Countering the Problem of Falsified and Substandard Drugs (2013) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-54
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From page 15... ...
Although the problem is most widespread in poor countries with weak regulatory oversight, it is no longer confined to underground economies as in postwar Vienna. As of January 2013, gross manufacturing negligence at a compounding pharmacy in Massachusetts had sickened 693 Americans and killed 45 (CDC, 2013)
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This expertise brought them a place in the WHO's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) , the largest international working group on drug safety to date.
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The following brief background on intellectual property, public health, and patent and trademark infringement gives some context to this discussion. Key Findings and Conclusions • long and acrimonious history of applying intellectual property rights A to medicines colors the discussion about drug quality.
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• isks in the supply chain: Identify the weaknesses in the supply R chain that allow falsified, substandard, and counterfeit drugs to circulate. • ealth effects: Explain the public health consequences, to pa H tients and at the population level, of SFC drugs and how to mea sure this.
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• ollaboration: Assess effectiveness of regulatory approaches C around the globe, including prevention, detection, track-and trace systems, compliance, and enforcement actions. o Based on such an assessment, identify areas where collective action among government regulatory authorities is most rel evant and sustainable; o Identify ways government, industry, and other stakeholders can work together to strengthen supply chains and fight coun terfeit, falsified, and substandard drugs; o Identify areas where industry or other stakeholders are best equipped to act; and o Recommend a collaborative path forward.
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all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, .
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As a 2011 Oxfam policy paper explained, "whether a falsely labeled, substandard, or unregistered product is also the result of willful trademark infringement on a commercial scale, as criminalized under the TRIPS Agreement, is irrelevant from the perspective of public health" (Brant and Malpani, 2011, p.
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At times, trademark infringement can become a public health problem, but it is not a public health problem in itself, even insomuch as it pertains to medicines. Competing Meanings of the Term Counterfeit The contentious history of drug patent and trademark enforcement colors discussions of drug quality, particularly the use of the term counterfeit.
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Drug companies, both innovator and generic, have the legal right to challenge counterfeiting; sorting out the nuances of trademark infringement should be left to the courts. This report is about drug quality as a public health problem; it is not concerned with trademark infringement.
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There are many internationally accepted pharmacopeias; some give, for example, different acceptable ranges for drug concentration.4 The committee agrees with the WHO's 2009 revision to the definition of substandard to specify the standards authorized by the national regulatory authority. It is more practical to let the national regulatory authority name the standard for a drug and test against that standard.
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That is, when a licensed manufacturer makes bad drugs, the deliberateness of the mistake is at least debatable. When an underground producer makes a bad-quality product there is not even a pretense of adhering to drug quality standards.
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. The Problem of Unregistered Medicines Medicines registration is one of the main responsibilities of a drugs regulatory authority (Ratanawijitrasin and Wondemagegnehu, 2002)
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In this framework, drugs that fail to meet the regulatory authority's standards are divided into failures of negligence (substandard drugs) and willful failures (falsified drugs)
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Although unregistered drugs are not by definition falsified or substandard, they are conceptually related and part of the problem. A Proposed Vocabulary The lack of a consistent vocabulary has held back public discourse on the problem of poor quality medicines in the market.
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Substandard: A substandard drug is one that fails to meet national specifications cited in an accepted pharmacopeia or in the manufac turer's approved dossier. Unregistered: An unregistered product lacks market authorization from the national regulatory authority.
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. This recognition made the drug quality standards legally binding.
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. While the FDA enforces pharmacopeial standards in the United States, both the national regulatory authorities and the European Directorate enforce the pharmacopeial standards in Europe (AVMA, 2012; EDQM, 2012)
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. Premarket review for drugs was not part of the drug registration process in the United States until the Federal Food, Drug, and Cosmetic Act of 1938, though premarket authorization of vaccines was mandatory after 1902 (FDA, 2012c)
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Good manufacturing practices issued from the 1938 Federal Food, Drug, and Cosmetic Act's stipulation that if "the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such [new] drugs are inadequate to preserve its identity, strength, quality and purity," the FDA would reject the new drug application.6 After the 1941 sulfathiazole disaster, FDA officials strengthened inspection protocols, requiring manufacturers not simply to prove drug quality but to demonstrate and maintain practices that assured uniformly standard drugs as well.
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The difference is that they are deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients" (WHO, 2003a)
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, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products.
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Federation Counterfeiting can apply to both branded and generic products and to traditional remedies. Counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with false or misleading packing; they may also contain different, or different quantities of, impurities both harmless and toxic" (FIP, 2003)
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a medicine that is either without active ingredients, or with amounts of active ingredients that are deliberately outside the accepted standard as defined in standard pharmacopoeias, or 3. a medicine that is deliberately and fraudulently mislabeled with respect to identity and/or source, or one with fake packaging, or 4.
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it is produced by using drug substances without approval number as required by this Law; or 6. the indications or functions indicated are beyond the specified scope."c Philippines "Medicinal products with correct ingredients but not in the amounts as provided there under, wrong ingredients, without active ingredients, with insufficient quantity of active ingredients, which results in the reduction of the drug's safety, efficacy, quality, strength, or purity.
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. India Mashelkar Report "The term, ‘counterfeit' that is commonly used worldwide for spurious drugs does not appear in Drugs and Cosmetic Act but the definition of spurious drug comprehensively covers counterfeit drugs.
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2008 Per the republic of Indonesia's Regulation No. 1010/2008, counterfeit medicines are produced by the party/ies who has/have no authority to produce the medicines by the government's act, or medicines whose identities are imitated by other medicines that already have a circulating permit.
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. European Medicines "Counterfeit medicines are medicines that do not comply with intellectual-property rights or that Agency infringe trademark law" (EMA, 2012)
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Normally, these standards and specifications are reviewed, assessed and approved by the applicable national medicines regulatory authority before the product is authorized for marketing. Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications" (WHO, 2010)
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. World Bank "Substandard drugs are manufactured with the intent of making a genuine pharmaceutical product, but the manufacturer saves costs by not following GMP (Good Manufacturing Practice)
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other cases where the drug standard are not conformed."a Philippines "Substandard product means the product fails to comply, with an applicable risk of injury to the public."b Thailand Substandard drugs are: "1. Drugs produced with active substances which quantity or strength are lower than the minimum or higher than the maximum standards prescribed in the registered formula to a degree less than the stated in Section 73 (5)
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Falsified Medicines medicines may: Agency • contain ingredients of low quality or in the wrong doses; • be deliberately and fraudulently mislabeled with respect to their identity or source; • have fake packaging, the wrong ingredients, or low levels of the active ingredients. Falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the European Union (EU)
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lower than the minimum or higher than the maximum standards prescribed in the registered formula by more than twenty percent."c India Misbranded "A drug shall be deemed to be misbranded -- a) if it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or b)
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if any substance has been mixed therewith so as to reduce its quality or strength."e a Directive 2011/62/EU on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products [2011]
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Presentation at Committee on Under standing the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products: Meeting One, Institute of Medicine, Washington, DC. BBC (British Broadcasting Corporation)
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2012. Opening remarks at the first meeting of the Member State Mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products.
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2003. FIP statement of policy on counterfeit medicines.
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Paper presented at First ASEAN–China Conference on Combating Counterfeit Medicinal Products, Jakarta, Indonesia. Pharmacopoeial Laboratory for Indian Medicine.
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2012. Uterotonic drug quality: An assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.
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2006. Fact sheet n°275: Counterfeit medicines.
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