JEDDAH — So long as there is no universal concerted action to criminalize counterfeit medicines and prosecute to the full extent of the law the malefactors, honest companies, pharmacists and doctors will find themselves prosecuted unjustly on one hand, with the loss in terms of legitimate revenues exponentially high, and on the other, the loss of human lives, in some cases, as a result of taking spurious drug. In an interview with the Saudi Gazette, Dr. Wail Al Qassim, the general manager of MSD (Merck Sharp & Dohme) Saudi Arabia pharmaceutical company, said the risk posed to global public health by these counterfeit drugs is already in the malignant state. Excerpts follow: If you would quantify the size of counterfeit drugs that are in the market, how big is it? Approximately, how much (in dollar terms) is loss annually on the part of legitimate pharmaceutical firms due to the widespread availability of counterfeit drugs? According to the World Health Organization (WHO), counterfeit drugs could make up as much as 50 percent of the global pharmaceutical market, with the largest share of counterfeit drugs appearing in the markets of developing countries. Despite this estimation, nobody knows just how big the counterfeit drug market is, especially since at least 50 percent of all counterfeit drug transactions take place online, making it even more difficult to track the trafficking of these pharmaceuticals. In 2010, it was estimated that the counterfeit drug market was over $70 billion, representing a 90 percent increase from 2005 figures. Although it is difficult to pin down the exact dollar amount pharmaceutical companies loose each year, due to counterfeit, the Center for Medicine in the Public Interest estimates that the counterfeit drug market is growing by around 13 percent each year; a number that is almost double that of the average growth of pharmaceutical companies per year. How big is it as a global public health risk? As this problem is pandemic globally, just like a disease, what steps do you think are necessary to control the further proliferation of problem? Borrowing a medical term, how would you describe the stage of counterfeit drugs at present – is it still benign or already malignant? When you consider that 16 percent of counterfeit drugs in the market contain the wrong ingredients, some of which maybe dangerous and evenly deadly, then we can definitely say this market poses an enormous risk to public health. At the very least when we an additional 17 percent of these drugs contain incorrect amounts of the required ingredients and another 60 percent contain no active ingredients at all, we can be sure that millions of sick patients around the world are not being properly treated. Since many of the drugs that are counterfeited are life-saving drugs, whilst the counterfeit market exists, people across the global are at serious risk. Taking these points into account, we can definitely not underestimate the seriousness of the counterfeit drug market. At this point I think we have to accept that we can safely say this is a malignant problem which will need to be treated through several simultaneous approaches. According to WHO, there are a number of issues that need to be addressed if we are to reduce the counterfeit drug trade. The first is government commitment. The ability of counterfeit drugs to thrive in any given country depends at least in part on the government's willingness to accept the seriousness of the problem and address it accordingly. This means developing the proper legal frameworks to address this issue and developing suitable penalties to deter counterfeiters. It also requires strong public private partnerships and the collaboration of all involved in the pharmaceutical and healthcare sector. The second important issue is quality control. The more control local authorities have over the manufacturing, distributing and importing of pharmaceutical drugs, the more difficult counterfeiting becomes. The final issue is exchange of information. The greater the exchange of information whether on the local level or on amongst global regulatory bodies, the easier it is for local governments to catch counterfeiters and prevent them from selling in the local market. Do you think the legislation of new stringent laws which criminalize and impose harsh penalty and fines would serve as a deterrent? How severe should the penalty be? Are you in favor of imposing capital punishment (death) to any body found guilty of such crime since counterfeit drugs can kill? Given the fact that the prevalence of counterfeit drugs is higher in developing countries where laws regulating counterfeit are more lax, there is definite evidence to suggest that strong legislation regulating the drug market does act as a deterrent to counterfeiters. Certainly, the higher the risk traffickers must take to smuggle or sell counterfeit drugs in a country, the higher the deterrent becomes. As for how this legal framework should be formulated, that is something that we must leave up to each individual government and its legislators. Is a unified global solution possible to address this problem? If yes, what measure/s should be undertaken? Please elaborate If we are to truly address this issue then global collaboration is definitely required, this means that local and international authorities need to work together to strengthen the legal frameworks in place, that regulate the global pharmaceutical industry. The first step in developing a global solution has to be through securing the supply chain. If we can develop a global minimum standard that all countries agree to, we will have take the first step towards addressing this epidemic. The second crucial point is that the private and public healthcare sectors, whether on the local or international level, must work together to develop stronger deterrents. In high risk countries, the private sector needs to work to enhance the recording of their trademark products. The public and private sectors need to work closely to identify sources of counterfeit and collect data to better understand how these counterfeit drugs are able to enter the supply chain. Additionally, pharmaceutical companies should make it a priority to prosecute those found to be counterfeiting their products, even in cases where legal cases are already being brought against the accused by local authorities. When companies bring their own suits against counterfeiters it sets a strong example and helps in deterring future incidents. What drugs are commonly misrepresented deliberately? Why? Is there no safety mechanism that legitimate pharmaceutical firms can use in the production of their drugs to protect and avoid being copied fraudulently? The largest percentages of counterfeited drugs are tablets and capsules, which represent around 88 percent of counterfeit drug market. In general the most expensive drugs in the market are the ones that counterfeiters focus on, mainly because they can make the largest profit on these drugs. Of course these drugs vary from country to country depending on the pricing system in place in the country in question. There are, however, a number of different safety mechanisms that legitimate pharmaceutical companies have in place to help in fitting counterfeit drugs. At MSD we use a number of techniques to regulate our supply chain and combat counterfeiting. There are four main techniques that we use on a regular basis; image analysis, Raman spectroscopy, topomicroscopy and FTIR spectroscopy. Image analysis allows us to identify differences between authentic and counterfeit packaging, providing us with the capability to identify counterfeit packing through logos and artwork. Topomicroscopy offers us an essential way to analyze tablets. Using a 3D microscope and tablet dye was can identify counterfeited tablets through irregularities in tablet shapes and their markings. The Raman spectrometer is probably one of the most important regulatory tools we have. The spectrometer allows us to conduct a chemical analysis of the tablets which are then run through a built in library, which is designed to detect counterfeit products. The final technique used is FITR spectroscopy, which is used to complement the Raman spectrometer. Where counterfeit is suspected this process is used to chemically analyze tablet formulation and coatings. Based on your professional knowledge, which countries are the primary sources of fake medicines? Is it not possible for legitimate pharmaceutical firms to have agreements with these countries to dissuade drugs fraudsters to operate there? According to official sources Asia has the highest incidence of counterfeit drugs, with Pharmaceutical Security Institute citing China as the number one country in terms of both pharmaceutical counterfeiting incidents, and the largest source of counterfeit drugs. Of course I cannot speak for other pharmaceutical companies, but certainly at MSD we work closely with the local authorities of each country we are based in to develop agreements and mechanisms that will best address counterfeit drugs. Just like any other problem that crosses national boundaries, solving drug counterfeiting needs political will of the government? In Saudi Arabia, what solution can you recommend to the government over this pressing issue? Firstly, I would like to say that the Saudi Arabian government has made exceptional efforts to address the counterfeit drug market, particularly in recent years where the local authorities have worked to develop a more stringent legal framework to help in detecting and punishing offenders. To my mind, it's more about what we can do for the government. As members of the private sector, it is our job to support the government's efforts, whether through developing public awareness campaigns or simply through the exchange of crucial data about counterfeited drugs. What role should the private sector play to check this illegal activity? In what ways should the private sector and government agencies collaborate with in order to address this prevalent issue of drugs falsification? As I mentioned earlier, MSD utilizes a number of techniques to detect counterfeit drugs and ensure they do not enter the supply chain. Almost all legitimate pharmaceutical companies conduct both routine and non-routine checks on pharmaceuticals, these can be physical or chemical tests, but testing techniques of course vary slightly from company to company. The private sector needs to work very closely with government authorities. If the private sector identifies cases of counterfeit, they should immediately share this with local authorities and vice versa.
