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MEDI
PHARM YEMEN 2006
May8th – 12th ,
2006
The
4th Int'l Medical Supplies, Pharmaceuticals
& Healthcare Exhibition in
Yemen
Yemen
is experiencing one of the world’s highest population
growth factors, The medical sector in Yemen has been witnessing rapid
development and modernization
-
Health
Care: Yemen's
Ministry of Public Health & Population is unable to cope with the
increasing demand for modern health services, so it has
encouraged the private sector to establish hospitals and
clinics. There is a significant market for medical
instruments, supplies, and pharmaceuticals.
Investments in small private hospital projects have
increased rapidly in Yemen.
-
Medical
Instruments, Supplies, and Pharmaceuticals (MED):
Yemen's Ministry of Public Health cannot cope with
increasing demand for modern health services, so it has
encouraged the private sector to establish hospitals and
clinics. Statistics
indicate that Yemen has over 2,250 pharmacies and over
450 small hospitals and clinics have opened in the past three years, representing a
Significant market for medical instruments, supplies,
and pharmaceuticals.
Investments in small private hospital projects
have increased rapidly in Yemen.
-
Drugs/Pharmaceuticals
(DRG), Health Care Services (HCS),
Medical Equipment (MED):
Reducing
the cost of medical treatment abroad is a high budget priority for
the Yemeni Government. Even basic health care services are
Unavailable. While imports of pharmaceuticals and
equipment should continue to grow, sources believe there
is also a niche for high-quality primary care clinics as
an alternative to foreign medical treatment.
- World
Health Organization (WHO)
The World Health Organization (WHO) has responded to the
Government's call for emergency assistance in a number
of key areas, providing both preventative and curative
health care. Since 1990, diarrhoeal diseases have become
a top priority in Yemen because of the large number of
cases and deaths witnessed in the last three years.
WHO
has provided financial and technical assistance
amounting to $550,000 to the Ministry of Public Health
and related ministries to control diarrhoeal diseases.
WHO input for the control of other communicable
diseases, including malaria, schistosomiasis, leprosy,
onchocerciasis, and upper respiratory tract infections,
amounted to $1.5 million.
In the area of health manpower development to improve
the
standard of performance of human resources, WHO has
provided $800,000 since 1990. Health promotion and
disease prevention include a broad spectrum of
activities covering health education and information,
vaccination, maternal and child health care, and
nutrition and amounting to $1.2 million. Health
management is a
particularly weak area in Yemen. To improve the
managerial process for national health development, WHO
has provided technical assistance and financial
assistance amounting to $700,000 over the period under
review.
Under its regular budget, WHO has provided $60,000 to
the
Government of Yemen for the supply of essential drugs
and
vaccines, as well as $1 million annually from its
Voluntary Fund.
Responding to the specific needs of Yemen, WHO has
intensified its collaboration with the Government to
develop infrastructure for human resource development,
district health systems based on primary health care,
and information systems and health financing. These
efforts have been funded through extra budgetary
resources amounting to approximately $500,000 per year.
- The Health Care System in Yemen
The
principal causes of morbidity and mortality in Yemen
need to be dealt with at the source. This requires more
emphasis on preventive and primitive health care
including immunization programs, mother and child health
care (Reproductive health), family planning, nutrition,
health education, and a better health environment with
safe water supplies and sanitation facilities.
-
Health
Care System
The
central objective of the government’s health policy
has been to improve the health status of the population
in both urban and rural areas, and to reduce regional
disparities in access to health care facilities. The
Ministry of Public Health (MOPH) has an overall
responsibility for the health sector. Its main functions
are to develop health policies, establish health care
services, prepare health legislation, train health
personnel, and elicit the participation of communities
and other sectors. Other functions include support for
health research, establishing technical standards for
health staff and facilities, coordinating environmental
health programs and ensuring quality.
The
health care system in Yemen consists of a large public
sector along with a sizable private sector. Public
health care is organized in three levels: primary health
care (PHC) supported by secondary and tertiary referral
care. PHC focuses on preventive and promotive health
programs (immunization, MCH and family planning, health
education, etc) and provides first aid and curative
care. It starts at the village level where PHC units are
run by paramedical staff. The units are backed up by PHC
centers, often managed by a physician and have
laboratory and X-ray facilities.
Patients who cannot be properly cared for at the PHC
level are referred to district or governorate hospitals
(secondary care) for further diagnostic and curative
treatment. Some of these hospitals also support national
or regional immunization and disease control programs.
Finally, tertiary hospitals provide specialized care and
serve as teaching hospitals for the medical faculties of
the country’s universities.
-
Medical &
Pharmaceutical Products:
CHALLENGES
OF THE FUTURE
1. Brief History of
Medical & Pharmaceutical Trade:
Since the British colonial system started in Aden, on
January 19th, 1839, trade between most of the Yemeni
hinterland and the United Kingdom started and grew.
First, under the East India Company and later through a
multiple of channels, exports from London and Cardiff to
Yemeni coastal territories increased in all fields of
business, especially medical and pharmaceutical
products.
The British encouraged their medical and pharmaceutical
companies, as sole agents and/or distributors, to spread
medical and pharmaceutical technologies into Arabia
through their base of Aden. Quickly, a profitable
business flourished.
By the mid-20th century, relations between the Britain
and the Crown Colony of Aden blossomed. The marketing of
pharmaceutical products was organized according to
British Medical standards and Boards, thus giving Aden a
reputable place. Many local traders and companies
started to handle the businesses since the 1940's within
the colonial system as general distributors and agents.
These include the Orient Pharmacy, A. Besse
International Group, and Al-Shifa'a Store, etc.
Legal Markets:
The laws of the Republic of Yemen provide equal chances
to all citizens dealing in medical, pharmaceutical, and
general trade. Under the policy of full and open
competition, people engage in the business of their
choice.
After May 22nd, 1990, a new system was introduced by
republican decrees, which are based on decisions made by
the Ministry of Public Health and the Supreme Board for
Drugs & Medical Appliances. Four years later, in
1994, the government issued a guideline called the Yemen
Drugs Index. This is a medical and pharmaceutical
registration for almost all foreign, Arab and local
medical goods legalized for importation and sale in
Yemen. The guideline offers the following ATC
classifications under which all medical goods are
imported.
1. Alimentary Tract and Metabolism.
2. Blood and Blood-forming Organs.
3. Cardiovascular System.
4. Dermatological.
5. Genital-urinary System and Sex Hormones.
6. Systematic Hormonal Preparations, excluding Sex
Hormones.
7. General Anti-infective, Systematic.
8. Anti-Neo-Plastic & Immunosuppressive Drugs.
9. Muscular-Skeletal System.
10. Central nervous system.
11. Anti Parasitic Products.
12. Respiratory system
13. Sensory Organs.
14. Various other organs
15. Medical Appliances
Many pharmacists think that, the registered drugs are
not sufficient in number, although the number had
reached over 12,900 items licensed to be imported until
January 1st, 1999, in the Republic of Yemen. Half of the
items registered are circulated and available in stock
markets.
The Yemen National Drug Company (YEDCO) produces 55
kinds of medicines to meet the needs of the local
society with proper-quality treatment and less cost. The
number of foreign and Arab manufacturing firms exporting
medicine to the Yemeni market is around 320 companies.
Yemeni agents and sole distributors are more or less 100
local merchandising firms specialized in importing
pharmaceuticals, perfumes, cosmetics and sanitary
products. Generic names used in Yemen markets might
reach 750, while trade names reached roughly 3200. The
United States and Europe provide Yemen with most of its
high-quality products and services, while other products
come from India, Egypt, and other countries.
Producing Drugs:
Usually, pharmaceutical products gain ground in
countries, which become famous for chemical laboratory
testing facilities and capabilities. The two activities
feed on each other and complement each other. It is
nearly impossible for backward societies to make a real
presence in this field because of the scientific
knowledge and skills required. Of course, it is possible
to import - a turnkey basis - plants to produce drugs
and other medical needs. But that is limited to
packaging, mixing and filling of ready-made or nearly
ready-made products.
In some cases, some products can be produced under
license. This requires continued surveillance and
control by the company, which holds the trademark.
In the Republic of Yemen, it is possible to meet up to
20% of local consumption through local manufacture,
while the bulk of the requirement will have to be
imported.
Distribution of drugs, like any other goods, depends on
effective advertisements.
Mass Media is a direct and efficient way to make
consumers aware of any product. Television, radio,
newspapers, and magazines play a great role in
consumers' tastes and orientation. Most people spend
their time watching or reading special programs, which
change public opinion. Other forms of advertisement use
flyers, posters, placards, and even prizes.
Advertisement use exciting and stimulating methods to
attract people to a certain behavior. Hence, some
medicines are sold more than others, not because they
are superior, though they could be, but because of a
larger advertising budget.
Intangible Assets:
Usually, intangible assets affect the performance and
movement of imported medical and pharmaceutical goods.
The most important is the reputation of a company and
its products, and the perception of users. As people
usually spend a lot of their income on medical needs,
many marketing agencies pay enormous attention to the
image of the products they sell. Factors affecting the
image of a product include:
1. Trade Marks &
Patents:
Manufacturers are quite keen on the trademarks and
patents of their products. Sometimes, goods are more
known by such symbols than by the chemical
components. Manufacturers rarely give exclusive rights
to produce and sell goods of their products. Such rights
are granted on the basis of lengthy legal arrangements.
2. Copyrights:
The exclusive right to publish and sell a literary,
artistic, or musical composition is granted by a
copyright. Copyrights are issued by the U.S. government
and extended for 50 years beyond the concerned person's
death.
3. Goodwill:
In business, goodwill refers to an intangible asset of a
business that is created from such favorable factors as
location, product quality, reputation, and managerial
skill. Goodwill allows a business to earn a rate of
return on its investment that is often in excess of the
normal rate for other firms in the same business.
Policy Measures:
Today, the Republic of Yemen needs to take some visible
steps in streamlining this sector. The following steps
seem appropriate:
1. Ministerial Quality
Control:
The government in general, and the Ministry of Health in
particular, should approve certain standards for medical
products. Though pricing should be left to the market,
quality and standards must be guided by certain
controls.
2. Prescription
Supervision:
Many harmful drugs are sold over the counter. The
authorities have to control the dispensing of drugs to
the public. All kinds of medical/pharmaceutical products
should be obtained from pharmacies by medical
prescriptions only. Of course, this does not apply to
ordinary medical products such as Febs, Tussils,
Strepsils, Lomotil, etc.
3. Encouraging
Competition:
Given that some companies achieve breakthroughs and
advanced research results earlier than others, the
industry is subject to bottlenecks in competition
leading to monopolies or at least oligopolies. It is up
to the authorities to smooth this out by encouraging
more fair and even competition.
The Supreme Board for Drugs & Medical Appliances in
Yemen has the role of ensuring adequate supplies of
medical needs.
4. New Projects in
Medical & Pharmaceutical Industries:
The medical industry in Yemen is basically limited to
YEDCO. Although there are giant importers, they have not
ventured into production. I spoke with one key
businessman and I barely put the question when he gushed
out complaints about corruption and government
mismanagement. "Most officials want to rob you by
proposing to join as partners simply because they would
allow you to proceed with it."
This explains why many would-be investors have refrained
from investing.
5. Low Taxation, Tariffs
& Customs on Medical and Pharmaceutical Products:
Medical and pharmaceutical products are essential
goods. Hence, the Yemeni government has decided to levy
no/low taxes, tariffs, and customs duty on them. This
policy takes into account the low income of the Yemeni
society and the draconian health needs in the country.
6. Government Health
Facilities:
Government health facilities are in poor shape it was a
wise decision to empower the private sector to come in
and provide the service. Allocations by the government
are less than 4% of the budget. This means health is not
a high priority, which is puzzling given the needs of
society.
- The SBDMA's role
SBDMA main role is to organize and control the import of
medicines and medical appliances into the country. This
process is aimed to fix a fair retail drug prices for
the public, by demanding the lowest possible export
prices from foreign manufacturers. This is an essential
procedure for the sale of patents and is in line with
government policy in this field. In order to achieve
such a goal, the SBDMA has adopted a Registration System
or the imported drugs. They advise foreign manufacturers
that, if they intend to export medicines into Yemen,
these drugs must be first registered with them. They
request a “Registration File” containing
certificates, scientific documents and some other
materials, and they require manufacturers to print the
price by non-erasable ink on the outer carton/packet of
the medicine.
The SBDMA, however, has also applied the registration
system for over-the-counter drugs. Almost full
registration system is being applied for this group of
medicines, unnecessarily. Surely, it is essential now
for this board to deregulate this group of medicine,
similar to what is applied in other countries. It is
time to differentiate between these OTC medicines that
could be dispensed without prescriptions, and the
prescribed only medicines” (PoM), medicines that can
only dispersed with doctor's prescription.
- The key for change: The Yemen
Drug Index
In 1994, SBDMA has already edited the Yemen Drugs
Index, which is an advanced step and an important guide
for doctors and other health professionals. This index
has adopted the Anatomo Therapeutico Chemical
classification (ATC classification system). In the
index, there is a chapter for the Registered Drugs
(medicines) and a chapter for the Registered Medical
Appliances.
The index includes 15 main groups based on ATC
classification, subgroups and five levels. Such unique
classification led to the creation of a special code for
each generic name. For example, the generic name
Paracetamol now has a scientific code: N02BE01. All
trade names containing paracetamol comes under this
code, so that each trade name has its own number
according to the pharmaceutical for (tablet, syrup,
suppository etc.)
This number was adopted by SBDMA as the Registration
Number for that particular commercial product, and the
board requested manufactures to print it on each pack,
to enable SBDMA to differentiate the officially
registered drugs from those smuggled ones. Therefore,
this index will ease for us to separate the registered
OTC products. It is, in fact, the key to simplify the
OTC drug system.
From my experience, I suggest that we categorize the OTC
products into three main groups:
1. Products of internal use for human body.
2. Products of external use for human body.
3. Products for hospitals use (medical appliances).
Internal drugs the first groups of products are those
preparations that are administered for internal use of
human body. These are preparations such as:
(a) Antacids, laxatives, antidiarrhoeals, worm
treatments, analgesics, cough preparations, as well as
travel sickness preparations, tonic and charcoal
preparations.
(b) Multi-vitamins with or without minerals, mineral
supplements, herbal medicaments.
(c) Sweetening agents for diabetics and Topical (oral)
contraceptives etc..
External drugs
the second group of products is those preparations that
are administered for external use. These are
preparations such as:
(a) Cream / ointments for the treatment of nappy rash,
skin and scalp, hemorrhoids, circulatory disorders,
antiseptic creams.
(b) Oral hygiene products such as mouthwashes, mouth
gargles and throat lozenges. Dental pastes, which
prevent or treat gingivitis, stomatitis, and other mouth
problems.
c) Eardrops without antibiotics for the removal of
earwax, pain in acute otities media and externa.
(d) Eye care solutions/drops without antibiotics for the
treatment of minor eye and eyelid infections.
(e) Foot care products for the removal of hard corns and
athlete's foot.
Hospital-related products
the third groups includes:
(a) Cotton wool, different kinds of bandages, tulles,
medicated dressings and plasters.
(b) Disposable syringes, water for injection and IV
solutions for various purposes.
(c) Enemas, topical anesthetics, intravaginal
contraceptive, condoms, vaginal dush and preparations
for diagnostic purpose.
Suggested registration and fee:
Internal drugs as the first group consists of
medicaments of internal use, then the registration file
should be arranged similar to those registration files
required for registering medicines for internal use with
prescription (PoM). The registration fee could be 50% of
the current stipulated fee fop PoM.
External drugs
As the second group consists of preparations for
external use, then the registration file may confine to
two documents, “Certificate of Good Manufacturing
Practice” and “Certificate of a Pharmaceutical
Product”, which conforms to the format recommended by
the World Health Organization (WHO).
The registration fee could be 25% of the current
stipulated fee for PoM.
Hospital use
as the third group consists of products for hospital
use, then the registration file may confine to two
documents, a Certificate of Good Manufacturing Practice
and a Certificate of Sterilization.
The registration fee could be a lump sum of USD 50/- for
each product.
The need for a guide directory for OTC products
as a completion step to the separation of OTC products,
it is essential for SBDMA to arrange an OTC Directory
for OTC products. This directory could provide a readily
accessible reference to products available without
prescription.
GPs and pharmacists will benefit from the directory
in the management of common ailments.
It is ideal if the products would be arranged in this
directory into therapeutic categories according to their
indications, to help locate and compare products that
may be used for the same conditions.
The directory should contain a table of Drug
Interactions of OTC preparation with other drugs taken
by the patent in the same time (Pharmaco-dynamic or
Pharmaco-kinetic). Where interactions are possible, the
OTC label should give sufficient warning.
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