NEWS on MEDICINES and HEALTH - February 2011
WAEMU regulates registration of medicines |
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Since January 2011, WAEMU, West African Economic and Monetary Union, has established regulation procedures for registration of pharmaceuticals products for human use. This harmonized and appropriate legislative framework takes into account international standards, and will enable member states drug regulation authorities to register pharmaceutical products, and to better control the importation and distribution of pharmaceuticals. The regulation aims at providing mechanisms for an increased monitoring of drug products on the market.
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Kenya High Court instructs UN in case against
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The United Nations has been enjoined in a case challenging the Government’s decision to ban generic drugs. The UN special Rapporteur to Heath claimed enforcement of the Anti-Counterfeit Act 2008 would endanger the lives of the infected with HIV/AIDs, by denying them access to affordable and essential medication. Generic drugs for the treatment of HIV/AIDS and other sickness are available and affordable compared to the branded version.
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The European Parliament approves
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A new law to prevent fake medicines from entering the legal supply chain was approved by Parliament on 16 February 2011. Protecting patient safety is the core aim of this directive. Internet sales will be covered by the law, which also introduces new safety and traceability measures, as well as sanctions against counterfeiters. This law still needs to be formally approved by the Council of Ministers. There has been a huge growth of this criminal activity, with an increase of 400% in seizures of fake drugs since 2005.
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Shortage of essential drugs amidst crisis in Côte d'Ivoire |
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There is a concern that stocks of essential drugs to treat malaria, a deadly disease for children, are running out . Some district pharmacies have run out of anti-malarial drugs, but the shortage could affect other essential drugs soon. If these drugs are not dispatched rapidly, patients could be forced to stop treatments, including basic antibiotics.
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Eye on the Ball - Oxfam Report |
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The report shows the need for regulation against substandard medicines, not enforcement of Intellectual Property Rights. Poor quality medicines threaten patients and public health in developing countries. Prioritization of medicines regulation by developing-country governments, is badly needed. Yet under the guise of helping to address dangerous and ineffective medicines, rich countries are pushing for new intellectual-property rules and reliance on police - rather than health regulatory - action. This approach can undermine access to affordable generic medicines and damage public health. |