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Regulatory disincentives in low and middle income markets
Regulatory disincentives in low and middle income markets
Lisa Hedman
World Health Organization
Copenhagen, September 2014
Manufacturers Meeting,
Copenhagen, September 2014 2 |
Lack of incentives to bring
medicines to markets
Manufacturers Meeting,
Copenhagen, September 2014 3 |
OverviewOverview
� Unbalanced markets
� Fragmented markets
� Inconsistent regulatory pathway
� Case study on paediatric tuberculosis medicines
� Options, opportunities?
Manufacturers Meeting,
Copenhagen, September 2014 4 |
Unbalanced markets: Preliminary data on market
authorizations and procurement status of tracer products in
Reproductive, Maternal, New born, and Child Health
programs
Burkina Faso
Comoros
DRC
Ethiopia
Ghana
Guinea
Kenya
Kyrgyzstan
Madagascar
Malawi
Nepal
Nigeria
Senegal
Sierra Leone
Somalia
Tajikistan
Tanzania
Uganda
Uzbekistan
Vietnam
Zimbabwe
Market authorizations
RMNCH tracer products% of countries
with 1+ MA
Ceftriaxone 91%
Gentamycin 40mg/ml 77%
Levonorgestrel 75 mg implant 77%
Oxytocin 77%
Ampicillin injection 77%
Amoxicillin dispersible tabs. 250 mg 68%
Levonorgestrel 0.75 mg tablets 68%
Levonorgestrel 1.5 mg tablets 55%
Magnesium sulfate 55%
Dexamethazone 50%
Zinc sulfate 50%
Misoprostol 32%
Chlorhexidine 7% 13%
RMNCH tracer products% of countries with
1+ MA
# of
manufacturers
with 1+MA
Ceftriaxone 91% 282
Gentamycin 40mg/ml 77% 103
Levonorgestrel 75 mg implant 77% 8
Oxytocin 77% 36
Ampicillin injection 77% 108
Amoxicillin dispersible tabs. 250 mg 68% 36
Levonorgestrel .75 mg tablets 68% 16
Levonorgestrel 1,5 55% 25
Magnesium sulfate 55% 16
Dexamethazone 50% 59
Zinc sulfate 50% 20
Misoprostol 32% 21
Chlorhexidine 7% 13% 2
RMNCH tracer products
% of
countries with
1 +MA
# of
manufacturers
with 1+ MA
% of countries
include in
procurement
Ceftriaxone 91% 282 64%
Gentamycin 40mg/ml 77% 103 91%
Levonorgestrel 75 mg implant 77% 8 55%
Oxytocin 77% 36 100%
Ampicillin injection 77% 108 64%
Amoxicillin dispersible tabs. 250 mg 68% 36 55%
Levonorgestrel .75 mg tablets 68% 16 36%
Levonorgestrel 1,5 55% 25 27%
Magnesium sulfate 55% 16 100%
Dexamethazone 50% 59 82%
Zinc sulfate 50% 20 64%
Misoprostol 32% 21 82%
Chlorhexidine 7% 13% 2 45%
Manufacturers Meeting,
Copenhagen, September 2014 8 |
Unbalanced marketsUnbalanced markets
� Proliferation of some products and paucity of
others
� Market data in LMICs is difficult to obtain
� Demand indicators eg burden of disease not
useful as predictors for some medicines
Manufacturers Meeting,
Copenhagen, September 2014 10 |
WH
O R
EP
OR
T 2
011 –
GLO
BA
L T
UB
ER
CU
LO
SIS
CO
NT
RO
L
38%
25%
21%
7%
6%4%
Southeast Asia
Africa region
Western Pacific
Eastern Mediterranean
Europe (Russian
Federation with a high
rate)Americas
1 MILLION
TREATMENTS
PER YEAR
SPREAD OVER
MORE THAN
22
COUNTRIES
Manufacturers Meeting,
Copenhagen, September 2014 12 |
The problem: for 22 countries,
repeat 22 times
The problem: for 22 countries,
repeat 22 times
Efficiency problem in fragmented markets Efficiency problem in fragmented markets
Manufacturers Meeting,
Copenhagen, September 2014 13 |
Fragmented marketsFragmented markets
� Iterations of regulatory processes is a
disincentive, especially for low margin generic
medicines
� Regulatory pathway information is unavailable in
many LMICs
� Maintaining distribution and registration in
multiples countries can be cost prohibitive
Manufacturers Meeting,
Copenhagen, September 2014 14 |
Inconsistent regulatory pathways: paediatric tuberculosis
Manufacturers Meeting,
Copenhagen, September 2014 15 |
Can we estimate the BE study costs?Can we estimate the BE study costs?
# patients
reached USD
2010 purchase data 250,000 3,000,000
(estimates of global disease burden pending) 1,000,000 14,000,000
BE with WHO PQ comparator products (or similar) USD50,000 1
BE with local comparator products 3
BE waiver 0
BE conducted locally 2
300,000 6
% of 2010 market / % of maximum market 10% 2%
Why 2010 data provided by the GDF? 2010 is the year that treatment guidelines changed
and represents the last year of “normal” demand for a paediatric formulation.
Manufacturers Meeting,
Copenhagen, September 2014 16 |
Possible to estimate the impactof multiple pathways?
Possible to estimate the impactof multiple pathways?
0% 5% 10% 15% 20%
BE studies
Submissions
Inspections
Total
Manufacturers Meeting,
Copenhagen, September 2014 17 |
Not really…and the impact is problematicNot really…and the impact is problematic
� Increased cost to markets
� Slows time to market, especially for countries with
more competing requirements
� Cost and time unpredictable in countries where
regulatory pathway information is not available
� Quality API market is difficult to navigate
Manufacturers Meeting,
Copenhagen, September 2014 18 |
� Development of basic information resources to predict
regulatory pathway
� Agreement across multiple regulators (in addition to joint
inspections and reviews
� Avoid penalizing manufacturers due to specific
regulatory environments
� Encourage uptake of WHO collaborative approach
� Support development and regulatory costs for critical
projects (example: Step TB project)
Are there options?Are there options?
19
• Catalyze pediatric TB market• Conducting market intelligence studies
• Landscaping regulatory environment
• Negotiations and scientific advice requests from stringent regulators
• Market intelligence studies
• Begin shortening timeline gap between adult and pediatric
formulations (new drugs/regimens)• Active engagement in Janssen pediatric clinical development program
(bedaquiline)
• Expert panel planned on utilization of moxifloxican in children
Speeding Treatments to end Pediatric TB (STEP-TB) Project
2014 Year To Date
20
• Prepare for demand generation activities• Release of comprehensive management guidelines for Childhood TB and
training materials
• Influencing adoption through regional meetings and training
• PK study underway to inform dosage guidelines for infants
• Established working relationship with both Global Drug Facility (GDF) and
The Global Fund
Speeding Treatments to end Pediatric TB (STEP-TB) Project
2014 Year To Date
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