One of the most complex problems resulting from the globalisation of healthcare delivery is securing the safety of the global medicines supply chain. Counterfeit forms of pharmaceuticals, sold illegally, create dangers to patient safety and public health that are almost impossible to unpick through international law. The extent of this international problem is far too large for a single law enforcement agency to handle. The issues include pharmaceutical products that span a host of therapeutic classes and lifesaving treatments, and involve multiple companies, governments and organisations.

Risk and response

Counterfeit drugs are a significant public health concern, as their safety and effectiveness is unknown. The most pressing concern about counterfeit drugs is that they could be made using ingredients that are toxic to patients, and could have been processed under poorly controlled or unsanitary conditions. These substandard drugs are a major public health concern, especially regarding infectious-diseases drugs such as anti-HIV and antimalarial drugs.

The US Food and Drug Administration (FDA) has, in recent years, set out new legislation aimed at strengthening the US’s closed pharmaceutical distribution system. It has made it a priority to investigate reports of counterfeit products. It has also worked with pharmaceutical supply chain stakeholders to improve their ability to prevent, detect and respond to threats of counterfeit and substandard drugs, and is developing standards for tracking and tracing prescription drugs.

One of the most pressing orders is for the pharma industry to work harder to combat the public perception that medicine counterfeiting is not a ‘real’ danger to health.

FDA is one many agencies worldwide that is also spending money and resources on educating consumers and the healthcare community about the risks of counterfeit drug products. Through recalls, public awareness campaigns and other steps, it hopes to reduce the exposure people will have to these substandard products. With its reputation as a respected benchmark-setter, many others are watching its actions.

A global view

The US National Library of Medicine and National Institutes of Health define the legitimate supply chain as "any supply chain that is regulated or licensed by a ministry of health or other regulatory body", or "any supply chain where a patient would reasonably expect to obtain authentic product, supplied via a controlled supply chain, from the manufacturer of the product to the point of dispensing".

The push for visibility is where much of the pressure lies. In 2015, French powers pushed for new labelling on medicines to show whether the contents were made in or outside Europe – a move to bolster its pharmaceutical industry, but one that could sow discord among drug makers reliant on Asian suppliers. Around 80% of drugs taken in the US are manufactured abroad, meaning that adherence to this might be difficult: it’s hard to identify whether fake drugs are entering the system in warehousing, transportation or at the manufacturing level, for example.

This is certainly the case in the US and Europe, but other parts of the world that are not so well-funded are facing these issues too. A 2015 study on fake medicines conducted by Sanofi in six Asian countries – China, Indonesia, Malaysia, the Philippines, Thailand and Vietnam – reported that while 67% of those surveyed considered fake medicines to be dangerous, 55-76% of people declared that they would not be able to distinguish a real drug from a fake one. The issues stretch to combatting the problem, too: 39% had bought medicines on the internet (citing the reasons as saving time and, more importantly, money), and only 58% stated they were aware of the risks of this. These numbers show the ease with which counterfeit drugs can enter the supply chain.

Compared with citizens of Europe and the US, people living in Asia appear to be very aware of the dangers of fake medicines. However, they also have a greater tendency to buy medicines online, exposing them more to the risks. In these areas, as populations grow, incomes soar and Western lifestyles are adopted (shown to lead to increased rates of diabetes, heart disease and cancer), more people will want to buy medicine – and may opt for the cheaper, more convenient options.

The role of pharma companies

One pharmaceutical company, Sanofi, claims that 30% of drugs in the developing world are counterfeit. It believes that securing the supply chain and developing protection technologies on product packaging will be effective deterrents, as it then becomes expensive and difficult for counterfeiters to reproduce the medication.

Combatting issues in the supply chain will be difficult, but one method would be to improve counterfeit detection with the development of new analytical methods. Reliable analytical techniques could provide insight into the phenomenon and drive appropriate enforcement actions.

The pharmaceutical supply chain will continue to be an area of high risk for the industry, so raising industry and public awareness is critical. Healthcare workers and governments will need to show strength in fighting the problem. One of the most pressing orders is for the pharma industry to work harder to combat the public perception that medicine counterfeiting is not a ‘real’ danger to health. And, by all accounts, it is clear that international cooperation will be necessary to fight against counterfeiting and other forms of transnational illicit pharmaceutical activities.

Evidence in the US and Europe shows that pharma companies can quite effectively lobby to reinforce legislation to help their supply chains stay safe. The MEDICRIME convention is one such example. Designed to protect public health, and criminalise and punish all acts related to counterfeiting medical products, it is this mixture of law, education and technology that will be the key to combatting counterfeiting in the supply chain.

FDA steps in

Stephen King, a spokesperson from FDA, agrees with this mixed approach.

"The drug supply chain has become increasingly complex as it reaches beyond US borders," he says, remarking that FDA takes any possible problems in the supply chain seriously. "Threats to the supply chain such as counterfeiting, diversion, cargo theft and importation of unapproved or otherwise substandard drugs could result in unsafe, ineffective drugs entering distribution streams."

FDA has issued several public alerts over the past few years regarding counterfeit drugs found in the US, to "help the public and members of the supply chain identify the counterfeit and unapproved products". Counterfeit Botox, Cialis, and cancer medicines Altuzan and Avastin have all entered the American retail drugs market, for example.

FDA routinely gives simple and practical advice to any concerned people working on the pharma industry frontline, to minimise the chances of patients being exposed to medicines that may be counterfeit, contaminated, or improperly stored and transported. The organisation says that healthcare professionals should be cautious when ordering products from new or unknown suppliers, and to look out for any portion – or all – of the labelling that is not written in English.

This might be helpful to those working with the drugs, but how do companies shield themselves from the counterfeits getting into production in the first place? Most of the emphasis on this enforcement appears to be on the individual consumer rather than on the pharmaceutical companies themselves, and FDA has limited advice for how to better protect chains of production.

"FDA has seen a growing trend of healthcare professionals and medical practice administrators purchasing prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain," King says.

To educate healthcare professionals about the potential health risks to patients and safe buying practices, FDA developed the Know Your Source campaign. "With these practices harming reputations and bottom lines, educating the public could be the quickest way to end the trade," he explains.

Threats to the supply chain such as counterfeiting, diversion, cargo theft and importation of unapproved or otherwise substandard drugs could result in unsafe, ineffective drugs entering distribution streams.

Act in the name of security

FDA and its international equivalents are also working with prescription drug manufacturers, wholesale distributors, repackagers and trading partners to implement a new system that enables product tracing, verification and identification as drugs travel through the market – which could help cover the risk to pharmaceutical companies. This effort is part of FDA’s implementation of the 2013 Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act.

DSCSA was enacted to further enhance the safety of the supply chain and protect consumers from potentially unsafe drugs. Under DSCSA, doctors that dispense or administer prescription drugs to patients are required to purchase their prescription drugs only from authorised trading partners, licensed by or registered with the state or federal government.

King believes DSCSA will be helpful to pharmaceutical manufacturers as well individual consumers, saying: "DSCSA provides a federal framework for identifying and tracing certain prescription drugs, by outlining critical steps to build an electronic, interoperable system by 2023, to trace drug products as they are distributed." FDA hopes the new system will enhance its ability to protect consumers from exposure to drugs that may be counterfeit, stolen or otherwise potentially harmful.

Regulators are focusing on the consumer, but behind the scenes, big pharma companies are focusing on the supply chain, and increasing visibility of the law and consequences, as well as putting a heavy emphasis on education. INTERPOL’s Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit is working with the Partnership for Safe Medicines to focus on raising awareness of fake drugs to spotlight the dangers.

The best advice, aside from education, remains the idea of making supply chains as transparent and origin-detailed as possible. Official advice is to map every step of the supply chain, from manufacturing through to distribution, labelling and packaging, and then test for potential vulnerabilities. Building a global team of investigators, and security and logistic professionals can help put the right processes in place to reduce counterfeiting and supply-chain security breaches. Opening up factories for inspection, only hiring documented workers and creating a strong, communicative environment where potential coercion can be excised are all important factors.

With ongoing attempts to face up to the realities of supply chain risks, pharma companies will get further together than by going it alone. But the most important thing is having openness about the potential risks, and reporting where recurring problems are spotted.