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Access to quality-assured medicines in low

resource countries: a neglected scourge

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J2J, 29 October 2013

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Key figures

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2011 global pharmaceutical market: a market worthUSD 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% ofthis 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

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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

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

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Manufacturing market today

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Active ingredients: more than 80% ofamounts 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

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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

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The WHO prequalification project assesses the quality of

medicines for AIDS, TB, malaria (+reproductive health andavian flu). It publishes the list of pre-qualified products

(product-manufacturer-site)

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Poor quality medicines: a sad reality

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The WHO list of essential medicines: +/- 350 medicines,

among them live-saving ones. About 300 for commondiseases .

For those, there is no international mechanism that

guarantees the quality of medicines.

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Poor quality medicines: a sad reality

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High prevalence of poor-quality medicines in

insufficiently regulated countries (actual extentunderestimated?): HIV-AIDS

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Poor quality medicines: a sad reality

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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

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High prevalence of poor-quality medicines in

insufficiently regulated countries (actual extentunderestimated?): antibiotics

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Poor quality medicines: a sad reality

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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

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High prevalence of poor-quality medicines in

insufficiently regulated countries (actual extentunderestimated?): 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

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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 internationalmarket?

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Do NRAs guarantee the quality of

medicines?

#LungHealth

NRA* 1

NRA 2

NRA 3

NRA 4

Political will?

Interests and lobbies?

Resources?

* National Regulatory Authority

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Do NRAs guarantee the quality of

medicines?

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NRA* 1

NRA 2

NRA 3

NRA 4

20% 50%

30% DevelopedVariable

Limited

The reality is that many

regulatory authorities don't

have the full capacity to

perform all regulatory

functions, due to chronic

shortages of human,

technical, financial andother resources WHO (15)

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Do NRAs guarantee the quality of

medicines?

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NRA* 1

NRA 2

NRA 3

NRA 4

4%

33%

24%

39% DevelopedModerateBasic

Limited

Regulatory authorities

in 46 African WHO

member states.

WHO (16)

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Do NRAs guarantee the quality of

medicines?

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NRA* 1

NRA 2

NRA 3

NRA 4

Country NRA

Yearly financial

Resources

( M)

StaffPopulation :

(millions)

Denmark DMA 31 307 5.5

Sub Saharian

African

country

0.64 (theory)

0.12 (available)3 5.5

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Do Procurement Agencies guarantee

the quality of medicines?

#LungHealth

Political will?

Interests and lobbies?

Resources?

NRA 1

NRA 2

NRA 3

NRA 4

PA * 1 PA 2

PA 3

PA 4

Competition?

* Procurement agency

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Do international organisations

guarantee the quality of medicines?

#LungHealth

Political will?

Interests and lobbies?

Resources?

PA 2

* International organisation

NRA 1NRA 2

NRA 4 NRA 3

PA

2

PA 1

PA 3PA 4

IO* 1

IO 3

NGO 3

IO 2

NGO 2NGO* 1

* Non Governmental Organisation

Rights andduties?

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Do donors / WHO guarantee the

quality of medicines?

#LungHealth

Interests?

Resources?

PA 2

* Donor

NRA 1NRA 2

NRA 4 NRA 3PA 2

PA 1

PA 3PA 4IO 1

IO 3NGO 3

IO 2

NGO 2

NGO 1

D*1

D 3 D 2World HealthOrganisation

Political will?

D d l ith th D l ti

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Do donors comply with the Declaration

of Paris for medicine supply?

#LungHealth

PA 2

PA 3

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124

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As a conclusion

#LungHealth

Globalization of the market: outsourcing,

subcontracting and diversification of the supply chain-> what happens to traceability?

Multiplicity ofstandards (WHO, ICH, EU ..) and

difficulties in applying them

Quality control and Quality assurance: Manyactors 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.

R f

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References

#LungHealth

(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 foreighAPIs. 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-chinas-

pharmaceutical-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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