I am delighted to welcome to my blog, author and lecturer, Elizabeth Ducie. Elizabeth is the author of the prize-winning novel, Gorgito’s Ice Rink, and several collections of short stories. She lectures and writes on business skills for authors and publishes The Business of Writing series. Her latest novel, Counterfeit!, is out this month. Set in Southern Africa, it is the first in a series of thrillers based in the sometimes murky world of international pharmaceuticals.
In your book Counterfeit! regulator, Suzanne Jones is on a mission to stop the production of counterfeit drugs in Africa before more people die. What part of the pharmaceutical industry inspired the novel?
Thank you for having me on your blog. For many people, the words ‘pharmaceutical industry’ conjure up a vision of greedy multinational research companies, developing life-style drugs for first world countries, and charging huge amounts of money for their products. That may, or may not, be a true assessment of the industry giants, but it’s not the issue I’m looking at here. There are thousands of small and medium sized companies around the world, struggling to produce generics (off-patent, older products).
Do you have a background in the pharmaceutical industry?
Before I became a full-time writer, I spent more than thirty years working in the international pharmaceutical industry, helping governments set the rules that ensured drugs were safe and worked; and helping companies interpret those rules effectively. On occasion, I worked for ‘both sides’ within the same country, at the same time and this could sometimes lead to interesting discussions.
What do you mean?
I vividly remember an email once from the production director of a company in Ukraine, complaining about a demand made by one of the new government inspectors—an inspector I had trained. The email finished with the question: “this is what he said; is he right?” And although I can’t remember the details of the complaint, I remember thinking at the time that the inspector was erring somewhat on the side of caution. But that’s what new inspectors do: they are so scared of getting it wrong, they are overly cautious. So I gave the only answer I could in the circumstances: “he’s your government inspector; he grants you your manufacturing license. Of course he’s right—even if he’s wrong!”
Tells us a bit about the countries where you worked?
Pharmaceutical manufacturing is an expensive process. And the areas I was working in—Russia and the former Soviet Union countries; Latin America; and sub-Saharan Africa—were ones where money was generally in short supply. The factories were often old and in poor condition. We were not pushing them to set up state of the art facilities, such as the ones in America and Western Europe. All we were looking for was Basic Minimum Standards, as defined by the WHO (World Health Organisation) but even that was a hard pill for some of the owners and financiers to swallow.
Were companies willing to embrace the recommendations to improve quality and meet international standards?
I spent a lot of time explaining that investment in manufacturing is just that—an investment—rather than an expense that brings no returns. And some companies, some industries, some countries got it; others didn’t. For example, when the Soviet Union broke up, the cluster of companies in Ukraine found their domestic market shrinking overnight from 291 million to 55 million. They desperately needed to develop export markets in order to keep their factories going and their people in work. Therefore, they embraced quite quickly the concept of quality and international standards. Russia, on the other hand, had a population of 148 million. While this was still a big fall in numbers, it was a sizable domestic market and for several years, the government and the companies concentrated on this, without worrying about needing to satisfy the requirements for international trade.
In sub-Saharan Africa, the situation and the problems were very different. Billions of dollars were being spent on importing drugs from America and Western Europe. There were factories in most of the countries in the region, but the standards were very low; the regulations differed from one country to another; no-one trusted anyone else; and inter-continental trade was minimal. For most people, in most of the countries, the government supplied what drugs there were—and there were never enough. So for the purchase houses, getting the finance, whether locally or from international aid, was critical and it needed to be spent on the greatest quantity of drugs possible.
And that’s why counterfeit drugs were, and still are, such a huge problem in Africa. I once had a conversation with a government Minister who told me he couldn’t afford to worry about the quality of the drugs he was sourcing. He had to get sufficient doses of medicines to satisfy the needs of his country and if a few people suffered as a result, that just had to be the case. Shocking, but in the end, an inevitable conclusion.
What is a counterfeit drug?
A counterfeit drug may simply be a safe and efficacious copy by an unlicensed manufacturer. However, it is more likely to contain too much or too little of the active ingredient; it may contain a totally different active ingredient, which might be harmful or lethal. It may be wrongly labelled. It is almost certainly a dangerous drug to take.
I would imagine there was a lot of money to make by producing sub-standard drugs.
The global market in fake medicines is around two hundred billion dollars, and comparing that to the global prescription market, which is worth nine hundred billion dollars, we can see just how big the problem is. The WHO estimates that somewhere between 1% and 10% of all medicines are counterfeit, but that in some countries, the figure may be as high as 50%. And with the growth of the internet and online trade, this problem is no longer just a third world one. In 2014, an Interpol operation led to the seizure of 8.4 million doses of counterfeit drugs and the shutting down of more than ten thousand websites selling counterfeit medicines.
What is the single most important thing you would recommend us to do to protect ourselves from counterfeit medicine?
These days, many of us make a lot of our purchases online. I buy books, clothes, computers and accessories, theatre tickets and food. One thing I would never buy online is medicine.