Although the purpose of No to Fakes is to impart information on all kinds of counterfeits, time and time again we find ourselves returning to the issue of counterfeit drugs. Yes it is very wrong that criminal gangs are reaping benefits from the sale of counterfeit handbags, and it is not an issue we would ever wish to sideline, but the massive global problem of counterfeit drugs is just so very worrying and, we feel, does not gain the media attention it really should.

With this in mind, we approached another eminent specialist in this field, Dr Roger Bate from the American Enterprise Institute, who is working hard to bring about a paradigm shift in policy making that will force the issue of counterfeit anti-malarials in developing countries to the fore. Through the vital role he plays with Africa Fighting Malaria, he has gained huge insight and an understanding of how the problem can be solved through cooperation and collaboration between the rich and poor countries.

For the past 11 years you have been a Board Member and Director of Africa Fighting Malaria. How does the issue of counterfeit drugs fit into the activities of this non-profit health advocacy group?

We were aware of the issue of drug resistance when AFM began its work on analyzing malaria control, and helping developing nations’ health departments to access the tools they needed to combat the disease. But we didn’t fully become aware of substandard and counterfeit drugs until about 2004, when we were in Zimbabwe and came across ineffective drugs then.

What was the African counterfeit drugs profile like back in 2000 when you joined Africa Fighting Malaria; were they already recognized as a massive threat?

By those fully aware of the problem the situation was thought to be bad in 2000, by the time we analyzed it directly in 2007 we found that over a quarter of the drugs we sampled failed at least one basic quality control test. Drug Regulatory Authorities across Africa have been battling with vast numbers of unregistered products on the market. In Nigeria there are over 250 different antimalarial drugs for sale, many of which are not registered and are dangerous. DRAs and customs departments are trying to ensure that only registered products are on the market ( My most recent peer review paper discusses the quality differences based on registration status, see http://www.dovepress.com/medicine-registration-and-medicine-quality-a-preliminary-analysis-of-k-peer-reviewed-article-RRTM ). At the same time as DRAs were trying to improve product assessments, legitimate manufacturers were also stepping up efforts to protect their brands.

Counterfeit drugs have been described as a ‘deadly scourge’ but what kind of effects are you witnessing specifically from counterfeit anti-malarials on patients in Africa?

Most patients, or in malaria’s case patients’ parents, since it is children most affected by the disease, are simply not aware that some drugs won’t work. They assume the drugs they are sold will cure the disease, cheaper drugs just may take longer they seem to think. Malaria is fatal in perhaps 1-5% of cases, so even if one takes a drug with no active ingredients most patients will survive. There is also a fatalism that some children will die from malaria and hence no reason to think the drugs are to blame when one does. The reality is that anti-malarials are therefore a good drug to counterfeit (from the counterfeiters perspective). It is impossible to say what the impact is in a countrywide setting, but hundreds maybe thousands of children across Africa die that wouldn’t otherwise have done so had they been taking effective malaria drugs. I’ve also spoken with doctors and parents of children who died from malaria who they thought should have lived, and these deaths were probably due to fake versions. It is impossible to quantify the impact that substandard drugs and counterfeits have on drug resistance, but it is sure to increase resistance, especially since there are so many unregistered artemisinin monotherapies on the market in Africa (see registration paper mentioned above).

One of the key elements of your current work into the prevalence of counterfeit anti-malarials in Africa is how rich and poor countries must collaborate to stop the trade in counterfeit drugs, and the development of a policy framework to facilitate this. Based on your research so far, and given the fact that drug counterfeiters are successfully operating in both rich and poor countries, how do you see this kind of global cooperation developing?

Cooperation occurs at numerous levels, from pharma companies and police forces to Drug Regulatory Authorities (DRAs). The problem is really with certain mid-income nations, notably Brazil and India, which are preventing effective action at a high political level. This stops more international collaboration and the funding that would go with it. However, Brazil and particularly India do have a point. They claim that substandard drugs are a far greater problem in poor nations than counterfeits and want more focus on this issue. In short there is little international agreement on what the priorities should be, which is limiting action against those actors which everyone does agree are dangerous.

Your current focus is on Africa and fighting counterfeit malarials, and undoubtedly patients in poor nations are more vulnerable to the threat of counterfeit and substandard medicine but do you feel that if the issue of counterfeit drugs was more effectively highlighted in developed countries there would be a knock-on effect in countries such as Africa? Would it, for example, put more pressure on the pharmaceutical companies to securitize their drugs more effectively, as well as possibly encouraging more financial support from government agencies?

More attention would help. But frankly western pharma companies do more, even in poor nations, than other companies to protect their brands. The failings are often in shoddy local drug production in emerging markets, and hence western support for development of DRAs would help

In your recent article on the proposed MEDICRIME convention, you highlight the good intentions of this treaty to fight counterfeit drugs yet go on to say that only a treaty initiated by the World Health Organization will suffice. Can you explain your reasons for this opinion and, if the WHO is the only organization that can implement a successful treaty on counterfeit drugs, why hasn’t one yet been drawn up?

This is a long and complex explanation and long history, so read my article! But in short, due to EU seizures of Indian drugs and other history, Indian interests are skeptical of any attempt by EU to lead on anticounterfeit efforts. WHO is the premier health body and has the precendence (from its Tobacco convention) to undertake a treaty. But without agreement from India and Brazil this will never move forward.

The final lines of your book Making a Killing: the Deadly Implications of Counterfeit Drugs read: “By chipping away at the small things and building a healthy policy framework, counterfeits can be fought – one pill at a time”. Do you really think the day will come when counterfeit drugs are a thing of the past?

No, counterfeiting is thousands of years old and will never go away, but it can be reduced from current levels, particularly in poorer nations, but also in the richest.

Dr Roger Bate is an economist and science policy scholar who specializes in international health policy with AEI (American Enterprise Institute for Public Policy Research), with particular focus on tropical diseases and substandard and counterfeit medicines. He also writes on general development policy in Asia and Africa and regularly writes for AEI’s Health Policy Outlook.

Amongst his other professional experience, for the past 11 years Dr Bate has been a Board Member and Director of Africa Fighting Malaria (US and South Africa). From 1993 to 2003 he was also Founder and Director of the Environmental Unit at the Institute of Economic Affairs, where he has also been a Fellow since 2000.

Dr Bate holds a Ph.D in economics and an MPhil in land economy from the University of Cambridge, as well as an MSc in environmental and resource management from University College, London University.

His research and writing has appeared in, among others, The Wall Street Journal, The New York Times, the Washington Post, the Financial Times, the Lancet, PLoS One, The Malaria Journal, and the British Medical Journal. He is author or editor of 11 books, his most recent monograph is Making a Killing: the Deadly Implications of the Counterfeit Drug Trade (AEI Press, May 2008). He is currently working on a longer book on drug quality.

Email address: rbate@aei.org

“Medicine Registration and Medicine Quality: A Preliminary Analysis of Key Cities in Emerging Markets,” Research and Reports in Tropical Medicine, December 13, 2010
This study attempts to ascertain whether registered medicines perform better in simple quality tests than those that are either not registered or not known to be registered.

“A Counterfeit Drug Treaty: Great Idea, Wrong Implementation,” The Lancet, October 29, 2010
The intent behind a proposed treaty to criminalize the manufacture and trade in counterfeited drugs is good, but only a treaty initiated by the World Health Organization will suffice.

“Antimalarial Medicine Diversion,” Research and Reports in Tropical Medicine, Sept 2, 2010
A significant portion of antimalarial drugs in Africa have been illegally diverted from the public sector, where they were intended to be dispensed free of charge in public health facilities, to the private sector.

“Assessing Website Pharmacy Drug Quality: Safer Than You Think?” PLoS One, August 13, 2010
There are many website pharmacies, including those from overseas, from which it is almost certainly safe to procure medicines, and U.S. consumers should be able to reduce their risk by relying on credentialing agencies recommended lists and by using common sense when examining packaging and pills.

“Anti-Malarial Drug Quality in Lagos and Accra,” Malaria Journal, June 11, 2010
Drug quality is probably improving in Lagos, the largest city of Nigeria, and Accra, the capital of Ghana, which each have serious problems with substandard pharmaceuticals.

“Fatal Pharmaceuticals,” Georgetown Journal of International Affairs, February 4, 2010
Until governments and industry significantly lowers substandard drugs in developing world markets, a significant health threat remains.

“Drug Procurement, the Global Fund, and Misguided Competition Policies” Malaria Journal, December 22, 2009
Requiring African countries to use international competitive bidding processes for certain drug purchases has caused more harm than good.