RESEARCH PROPOSAL ON COUNTERFEIT OF PHARMACEUTICAL PRODUCTS IN SAUDI ARABIA
Title of proposed project
“COUNTERFEIT OF PHARMACEUTICAL PRODUCTS IN SAUDI ARABIA”
Counterfeit drugs are a global public health problem causing death, disability and injury affecting adults and children. No country is free of this problem, which plagues developing and developed countries alike. Based on mounting evidence, national measures alone appear to be insufficient appear to address the international nature and scope of the problem of counterfeit drugs and the growing expertise and sophistication of those that produce and market them. As such WHO seeks to launch discussions on whether an international framework convention or another mechanism of effective international collaboration for combating counterfeit drugs is desirable to address the international dimensions of the problem and to establish normative guidelines on national standards to combat counterfeit drugs. WHO estimated that 10 percent of the medicines in the world trade were counterfeit drugs and states that it is preferable not to refer to one number for the entire world, but rather to see to the specific circumstances in the different parts of the world.
Background to research topic
Counterfeiting is generally perceived by society as a victimless crime, with ‘fakes’ simply constituting a cheap alternative option, and seen by criminals as having a low risk of prosecution with light penalties relative to the large profits to be made. The reality is that the international trade in counterfeit products is estimated to exceed six percent of global trade. The range of counterfeit products is extremely broad and the trends indicate that counterfeiters no longer confine their activities to luxury goods but increasingly are exploiting consumer goods, including everyday items such as baby food, medicines, cosmetics, aircrafts and vehicle parts. But the counterfeiting of medicines is a particularly insidious practice. This is not only illegal but constitutes a serious threat to public health and safety since counterfeit drugs are not subject to safety checks. For example, a total of 1, 92,000 patients are reported to have died in 2001 only in China from fake drugs. Today, the production of substandard and fake drugs is a vast and underreported problem. Information on the scale of the problem is inadequate.
Identification of problem to be addressed, including statement of the hypothesis
The problem with regards to the counterfeiting of drugs is growing and that the society needs enough awareness and such policies and rules with regards to drug manufacturing, packaging as well as distribution should conform to quality standards and norms and the process should be well organized and must follow a systematic set of regulations as authorized by certified organizations as well as alliances supporting public awareness campaigns keeping track counterfeit drugs that Saudi Arabia can positively adopt. The core hypothesis can be that there is a significant positive relationship to execute and realize certain plan of actions in stopping the reality of counterfeit pharmaceutical drugs in support to law and its guiding principle. Another hypothesis point can be that, there can be positive useful outcomes to counterfeiting of such drugs if ample measures are to be followed accordingly and strict distribution to markets are achieved. Thus, the problem of counterfeit drugs is much more serious in developing countries, extreme differences exist in legal and economical situations of almost all countries making it nearly impossible to properly compile, study and interpret the problem altogether.
Henceforth, in this study Saudi Arabia is selected as an example country, within study of similarities and differences in drug regulatory system, extent of fake drugs on the market etc. between two extremities is not worth because the outcome is obvious.
India is a classical example of developing country with a strong pharmaceutical industry and which also has effective drug regulatory system Saudi consumers have good reasons to be concerned about the quality of drugs produced and distributed from India considering weak legal enforcement.
The aim of present work is to analyze related facts and to derive conclusions as given:
- The scope and extent of the fake drug penetration will be documented
- The problem will be studied from a perspective of overall legal system and drug regulatory environment
- The extent of damage to the public health and directly to the pharmaceutical industry will be discussed
- The reasons for proliferation of fake drugs will be studied
How the Saudi government can give better chances to the pharmaceutical industry by facilitating and promoting the use of sophisticated technologies to stop counterfeit versions
The data and information will be acquired through primary and secondary sources. Primary sources include press release or information from the official web site of the concern Agencies for example WHO, FDA, MHRA, etc. Information about drug regulatory system, legal system, export-import regulations, will be taken from the primary sources. Secondary sources consist of reviews of peer reviewed and other published literature including but not limited to articles from the journals, periodicals, and related web based sources and the author’s review and opinion.
Justification of counterfeiting
This particular research should be undertaken in order to understand issues concerning counterfeit drugs as it posits public health awareness and provides the general public best reason to truly keep an eye on the medicines they are buying since, the effect of it can be serious and lethal affecting majority of the household there can be.
Research Design and details
This study intends to determine the rate of use of the citizens of Saudi Arabia of counterfeited pharmaceutical products based on the presumed effects of the products, the negative consequences they have experiences, and information from where they were able to purchase them. For this study, primary research and secondary research will be used. Moreover, the descriptive research method will be utilized. In this method, it is possible that the study would be cheap and quick. It could also suggest unanticipated hypotheses. Nonetheless, it would be very hard to rule out alternative explanations and especially infer causations. Thus, this study will use the descriptive approach. This descriptive type of research utilizes observations in the study. To illustrate the descriptive type of research, Creswell (1994) guided the researcher when he stated: Descriptive method of research is to gather information about the present existing condition. Primary research is conducted using questionnaire surveys that are sent randomly to citizens in different chosen cities in Saudi Arabia. The questionnaires will be used to collect quantitative data and the interviews will be used to provide qualitative insights into the data collected. Apparently, secondary data are based from the recent literatures related to the topic.
This study will also employ qualitative research method because it will try to find and build theories that will explain the relationship of one variable with another variable through qualitative elements in research. Through this method, qualitative elements that do not have standard measures such as behavior, attitudes, opinions, and beliefs within the health institution domain will be analyzed. The general population for this study is composed of random citizens in different chosen cities of Saudi Arabia who have been able to encounter using counterfeited pharmaceutical products in any circumstance. Basically, these respondents are asked regarding their negative experiences with the products and what have they done after knowing that what they have purchased were counterfeited products.
Definition of counterfeit medicine and the legislation of counterfeiting
The WHO in conjunction with the pharmaceutical industry and drug regulators has developed the following definition of counterfeit drug: “medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” (WHO, Counterfeit medicines: Fact sheet, 2006)
Counterfeiting can apply to both branded and generic products, and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” The U.S. Food and Drug Administration (FDA) reports that the number of open investigations into domestic counterfeit drugs jumped from about five per year, FDA has seen growing evidence of efforts by increasingly well-organized counterfeiters backed by increasingly sophisticated technologies and criminal operations to profit from drug counterfeiting at the expense of American patients. Modern electronic technology is rapidly approaching the state at which it can reliably and affordably provide much greater assurances that a drug product was manufactured safely and distributed under conditions that did not compromise its potency. The MHRA operates a comprehensive anti-counterfeiting strategy, led by its Enforcement & Intelligence (E&I) Group. MHRA’s enforcement powers have been strengthened by inclusion in an Order to the Regulation of Investigatory Powers Act 2000 which allows MHRA Investigators to acquire specific subscriber information directly and in particular, with reference to Internet investigations and to identify website operators.
Figure One: Alternate Routes for the Potential Supply of Counterfeit Medicines
Why to counterfeit medicines?
It is because the counterfeiting of drugs presents a more complex problem due to the safety related risks though economic losses it could involve for the affected companies and countries should not be overlooked, however the main issue is that counterfeited drugs are in fact potentially lethal. The occurrence of counterfeit medicines is growing problem, which impose serious threat to human lives. It could potentially lead to extensive economic implications for affected companies and countries in Europe. The knowledge of safe drugs is crucial when it comes to pharmaceuticals as there must be adequate balance between consumer protection and free trade. Study outcomes may indicate that there is no direct connection between parallel trade and counterfeiting of pharmaceuticals. In order to decrease occurrence of counterfeiting intensified international cooperation in the fields of legislation and technical measures is necessary. The public must be made more aware of the problems with counterfeit drugs and the risks associated with buying them, the control system must be improved in order to protect consumers.
Some data about counterfeit
Counterfeit medicines are an insidious threat to global health, and the risks they pose have been largely underestimated to date. Fake drugs containing insufficient active ingredients breed resistance, which can make standard drugs useless. No area of the world is unaffected, but mounting evidence shows that the problem is disproportionately severe in developing and emerging-market countries, which also have the highest burden of infectious diseases. While monitoring of outright fakes is improving and arrests of those trading in them are increasing, some global agencies are promoting drugs they assume to be good copies of branded drugs but which are probably substandard. Counterfeit drugs contain little or none of the active ingredients of legitimate drugs, with varying consequences depending on the disease.
Counterfeit pharmaceutical products are threat to global public health, patients, and the pharmaceutical industry. Consumers might be using a drug without the proper dosage or even without the proper ingredients, resulting in deterioration of their illness and potentially disability and death. Public health is threatened by the development of resistant strains of infectious agents. The industry is threatened by damage to its reputation resulting from the devastation caused by counterfeit versions of medicines, as well as the reduced sales when counterfeits replace legitimate product in the supply chain. Currently, the most timely and practical way of identifying counterfeit medicines in the marketplace is the routine checking of packaging and use of covert markers and security features such as holograms. As soon as suspect counterfeit medicines have been sighted in the marketplace, they are further analyzed in the laboratory to confirm that they are counterfeit and to assess the potential harm that they might cause to patients
Source: (2007). NIR Chemical Imaging for Counterfeit Pharmaceutical Products Analysis
Dangers for the health
Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realized that strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively cooperate to the situation.
Source: Health Risks of Counterfeit Pharmaceuticals. Current Opinion Drug Safety. 26(14):991-997, 2003. ten Ham, Martijn
There has been an astronomical increase in the detection of counterfeit medicines worldwide. The magnitude of this increase and consequent death toll demands greater attention in the consideration of the safety of medicines. Counterfeit medicines constitute risk to the pharmaceutical industry, healthcare providers, the healthcare system as a whole and ultimately to the patient. Due to dearth of information and research and lack of globally coordinated approach to anti-counterfeiting, global estimates of deaths due to counterfeit medicines can only be guessed. Indications from both published data and anecdotal evidence indicate that millions of lives may be saved annually if there are no counterfeit antibiotics, vaccines and other life saving medicines.
Source: Wertheimer, Albert I.; Santella, Thomas M. International Journal of Pharmaceutical Medicine. 19(5-6):301-308, 2005
Recent studies does suggest that drug counterfeiting is not just a national but also an international concern, affecting health policy makers, drug manufacturers, wholesalers, drug enforcement agents, healthcare providers and patients across the globe. It is also clear that counterfeiting is not limited to the least developed nations but is increasingly prevalent in the largest pharmaceutical markets. Like the problem itself, the response to counterfeiting has gained credence at an international level, specifically within World Health Organization's development of global anti-counterfeiting strategy. Government too have begun to focus on the issue and industry leaders are now utilizing new technologies against the counterfeiters, the increasing use of radio frequency identification tagging systems holds significant promise for the reduction of counterfeit drugs in the future.
Description of a fake medicine and some examples to be given
Fake medicines are a growing problem across the world and the internet is aiding their spread. The good news is that industry, regulators, legislators and enforcement authorities are now working together to fight back as time is of the essence. Persistent and targeted action across international borders is needed to address and defeat the very real public health threat posed by counterfeit prescription medicines.
An example of counterfeited drug
Thus, companies like Merck & Co. believe that a concerted effort on the part of the pharmaceutical industry, medical and pharmaceutical regulatory authorities and governments worldwide particularly in the EU, the US and China to stop the spread of counterfeit prescription medicines must begin in earnest immediately. They are very committed to this endeavor and call on all stakeholders to join in making this a global priority – the health and wellbeing at stake.
Counterfeit medicines can cause harm in various ways: the presence of toxic chemicals frequently causes injury or death; inappropriate delivery systems and/or inadequate amounts of active ingredient prevent the drugs from working effectively and, again, can lead to injury or death; more broadly, under-dosing fosters resistance to the active chemical. In the cases of HIV/Aids and malaria, this latter aspect is particularly worrying for example, when 89 people in Haiti died after ingesting cough syrup manufactured with diethylene glycol (a chemical commonly used as antifreeze). This particular product was made in China and transported through a Dutch company to Germany, before winding up on the Haitian market.
What to do against this phenomenon?
The problem of counterfeiting drugs is rampant in both developed and developing countries. In wealthier developed countries, counterfeiting most frequently affects “lifestyle drugs” such as hormones, steroids, erectile dysfunction, and anti-allergy medicines. Recently, in May 2003, nearly 20 million doses of fake Lipitor, a cholesterol-lowering medication, had to be pulled from U.S. pharmacies.12 Altogether, because wealthy countries have stricter regulatory mechanisms, and since most patients in wealthy countries can afford branded medicines, counterfeits account for less than 1 percent of the market value although 50 percent of Internet sales are estimated to be counterfeit. The production of counterfeit medicine often occurs through a “multi-national chain of production and sale” that originates in countries that either do not recognize or loosely enforce patent laws, where the drugs can be synthesized or their component parts bought. The fake drugs eventually make their way through several cut-rate brokers to a pharmaceutical distributor as findings suggest that massive amounts of fake drugs are circulating in drug distribution chains.
International Medical Products Anti-Counterfeiting Taskforce — IMPACT WHO.
The office of the Executive Board of Health Ministers Council for Gulf Cooperation Council States should initiate action so as to actively engage themselves with worldwide activities like IMPACT (International Medicinal Products Anti-Counterfeit Task Force). The office of the Executive Board of Health Ministers Council for Gulf Cooperation Council States should take the lead to address this problem at the next meeting of Arab Health Ministers.
- National pharmacovigilance infrastructure and implementation needs to be established and/or strengthened in the GCC member countries. The concept of pharmacovigilance is a broader concept than just ADR reporting and should be operationalized in this sense.
- Develop network of Single Points of Contact (SPOC) per sector
- Develop network of Official Medicines Control Laboratories and specific anti-counterfeit expertise. A multi-stakeholder national level committee should be formed involving at least MOH, customs department and law enforcement agencies to develop specific national strategies and operations to combat counterfeit problems.
Thus, national level study should be launched to assess the situation with regard to counterfeit medicines and certain level approach should be adopted for collaborating with other countries in terms of joint action and information sharing
- At GCC level
- At EMRO level
- At global level
Drug regulatory authorities must ensure that drug master file (DMF) must be submitted along with registration file of the Pharmaceutical product; drug regulatory authorities should request GMP certificate of API manufacturers and that certificate of suitability (COS) is submitted along with registration file and that, drug regulatory authorities are encouraged to train their staff in process validation and laboratory analysis. Aside, drug regulatory authorities should develop experienced inspectors in sufficient numbers that will meet the high demand for conducting Good Manufacturing Practice Inspection to ensure compliance of manufacturers of pharmaceutical products.
Source: The GCC Drug Quality Symposium on 26-27 February 2007 Declaration of Riyadh
Regulatory Authorities in developed countries (USA, WHO, E U commission) how they Plan to Combat the Distribution of Counterfeit Pharmaceuticals
Indeed, it has been mentioned that there are several different technical anti-counterfeit measures that could help to prevent counterfeiting. It is necessary to develop the technical anti-counterfeit measures and to increase the use of these. It might not be enough to use them only in high-risk products due to the fact that almost every kind of pharmaceuticals is counterfeited today. The pharmaceuticals can be identified through batch numbers and the different actors in the distribution chain must have documentation showing where they bought the medicines. Due to the large batch quantities the pharmaceuticals can be spread all over Europe, which makes a recall more difficult. Thus, having separate national databases in Europe would not be efficient due to the single market in pharmaceuticals in EU, so an EU or European level database would at least be necessary. Another option would be an international database through United Nations, maybe through the WHO Impact-collaboration.
INTERNATIONAL AND NATIONAL EFFORTS TO ADDRESS THE PROBLEM
Fortunately neither the WHO nor member states have waited for precise statistical quantifications of the problem of counterfeit drugs before taking appropriate actions. Nonetheless, despite these efforts, the quantity of counterfeit drugs circulating in the market place appears to be increasing and in many countries as indicated, the rates are unacceptably high. This section will review some of the efforts that have been made at national and international level to address the problem. The quality of pharmaceuticals has been a concern of WHO and establishes its obligation to set standards which has been implemented with regard to drugs by the Quality Assurance Program. It has the responsibility of setting norms, developing guidelines and advising WHO Member States on issues related to quality assurance of pharmaceutical preparations in national and international markets, with particular emphasis on generic products. Combating and preventing counterfeit drugs is an essential component of ensuring the quality of pharmaceuticals in national and international markets. International consideration of the problem of counterfeit drugs was first undertaken in a 1958 conference of Experts on the Rational Use of Drugs. Subsequently, the first multidisciplinary international meeting was jointly organized by WHO and the International Federation of Pharmaceutical Manufacturers Association in 1992, which settled a working definition of counterfeit drug, still in use by the WHO today, and participants made commitments to solve the problem. Countries should adopt the WHO Guidelines on Developing Measures for Combating Counterfeit Drugs, raise public and political awareness of the problem, and increase national, international cooperation and data exchange between all stakeholders and relevant international organizations.
Preliminary recommendations for measures at the international level include that
(1) American stakeholders should consider working with foreign stakeholders to better coordinate their anti-counterfeiting efforts
(2) The strengthening of international cooperation in law enforcement efforts
(3) The identification of counterfeit products
(4) Use of anti-counterfeiting technologies
(5) Education of stakeholders and consumers
(6) The development of global standards for (a) the packaging, (b) the use of tamper evident packaging, (c) product pedigrees, (d) the use of anti-counterfeiting measures, and (e) the use of track/trace technologies.
In many countries there is no drug regulatory authority at all and in those where one exists, it is either inadequate to regulate drugs generally and/or does not have the power to apply measures to suppress the factors that lead to counterfeiting. A framework convention can establish norms for both the substance of national measures and the manner of their implementation. Lack of regulation is one of the reasons why basic medicines can be scarce and/or their supply erratic or where drug prices are high or there are significant price differentials. An international framework can provide the minimum standards for drug regulation and enforcement. It is true that many of these can be the subjects of national laws, however, in more than one half of the countries of the world no drug regulatory or consumer product safety authority is in place. Counterfeit drugs also pose a threat to the public's health and safety such that criminalizing this behavior is appropriate. Clearly if a counterfeit drug causes a death whether directly by some toxic reaction or indirectly because a patient does not receive the therapeutic benefit of the intended drug, a murder has taken place. And if a counterfeit drug does not cause death, but illness or delayed healing there is an injury in the legal sense that can be seen as the result of an imputed intention to harm and should be criminalized as an assault and/or battery or other crime. Generally, since counterfeiting is also a violation of property rights, many countries do provide for liability in the case of infringement. However, this liability is private to the property rights holder and bears no direct benefit to society or to an injured consumer. Unless the judiciary is authorized to impose harsh sentences of both monetary penalties and imprisonment, counterfeiters bear little or no personal consequences for their actions. Free trade zones and ports are not under the jurisdiction of the drug regulatory authority exporting countries do not control drugs destined for export nor does the drug regulatory authority have oversight over imported drugs destined for re-export. These many avenues for trade present unlimited opportunities for counterfeiters and limited opportunities for national governments to comprehensively combat the problem. Criminals who counterfeit drugs do not limit their activity to one country and the potential for profit primarily motivate the criminals who trade in counterfeits. Once counterfeiters are blocked by local efforts, they quickly move to where they can operate without interruption. National legislation does not reach beyond national borders, thus cooperation between countries, especially trading partners becomes essential to combat counterfeiting. Measures to address the factors that lie beyond the reach of national legislation can be advanced through the creation and implementation of a treaty.
Discussion and Conclusions
The use of such measures on drugs, starting with those considered most likely to be counterfeited, is an important part of an effective anti-counterfeiting strategy. Because counterfeiters will adapt rapidly to any particular measure and because the most effective measures differ by product, the most effective use of authentication technology will vary by drug product over time. FDA intends to clarify its policies and procedures to help manufacturers employ and update these technologies safely and effectively. In particular, FDA intends to continue to evaluate and provide information to stakeholders on forensic technologies and other analytical methods that allow for rapid authentication of drug products. FDA also plans to support the development of criteria that contribute to counterfeiting risk, to be counterfeited based on these criteria, to assist stakeholders in focusing their use of anti-counterfeiting technologies as effectively as possible. Effective protection against counterfeit drugs includes actions by drug producers, distributors, and dispensers to secure their business practices such as ensuring the legitimacy of business partners and refusing to do business with persons of unknown background, taking steps to ensure physical security and identifying an individual with primary responsibility for ensuring that effective security practices are implemented. FDA will continue to work with other major participants of the drug supply chain to develop, implement, and disseminate such business practices, through such steps as issuing guidance and supporting the development of industry best practices. To help ensure secure business practices, FDA intends to increase its inspection efforts of re-packagers whose operating procedures place them at increased risk for the introduction of counterfeit drugs. Counterfeit drugs are a global challenge to all nations, and criminal counterfeiting operations are increasingly operating across national borders. FDA intends to work with the World Health Organization, Interpol and other international public health and law enforcement organizations to develop and implement worldwide strategies to combat counterfeit drugs.
FDA believes that counterfeiting is not widespread within the system of manufacturing and distributing pharmaceuticals legally in the United States, as a result of an extensive system of federal and state regulatory oversight and steps to prevent counterfeiting undertaken by drug manufacturers, distributors, and pharmacies. Thus, drug counterfeiting poses real public health and safety concerns today, and may pose an even greater threat in the future if we fail to take preventative measures now. As counterfeiters continue to seek out new technologies to make deceptive products and introduce them into legitimate commerce, our systems for protecting patients must respond effectively.
Figure Two: FDA open investigations 1997-2003
Although prevalence rates in the U.S. are not known, outside the U.S. drug counterfeiting is known to be widespread and affect both developing and developed countries. In some countries more than half of the drug supply may consist of counterfeit drugs. FDA agrees that the danger of unwittingly assisting counterfeiters and stifling technologic development outweigh the benefits that would accrue if it were to mandate the use of a specific authentication technology at this time. Furthermore, due to the high costs and technical barriers that authentication technologies create for counterfeiters, their use is a critical component of any effective multi-layered anti-counterfeiting strategy, especially for products that are likely to be counterfeited. Therefore, FDA believes that an appropriate role for it is to facilitate the use of authentication technologies by reducing any regulatory hurdles that may exist relating to their use.
The revision of model rules diagram below sought to enhance the protections included in the original version of the Model Rules and close existing gaps. The table below contains highlights of the revised Model Rules:
Figure Three: Revision of Model Rules
Counterfeiting is a problem that is not isolated to one state. If a state strengthens its licensing requirements while bordering state does not, the counterfeiters and illegitimate wholesalers will likely move into the bordering state. Widespread state adoption, implementation, and enforcement of the Model Rules would help combat counterfeiting. Many countries have taken steps to secure their nation's drugs supply, while others struggle because of limited resources, inadequate regulatory infrastructure, or competing national health priorities. WHO has taken the lead to increase worldwide collaboration and to develop strategies to deter and detect counterfeit drugs.
The table shows when certain anti-counterfeiting measures will be available:
Figure Four: Anti-Counterfeiting Strategies
Source of the figures, adopted from: <http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html>
Therefore, strategies identified by the regulatory agencies and industry bodies and described above show the emergence of common and guiding principles for all those involved in combating the medicine counterfeiters and protecting public health:
- high standard of protection and regulation of the prescription medicine supply chain – including no tolerance of counterfeiting and illegal supply of products that threaten public health and infringe on patents and trademarks
- Cooperation and partnership with other industry partners and law enforcement agencies and the encouragement of good IP legislation and enforcement.
- Identification of and effective enforcement against sources, products and methods of supply/distribution of counterfeit drugs
- Effective communication to the public by both regulatory authorities and the pharmaceutical industry of the dangers associated with counterfeit drugs.
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