the challenge of asthma (part i)
TRANSCRIPT
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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?
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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?
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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?
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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?
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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?
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PA 2
PA 3
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As a conclusion
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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
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(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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