Countering the Problem of Falsified and Substandard Drugs (2013) / Chapter Skim
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7 An International Code of Practice for Falsified and Substandard Medicines
7 An International Code of Practice for Falsified and Substandard Medicines
Pages 295-308
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From page 295... ...
Executing these responsibilities requires strong national systems for drug regulation, surveillance, and law enforcement. Governments must work with key stakeholders in industry, professional associations, and civil society to protect the drug supply.
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From page 296... ...
The Council of Europe's Medicrime Convention (officially, "the Convention on the counterfeiting1 of medical products2 and similar crimes involving threats to public health") is a multilateral treaty intended to prevent the public health threats of illegitimate medicines (Council of Europe, 2011)
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From page 297... ...
is the other treaty relevant to falsified medicines. ACTA sets international standards for intellectual property protection and creates a regime outside of the World Trade Organization (WTO)
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From page 298... ...
The committee believes that a similar process, led by the WHO, will be essential to international action against illegitimate drugs. The WHO is also the international leader in the current discussion about substandard and falsified drugs.
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From page 299... ...
. Contributing to the law enforcement and criminal justice sections of an international code on falsified and substandard medicines would draw on the agency's strengths and complement the goals set out in its 3-year strategy.
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From page 300... ...
Similarly, a partnership with the UNODC and WCO would benefit the development and implementation of the proposed code of practice. Recommendation 7-1: The World Health Assembly, in partnership with the United Nations Office on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsified and substandard medicines.
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From page 301... ...
The use of minilabs and hand-held detection technologies could also alleviate the added strain surveillance testing will place on drug quality laboratories. Building surveillance also requires building a workforce dedicated to data analysis and the prompt dissemination of public alerts when necessary.
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The code could suggest methods for governments to ensure sustainable financing for their regulatory authorities. Most regulatory authorities run off public money or market authorization fees; many face an additional dilemma in soliciting user fees from the pharmaceutical industry (Abdul-Rahman, 1996)
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From page 303... ...
The nature of pharmaceutical crimes and the constraints on law enforcement agencies pose challenges to prosecuting and punishing offenders. The illegitimate drug business is a global industry that mirrors legitimate business in many ways: it sources materials from around the world and bases manufacturing in countries with the cheapest labor and most favorable regulatory regimes.
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From page 304... ...
They would also allow police and prosecutors to make these crimes a priority. At a minimum, the code should establish definitions for different crimes involving the medicine supply, establish minimum penalties for these crimes, recommend protocols for international cooperation on investigations and extradition, and clarify the role of customs and border police in investigating medicines trafficking.
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From page 305... ...
It is difficult to accurately measure the burden of the problem, but illegitimate medicines appear in all countries, threatening health and undermining confidence in the medical system. The proposed code of practice will encourage coordinated international monitoring of medicine quality, strong regulatory systems, and the appropriate investigation and punishment of crimes against the drug supply.
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From page 306... ...
1981. International code of marketing breast-milk sub stitutes.
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From page 307... ...
2012a. International Conference of Drug Regulatory Authorities.
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