threat of oral arteemisinin-based monotherapies...threat of oral arte monotherapies dr a. bosman,...
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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
Artemisinin Conference 13 October 20103 |
es/place of registration artemisinin monotherapies es/place of registration artemisinin monotherapies artemisinin monotherapies artemisinin monotherapies
22 1 11
ChinaDRCDubaiGhanaIndiaIndiaNetherlandsNigeria PakistanPakistanSwitzerlandViet Nam
22
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 20104 |
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
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 20105 |
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
GLOBAL MALARIA PROGRAMME
Public Sector AvaiPublic Sector Avaiub c Secto aub c Secto a
Artemisinin Conference 13 October 20106 |
lability of Antimalarialslability of Antimalarialsab ty o t a a a sab ty o t a a a s
GLOBAL MALARIA PROGRAMME
Private Sector AvaPrivate Sector AvaPrivate Sector AvaPrivate Sector Ava
Artemisinin Conference 13 October 20107 |
ilability of Antimalarialsilability of Antimalarialsilability of Antimalarialsilability of Antimalarials
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 20108 |
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
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 20109 |
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
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 201010 |
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.
GLOBAL MALARIA PROGRAMME
Artemisinin Conference 13 October 201011 |
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
Artemisinin Conference 13 October 201012 |
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
GLOBAL MALARIA PROGRAMME
Artemisinin Conference 13 October 201013 |
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
GLOBAL MALARIA PROGRAMME
Artemisinin Conference 13 October 201014 |
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
GLOBAL MALARIA PROGRAMME
Artemisinin Conference 13 October 201015 |
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.
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 201016 |
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)
GLOBAL MALARIA PROGRAMME
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
Artemisinin Conference 13 October 201017 |
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