Visiongain's third annual conference on Pharmaceutical Anti-counterfeiting Strategies kicks off next week, covering many aspects of the problem from technological deterrents, regulatory developments in the EU and US and the implications for parallel trade.
Ahead of the conference, in-PharmaTechnologist.com spoke with the event's chair, Dr Eric Noehrenberg of the International Federation of Pharmaceutical Manufacturers Associations, about some of the key factors facing the industry as it steps up attempts to combat the problem.
One of the most important things that needs to be considered is the very real difference in the impact of counterfeits between the developed and developing world, where in some countries up to 30 per cent of the total medicines supply may be fake, said Noehrenberg, who is director of international trade and market policy and public health advocacy at the IFPMA.
What's in a word?
Simply defining medicines counterfeiting is a challenge, he said, as there is a real blurring of the boundaries now between artfully copied finished products and drugs which have been made with mislabelled or substandard ingredients.
Theft of medications is a big issue in emerging markets, more so than in the established pharmaceutical markets, and these are considered counterfeit as they have been taken out of the legitimate supply chain and are often relabelled. From IFPMA's perspective counterfeiting also covers mislabelled medicines, such as those which have had their expiry dates altered.
The IMPACT programme - a collaboration between the World Health Organization (WHO), IFPMA and other groups including national governments - is developing its own definition that to differentiate between counterfeit, mislabelled or substandard medicines based on some of these principles.
"The issue of a clear legal definition is very important," said Noehrenberg, who noted that a new IMPACT statement would be discussed at some length at next week's conference.
Definitions can cause real problems. For example, a counterfeiting resolution tabled at the last World Health Assembly was not passed because certain countries, such as Brazil and India, were concerned that it would affect their legitimate generics industry. This was absolutely not the case, stressed Noehrenberg, but provides clear evidence of the need for a common frame of reference if the fight against counterfeits is to be taken forward.
The resolution has been referred to the WHO Executive Board, which will meet to review it in January 2009. "The hope is that in the meantime the concerns of these countries can be addressed."
Acknowledging the major efforts announced by the European Federation of Pharmaceutical Industry Associations (EFPIA) at its annual conference last week with regards to the mass serialisation of packs due to be piloted in Germany next year, Noehrenberg said however that for developing markets "technology is not the answer."
"There is a lot of debate on both sides about the role that parallel imports, and particularly repackaging, has in allowing counterfeits to enter the legitimate supply chain. But in developing regions it is clear cut," said Noehrenberg.
"When a product is diverted - for example procured in once market, re-boxed and sold in another market without the approval of the original patent holder - experience has shown that taking the product out of official market channels presents opportunity for unscrupulous intermediaries to substitute fake for genuine drugs."
In Kenya, South Africa and other emerging markets, cases have been seen where re-packaged has occurred with some of the medicine removed or indeed substituted with counterfeit drugs.
"A spot check is very unlikely to catch that practice," said Noehrenberg, "especially in countries where regulatory regimes may not be particularly strong yet."
Parallel traders in the EU have a code of conducted and are regulated, he noted. But that's not the case in the developing world. So while parallel trade in medicines is clearly supported by international remits and World Trade Organisation principles, additional checks and controls are needed when the trade is viewed in an international context.
"We would simply ask national decision makers to take seriously the concerns about parallel trade. That includes the counterfeiting issue, but also the diversion of medicines away from impoverished people to those in countries where a higher price can be charged."
The profits to be made from counterfeits are huge, such that organised criminal syndicates such as Chinese triads, Latin American cartels and other mafia groups are all thought to be involved in this trade because the profits are high and the penalties low.
"If you're caught with a kilo of heroin at a border crossing you'll go to jail for a very long time. If you're caught with a kilo of counterfeit medicines, that penalty may be the same if you're caught with a kilo of counterfeit T-shirts," said Noehrenberg.
And this involvement of serious criminal groups means that the counterfeiters are prepared to go to serious lengths to protect their illicit trade.
One of the best examples of that concerns the head of drug quality in Nigeria, Dr Dora Akunyili, whose own sister died as a result of taking a counterfeit drug.
She has put in place measures that have led to a big decrease in the circulation of counterfeit drugs in Nigeria, but the counterfeiters are literally fighting back.
"She has received death threats, been shot at, her car has been destroyed and office firebombed, and her employees have been threatened with serious bodily harm," said Noehrenberg. Meanwhile in other countries, including India, people have been killed in the course of raids upon counterfeit drug factories.
What is needed is more collaboration between international regulatory bodies, customs, enforcement agencies, industry and other stakeholders to turn the fight against counterfeiting into a truly global effort, according to Noehrenberg.
"And one big aspect of making the fight against counterfeits global is to require that all countries implement deterrent criminal penalties for medicines counterfeiting."
Noehrenberg pointed out that it is a requirement for the WTO/TRIPS agreement which sets the basic ground rules for intellectual property, has a specific article that mandates all WTO member states to have such criminal penalties.
"Not everyone is up to that level yet," he said. "One avenue that we're looking down is to encourage all countries to live up to their obligations."
Another critical step in solving the problem of drug counterfeiting is to engender an awareness of the problem across the supply chain, including patients, doctors and all intermediaries in between.
"If a patient reacts badly or unusually to a drug, there should be a mechanism whereby a doctor will consider the possibility of counterfeiting, and be able to send a sample of the medication for testing," said Noehrenberg.
But can the counterfeiters eventually be beaten? Technology and other regulatory approaches will certainly reduce the problem of counterfeiting, but the fakers have a lot of money and will respond in kind.
In developed markets these measures can probably have a big effect, said Noehrenberg, but the door will always be open if consumers continue to source medicines over the Internet. EFPIA estimates that 80-90 per cent of medicines supplied over the Internet are fake.
Leaving aside legitimate web-based pharmacies - Boots has a robust Internet system in the UK for repeat prescriptions, for example - consumers must be made aware of the dangers of going outside these legitimate channels to source medicines, particularly in the absence of a doctor's prescription, stressed Noehrenberg.
"We really need an information drive on that," he said.
In-PharmaTechnologist.com will be presenting coverage from Visiongain's 3rd Pharmaceutical Anti-counterfeiting Strategies from next week.