white knight’ coming to the rescue of an orphaned, typically tropical disease. Instead, it competes with other buyers, mostly of greater means.

To put it bluntly, the Covid-19 pandemic context is quite different from the ‘neglected diseases’ problem which the AMC was conceived to address, i.e., contemporary Western R&D efforts presumed to be driven primarily, if not exclusively by the prospect of profits.

The highly infectious ‘aerosol-borne’ virus quickly achieved a global reach. Apparently more likely to be lethal with advancing age, mass vulnerability to infection ensured a broad, inclusive, international market for Covid-19 vaccines from the outset.

Recognising the extent and impact of the pandemic threat, vaccine developers expect to sell their vaccines very profitably. They made advance sales to many rich-country governments, rather than, or even while committing to COVAX. Unsurprisingly in these circumstances, the COVAX AMC approach has not worked well, let alone equitably.

The companies did not require AMC advance purchases to start their efforts. Expecting the WHO to protect their interests, participating developing country governments, mainly of upper-middle income economies, have generally not worked together to push for further price moderation.

COVAX subverted

Advance Covid-19 vaccine purchases by many rich country governments are not only greatly in excess of their population requirements, but also not made in a transparent manner conducive to improving equity.

Unsure of the efficacy and effectiveness of the often still experimental vaccines, some booked, paid for and now demand far more than needed by their populations. Thus, COVAX has been subverted by rich country government actions.

Ironically, instead of protecting and promoting the interests of the poor, the public interest and the common good, the COVAX AMC has served to set floor prices. Arguably, COVAX has ensured profits for vaccine companies without addressing the ‘only money talks’ problem and competitive ‘vaccine nationalism’.

To ensure a ‘people’s vaccine’ available to all, Acharya and Reddy have proposed public financing to develop or buy over vaccine formulas. This can ensure patentable and other relevant information is freely shared, enabling generic vaccine producers to greatly increase supply at much lower prices.

As rich country governments have already paid much to accelerate vaccine development, they can more easily secure and share the thus far undisclosed information needed to greatly and affordably scale up generic vaccine output.

As vaccine developers do not really expect much revenue from selling vaccines to the poor, such ‘generosity’ would cost them little, while earning them and the enabling governments priceless appreciation and goodwill in the process.

Way out

The best way forward now involves approving the TRIPS waiver at the WTO, which the Trump administration, the EU and some allies, such as Brazil, have stubbornly blocked.

The TRIPS waiver – sought by developing countries led by South Africa, India and Pakistan – seeks to temporarily suspend several TRIPS provisions on patents, design and protection of undisclosed information.

The Biden administration has shown renewed commitment to multilateralism by re-joining the World Health Organization (WHO). It can demonstrate leadership by not only lifting the US embargo on exports of vaccines, vital medicines and equipment, but also advocating strongly for the TRIPS waiver proposal at the WTO.

US taxpayers have already spent many billions to accelerate private vaccine development and distribution. Vaccines for the world can be greatly increased, at little additional cost, by working with the rest of the world, as Chinese researchers did by sharing the virus’ genome sequence with the world within a fortnight of its discovery over a year ago.