Poster - How China's Fake Vaccine Scandal explains Kenya's Fake Drug Crisis

What an In depth Look at China’s Fake Vaccine Scandal Informs About Kenya’s Complex Fake Drug Crisis

The news report was framed as political analysis. Hidden within the enchanting intrigue of real life compelling political gossip, was a number. Though nested within the newscaster’s rumblings, it stood out – two hundred billion Kenyan shillings. This figure has been regurgitated over and again in recent times. From a time in the preceding months when a lobby group valued the Kenyan counterfeit goods market at $2 billion. Though the methodology is unclear, $2 billion likely accounts for taxes and the market value of goods not sold by local manufacturers and distributors. For it sure doesn’t speak of the Qaly and Daly cost of fake drugs, fake vaccines and substandard non pharmaceutical goods on Kenya’s UHC goals.

The $2 billion figure may also not account for the damage to Kenya’s dreams of becoming a top destination for medical tourism. Because who travels to seek healthcare in a health system under the spell of fake drugs?

Nor does it factor the personal, societal and fiscal burden of unwanted pregnancies that result from taking fake morning after pills. Or losses in gross national happiness thanks to the anguish of sexually transmitted diseases when fake condoms burst during intercourse.

Worrying? Well, we are just getting started.

No one is Safe: Fake Drugs in Kenya – The Tragic Proportions of A Silent Killer

Kenya’s Anti-Counterfeit Agency estimates that about 1 in 5 products sold in major towns in Kenya are counterfeit. The figures get tragic when it comes to counterfeit drugs. WHO estimates that 60% of drugs sold in developing countries are fake. Worse, a 2015 report estimated that one in three pharmaceutical products sold in Kenya are counterfeits.

In an Op- ed published in Kenya’s Anti-Counterfeit agency’s website, the agency’s Chairman Mr. Pradeep Paunrana offers “Counterfeited medicines and cigarettes are among some of the prized products that pass through Kenya into the regional markets with some spilling over to local consumers.”

Given the Chairman’s diagnosis of the problem, we have to ask: What proportion of the $2 billion illicit goods trade in Kenya are fake drugs?

$60 Million, 113 Million Fake Drugs, 16 Countries, 10  days

In September of 2016, the World Customs Organization (WCO) and the International Institute for Research Against Counterfeit Medicines (IRACM) reported (published in Jan of 2017) seizure of fake drugs worth $60 million. This was following simultaneous inspection of containers in ports in 16 African countries.

Two things to note about this joint exercise that roped in law enforcement of the host countries. First, it took place over a 10 day period. A period that is good enough for point estimates but not adequate to tell trends or absolute numbers. Second, the survey was conducted only on the major ports of entry of the participating countries. Common sense tells us that the smaller routes, illegal points of entry may have a thing or two to say about their contribution to proliferation of counterfeit drugs in Kenya. However, even with such constraints, 113 million illicit and potentially dangerous pharmaceutical products were seized. The report gruesomely reads:

Most were essential treatments: antimalarial drugs, anti-inflammatories, antibiotics, and analgesics, as well as gastro-intestinal medicines. Even if most of the seizures were of everyday medicines, anti-cancer drugs, with over 2 million doses discovered, are also included in this tragic record.

The port of Mombasa, gateway to East Africa, was flagged as a key trafficking point for counterfeit drugs, therefore affirming Mr. Pradeep Paunrana’s assertions. However, what Mr. Pradeep’s diagnosis failed to distinctly illustrate was that the tragedy of the fake drugs in Kenya is both within and without. In attempting to cover this last mile, we will start from without, China. Then head in to highlight bad practices in Kenya’s nascent pharmaceutical industry that continue to place Kenyan consumers at risk.

Fake Drugs : The China Connection

Two stories, happening roughly a year apart, in China’s pharmaceutical industry serve to highlight how convoluted this fake drug problem is. The first is a story of the Swahili proverb: Mbwa hawezi kula furushi waliomfungia shingoni. The dog cannot eat the bundle they tied to its neck. Meaning, he who is put in charge of an object isn’t allowed to dispose it. In this context, the proverb warns of the folly of state regulation in countries where the government directly produces up to 70% of economic output.

We will cover the second story that happened almost over a year go today, a little later. Lets tackle the first by mulling over Chinese government actions following the fake vaccine story scandal in China in days past.

Lets begin with a rhetorical question. In the aftermath of the fake vaccine scandal, what can observers make of the uncharacteristic show of openness by Beijing? Is it meant to demonstrate government commitment to international standards on safety and testing requirements? Is it meant to prepare the way, as John the baptist did, for Chinese pharmaceutical industry to global markets?

Or is it what it is. China’s second largest pharmaceutical company falsified research reports, manufactured a fake vaccine that has hundreds of thousands of children receiving junk jabs. Therefore, Chinese big pharma, Chinese children, Chinese problem. While on the surface this might appear as a Chinese problem, health practitioners in Cape Town to Nairobi and even Washington, should all be worried. Here is why.

State of China’s Pharmaceutical Industry: Ambition, Good Distribution Know- How and Not So Good Standards Place Global Consumers at Risk of Fake Drugs

If anything, the China’s fake vaccine scandal is indicative of weak Chinese enforcement of good manufacturing and good clinical practice standards. Sadly, there is more evidence of this failure in regulation of Chinese Biopharma. In December of 2017, Kenya’s ministry of health recalled a popular Malaria drug, Duo-Cotexin, for failing laboratory tests. Chemical assays had revealed that the Chinese manufactured antimalarial did not have the ingredients it claimed to have.

A bit of context: Kenya is a malaria endemic country. The mosquito borne parasitic infection is among the highest contributors to morbidity and mortality in Kenya, especially in children under the age of five. How murderous!

Meanwhile, as the fake vaccine scandal ebbs on, South Africa is recalling a Chinese manufactured generic drug used in treatment of high blood pressure. The concern here is the generic drug contains a compound that causes cancer. A simple google search should reveal similar actions by governments worldwide triggered by concerns over the safety and quality of Chinese manufactured pharmaceutical products. We end our search for more examples as the South African case completes the fake drugs ring of death that hangs over Chinese pharma.

How Counterfeit Drugs are a Danger To Health and Life

First, there is death from the disease due to ineffective treatment as the fake drugs may lack of active ingredients. Then there is increase in disease burden, morbidity and mortality as more severe forms of disease emerge. All this trouble thanks to the emergence of drug resistant strains from sub-optimal dosing. Finally, there is demise of the user secondary to poor health brought about by harmful molecules in substandard drugs.

It’s tragic. Even without mention of the global health implications of sub-optimal vaccination of children in the world’s most populous country.

Furthermore, the tragedy of the China’s fake vaccine scandal also tells of the dire state of pharmcovigillance in the world’s second largest market for pharmaceuticals (worth $122.6 billion). China is also the fastest emerging market (compound annual growth rate from 2013 to 2017 was 9.4 percent).

Notorious fragmentation of this lucrative market has been blamed for many of these ills. Not only does it make regulation cumbersome, the small size of the companies involved means that fewer dollars go into R&D. However, such beautiful numbers can also mean one thing, that China’s pharmaceutical industry is ripe for investment. That Big Pharma to serve the domestic Chinese market and international market is the likely next evolutionary step.

Still, A Rose Grew From The Concrete

The question for Kenya and other markets as this Chinese government led assault takes root, is: How consistently safe and efficacious are Chinese pharmaceutical products? The current troubles of Kenya, South Africa and others with fake drugs originating from China is likely to yield a negative verdict.

Not too fast though.

The Swahili have a saying ‘Mgala muue lakini haki mpe’. You should give credit where it is due, however how much you dislike the recipient. Even if you’d wish them dead. This saying sets the stage for the second story of the convoluted fake drug labyrinth. It is a story of unprecedented medical science sucess. A story that prods us to seek deeper the genesis of Kenya’s counterfeit drug problem. With this story we accept Tupac’s wisdom in The Rose That Grew From Concrete that warns against criticizing things based on their origins.

“Made in China 2025” and China’s Big Pharma Dreams

Laika is a pig born in China. Named after the first dog to orbit Earth in 1957, Laika has 36 siblings. Their ‘mother’  is Chinese bioengineer Luhan Yang. Yang is a pioneer of novel gene editing technology CRISPR. Together with Chinese and European colleagues Yang at her Biopharma startup eGenesis, continues to surmount challenges in a quest to use pigs to grow organs for transplant in humans.

Dear reader, this, is, “Made in China 2025.”

“Made in China 2025” is a government led policy and investment effort geared at enabling Chinese manufactures compete with traditional players in highly specialized industries such as robotics and biopharma. Juxtapose these efforts with the chaos above, and it becomes perplexing. How can such good emerge from such bad? However, anyone who’s been to China on a trade mission quickly recognizes this situation. One that we would term as China’s unique offering a “You Get What You Pay For” market. It is not that straight forward though, as doing business with Chinese traders requires tons of street smarts to navigate.

You Get What You Pay For

In a CSIS interview on “Made in China 2025”, Scott Kennedy , Deputy Director, Freeman Chair in China Studies, and Director, Project on Chinese Business and Political Economy, describes this paradox best:

Made in China 2025″ is an initiative to comprehensively upgrade Chinese industry. The initiative draws direct inspiration from Germany’s “Industry 4.0” plan,…… The Chinese effort is far broader, as the efficiency and quality of Chinese producers are highly uneven, and multiple challenges need to be overcome in a short amount of time if China is to avoid being squeezed by both newly emerging low-cost producers and more effectively cooperate and compete with advanced industrialized economies.

Scott Kennedy’s synopsis of the situation inspires this analysis to wander into the unusual. Such as likening quality of pharmaceutical products in a market to the quality of product in illicit weed trade. This is an analogy that works well in explaining the Kenya’s fake drug crisis beyond simple appropriation of blame.

First, the quality of your weed depends on your dealer’s knowledge of what constitutes good product. In securing good stuff for distribution, the source of the weed is also key. Finally, there is how the prevailing regulatory environment shapes access to product from different producers. Any kink in any of these three interconnected areas, and we end up with an unhappy triad.

The Unhappy Triad of Kenya’s Counterfeit Drugs Problem

Three facts emerge from this discourse on China pharmaceutical industry and Kenya’s fake drugs problems. First, there is no denial of the problem. Moreover, Kenya’s strategic placement in global trade routes places her at risk. Thus Nairobi’s prominence in China’s Belt and Road initiative could mean more trouble.

Secondly, China’s pharmaceutical industry ranges from the absurd (counterfeit vaccines for its own children) and is far reaching ( Kenyan fake malaria drug and South Africa hypertensive drug recall). However, Chinese Biopharma is capable of ground breaking scientific discovery as evident with Chinese leadership with CRISPR.

These three facts partly explain aspects of the schema above based on the allegory of illicit marijuana trade. The missing parts, regulation and dealer attributes, are explained by practices prevalent in Kenya’s pharma space. Consider this case filed by an Indian drug manufacturer suing its former distributor. The Indian firm accuses its former Kenyan agent for importing counterfeit drugs using the Indian firm’s drug registration. This happened after the Indian pharmaceutical company had terminated a distribution contract with the Kenyan pharmaceutical wholesaler and distributor.

Tough Questions for Kenya’s Pharmaceutical Industry Players

In this case, well meaning Kenyans should demand to know how such gross malpractice went undetected by regulatory bodies. There are a host of them: Company Registrar, Pharmacy and Poisons Board of Kenya, Kenya Revenue Authority and others.

The case, if in favor of the plaintiff, raises questions on the assumption that Kenya is unfortunate victim. Simply, answers to Kenya’s problems with counterfeit drugs don’t lie in victim hood. Any sober mind won’t, can’t speak for the mess in Kenya’s pharmaceutical space. At least not as they would speak for say, lands that suffer floods when a river passing through swells.

Upstream Kenya’s pharma industry, lack of investment in clinical trials stymies Kenya’s dreams of the highest standard of healthcare for all. Midstream, the recent recall of different brands of the same drug manufactured by different Kenyan pharmaceutical manufactures, ought invite requisite questions on local drug manufacturing standards.

Moreover, Kenyan pharmaceutical industry players have to question whether regulatory bodies have sufficient operational independence. Does the Kenyan legal framework afford them the leeway to perform their duty of public good? What about their fiscal model and corporate governance standards as government entities? Do regulatory bodies deliver value for public funds spent?

As for regulatory bodies, unpalatable situations such as this public tiff between the Pharmacy and Poisons Board (PPB) and the National Quality Control Laboratory (NQCL) can only be counterproductive. Finally, we have to question the status quo. Like how can we supplement the cane (closing illegal pharmacies) with the carrot (modernization of pharmacy practice) in order to encourage investment in the sector?

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