Professional Documents
Culture Documents
The Pharmaceutical Products Market in Bolivia
The Pharmaceutical Products Market in Bolivia
products market
in Bolivia
This study has been carried out by
Paloma Munguía Pérez, under the supervision of the
Economic and Commercial Office of the Spanish
Embassy in La Paz
INDEX
1. RESUMEN EJECUTIVO 4
5. PRECIOS 21
• Spain
• X Export
• •A" and Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
7. CANALES DE DISTRIBUCIÓN 26
8. ACCESO AL MERCADO-BARRERAS 29
1. CONDICIONES DE ACCESO 29
2. BARRERAS ARANCELARIAS 29
3. BARRERAS TÉCNICAS 31
4. OTRAS BARRERAS 33
4.1. Transporte 33
4.2. Contrabando 34
9. PERSPECTIVAS DEL SECTOR 36
10. OPORTUNIDADES 37
1. FERIAS 38
2. ASOCIACIONES SECTORIALES 38
3. OTRAS DIRECCIONES DE INTERÉS 39
1. EXECUTIVE SUMMARY
The pharmaceutical market in Bolivia is experiencing strong expansion. Pharmaceutical laboratories invest
significant sums of money and the consumer can find a far macia practically on every corner.
The country has 26 laboratories that supply most of the internal demand for medicines. generic products. The
imports that are carried out are of more complex products that the Bolivian industry does not have the
capacity to produce. Although in the last 10 years the pro national production has doubled, the growth of the
market is such that between 2010 and 2014 imports grew by 30%. As in most sectors, the pharmaceutical
sector is strongly affected by smuggling: 20% of the merchandise introduced into the country is illegal.
Regarding the origin of imports, Argentina and Chile, due to geographical proximity, are the main suppliers;
however, more and more products are sold from India and China due to their low prices but whose quality is
questioned by several sectors. From the market.
Spain is among the top 20 exporters to Bolivia. There is hardly any notoriety in the market ced for the Spanish
product, however, some of the main local laboratories re They present several Spanish brands. Although they
are scarce, the quality of Spanish products is appreciated by consumers, although it is below that of large
German or American laboratories.
The State, through the Ministry of Health and the Medicines Unit, articulates the public system. health co.
Public purchases of medicines are carried out through bidding processes. tation that must be published in the
State Contracting System. Once the State receives the medications from the winning company, the Central
Supply and Health Supplies is in charge of inventory control and distribution to the Institution Pharmacies.
Municipal Pharmacies, Health Brigades and Community Pharmacies.
Despite the efforts made by the State to provide basic medicines to the largest possible population, for
economic, social and geographical reasons, only half of the population has access to medicines.
As for the private sector, the supply of medicines is carried out directly through importers or distributors who,
in many cases, are the laboratories themselves. tional given that they have greater economic and distribution
capacity than other smaller companies.
ICEX
In order to introduce medicines into Bolivia, the first step is to obtain the health registration issued by the
Ministry of Health. Once granted, the Prior Import License is requested and finally the Authorization for the
Customs Clearance of Controlled Substances is requested and issued. Most medications also require special
certificates so that they can be nationalized.
Pharmaceutical products are taxed with tariffs ranging from 0% to 10%. Likewise, the applicable VAT is
14.94%.
There are other barriers to entry for this type of goods: one of the main ones is transportation. tea. A large part
of the medicines that come from outside the continent enter by air. area and road. The precariousness of the
road network means delays in deliveries and increases in costs. Another part, the highest value, is imported
through the air under very specific conditions (refrigerated merchandise at a narrow temperature range), the
transport of merchandise by air involves enormous increases in costs compared to transport by sea or te drag.
It must be emphasized that in Bolivia there is a strong substitute for conventional medicines, which is
traditional medicine. A large part of the population turns to it to alleviate their ills. tasks, and its presence is
such that it has been declared Oral and Intangible Heritage of Humanity.
In conclusion, and in the same way that this summary began, the increase in the middle class, the
improvement of the health system and the increases in productive capacity promote growth. of this sector.
While the internal capacity is practically sufficient to supply the demand for medicines considered generic, the
country depends entirely on the outside world. rior for more complex and innovative products. The
opportunities for a Spanish company that decides to import its products to Bolivia are to offer a novel and
quality product. that allows us to make a difference with Asian products that are competitive only in costs; and
focus on those segments that currently and in the long term can offer greater profitability, that is, specific
medications to treat non-communicable diseases. serious diseases such as cancer or diabetes, which have a
high incidence in the country and for which, unless circumstances radically change, the forecasts are for
growth.
2. DEFINITION OF THE
SECTOR
Within the branch of drugs, a wide range of categories can be found, such as like medicines, natural plants or
parapharmacy products.
To simplify the study, and based on usefulness reasons, it will focus on the category of medicines defined as
mixed or unmixed pharmaceutical products, dispensed two with or without a prescription for sale to the public;
used for the prevention, diagnosis or treatment of a disease.
For the correct classification of medicines, in 1950 the World Health Organization established the INN
(International Nonproprietary Name) system that classifies pharmaceutical substances. macological by its
official non-commercial or generic name. Currently this list has about 7,000 substances and about 120 new
ones are added every year.
More specifically, in Bolivia, Law No. 1737 of December 17, 1996 in its Chapter IV is establishes the following
as medications:
ICEX
Economic and Commercial
Spain 6 Office
Export from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
2. TARIFF CLASSIFICATION
Pharmaceutical products are cataloged under part of chapter 29 and chapter
30 of the Harmonized System established and updated by the World Customs Organization.
2941 Antibiotics.
CHAPTER 30 PHARMACEUTICAL PRODUCTS
Glands and other organs for opotherapeutic uses, dried, including powder zados;
extracts of glands or other organs or their secretions, for opioid therapeutic uses;
3001
heparin and its salts; other human or animal substances prepared for therapeutic
or prophylactic uses, not specified or included give somewhere else
Wadding, gauze, bandages and similar articles (for example: dressings, tape pos,
synapisms), impregnated or coated with pharmaceutical substances or put up for
3005
retail sale for medical, surgical, dental or veterinary purposes
3.
1. SIZE OF THE MARKET
The pharmaceutical supply in Bolivia is quite atomized, it comes from national production and imports and is
made up of different actors: laboratories, distributors, pharmacies, public and private hospitals, government
institutions (Ministry of Health), NGOs and prepaid medicine agents such as They are health insurance and
other medical specialists. Additionally, over-the-counter (OTC) medications may also encounter go to
supermarkets and neighborhood stores.
Regarding the size of the market, the total Bolivian population (a little more than ten million inhabitants) is
likely to be a target market for the pharmaceutical sector at least. some occasion. With the improvement in
living standards, the demand for pharmaceutical products has increased. tics with greater added value such
as body creams, vitamin supplements and medications items that are not so “first necessity”.
According to the World Bank, health spending per capita is 174 dollars 1 , one of the lowest of all. in Latin
America, and total pharmaceutical spending represents 1.5% of GDP (according to 2010 data). In 2013, the
pharmaceutical market moved a figure of 530 million dollars, a large part of which was allocated to the
importation of medicines.
Regarding spending on medicines, according to the Medicines Unit of the Ministry of Health (UNIMED), 70%
comes out of citizens' pockets while social security funds and the State are responsible for the remaining 30%.
Pharmacies, pharmacies and chains are the three types of establishments that dispense medicines in Bolivia.
And they can be public or private.
Regarding public institutions, the main actors are the pharmacies of the System ma of Universal Health and
the Ministry of Health.
1
Total health expenditure is the sum of public and private health expenditures, as a proportion of the total population. Covers the
pressure provision of health services (preventive and curative), family planning activities, nutrition activities and assistance emergency
services designated for health, but does not include the supply of water and sanitation services. Data in US$ at current prices tuals.
ICEX
Municipal Institutional Pharmacies (FIM) are public establishments located within second-level health
establishments that depend on the Municipal Government for the financial part and the Local Health Directorate
(DILOS) for the technical-administrative part. goes.
The following table shows the evolution of imports and exports of medicines over the last five years
TABLE 2: IMPORTS, EXPORTS AND RE-EXPORTS OF MEDICINES 2010 – 2014.
2013 2014
WEIGHT KG FOB USD WEIGHT KG FOB USD
IMPORTS 7.194.574 163.500.214 7.217.333 177.189.035
EXPORTS 198.039 3.178.876 190.630 3.031.533
RE-EXPORTS 4.627 879.320 1.387 258.888
Source: National Institute of Statistics of Bolivia (INE)
From the previous table we can deduce the fact that Bolivia is a clearly importing country. Although it has an
important pharmaceutical industry, it is basically dedicated to the manufacture of generic medicines; however, the
more complex products with greater added value have to be imported. The importation of human and animal blood
and medicines prepared and dosed for retail sale stands out.
In this section it is necessary to take into account the fact that the Bolivian economy stands out for its enormous
volumes of smuggling which, according to a 2011 report by The Tax Justice Net work , reach practically 70% of
the GDP . The medicine sector is not left out of this situation: UNIMED estimates that 20% of the total number of
medicines are introduced illegally into Bolivia. The Bolivian Chamber of Industry (CIFABOL) estimates the losses
due smuggled in 60 million dollars.
Currently there are 26 laboratories, according to the Pharmaceutical Profile of the Plurinational State of Bolivia for
20125 and 22 laboratories, according to the Structural Statistics of the Manu Industry invoice for 2012.
Of the total laboratories, only four have the Manufac Good Practices Certificate ture.
5 Pharmaceutical Profile of the Plurinational State of Bolivia for 2012, prepared by the Ministry of Health in collaboration ration with the
Pan American Health Organization (PAHO), which depends on the WHO
Investment in the Bolivian pharmaceutical sector between 2010 and 2013 was 95 million dollars. In May 2014,
Cuba and Bolivia agreed to jointly manufacture medicines with the fine ability to not depend on large multinational
pharmaceutical companies.
According to the president of the Latin American Association of Pharmaceutical Industries, the industry The
national pharmaceutical company has the installed and technical capacity to cover 80 percent of the medications
included in the National List of Essential Medicines (LINAME), required by the short-term social security
management entities at the national level and 70 percent of the drug needs of the population in the private drug
market (pharma ciations). He also adds that the medications for which the Bolivian industry is not prepared Rada
are those with a narrow therapeutic effect, which require very cutting-edge technology and therefore expensive for
their production, such as oncological or retrovirals.
The growth of the national pharmaceutical industry has partly modified the nature of imports: where previously
finished products were imported for consumption by the end customer, raw materials are now being imported for
the manufacture of medicines in the country.
In relation to the local production of medicines, the main representatives of the industry complain of a lack of
protection of national production and an excessive openness to the market that translates into low tariffs and few
technical-sanitary controls.
The national manufacturing capacity is presented in this table.
MANUFACTURING CAPACITY
Capacidad de fabricación Investigación y desarrollo para el descubrimiento de nuevos principios activos (PA) SI
Producción de materias primas farmacéuticas NO
Formulaciones a partir de materias primas farmacéuticas SI
Reacondicionamiento de formas farmacéuticas definitivas SI
Source: National Pharmaceutical Profile 2012
National production accounts for between 30% and 40% of the total market.
The table below shows data referring to the manufacturing of pharmaceutical products, medicinal chemical
substances and botanical products for pharmaceutical use. It is impossible to segment the information to obtain
data only on the focus products of this study.
2010 2012
MANUFACTURING OF PHARMACEUTICAL PRODUCTS, CHEMICALS
MEDICINAL PRODUCTS AND BOTANICAL PRODUCTS FOR
1.041.644 1.359.482
PHARMACEUTICAL USE
BUSY STAFF 3.593 4.420
Source: INE
Annex I shows graphs that represent the distribution of medications by principle. active ingredient, pharmaceutical
forms according to categories, routes of administration of the medications medicines with registration, and the
participation of anatomical groups in the supply of medicines.
2.2. Imports
As already indicated, the pharmaceutical products market in Bolivia is mainly nourished mainly from imports.
The evolution of the main suppliers for the articles studied during the years 2010 to 2014 is shown in detail below
using data provided by the INE of Bolivia.
■ CHINA
SWISS 5.018.883 3,63%
■ BELGIUM-LUXEMBOURG
■ ARGENTINA
INDIA 9.283.799 5,78% ■ PARAGUAY
■ COLOMBIA
TOTAL 160.590.395100,00%
Source: own elaboration with data from the INE
■ INDIA
USA 9.051.778 5,94% ■ BRAZIL L
■ COLOMBIA
TOTAL 152.309.299100,00%
■ ARGENTINA
■ PARAGUAY
CHINA 10.569.178 6,46% ■ USA
■ FRANCE
URUGUAY 5.816.312 3,56% ■ URUGUAY
Although there is no clear dominant, Chile and Argentina are currently the main suppliers. manufacturers of
pharmaceutical products in Bolivia, taking between them 25% of the market. It's im It is important to mention
the drop in the share of products from the United States, which has gone from 17% to 8% in market share.
The products with the most added value are those that come mainly from Germany, France, Switzerland and
also the United States.
Regarding Asian countries, the presence of products from India stands out, one of the main exporters of
active ingredients and pharmaceutical products globally. Regarding China, although it is climbing positions, it
still does not hold a position of supremacy. macía, unlike what happens in many other sectors.
ICEX Spain
Export
1
6
Economic and Commercial
Office
from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
4. DEMAND
In the Bolivian pharmaceutical products market, a differentiation must be made between the demand of the
public sector and the private sector.
On the private sector side are pharmaceutical laboratories, importers and distributors. providers, private
clinics, and all establishments in charge of providing medical ments available to the final consumer.
As for the public sector, it makes its purchases centrally through the Ministry of Health with the Single National
Supply System 3 (SNUS) and the Central Supply and Health Supplies (CEASS) which constitutes its
operational arm. The purchasing procedure to follow is mandatory for all those entities that administer
medications, medical supplies. medical and reagents of the Public Health System, Short-Term Social Security,
institutions that provide health services by delegation (first, second and third level health care establishments),
hospital pharmacies and NGOs. Public sector purchases are also carried out in a decentralized manner
through the mayors' offices.
National centralized procurement is carried out annually through me bidding channels. In the case of mayors'
offices, purchases are also through bidding processes but on a quarterly basis.
Based on historical demand data, tenders containing drug orders are prepared. The tender must be published
in the State Contracting System (SICOES). In order for the contest not to be void, it is necessary that at least
three companies, including producing laboratories, importers or distributors, present themselves. The winning
company is always the one that presents a lower price without it being taken into account, in many cases nes,
the quality of the products offered. Furthermore, the award system based on the price This can be a
disincentive to the national industry whose products are sometimes more expensive than those coming from
countries like China or India.
3
Single National Supply System: regulated by Supreme Decree No. 26873.
ICEX
Economic and Commercial
JAI *F Spain 1 Office
7
fl «. 1 X Export from the Spanish Embassy
in peace
I "e• • e Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
Once the order has been received (within a period of 15 days to one month) by the winning company, the
medicines must be registered in the Stock Registration Form SNUS - 016 .
In the case of the mayors, the financing for the supply of medicines comes from the General Treasury of the
Nation, a part of the Direct Tax on Hydrocarbons and the Diálo Plan go 2000 established for the reduction of
poverty in Bolivia and which is nourished thanks to foreign capital.
Of the total health spending carried out by Bolivia, 43% would be acquired by the private sector do and the
remaining 57% by the public. According to the Pharmaceutical Profile of the Plurinational State of Bolivia,
pharmaceutical spending is 25% of total health spending.
The policies in this matter seek convergence with the guidelines of MERCOSUR and the Andean Community of
Nations with the aim of proposing common objectives that pursue the availability and equitable access to
healthcare and medicines for the most unprotected populations.
SECTOR
MONEY
BUYERS
SUPPLIERS
USERS
7
Bolivian Health System (The health system of Bolivia). Carmen Ledo and René Soria (ISSN 0036-3634)
ICZX
Economic and Commercial
JAI *F Spain 1 Office
9
fl «. 1 X Export from the Spanish Embassy
in peace
I "e• • e Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
The Bolivian health system is organized into two large sectors: public and private. The Ministry of Health serves
part of the population through entities such as the Comprehensive Health System, regulated by Law 475 of
December 2013.9 which replaces the previous Seguro Uni Maternal and Child Insurance that covers pregnant
women and children under 5 years of age (SUMI) and Health Insurance for the Elderly (SSPAM). The Social
Security subsector is made up of Mandatory Social Security, which applies to all workers in the formal sector, and
labor insurance. go term administered by the Pension Fund Administrations (AFPs). The pub subsector The public
sector is financed through public funds assigned to each municipality and the social security subsector is financed
with contributions and premiums provided by employers and workers. jadores.
As for the private sector (private clinics and traditional medicine), it works mainly through out-of-pocket payments
from beneficiaries. The private sector is in turn divided into or for-profit organizations, such as private clinics; and
non-profits, NGOs and church)
Table 10 shows the medications offered by the public sector at no cost to the patient.
Although more and more population is concentrated around urban centers with better access to health systems,
there is still a significant volume of population dispersed throughout the country that cannot access these services.
However, in recent years Bolivia is experiencing a progressive increase in the middle class as a consequence of
the economic boom that the country is experiencing so far, which allows inhabitants to purchase pharmaceutical
products with greater added value.
In Bolivian pharmacies, unlike most countries, products are dispensed 'a ra leo', that is, it is not necessary to
purchase entire boxes of medications. Due to the difficulty of access to these products for a large part of the
9 Law 475: Comprehensive Health Services Benefits of the Plurinational State of Bolivia of December 30, 2013
population, what many clients do is purchase, for example, half of the medications prescribed by a doctor. When
they begin to notice improvement, they leave the treatment without finishing it with all that it entails: not reaching a
complete complete healing and the emergence of drug resistance.
Finally, it is very important to mention that in Bolivia the traditional medina has great weight in society.
Approximately half of the country's population practices it or has practiced it on some occasion.
In 2003, Kallawaya Traditional Medicine became part of the Oral and Intangible Heritage of Humanity.
The State preserves and protects this practice, so much so that in 2013 the Bolivian Traditional Ancestral
Medicine Law came into force.10 which defines this type of medicine as “a con together with concepts, knowledge,
knowledge and ancient ancient practices, based on the uti “lization of material and spiritual resources for the
prevention and cure of diseases, respecting the harmonious relationship between people, families and the
community with nature and the cosmos, as part of the National Health System.”
The main objectives of the law are the following:
- Regulate the exercise, practice and articulation of traditional ancestral Bolivian medicine na, in the
National Health System.
- Regulate the structure, organization and operation of associative bodies, consult tive, training and
research; and the rights and duties of the users of traditional ancestral Bolivian medicine in all its forms,
modalities and procedures. therapeutic instructions.
- Promote and strengthen the exercise and practice of traditional ancestral Bolivian medicine na.
The scope of natural medicine is such that the best-selling product in Bolivian pharmacies is Mentisan,
manufactured by Inti Laboratories. It is a balm composed of natural essential oils of sage, pine and eucalyptus,
and ingredients such as menthol, camphor, turpentine essence and lanolin.
5. PRICES
Price is one of the fundamental components in access to medicines. Until the in When Supreme Decree 21060 of
1985 came into force, the State controlled the price of medicines. caments. Subsequently, it has been the law of
supply and demand that has governed behavior. ment of drug prices in the country.
However, and although the prices of medicines must be made public by the different actors, the escalation in their
prices has led to the fact that in 2014, through the Cir cular 33/2014, a minimum and maximum price has been set
for 600 medications in which They include taxes and transportation and distribution costs. All sales
establishments The prices of the medicines on offer must also be visible to the consumer. two.
The part of the population that has access to the Integrated Health System receives medications cough for free.
However, the low availability of these medications forces a large part of the population to acquire them in the
private system at prices that not everyone can access.
Through the Median Price Index (IMP), the difference between market prices is established. international price
(international reference prices)11 and prices in the Bolivian market. The latest data available show that the price of
medicines in Bolivia is clearly higher than international reference prices. For public purchases of generic
medicines, the IMP is 1.05, that is, it is 1.05 times higher than the international reference prices. Regarding the
prices paid by patients, the IMP in the public sector is 17.47 for original brand medicines and 3.46 for generics. In
the case of the private sector, the differences skyrocket: the IMP for branded drugs is 30.26 for branded drugs and
4.54 for generics.
11 The international reference price is understood to be the median of the prices offered by international suppliers. national.
The graph below shows a comparison of the prices of the different establishments. cough where medications are
dispensed in relation to the reference price.
NATIONAL IMPORTED
MEDICINE
GENERIC BRAND PRICE DIFFERENCE GENERIC BRAND PRICE DIFFERENCE
PRICE (BOB) (BOB) (%) PRICE (BOB) (BOB) (%)
AMOXICILLIN 500
MG 0,45 1,65 266,67 0,5 3,75 650
DICLOFENAC 50
MG 0,15 0,8 433,33 0,2 1,75 775
OMEOPRAZOLE 20
MG 0,9 6 566,67 0,6 8,75 1358,33
Source: Study of drug prices prepared by UNIMED.
Finally, the following graph shows the evolution of drug prices. It shows an increase in prices since 2010 of up to
48%.
80
60
40
20
0
2010 2011 2012 2013 2014 2015*
Regarding how prices are formed in the market, a study by Action International for Health 11 indicates that in
the private sector, the added costs, taking into account all phases of the distribution chain are 415.82% and
441.61% in the public sector in the case of imported generic medicines. According to the National
Pharmaceutical Profile, the margin with which retailers operate is 30% for national products and 35% for
imports. two.
11
Study of Prices, Availability and Access of Medicines and Price Components in Bolivia prepared by Acción Interna tional for Health
ICEX Spain 2
Economic and Commercial
Office
Export 5 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
6.
As seen in previous sections, in recent years, the main protagonists in the export of pharmaceutical products
to Bolivia have been other Latin American countries (Chile, Argentina and Brazil), the United States and
increasingly India and China. . Regarding multinationals pharmaceutical companies, those with the most
notoriety are the German and American ones representing sitting through local laboratories.
In this context, Spanish products have little to say. According to officials consulted at the SEDES in La Paz,
there is hardly any brand image of the Spanish product because it is not widely introduced. However, some
laboratories represent several special laboratories. ñoles such as Kin, dedicated to oral health; Leti,
specialists in allergy treatment dermatological diseases and conditions or Rovi. It is also possible to find
cosmetic and parapharmacy products, for example, Imexfar represents Babé, a Spanish brand of pa
rapharmacy that sells creams, shampoos, gels, etc.
Although Spanish products are not very present in the market, their image is associated with quality, an
aspect that must be taken into account when differentiating from the pros. pipelines from India and especially
China, whose perception in the local market is that of cheap, low-quality products that do not earn the trust of
a good sector of the market. fallen
7. DISTRIBUTION CHANNELS
The value chain in the pharmaceutical sector can be broadly broken down into three levels:
- PRODUCTION: in charge of the laboratories.
- DISTRIBUTION: the protagonists may be the importers themselves or laboratories. HE According to
UNIMED data as of December 31, 2014, there are 549 importers of medicines, cosmetics, raw
materials, domestic hygiene or medical equipment in Bolivia and 18 medicine distributors.
- MARKETING: Carried out by hospitals, clinics and pharma establishments ceuticals.
In this section we must, once again, differentiate between the public sector and the private sector.
The CEASS has a central medicine warehouse on a national scale and there are 11 warehouses. public
sector at the secondary level of public sector distribution. In the central warehouse, the forecast of the number
of orders is carried out, the preparation of delivery notes, the report of the existing cias, report on pending
order lines or control of expiration dates.
At the retail level, medicines are made available to the consumer through Municipal Institutional Pharmacies,
Health Brigades and Community Pharmacies.
Although the New Political Constitution of the State protects the national industry, representatives of the
different pharmaceutical associations consider that the State does not buy enough products. national pipelines
because some foreign ones are more competitive.
ICEX
Economic and Commercial
Spain 2 Office
Export 8 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
12 Ethical Standards for the Promotion of Medicines approved by the Ministry of Health and Social Welfare through the RS No. 0139/94
of March 1, 1994
MARKET ACCESS-BARRIERS
8.
1. ACCESS CONDITIONS
In addition to the tariff barriers that try to protect the national market against the pros ducts from abroad, the
importation of medicines into Bolivia requires various requirements and with trolleys for different products.
2. CUSTOMS BARRIERS
The following table shows the tariff barriers established for pro products. ceders of the European Union and
which range between 0% and 10% depending on the type of measure camento.
ICEX
CHAPTER 30
TARIFF
Glands and other organs for opotherapeutic uses, dried, including they
are pulverized; extracts of glands or other organs or their secretions,
3001 for opioid therapeutic uses; heparin and its salts; other human or 5%
animal substances prepared for therapeutic or prophylactic uses, not
elsewhere specified or included
ICEX
Economic and Commercial
Spain 3 Office
Export 1 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
3. TECHNICAL BARRIERS
The first step to be able to introduce a medicine into the country is to register it. The registration of medicines is
regulated by the Medicines Law.
Health registration is understood as the procedure by which pharmaceutical products undergo a strict evaluation
prior to their marketing.
The Medicines Law includes requirements, procedures, forms and instructions for different types of medicines.
- Generic medicines (International Common Name - INN)
- Brand name medications
- Homeopathic medicines
- Products of plant, animal or mineral origin that have medicinal properties
- Special medications, biological, blood products, dietary, dental, radio-drugs
- Vaccines and biologicals
- Cosmetics
- Medical devices
- Reagents for diagnosis and clinical laboratory
- Traditional handcrafted natural products
Industrial pharmaceutical laboratories and importers, to request a health registration, must have a ministerial
resolution authorizing operation.
All Health Registration procedures must be presented by the legal representative of the company and the
pharmaceutical regent accredited for this purpose.
In addition to the proper registration of medicines, importers must obtain prior import licenses for medicines and
controlled substances that are issued by the Minis. Health theme. The requirements to be met to obtain these
licenses are:
- Application for prior import license: memorial with signature of lawyer and ad regent putting together:
o Proforma invoice for the products
o Photocopy of the regent's identity card
o Photocopy of the invoice corresponding to the payment for issuing the license
Once the request for a prior import license has been made, it is escalated to the Medicines and Health
Technology Unit, dependent on UNIMED, where it is analyzed whether the request is appropriate, if so, through a
ministerial resolution, and in a within a period of no more than 180 days, the import request is granted, after
signing the Commitment to Use Controlled Substances. The period for obtaining import licenses is a maximum of
180 days.
Finally, to introduce pharmaceutical products into the country, Authorization must be requested. ra the Customs
Clearance of Controlled Substances, issued by the Ministry of Health.
The requirements to obtain this certificate are:
- Note Request for Authorization for Customs Clearance, addressed to the Directorate of Me medications
from the Ministry of Health, attaching:
The National Customs of Bolivia establishes specific requirements for the importation of some of the types of
medications studied in this document.
4. OTHER BARRIERS
4.1. TRANSPORT
The distance between Spain and Bolivia and the fact that the latter has no access to the sea, affects the cost and
competitiveness of Spanish products that reach the Bolivian market.
13 General Customs Law: Law No. 1990 of July 28, 1999, modified by Law 615 of December 15, 2014
The majority (in volume) of the pharmaceutical products that enter Bolivia from outside the American continent do
so through the ports of Arica or Iquique, both in Chile, and from there they go by road to Bolivia. The current
precariousness of Bolivian road networks translates into longer transit time until goods reach their destination.
However, it is necessary to highlight at this point the work that is currently being carried out to improve the
country's logistics infrastructure with the recent inauguration of the La Paz - Oruro double road, or the paving of
the Tupiza - Atocha - Uyuni road, which allows not only to connect the populations of southern Bolivia, but also
the connection with Argentina, Chile and Peru through Oruro and La Paz. Added to this is the construction project
of the Bioceanic Corridor, nothing less than a train that will connect the Atlantic with the Pacific passing through
Brazil, Bolivia and Peru, thus lowering transportation costs and concentrating a greater volume of international
trade in the ports. Bolivian land areas of Ilo and Matarani
The transit time necessary to transport goods from the interior of Spain to the interior of Bolivia by sea and land
ranges between 35 and 45 days. If we add the times necessary to prepare the freight and the different
documentation, orders cannot be fulfilled in less than approximately 60 days.
The cost of freight varies depending on the transit time, the insurance of the merchandise or whether the
merchandise company is transported under the FCL (full container) or LCL (consolidated) regime. For the case of
ma raw materials, active ingredients, etc. Depending on the needs of the laboratories, a complete container could
be filled, however, to save storage costs and given that these are more or less perishable products, the LCL
regime is the usual one.
As previously mentioned, Bolivia has enough capacity to supply itself with medicines. Generic products, however,
need to import those products that are more complex and have greater added value. Many of these medications
enter the country by air, under very specific transport conditions, given that the products must be kept at low
temperatures throughout the entire logistics chain. All these requirements make the goods more expensive and
this affects the final price.
The following table indicates the volume and value of imports of the pharmaceutical products studied that enter
the country by air.
DEPARTURE WEIGHT KG FOB USD WEIGHT KG FOB USD WEIGHT KG FOB USD WEIGHT KG FOB USD WEIGHT KG FOB USD
2936 15.278 1.165.064 18.800 1.163.624 29.175 1.374.343 27.515 1.059.771 32.000 1.224.747
2937 1.449 211.044 3.442 323.364 1.299 290.734 1.199 448.968 1.776 306.178
2941 32.772 2.442.522 25.724 2.039.033 26.561 1.650.423 30.479 1.902.185 35.250 2.315.165
3001 1.449 266.127 328 241.847 196 6.237 373 78.947 563 182.494
3002 234.409 35.105.143 278.105 43.152.437 258.022 20.497.183 256.134 22.439.058 306.587 32.790.045
3003 4.382 176.154 1.824 37.503 1.154 42.223 1.939 217.018 4.366 353.062
3004 705.396 40.898.415 800.014 46.362.561 869.940 52.170.751 833.158 52.911.292 824.172 53.379.136
3005 2.446 112.375 8.568 287.503 7.649 253.003 11.195 399.651 20.999 425.580
3006 58.832 4.022.907 48.468 4.377.046 56.128 4.917.399 48.576 4.948.690 55.856 5.328.425
TOTAL 1.056.413 84.399.751 1.185.273 97.984.918 1.250.124 81.202.296 1.210.568 84.405.580 1.281.569 96.304.832
%
TOTAL 18,16% 60,99% 18,54% 61,02% 17,80% 53,31% 16,83% 51,62% 17,76% 54,35%
RESPECT
Source: INE
As can be seen, although in volume, the products that arrive in Bolivia by plane are less than 20% of the total, in
value they represent more than half of the imports. By tariff headings they are 2937 (Hormones, prostaglandins,
thromboxanes and leukotrienes), 3001 (Glands and plus organs for opotherapeutic uses, dried or pulverized) and
3002 (Blood), which have a higher price (FOB value ratio in USD / weight in Kg.).
Regarding the terms of trade, the majority of Spanish exporters choose to exi require advance payment for the
merchandise, or at least a percentage of it.
In addition to the above, it must be taken into account that Bolivian customs can be complicated you give. The
bureaucracy is excessive and the merchandise can be detained at the various controls.
4.2. SMUGGLING
Approximately 20% of the medicines that enter Bolivia are smuggled or falsified. sified. This activity not only
represents unfair competition for companies that import so legally, but it is also a risk to the health of end users.
The National System for Surveillance and Control of Medicines 14 try to fight against side through inspections in
the different establishments. Likewise Peru and Bolivia in April
14 National System for Surveillance and Control of Medicines whose legal basis is the Medicines Law No. 1737 and the Supreme Regulatory
Decree No. 25235
2014 agreed to a joint fight to try to reduce smuggling through the Comi Peruvian – Bolivian Binational sion to
Fight Against Smuggling.
ICEX
Economic and Commercial
Spain 3 Office
Export 6 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
9. SECTOR OUTLOOK
The Bolivian pharmaceutical market is in full expansion. The economic boom, the increase in the standard of
living and advances in health mean that increasingly stable foundations capable of providing medicines are
opened in the country.
Pharmaceutical laboratories are undertaking heavy investments that allow them to develop llar higher quality
products. In the last 4 years the investment has been approximately 95 million dollars and in the last 10 years
production has doubled. However, he grew The development of the sector and market demand is such that
despite the increase in national production, imports have grown by approximately 30% in recent years.
In relation to public purchases by the State, the preference for a low price at the time of ad buying medicines
gives a strong advantage to Asian products, whose manufacturing costs cation no longer have competition for
Chilean, Argentine or Brazilian products that have cheaper transportation costs.
With regard to European and Spanish products, the differentiation in quality, the capacity ability to produce
more specific products with greater added value, the renown and experience of its laboratories, together with
greater efficiency in production and transportation technology. size, represent its strong assets for penetration
into the Bolivian market.
10.
Together with the previous section, business opportunities in the Bolivian pharmaceutical market involve the
introduction of those medicines whose production requires technological capacity. nological not installed in the
country.
Medicines to combat cancer and diabetes are good niches for the market due to their incidence.
According to World Health Statistics prepared by the WHO in 2012, in Bolivia 10% of the population suffers
from diabetes and the forecasts are not very promising. The data indicate that an average of 160 new cases
are diagnosed every day (The Bolivian population is just over 10 million inhabitants).
Regarding cancer, there are currently about 15,000 patients diagnosed with this disease. medity. According to
the Cancer of the Americas 2013 report prepared by the Paname Organization Ricana de la Salud, the types
of cancer that have a higher mortality rate in Bolivia are cervical, lung and stomach cancer. The same report
indicates that, unlike Like other countries in the region, cancer mortality in Bolivia is increasing.
The WHO indicates that this type of disease, called non-communicable, will increase significantly sibably until
2030, especially in developing countries. In the case of the countries In developing countries, the highest
incidence of these diseases is due, on the one hand, to the better standards of living achieved and, on the
other hand, to health infrastructures and vention that despite development still present deficiencies. In Bolivia,
the possibility of dying from any of these diseases is 18%.
For the control, treatment and information of these diseases, the Ministry of Health establishes the Non-
Communicable Diseases Program.
ICEX
Economic and Commercial
Spain 3 Office
Export 8 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
1 . PRACTICAL
1. FAIRS
1
There are no large fairs dedicated to the pharmaceutical and health sector in Bolivia. Last February the first
edition of the health fair took place.
- Health Fair promoted by UPEA (Public University of Alto)
Edition: first (February 2015)
Location: Viacha (Department of La Paz)
There are other multi-sector fairs in which pharmaceutical products have a place, associate tions of the
medical equipment sector and companies. The most important ones are:
- Santa Cruz International Fair (Expocruz): XXXII edition ( http://www.fexpocruz.com.bo/ )
- Cochabamba International Fair (Feicobol): XXXIX edition
( http://www.feicobol.com.bo/ )
2. SECTOR ASSOCIATIONS
Some associations related to the sector are listed below:
- CIFABOL: Chamber of the Bolivian Pharmaceutical Industry
Av. Marshal Santa Cruz Nº1932. National Chamber of Commerce Building
Tel: +591 2 2364271
Email: cifabol@entelnet.bo
ICEX Spain
Export
3
Economic and Commercial
Office
9 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
Citizen security
Bolivia is a relatively safe country for travelers, which does not mean that they should not Take due
precautions to prevent crime, especially in street markets, at bus terminals and at night.
As in any other city, you should avoid the suburbs and more marginal areas. However, a significant increase in
crime has recently been observed in the cities of Santa Cruz and La Paz where robberies in single-family
homes and chalets would make it advisable to give preference to renting apartments with security over single-
family homes.
Caution should also be taken with the taxi service due to the risk of robberies or kidnappings. It is advisable to
pre-book a taxi service by phone or use the smartphone application hones Easy Taxi which shows the name,
car model and license plate of the taxi driver who has just been booked.
ICEX
Economic and Commercial
Spain 4 Office
Export 1 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
Legal security is an aspect that must be taken into account mainly for activities that have to do with
investment. Trials in Bolivia are very long and expensive, while going to court has become a very complicated
task, sometimes marked by corruption. The APPRI (Reciprocal Investment Promotion and Protection
Agreement sions) between Bolivia and Spain has been denounced 15 , so that although there is security for
investments made prior to July 9, 2012 for the following ten years, all those investments that have been made
or are going to be made after that date are not protected by the agreement. Currently, work is being done on a
new Investment Law, the terms of which still do not guarantee protection to foreign entrepreneurs.
In this section, it is worth highlighting the importance of agreeing on a secure payment method that covers the
Spanish company against possible fraud. Prepayment is the safest option for most cases
Bolivia denounced the APPRI with Spain on January 4, 2012, six months before the end of its 10-year validity. (
15
http://www.comercio.es/atrabajos )
ICEX
Economic and Commercial
Spain 4 Office
Export 2 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
1. ANNEXES
1.1. MEDICINE SUPPLY IN BOLIVIA
The information in these graphs comes from the Medicines Market Study in Bolivia prepared by the Authority
for Supervision and Social Control of Companies (AEMP) in December 2013 with data from UNIMED
FIGURE 1. DISTRIBUTION OF MEDICINES BY ACTIVE INGREDIENT (OCT. 2013)
ICEX Spain 4
Economic and Commercial
Office
Export 3 from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
6000
5000
4000
1544
110
ICEX Spain
Export
4
4
Economic and Commercial
Office
from the Spanish Embassy
and in peace
Investments
THE MARKET FOR PHARMACEUTICAL PRODUCTS IN BOLIVIA
ICEX Spain
Export
4
5
Economic and Commercial
Office
from the Spanish Embassy
and in peace
Investments