Cambodia is an LDC with a small market for companies and no central procurement agency for ARVs. Internationally offered prices are often unavailable locally.
4.1.1 Overview
Country profile |
|
Population (millions)1 |
14.1 |
Level of development: UNDP classification |
Medium Human Development Country |
UNCTAD classification |
Least Developed Country |
Number of people living with HIV/AIDS2 |
220,000 |
National HIV/AIDS prevalence among adults2 |
4% |
National drug regulatory authority |
Department of Drugs, Food, Medical Material and Cosmetics (under Directorate General of Health) |
Authority in charge of patents |
Ministry of Commerce/Intellectual Property Division |
MSF AIDS programme |
|
Location |
Preah Bat Norodom Sihanouk Hospital |
Level of care |
National referral hospital |
Partners |
National health authorities |
Initiation of the AIDS programme |
1997 |
Initiation of ART |
July 2001 |
Number of patients on ARVs (April 2003) |
660 |
PMCT |
No (referred to another hospital) |
ARV protocols selected |
|
Conformity to national recommendations |
No existing recommendations |
Regimen used (March 2003) |
|
- First-line regimen |
- d4T/3TC/NVP* |
- Second-line regimen |
- ZDV+ddI+LPV/r |
ARV procurement |
|
General situation |
Complex supply, with multiple sources of ARVs |
Generics purchased |
Yes (imported) |
MSF price (ppy, March 2003) |
|
- First-line regimen |
US$350 |
- Second-line regimen |
US$1215 |
1 UN: World Population Prospects: The 2002 Revision. (www.un.org/esa/population/publications/wpp2002)
2 UNAIDS/WHO 2002 Report on the global HIV/AIDS epidemic.
* FDC
4.1.2 Details of procurement
Context
Availability at country level: Both originator and generic pharmaceutical companies have a very limited presence in Cambodia, perhaps due to the population's low income levels. In early 2001 when MSF first started procuring ARVs, only a few drugs from originator companies were available on the private market. Some generic and originator products were available through local distributors, but they only ordered on demand and did not stock these drugs incountry. Long delivery delays were inherent in this system. In May 2003, the National Drug Procurement Centre (CMS) was still not providing ARVs.
Registration: A very limited number of originator or generic ARVs have been registered in Cambodia. For example, of the originator drugs, Roche's Viracept® (NFV) only has a temporary licence,12 while neither Merck & Co's Stocrin® (EFV) nor Abbott's Kaletra® (LPV/r) are registered yet. Among generics, only Cipla's ZDV was registered in 2001 when MSF began its ARV project.
12 Temporary Licence: only the registration dossier has been evaluated, and no analysis has been conducted at the national Laboratory for Drug Quality Control.
However, this situation is changing. At the end of 2002, several Cipla and Ranbaxy's WHO prequalified ARVs had been temporarily registered. In addition, Thailand's government-led pharmaceutical manufacturer (GPO) has begun the registration process for some of its medicines in Cambodia. During this process, importation authorization is considered on a case-by-case basis.
Patents: Cambodia did not have a patent law until early 2003 so there are no patents on pharmaceuticals in the country. Cambodia is about to join the WTO as an LDC and its new patent law states that patents will not be granted to protect pharmaceutical products until 2016, in accordance with the Doha Declaration on TRIPS and Public Health. This may however have been compromised in accession negotiations with WTO.
Prices at country level: As an LDC, Cambodia should be able to access many originator ARVs at the internationally-offered differential prices. However, in MSF's experience these drugs are often not available in-country at differential prices. For example, in 2002 the local price for Roche's Viracept®‚ (NFV) was US$4000 ppy, compared to the differential price of US$3172 ppy offered internationally. Similarly, the generic ARVs available in-country through private distributors are much more expensive than those imported directly from manufacturers.
MSF procurement strategy
In February 2001 when Cipla announced that it would sell a first-line ARV treatment for US$350 ppy, MSF decided to look into how to obtain this price in Cambodia.
Since there was no WHO pre-qualification project at the time, MSF conducted its standard review of new products, including a visit to the manufacturer (see page 11).
After validating the drugs for use in MSF programmes, MSF applied for and was granted permission by the Ministry of Health to import and use the drugs. Cambodia was the first country to which MSF imported Cipla ARVs.
MSF routinely asks ARV-producing companies to apply for registration in Cambodia in order to increase access to ARVs at country level. In addition to using generic medicines, MSF imports several drugs from originator companies at differential prices. As with generics, when the medicine is not registered, MSF requests authorization from the national drug authority. This is the case for Stocrin‚ (EFV) from Merck & Co, Kaletra‚ (LPV/r) from Abbott and Viread‚ (TDF) from Gilead.
4.1.3 Comments/analysis
The MSF ARV supply system for Cambodia required considerable resources to set up and it remains extremely complex. Many ARVs are still not registered or locally available. In particular, the drugs that originator firms are offering internationally at differential prices are not available locally at those prices. While Cambodia's LDC status makes it eligible for most of the discounts, in practice, taking advantage of them remains logistically difficult. Similarly, the prices of Cipla ARVs are relatively high on the local market, and MSF has had to order directly from Cipla's headquarters to obtain best prices. This lack of local availability of affordable medicines presents a challenge to the scaling-up and sustainability of treatment programmes.
Because of the complexity of procuring ARVs from a fragmented network of producers/suppliers/agents, it would be helpful if a government-led or non-profit central distributor took responsibility for supplying ARVs nationally.
Summary of ARV supply in Cambodia in March 2003
Drug Dosage Form |
Manufacturer chosen |
Supply channel |
Comments |
ZDV (100 and 300mg tab)
ZDV/3TC* (300, 150mg tab)
ddI (25, 100, 200mg tab)
d4T (30 and 40mg cap)
NVP (200mg tab)
3TC (150mg tab)
d4T/3TC/NVP*
(200+30 or 40+150mg tab)
3TC (50mg/5ml 100 ml Syrup)
NVP (50mg/5ml 100 ml Syrup) |
Cipla |
Imported from Cipla in India |
- Of these drugs, only ZDV has been temporarily registered. The other ARVs are imported and used with authorization by the NDRA.
- The drugs need to be imported directly from India to get the internationally offered price. The local distributor does not offer prices that are competitive with Cipla in India.
- Delivery time (DT): 3 months. |
EFV (200 and 600mg cap) |
Merck & Co |
Imported from the Merck & Co regional branch in Singapore. |
- EFV has never been registered in Cambodia. In 2001, Merck & Co shipped the drug from Thailand and asked MSF to obtain an authorization to import. Although Merck& Co had publicized the US$350 price ppy, distribution through Thailand added 20% to that price. It was only after MSF complained about this added charge that Merck& Co sold the product at the publicized differential price.
- DT: 4-6 weeks. |
NFV (250mg cap) |
Roche |
Imported from Roche in Switzerland |
- Temporarily registered, available locally at the full European price.
- In order to get the differential price, the drug had to be imported from Switzerland. At first, MSF experienced some logistical problems due to Roche's request to work through SGS13 in Cambodia and arrange for a RIA.14 In principle, pre-shipment inspection is not required for NGOs.15 After MSF headquarters contacted Roche headquarters, this request was dropped. |
LPV/r |
Abbott |
Imported |
- Not yet registered.
- MSF applied to AXIOS16 to get the differential price.
- Products come from Indonesia on order. DT: 3 weeks. |
TDF |
Gilead |
Imported |
- AXIOS is also the supplier of this drug. |
NVP/d4T/3TC (tab)
d4T (15 and 20mg caps) |
GPO |
Imported from |
- Authorization for import and use given by the Cambodian NDRA.
- DT: 2 months, production on request. |
d4T (syrup)
ZDV/3TC*
D4T/3TC* |
Ranbaxy |
Thailand Imported from India |
- DT: 3 to 4 months (due to new supply channel needing to be put in place). |
13 SGS: Société Générale de Surveillance S.A. an organization that controls international shipping
14 RIA: Registered Import Advice
15 In the Cambodian Notice to Importers, Republic of Cambodia, 31 August 2000: donations made by foreign governments or international organizations to foundations, charities and recognized humanitarian organizations are exempt from the pre-shipment Inspection Programme.
16 AXIOS: http://www.axios-group.com or AccesstoHIVCare@axiosint.com.
* FDC
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