Fake medicines – hidden threat

In some senses, growing concern about the quality of medicines and other medical products (such as vaccines and diagnostic kits) is the result of the world’s partial, and still inequitable, success in increasing access to medical care. Far too many people in the world still have no access at all to basic health care. Up to two billion people cannot get medicines that are crucial for their health and many millions more risk being tipped into abject poverty by health care costs that they simply cannot afford. Despite this huge and continuing challenge, efforts to reduce global inequities in access to health care have succeeded at least partially. Per capita spending on health more than doubled worldwide in the 20 years to 2014, the last year for which comprehensive data are available. In low-income countries, spending on health came close to tripling over those two decades. Although much of that still comes out of the pockets of families who can ill-afford it, the percentage of the health care bill paid by governments rather than families is rising fastest in the poorest countries. One effect of these collective successes is that the market for medicines and other medical products has shown unprecedented growth. Some 15 years ago, global sales of medicines rose above US$ 500 billion for the first time. Since then, sales have doubled again, to approximately US$ 1.1 trillion, with by far the largest growth occurring in middle-income markets. Unfortunately, this growth has opened the door not just to quality, safe and effective medicines, but also to medicines, vaccines and other products that do not meet quality standards and that are sometimes positively dangerous. What are substandard and falsified medical products? For many years, the response to this important threat to public health was embroiled in the discussion of complex definitions that meant different things to different people. Reflecting this complexity, until May 2017, WHO used the term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC). The WHO Member State mechanism on SSFFC medical products was tasked with revising these definitions to ensure that they were based on a public-health perspective, with no account taken of intellectual property concerns. Based on their deliberations, the World Health Assembly, which governs WHO, adopted the following definitions: Substandard medical products: Also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or their specifications, or both. Unregistered/unlicensed medical products: Medical products that have not undergone evaluation and/or approval by the national or regional regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation. Falsified medical products: Medical products that deliberately/fraudulently misrepresent their identity, composition or source. Although the terms falsified and counterfeit are commonly used interchangeably in everyday language, these terms have different meanings in terms of pharmaceutical law. Falsified medicines are not the same as counterfeit medicines: Falsified medicines are fake medicines that are designed to mimic real medicines. Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law. Counterfeit Medicine may include products: - with the correct ingredients, - with the wrong ingredients, - without ingredients, - with incorrect quantities of active ingredients, - with fake packaging. FLOWCHART 1: PRODUCTS RECEIVED THE PHARMACEUTICAL MARKET A global issue The first question most people ask about substandard and falsified medical products is: how many of them are there? It is a question that cannot be answered using information from WHO’s GSMS alone. This is because the system receives reports mainly from focal points in NMRAs who have been trained to identify and report incidents. However, the absolute magnitude and overall shape of the problem can be further illuminated through deeper analysis of the 1500 reports of substandard and falsified medical products reported to WHO’s surveillance and monitoring system in its first four years of operation. The WHO system receives reports from every region of the world, providing strong evidence that the problem is global. Fig. 1 maps all of the incidents recorded in WHO’s substandard and falsified medical products surveillance database from 2013 to 2017. FIG. 1: COUNTRIES IN WHICH SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS HAVE BEEN DISCOVERED AND REPORTED TO THE WHO GSMS (2013–2017) Many assume that high-income countries with strong regulatory systems can effectively exclude substandard and falsified medical products from their markets, but, as the map in Fig. 3 shows, that is not necessarily the case. Well-regulated countries usually have the resources and the networks to survey, investigate and respond internally, so unless there is a clear cross-border threat, they may be less likely than under-resourced countries to report the discovery of substandard or falsified medicines to WHO. Equally the manufacture of falsified products is also a global and complex activity. Manufacturing sites linked to the clandestine production of falsified medicines and vaccines have been discovered on all continents. Sometimes production is carried out on an industrial scale at one location or it may be on a smaller and less sophisticated scale. Often the packaging and the medicines are manufactured and printed in different countries and all of the components are shipped to a final destination where they are assembled and distributed. For example, falsified medicines originating in Asia might be packed in falsified packaging originating in Africa or the reverse. The products are sometimes concealed or smuggled and declared on the accompanying paperwork as something other than medicines. Falsified medical products are commonly shipped by air or sea, often using complex or unusual routes. Sometimes, offshore companies have been used to facilitate the sale of the falsified medicines and offshore bank accounts used to make payments and for the movement of funds. As it can be seen from the Diagram 1 no part of the world escapes the challenge of substandard and falsified medical products. DIAGRAM 1: PERCENTAGE OF REPORTS FROM EACH WHO REGION TO THE GSMS (2013–2017) The database reveals a fact that substandard production and falsification affect all types of medical products. Much of the media coverage concerning “fake” medicines, particularly those purchased over the Internet, has focused on what are sometimes known as lifestyle medicines, such as slimming tablets and treatment for impotence. Table 1 shows the number of different products of a given type, the number of countries reporting substandard or falsified versions of such products, and the total number of reports in each category. TABLE 1: EXAMPLES OF SUBSTANDARD AND FALSIFIED PRODUCTS REPORTED TO THE GSMS (2013–2017) a - Since only selected products are reported in this table, the percentages in this column do not add up b - So-called lifestyle products include products for cosmetic use, erectile dysfunction, body-building and dieting. The Causes In short, substandard and falsified medical products are most likely to be found at the intersection where: Access to affordable, quality, safe and effective medical products is constrained. Standards of governance are low, from poor ethical practices in health care facilities and medicine outlets, through to corruption in both the public and private sectors. The tools and technical capacity to ensure good practices in manufacturing, quality control and distribution are limited. Fig. 2 represents this graphically. FIG. 2: CONTRIBUTORY FACTORS TO THE EMERGENCE TO SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS Identifying a substandard or falsified medical product Some falsified medical products are almost visually identical to the genuine product and very difficult to detect. However, many can be identified by: examining the packaging for condition, spelling mistakes or grammatical errors; checking the manufacture and expiry dates and ensuring any details on the outer packaging match the dates shown on the inner packaging; ensuring the medicine looks correct, is not discoloured, degraded or has an unusual smell; discussing with your pharmacist, doctor or other healthcare professional as soon as possible if you suspect the product is not working properly or you have suffered an adverse reaction; and reporting suspicious medical products to your National Medicines Regulatory Authority. You can test yourself and learn more by clicking - https://www.youtube.com/watch?v=aEJd0T7Nhf4&index=1&list=PLXg_1uVJPtYCTrZmX5sU8CGssttZaCrfc&t=2s&ab_channel=InternationalPharmaceuticalFederation By Afandiyev R. References: Appendix 3 to Annex, World Health Assembly document A70/23, 2017. https://www.fip.org/www/index.php?page=counterfeit_medicines http://www.im.bsu.by/docs/prasintation/L%204%20Falsification%20of%20Medicines.pdf https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines