Post on 01-Oct-2020
Urging WHO Member States to phase out oral artemisininbased monotherapies
Dr Andrea Bosman, WHO Global Malaria Programme
Global Health Histories Seminars WHO, Geneva, 22 September 2009
Global Health History Seminars | 23 Sept 09
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January 2006
Global Health History Seminars | 23 Sept 09
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Steps to implement WHO recommendations
19 January 2006 – WHO Press Release Monitoring marketing practices and position of NDRA on
http://malaria.who.int/ Dissemination of WHO position via WHO Offices, WHO staff
briefings, inter- country and regional meetings with MOH officials
19 April 2006 – WHO technical briefing on malaria guidelines and artemisinin monotherapies
Alignment of funding and procurement agencies 23 May 2007 - WHA Resolution 60.18 24 August 2007 – WHO informal consultation with
manufacturers of artemisinin-based antimalarials WHO country meetings with NDRA, NMCP and pharmaceutical
companies (India, China, Pakistan, Viet Nam)
Global Health History Seminars | 23 Sept 09
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Response to WHO appeal of 73 manufacturers
of oral artemisinin-based monotherapiesCompanies positions towards phasing out oral artemisinin
based monotherapies as per WHA60.18
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Intentions not disclosedIntend to comply Withdrawn monotherapies
36% 25%
15%
Global Health History Seminars | 23 Sept 09
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Main challenges
A number of companies do not respond to WHO appeal
Most of "non-responders" market oral artemisinin monotherapies
Poorly regulated pharmaceutical market in endemic countries
Limited access to ACT: i) slow roll-out of ACTs in the public sector and ii) limited penetration of ACTs in the private sector
Manufacturing of sub-standard products exploiting "niche market" left open by companies complying to WHO recommendations
Need of multiple sources of information for monitoring
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39 (51%) countries provide marketing authorization
of oral artemisinin-based monotherapies
Risk of development of resistance
Countries in line with WHO recommendations
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Countries implementing WHO policy tophase-out oral artmisinin monotherapies
Risk of development of resistance
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sLast updated 23.9.09
Global Health History Seminars | 23 Sept 09
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Phasing out of oral artemisinin-based monotherapies: Examples of
country success stories Benin: Consensus meeting in March 2006 – Agreement on
transitional period – Critical step: large-scale availability of ACTs <= AMFm
China: Meeting in October 2006 – Areas of collaboration – 2007: only ACTs used for drug donation programmes - 2008: De-listing of mono-therapies from the national treatment guidelines
Pakistan: May 2007: Consensus meeting – November 2007: Importation stop – March 2008: Withdrawal of marketing authorizations
Viet Nam: Since December 2007 dialogues with the country to phase out monotherapies - 2008: De-listing of monotherapies from national treatment guidelines
India: Major role in exporting antimalarials – October 2008: Timelines for withdrawals were defined – December 2008: Withdrawal of marketing authorizations (domestic and export markets) over 6 months
Global Health History Seminars | 23 Sept 09
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A proposal for a Code A proposal for a Code of Artemisinin Marketing of Artemisinin Marketing
Practices (CAMP)Practices (CAMP)
1. Phasing out of oral artemisinin-based monotherapies and manufacturing and marketing antimalarials in line with WHO Guidelines for the treatment of malaria (WHO, 2006)
2. Manufacturing compliance with Good Manufacturing Practices (GMP) certified by WHO Prequalification Programme or by stringent regulatory authorites
3. No misuse of WHO name/logo for commercial purposes
4. Reporting under confidential cover to WHO evidence of bad marketing practices, substandard or counterfeit products
Global Health History Seminars | 23 Sept 09
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Submission of reports to WHO
Reports must by in writing (fax or e-mail) and include:
– Identity of the reporter, with fax or e-mail address for correspondence
– The identity of the reporter will be kept confidential by WHO
– Identity of the company which is alleged in breach of the "Code of Artemisinin Marketing Practices" (CAMP) and the name of any product or products which are specifically involved
– Specific reference to the source of the advertisement/activity/test and copy of the material in question provided to WHO
– Date of the event, allegedly in breach with the CAMP
– Summary of the findings
Global Health History Seminars | 23 Sept 09
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Use of the reports by WHO
All correspondence should be addressed to:– Director WHO Global Malaria Programme, attn. GMP/SCM
Unit Av. Appia 20, 1211 Geneva, Switzerland
Fax: +41 22 791 4824, e-mail: schwartes@who.int
WHO/GMP has designated Ms Silvia Schwarte, WHO staff member, to follow-up all activities related to this operating procedure
Within 30 days from receipt of the report and documentation, WHO/GMP will investigate the case with the company in question, asking what action has been/will be taken to remedy the matter
WHO will make available to the public regular status reports of the CAMP, through its website (www.who.int/malaria) and the media
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Countries allowing the marketing of oral artemisinin-based monotherapies
Angola, Bangladesh, Bhutan, Bolivia, Botswana, Burkina Faso, Cape Verde, Central African Republic, Chad, China, Colombia, Congo, Equatorial Guinea, Gambia, Guinea, Guinea Bissau, Indonesia, Lao People's Democratic Republic, Liberia, Malawi, Mali, Mauritania, Mozambique, Myanmar, Namibia, Nepal, Niger, Papua New Guinea, Sao Tome and Principe, Sierra Leone, Solomon Islands, Somalia, Swaziland, Timor Leste, United Republic of Tanzania, Vanuatu, Zambia, Zimbabwe and Yemen