How effective is Kenya’s system for regulating new medicines and compensating citizens who suffer side-effects from taking them? Since March 2021, Kenya has been using the AstraZeneca vaccine supplied through  COVAX to inoculate its frontline workers and the older population. This is available to the public free of charge, according to a priority list drafted by the Ministry of Health (MOH). The Pharmacy and Poisons Board (PPB) also approved the importation of the Sputnik V vaccine from Russia, which was initially available through private health facilities only at a cost of KSh8,000 per jab, before the MOH banned it altogether. However, there were reports in the media that the vaccine continued to be administered secretary even after the ban.

Although side effects are rare, we know that all vaccines come with certain medical risks. Kenyans taking vaccines run these risks not just for their own protection, but also for that of the wider community. The state has a responsibility to protect citizens by carefully controlling the distribution of vaccines and by ensuring that adequate and accessible compensation is available where risks materialise. These duties are enshrined in the constitution which guarantees the right to health (Article 43) and the rights of consumers (Article 46).

A system of quality control before the deployment and use of medicines is set out in the Pharmacy and Poisons Act the Standards Act, the Food, Drugs and Chemical Substances Act and the Consumer Protection Act. However, the controversy over Sputnik V in Kenya has cast doubt on the coherence and effectiveness of this patchwork system. Moreover, none of these Acts provides for comprehensive compensation after deployment and use of vaccines.

Vaccine approval and quality control

Subject to medical trials and in line with its mandate to protect global health, WHO has recommended specific COVID-19 vaccines to states. Generally, WHO recommendations are used as a form of quality control by domestic regulators who view them as a guarantee of safety and effectiveness. However, some countries rely exclusively on their domestic regulators, ignoring WHO recommendations. For instance, the UK approved and administered the Pfizer vaccine before it had received WHO approval.

The COVAX allocation system fails to take into account the fact that access to vaccines within countries depends on cost and income.

By contrast, many African states have relied wholly on the WHO Global Advisory Committee on Vaccine Safety given their weak national drug regulators and the limited capacity of the Africa Centre for Disease Control (CDC). The Africa CDC itself deems vaccines safe for use by member states on the basis of WHO recommendations. Kenya has a three-tier approval system: PPB, Kenya Bureau of Standards and WHO. The PPB relies on the guidelines for emergency and compassionate use authorisation of health products and technologies. The guidelines are modelled on the WHO guidelines on regulatory preparedness for provision of marketing authorization of human pandemic Influenza vaccines in non-vaccine producing countries. However, prior to approval by PPB, pharmaceuticals must also comply with Kenya Bureau of Standards’  Pre-Export Verification of Conformity standards .

Vaccine indemnities and compensation 

To minimise liability and incentivise research and development, companies require states to indemnify them for harm caused by vaccines as a condition of supply. In other words, it is the government, and not manufacturers, who must compensate them or their families where required. Failure to put such schemes in place has undermined COVID-19 vaccine procurement negotiations in some countries such as Argentina.  Indemnities can be either “no-fault” or “fault”-based’.

No-fault compensation means that victims are not required to prove negligence in the manufacture or distribution of vaccines. This saves on the often huge legal costs associated with tort litigation. Such schemes have had a contested history and are more likely to be available in the Global North. By contrast citizens of countries in the Global South must rely on the general law, covering areas such as product liability, contract liability and consumer protection. These are usually fault-based, and require claimants to show that the vaccine maker or distributor fell below widely accepted best practice. Acquiring the evidence to prove this and finding experts in the sector willing to testify against the manufacturer can be very difficult.

By default, Kenya operates a fault-based system, with some exceptions. Admittedly, citizens have sometimes been successful in their claims, as in 2017 when the Busia County Government was ordered by the High Court to compensate victims of malaria vaccines. The High Court held that county medics were guilty of professional negligence, first by not assessing the children before administering the vaccines, and second by allowing unqualified medics to carry out the vaccination.

The problem is that the manufacturer has not published sufficient trial data on the vaccine’s efficacy.

In recognition of these difficulties, and in order to ensure rapid vaccine development during a global pandemic, WHO and COVAX have committed to a one-year no-fault indemnity for AstraZeneca vaccines distributed in Kenya. This will allow victims to be compensated without litigation up to a maximum of US $40,000 (approx. KSh4 million). To secure compensation, the claimant has to fill an application form and submit it to the scheme’s administrator together with the relevant evidentiary documentation. According to COVAX, the scheme will end once the allocated resources have been exhausted. The scheme also runs toll-free telephone lines to provide assistance to applicants, although the ministries of health in the eligible countries are also mandated to help claimants file applications.

Beneficiaries of the no-fault COVAX compensation scheme are barred from pursuing compensation claims in court. However, it is anticipated that some victims of the COVAX vaccines may be unwilling to pursue the COVAX scheme.  At the same time, since the KSh4 million award under COVAX  is lower than some reliefs awarded by courts in Kenya, some claimants may avoid the restrictive COVAX compensation scheme and opt to go to court. Because such claimants may instead sue the manufacturer, COVAX requires countries to indemnify manufacturers against such lawsuits before receiving its vaccines.

Sputnik V 

Sputnik V is different. Neither the WHO-based regulatory controls before use, nor the COVAX vaccine compensation scheme after use applies. Sputnik has not been approved by WHO or the Africa CDC. The PPB approved its importation in spite of the negative recommendation of Africa CDC, and in the face of opposition from the Kenya Medical Association. The rejection of Sputnik in countries like Kenya is partly due to the reluctance of Russia’s Gamaleya Institute to apply for WHO approval, partly because the manufacturer has not published sufficient trial data on the vaccine’s efficacy, and partly due to broader mistrust of the intentions of the Russian state. This may be changing as Africa CDC Regulatory Taskforce and European Medicines Agency are now reviewing the vaccine for approval while 50 countries across the globe have either approved its use- or are using it already. In Africa, Ghana  Djibouti, Congo and Angola have approved the use of Sputnik V with Russia promising to donate 300 million doses to the African Union. Such approvals have been hailed for providing an alternative supply chain and reducing overreliance on the West.

As regards compensation, Russia has indicated that it will provide a partial indemnity for all doses supplied. However, no clear framework has been set out on how this system will work. There has therefore been no further detail on the size of awards, and whether they will be no-fault or fault-based. This lack of legal specifics has added to the reluctance of countries around the world to adopt the vaccine.

As matters stand, therefore, the Kenyan government would not be able to indemnify private clinics importing and administering Sputnik V. The absence of a statutory framework on vaccine compensation by the state makes this possibility even less likely. Nor would compensation be available from the Gamaleya Institute. The only route then would be through affected citizens taking cases based on consumer protection legislation and tort law in the Kenyan courts. As we have noted, this is complex and costly. Claims might be possible in Russia, but these problems would be exacerbated by language barriers and differences between the legal systems, as well as the ambiguity of the Russian compensation promises.

The private sector can complement state vaccination efforts, but this must be done in a way that guarantees accessibility and safety of citizens.

Although the importers obtained a KSh200 million insurance deal with AAR as a precondition for PPB authorisation, the amount per claimant was restricted to KSh1 million, which is well below the WHO rates and the average tort rates ordered by Kenyan courts.  As an alternative to claiming against the manufacturers and distributors, injured patients might sue the Kenyan government. Such a claim would allege state negligence and dereliction of statutory and constitutional duties for allowing the use of a vaccine that has not been approved by global regulators such as WHO, thus exposing its citizens to foreseeable risks. This would be particularly attractive to litigants given the difficulties in recovering from the Russian authorities and the risk that Kenyan commercial importers would not be able to meet all possible compensation claims. Ironically, the use of the Sputnik V vaccine in private facilities still exposes the government to lawsuits even if it didn’t facilitate the vaccine’s importation and distribution.

What the government needs to do

The acquisition of vaccines has been undermined by the self-interested “nationalism” of states in the Global North. Only after buying up the greater part of available vaccines have they been willing to offer donations to the rest of the world. These highly publicised commitments fall far short of what is required in the Global South. Kenya’s first task must be to intensify its diplomatic efforts to increase supply through bilateral engagement with vaccine manufacturing states and in multilateral fora like the World Trade Organization, acting in alliance with other African states. Such steps are only likely to bear fruit in the medium term, however. In the short term, it is certainly sensible to involve private companies in vaccine procurement and distribution in order to supplement the supplies available through COVAX. This is recognised in Kenyan and international law as an acceptable strategy for securing the right to health. But it must be done in a way that guarantees accessibility and the safety of citizens. Accordingly, Kenya should encourage Russia (and all vaccine manufacturers) to publish full trial data showing effectiveness and risks, and to seek WHO approval on this basis. It should require them to establish and publicise detailed indemnity frameworks to allow for comprehensive and accessible compensation. It should acknowledge that citizens accepting vaccines are not only protecting themselves, but also the wider national and global community. With adequate regulation before use, the risk of doing so can be minimised and made clearer. But some risk remains, and those who run it deserve to be compensated for doing so. It is therefore imperative for Kenya to establish its own no-fault indemnity scheme for all state-approved vaccines, including those imported by the private sector.

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This article draws from COVID-19 in Kenya: Global Health, Human Rights and the State in a time of Pandemic, a collaborative project involving Cardiff Law and Global Justice, the African Population and Health Research Centre, and the Katiba Institute, funded by the Arts and Humanities Research Council (UK).

17 June 2021

Tonight, I was welcomed in Addis Ababa, Ethiopia, by the sad news of the death of the first President of the Republic of Zambia and a founding father of the nation, His Excellency Dr. Kenneth Kaunda.

In this moment of great loss to Zambians and indeed all Africans, I wish to express my heartfelt condolences to the Kaunda family, President Edgar Lungu, and the government and people of the Republic of Zambia.

The demise of President Kaunda at the grand old age of 97 years brings to end the pioneers and forefathers who led the struggles for decolonisation of the African continent and received the instrument of Independence from the colonial masters in Africa.

Let all Africans and friends of Africa take solace in the knowledge that President Kaunda has gone home to a well-deserved rest and to proudly take his place beside his brothers such as Jomo Kenyatta of Kenya, Kwame Nkrumah of Ghana, Julius Nyerere of Tanzania, Habib Bourguiba of Tunisia, Léopold Sédar Senghor of Senegal, Nnamdi Azikiwe of Nigeria, Ahmed Sékou Touré of Guinea, Félix Houphouët-Boigny of Côte d’Ivoire, Patrice Lumumba of Congo, Nelson Mandela of South Africa to name but a few.

All of them, without exception, were nationalists who made sacrifices in diverse ways. Some, like Patrice Lumumba, untimely lost their lives soon after independence. We are consoled that God granted President Kaunda long life to witness the progression of Africa through five decades of proud and not-so proud moments.

In December 2015, I visited President Kaunda at his home in Lusaka in what was to be our last meeting. As we discussed about everything from family to politics in our two countries and indeed in Africa generally, I asked him if the Africa that we have today is the Africa for which he and his contemporaries struggled and fought. President Kaunda was visibly pained in his response and at some point he broke down and wept. It was obvious to me how disappointed he was about some of the challenges that have plagued our continent for decades since independence.

As we mourn President Kaunda, my prayer is that the death of this great African son and leader will remind us of the sacrifices that he and his contemporaries who fought for Africa’s independence made. Let it remind us of the vision that they had for Africa; their hopes and aspirations; their dream for a free, strong, united and prosperous Africa. Let us, African leaders and people, never let the labour of these heroes past be in vain.

Rest well, KK. Africa is free and will be great.

It has become increasingly common for scholars, activists and politicians who see Africa from African vantage points to be outraged by neo-orientalist portrayals of Africa by scholars and media from the West. By “African vantage points”, I mean that they tend to explain and offer context, on the global stage, to the well-publicised crimes of Africa’s leaderships as opposed to calling them out. I mean, whilst they are critical of Muammar Gaddafi or Robert Mugabe, they are unwilling to support coalitions of “vanguards of justice and human rights” to flash them out, even if flashing out a bad leader comes by way of sanctions. These scholars and activists are my main audience.

It is my contention that we need to be kinder and more sensitive to the West’s celebrity-missionary intellectuals and media. They commit no crime when they “misrepresent” the continent. In fact, misrepresentation as a term does not even apply to them as, indeed, they are not mispresenting anything but simply doing their job. It is liberating to be aware that 95 per cent of academics, the media, and other commentators from the West will — oftentimes involuntarily, instinctively or by association — follow the foreign policy positions of their countries. So, Michela Wrong, Nic Cheeseman, Robert Guest and others remain intellectuals of empire. But with a sophistication; they are not crude like their predecessors (such as the colonial anthropologists who were, among other things, openly racist and abusive). This new breed of missionary-scholar speaks to the visible wrongs in our midst, but decides never to offer them any context, longue durée, causation, and abstraction whatsoever, to the point that they have even conscripted surrogates from amongst us. This new breed is more tactical, more sophisticated, but as dangerous as their predecessors.

Reflecting on Wrong’s recent book, Do Not Disturb, Jörg Wiegratz and Leo Zeilig have reminded us about the timeless monster trope in the Western media and academia in reference to African “autocratic” presidents. It is worth stressing that presidents that are labelled “monsters” are not necessarily innocent individuals; they are and have actually committed crimes to fit the label. But while their badness ought not to be denied, it has to be understood as a timeless fact about all politicians: their monstrosity ought to be understood as a function of power – thus the truism that power corrupts, and this is not limited to Africa. In reality however, those characterised as monsters across formerly colonised places have been men (and women) unwilling to allow modern imperial plunder disguised as free trade and often sold in the language of human rights. Please note that monsters do not start out as monsters in both their political character and in the ways in which the world sees and writes about them. Oftentimes, they simply undergo a key transformation at that sobering moment of encounter with the imperial capitalist machine. Slovenian theorist, Slavoj Zizek has described this moment, as a “key dilemma” for any president.

This new breed of missionary-scholar speaks to the visible wrongs in our midst, but decides never to offer them any context, longue durée, causation, and abstraction.

Ugandan president Idi Amin started out as a darling of the West. But he became a monster as soon as he chose to get the natives out of the backwaters of the economy, which actually meant taking the economy away from the Indian-Asians, the “deputies of colonialists” as historian Lwanga-Lunyiigo calls them. (Since they were neither settlers nor natives at independence, the only category left in this push and pull of belonging was as deputies to the colonialists, but they inexplicably stayed on in the colonies even after the end of colonialism). After Amin radically pulled the rag from under their feet — as Kenya and Tanzania had done using their legal systems — Uganda’s former colonisers who had actually shipped Indians into the region and deliberately privileged them over the natives, were the first to demonise Amin. Once politically bad, Amin also became bad in the scholarship. Most famously, he became a “white pumpkin” in popular media circles.

Queen Elizabeth II bestowed a knighthood on Mugabe, a subtle bribe to get him to ignore land reforms, a burning issue at independence.  For 20 years, Mugabe remained a darling of the West, never antagonising white farmers and instead, becoming ensnared in endless negotiations with them and the UK government to find a less radical or less painful way to allow them to keep the land they had grabbed under colonialism. Even when the British government gave Mugabe money to buy land for redistribution, the white landowners refused to sell. Caving in to pressure from inside his own party and from former combatants, Mugabe then took a hard stance on land. Shamelessly, Zimbabwe’s former colonisers took back their bribe, and the media and academia competed in badmouthing Mugabe.

In nearby South Africa, the bribe that was the Nobel Peace Prize awarded to Nelson Mandela was working wonders. Mandela admitted in his memoir, Long Walk to Freedom, that he had blatantly defied the ANC’s resolutions in his ignorant and childlike pursuit of political independence. In effect, he left South Africa’s entire economy in the hands of white South Africans. As Zizek puts it, if Mandela had really won, he would never have become a darling of the West — and of the world. Similarly, before Kagame started taking a hard stance towards the West, he had been their darling for years. He is now a monster. Ever wondered why with all Museveni’s crimes, he is yet to become a monster? Well, Museveni is in Somalia, Central African Republic, South Sudan, and in the Democratic Republic of Congo. He is providing the calm under which foreign mining companies enjoy Congolese resources, and European pirates enjoy Somalia’s marine resources. Thus, despite his crimes against Ugandans, he is yet to make the label, to be called a monster.

The point I am making here is that a huge percentage of scholarship and media in the West reflects the foreign policies of their masters. This is true not just in the so-called “formerly colonised” places but it is also true of Europe’s and America’s relations across the world where their exploitative tentacles are being resisted. Mainstream scholarship, and media, which is largely “a bunch of frauds” as Noam Chomsky puts it, will often find the “ethical imperative” to blast leaderships in Russia, Syria, Iran, Turkey, Pakistan, Bolivia, Cuba, Venezuela, Brazil, China, and even helpless Palestine — as long as their multinationals face stiff opposition to attempts to monopolise the economies of these countries.

They simply undergo a key transformation at that sobering moment of encounter with the imperial capitalist machine.

The crime of the leaderships of these countries is trying to extract maximum benefit from their mineral resources — especially oil, gold, lithium and platinum —  and fighting for their land. As these leaders are derided by EU and American politicians, Western scholars and journalists endlessly chant their badness. These same scholars and media also pour their blood, sweat and tears to ensure that the crimes of empire are not exposed. Ali Mazrui told us as much in 1997 when the BBC censored him for reporting factually about Muammar Gaddafi. More recently, The Conversation killed a well-researched piece by Matthew Alford on how “western media rationalises and amplifies state-sanctioned violence and wars as millions die.”

Please note that these fellows in the Western-based media and academia hate being associated with their countries’ foreign policies. They will vehemently deny this accusation. They prefer to appear to be objective academics and analysts building their craft on fieldwork and evidence. But there are two handicaps: first, you’ll never hear them speak out against the crimes of their own countries the way they do about those of other countries. You do not see them calling out Israel’s colonisation of Palestine. You do not see them joining Black Lives Matter, nor see them call out the wars in Yemen, Iraq, and the entire Middle East that were started on the basis of inexistent intelligence.  And this isn’t a case of disciplined focus or areas studies; it is a lie. A true activist-scholar has to start at home. Sadly, you have heard them downplay the double standards of structural adjustment, or simply keep quiet. They are happy to harp on about democracy and human rights as if there is no close connection between livelihoods and the resultant modes of governance. Or they do not see the continued pain of structural adjustment with which their countries have disempowered local African populations.

Second, and this is the big point I intend to make: working or simply following the foreign policy positions of their countries is not a crime on their part. They really have no choice.  Even those most aware of it end up with very limited choices. To appropriate David Scott, they have been conscripted to this mission. They did not choose to work for their countries as earlier intellectuals of empire did; they were simply conscripted. To survive as scholars, they have to stay true to the mission of the master who not only introduced them to these parts of the world, but who also enables their intellectual and financial power to undertake scholarship in these parts.

That the majority are unaware of their conscription is how it is meant to be. But even for those who are seemingly aware of their conscription and would want to resist, there are limits as to how far they can go in challenging the dream of their master, the very one who enables them to thrive in the first place. This is an existential dilemma. The conscription is more discreet nowadays as it takes the form of funding, historical connections, etc. For example, there are exponentially more scholars from the UK than from France or Germany working in the former British colonies, in the same way that there are more scholars from France than from the UK in the former French colonies. And although this form of conscription runs deep, it remains largely invisible.

The bigger point I wish to make is this: scholarship is closely linked to the economy—and to politics. Until Africans develop their economies to fund their scholarship, these chaps from the West will continue to say whatever they want – and there will always be good evidence to back up any arguments they choose to make, which actually makes their scholarship appear sound and objective. But as Foucault has told us, to focus on a particular argument is often a political position and not an intellectual one. It is not intellectual persuasion or a case of overwhelming evidence. It is power and politics.

My intention is not to make the conscription of Western media and scholars at the service of their countries’ foreign policies a crime (perhaps if they knew, they would be humbler). It is to remind African intellectuals and activists that there is need to spend more time fighting at home to better their politics and economies. This, in turn, will give them the intellectual and political power to also push our side of the story.