The problem of fake medicines is a big one. But precisely how big?
Many institutions have published jaw-dropping figures on its size. Interpol, the international police organisation, raids dodgy pharmacies and online operations around the world. It reckons that up to 1 per cent of medicines available in the developed world are likely to be counterfeit. This figure rises to 10 per cent globally, but in some areas of Asia, Africa and Latin America counterfeit goods can form up to 30 per cent of the market. In fact, it quotes WHO estimates.
And in July, EU customs announced that it had seized over more than 41 million fake and counterfeit products at the EU’s external border in 2016. It said India topped the list for counterfeit medicines.
There are big numbers. The problem is, when reporting numbers, news stories, reports and institutions have historically bundled the different kinds of medicines together, says Michael Deats, group lead, substandard and falsified medicines at the WHO. It’s often difficult to determine which medicines floating around endanger public health and which are good quality but are the subject of intellectual property disputes, he said.
“How many of these things are down to bad manufacturing or bad storage or bad transportation and how many of these things are just unregistered? They might be registered in the country next door, it makes them illegal but the health risk is probably low,” he said. “You need to understand those different categories because there are very different responses to dealing with each of those categories.”
So, the WHO is conducting a study that will, for the first time, quantify the market in substandard and falsified medicines. Released in November, the study aims to quantify prevalence figures, compare them with the larger pharmaceutical market in countries and determine cost in terms of pharmaceuticals. It is part of a larger global mechanism to improve the surveillance of medicines that can harm human health, and prevent them from reaching patients in the first place.
The study will not focus specifically on those medicines that are purely the subject of intellectual property disputes, which it calls counterfeits.
In fact, counterfeits have been largely expunged from the vocabulary of public health officials, by the World Health Assembly in May. Member states decided to focus solely on falsified and substandard drugs that endanger public health. “The new terminology aims to establish a common understanding of what is meant by substandard and falsified medical products and to facilitate a more thorough and accurate comparison and analysis of data. It focuses solely on the public health implications of substandard and falsified products, and does not cover the protection of intellectual property rights,” said the WHO in a statement.
The move came after years of disputes over definitions between public health officials, governments, the pharmaceutical industry and generic manufacturers.
In fact, disputes came to a head a decade ago when customs officials at European airports seized dozens of shipments of legitimate Indian generic antibiotics and antiretrovirals on their way to Latin America and Africa. They did so on the grounds that these might be counterfeit. Public health activists, like Médecins sans Frontières (MSF, Doctors Without Borders), said at the time that the term ‘counterfeit medicine’ was overly broad and created confusion because it conflates intellectual property issues with public health problems.
More recently, public health officials have been stumbling over a compromise terminology: the tongue twisting acronym “substandard spurious falsely-labelled falsified and counterfeit” (SSFFC).
Experts have welcomed the need for clarification on the number of drugs that cause harm to human health. Jaimie Love, of NGO Knowledge Ecology International said there are many pharmaceutical producers around the world, especially in low to middle income countries, with terrible standards for manufacturing, and are of low quality. “This includes sales of products from companies with names that no one has ever heard of, and may not even exist,” he said. “These aren’t counterfeits, in that they are not marketed fraudulently as someone else’s unauthorised brand.”
That said, Love says it’s important to evaluate numbers on both fraud and low-quality medicines. “All forms of fraud and low quality are important, but knowing what the problem is helps one figure out the remedy,” he said. “If there is a big problem with a lack of regulation of quality, and the sale of unregistered drugs from unknown companies, then diverting resources to combat trademark infringement isn’t an efficient solution, for example.”
Those who specialise in intellectual property rights agree better numbers are required. “We need more precise estimates of the magnitude of the problem (however it is defined) and better methodologies for making those calculations,” said Dr Kristina M. L. Acri, associate professor of economics, Department of Economics & Business at The Colorado College. She has testified in more than a dozen states on the economics of pharmaceutical counterfeiting, worked for the US Food and Drug Administration, Organization for Economic Cooperation and Development (OECD) and PhRMA.
She disagrees with attempts to put a distance between intellectual property disputes and public health. “While I think that it would be valuable to fine-tune the available estimates to distinguish between falsified, substandard and counterfeit, I believe it is naive to think that counterfeit drugs do not pose a potential risk to global health,” she said. “If a counterfeit manufacturer is willing to steal my patent and my trademark, I have serious doubts that they aren’t taking other shortcuts, specifically in regard to good manufacturing practices. Medicines that are counterfeit may also be falsified or substandard. The distinction becomes very blurry very quickly,” she said.
Agencies like the OECD and European Union Intellectual Property Office (EUIPO) are distinguishing between different kinds of medicines. One recent OECD-EUIPO study says the market for counterfeit pharmaceuticals is worth $16.2 billion in 2013, or 3.3% of total trade in pharmaceutical products. That makes pharmaceutical industry the eighth most affected by global counterfeiting and piracy in terms of value, it said. It defines counterfeits only as those drugs infringing trademarks.
That said, the study reckons some counterfeit drugs seized by customs authorities between 2011 and 2013 were medicines for the treatment of malaria, HIV/AIDS and cancer. It said that these seized counterfeit medicines pose a very serious threat to consumer health. It did not explain how many of these trademark-infringing medicines were falsified or substandard, however.
Other figures are still more confusing. In its most recent Illicit Trade Report, released last year, the World Customs Organisation for the first time began to count drugs with trademark infringements separately from a brand-new category, called “other types of illicit medicines,” defined as those which have been smuggled, expired, transported in ports/inappropriate conditions, or lack document such as a licence or authorisation to enter the market.
It ran into problems collecting enough data to reflect new categories, however. It said: “Due to the lack of information about trademarks, rights holders and whether or not pharma product was counterfeit, we were not able to include this feature in the analysis. Only 576 out of a total of 2627 cases reported providing information on whether medicines were counterfeit or not.”
By Tatum Anderson