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Journal of Pharmaceutical Policy and Practice

, 9:36

First Online: 10 November 2016Received: 14 September 2016Accepted: 01 November 2016


The globalization of pharmaceutical production has not been accompanied by a strengthening and harmonization of the regulatory systems worldwide. Thus, the global market is characterized today by a situation of multiple standards, and patients in low- and middle-income countries are exposed to the risk of receiving poor-quality medicines. Among those who first raised the alarm on this problem, there were pioneering humanitarian groups, who were in a privileged position to witness the gap in quality of medicines between high-income countries and low- and middle-income countries.

Despite an increasing awareness of the problem and the launch of some positive initiatives, the divide in pharmaceutical quality between the North and the South remains important, and insufficiently addressed. More advocacy is needed for universal access to quality-assured medicines. It should target all those who are strongly -involved- with medicines: regulators, international organizations, journalists, purchasers, prescribers, program managers, policy makers, public health actors and the patients. Advocacy should be based on evidence from research and monitoring programs, and technical concepts should be translated in lay language through communication tools that address all the stakeholders. The fight to ensure universal access to quality medicines needs the participation of all, and can only be successful if grounded in common understanding.

KeywordsQuality of medicines Low- and middle-income countries Pharmaceutical regulation Quality assurance Equity in health AbbreviationsLMICsLow- and middle-income countries

PQPre-qualification programme

SSFFCSubstandard, spurious, falsely labelled, falsified and counterfeit

WHOWorld Health Organization.

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Author: Raffaella Ravinetto - Daniel Vandenbergh - Cécile Macé - Corinne Pouget - Brigitte Renchon - Jean Rigal - Benedetta Schia



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