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Key figures
2011
global pharmaceutical market: a market worth USD 956 billion (vs USD 405 billion in 2000 and USD 1.200 billion expected by 2016) (1, 2) Sub-Saharan Africa accounts for less than 0.5% of this amount (3) Up to 90% of the population in poor countries purchase medicines out of pocket (4) Medicines account for the 2nd expenditure of a poor household (just after food). (5)
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Active ingredients: Europe and US = 90 to 95% of self-production (6) Finished products: Europe and US = main exporters to LMICs
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Active ingredients: more than 80% of amounts used in Europe and US come from abroad, (mainly from Asia) (8, 9) India: 1st producer and exporter of generics to DCs
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prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): chronic diseases
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prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): IV fluids
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prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): malaria
Kenya, Tanzania: the quality of antimalarials seems to be reasonably under control Ethiopia: No samples failed, but 41% were not registered Nigeria: The possibility of being treated with an antimalarial that complies with quality standards is less than the possbility of receiving substandard medicine (63.9% of the samples) Ghana and Cameroon: patients have approximately 60% chance of obtaining medicines of good quality.
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Political will?
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The reality is that many regulatory authorities don't NRA* 1 have the full capacity to perform all regulatory NRA 3 functions, due to chronic shortages of human, 30% NRA 2 technical, financial and other resources WHO (15) NRA 4
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4%
NRA 3
39%
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Staff
Population : (millions)
DMA
NRA 2
31 NRA 3
307
5.5
5.5
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NRA 1 NRA 3
Competition?
PA 3
NRA 2
* Procurement agency
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Political will?
NRA 2
IO 2
PA 2
IO 3
* International organisation
NGO 3
D* 1
D3
D2 Interests?
IO 1
PA 3 PA 1 NRA 1
PA 4 PA 2
NGO 2
NGO 1
NRA 4
NRA 2
IO 2 PA 2
IO 3 NGO 3 NRA 3
* Donor
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PA 3 PA 2
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1
As a conclusion
Globalization of the market: outsourcing, subcontracting and diversification of the supply chain -> what happens to traceability? Multiplicity of standards (WHO, ICH, EU ..) and difficulties in applying them Quality control and Quality assurance: Many actors blur these concepts together. Many incorrectly believe that quality control is sufficient. This can be due to ignorance....right through to corruption. Counterfeit and informal markets hide the growing issue of substandard medicines Increasing pressure on price -> Affordability vs. Quality. Sometimes quality is sacrificed for price.
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References
(1). http://www.ifpma.org/fileadmin/content/Publication/2013/IFPMA__Facts_And_Figures_2012_LowResSinglePage.pdf (2). IMS Health, Market prognosis. March 2008. (3). http://www.unido.org/fileadmin/user_media/Services/PSD/BEP/IFC_HealthinAfrica_Final.pdf (4) http://www.who.int/medicines/technical_briefing/tbs/lancetmedprices.pdf (5) http://www.who.int/dg/speeches/2010/access_medicines_20100716/en/index.html (6) Inspection process differences in Chinese domestic and export APIS. European Chemical News. 31 October 2005 (7) Barnes K. US and EU pharma trade bodies slam poor regulation of foreigh APIs. In-Pharma technologist.com. 20 October 2006. (8) http://www.pharmaceutiques.com/phq/mag/pdf/phq149_51_industrie.pdf (9) http://www.economist.com/node/21564546 (10) Villax G., Oldenhof C. Global API sourcing: What is next for suppliers for the European union? Pharmaceutical Technology Sourcing and Management. July 2006 (11) http://www.aei.org/article/health/medical-technology/pharmaceuticals/the-problems-and-potential-of-chinaspharmaceutical-industry/ (12) http://inde.cnccef.org/542-pharmacie.htm (13) http://www.who.int/mediacentre/factsheets/2003/fs275/en/ (14) http://apps.who.int/medicinedocs/en/m/abstract/Js17069e/ (15, 16) Roles of National Medicines Regulatory Authorities, Dr Samvel Azatyan, WHO / Global Fund joint meeting on Quality Assurance of essential medicines, 30-31 August 2011, Geneva.
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