Is the Government Doing Anything Against Counterfeiting?

We have been aware of the present critical phase of the issue of counterfeiting among pharmaceutical medicines across the globe. As you may also have noticed, the information is mostly provided by non-profit organizations and international agencies which have been campaigning against this deadly illegal act. World Health Organization (WHO) even tagged this crime as silent terrorism as it can create an outbreak of highest mortality rate in just one blow just as what had happened in South Africa when an entire village was poisoned by a fraud anti-malarial medicine on a malaria epidemic.

When the news gained public attention, the blame was pointed to the loose security, corruption and bribery occurring within the government. In turn, the political powers prove their innocence by deploying authorities and procuring technologies which can identify the fraudulent copies of medicines being imported, distributed and exported in and out of the country. However, after the issue subsides and the public returned to their subtle reproach towards the government, the business of counterfeit medicines – this time, of different brand and substance – thrives once again. 

Indonesia is no different despite the strict death penalty on anyone found guilty of smuggling and distributing illegal medicines within the archipelago. The country is known to have lucrative manufacturing business of counterfeit medicines in Jakarta, second to China which still holds the title of the most productive country for counterfeiting. 

On the other hand, the United States boasts of their 1% counterfeiting rate when the rest of the world records 30% of the overall medicines as counterfeited. Still, as the Peterson Group, one of the NGOs providing information on counterfeit drugs, points out, this number is nothing to be proud of. As long as there is a number existing, the citizens are still not safe from the dangers of counterfeiting can bring. 

The warnings of WHO and Food and Drug Administration (FDA) are being disregarded with the issues of poverty and illiteracy. There may have hopes and solutions for these problems, yet, with the time dragging by and no active measures still being implemented, it may well be improbable that these are not meant to be solved. 

There are only a few World Health Organization (WHO) pre-qualified quality control laboratories across the world. Drug buyers and suppliers should utilize these facilities. Laboratory testing assures quality and ensures the procurement and supply of safe and quality medicines.

However, these laboratories alone cannot meet the needs of the entire population. 

The government and other non-state actors should invest in more testing equipment, especially in rural areas. 

But without any possible feedback from them, we can’t help but ask, is the government doing anything against counterfeiting?

The Peterson Group to Join Medicrime Convention

Counterfeiting has been a long-time issue among health advocates. It has brought frustrations and arguments on top of complaints on the seemingly unsolvable problem. Dozens of seminars and raids have already been conducted to abolish counterfeiting but the business just seems to get bigger. It is already being considered in many reviews as one of the most lucrative criminal business around the world.

With the world in danger of falling victim to counterfeit medicines, a lot of NGOs, government agencies and international organizations are summing up ideas on the best approach to defeat fraudulent practice on drug production, exportation, importation and distribution. European nations have been leading the campaign against counterfeiting even with lower counterfeiting cases than the United States. Asia, with its diversified cultures, variety of languages, and numerous traditions falls behind the battle considering it is also a home to the most number of counterfeit drugs and the largest producer of illegal medicines.

Tired of all the intrigues on the inadequacy of the authorities to take down the groups behind these scams, the Medicrime Convention of the Council of Europe sets the first international standard for criminalizing the manufacture and distribution of counterfeit medicines. The Peterson Group, with foundations in Jakarta, Indonesia and Kuala Lumpur, Malaysia, has readily signed up as one of the active members among dozens of non-profit organizations who also participated in the cause. 24 other countries also signed the agreement which is to be ratified on January 1, 2016.

Headed by the Council of Europe with 60 years of experience in promoting healthy and quality medicines, this innovative treaty is adopted in 2010 by Medicrime Convention is designed as the first international medical treaty with the main goal to protect the quality of medicines being distributed across countries.

Global pharmaceutical companies welcomed the entry of force by Medicrime convention.

According to an interview with Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), strong legislative framework is needed to combat the rampant issue and Europe has the sense to lead international parties in strengthening the policies which has lacked stern implementation in the last few years.

The criminals who deliberately endanger the health and lives of the patient and the overall public have been undermining the confidence in public health system and should therefore be considered as a matter of urgency.

How to Identify Fake Online Pharmacy

After a massive close down of thousands of websites found to be fake online pharmacies using individuals claiming to be doctors and issuing fraudulent prescriptions or selling counterfeit medicines, the authorities have imposed warnings to be the public to be more cautious in any transactions done online especially on pro-health claiming sites. In response, sales of online pharmacies began to drop, affecting even the legitimate entrepreneurs online.

Although most would not comment, there are those who filed their complaints for the public to see such as the Canadian-based online pharmacy, BestCDS.info who asserted that their products are legitimate. This company, along with that of several others in UK stated that they never give prescriptions even when it is only to comment on an inquiry but instead encourage their clients to seek a physician first. The medicines prescribed by a legitimate doctor is then emailed or faxed to them.

The manager, under the name Carl, admitted he had lost most of his clients who suspected his business and has therefore spoiled his good name. In an interview with The Peterson Group, a non-profit organization providing imperative information on counterfeit medicines, one of Carl’s clients who chose to speak anonymously accused Carl’s company for selling “sugar pills”. Carl then resolutely stated that these allegations are without merit and that his company has never sold any fraud medicines. The case is still under investigation as the drugs were traced to be manufactured in Jakarta, Indonesia.

According to Food and Drug Administration (FDA), “Legitimate pharmacy sites on the Internet provide consumers with a convenient, private way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home.”

But this is not without risk. There is still no knowing whether the site is safe just because the purchase is convenient and the appearance looks legitimate enough.

To be sure, FDA encourages consumers to first check http://www.nabp.net/ where a list of illegitimate online pharmacies is published.  These include those that claim to dispense drugs without a prescription or sell products not approved by the FDA, and, of course, fake online pharmacies that are downright fraudulent.

In addition to being included on this list, other warning signs of fake online pharmacies include sites that don’t provide a physical address for their business or don’t list a verifiable phone number.

Process of Diversion in Legitimate Process

There is a definite process followed by a lot of counterfeiters across the world. Some of these methods have already been tackled by authorities. These have been tracked and sought after in many countries for similar processes. Others remain a mystery even to the Interpol and Food and Drug Administration (FDA).  For instance, how the counterfeiters were able to infiltrate the tight security around Jakarta without being detected in Java and other islands of Indonesia is still being reviewed. Even more surprising is the increasing number of counterfeiting cases when the government has clearly imposed immediate execution to anyone found to illegally smuggle goods within the archipelago. One thing is for sure though, these counterfeiters not only work with black markets selling ample amount of fraud goods. They have also already penetrated the legitimate market, blending in with the real products and making it hard for the authorities to capture the main culprit.

While there is the emergence of tampering and stealing of intellectual property rights from legitimate manufacturers, other methods of fraudulence include Diversion. 

In this level, medicines created and designed for a specific market or function is remarketed in violation of the producer’s instructions. These counterfeiters mostly target non-profit and humanitarian organizations or the supply of free samples to hospitals and clinics. 

According to a study conducted by The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines across the world shows that between 1992 and 2002, prescriptions written for unscheduled and scheduled drugs increased by 56.6% and 154.3% respectively.

Further emphasized in the study is that diversion can happen within the limits of a specific country or it may become an international scope.

Drug diversion in North Korea is one of the examples the first form of this kind of phenomenon. Since there are no other sources of medicines in this secluded country, some corrupt officials steal some of the medicines and resell it to the citizens even when it is marked as “UN aid”.

The other form of this phenomenon is driven by economic motive. For instance, an aid from the western countries can be halted by other leading countries and sold to neighboring nations for a higher price. The entity can also fraudulently acquire the products from the producer, declaring an intention to deliver the drugs for humanitarian purposes but in reality it re-markets the drugs after acquiring them at low cost. These international exchanges are implemented through multiple transfers and involve frequent repackaging of the product, thereby providing opportunities for counterfeit products to penetrate the legal distribution chain.

China still a Drug Counterfeit Hub

For decades, we have heard of different warnings by the Food and Drug Administration (FDA) on the dangers of counterfeit medicines which dominate today’s online pharmacies and most of the gray markets across the world. Variations of counterfeit medicines are being introduced from Tamiflu found in the United States; Bevacizumab in Turkey, Switzerland, Denmark, UK and Canada; chloroquine and hydroxychloroquine as antimalarial drugs in Kenya and Africa; and Viagra and Cialis in Jakarta, Indonesia and Victoria, Hong Kong. The number and varieties are continuously growing as more and more counterfeit medicines are being discovered. The likely targets are the expensive ones since it can be hard to procure and are less to get any suspicion.

Tracing back the root source of these medicines, we are always led towards China, the leading manufacturer of counterfeit medicines. The world’s largest country’s reputation for counterfeiting not only medicines but also other products has been known globally. This status is not without any statistics and claims as well. There is enough reason to acknowledge any complaints on fraudulent distribution and shipment from China.

Local Chinese police, together with The Peterson Group, non-profit organization campaigning against the proliferation of counterfeit medicines, Food and Drug Administration (FDA) and Interpol has arrested 1, 900 people on a crackdown in 2012 which was considered as one of the most lucrative operations in the history of counterfeiting earning millions of dollars each year.

Despite this arrest three years ago, the problem of fake medicines was far from being rooted out as operation after operation are still being raided every year. If so, fraudsters have even become more elusive and deceptive with new methods of production and distribution.

Fortunately, local units and organizations in the People’s Republic of China have realized the danger of the business that they too, started to create laws and regulations against the illegal practice. As reported by World Health Organization (WHO), the Chinese government has developed strict legal scheme for anti-counterfeiting by creating the Drug Administration Law of the PRC. The amendment not only adapted the need of drug supervision, but also represented the public will, somehow reflecting China’s determination in combating counterfeit medicines and not tolerating it, just as many people believe.

Since 2009, the local task force has also been in an active participation to any raids and buy-bust operations against illegal marketers of counterfeit medicines and has since joined forces with international organizations. The battle continues even until today.

FDA Investigates the Use of Oxytocin in Ghana

Through the passing of years, the continent of Africa is one of the most frequented by drug smugglers. Not only are the less developed countries in the region were the ones mostly visited. Urbanized ones have been the venue for transaction. From these places, it gets easier for fraudsters to transfer their counterfeited drugs to other less secure regions. 

The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines, has reported new methods on the widespread of Oxytocin in Ghana, according to a tip by an anonymous informant. Food and Drugs Administration (FDA) has decided to further investigate on the matter and found out several big companies for fraudulently importing fake products in the country.

According to a report review, FDA claims the “dangerous drugs” have already found their way into hospitals and pharmacy shops.

Some women have apparently been administered with two such drugs, Oxytocin and Ergometrine, which are injected to control bleeding after delivery.

The contaminated Oxytocin reportedly was manufactured in China by companies with fake addresses.

In the case of Ergometrine, the FDA said their investigations showed that it was imported from Jakarta, Indonesia and contained no active pharmaceutical ingredients.

Critics, on the other hand, blame the laxity of FDA security in order to prevent the proliferation of the counterfeited drugs earlier. If not for NGOs and local units who are actively gathering more information, FDA, which has the main function to take down counterfeiting, would have never found out about the new methods. The authority does not have any idea on how the medicines are distributed in the country and on how it has been circulating between legitimate pharmacies.

Statistics show that on the Ghanaian market between August and September 2012. A total of 303 samples— 185 Oxytocin injection, 103 Ergometrine injection, and 15 Ergometrine tablets—were sampled from both public and private hospitals, clinics, medical stores, pharmaceutical outlets, and the informal sector across the ten regions of Ghana

In addition, the storage conditions recommended by the manufacturers of more than 50% of both the Oxytocin and Ergometrine injections were not consistent with recommendations in the official compendia. This indicates a lack of awareness of the appropriate storage conditions for these uterotonic products. The pharmacies involved also face complaints from critics. FDA, on the other hand, has promised to undergo proper implementation of jurisdiction if the companies are found to be involved in the distribution. 

Patent: The First Line of Defense in Counterfeiting

Drug counterfeiting is one of the biggest issues encompassing a global scale. From local governments to private pharmaceutical giants to various international non-profit organizations, anti-counterfeiting campaigns have been founded. The internet has been penetrated so has been the local market units from legitimate pharmacies to gray markets to black ones. Large authorities such as Food and Drug Administration (FDA), United Nations (UN) and World Health Organization (WHO) have already been involved, creating their own awareness programs and raid operations. Billions of dollar-worth of medicines was already confiscated from various physical manufacturers and online pharmacies. This goes to show that everybody is now taking this crucial issue more seriously.

Despite the best efforts, a lot of critics continue to question the late response of authorities to issues of counterfeiting. This, they say, has already been too late as thousands of people have already lost their lives from taking mislabeled, fraud, substandard, scammed and counterfeit medicines which contain little or no active ingredient at all but instead has hazardous substances such as chalk, paint or detergent.

“The persistence of this issue shouldn’t have been here if they have gotten security in the first place”, says Nicole Parker, head pharmacist and member of The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicine.

Big companies claim their security is legit, yet, their brands are the most likely to be counterfeited. For example, hundreds of counterfeit Tamiflu manufactured by Roche, one of the world’s largest and most trusted producers of medicines, have been seized in one of the legitimate pharmacies in Jakarta, Indonesia. When and how was the medicines distributed in one of the most anti-counterfeiting countries in the world, everybody is still trying to find out.

While the operations are still underway, the new medicines are being processed patents, the process which should have been implemented as the first step in countering production of fraud meds.

A patent allows the patentee to exclude third parties from making, using, importing, selling, or offering for sale patented products or methods of manufacture or use for a finite period of time, typically no more than 20 years from the date of initial patent filing. Patent protection must be obtained on a country-by-country basis. It is used to prevent others, for that geographical area and without the consent of the patent holder, from manufacturing and/or selling exact and close copies of the patented technology.