Counterfeit Medicines: A Global Threat

1.1 Introduction

A counterfeit medicine is referred to the product which is manufactured by combining wrong or inappropriate measurement of ingredients with the intention for imitating the original product (WHO, 2018). According to the World Health Organisation (WHO), counterfeit medicine is a nature of the falsified product that is fraudulently and deliberately mislabelled in relation to the source of identity (WHO, 2018). The prevalently common meaning of the term counterfeit is that a thing that is made as an exact imitation of anything valuable in nature with the intention of deceiving or defrauding someone (Oxford Dictionaries 2019). This meaning has inspired WHO, Council of Europe, Pharmaceutical Security Institute and the government of India, Kenya, Nigeria, Pakistan and some other countries to use the term. The counterfeit medicines are mainly applied to brand or generic medicinal products in which the drugs are made without specific ingredients or with inappropriate and insufficient active products (Buowari 2013, Wertheimer et al, 2012, Rodionova et al. 2005). These natures of medicines are also called fake drugs and they may be expired medicines which are stored in new packages with altered dates of expiry (Wertheimer et al. 2012). The Counterfeiting medicines are seen to avail the advantage of the good image and reputation of the branded products that are established by providing high-quality services to the consumers. The counterfeiters are mainly interested to manufacture medicines that are look-alike of original high-quality products and do not bother to think the way it is going to affect the health of the patients as it is found to be one of the ways for lucrative business where increased profit is able to be incurred with less investment (WHO 2018). The compounds with which the counterfeit medicines are produced found to be harmful in nature and in extreme cases cause death of the individuals (WHO, 2018). In global context, the counterfeit medicines are creating huge problem for the individuals (Cockburn et a,l 2005). As the global population is seen to be increasing at a massive rate, the demands for medicine for treatment purpose are found to be increasing at an equally massive rate. The counterfeiters mainly develop this nature of medicines with the intention to make increased revenue and profit from the business which is actually illegal and unethical practice. The rising complexity and problem with counterfeit medicines is not a new condition but it is old principle issue in the medical field which requires proper effort to resolve it (WHO, 2018).

In relation to counterfeit medicine, the United Nation has emphasised that the world require to have the vision of ensuring access to safe, high-quality and affordable medicine for essential purposes. This is because it would mean effective sustainable development in the field of healthcare that ensures better health of the patients (UN, 2015). The WHO’s reports regarding counterfeit medicine inform that an estimation of 15% of drugs that are sold globally is counterfeit and unsafe in nature (WHO, 2018). In different parts of Asia and Africa, the percentage of counterfeit medicine being sold has presently reached up to 50% as the regions are the worst-hit areas with increased burden of diseases that needs to use expensive medicine for treatment of the patients (WHO, 2018). The key concern with counterfeit medicine is that it is able to harm the vulnerable population such as pregnant women, children with fatal and genetic diseases, patients with complex health condition and others. In this condition, the medicine provided would not properly work to resolve their health issues and in turn would create vulnerable effect on their health due to side effects of wrong composition of counterfeit medicine (Quique et al, 2016). The recent reports inform that increased use of internet in the developed countries has given rise to the increased growth of counterfeit medicine. The National Association of Boards of Pharmacy (NABP) has informed that many of the websites that offer prescription-only medicines for selling are not compliant with the state law regarding medicines or industrial standards suggested by the medical associations and 50% of the sold medicines are counterfeit in nature. The evidence informs that widespread presence of counterfeit medicine in the countries is due to weak governmental legislations and improper actions of law enforcement bodies in the import, distribution and supply, manufacturing and selling of drugs in the market (Anthony and Cassandra, 2016). This condition informs that it is essential to identify the dangers that the counterfeit medicines are making and suggest proper strategies which would help to reduce the buying or selling of this nature of the medicines.

The government in the European Union (EU) is seen to have taken steps to control the circulation of counterfeit medicine through the framework set by the European Medication Agency where specific guidelines are mentioned in buying and selling of medicine (EMA, 2015). In the framework, the key aim is to inform individuals regarding the way they are to buy proper medicines by following guidance developed so as to avoid counterfeit drugs. In EU countries, this strategy is going to help the common people avoid buying medicines from unregistered drug retailers which are regarded to be paramount step taken by the authorities in controlling circulation of counterfeit medicines. In other countries such as Africa, it is informed that there is lack of strong legislation to control the circulation of counterfeit medicines and not many measures are taken to overcome the factors which are hindering the existing legal effectiveness (EMA, 2015). However, it is seen to be equally essential for recognising the side-effects of the counterfeit medicines based on what are the products used in such medicines that can potentially damage the health of individual causing life-threatening issues. In this research, various issues towards counterfeit medicine are to be explored to understand the way they are acting as threat of the everyday life of the public. In order to get improved insight into strategic planning across the world, various trends regarding counterfeit medicine are to be explored. Further, the impact of existing legislative structure, health burden, socio-economic issues and related risk factors regarding counterfeit medicine are to be focussed in the research. The gap in documentation, as well as the efforts to achieving better standards within developing countries, will be a primary focus with the aim of proffering possible or probable solutions is paramount to this study.

1.2 Aims and Objectives

1.2.1 Aim

The aim of the study is to explore the issues regarding counterfeit medicine and its potential effect and threat to public health by executing literature review.

1.2.2 Objectives

To identify the requirement of better modalities to record the effect of counterfeit medicine

To discuss the clarity on intent of deception regarding counterfeit medicine

To analyse the need for improved media coverage to aware regarding counterfeit medicine use for consumption

1.3 Research Question

What are the ways in which modalities for recording the effect of counterfeit medicine and its better awareness in public can be improved?

What are the ways in which the legislative actions can be improved and tightened for counterfeiters?

How to create safer medium to access and avail proper medicine through online services and in health institutions?

2.1 Study Design

The study is been executed by performing critical review of existing literature to develop knowledge and gather the facts about the problems regarding counterfeit medicine. The following steps are to be taken to get the outcome:

The existing literatures are to be collected electronically and they are to be written in English as well as need to be within the mentioned appropriate time scale.

Various databases such as PubMed, Google Scholar, African Journal of Medicine and others are to be searched to gather evidence regarding the study

The abstract and title of the articles are to be screened and then the papers are to be considered as a whole with the consideration that they are relevant to the study

The evidence from paper are to be carefully selected as well as reviewed

Inclusion Criteria

Data type: Qualitative as well as quantitative papers

Language: English

Time frame: 2003-2018

Study Variety: Research and Grey literature

Exclusion Criteria

Papers before 2003

Researches that are executed externally

Data Analysis

The appraising of the data is to be done by including information about the way researchers arrived at the themes, findings and conclusions, epistemology orientation, background of authors, contribution to existing evidence and others. The data is to be synthesised by following disciplinary context, professional acculturation and professional education.

2.1.1 Study strengths

The study is based on review articles that are closely related to the topic

It is effective to resolve competing theories to address the topic

2.1.2 Study Weakness

It is not a finalised evaluation study

2.2 Ethical Consideration

There are no know ethical issues or dilemma faced as the papers selected for the study are already at disposal and in these papers, no personal data are used.

3. Literature Review

3.1 Definition of the problem

The spreading of counterfeit medicines are related to variety of factors like failed distribution network of original medicine, weak supply chain, increased number of small-scale suppliers, poor technological systems, improper integration of regulatory actions and limited number of financial resources. The counterfeit medicines are seen to have serious public implications. They tend to be of sub-standard in nature as they do not contain proper amount of required ingredients and is able to process in small industries, homes and backyards that makes it difficult to be managed and regulated form being manufactured and supplied (International Medical Products Anti-Counterfeiting Taskforce 2008).

3.2 The harmful effect of counterfeit medicine

The counterfeit medicines are regarded and identified as sub-standard at any point in the supply chain ranging from its manufacturing to its distribution. During manufacturing, the medicines are produced with improper as well as impure portions of ingredients making them counterfeit in nature. At distribution, the counterfeit medicines are subjected to being compromised during warehousing, transportation, distribution and others which results them to be stored improperly. The counterfeit medicine irrespective of where in the supply chain get sub-standard and it is seen to pose a threat for the public health (Newton et al. 2011; Newton et al. 2010; Nsimba 2008). The use of these counterfeit medicines for the treatment purpose of the individual increases the rate of mortality and morbidity and is seen to give rise to allergies among patients showing their harmful side (Bate, 2012b). The medicines that are counterfeit in nature is seen to have effective contribution for increasing the spread of infectious diseases as they fail to control the spread of pathogens and toxic elements (Caudron et al. 2008; Aldhous 2005). The WHO informs that out of one million deaths which occurs as a result of malaria nearly 200,000 could have been avoided if properly formulated medicines are available and delivered to individuals (WHO, 2003). The counterfeit medicines apart from health effects also adversely affects economically as well as socially because they are able to reduce the confidence of the patients from doctors, pharmacists and even modern system of treatment as a whole (Nsimba 2008; WHO 2018). The individual or patients who use this nature of medicine also suffer financial losses as expenditure of the earnings to get proper care remains ineffective in nature. In the modern world, where buying medicine includes effective amount of financial expenditure in this situation it is evident that people by buying counterfeit medicines are going to face economic losses. The illness, as well as the death of the people, is seen to impact on national economies and individual income as it results to deplete time and productive human resources. In addition, increased medical cost, as well as intense suffering from illness, is to be faced by individuals on using counterfeit medicines. The development of safeguarding process to ensure safety of the population from counterfeit medicine also requires added amount of enforcement authorities as well as the formation of different regulatory agencies (Newton et al. 2010). This development of additional authorities results to increase the overall healthcare management costs. The increased spread of counterfeit medicine is also seen to have political ramifications (WHO, 2010b). This is evident as counterfeit medicines erode the governmental investment within the healthcare deliver projects and systems. This results in undermining the trust of the citizens from their government regarding the ability to maintain law and order. It also erodes the image of the government's ability to ensure proper provision of quality healthcare for the public.

3.3 Extent of the problem

The presence of counterfeit medicine is found globally throughout the supply chain management of medicine and this problem is seen to take an acute image in the developing countries. It is estimated by WHO that 10% of the total medicine that is consumed in the countries that are developed or developing are counterfeit in nature (WHO, 2018). The reports by WHO informs that 30% of the countries in the world do not have proper drug regulation capacity or hardly has properly functional authorities to ensure proper drug supply (Newton et al. 2011, 18). It is also seen that even in places where there is the existence of national medicine distribution channels, the channels are disabled in nature and is incapable to resolve the menace created by counterfeit medicine (Newton et al. 2011; WHO 2018). The deterioration of this condition is further contributed by the use of internet where unlawful sites which do not reveal their real physical address sell medicines that are counterfeit in nature (WHO 2010b; Anthony P and Cassandra MS 2016). The counterfeit medicines do not even pass the basic quality-control tests and the data retrieved regarding their propagation is also scare (WHO, 2018). In many studies, although it is seen that many quality control tests are implemented on medicine samples for detecting the ratio of counterfeit medicine yet they are unable to prove if proper standards have been maintained or not. In some studies, it is seen that the prevalence of medicines that are counterfeit in nature are detected alone whereas other studies focus on detecting the quality of medicines used in tuberculosis, malaria and bacterial diseases.

3.4 Counterfeit medicines as market and governmental failures

The medicines are reported to be post-experience products which mean that their quality cannot be determined also after consumption. The consumers face difficulty to isolate the impact of the product because they are unable to compare between observed outcome and counterfactual outcome which mainly comes after differential treatment on identical patients under specific circumstances. The markets for the post-experience products are seen to be prone towards failure in circulating even information. More specifically, the consumers, as well as producers, do have access to various degrees of data regarding the product that leads to create ineffective outcomes in the market (Weimer and Vining, 2011). The inefficient outcomes in the market occur in the condition when people use counterfeit medicines as they do not have proper information and awareness regarding the quality of the medicinal products. In case, the individuals have proper information they would have opted for improved products. This is because improper information has lead the individuals unable to identify proper medicine to be consumed making them become endangered to face health issues. The secondary effect of such action makes the individuals be exposed to develop contagious disease. The producers, as well as consumers of medicine, incur incentives through buying and consuming high-quality products. In order to maximise their profits, the producers tend to cut cost in manufacturing medicine making them prone to use inappropriate products in making medicines. However, the consumers are unable to determine the quality of products and this leads the low-quality medicines to be circulated in the market creating higher profit margin for the producers.

The decision of an individual to consume medicine is seen to affect the public health and its act to represent an additional nature of failure of the market that is negative externality. The population does not participate in directing individuals to make choices but it is the choice of the wider individuals that influences a single person to make a choice. The illness and health issues act to impose economic as well as healthcare cost on society. The government mainly respond to uneven market failure by developing and implementing regulations. These regulations act to deliver missing data in direct manner by making the medicine companies inform potential side-effects as well as contradictions regarding the drug to the consumers. In ideal condition, these nature of service helps to simplify the choices of the consumers as they are given data based on which proper judgement can be made to make quality consumption of medicine. However, in real-life situations, it is seen that the national regulatory agencies do not have proper funding, processes and expertise in the place required for fulfilling the role in efficient manner (Caudron et al. 2008). The government failure is the key reason due to which large number of counterfeit medicine reaches the population. The failure is mainly faced because the government often do not have proper incentives to be devoted to arranging sufficient resources to regulate as well as monitor the medicinal drug market. In case, during exports the producers and consumers still purchase medicine regardless of risks from the manufactures then it indicates that the government has little incentive to be able to regulate the manufacturing of medicine. For instance, in India and China have few of the largest market for selling counterfeit medicine but these countries are also one of the largest medicine exporters in the developing world. During imports and domestic production of medicines, if the government is not forced by the consumers to regulate proper medicine marketing rules then the government would never commit to arrange necessary resources to effectively regulate the services (Médecins Sans Frontières, 2011). Moreover, there are various countries which do not have proper regulatory framework which proper arranges an outline of legislation and punishment for the breach of law regarding selling of medicine (Caudron et al, 2008). In many countries and mainly in developing countries, it is seen that there is lack of presence of any proper processes to monitor and regulate supply chain of the medicine. In cross borders, the supply chain for medicine market requires proper regulation and coordination among government officials, custom services, police as well as national judiciaries. The medicine market is spread internationally and there is no government present who has shown success to have the capacity of properly regulating medicine that is produced and sold within their national border. Thus, to address the problem of counterfeit medicine there is requirement of international cooperation between the national and international governments (WHO, 2003).

The legislative bodies may be seen to fail at properly safeguarding the population in relation to funding issues, bureaucratic failures and hindrance to gain top expertise in a situation where the manufacturers’ gains more compared to the regulators (Caudron et al, 2008). These failures of the bureaucrats are going to lower efficiency due to expensive civil services, agency loss, limited competition and hindrance to asses achievement of monetary value (Weimer and Vining, 2011).

3.5 Actors along Supply chain

The distribution chain of medicine can be visualised as nature of pyramid where there are less suppliers at the top rather than the bottom (Patouillard et al. 2010). This means that there are few numbers of wholesale centres but the network of distribution is vast. The medicines do not directly is shipped to the consumers but it comes through wholesalers as well as retailers before it comes within the hand of consumers (Dutton, 2004). This indicates that each level there is probability that problem may arise which can hinder the medicine quality leading it to become counterfeit medicine. The studies which compare and contrast medical supply chains with large retail chains provides lessons to be learnt for developing strategies to manage counterfeit medicine. This is because the large retail chains present in the non-medical markets priced the products at lesser amount and provides better quality products by eliminating middle suppliers, embracing price competition and buying as well as storing products in bulk. The adoption of these similar mechanisms is going to improve the quality, affordability and reach to quality medicines for the customers (Agwunobi et al. 2009). The medical supply chain is seen to differ in many ways from the common consumer product supply chain which makes it difficult in creating certain improvement by following the principles in the common supply chain. In the first condition, the manufacturing and production of original medicines are seen to be mainly skill and capital intensive in nature. The instantly available financial resources and expertise in technical field which ensures higher quality supply chain for medicine are seen to differ from one country to another. In second condition, it is seen that medicines need increased level of security, traceability as well as monitoring but the technical tool used in the modern world is not properly suitable to effective manage the supply chain for the medicine. In the third condition, it is seen that unlike the consumer goods that leave the market if proper contracts are not enforced or complied in case of medicine is not seen to act in the same way. In fourth condition, the production, as well as consumption of medicine, is mainly governed by legislations and regulations in most countries which create challenges for the international aid organisations to act collaboratively to avoid circulation of counterfeit medicine. The delivery of the medicine may be delayed while the international organisations are going to work with the host government in registering and checking a specific drug. In last condition, the intensive length and complexity of chain of consumers, reduced number of manufacturers in comparison to distributors in the medical field is creating restriction for the manufacturers to be able to provide platform for incentives to be earned by other actors within the medical supply chain (Yadav et al. 2010).

3.5.1 Manufacturers

The industry of pharmaceutical manufacturing is complex in nature and is divided into five categories which are research and development-based multinationals, local organisations in a particular country, generic manufacturers in the international market, biotech companies and contract producers who lack any portfolio of their own. The pharmaceutical industry is mainly made of two stages of production which are active ingredient production and another for packaging and formulation. The active ingredient products are manufactured in fewer amounts and have few centralised locations due to their increased value. The non-active ingredient and medicines that are utilised for producing them are manufactured by various companies in different parts of the world (Sousa et al. 2011). The substandard quality acts as a vulnerable factor in the pharmaceutical industry. This is because manufacturers mainly depend on the quality of supplied chemicals and in this case if substandard materials are supplied then it is able to compromise even the most effectively produced medicines. The global operation and reach of the manufacturing industry indicate that many countries are unable to have direct control in the manufacturing process until the produced medicine reaches their country borders (WHO, 2003). In relation to value, medicines do not require large spaces and resources to get manufactured when they are made in a poor manner or when their quality is compromised deliberately. The higher quality medicine for treatment of tuberculosis, HIV, malaria and others are seen to be expensive in nature and are generic in form. The manufacturers are able to make huge profit on medicines by just lowering the level of active ingredient used resulting to form a counterfeit product (Wertheimer and Norris, 2005).

3.5.2 International Organisations

The international organisations mainly fund the medicines that are used as humanitarian aid. The organisations assist to coordinate the delivery of medicine in situations of emergency and collaborate with others for obtaining donations regarding medicine. Moreover, for purchasing and delivering essential medicine the international companies provide solutions by analysing the issues present within the supply chain and development of collaboration with actors regarding medicine. Although these organisations are seen to acknowledge the issues regarding counterfeit medicine and proper emphases to commit for reducing the supply of counterfeit medicine, yet the medicines are contributed to being circulated in the different supply chain regarding medicine. The international organisations have limited ability to regulate the circulation of counterfeit medicines as many of the regulations and legislations regarding medicine are developed at a national level.

3.5.3 National Governments

The accessibility to basic health services irrespective of socio-economic status is seen to be recognised as a nature of international fundamental right as been stated by the UN Universal Declaration of Human Rights in the Article 25 (1948). Therefore, it is an essential component that the consumers are able to get proper medicine which abides by the formidable safety and quality standards. As mentioned before, the markets are unable to supply proper quality of medicine thus the government require to take steps in the process to ensure reach of safe medicine to the consumers. This nature of regulations are mainly carried by the national governments that are entrusted to develop comprehensive system for providing confidence of safe and constant supply of medicines. The national policies for medicine mainly combine different functions into single regulation system of comprehensive nature. These natures of functions mainly involve product registration, clinical trial standards, advertisement regulation, post-sale quality monitoring, importers and exporters mad others (WHO, 2010). The implementation, as well as enforcement process of a proper medical policy of national level, is challenge for developing countries in places where the issue of presence of counterfeit medicine in the market is great. There are many factors which complicate the issues at each level of supply chains such as the increased burden of diseases, limited financial resources for procuring medicines, logistical difficulties in safe storage, insufficiently trained personnel and others (WHO, 2010a). The developing countries are seen to vary in greater amount regarding their capacity to properly manage robust regulation system for medicinal drugs. The variations result from funding, political investments, the burden of disease and many other factors (WHO, 2010a).

3.5.4Wholesalers

The wholesalers act as essential actor in the supply chain of the medicine as they are seen to influence the supply chain management by influencing the behaviour of the participants in the market and betterment of accessibility and price of medicine. In regards to initial point, the non-governmental organisations that often act as wholesalers have considerably low monetary incentive to lower the quality as well as increase the medicine prices as there are no presence of shareholders who demands payouts increases. Apart from international agencies and governments, the relief agencies also procure important medicines for humanitarian aid from the wholesalers. The quality assurance by the wholesalers is largely imperative but the efforts to accomplish quality control vary in great manner. For instance, the non-profit wholesalers such as International Dispensary Association provides high-quality important medicines and supplies at most affordable prices to the low and middle-income countries (International Dispensary Association Foundation, n.d.).

3.5.5 Transporters

The transports are seen to provide medicine to ensure they reach the recipient consumers and countries through proper supply chain. The issues that arise is that during transportation the quality and potency of the medicines get reduced or allows entry of counterfeit medicine in the supply chain process. It may occur as a result of the non-regulation of medical transports in a proper manner to avoid influx of counterfeit medicine (Yadav et al. 2010).

3.5.6 Retailers

The prices, availability and quality of medicine are mainly dependent on suppliers but on going further up the levels in supply chain it is found that the retailers which are the drug shops, medical stalls, and others in the market offer key information about the way medicines are used by the customers (Patouillard et al. 2010). The general problem at the retailer level is lack of information regarding medicine which they are handling and stocking, expiry dates of the medicines and others (Patouillard et al. 2010). In the study by Syhakhang et al. (2004), which was executed in Laos based on the information and understanding regarding the quality of medicine among the consumers and sellers it leads to the conclusion that sellers do not have effective scientific knowledge regarding medicine. In the study, the knowledge regarding medicine is evaluated on the basis of four criteria which are testing, correct labelling, knowledge regarding active ingredient and medicine registration. Out of the 59 sellers interviewed in the study, it was found that only one seller has proper knowledge regarding what specifies a high-quality medicine. It is seen that 51% of the sellers are only able to identify tow criteria out of the four criteria regarding proper quality medicine.

The next issue identified is related to stocking as well as selling of illegal or unregistered medicine. The outlets which are only allowed to sell registered medicines are seen to be often involved in selling and stocking illegal medicine. For instance, in Tanzania, the stocking, as well as selling of medical supplies and drugs without any permit, is the natural norm in the country. Moreover, while the medicines are allowed to be sold in packages it is seen that they are also sold as loose tablets. It is found that 29 and 22 drug stores respectively sold lose tablets of painkillers and anti-malaria which are mainly packaged in homemade packages and has been labelled with notes that are hand-written which in turn is allowing chances of selling counterfeit medicines (Goodman et al. 2007). The bulk purchase executed by the organisation of international level can lead overstocking and encourages miscreants to slide in counterfeit drugs in the bulk stock. In addition, the inefficiency, complexity and lack of increased scale distribution network in supply chain of medicine contribute to the existence of counterfeit and expired medicines. As previously informed, the sellers do not have effective knowledge about the quality of medicine which makes them sell the counterfeit medicines to the consumers creating circulation and reach of the medicines to the public (Syhakhang et al. 2004).

3.5.7 Consumers

The consumers are regarded as the one who is at the final level in the supply chain of medicine as they purchase drugs directly from the drug retailers. It is seen that as the medicine retailers there are many individuals who lack proper concept regarding the quality of medicines. In the developing countries, the consumers of the urban areas are found to be more aware regarding counterfeit medicines compared to the consumers in rural areas (Syhakhang et al. 2004).

3.6 Regulations and Safeguards

In the supply chain, for each actor which is manufacturers, medicine suppliers, retailers and others it is identified that there is weakness existing in the regulatory system. The weaknesses are identified and efforts to resolve the weaknesses are evaluated as well as policy solutions are proposed which are able to resolve the source of the issues.

3.6.1 Manufacturers

The collection of manufacturing data is a complex task as analysis of the samples of medicine from the globe, in general, does not consider the medicine manufacturers but they mainly identify the country as the source. The two categories of medicine manufacturers who are of vital importance are the small manufacturers from the developing countries and the large multinational manufacturers from North America and Europe. In order to develop a study regarding large multinational medicine manufacturers, ten companies are selected from the Fortune 500 lists. The companies are found to have registered products with the World Health Organisation (WHO) Prequalification of Medicine Program. The companies include GlaxoSmithKline, Pfizer, Novartis, Abbott Laboratories, Sanofi-Aventis, Roche Group, Merck, Bristol-Myers Squibb and Wyeth (WHO, 2019; CNN Money, 2009). In order to develop a study regarding small manufacturers, the analysis is executed based on the data obtained from the Medicine Quality Database regarding manufactures with failed samples and by using internet to identify the country of the origin of the manufacturers in the list. The countries which matched with manufactures that have lower standards of medicine are Guyana, India, China and Kenya, Vietnam and Thailand and out of these countries, it is found that Vietnam has the largest manufacturers with failed medicine samples (Laura Christian et al. 2012). The information regarding the approaches of the manufacturers regarding counterfeit medicine management is difficult to ascertain which are outside the multinational producers. The small manufacturers are found to appear at a majority rate regarding failed medicine sample from the Medicines of Quality Database. These natures of manufacturers are seen to have no information on the internet apart from phone number and address. There are evidence which informs that small manufacturers who are present on the WHO Prequalified Medicine list have fewer problems regarding substandard medicine. The pharmaceutical companies are the key actors who minimise the safeguarding issues and improving the medicine supply chain in the developing countries (Laura Christian et al. 2012).

3.6.2 International Organisations

The international organisations of varied sizes supply medicines to the developing countries. The exact duties played by the organisation may be bewildering for the professionals in the field of medicine (International Medical Veritas Association, n.d). These organisations of international nature are mainly categorised into two categories which are long-term medicine providers or healthcare and organisation that specialises in providing emergency relief. The long-term providers of medicine are seen to work in a consistent manner with the same program and in general purchase from same medicine manufacturers. These organisations experience issues of counterfeit medicine because they are unable to track the source and quality of the medicine purchased. The main comprehensive regulation that outlines guidelines for assuring quality of global medicine is the WHO’s Prequalification of Medicine Program (PQP). These guidelines mainly serve as only global medicine quality program and these are followed by international organisations which help them ensure the medicines used for humanitarian relief are of proper quality, safety and efficacy standards as mentioned by medical board. The program is seen to maintain and annually updates acceptable medicine lists and laboratories name that has been successful in meeting the quality standards of medicine and medicine supplies globally. In order to quality in the list, the manufacturer is required to receive an invitation from the PQP is a must criteria and need to submit dossier with proper information regarding safety, quality and efficacy of their product. The obtained information is later analysed by team of WHO staffs and expert and before taking any decision the sites of the manufacture are inspected by the WHO members as criteria to ensure all the standards are met properly. After all the standards in the site as well as information obtained regarding the medicine is met, the WHO places the medicines in their list of prequalified medicine products (World Health Organization, 2010c). The emergency relief organisations are seen to mainly deal with time-sensitive conditions and due to this consequence, they are unable to have proper time for tracking their donations. Moreover, the organisations arrange forums and in this duration, the partners meet on regular basis for discussing the common problems and share between them information about best practices. They are seen to be committed to expand their assistance for getting access to lifesaving drugs, vaccines and diagnostic tests for the population both at the international as well as national level. The seven international organisations which are regarded as top financial players on the basis of available information includes International Committee of the Red Cross, UN Children’s Fund, World Health Organisation, UN Population Fund, Medecins Sans Frontieres, UN Developmental Program and International Federation of Red Cross and Red Crescent Societies. Apart from providing aid through medical supplies and medicine in international organisations, they also assist in training local professionals, improve technical expertise and involve in medical research projects.

3.6.3 National Governments

The focus on countries such as China and Nigeria is provided for reviewing the regulations regarding medicine supply and influence of presence of counterfeit medicine in this study. The evaluation of the sources of counterfeit medicine and response towards them in the mentioned countries provides a general analysis of the problem. Since systematic global data is not available regarding the prevalence of counterfeit medicine in the national context, literature review regarding counterfeit medicines has been done based on the selected countries. It is identified that China is primary the key exporters and Nigeria are the key importers of medicine. In this review, the variation in characteristics regarding medicine reforms, regulation, challenges and success are being focussed. The selection is mainly made so that geographic variety remains and considering that many literatures are present focusing on African and Asian Countries.

China

China has the world’s largest market for counterfeit medicine (Bate 2012a; Torstensson and Pugatch, 2010). The manufacturing of medicine is the largest industry in China and the pharmaceutical business is growing at a massive rate in the country. It is found that between 1997 and 2007, the value of the pharmaceutical industry in China increased from $22 billion to $106 billion (Torstensson and Pugatch, 2010). The United States is seen to alone make purchase of more than $1.5 billion worth of medicine from China each year (Bate, 2012). The country does not only manufacture medicine but they also manufacturers chemicals that are required for making medicines and it is found that 80% of the active ingredients regarding for the medicine sold in the United States is bought from China (Hormats, 2011). On this condition, where China is the largest supplier and manufacturer of medicine they remain as a large producer of medicines that are counterfeit in nature. The Chinese pharmaceutical manufacturers are demanded to have perfected the art of counterfeiting medicine in such a way that they even surpass the tests. For example, 95 individuals in the United States are reported to have died from allergic reactions due to contaminated heparin which is blood thinner manufactured in China. A toxic chemical is reported to be added in the products that have able to fool the quality tests performed for judging the quality of heparin (Bate, 2009). In the recent era, it is found that China is cracking down various sources of counterfeit medicines. They have improved their State Food and Drug Administration which is the nation’s primary regulatory and enforcement agency responsible to register drug and formulate the policies related to medicine composition, production and dispensation (Torstensson and Pugatch, 2010). The agency is been provided resources for supervision and implementation of regulations as well as to start investigations regarding violation of laws. The initiation of these recent reforms has led emphasis on initiating transparency, abidance of strict regulations and enforcement mechanism regarding manufacturing and selling of medicines in China. The manufacturer of medicine in China also required to follow the WHO’s Good Manufacturing Practices regarding pharmaceutical products and needs implementation of regulation that provides certificates to manufacturers which proves their compliance with laws (Torstensson and Pugatch, 2010). The State Food and Drug Administration in China have formed a large network of pharmacovigilance that has helped them to collect reports regarding adverse reactions of drugs. The administration has formed local station from 2002 for monitoring the adverse effects of medicine on regular basis. The stations are seen to receive nearly 400 complaints per million of individuals in the population (Torstensson and Pugatch, 2010). The government has developed these practices to show proof of their serious effort regarding finding out substandard and counterfeit medicine. Moreover, China has implemented huge penalties for association with production of counterfeit medicine in the country that has helped them to deter the manufacture and sale of these natures of faulty medicines. According to current legislation, the penalty provided for breach of law regarding medicine manufacturing where serious harm is caused to the human health is imprisonment for 3-10 years along with fine of the earnings made from the sale of drugs. In case, the medicine is found to be substandard and causes harm to the individual then imprisonment and fine is imposed but if the medicine is found to be counterfeit in nature which led to cause death of the individual then death penalty is imposed (Torstensson and Pugatch, 2010).

The efforts of China to control counterfeit medicine by implementing various regulations have failed because the regulation implemented remains inconsistent. This has led to undercut of corruption making the country to become the world's one of the largest producer of counterfeit and substandard medicine (Zeldin 2009). Moreover, in the China formulation of the policies and registration regarding new medicine is managed at a national level but the monitoring, as well as enforcement of the laws, is managed at the provincial level. Thus, this results the local leaders to be entrusted with essential power which they use to their advantage by undermining the system making them instigate the development of corruption. The system also has lack of insight and accountability regarding key regulations and legislation related to medicine (Bate 2012a; Torstensson and Pugatch, 2010). In addition, the local leaders are found to have low pay or incentives for advancement in career for properly enforcing drug regulation standards. This condition in China has led it unable to resolve manufacture of counterfeit medicine.

Nigeria

In Nigeria, a comprehensive regulatory framework is present that manages the export and import, production, advertisement, distribution, selling and use of regulated medical drugs. The National Agency for Food and Drug Administration and Control (NAFDAC) is mandated to design regulations and guidance for registration of products, testing products for identifying quality, extracting fines, providing licence to manufacturers, wholesalers and distributors, examining the products and local manufacturing outlets and others (Nigeria National Agency for Food and Drug Administration and Control, n.d; Nigeria Federal Ministry of Health, 2011). The agency has the fundamental goal of eradicating fake medicines and other nature of substandard medical products (Nigeria Federal Ministry of Health, 2011). The NAFDAC is seen to occupy a central office and has six zonal offices along with 36 state offices in Nigeria. The pharmaceutical regulations in Nigeria are implemented in such a poor manner that it has led the country to become one of the famous regions for counterfeit medicine. In 2001, it is estimated that 60-70% of the medicine sold in the country are substandard, fake, expired or adulterated medical products which are banned across Africa (Adinuba 2003; Innovations for Successful Societies 2009). The NAFDAC was seen to undergo restructuring, revamping and retraining of their staff after the appointment of Dr Dora Akunyili in the position for director-general of the agency in the year 2001. This was followed by improved accessibility as well as refurbishment of analysis of the medicines in the laboratories across the country for resolving corrupt practices which was present prior to the arrival of the individual. The change gave rise to offer support for the public to fight for curbing counterfeit medicines in the country (Innovations for Successful Societies, 2009). The image of the agency in public was further improved by executing series of public and valuable medicine seizures and destruction of the medicines that are found to be counterfeit in nature. The NAFDAC developed guidelines to be abided by the companies as well as individuals to let them have knowledge regarding the way to apply for license and registration. Moreover, guidelines are also made regarding the way public awareness campaign is to be organised so that the citizens are knowledgeable to understand the way they are to check expiry dates of the medicine and NAFDAC certificates so as to make proper purchase. The implementation of the reforms led multiples attempts to take life of Akunyili and her immediate family and attempts to burn down NAFDAC officers in early 2000 (Innovations for Successful Societies, 2009).

The reduction of counterfeit medicines as mentioned previously led to the growth of domestic manufacturing companies in Nigeria (Innovations for Successful Societies, 2009). However, as per condition in 2009, it is seen that the domestic manufacturers in Nigeria produce 1/3rd of the total supply with the rest of the bulk required medicine to be imported from China and India (Garuba et al. 2009). Moreover, in Nigeria, the raw materials required to manufacture medicines are not present (Echenim, 2011). This condition has led a vital duty on the Ports Inspection Directorate to protect markets of Nigeria to be infested with substandard medicine but they were seen not to be allowed to enter the ports. In 2011, the Nigerian Ports Authority implemented joint inspections to be made to lower the processing time. However, in relation to the decision, it was found that some security agencies such as NAFDAC objected to execute joint inspection and avoided participation (Airahuobhor, 2011). The NAFDAC along with various other agencies were found to be banned from entering the ports. It is found that NAFDAC faces struggle without direct access to ports in controlling corruption and poor implementation of regulation regarding medicine making the agency to remain powerless in regulating imports of proper quality medicine. The online news and opinion columns were seen to accuse official of NAFDAC at al level be unable to manage corruptions and get involved in unlawful activities. In 2009, in a survey, it is revealed that official and stakeholders in the pharmaceutical industry such as NAFDAC and others are taking bribe and creating bias in controlling corrupted medicine to be manufactured along with impersonating inspectors. It is found that the officials of the NAFDAC and others often receive gifts and transports from the organisation where they inspect to ensure quality for medicine production. The offer of transports is regarded as an essential sign for corruption as well as it indicates safety hazards for the officials (Garuba et al. 2009). The NAFDAC officials were found to face threats and violence activities at ports and at many other phases in the regulatory process (Garuba et al. 2009).). The survey regarding corruption informed that as result of presence of lucrative business in Nigeria it has led individuals to use unscrupulous way for evading inspection (Garuba et al. 2009).). The legislation requires transparency such as the NAFDAC needs to post as well as update the list of registered medicines for the public and disclosure of licence of pharmaceutical companies, wholesalers and distributors (Nigeria Federal Ministry of Health, 2011).

The initial cause of less compliance with the regulatory policy is the lack of proper ways of law enforcement. This has mainly originated from the lack of professional training of personnel at NAFDAC leading them failure to manage a decentralised supply chain, in turn, making them face problem regarding corruption and lack of transparency as well as intimidation of officials. The limited efforts of the NAFDAC officials for improving transparency at all levels and their quarrel with the Nigerian Ports Authority signal lack of will in regulation proper medicine supply chain in the country. These activities have lead to create an immense negative effect on the public health as it can be seen that increased incidence of HIV and malaria is seen in the regions (Garuba et al. 2009, Nigeria Federal Ministry of Health, 2011).

4. Discussion and Conclusion

At the core, the issue with counterfeit medicine is mainly due to the misaligned incentives which have led to create failure in the market and inability of the government to tackle the issues. The international organisations and consumers are found to have incentives for purchase and consumption of goods whereas the actors within the supply chain are provided incentives for cutting down costs of medicine. Since it is unable to make reliance on mechanisms regarding international enforcement, much of the discussion is focussed on the way actors can be able to align incentives so that spread of counterfeit medicines is controlled. The better alignment of incentives is seen to prove a way that can be able to alleviate the issue of lack of proper international mechanisms and regulation regarding medicine as it is going to offer way to actors in the supply chain to self-regulate them. In the discussion, three points are to be focussed out of which the first point is to identify the need of bringing incentives of national governments and manufacturers at par with those of the consumers and procurers. The second point to be focussed on will be is outlining ways in which procurers and distributors are able to monitor the supply chain of medicine in a proper way. The third point to be considered is that international and national governmental organisations, as well as researchers, are to clarify and improve their emphasis on managing counterfeit medicine and its effects on the population. In addressing the point, WHO is to be used as central player to coordinate the health-related activities in the national and international organisations as well as government and non-government organisations to carry out pharmaceutical research. In addition, WHO has large member of member countries and thus it is arguably the best platform regarding discussion and implementation of international policies as well as recommendations.

1. Alignment of incentives across the supply chain of medicine

There are different incentives for acting along with the supply chain to ensure the quality of medicine. It is evident from the literature review that bringing the incentives of manufacturers and national government in line with the producers and consumers is of fundamental importance.

Creating incentives for national government so that regulation and enforcement mechanism may be tightened:

The regional literature study informs that some of the worst importers and exporters of counterfeit medicine have regulations in place but they do not function properly. There are two important issues that lie at the core of the problem regarding poor enforcement one is that the developing countries have lack of resources to run a comprehensive regulatory system and secondly they lack incentives to execute both. It is high time that both issues are addressed so that the problem of counterfeit medicine is resolved. The problem of lack of resource can simply be resolved by arranging more resources. In case the government are able to set aside some developmental aids for the improvement of regulatory as well legal institution then it can be effective for them to act in resolving the problem of counterfeit medicine as well as it would help them to include Good Manufacturing Practices and Good Manufacturing Practice guidelines. It will be beneficial as the aid can be used in achieving measurable outcomes related to strength of medical regulation and legal regimes that varies on the basis of circumstances in countries. Moreover, for countries which propose development of concrete plans to implement national projects that offers consumer chances of participation to identify counterfeit medicines required to be granted special funding to support such cause. The World Health Organisation may publicise the poor regulatory and manufacturing countries and then encourage patronage for the countries that would provide incentive to others for improving their enforcement mechanism and regulations. In order to create such incentives, World Health Organisation (WHO) require to execute systematic, regular and on-going researches to identify which developing manufacturers and countries produce high and best quality medicine at cheapest price. In parallel, research is required to be carried out for developing a list of poor quality manufacturers and make the list public with a penalty notice. The International agencies and the public procurement sector of the developing countries can also develop an external checking to put pressure on low-performing countries or manufacturers to effectively abide by regulatory regimes.

Creating incentives for manufacturers to self-regulate:

The successful encouragement of manufacturers of medicine for upholding high standards of production needs the procurers to patronise manufacturers on the basis of ability to consistently provide medicine of proper quality. The agencies which grant funds require the procurers to research which large pharmaceuticals have the best manufacturing records. In order to determine from which manufacturers the purchase is to be made, then the tools such as WHO’s Pre-Qualified Medicines List and US Pharmacopeia Convention’s Medicine Quality databases that are mentioned in the literature are to be used. The database is required to be made more user-friendly for allowing potential procurers to show performance in quicker manner for making searches regarding manufacturers. As seen from the literature, there are limiting political factors which are able to create barriers for the procurers to use the tools such as funding sources, nature of treaties, efforts for supporting local producers and others. In such cases, where the political realities are unable to be ignored, options are to be made available so that it enables them to gain access for purchasing and distribution of improved quality medicine as by executing these activities self-regulation is able to be improved. Patronage is to be made for the manufacturers on the basis of transparency meaning supporting those who have clear and open manufacturing as well as monitoring processes. In order to create economic incentives for the developing countries so that they are able to make their practices better, the procurers may approach the manufacturers present in the developed countries to consider if they are able to match with the prices of medicine as seen in developed countries. It may be achieved if the distributions of low-cot medicines are controlled in a tight manner so that no black markets are created in the world. The involvement of manufacturers is crucial as they are the consistent producers of medicine of high quality. In case the companies have the will and ability to match with the prices set by procurers for medicine in the developing world, then manufacturers in the developing countries will be instigated to improve their standards of production as otherwise, they are going to lose customers.

2. Improving supply chain management

The actors in the supply chain instead of acting independently to achieve incentives are to be made to monitor each other mainly the manufacturers and procurers to gain incentives. This is because in many cases it is seen that manufacturers and procurers avoid taking responsibility for monitoring medicine after they leave their possession. The distributors are also required to be monitored and non-state actors are to be allowed to play a key role in this over sighting.

Manufacturers: The manufacturers in the supply chain management of medicine are to have the responsibility of assuring that the quality of ingredient used in making medicines are of proper quality. They are also required to monitor the quality management in the supply chain. This is able to be achieved through effective monitoring and testing of ingredient’s quality after purchase in routine manner, monitoring of medicine after they leave the production by working with trustworthy and well-established transporters. The channels of communication are also regarded as vital importance to effectively implement the process. In order to improve the confidence of the consumers and procurers, all the manufacturers like Novartis are needed to be transparent regarding their monitoring policies and procedures regarding medicine. They are required to have a medium such as website through which the consumers may be able to report where they have made purchase of any suspected substandard or counterfeit medicine.

Procurers: The medicines are to be properly monitored from the point of manufacture to the end of delivery. The packages of the medicines are to be stamped with bar codes which at each point can be scanned in the supply chain. In order to counteract counterfeit medicine, this method is required to allow procurers have the option to track purchase location of the medicine. The pamphlets are to be printed in local languages so that proper dosage, storage and usage information can be surpassed through the supply chain at each level. The procurers are required to be transparent regarding their monitoring practices and are to be listed on the website. In order to assist in creating incentive for manufacturers to produce improved quality medicine, the procurers are required to patronise manufacturers who adhere to them.

Distributors: The international organisations, as well as national government, are often seen to face problems to manage realities of substandard or counterfeit medicine on the ground. The networks of distribution are many and it is impossible to completely control as the distribution of standards are seen to vary greatly. In order to increase quality of distribution and uniformity, the local actors are required to help in monitoring and spreading awareness regarding medicine quality at the local level. These include non-governmental organisations as well as civil groups who are interested in managing healthcare. The engagement of the actors is able to help to resolve the information asymmetry issues. In order to implement such efforts, the grants and funding are required to be made available to the organisations who are involved in supplying medicines and avenue for the population are to be arranged for reporting any suspicion of counterfeit drugs on the websites available.

3. Clarity and increasing emphasis on counterfeit medicine as well as its effect on public health:

In the literature review, it is seen that WHO has made strides for clarifying the concept regarding counterfeit medicine and its key harm to the population. In addition, the literature has noted that communication in the developed countries acts as essential tool for adding the understanding as well as awareness regarding counterfeit medicine to the public. These measures are able to be replicated in the developing countries by taking initiative to educate population through radio, television, newspaper and seminars regarding counterfeit drugs. Moreover, the initiative is going to make readily available publications regarding impact of counterfeit medicine in living standards in a country. A recognition that we as the consuming public are empowered to influence the course of our health and living standard by simply working collectively to combat counterfeit medicine will go a long way to making for a healthier nation.

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