United States / Regulation

The Public Health Crisis of Counterfeit Drugs

The illegal manufacturing of counterfeit drugs has become one of the most pressing public health issues worldwide. According to the Lancet, many African health officials believe that counterfeit drugs “are a greater public health threat than AIDS or malaria.” The World Health Organization defines a counterfeit drug as one “which is deliberately and fraudulently mislabeled with respect to identity and/or source.” Counterfeit drugs “may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

The most commonly forged drugs are antibiotics and antimalarial medicines, and in developed countries, hormones and steroids. The high forging rates of these drugs are most likely due to the high prices and common use of the medicines. There are many factors that encourage and allow the counterfeiting of medicine, including a lack of successful regulation by the government, high prices, and shortage of medicines. In recent years, some improvements have been made to combat the problem of illegal manufacturing, but governments must take a stronger stance on this issue and implement reform in order to make meaningful change.

Counterfeit drugs pose an incredible danger to individuals and society as a whole. Spurious drugs can cause serious health consequences to patients who take them. These medicines can either cause direct harm or prevent patients from receiving the needed therapy that the true drugs would provide. For example: In 2008, imitation blood thinner drugs marketed as Heparin led to the death of 81 individuals. In Pakistan, in 2012, more than 100 cardiac patients died after being given counterfeit medicine. Furthermore, research has shown that almost one third of malaria drugs are fake.

The magnitude of the situation is difficult to quantify, which is one challenge in addressing the problem, but it is estimated that more than 10 percent of medicines sold globally are counterfeit drugs. According to the World Health Organization, 60 percent of cases of counterfeit medicines occur in developing countries and 40 percent of cases of counterfeit medicines occur in developed countries.

The counterfeiting of drugs has deleterious social implications as it leads to distrust in doctors, prescribers, and drug manufacturers. According to the World Health Organization, when citizens have doubts about the credibility of the health care in their county, the health system as a whole is unable to function because people are less likely to seek out care or adhere to doctors’ medical orders.

There are many factors that are both causing and enabling the counterfeiting of drugs. Firstly, according to the World Health Organization, medicines are “attractive for counterfeiting” because they are expensive items, have an infinite demand, are easily transportable, and are producible without a large amount resources or infrastructure. In many counterfeit drugs, there is a deficient or non-existent amount of the active ingredient. A large gap between manufacturing cost and market price also presents an opportunity for counterfeiters to make a large profit.

The stark lack of drug regulation worldwide by national governments and other authoritative bodies further exacerbates the problem. There are very few national medicine regulatory authorities and they typically do not have the political and financial support of their governments. Moreover, currently very few countries have national legislation on spurious drugs. Even in countries with regulations, there is a concerning lack of enforcement. Out of 193 member states of the World Health Organization, only about 20 percent have well-developed medicine regulation.

Finally, there is a worldwide shortage of medicines that forces patients to look to alternative sources, which provides an opportunity for counterfeiting. In 2012, there were 456 cases of drug shortages in the United States.

All of these factors must be addressed in order to rectify this major public health issue. Several recently introduced efforts have been moderately successful, but more reform is needed. Manufacturers have been taking measures such as utilizing barcodes, two-dimensional encryptions, taggants (markers used to confirm the identity of the product), and blister packaging to fight counterfeiting. Many countries have mandated the use of track and trace systems. But the lack of common standards prevents the success of these strategies in the face of a multi-step production process for medicines and the recent increase in world trade. Also, there are security concerns because the proposed tracking strategies would include sensitive information about the patients and pharmaceutical companies. There are also financial concerns as these strategies cost a significant amount and slow down production.

While these strategies have had some success in reducing counterfeiting, governments must take strong initiatives to confront this issue for significant progress to be made. The World Health Organization maintains that for the issue to be resolved, “Governments must regulate the manufacture, export, import, storage, distribution, supply and sale of medicines to ensure the safety, efficacy, and quality of medicines.” Individual governments are uniquely positioned to resolve this issue because there are so many players and processes involved in the manufacturing and distribution of drugs, but the government oversees all of these processes. According to Kristina Lybecker, Professor of Economics at Colorado College, “Counterfeit pharmaceuticals slip into the supply chain at every link…ethical drugs are prescribed by a physician who never sees the drugs, delivered by a pharmacist who commonly uses multiple wholesalers, in some cases paid for by an insurance company, and consumed by the patient.”

Governments can and must manage all of these steps. In order to enact reforms such as electronic tracking, governments ought to play a significant role in implementation. Furthermore, counterfeit drug production is a government issue because it is a serious problem in every country, has international ramifications, and jeopardizes the health care system. Government is typically held responsible for relationships with other countries and for protecting the health of its citizens; therefore, preventing the distribution of counterfeit drugs should fall under the jurisdiction of government.

To successfully halt the production of counterfeit drugs, governments must establish strong medicine regulatory authorities (MRAs). These MRAs must ensure that all drug production sites are licensed and operating appropriately, define ports of entry for medicine, and foster cooperation among countries and national organizations, including the World Health Organization, Interpol, and World Customs Organization. These organizations need strong political support and adequate resources from the government in order to be successful.

Finally, governments must inform their citizens about the issue and measures that they can take to fight the counterfeit of medicine. Consumers should be educated to buy medicines only from licensed sources, be wary of very inexpensive medicines, get receipts whenever purchasing medicines, check the packaging of medicines to see if the proper information is displayed, and inform their doctor if their condition does not improve after taking medicine.