Counterfeit pharmaceutical and healthcare products pose a threat to European consumers
With a global pandemic still wreaking havoc across the globe and while the world awaits a vaccine for COVID-19, much of the public’s attention is focused on the pharmaceutical industry.
New Europe’s Elena Pavlovska spoke with the European Union Intellectual Property Office (EUIPO) about the health and safety risks that counterfeit pharmaceutical and healthcare products pose to consumers, as well as the main objective of the counterfeiters.
The interview follows a new study released by EUIPO and the Organisation for Economic Cooperation and Development. The research has found that counterfeit medicines can be harmful to a patient’s health, because they do not comply with intellectual property law.
The study is part of the #YourHealthIsPriceless campaign, which aims to raise awareness of the harms that counterfeit pharmaceutical and healthcare products can cause.
NEW EUROPE (NE): What are the most common and most dangerous consequences of the trade in counterfeit medicines? What can the consumption of counterfeit medicines lead to?
European Union Intellectual Property Office (EUIPO): The 2020 OECD-EUIPO Trade in Counterfeit Pharmaceutical Products Report states that the trade in counterfeit medicines have adverse consequences not only on the health and well-being of people who consume and ingest them, but also on producers, governments, and economies.
The impact of counterfeit medicines falls in four main categories: (1) impact on individuals who consume counterfeits that may not meet their medical needs; (2) legitimate producers suffer economic losses and bear costs of ensuring that supply chains are not infiltrated by counterfeiters; (3) government which manage health care in their countries and so deal with the medical consequences of counterfeits; and (4) entire economies, in terms of impact of organised crime on society, impact on the environment from manufacturing and storing counterfeits.
For patients, the most serious consequences include adverse effects (toxicity) from wrong active ingredients; failure to cure diseases, thereby increasing mortality and morbidity; progression of antimicrobial resistance and drug-resistant infections.
Thus, counterfeit medicines can have very serious effects on the health of consumers. They are often produced in unhygienic conditions and by unqualified personnel, leading to dangerous changes in the molecular structure of the medicine, loss of confidence in health care professionals, health programmes and health systems, lost income due to prolonged illness or death, and lost productivity costs to patients and households when seeking additional medical care.
NE: Which countries are the largest producers of counterfeit pharmaceuticals and which countries are suffering the biggest losses in terms of illnesses and losses of life from the illegal trade?
EUIPO: According to the 2020 OECD-EUIPO Trade in Counterfeit Pharmaceutical Products Report, the production of counterfeits is carried out on all continents both on an industrial scale and on a smaller and less sophisticated scale. The packaging and the medicines are often manufactured and printed in different countries and then shipped to a final destination where they are assembled and distributed. For example, fake medicines originating in Asia might be packed in falsified packaging originating in Africa or the reverse. Products are sometimes concealed or smuggled and declared as something other than medicines.
Globally, in terms of key provenance countries, India remains the main provenance economy of counterfeit pharmaceuticals, being the origin of 53% of the total seized value of counterfeit pharmaceutical products and medicines worldwide in 2016. It was followed by China, United Arab Emirates, and Hong Kong (China). In terms of the number of global customs seizures, Singapore (17.5%), Germany (7.8%), Switzerland (5.7%), Australia (2.8%) and Egypt (2.5%) are also identified as key provenance economies.
According to the data gathered in the OECD/EUIPO database on global customs seizures, between 2014 and 2016, the top four provenance economies for counterfeit pharmaceuticals traded worldwide (India, Singapore, China, and Hong Kong [China]) are the same as for the period 2011-2013.
In the EU, the range of provenance economies of counterfeit pharmaceuticals imported to the EU is more limited. However, it is interesting to note that the top three provenance economies of fake medicines and pharmaceutical products imported to the EU are exactly the same as for those traded worldwide. In terms of value, India is the main provenance economy of counterfeit pharmaceuticals shipped to the EU, being the origin of 47% of the total value of counterfeit pharmaceutical products and medicines seized by EU customs authorities. It is followed by China (37%) and Hong Kong (China) (8%). Although a main source of counterfeit pharmaceuticals globally, the United Arab Emirates is not an important provenance of these type of fake goods for EU economies. The provenance economies of Singapore, Switzerland, Australia, and Chinese Taipei are more important.
As for countries suffering the biggest losses in terms of illnesses and losses of life from the illegal trade of counterfeit medicines, it is a challenge to obtain accurate data on this, for a number of reasons. For example, in cases where people suffer illnesses or succumb to death, ingesting counterfeit medicines is not usually reported as the direct cause of the illness or death. Rather, it is the symptom or dangerous effect to the body resulting from the counterfeit medicines that is cited as the cause. Moreover, consumers of counterfeit medicines are not the only ones susceptible to illnesses or death from such illicit products, as even people who produce, manufacture, and traffic such goods can be exposed to its toxic and dangerous substances.
Nevertheless, some studies indicate that while counterfeiters could likely attain a far higher rate of return or profit in developed countries, it is surmised that the low risk of detection greatly enhances the appeal of the lower-price markets, particularly in low- and middle- income economies. The 2020 OECD-EUIPO Trade in Counterfeit Pharmaceutical Products Report cites various studies that estimate that the prevalence of substandard and falsified medicines in low- and middle- income countries was 13.6%. Among the studies included a report that the highest prevalence of the falsified and substandard medicines was registered in Africa (18.7%), where thousands of patients die each year as a consequence of fake anti-malaria drugs and other fake medications, and Asia (13.7%). A study carried out by the UNODC in 2013 examining transnational crime in East Asia and the Pacific includes a close examination of the situation in pharmaceuticals, where forensic testing revealed that one-third to two-thirds of the samples tested in the region were fraudulent.
NE: Who is actively pursuing the counterfeiters and has anyone been caught and punished so far?
EUIPO: The 2020 OECD-EUIPO Trade in Counterfeit Pharmaceutical Products Report cites various specific cases of law enforcement operations in countries around the world, including international cross-border operations with a number of countries cooperating, which have been conducted in order to seize counterfeit medicines and stop their illegal trade..........................
Betrug als System in Europa, inklusive Erpressung, mit Covid-19, für Pharma Geschäfte der Super Ratten, der EU und aus Berlin
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