WHO to Reward Whistleblowers on Drug Counterfeiters

World Health Organization (WHO) together with the local authorities of Indonesia held a buy-bust operation in a dilapidated building just outside Menteng in the city of Jakarta last September 25, 2015. 4,000 packages of generic Cialis and 200 boxes of Viagra were confiscated along with three counterfeiting machines, dirty syringes, and three pails of chalk.

The five personnel, all local, admitted to packaging and sealing these drugs to be picked up by a dealer known by “Sam” at dawn every day. As to where the products are distributed and how it is being supplied, the workers do not have knowledge of. Another man named Jafar is in charge of refilling their supplies every week while a woman named Alice comes by every two days to give their wages. They are not allowed to ask any further questions and are not able to do so as even if they, most of the times, work by themselves inside that building for their activities seemed to be monitored. One of their fellow workers was once killed while going home after he told a friend where he was working. A few days later, that friend was also dispatched. Living in fear for their lives and their families, they cannot complain nor tip the authorities of their illegal employment.

While these personnel spent their time in prison before their trial, their spokesperson they call Matti was killed in what the authorities say is caused by a prison fight. The others, now fearing more for their lives and unsure of their fate and security even within the prison walls refused to talk and testify. The government also takes full control of the situation and does not communicate well with non-profit organization anymore.

Once again, WHO would have to restart from scratch. Calling a conference with other non-profit organizations campaigning on the same cause, WHO has opened its willingness to offer a reward to anybody who has lead information on the continuous fraudulent operations on counterfeit medicines.

The Peterson Group, a fellow NGO who campaigns against the proliferation of counterfeited medicines            stated that a bounty of up to 20% of the value of any drugs being seized is available for anyone who can provide assistance. Private pharmaceutical companies also stated that they are to give their own rewards when generic copies of their own medicines are to be found.

Of course, counterfeit medicines are a global problem and both eastern and western pharmaceutical industries are equally disturbed by the presence of phony drugs in the supply chain.

Distribution of Counterfeit Medicines to Legitimate Pharmacies

Substandard medicines have been widespread on developing nations despite the strengthening security and laws against counterfeiting in these countries. Conflict arises between individuals and organizations on how and why this issue has been continuously prevailing. Its penetration and acceptance in the market have caused alarming number of sickness, complications and deaths in which ordinary citizens are starting to question the authorities. The complaints have been outpouring that World Health Organization, Food and Drug Authorities in each country and other non-profit organizations campaigning on the same cause have been involved.

Reasons have led to one and another. Politics, bribery to the government, the worsening case of poverty and the weak security system have been pointed as factors to its continued existence. One of the reasons which is noted by The Peterson Group, one of the NGOs exclusively working against counterfeited medicines, has caused extra agitation to the government, private pharmaceutical companies and consumers: trade within legitimate pharmacies and counterfeit fraudsters.

Trade in legal commerce has been overlooked with the common perception that legal businesses remain untouchable against counterfeit medicine scams.

United Nations Interregional Crime and Justice Research Institute (UNICRI) has been able to confirm the suspected loophole in private pharmacies’ products. In reviewing the methods used, the term parallel trading came to light.

The practice of parallel trading is legal in the commercial world; however, its application and contribution in the current issue have weighed the issue even further. At this rate, it is near impossible to trace the real culprit as the process involves at least 20 parties.

In a raid in one of the biggest counterfeit drug smuggling in Jakarta, Indonesia last 2013, fraudsters admit to following a cycle but they themselves hardly have any idea as to how the medicines managed to travel and be distributed.

The perpetrators explained that parallel trading involves a drug that is sold in a given country, which after having already moved through the various stages of the ordinary distribution chain, is acquired again by the major distributors and is entered into the parallel distribution chain. The product is then transferred to a new and more lucrative market by means of parallel intermediaries/distributors. The times a pharmaceutical product is transferred can be numerous. It is estimated that, on average, a drug which is entered into the parallel market may be subject to 20-30 intermediary transactions.

This extension of the distribution chain creates a problem of verifiability since some of the intermediaries do not need licensing to operate.

The issue is still under investigation. Our greatest fear is that by the time the real mastermind has been apprehended, it can be too late.

Deadly Fakes Around the World

The widespread of counterfeit medicines is inherently a dangerous problem. However, its distribution is not even in different parts of the world. Despite World Health Organization’s (WHO) effort to defeat counterfeiting in one stride, different measures are needed for each region. The loose punishment scheme in many countries and the strictness on others, the different strategies, transportation and distribution methods used and the variety of medicines being falsified are considered as hindering factors for full implementation of security measures. Although rich nations have fewer breakdowns on the issue, they are not exempted from the threat.

A plethora of evidences, methods and types were covered by WHO and have shared to other institutions campaigning on the same cause. One of them is The Peterson Group, a non-profit organization which has been advocating against the proliferation of counterfeit medicine since 2005. On its ten years, the group, which has formed members across South East Asia, Australia, the United States and United Kingdom, has gathered reports from different developing cities and nations. The following is the summary of each region’s brief background on counterfeiting medicines:

North America

Counterfeit medication is a recognized and well documented problem in the United States. One case in 1937 has featured more than a hundred deaths after consuming medicines containing the dangerous solvent diethylene glycol.

Some counterfeiters in the United States are even found to be using fraudulent connections to terrorism. WHO has also found that the profit from counterfeit medicines have been used to fund the famous terrorist group Hezbollah.

Europe

There are few fake and substandard drugs in most European countries for reasons similar to those articulated above for the United Sates: quality producers dominate the market, supply chains are generally well regulated, and officials provide strong oversight and strict enforcement when pharmaceutical standards are violated. Still, preventing fakes from entering or travelling through the two dozen European territories is a constant challenge for enforcement officials.

Cambodia

Cambodian Ministry of Health has released a statement stating that 13% of the nation’s medicines are fraudulent. Warnings on health precautions are already released by local government units and private pharmaceutical companies as most counterfeit medicines are found in informal and unlicensed units.

Indonesia

Counterfeiting in Indonesia has grown despite the warnings of death penalty as punishment. By 2008, 44% of medicines in the market are counterfeited, even sold in legitimate pharmacies. 11 men were arrested in the capital city, Jakarta for refilling syringes with water, forging expiration dates and repackaging. 

Precautions and Warnings on Counterfeiting

Asia is famous to nearly all kinds of forgery and fraudulence. China leads the rest of the continent in bearing the name ‘fake’. Perhaps these accusations have their bearing. After all, the products which are counterfeited would trace back to illegal production companies in the region. Dirty politics and lax of security has had a lot to do with it, as so many bad reviews had pointed out.

Nevertheless, Asia, with more developing countries than developed ones, has had a lot of records in combating the issue at hand. The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeiting medicines notes that changes have been developing and plans have been integrated to prevent this issue from spreading. In fact, World Health Organization has summarized more legislations and suggestions on counterfeit combating as advised by many Asian members in the congress.

The following are possible measures in contending the problem:

•              National Government

The government, perhaps, has the most important role in stopping counterfeiting. With a stable policy and regulation, proper execution of security, there would be a good chance penalty can be imposed on fraudsters. Those in office have the power to enact rules and legislations which can help strengthen the campaign against spurious, falsely-labeled, falsified and counterfeit medicines. They can foster cooperation between different sectors of the government that play a role in the process. Medicine legislation should be formed and they should be the ones to ensure that counterfeit meds are confiscated and destroyed. United Kingdom has started their own government campaign but many critics say that developing cities who are also taking their own stand like Jakarta, Indonesia and Singapore have too much politics to implement proper policies.

•              Consumers

Consumers also have their share of responsibilities. We cannot always complain and do nothing. We, as the people who would be directly affected by the effects of counterfeit medicines should be suspicious and cautious of our every purchase. As much as possible, do not buy from a peddler or in market places, do not trust large discounts and check if labels or packaging would hint distrustful information about them. Also, be aware of emergency numbers to dial in case you may encounter one.

•              Medical Organizations and Pharmaceutical Companies

Since there are issue and conflicts occurring between the government and private companies when it comes to disclosure of information, there would always be miscommunication. These companies should work closely with national law enforcement and not entirely conceal their own information to themselves.

WHO Warning Falls to Deaf Ears

It would have been better if World Health Organization has cautioned the blind and the deaf, they may have listened more but the ignorance of people to precautions and warnings has led to high mortality rate and worsening disease symptoms.

Using different media and even fellow non-profit organizations, WHO has rounded up most information both in developing and already developed countries? From the busy streets of New York to the heavy traffic in Jakarta, Indonesia, the information has been passed on. The organization also took advantage of the partnership with other institutions. The Peterson Group, an online non-profit society is one of the institutions avidly campaigning against the proliferation of counterfeit medicines in South East Asia. Along with numerous local groups campaigning for the same cause, a lot of developing Asian nations are already informed. Yet, there may be possible reasons for people to become unaware.

The variety of information makes compiling data a difficult task. Sources of information include historic data which can sometimes already be obsolete. This is one of the reasons why there is not much trust in the information given by WHO and the main details are oftentimes overlooked.

Another factor hindering information from being spread are the political powers moving behind their names and standing in society. Those who have the authority to inform may not have fully discussed the severity of the situation and may have not emphasized the impact of counterfeit medicines to one’s health. It may also be that the authority itself is behind fraudulent transactions, gaining profits from mafia groups and scammers.

Strengthening medicine regulatory authorities (MRAs), improving quality of production, and facilitating the availability of relatively inexpensive, good-quality anti-infective are likely to be key factors in the effectiveness of the information being responded to.

There is an urgent need for data of sufficient sample size with random sampling design to reliably estimate the prevalence of counterfeited medicines. Such data are vital to select appropriate interventions, assess their effectiveness, and follow changes through time. Recent literature has concentrated on poor-quality anti-malaria, but it is likely that other anti-infective medicines are also profoundly affected. We do not know how counterfeit and substandard medicines compare with respect to their impact. We also have little information on what proportion of patients or health workers are aware of the issues in different societies, and which interventions may be the most effective. Without the help of different sectors, these planned interventions may not come to realization.

Medicines, an Intellectual Property

Counterfeit, substandard and fake medicines pose a great risk. Counterfeited clothes, bags and accessories have economic effects, loss of profits and perhaps cause financial downfall. Employment and income which is supposed to be directed to the legitimate brand are being distributed to counterfeiters and imitations. However, the concern of brand owners are being disputed since counterfeited items are helping these brands market their name.

Counterfeit Medicines do not rock the same boat. Not only would the manufacturers lose economically. Fraudulence in this field also poses a great risk in health. The World Health Organization (WHO) which plays the main fortress of many organizations and causes against the widespread of counterfeiting medicines has highlighted the issue by decreeing different kinds of trump cards and bylaws. In the passing of time, while the panic withers away, fraudsters have also strengthened their strategies. They got fiercer, not even considering trademark issues and deceitfully duplicated brand after brand. Unlike the spreading market for clothes’ brands, counterfeited labels bring trust down and cause reputation to plummet.

According to reviews archived by The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines, in 2003, the biggest conflict faced by authorities regarding protection of intellectual property rights is the agreement of the World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS) who both offers vague rules and statements against trademark infringement in medicines being exchanged internationally. A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy. Drugs exported under such a regime may be packaged or colored differently in order to prevent them from prejudicing markets in the developed world.

Many critics stated that there should be a clear line for differentiating normal cases of trademark infringement to counterfeiting which penalties for offenders apply. It is for the trademark owner to initiate infringement proceedings. However, for a number of reasons, developed countries, including Germany, USA and UK are opposed to extending criminal sanctions for infringement.

Developing cities have also participated in the agreement between WTO and TRIPS but they are given longer time for proper implementation. Surprisingly though, they have faired better in the adaption of sanctions. Jakarta, Indonesia and Bangkok, Thailand are both emphasizing their complaints against intellectual property rights as they have local medicine manufacturers in their stead.

However, it is a different issue for less developed countries. It has been argued that TRIPS implementation is far detrimental to these countries’ development. The flexibilities may not be drafted because of the lack of legal and technical expertise. It is yet to be determined when the extension of the transition to TRIP method happens on January 2016.

PROBLEMS AND SOLUTIONS TO COUNTERFEITING

Warnings on the global boom of counterfeit medicines have been known to bring forth realization of the unwanted and dangerous business. Moreover, those who are often victimized are from developing nations but global awareness has been expected to reach even the most illiterate parts of regions through advanced technology. It is now a race on who would reach the market first: the warnings or the advancing fraudulent methods used by scammers.

According to The Peterson Group, a non-profit organization advocate in eliminating the production and distribution of counterfeit drugs, 80% of counterfeit medicines proportion has been dominating in some wholesale pharmaceutical companies in Africa. 

China still remains to be the largest distributor of counterfeit medicines, operating in almost 500 factories around the country. The number has been expected to increase over time. Far from what is also expected to developing nations, these counterfeited medicines still cause adverse effect and reactions and can still cause deaths despite advanced methodologies being practiced? 

In South East Asia, the weak implementation of law is still a prevailing issue. Despite the efforts of Jakarta, Indonesia and Singapore to stop illegal smuggling of counterfeit medicines by putting warning signs at airports and implementing death penalty on anyone who breaks the law, transactions within these regions are still predominating. It makes it easier for smugglers in Indonesia since there is more than one entrance for inter-island transactions. 

In order to contain global scourge, the more advanced countries should assist less developed ones. Dynamics of these developing sources should be integrated with that of properly implemented nations. This problem cannot be eliminated if the supply-demand issues continue to hinder non-profit organizations, the government and the public to fully enforce proper solutions. 

Since there are more than concerns which should be done, International Policy Network of London has listed some possible solutions for this prevailing issue which causes thousands of deaths annually:

• Adjudication of disputes over contracts should be simpler and cheaper, so that contracts may be more readily enforced.

• Bureaucratic restrictions on doing business should be removed.

• The manufacturers of brand goods should be able more effectively to protect their trademarks.

• Most fundamentally, courts of law should be granted greater independence, so that their rulings are more impartial and less influenced by powerful vested interests.

• The legislature should not have the power to interfere with judicial decisions.

• The power of law enforcement agents should be curtailed and their actions subject to judicial review.

• The actions of other government agents (e.g. regulators) should be subject to judicial review.

• Regulation restricting the supply of medicines should be improved or scrapped. 

• Governments should reduce taxes and tariffs on all medicines.