Surmounting Challenges: Procurement of Antiretroviral Medicines in Low- and Middle-Income Countries: 4. Country cases

Surmounting Challenges: Procurement of Antiretroviral Medicines in Low- and Middle-Income Countries
(2003; 56 pages)

Table of Contents

4. Country cases

In each country where MSF initiated ARV treatment, potential sources, patent and registration status, prices and distribution options were analysed in depth. The information in the country cases that follow on pages 16 - 43 has been compiled with the help of the MSF teams in those countries, as well as with legal and pharmaceutical experts. The information compiled in the country cases reflects the situation until March 2003. The context and international environment change rapidly and access to some information, (e.g. on patents) is limited, so MSF cannot guarantee that the following information is always accurate. The main findings of the country cases are summarized in the table on pages 16 and 17.

A group of patients celebrates the 2nd anniversary of MSF's ARV programme in Khayelitsha, South Africa.

© Eric Miller

Summary of MSF's procurement experience in 10 countries (information as of March 2003)

	Level of Development	Availability	Registration Situation	Patent Situation	Generics Purchased?	MSF 1st line and price (per patient/year)	MSF 2nd line and Price (per patient/year)	International Price Offers Available?	National Production?	Government Commitment?	Main Characteristics of Procurement
Cambodia	Medium HDI¹, LDC²	Generics and originators imported, not locally available.	Few ARVs registered; special govt authorization obtained.	No patent barriers. As LDC, not obliged to enforce patents before 2016.	Yes.	D4T/3TC/NVP US$ 350	ZDV+ddI+LPV/r US$ 1215	Differential prices sometimes not available locally; needed to contact companies' headquarters.	No (but announced).	No.	Procurement is resource- intensive and complex.
Cameroon	Medium HDI	Local purchase through national government procurement centre.	All govt purchased drugs registered, or in process.	Several key ARVs patented, but govt authorizes purchase of generics.	Yes.	D4T/3TC/NVP US$ 277	ZDV+ddI+NFV US$ 4763	Yes. Access to some of the best prices internationally.	No.	Yes.	Centralized procurement strategy. Procurement is simple, efficient, and reliable.
Guatemala	Medium HDI	Generics imported; originators bought locally or regionally.	Few ARVs registered; special govt authorization obtained. Data exclusivity limits access to generics.	No patent barriers.	Yes.	ZDV/3TC+EFV or ZDV/3TC+NVP US$ 867 or US$ 520	D4T+ddI+NFV US$ 1161	Guatemala eligible for few originator differential prices; prices often very high.	No.	No. Import fees add to costs; data exclusivity provision hampers access.	Time- consuming negotiations with originator firms required.
Honduras	Medium HDI	Generics bought locally; originators bought regionally.	Govt information unclear; most generics registered.	Govt information unclear.	Yes.	D4T/3TC/NVP US$ 426	ZDV+ddI+NFV, or D4T+ddI+NFV US$ 3796 for NFV only	Yes.	No.	No.	Local generic agents facilitate procurement.

Kenya	Medium HDI	Generics imported; originators bought locally.	Originators registered; generics not, but some generic applications pending.	Most ARVs on patent; exceptions made for NGO/mission sector.	Yes.	D4T/3TC/NVP US$ 292	ZDV+ddI+NFV US$ 1594	Yes.	No (but announced).	No. Lack of national AIDS plan hampers access; generics only available as special case.	Cumbersome; special authorizations for generics required.
Malawi	Low HDI, LDC	Generics and originators bought locally.	Generics and originators widely registered.	Little patent information available. As LDC, not obliged to enforce patents before 2016.	Yes.	D4T/3TC/NVP US$ 288	ZDV+ddI+NFV US$ 1875	Yes.	No.	Yes. By registering both generics and originators.	Dynamic private sector distributors; but no central procurement agency.
Mozambique	Low HDI, LDC	Generics and originators bought locally through private distributors.	No registration system yet; special govt authorization obtained.	No patent barriers. As LDC, not obliged to enforce patents before 2016.	Yes.	D4T/3TC/NVP or D4T/3TC+EFV US$ 389 or US$ 463	ZDV+ddI+NFV Not yet purchased.	Differential prices sometimes not available locally; needed to contact companiesÕ headquarters.	No.	Yes. By quickly authorizing imports of generics.	Not overly cumbersome; central procurement agency planned.
South Africa	Medium HDI	Generics not available; originators bought locally.	Most originators and a few generics registered; special govt authorization obtained.	Most ARVs on patent.	Yes, by MSF under special authorization.	ZDV/3TC+EFV or ZDV/3TC+NVP US$ 1000 or US$ 400	ddI+d4T+LPV/r US$ 1203	Yes.	Yes (under voluntary license).	No.	Cumbersome; special authorizations for generics required.
Thailand	Medium HDI	Locally produced generics (GPO³) available; originators bought locally.	All originator and GPO generics registered.	Some ARVs on patent.	Yes.	D4T/3TC/NVP US$ 352	ZDV+ddI+SQV/r US$ 3500	Thailand eligible for few originator differential prices.	Yes (GPO).	Yes.	Easy for locally- produced drugs; complex for originators.
Ukraine	Medium HDI	Afew generics imported; originators usually bought locally.	Most originator and some generics registered.	Some ARVs on patent.	Yes.	ZDV/3TC+NVP US$ 500	ddI+d4T+LPV/r Not yet purchased.	Ukraine eligible for few originator differential prices.	No.	No. Govt only negotiates with originators.	Somewhat difficult; no local distributors for generics, and small stock for originators.

Key: 1HDI: Human Development Index
² LDC: Least Developed Country
³ GPO: Government Pharmaceutical Organization (public-sector drug manufacturer)