DRAFT
Situational Analysis
Pharmaceutical Sector
in Cambodia
Table of Contents
Introduction ......................................................................................................................... 1
Context ................................................................................................................................ 1
1. Pharmaceutical control.................................................................................................... 2
1.1 The Department of Food and Drugs, Ministry of Health.......................................... 2
1.1.1. Registration and Cosmetics Bureau .................................................................. 2
1.1.2 Essential Drugs Bureau ...................................................................................... 2
1.1.3 Narcotic Control and Pharmaceutical Trade Bureau ......................................... 3
1.1.4 Drug Regulation Bureau .................................................................................... 3
1.2 Procurement of pharmaceuticals ............................................................................... 3
2. Progress to date ............................................................................................................... 5
3. Major issues .................................................................................................................... 6
3.1 DDF and the private sector ....................................................................................... 6
3.2 Unregistered drugs .................................................................................................... 6
3.3 Counterfeit drugs ...................................................................................................... 6
3.4 Unlicensed drug sellers ............................................................................................. 6
3.5 Strategic Planning ..................................................................................................... 7
3.6 Prescribing practices and irrational use .................................................................... 7
3.7 Lack of knowledge .................................................................................................... 7
3.8 Procurement and supply system................................................................................ 7
3.9 Registration process .................................................................................................. 7
3.10 Training of pharmacists .......................................................................................... 7
3.11 Inspections .............................................................................................................. 8
3.12 Prosecution of illegal drug stores ............................................................................ 8
Introduction
This report provides an assessment of the pharmaceutical situation in Cambodia and
identified key issues. For people in Cambodia, like those in many developing countries
with a large rural population, drugs are often the first and only access to modern
medicine. Most access drug through a poorly regulated private sector as the public lacks
of health personnel and infrastructure. Several problems related to pharmaceuticals limit
even this minimum access to the medicines necessary.
The Department of Drugs and Food in the Ministry of Health is responsible for the
quality and control of pharmaceuticals in Cambodia. For the purposes of this work, Food
Safety Bureau in the Department will not be considered.
Context
Years of internal strife have had a major impact on the pharmaceutical sector in
Cambodia. During the Khmer Rouge years, the country lost most of its pharmacists and
pharmacies. Prior to this strife, pharmaceutical laws and regulation were well enforced,
and only over-the-counter drugs could be bought without a prescription.
However, since the period of civil unrest and the introduction of a more open market
prescriptions are no longer needed to obtain pharmaceuticals. Most drugs can be
purchased over the counter and most people choose to obtain drugs directly from drug
stores rather than consulting doctors.
There are three legal outlets for selling drugs in Cambodia i.e. outlets that are licensed.
a) A pharmacy-run by pharmacist
b) A depot A-run by assistant pharmacist (three years of training)
c) A depot B-run by a “retired” nurse
However, there are a large number of illegal drug sellers, 81% of drug shops in the
provinces are unlicensed and 71% of all drug shops are unlicensed.
The table below shows the number of licensed and unlicensed drug outlets.
Population Pharmacy Depot A Depot B Illegal stores
Total: Province
10,700,000 129
95
334
2394
Total: Cambodia 11,700,000 393
175
446
2461
The above “Illegal drug stores” only include large stores that openly sell drugs.
Unlicensed drug sellers are often the only providers of drugs in rural areas.
1. Pharmaceutical control
1.1 The Department of Food and Drugs, Ministry of Health
The Food and Drug Department in the Ministry of Health is the government agency
responsible for pharmaceutical control in Cambodia. The department is led by a Director
who reports directly to the Director General of Health. The Director has overall
responsibility for the department and also has responsibilities in the School of Medicine.
There is one Vice Director whose role is to support the Director.
It has five bureaus:
1) Registration and Cosmetics Bureau
2) Essential Drugs Bureau
3) Pharmaceutical Trade Bureau
4) Drug Regulation Bureau
5) Food Safety Bureau
1.1.1. Registration and Cosmetics Bureau
The Registration and Cosmetics Bureau is responsible for registering all drugs and
specific cosmetics coming into the country. Registration is the main mechanism for
controlling the quality of pharmaceutical in the country. It involves evaluating documents
on the following criteria:
o Administrative-application, summary of product info, GMP, CPP (certificate of
pharmaceutical product)
o Quality- qualitative quantification formulation, manufacturing process, certificate
of analysis of ingredients, control procedures of ingredients, stability, bioavailability and bio-equivalence
o Pre-clinical-pharmaco-kinetics, toxicology
o Clinical trials
Activities in this bureau are supported by the national budget and WHO
1.1.2 Essential Drugs Bureau
The Essential Drugs Bureau Chief is responsible for rational drug use, for ensuring
adequate supplies available in the public sector, and for improving the quality of clinical
pharmacology.
Its main functions are to:
 Provide support, supervision and training in ODs, referral hospitals, and health
centers, inspect expired drugs in provinces;
 Redistribute pharmaceuticals from over-stock units to out of stock facilities to
ensure access.
 Keep central records for 72 ODs of pharmaceutical supplies in a central data base
 Translate information documents from WHO and other sources and produce
quarterly bulletin, which are distributed to all public sector health facilities.
 Prepares posters, TV spots, and radio broadcasting related to rational and safe
pharmaceutical drug use.
.
This bureau receives supported from the national budget, UNICEF, RACHA, KFW,
WHO, and WB.
1.1.3 Narcotic Control and Pharmaceutical Trade Bureau
Narcotic Control and Pharmaceutical Trade Bureau licenses pharmaceutical companies in
collaboration with the Ministry of Commerce.
It also
 Registers import/export companies
 Publishes drug import permit following the international convention on
narcotics control
 ????? Registers traditional medicine
The activities in the bureau are supported by national budget.
1.1.4 Drug Regulation Bureau
The Drug Regulation Bureau is responsible for drug legislation.
Its main functions are to:
 Develop drug legislation and regulation
 Produce policy and guidelines such as the rational drug use policy, GMP
guidelines
 Inspect manufacturing plants, drug import and export companies and drug retail
outlets (pharmacies)
 Advertise licenses, translate drug leaflets into Khmer, and control drug
advertisement
 Oversee the administration, documentation, and security of department
The activities of this bureau are supported by the national budget. The donor support
currently available to the Department of Drugs and Food suggests significant gaps in
funding to drug regulation.
1.2 Procurement of pharmaceuticals
The availability of drugs at each health facility, from referral hospitals to health centers,
is one of the most critical elements of a successful health sector in Cambodia. The
responsibility for the procurement of pharmaceuticals must take into account quality, cost,
and timely supply. The pharmaceutical “market” has unique characteristics that require
expert knowledge over and above that needed for the procurement of other items.
The structure of drug procurement in Cambodia has unstable history. From 1994-1995
the procurement of pharmaceuticals was managed by the Department of Drugs and Food.
In 1995-1998 procurement was managed by a MoH procurement committee but 19982003 it was transferred to a unit in the Department of Budget and Finance. This unit
worked as MoH procurement bureau to prepare tendering documents.
In 2003,a sub-degree initiated by the MoEF shut the procurement bureau and established
a procurement committee that is independent from the existing Departments and Bureaus
at MoH. The procurement committee members all have another position in Department
of Budget and Finance. Its establishment appears to be linked with a decision to introduce
an open tendering process aimed to improve procurement prices through competitive
bidding. .
The PEAC= Pre-qualification Evaluation and Awards Committee has been established
since 1995. The PEAC is responsible for overseeing the procurement of pharmaceuticals.
Final decision is made by PEAC, not the procurement committee.
It membershipare senior officials from the MoH and MoEF.
The current members are:
o Ex. Eng Huot (Director General of Health)
o Ex. Ung Phirum (Secretary of State)
o Ex. Te Huy Sieng (Director General of Administration and Finance)
o Mr. Chea Kim Long (Director of Department of Finance)
o Mr. Bun Leang Heng (Chief of Cabinet)
o Mr. Nop Yim (Chief of the Procurement Committee); and
o A controller from MEF
This committee does not include a person with “technical expertise” in drug procurement.
Within the MoH the structure and process for ordering drugs is:
The Department of Drugs and Food provide a list of drugs and quantities needed based
on prior use. They also provide information on the most cost effective drugs available to
the MoH procurement committee.
The MoH procurement committee:
 Estimates the total cost of the drugs needed
 Seeks MoEF approval of the budget
 Prepares the bidding documents and tender, and
 Selects the suppliers
The MoEF and provides final approval of the tender documents and suppliers.
In 2002 the MoEF made decisions, with little technical input from the MoH that
resulted in significant delays in drug procurement. In an environment of
decentralization, this level of decision-making after the budget has been approved is
difficult to understand, especially when pre-selection of pharmaceutical providers
requires considerable technical knowledge.
There has been serious shortages of drugs in the public health system. In August 2003
only 40% of drugs bought were in the central medical store (CMS) when usually 100% of
all drugs for a year should be available by June.
The “open tender” process that has been introduced is in fact very restrictive. Although
in theory it is an open tendering process a number of official and un-offical rules severely
restrict it.
The tender documents are provided and prepared in Khmer only. This restricts non
Khmer firms from bidding and defeats the purpose of open tendering.
There is a lack of clarity and transparency in the tender criteria. Payment is made after
delivery and there is often a delay in payments. There is no open letter of credit, and it is
unclear what current payment can be made in. These “rules” or tendering criteria restrict
the number of companies that would be interested in bidding.
For instance, it is reported that in one instance a successful bidder did not contact the
pharmaceutical companies before submitting tender. It was only after the company was
selected that it started contacting the companies to provided the drugs. Most companies
could not provide at the tender price. Issues of quality and delivery time were not
addressed by the successful bidder.
There is no pre-qualification for the bidders therefore, reliable suppliers of high quality
products with experience in procurement were not ensured.
There is poor collaboration between the Ministry of Economics and Finance and the
Ministry of Health and an apparent unwillingness to use technical support available in the
MoH to assist the procurement process. For instance, in 2002, MoH selected 5 reputable
companies but only one of these companies was by approved the MEF.
2. Progress to date
The Ministry of Food and Drugs has made solid progress in pharmaceutical control over
the last 10 years. There have been improvements in the quality of drugs available in the
country.
The number of pharmacists has increased XXXXXXXXX
There has been an improvement in the supply system the public health facilities. An
efficient system of collecting pharmaceutical data is in place. A computerize supply
management system has been introduced.
There has been a considerable amount of in-service training in XXXX
There has been a significant improvement in rational drug use in some referral hospitals
XXXX
A drug registration system has been introduced and staff have received training. Fifty
precent (50%) of drugs in the country are registered.
The Malaria, TB, HIV/AIDS programmes are actively involved in ensuring there are
good practice guidelines and an adequate supply of quality drugs so that treatments is
available for these major diseases.
What percentages of patients have access to treatment? XXX Ask Jay,Reiko and
Veronique
There are good relationships between the Essential Drug Bureau, WHO, KFW, UNICEF,
and RACHA. Each fund specific and different activities to support essential drugs management
Regular meeting with partners are held at central level. Coordination of donor funding is
reported to be improving.
Most provinces have just had computers installed so that the drug supply system can be
computerized. Training is in progress.
3. Major issues
3.1 DDF and the private sector
Eighty percent (80%) of the people purchase drugs in the private sector. The Department
of Food and Drugs has few activities focused on the private sector. It receives no donor
support to increase the licensing of pharmaceutical outlets or to influence the behavior of
vendors.
3.2 Unregistered drugs
Only 50% of drugs in the country are registered. There is a backlog of drugs waiting for
registration. More than 3000 un-registered drugs can be found in the market. Illegal
importing is a problem. Cambodia has neighboring countries bordered, and the drugs can
be smuggled easily, especially from Vietnam and Thailand. Some companies don’t have
import license, but have found ways to avoid customs control. Inspection are not carried
out regularly of drug store, importing companies, and manufacturer
3.3 Counterfeit drugs
There is a significant problem with counterfeit drugs in the country. One study
demonstrated a high distribution (25% to 38%) of fake artesunate, a key antimalarial drug
in the treatment of multi-drug resistant malaria. Counterfeit artesunate aggravates the
problems of worsening drug-resistant malaria in the region.
The majority of the population is unable to distinguish between a legitimate and
counterfeit drug, and it is sometimes even difficult for trained pharmacists to distinguish
the differences due to their high resemblances to the original “real” drugs.
3.4 Unlicensed drug sellers
Seventy percent (70%) of the population use the private sector , most of which is
unregulated. The poor tend to use unlicensed drug vendors because it is easier and faster
than the public sector (where they provide drugs without charge), and in the current
system, they often have to pay for drugs and consultation anyways. Therefore the poorest
people often do not get treatment at the public health facilities. Unlicensed drug sellers
are the reality, and they sell most drugs in the country. Because they are unlicensed there
is a reluctance to work with them to improve their service. One NGO has elected to train
unlicensed drug sellers in rational drug use, but they are facing criticism for working with
the “illegal drug sellers.”
3.5 Strategic Planning
There is no strategic planning for the pharmaceutical sector to focus donor contributions
where the need is greatest. Most donors support activities in the Essential Drugs Bureau,
whereas many major problems are related to procurement and regulation.
3.6 Prescribing practices and irrational use
Prescribing practices and pharmaceutical use in Cambodia is inappropriate both from the
supply and demand side. Poly-pharmacy: e.g. prescription for 15 drugs for one patient is
a common practice. There is abuse of use of injections and antibiotics, poor patient
compliance, and no prescription required to purchase drugs. Most people go directly to
the pharmacy to avoid consultation fee from the doctors.
3.7 Lack of knowledge
Drug providers themselves have limited knowledge on rational drug use and the high
illiteracy rate in the country means that much of the population is unable to read or
understand labels on medicines. There is a lack of training of drug sellers. There is
inappropriate health seeking behavior and lack of knowledge among the population about
the appropriate use of pharmaceuticals.
3.8 Procurement and supply system
In addition to problems resulting from the current procurement structure there are some
longer-term problems associated with procurement. There are frequent stock-outs at
CMS, OD pharmacies, referral hospitals, and health centers. The exchange of information
from provinces to the central level is slow, there is poor forecasting, procurement is only
done once a year by the central team, and there is over-stocking (due to poor forecasting)
that leads to expired drugs. The current quantity of drugs ordered is calculated from the
past consumption of CMS and each OD, which does not take into account changes in
requirements. The centralized ordering and delivery makes precise forecasting
cumbersome. Requests from PHD are delayed and inconsistent so rough estimates have
to be made.
3.9 Registration process
The process for registration of drugs is limited. The laboratory facilities have low
capacity to test quality so registration is based on documentation only and work from
other countries.
3.10 Training of pharmacists
Only a limited number of pharmacists exist????? Most pharmacists and legal drug sellers
tend to work in cities, and not in the rural regions. Responsibility of drug sellers is low.
They do not necessarily think of what are the good drugs, what is the right quantity, but
focus more on what is profitable.
3.11 Inspections
Low public service salaries and lack of funds to transport and support costs together with
an attitude of “no work if there is no incentives” means there is limited inspection of drug
vendors.
3.12 Prosecution of illegal drug stores
It is illegal to open a drug store without license and the law provides for a fine of up to 1
million riel (?) for vendors who do. Enforcement of this law is weak. MoH has right to
prosecute but prosecution through the legal system is seldom successful.