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Access to quality-assured medicines in low resource countries: a neglected scourge

J2J, 29 October 2013

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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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Manufacturing market before 1990

Active ingredients: Europe and US = 90 to 95% of self-production (6) Finished products: Europe and US = main exporters to LMICs

Less than 5% of medicines circulating are generics (7)

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Manufacturing market today

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

More than 50% of the worldwide prescriptions are generics (10)

Yearly growth of Chinese and Indian pharma. exports: 15 to 20% (11, 12)

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Poor quality medicines: a sad reality

According to WHO, it is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard and the few studies that have attempted to quantify the problem of poor-quality medicines have estimated prevalence levels as high as 44 per cent. (13, 14)

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Poor quality medicines: a sad reality

The WHO prequalification project assesses the quality of medicines for AIDS, TB, malaria (+reproductive health and avian flu). It publishes the list of pre-qualified products (product-manufacturer-site)

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Poor quality medicines: a sad reality

The WHO list of essential medicines: +/- 350 medicines, among them live-saving ones. About 300 for common diseases . For those, there is no international mechanism that guarantees the quality of medicines.

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Poor quality medicines: a sad reality

High prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): HIV-AIDS

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Poor quality medicines: a sad reality

High

prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): chronic diseases

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Poor quality medicines: a sad reality

High prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): antibiotics

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Poor quality medicines: a sad reality

High

prevalence of poor-quality medicines in insufficiently regulated countries (actual extent underestimated?): IV fluids

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Poor quality medicines: a sad reality

High

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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Poor quality medicines: a sad reality

Concentration in Active Pharmaceutical Ingredient: Over/Under-dosing Poor bio-availability Unexpected impurities Decreased efficacy of the active ingredient Contamination with environmental pollutants, pyrogens, microbiological particles Cross-contaminations with highly active molecules, toxic contaminants, including from the excipient, etc Lack of stability Alteration of pH Accelerated deterioration due to poor packaging (e.g. IV fluids) Leaflet / packaging / labelling (mistakes)
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Who is responsible for the quality of medicines on the international market?

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Do NRAs guarantee the quality of medicines?

Resources? NRA* 1 NRA 3 NRA 2 NRA 4 Interests and lobbies?

Political will?

* National Regulatory Authority

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Do NRAs guarantee the quality of medicines?

20% 50%

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

Developed Variable Limited

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Do NRAs guarantee the quality of medicines?

33% 24%
Regulatory authorities in 46 African WHO member states. WHO (16) NRA 2 NRA 4 NRA* 1

4%

NRA 3

39%

Developed Moderate Basic Limited

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Do NRAs guarantee the quality of medicines?

Yearly financial Country NRA Resources ( M)
NRA* 1

Staff

Population : (millions)

Denmark Sub Saharian African country

DMA
NRA 2

31 NRA 3

307

5.5

0.64 (theory) NRA 4 0.12 (available)

5.5

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Do Procurement Agencies guarantee the quality of medicines?

Resources? Political will?
PA * 1 PA 2

NRA 1 NRA 3

Competition?

PA 3

NRA 2

NRA 4 PA 4 Interests and lobbies?

* Procurement agency
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Do international organisations guarantee the quality of medicines?

Resources?
NGO* 1 PA 3 PA 4 PA 2 IO* 1 PA 1 NRA 1 NGO 2

Political will?

NRA 2
IO 2

NRA 4 Rights and duties?

NRA 3 Interests and lobbies?

PA 2
IO 3

* International organisation

NGO 3

* Non Governmental Organisation

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Do donors / WHO guarantee the quality of medicines?

World Health Organisation
Resources? Political will?

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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Do donors comply with the Declaration of Paris for medicine supply?

PA 3 PA 2

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24
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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