Threat of oral arteemisinin-based monotherapies...Threat of oral arte monotherapies Dr A. Bosman,...

Threat of oral arteThreat of oral artemonotherapiesmonotherapiesDr A. Bosman, Dr A. Bosman, WHO Global Malaria Programme WHO Global Malaria Programme Dr A. Bosman, Dr A. Bosman, WHO Global Malaria Programme WHO Global Malaria Programme

Artemisinin Conference 201013 October 2010 Antananari o M13 October 2010, Antananarivo, M

emisinin-based emisinin-based

MadagascarMadagascar

Slow Companies market

monotherapies by ymonotherapies by y37/76 (49%) comp

39/76 (51%) not yet in(last up

s

25

30

com

pani

es

15

20

Num

ber o

f c

5

10

N

02005 2006 2007

Artemisinin Conference 13 October 20102 |

progress…..p gting oral artemisinin-based

year of identification by WHOyear of identification by WHO panies withdrew their productsn line with WHO recommendationspdated 14.09.2010)

Not yetcontactedWithdrawnmonotherapiesIntention tocomplyNo intentiondisclosed

2008 2009 2010Last updated on 26.04.20

GLOBAL MALARIA PROGRAMME

Manufacturing siteof producers of oral a

Manufacturing siteof producers of oral aof producers of oral aof producers of oral a

21 1 2

5

1


es/place of registration artemisinin monotherapies es/place of registration artemisinin monotherapies artemisinin monotherapies artemisinin monotherapies

22 1 11

ChinaDRCDubaiGhanaIndiaIndiaNetherlandsNigeria PakistanPakistanSwitzerlandViet Nam

22


Slow pNational Drug

28/78 (36%) till

p

28/78 (36%) still (last

es

Last u

50

60

70

er o

f cou

ntrie

20

30

40

Num

be Ris

0

10

an-0

6Ap

r-06

Jul-0

6O

ct-06

an-0

7Ap

r-07

Jul-0

7O

ct0

Ja Ap J Oc

Ja Ap J Oc

Number of 2006 2007


progress….. Regulatory Authorities:

ll l th i

p g

allow oral monotherapies updated 14.09.2010) updated on 26.04.2010

sk of development of resistance

Oct-

07an

-08

Apr-0

8Ju

l-08

Oct-

08an

-09

Apr-0

9Ju

l-09

Oct-

09an

-10

Apr-1

0Ju

l-10

Oc

Ja Ap J Oc

Ja Ap J Oc

Ja Ap J

f countries still allowing monotherapies 2008 2009 2010


28 countries alloartemisinin based m

28 countries alloartemisinin based martemisinin-based martemisinin-based m

Algeria, Angola, BBotswana Cape VerdBotswana, Cape Verd

Chad, Colombia, CGambia Malawi MGambia, Malawi, M

Papua New Guinea, SIslands Somalia SwIslands, Somalia, Sw

Vanuatu, Zambia


ow the marketing of oral monotherapies: 17 in Africaow the marketing of oral monotherapies: 17 in Africamonotherapies: 17 in Africamonotherapies: 17 in Africa

Bangladesh, Bhutan, Bolivia, de Central African Republic de, Central African Republic, Congo, Equatorial Guinea, Myanmar Namibia Nepal Myanmar, Namibia, Nepal, Sao Tome & Principe, Solomon waziland Timor Leste Togowaziland, Timor Leste, Togo,a, Zimbabwe and Yemen


Public Sector AvaiPublic Sector Avaiub c Secto aub c Secto a


lability of Antimalarialslability of Antimalarialsab ty o t a a a sab ty o t a a a s


Private Sector AvaPrivate Sector AvaPrivate Sector AvaPrivate Sector Ava


ilability of Antimalarialsilability of Antimalarialsilability of Antimalarialsilability of Antimalarials


Relative Volumes oby Sector

Relative Volumes oby Sectorby Sectorby Sector

100

80

90

50

60

70

%

30

40

0

10

20

Public Private Public Private Public Pri

Benin Cambodia DRC

First line ACTs Other ACTs


f Antimalarials Distributedr and Drug Typef Antimalarials Distributedr and Drug Typer and Drug Typer and Drug Type

vate Public Private Public Private Public Private Public Private

Madagascar Nigeria Uganda Zambia

Non-artemisinin monotherapies Oral artemisinin monotherapy


Main chMain cha ca cA number of companies do nA number of companies do nMost of "non-responders" mPoorly regulated pharmacLimited access to ACT: i) slo)and ii) limited penetration ofManufacturing of sub-standaa u ac u g o sub s a daleft open by companies comNeed of multiple sources of Need of multiple sources of


hallengeshallengesa e gesa e gesnot respond to WHO appealnot respond to WHO appeal

market oral artemisinin monotherapiesceutical market in endemic countriesow roll-out of ACTs in the public sector pf ACTs in the private sectorard products exploiting "niche market" a d p oduc s e p o g c e a e

mplying to WHO recommendations information for monitoring information for monitoring


Phasing out chloroPhasing out chlorogg

2001 - efficacy studies comparingalternatives to CQ (1st-line) and SJuly 2003 – adoption of AS + AQN b 2003 i t d ti f tNovember 2003 - introduction of t(ordonnance) to remove CQ and

– stopping importation of CQ and SP– active recall of CQ and SP from al– immediate stop of in-country distrib

by the Centrale d'Achat des Médicfdonation of these stocks to neighb

– sales ban of CQ and SP products In 2008 the DNDi survey on ACTIn 2008 the DNDi survey on ACTcomplete absence of CQ and SPfacilities, warehouses and pharma


oquine and SP in Burundioquine and SP in Burundiqq

g AS+AQ vs AL to evaluate potential SP (2nd-line) for malaria treatment as 1st-line treatment based on study resultsth di i d MOH l ti the new medicine and MOH regulation SP from the market. Measures included:

P,l public health facilities and Provincial warehouses bution of CQ and SP stocks available at central level caments Essentiels du Burundi (CAMEBU) and

bouring countries still deploying these medicines, andin the private sector. implementation in Burundi confirmed the implementation in Burundi confirmed the in both public and private sector health acies across the country.



Decision of Cameroonin May 2006

Decision of Cameroonin May 2006in May 2006in May 2006

Including rectal artesunateIncluding rectal artesunaterecommended by WHOrecommended by WHO

Including rectal artesunateIncluding rectal artesunaterecommended by WHOrecommended by WHOrecommended by WHOrecommended by WHOfor prefor pre--referral treatmentreferral treatment

of severe malaria in childrof severe malaria in childr

recommended by WHOrecommended by WHOfor prefor pre--referral treatmentreferral treatment

of severe malaria in childrof severe malaria in childrGLOBAL

MALARIA PROGRAMME

• widespread disse• widespread disse• widespread disse• empowerment of dru

• lette

• widespread disse• empowerment of dru

• lette


Decision of Cambodiain March 2009

Decision of Cambodiain March 2009in March 2009in March 2009

Withdrawal of Withdrawal of Marketing Authorizationof oral artemisinin-basedMarketing Authorizationof oral artemisinin-basedantimalarial medicinesantimalarial medicines

emination of new regulation (posters + leafletsemination of new regulation (posters + leafletsemination of new regulation (posters + leafletsug inspections (confiscation, fines, prosecutionrs of appreciation + logos for approved outlet

emination of new regulation (posters + leafletsug inspections (confiscation, fines, prosecutionrs of appreciation + logos for approved outlet



Decisionof BeninDecisionof Beninof Beninof Benin

Withdrawal of Withdrawal of Withdrawal of Marketing

Authorization

Withdrawal of Marketing

Authorization of 22 brands

of chloroquineof 22 brands

of chloroquine

and of and of and of 24 brands of ora

artemisinin-based

and of 24 brands of ora

artemisinin-basedartemisinin basedmonotherapies

artemisinin basedmonotherapies



Decision oDecision oCôte d'Ivoire in

A g st 2009August 2009withdrawal owithdrawal owithdrawal ocertain ACT

from the marke

withdrawal ocertain ACT

from the marketo align the

private sectoto align the

private sectowith the

public sectowith the

public secto



the example of NYD Pharmathe example of NYD Pharma

Consultation with Swissmedic (30.3.10The company NYD has an authorisatiofrom Swissmedic for the "Trade of medicinal products in foreign countriesSi th d t t Since these products are not manu-factured in Switzerland and do not transit Swiss territory, they don't need market authorisation from Swissmedicmarket authorisation from SwissmedicArticle 21 al. 1 of the LPT stipulates thathe export of medicinal products and th i f i t d f S it l d their foreign trade from Switzerland shall be prohibited if:

– a. they are prohibited in the destination tcountry;

– b. circumstances suggest that they couldbe intended for an illegal purpose.


Since neither a) or b) apply, the Swisslaw does not allow any intervention.

Phasing out oral artemPhasing out oral artemggA. annua seA. annua se

Artemisi

API supplierAPI supplier

of or

igin

of or

igin

Manufacturers ManufaAMFm AMFm

Domestic marketDomestic marketExport of co

untry

o of

coun

try o Manufacturers

of quality ACTs Manufasubstan

AMFm Phase IAMFm Phase I

Domestic marketDomestic marketExport

NRA

NRA

N ti l R l t A thNational Regulatory AuthMarket intelligence (s


misinin-based monotherapiesmisinin-based monotherapiesppeed producers/distributors eed producers/distributors

inin extractors/growers

rs of artemisinin derivativesrs of artemisinin derivatives

acturers of Manufacturers of oral

ExportExport

acturers of ndard ACTs

Manufacturers of oral artemisinin monotherapie

ExportExport

h it (NRA) f i i t t ihority (NRA) of recipient countriessurveys of quality of medicines)


ProgressProgressgg1. Follow-up of 2nd African Med

2009, Maputo, Mozambique)2009, Maputo, Mozambique)a. Meeting with African NRAb. Meeting with African NRA

2. WHO/AFRO Regional Commof Malaria Control towards erelated to Malaria Tuberculorelated to Malaria, Tuberculo

3. Presentation to Ministerial S4. Presentation African Leaders5. Meeting with manufacturers 6. International Conference of D

(30 Nov - 3 Dec 2010, Singa


and next steps and next stepsppdicines Regulators Conference (24-26 Nov))

As (Francophone - Douala, 28-30 June 2010) As (Anglophone - Dar Es Salaam, 8-9 Nov 201mittee (RC 59) Resolutions on Accelerationelimination and Monitoring Drug resistance osis and HIVosis and HIVession at RBM Board, 14 May 2010s Malaria Alliance (ALMA) – July 2010 (Artemisinin Conference – Oct 2010)Drug Regulatory Authorities (ICDRA)

apore)GLOBAL

MALARIA PROGRAMME

Threat of oral arteemisinin-based monotherapies...Threat of oral arte monotherapies Dr A. Bosman,...

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