As well as being the author of a book on anti-counterfeiting and head of consultancy company Blue Sphere, you regularly write a blog on your Blue Sphere Health website , which contains very interesting and topical observations and insights on the global issue of counterfeit drugs. Back in 2010 you wrote about the situation in Africa and highlighted how, in terms of product safety, this continent is at the bottom of the pile, sentencing Africans to poor health as a consequence. Almost one year has passed since you wrote that entry – do you feel that any progress has been made in Africa since then? There has been a lot of publicity about, for example, the problem of counterfeit artesunate, but has this interest been translated into useful action?
Interpol’s recent Pangea 4 operation and other international collaborations such as the Operation Mamba series have shown the potential for coordinated action. African regulatory authorities are also becoming better trained and better equipped to find and deal with counterfeits. The problem is still acute, and we need to support developing countries with further funds for infrastructure development, but there has been improvement.
“In the same way that the car industry has incorporated passenger safety into every facet of automobile development and production, the pharmaceutical industry needs to re-evaluate anti-counterfeiting from first principles.” This quote from your blog carries a lot of impact, because it emphasises both the responsibility to protect that lies with the pharmaceutical companies, and the vulnerability of consumers should they fail to do so. Do you feel that the buck stops with the pharmaceutical companies and that governments and their agencies, although necessary to the process, can’t ultimately be held accountable if counterfeit drugs find their way into public circulation?
No, I think all stakeholders (including patients) have a role to play in eliminating fake drugs. However, the consumer should not be the one carrying the burden of authentication. Drugs companies have a responsibility to make sure that their drugs are packaged and distributed in a way that discourages counterfeiting, tampering, diversion and theft. The sophistication of drug packaging does not usually match that of the drug it contains and we need to do better. Law makers need to ensure a level playing field, so that all manufacturers carry a proportionate cost and no-one is unduly penalised. One of the key factors in Africa is that the most critical drugs are often generics, sold at relatively low cost and made by companies who compete on price not innovation. However, even cheap drugs are counterfeited. Getting the buy-in of these low-cost generics companies is critical to long-term success against counterfeits. Regulators have to ensure that inspections are thorough and regular. Law enforcement has to ensure that corruption is rooted out. Patients are the last in line and we need to educate them about the dangers and give them the appropriate tools, but everything I’ve listed above needs to happen as well.
In the preface to your new book Pharmaceutical Anti-counterfeiting: Combating the Real Danger of Counterfeit Drugs, you explain your focus in the book on American and European laws as being due to the well-placed regulatory systems that are in place there…and yet they still face problems with counterfeit drugs. If developed nations can’t cope with the influx of counterfeit medicines – what hope is there for developing countries such as Africa and India?
A very good point and I think we need to think about how best to help. Donating drugs to poor countries is a headline grabber, but donating infrared scanners and training the regulatory authority is less high-profile. However, it represents great value for money. Africa needs aid so that it can help itself. India is doing quite a good job of tackling its problems, with recent initiatives to put bar codes on exports and SMS verification codes on domestic drugs.
Turkey is one country under pressure to show significant efforts with regards to anti-counterfeiting activity, its accession to the EU being the major incentive. Considerable action has been taken and Turkey has been working in close collaboration with the EU to overhaul its counterfeiting legislation. What lessons do you feel are being learned in Turkey and can it be used as an example for positive change in developing countries?
Specifically in terms of drug traceability, the Turkish initiative has taught the Ministry of Health and the drug companies a number of lessons. Firstly, traceability at item level is feasible in a large country but it takes more time and effort than first anticipated. Secondly, the next stage of aggregating codes at higher packaging levels (case and pallet) makes the process very complex indeed and introduces a whole new set of challenges which are currently being wrestled with. In terms of lessons for elsewhere, the main one is to keep the traceability system as minimally complex as possible and ensure that it is based on GS1 open standards.
In early 2011 a new law to prevent fake drugs from entering the supply chain was approved by the European Parliament. This legislation covers internet sales and introduces new safety and traceability measures, as well as sanctions against counterfeiters. What are your thoughts on this EU-wide initiative - both in terms of immediate approach and its future implementation?
The move is to be welcomed. It is the first time that a major economic bloc has put down a marker for drug traceability and authentication. The language in the legal documents of the initial Directive is necessarily vague, and the detail will be fleshed out in the Delegated Acts process over the next year or two. If all goes to plan, in five years or so we will have a European drug traceability system which will be a major step forward for patient safety. In the longer term this traceability could be extended to the hospital bedside to help prevent medication errors.
In Pharmaceutical Anti-counterfeiting you make it clear early on that you view any kind of anti-counterfeiting activity as ‘control’ rather than ‘elimination’ and use the comparison of eliminating burglary which is, as you point out, a useful aim but unrealistic to expect it to happen. So, in your view, are counterfeit drugs really here to stay? Is it impossible that a combination of education, legislation, surveillance and security measures can simply impede counterfeit drug production to such an extent that the business ceases to be lucrative enough?
Of course, my personal wish and professional goal is the complete elimination of fake drugs. However, the profits involved in counterfeit medicines are huge – reportedly more than illegal narcotics – so the incentive is there for criminals and the money is there to pay corrupt officials to look the other way. In the absence of effective infrastructure in some countries, combating this threat will take some time. All stakeholders need to do what they can and the combined efforts will gradually reduce the threat to a lower level but I don’t think it will reach zero anytime soon.
You have considerable experience of the pharmaceutical and biotechnology industries. When you first entered this career path, did you ever anticipate the havoc that counterfeit medicines have caused across the globe?
No, the issue was not very high profile until maybe ten years ago although the problem goes back much further. I think that collectively we have been a bit complacent about the dangers. As drug companies look to the developing countries for sales growth, and they move their manufacturing to low-cost regions, they will face challenges from criminals looking to make a fast buck on the back of their brands.