Counterfeit pharmaceutical and healthcare products pose a threat to European consumers

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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.

A table loaded with illegal painkillers at the customs office in Essen, Germany. EPA-EFE//ROLF VENNENBERND

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.

As an example, Operation Pangea has been carried out since 2008 with the coordination of INTERPOL, with the number of countries participating rising from 8 to a record 123 in 2017. The operation targets the online sale of counterfeit and illicit medicines and medical devices. Participating agencies carry out co-ordinated operational activities against illegal websites during the same week in order to identify the criminal networks behind the trafficking. During Pangea XI, which was carried out in 2018, police, customs and health regulatory authorities from 116 countries targeted the illicit online sale of medicines and medical products, resulting in 859 arrests worldwide and the seizure of USD 14 million worth of potentially dangerous pharmaceuticals. Almost one million packages were inspected during the week of action, with 500 tonnes of illicit pharmaceuticals seized worldwide. Seizures included anti-inflammatory medication, painkillers, erectile dysfunction pills, hypnotic and sedative agents, anabolic steroids, slimming pills and medicines for treating HIV, Parkinson’s and diabetes. More than 110 000 medical devices including syringes, contact lenses, hearing aids and surgical instruments were also seized.[3]

Also, the World Health Organization champions a “prevent, detect, respond” approach; the Council of Europe has the Medicrime Convention, and the EU has its Falsified Medicines Directive.

NE: Which kinds of counterfeit products are most frequently found on the market? How can one identify if it is a fake product?

EUIPO: The 2020 OECD-EUIPO Trade in Counterfeit Pharmaceutical Products Report states that a closer look at the types of pharmaceutical products that are counterfeited is alarming. Over the period 2014-2016, seized counterfeits included medicaments for various kinds of diseases, including malaria, HIV/AIDS and cancer. Data from seizures by customs authorities shows that counterfeit antibiotics, lifestyle drugs and painkillers were the most targeted by counterfeiters. Other types of counterfeit pharmaceuticals often seized by customs authorities worldwide include those targeting treatment for malaria, diabetes, epilepsy, heart diseases, allergy, blood pressure, cancer, and stomach ulcers ailments as well as local anaesthetics.

In addition, the EUIPO-EUROPOL Intelletual Propertry Crime Threat Assessment 2019 Report indicates that, in the EU, counterfeit pharmaceutical goods pose a growing threat, affecting a large number of Member States. A wide and increasingly diverse range of different medicines are targeted by counterfeiters. Erectile dysfunction medicines are traditionally among the most common type of counterfeited medicines, but counterfeited performance-enhancing drugs, such as anabolic steroids and doping substances, are also increasingly being detected.

It is often very difficult for the consumer to identify the counterfeit medicines, especially in cases where legitimate supply chains have been infiltrated. To identify and avoid purchasing fake products, consumer diligence should always be practiced, taking care to ensure that the sources or pharmacies of the products are verified and duly licensed to dispense the medicines, and that the products themselves appear to be of sufficient quality and price, with the correct packaging. Legitimate producers of the genuine medicines could also employ different ways of specifically marking the products to ensure their authenticity, and consumers should make themselves aware of such indications such as by checking the websites of the brand owners and checking for the list of licensed sellers and retailers.

The indications provided by the European Commission – Taxation and Customs Union on “How to identify fakes and other IPR infringing goods” can also be helpful.

NE: What are the current trends in the trade of counterfeit pharmaceuticals? How much has this kind of trade has grown since the beginning of the coronavirus pandemic?

EUIPO: We cannot answer that authoritatively yet. However, according to industry and enforcement sources, IP crime related to Covid-19 is more focused on counterfeit and substandard personal protective equipment, unapproved test kits and similar. The enforcers and industry do expect that once a treatment for Covid-19 has been found, it will be counterfeited as well.

More generally, according to the EUIPO-EUROPOL Intelletual Propertry Crime Threat Assessment 2019 Report, there are different modi operandi when it comes to the production of counterfeit medicines. In some cases, the medicines and packages are produced in the same clandestine laboratory, while in other cases production is done at separate sites or even by separate organised crime groups. In one case, an organised crime group was found to have sent samples of branding to China, where stickers were produced on a large scale and sent back to be placed on the packaging. Finally, there are also filler sites, where medicines and packaging manufactured elsewhere are put together.

One of the trends observed in this area is the importation of raw materials in order to proceed with local production. In recent years there have been regular seizures of pill presses, mixers, blister machines, bottles and labels. Raw materials are illegally brought into the EU, usually using fake documents under a fictitious brand. Illegal medicines are then manufactured in laboratories that have all the necessary infrastructure to produce fake and illicit medicines. In some cases, counterfeit medicines are produced by the organised crime groups that are also involved in producing and trading synthetic drugs, such as MDMA, LSD and ketamine.

Moreover, there is a continuous expansion of unauthorised and unregulated online pharmacies, selling a wide range of counterfeit, illicit and substandard pharmaceutical goods. These online pharmacies capitalise on the increasing self-medication trend and consumer demand for cheap medicines. Some of these online shops advertise with the slogan ‘original preparation at low prices’, but are in reality operated by criminal groups. In recent years, law enforcement authorities have also detected a growing number of counterfeit medicines in postal packages, often ordered on social media pages and other online marketplaces. There are also indications that counterfeit medicines are being traded via mobile instant messaging platforms.”

NE: Which counterfeit medicines have been the most widely used during the coronavirus crisis?

EUIPO: There is no data about that yet.

NE: What are EUIPO’s recommendations on how to stop the trade?

EUIPO: Stopping the global trade in counterfeit medicines entails getting to the root of the problem as to why counterfeiters choose to engage in this illegal activity in the first place. High profitability, combined with factors such as the low risk of detection, the low risk of prosecution once detected, and finally, weak penalties imposed on counterfeiters once prosecuted, make counterfeiting a high-profitability and low-risk endeavour for criminals. Addressing these issues would therefore not only require enhancements to the IPR enforcement legal framework, in order to sufficiently empower law enforcement authorities to act on cases of infringement, but also to ensure the effective implementation of the laws in actual cases.

EPA-EFE//DAREK DELMANOWICZ

Some of the initiatives are related to securing the supply chain to prevent infiltration by criminals, and informing consumers about the dangers of using online pharmacies and in general purchasing medicines online. Various countries, including the EU, have developed authentication schemes for online pharmacies to identify to consumer those that operate in a legitimate manner and in accordance with the law.

The European Commission adopted the Communication “Towards a renewed consensus on the enforcement of intellectual property rights: An EU action plan” in July 2014. In the action plan, the Commission adopted measures to pave the way towards the ‘follow the money approach’, which seeks to deprive commercial scale infringers of the revenue flows that draw them into such activities, rather than penalising individuals or end-users for consuming IPR-infringing goods or content.

In addition to establishing a solid legal framework and adopting a long-term and holistic policy approach to enforcement, some of the actions that could be adopted include continuing to raise public awareness on the dangers and risks of consuming infringing goods, having consistent and relentless law enforcement operations against infringers, and establishing good communications and mechanisms of cooperation between countries where counterfeit goods are produced and trafficked.

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