“WHO member states must ask for exceptions in the U.S. sanctions to allow Cuban biotech to work, both for Cuba and the world”: The Files Interview

Newsletter Edition #190 [The Curated Primer]

Jun 21, 2023

Hi,

Today we bring you an insightful interview that straddles the geopolitical, trade, financial, economic and regulatory barriers that the Cuban biotech industry faces in meeting the demand for medical products during health emergencies.

Achal Prabhala from the AccessIBSA project, and Vitor Ido at the South Centre, present their views on making Cuban medical products more accessible in the future, and the role that WHO member states can play.

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Until later!

Best,

Priti

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

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I. THE GENEVA HEALTH FILES INTERVIEW

“WHO member states must ask for exceptions in the U.S. sanctions to allow Cuban biotech to work, both for Cuba and the world”

In an interview, global health experts Achal Prabhala and Vitor Ido talk about the evidence and promise of the Cuban biotech industry, and what this could mean for equitable access of countermeasures in health emergencies. Economic, trade, regulatory, geopolitical and diplomatic hurdles have constrained the access to Cuban-made medical products. Can this be fixed? Read on.

Prabhala is the coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa. Vitor Ido is a program officer in the Health, Intellectual Property and Biodiversity Program at the South Centre in Geneva.

Image credit: Photo by Brett Sayles, Pexels

[GHF] 1. What is the specificity of Cuban vaccines for COVID-19? How many have been administered and where? What are the economics of producing these vaccines?

ACHAL: BioCubaFarma, which is the umbrella body representing the Cuban biotech industry, and comprises several laboratories, began working on Covid-19 vaccines as soon as the pandemic became a fact in 2020. Their reasoning, as we quoted in a recent op-ed we wrote for the Washington Post was simple: they knew they had to make their own vaccines, as they would not be able to afford to import vaccines. (Owing to the historical sanctions, and Trump’s increased sanctions since 2016, the country experienced its worst ever economic crisis during the pandemic).

By the summer of 2021, they had two vaccines ready. Abdala, a 3-dose vaccine from the Center for Genetic Engineering and Biotechnology or CIGB, and Soberana 2, a 2-dose plus booster vaccine from the Finlay Laboratory. Both vaccines were protein-based, or technically, protein sub-unit vaccines, which is a desirable technology.
For context, the only other protein sub-unit vaccines, Novavax and Corbevax (the former a commercial vaccine backed by hundreds of millions of dollars in US government investment, and the latter, a non-profit, patent-free vaccine developed in the US) only came to market one year after their Cuban counterparts.

A full dose of both vaccines resulted in above-90% efficacy, which made them comparable to the leading Western vaccines in use at the time. Both institutes published their clinical data for each of their vaccines across a range of journals, and, notably, in the Lancet as well.

Sanctions made exports near impossible, but some exports happened anyway. Cuba exported about 40 million doses of vaccines to Venezuela, Mexico, Iran, Vietnam, Syria, Nicaragua, Belarus, the Saharawi Arab Democratic Republic and Saint Vincent & the Grenadines; they further entered into a licensing agreement with Iran and produced 15 million doses at a plant in Tehran. One or both Cuban vaccines received regulatory approval in Venezuela, Mexico, Vietnam, Nicaragua, Iran and Belarus.

Within Cuba, nearly 45 million doses were given out in the country, covering 91% of the Cuban population. This effectively means that the number of vaccines Cuba exported is roughly the same as the number used domestically, which is unlike any other country – most vaccine-producing countries exported a small fraction of what they used domestically.

In terms of the total cost of developing both vaccines, the figure given to us – a figure that BioCubaFarma had not previously released – was $50 million. Just to be clear, that’s $25 million to produce one effective Covid-19 vaccine. This is absolutely remarkable, given the billions, or at the very least, hundreds of millions, that went into producing every Western Covid-19 vaccine. And we think it’s something that should be paid more attention to.

Here’s the deal: Cuba made two excellent vaccines at an astonishing low cost, which they were willing to share, both actual doses and the underlying vaccine technology, with anyone who wanted them. And yet, none of the countries in Africa or South Asia who needed vaccines in 2021 could take them up on their offer, despite suffering acute vaccine shortages that cost lives. Why? Because, despite these countries maintaining normal diplomatic relations with Cuba, they were prevented from trading with Cuba by US sanctions against the country.

This is absurd, and the fact that we, the global public health community, barely noticed it, is even more absurd. (Good on Knowledge Ecology International though, for taking it up with the Biden administration, even though they didn't get a response).

[GHF] 2. How did trade policies affect the access to Cuban vaccines? Please elaborate on the crippling effects of economic sanctions.

VITOR: Cuba has been for decades, under a strict US embargo which prevents it from truly partaking in international trade by prohibiting transactions with Cuban institutions. Although this is an illegal unilateral coercive measure under international law, since most financial transactions in the world are made in US dollars, US institutions enforce the embargo – therefore becoming a globally enforceable standard.

It basically impedes Cuban institutions from both importing and exporting goods to other countries. In rare cases, it forces Cuban institutions to find entities willing to conduct transactions (often other sanctioned countries, and more recently transactions in other currencies other than USD), which is much more costly. In other words, the embargo impedes Cuba’s international trade, a massive contradiction to the free trade speech which reigns in the US discourse, and quite clearly another iteration of how historically the US dealt with Latin American and Caribbean countries.

This means that even if health is a high priority for Cuba (which has a remarkably successful and robust universal public health system), the economic sanctions have a clear social and humanitarian impact that, if anything, affects individuals and families in Cuba even more than its government.

Although the embargo contains a humanitarian exemption that is supposed to allow for the import of health products, in practice, the exception is not really applied, and the embargo does prevent the development of Cuban vaccines, including access to materials and equipment which are part of the manufacturing process, and the economic viability of exporting the final product to most other countries.

The main issue here is that banks and other financial operators around the world actually overcomply with the sanctions (also see here). This means that financial institutions go way beyond what is in principle necessary to comply with the illegal restrictions, so that they are sure that US institutions will not eventually sanction them as well.

Accordingly, any transaction with Cuba becomes a potential risk for financial institutions so that even those willing to work with Cuban institutions under the health exemption of the embargo will not do so. The most obvious consequence is that Cuban pharmaceutical industry (as all other sectors) is unable to take part in international trade. The market prospects for a R&D process in Cuba needs to take into account these obstacles to obtain materials and in terms of what countries its products can really be exported to.

This means that, in the best-case scenario, Cuba needs to pay much more for the necessary manufacturing products (finding a company and a financial operator willing to conduct such business). Given the hurdles, it will invariably cost much more than the international average. In the worst-case scenario, it simply cannot have access to what is needed even if overseas partners (e.g., companies, research institutions, medical suppliers) are willing to conduct this transaction.

During our research on this, we were told a concrete story which exemplifies the problem: biological samples were pre-cleared to be exchanged between Cuba and the United States as part of a collaboration between institutions. The samples were however halted at US customs, and once they were finally cleared a few days after, the samples were no longer utilizable.

Finally, the inclusion of Cuba in the list of terrorist-sponsoring states at the end of the Trump presidency (which continues under the Biden administration) made things much worse, as it heightened both the direct restrictions and the anxieties related to transacting with Cuba. A prominent consequence was to impede the commercial viability of the Mariel Port, a Cuban initiative expected to become a free trade area with much more economic openness and more attractive to foreign investors. This new port area was expected to strongly upgrade the Cuban biotech industry and provide more avenues for international collaboration (commercial and non-commercial).

From our interviews, the perception is that the presence of Cuba in the list impedes the success of the initiative, particularly with respect to biotechnology and international R&D, since foreign investments became de facto or nearly impossible.

[GHF] 3. What can be done to improve the access to Cuban technology for future health emergencies? Specifically, in terms of regulatory processes at WHO; and regulatory processes in other jurisdictions such as those pertaining to FDA, EMA or other regional regulators in India and elsewhere.

ACHAL: The WHO’s pre-qualification programme is meant to benefit developing countries; it is designed explicitly for us. During Covid-19, Cuba could not take full advantage of the programme because its own facility upgrades were mired in the sanctions mess; they were unable to afford and get the equipment upgrades they needed, as well as unable to gather the right human infrastructure to clear the WHO hurdle. This is despite CIGB having done so twice before, in 2001 for a Hepatitis-B vaccine, and in 2010 for an influenza vaccine.

I agree with Vitor that the primary way in which WHO and its multilateral member states can help global public health is by asking for exceptions in the US sanctions to allow Cuban biotech to work, both for Cuba and the world.

However, perhaps there is also an opportunity for the WHO to also actively invest in hubs, with shared technology, in the way that it does for mRNA vaccines, for instance, in South Africa.

On the facts alone, it would seem as if Cuba is ideally placed to serve as a hub for public health solutions across a variety of diseases, with an in-built desire to share technology, and a proven track record of delivering results. If the WHO found itself able to provide a kind of protective cover to Cuban laboratories, for a specific project, perhaps that would allow Cuban biotech to work – by helping Cuba achieve the regulatory requirements of WHO pre-qualification – both for itself, and also for other countries in the world.

As far as other countries go, it does seem strange that every country in the world is seemingly willing to allow one country’s unilateral embargo against another country to become their problem too, and to manifest as a de facto embargo on their part as well. It is not clear that most countries are even aware of how complicit they are in the US embargo against Cuba.

It is really hard to imagine Cuba engaging with drug regulators in high-income countries. But middle-income countries, such as Argentina, Brazil, Mexico, South Africa, Turkey and Indonesia, to name just a few, have a unique opportunity here, which is to use their highly regarded drug regulatory agencies to evaluate Cuban pharmaceuticals, and then use them if they need to. In lower-income countries like India, it is hard to see the same opportunity, as the Indian drug regulator has an abysmal reputation, and hardly the kind of confidence to evaluate a pharmaceutical product entirely on its own, without relying on parallel evaluations from high-income countries.

[GHF] 4. What is the political route to get language in current global health negotiations to address challenges faced by Cuba, and potentially other countries facing sanctions?

VITOR: In such sense, the current negotiations at the WHO, particularly at the INB, should ideally contain a provision that clarifies that unilateral coercive measures are not and must not be applicable to health-related R&D, manufacturing, and imports/exports.

We understand that the US – as well as many of its geopolitical supporters – strongly oppose any language that signals the illegality of its unilateral sanctions (such as but not restricted to the Cuban embargo).

But this is a global health instrument in the making, which should not be focused on the same nationalistic views we saw during the pandemic but rather a global solidarity commitment that identifies how health is by definition and always cross-cutting and transnational.

If a language that explicitly addressed unilateral coercive measures cannot be agreed on, there are still others which should be contemplated: an obligation for States to ensure that trade-related and investment-related rules, including the rules governing financial transactions, that should not create barriers to the trade of goods and the sharing of health-related technologies.

This kind of language is perhaps surprisingly aligned with calls made by the WTO during the Covid-19 pandemic, and it would be even more absurd for the US to oppose this kind of obligation.

Additionally, a simple statement by the US government in that regard can be sufficient (or at least conducive) to reduce the level of overcompliance by financial institutions around the world.

Get in touch with Achal and Vitor: aprabhala@gmail.com and vitor.ido@gmail.com

(This interview was subsequently edited to refer to KEI’s efforts on the Cuban vaccines with the Biden administration)

II. PODCAST CORNER

Clearing the air for a healthy future

This episode brings together two grassroots advocates for clean air who share country case studies from India and South Africa, explaining why it is impossible to have healthy people living on a sick planet.

Host Garry Aslanyan navigates the concepts of environmental justice and the impact of air pollution on communities, with the following guests:

Shweta Narayan from Health Care Without Harm, who shares how community health workers were successful in pushing for stronger pollution control measures.
Rico Euripidou from groundWork, who reiterates the need for the health sector to advocate for environmental justice.

Listen to the episode.

Garry Aslanyan is the host and moderator of the Global Health Matters podcast. You can contact him at: aslanyang@who.int

This podcast promotion is sponsored by the Global Health Matters podcast.

If you wish to promote relevant information for readers of Geneva Health Files, for a modest fee, get in touch with us at patnaik.reporting@gmail.com.

III. WHAT WE ARE READING

Policy Updates

People with medical needs are “left behind in pain” reveals new report: WHO

Global Congress opens to counter harmful marketing of formula milk: WHO

News

Journals & Reports

Gender equality and pandemic response: The BMJ
Resisting unchecked pragmatism in global health: Correspondence in The Lancet
The EU must step up its actions and leadership on global health: The BMJ

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