urging who member states to phase out oral artemisinin ......most of "non-responders"...

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

2 |GLOBAL MALARIA

PROGRAMME

January 2006


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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)


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PROGRAMME

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Intentions not disclosedIntend to comply Withdrawn monotherapies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%


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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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30

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60

70

Jan

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7

Oct07

Jan

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Jan

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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


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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


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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


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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


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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: [email protected]

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

http://www.who.int/malaria


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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

urging who member states to phase out oral artemisinin ......most of "non-responders"...

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