regulatory disincentives in low and middle income markets · 2016-06-13 · regulatory...

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



OverviewOverview

� Unbalanced markets

� Fragmented markets

� Inconsistent regulatory pathway

� Case study on paediatric tuberculosis medicines

� Options, opportunities?



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%



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



Fragmented markets: Tuberculosis



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



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



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



Inconsistent regulatory pathways: paediatric tuberculosis



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.



Possible to estimate the impactof multiple pathways?

Possible to estimate the impactof multiple pathways?

0% 5% 10% 15% 20%

BE studies

Submissions

Inspections

Total



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



� 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



THANK YOUTHANK YOU

Acknowledgements and thanks to

Deus Mubangizi, WHO

Robinah Najjemba, Consultant

Cherise Scott, TB Alliance

For questions, contact Lisa Hedman, WHO

[email protected]

regulatory disincentives in low and middle income markets · 2016-06-13 · regulatory...

Documents