You have just heard from Patrick Lukulay of US Pharmacopeia and Aline Plançon of INTERPOL, two of the leading lights in improving drug quality in developing countries. Their work encapsulates many things, but particularly how to overcome two main problems. The first is overcoming inadequate oversight of the drug supply system, by improving a variety of parts in the chain, including local production, storage, distribution and retail outlets-the basics of a medicines regulatory agency, the things we take for granted in rich nations. The second is how to overcome inadequate legal powers, or enforcement of those powers, to protect patients from the criminal or negligent, with actions ranging from improving the regulatory environment to helping with police, customs and intelligence agency investigations. Both jobs are important and I commend the work they're doing.
They and their colleagues would be able to do more if certain issues were resolved, and most of these are political in nature. And it is some of the political problems, large and small, that I want to dwell on today, starting from the highest level to the lowest.
But I should stress that the market for counterfeit products is barely understood, for example not all counterfeiting is deceptive, what is the best policy to deal with that reality?
There is no universally accepted international agreement on the definition of a counterfeit drug, let alone an agreement on how to deal with the organized crime behind the largest and most transnational parts of this odious trade. Aline's organization successfully works with authorities in many locations, but the wide variation in national laws regarding pharmaceutical crime means that there are not many countries prepared to act in unison.
Existing international law can offer a solution, but only under WTO rules on intellectual property right (IP) infringement. Similarly if a country cannot or will not act against a person living within its borders, international law can assist, but only if that country allows extradition for the alleged offence. But again the lack of agreement on the importance of counterfeiting means extradition is a rarity and likely to remain so. Extradition often requires that not only do both jurisdictions agree that a certain act is a crime but also that the punishment for such a crime is broadly equivalent across both countries. When in some countries counterfeiting is scarcely a crime, with punishments measured by fines or a few weeks in jail at most (e.g. many countries of the Middle East), whereas in other countries (such as China) counterfeiting might result in execution, extradition is extremely unlikely to occur.
A few of the lawyers who are aware of the dangers of fake drugs, that I have discussed the issue of extradition with, could not condone extraditing someone to China because of its policy of execution.
Political efforts have been made on the topic, but not everyone has been pulling in the same direction-the result has generated far more heat than light. Part of the problem is that combating counterfeit drugs is rarely a high priority. With the possible exception of Interpol's division that Aline heads, it is hard to think of any group whose top priority is combating fake drugs. For sure it's a major problem and one that deserves attention, but other concerns often trump anti-counterfeiting. I think this is probably the most important reason for a lack of concerted effective action.
Drug companies are concerned about maintaining the reputation of their brands and hence shy away from publicity when their brands are faked; furthermore, they demand greater international protection for intellectual property, as a broad policy goal, claiming it will also be a remedy for drug counterfeiting. Similarly, western governments often align with these interests, especially if they see it as protecting domestic jobs.
So while both companies and governments want to combat fakes and generally push efforts in the best direction, they may do things which antagonize potential partners whose support would be essential to establish international legal interventions against fake drugs.
Some mid-income drug-producing nations have a more ambivalent attitude to IP rules. For example, India has enacted patent protection, and it is prospering as a result, with significant domestic and foreign investment accelerating in its increasingly impressive drug industry. But many of India's companies still benefit hugely from copying others' innovation and some resent the constant pressure to further enforce IP rules, which they see as benefiting western interests more than their own.
These concerns have been reinforced by ill-advised moves by certain people within western industry and European officialdom over the past two years, including detaining legitimate Indian generics, as well as helping draft anti-counterfeit laws in Europe, Kenya and Uganda, which can be interpreted as conflating generics with counterfeits. It doesn't matter that these efforts may have been well intentioned, or that they can be interpreted in more benign ways, they have given India (as well as Brazil and Thailand and perhaps others) cause to believe that western actions against counterfeits are at least partly being driven by a desire to strengthen IP rules, and even limit access to generic medicines. As a result these mid-income emerging nations have sustained a largely illogical campaign against nearly all efforts to combat fake drugs-including unfairly targeting WHO's efforts against counterfeit medicines, claiming WHO's IMPACT was too close to western industry.
WHO's IMPACT initiative, to which both previous speakers are affiliated directly or indirectly, has done a great job of alerting people to the problems of fake drugs, and I have been particularly impressed by the model legislation it has provided and promoted to help developing nations think about how to draft anti-counterfeit laws. But while this has been impressive, IMPACT has no strong mandate from within WHO, or at least it is not viewed as having a legitimate mandate by India, Brazil, Thailand and some of the more ardent non-governmental organizations (NGOs). This is a shame, but it is also relatively easy to resolve: WHO (perhaps under IMPACT's leadership or at least guidance) could, and I believe they should, sponsor an international convention to combat drug counterfeiting.
We have had international conventions against counterfeiting of currencies for 81 years, and WHO has experience in establishing a convention-the Framework Convention on Tobacco Control. And there is surely at least as good a case to be made against counterfeit drugs as there is against tobacco. For while smoking is lethal for many, cigarettes are at least legal and the dangers of smoking widely known; fake drugs can also be lethal, but are not legal and their harms are often not known by even relatively well-educated people. It is ironic that there are currently moves against fake cigarettes within the tobacco convention. Surely, if we act against fake cigarettes we can act in unison against fake and potentially lethal drugs?
Furthermore, the convention against smoking started from a very flimsy base-the simple acknowledgement that smoking was dangerous and that it should be discouraged internationally. I have ideas as to what should be included in a pharmaceutical crime convention, but it doesn't matter so much what I think or say, or even what the head of the US delegation to any negotiations might think, just that the negotiations start, for with transparent processes and dialogue, a reasonable consensus document should be achievable. For what it's worth I'd suggest agreeing definitions for falsified medicines, pushing for similar offences and reasonably equivalent punishments in each jurisdiction, so that extradition is possible; and most critically, making the convention about improving public health. At the moment the only international defense against fake drugs is IP enforcement. And while that is useful, it is not sufficient, or even the right starting point, if your concern is public health.
Without significant international leadership it is up to a few to lead the way, but there are pockets of success from which to learn. I'll highlight one-NAFDAC. Nigeria is widely recognized as one of the more corrupt nations on Earth, but it shows what can be done against fake drugs. For the best part of a decade the National Agency for Food and Drug Administration and Control has acted with determination and courage against fake drugs. It has improved drug registration processes; it has deployed simple technologies (such as simple chemistry to assess products) and basic logistics, as well as the more complex technologies (such as handheld Raman spectrometers) to identify fakes; it has run raids against local fake drug traders; it has worked with international agencies to book criminals from as far afield as China; it has provided regional leadership; and it has overseen a significant reduction in fake drugs, at least in the major cities of its country. My own research team has seen failure rates of procured drugs drop from 30% to around 10% over the past three years. And it has done this without a major budget. In Kano region in the North, NAFDAC has only one functioning car, yet still it has overseen a reduction in fake drugs.
So, successes like NAFDAC's exist, the work of Aline and Pat demonstrate that efforts can make a huge difference, but narrowly defined self-interest, in all parts of the pharmaceutical industry, and a genuine lack of political will is undermining progress. We must all look to how we can move debate forward so that we can sooner help the poor and vulnerable shake off one of the terrible burdens they face.
Roger Bate is the Legatum Fellow in Global Prosperity at AEI.