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Analysis of the Ecuadorian pharmaceutical market

Analysis of the Ecuadorian pharmaceutical market : 작성자, 카테고리, 작성일, 조회수, 원문,출처, 정보 제공
작성자 관리자 카테고리 전문가 인사이트
작성일 2016-01-12 조회수 1,758
원문
출처

Analysis of the Ecuadorian
pharmaceutical market

전문가
글 Esteban Ortiz-Prado
GPKOL위원
학력사항
  • 2009 University of Calgary / Medical Science(MS)
  • 2005 University of Ecuador / Medicine(MD)
경력사항
  • 2013-2015 Manager, R&D department, ENFARMA
  • 2012-2013 Senior Adviser, Minister of Higher Education
  • 2011-2012 Clinical Research Coordinator, Tom Banker Cancer Centre
  • 2006-2010 Research Associate, Department of Radiology University of Galgary
세부 전문분야 및 컨설팅 내용
  • R&D Planning : I worked until august 2015 as the manager or director of the R+D of the only government owned pharmaceutical company in Ecuador
  • Clinical Trial : I directed the first vaccine clinical trial lead by the government of Ecuador for the pentavalent vaccine
  • GMP, GCP and Regulatory Affairs : All the regulatory needs in order to register a new product, homologation for Korean products and experience rebuilding the vaccine facility in Ecuador
  • Project management : All the necessary experience for Drug discover, Project management, Research Team building, Scientific writing for grants competition and academic diffusion, Carry out clinical trials (Phase I-IV), Offer higher recommendations , Conferences and academic events organization, Regular capacitation’s, Regulatory affairs

Table of Contents

ABSTRACT

INTRODUCTION

Analysis of the pharmaceutical market in Ecuador

Drugs Commercialization Tendency

Pharmaceutical market stucture

The Market´s response

The present role of the State

Conclusion

References

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ABSTRAC

The Ecuadorian pharmaceutical market it is characterized by a complex system of drug distribution. The objective of this research is to conduct an analysis of the pharmaceutical market in the country, the trend of marketing with or without a prescription, the price preferences as to the type of product and the state's relationship with this industry.
Within the distribution system identified, 2 pharmaceutical chains account for 53% market share and 93.3% of sales in the past year. Referring to the type of drug, 69.6 % of costumers consume brand name drugs and 30.4% buy generics, in a market in which only 6.85% of drugs are generics. There has been an increase in the price of brand name drugs of 12.5% in the last 5 years, compared to a raise of only 0.86% for generics.
In Ecuador the pharmaceutical market moves an immense amount of money comparing to its population, the country consume more brand names than generics, mostly of them, imported final products. These features make the current pharmaceutical market very attractive for private companies, however, the overall productive matrix it is very negative and Ecuador spent millions in importations while exportations output are very small. Keywords: pharmaceutical market, generics, social investment, drugs

INTRODUCTION

The pharmaceutical market is a complex sector that involves diverse actors, from the process of investigation, development and production of pharmaceuticals, to its consumptions. According to data from the World Health Organization, while 14% of the population consumes 80% of the pharmaceutical production, the 86% consumes the remaining 20% (1). This demonstrates a breach of one third of the world population that has no access to essential drugs causing public health problems known in developing countries. Access to drugs is an indicator commonly used to measure the standard of living of a country due to its social and economic impact, as well as a good indicator for the expenses destined to the health sector (2). Such inequality is repeated on a global level with marked differences between countries, many of which have taken measures to exercise active participation and regulation by the state in order to obtain a more proper distribution for the population generating substantial savings for the country´s arcs.
In an industry that handles millions of dollars annually it is important to recognize the influence that the markets have over the prescriptions methods of many doctors and specialists, due to the incentives towards the prescriber or simply because of their role as promoters of the ”continuous medical education” which is a common practice in Latin-American countries causing outstanding earnings for the private industries, most of them being multinationals.
The objective of this present review is to analyze the pharmaceutical market in Ecuador, the tendency of its commercialization with or without medical prescription, the population preferences surrounding the use of brand drugs versus generic ones, the demand from the State, as well as its strategic role referring to the economic future of the country.
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ANALYSIS OF THE PHARMACEUTICAL MARKET IN ECUADOR

What composes the Ecuadorian pharmaceutical market is the result of the interrelation between the enterprises that integrate the local and multinational pharmaceutical industry and the interaction between them and the different actors and institutions that conform the Ecuadorian public health system and the private market.
In Ecuador, every pharmaceutical market sector is regulated by the Ministry of Public Health, which is the governing body of health of the State and responsible for giving the authorization to commercialize drugs based on the demand and the determination of its risks through the recently created National Agency of Sanitary Regulation, Control and Vigilance (ARCSA).
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In the institutions and private markets, the pharmaceutical enterprise sector confronted various changes that were posted by the National Government regarding topics such as the fixation of prices through the Inter-ministry Committee of Prices in which intervened the Ministries of Public Health, Industries and Productivity, Social Development Coordination and Production Coordination, Employment and Competitiveness; the management and dispense of pharmaceutical products and its access to the population (3).
In this sense, although the prices of drugs of first need have had to be restricted, there is still a marked difficulty in most of the imported products, orphan products or of little consumption, causing higher costs for the population and the integral health system of Ecuador.
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Figure 1 Ecuadorian Market 2007-2011

Historically, the Ecuadorian markets has been considerably big compared to its population needs and to the epidemiology of the principal causes of mortality and morbidity. This is one of the reasons why the market has been growing significantly in the last years according to the Central Bank of Ecuador to approximately $1,200.000.00 USD (4,5) (Fig 1).
According to data from the Association of Pharmaceutical Laboratories of Ecuador (ALFE), around 85% of the drugs commercialized in the country are imported, contributing to expenses outside the country (5)
Siguiendo con esta lógica, el hecho de tener empresas locales productoras de fármacos no garantiza que los recursos se queden en el país, ya que muchas de estas empresas o casi todas, importan el principio activo por toneladas o el producto finalizado per se sin necesariamente contribuir al cambio de la matriz productiva ya que la inversión que deberían destinar a la investigación es mínima, traducido en la poca producción científica de estas instituciones.
On the other hand, the pharmaceutical industry has seen Ecuador as its major client. This has caused that the demand that the State has to supply the needs of its health integral system, to be supplied mostly be the private industry.
In this sense, and to play an important role referent to research, production and commercialization of the pharmaceutical products, Ecuador in the year 2009 created by decree the only public enterprise of drugs with the aim of contributing strategically to the satisfaction of the basic needs of the population and to change the productive matrix.
According to official statistics, the bird population predominates over other productive species in the country (78.40%), therefore this is the population that demands greater attention for disease prevention, additionally these species epidemiologically have high levels of disease transmission. Secondly ranked is the cattle population (10.11%) which represents an important sector of the agricultural industry. These two sectors represent the largest share of veterinary vaccines in the Ecuadorian national market.
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DRUGS COMMERCIALIZATION TENDENCY

The Ministry of Public Health assigns the drugs to certain categories of care and stablishes its selling conditions. In Ecuador, the selling of drugs depends principally on the risks that they represent for the health of the people. Under this premises, they are sold under two denominations as “over the counter” and “with prescription” drugs (6).
In Latin-American, the drugs sold with prescription comprise around 70% of the total offer, being the remaining 30% over the counter. This differs from the US and Canada (12%), and Europe (19%) percentages of over the counter drugs sold (1, 7, 8).
The Ministry of Public Health registers the existence of 13.451 products catalogued as drugs commercialized by the country. This drugs include a same medicament in different presentations and concentrations; 69.6% of this drugs correspond to brand name medicaments and 30.4% to the generic medicaments (6,9).
From the registered products, 5.480 have a Provision of Drugs Sanitary Certificate, an indispensable document for selling this products to Institutions from the States. In a similar way, from all the registered drugs, 1.829 are considered as over the counter and correspond to the 13.6%, and 11.622 are prescription drugs which correspond to the 86.4%. This last group has 354 drugs commercialized exclusively to medical establishments (9, 10).
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Table 1 Type of products available in Ecuador, Source Enfarma 2014, Ortiz-Prado 2014

PHARMACEUTICAL MARKET STUCTURE

The structure of the pharmaceutical market in Ecuador is highly competitive at the end of the production chain. The demand for drugs in the country is determined essentially by doctors´ prescription given in consulting services, ambulatory attention, hospitalization and rehabilitation, and/or by the user (auto-medication – auto-prescription), and depends directly on the level of earnings of the population, the prices of the drugs, the mechanisms of financing for its acquisition, the structure of the offer, the regulations for the access, the management and use of the drugs, and the epidemiologic profile of the population (1, 5, 11, 12).
In the country there are around 6.000 pharmacies, almost five times more pharmacies per habitant than in Chile (Table 2) (13). Ninety percent of the pharmacies are found in urban areas and only 10% in rural areas. It is important to point out that 53% of the country´s registered pharmacies belong to two main pharmaceutical chains: the Farcomed Group with Fybeca and Sana Sana pharmacies, and the Difare group with Pharmacys, Cruz Azul and Comuniatarias pharmacies (5,14).
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Table 2 Pharmacies per country and per capita, Source, Government of Chile

The private pharmaceutical market has experienced a considerable growth related to its sales in the last five years, going from $680.94 million dollars in 2007 to $1.142,49 million dollars in 2012, which represents a 56.6% growth. In the last year, the country´s two principal pharmaceutical chains, Farcomed and Difare, declared earnings of $1.066 millions of dollars comprising 53% of the private market sales of drugs (14, 15).
As to the evolution of the institutional pharmaceutical market, there is a considerable growth passing from $107 million dollars in the year 2008 to an investment of $300 million dollars in the year 2012, turning the market appealing for the national and international pharmaceutical industry. In this context, the Ministry of Public Health indicates that 84.58% of the commercialized drugs in the country are imported. According to the origin of the capital, the Ecuadorian pharmaceutical market would be composed by 37.94% of European origin, 25.27% Latin-American, 19.71% North American, 1.66% Asian and 15.42% national (4, 5, 9, 10).
As to the evolution of the institutional pharmaceutical market, there is a considerable growth passing from $107 million dollars in the year 2008 to an investment of $300 million dollars in the year 2012, turning the market appealing for the national and international pharmaceutical industry. In this context, the Ministry of Public Health indicates that 84.58% of the commercialized drugs in the country are imported. According to the origin of the capital, the Ecuadorian pharmaceutical market would be composed by 37.94% of European origin, 25.27% Latin-American, 19.71% North American, 1.66% Asian and 15.42% national (4, 5, 9, 10).
This captive market represented by the State is very susceptible due to the majority of requirements are made in each of the Operative Units, this is consolidated in the Ecuadorian Ministry of Public Health which summons a public competition, where the best bidder is the winner, existing in many cases drugs without offer, others with irrational offers, forcing the acquisition of drugs with a higher cost for the State than for the private health system.
Another point of conflict was the lack of decisions base on pharmacoeconomic analyses, for example in Ecuador, the reverse auction of 2011, the State bought Atorvastatin for more than 44 million dollars, a disproportionate petition in relationship the morbidity of the country and to the rational knowledge of its use(fig 3).
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Figure 2 National demand for Atorvastatine

To study the private pharmaceutical market in more detail, there are two analysis categories; the first is to determine the sales margin of the drugs according to its category of dispensation, being “sold with prescription” and “over the counter”, the second is to stablish the market preferences according to the sales margin of the drugs according to the type of product, being “brand name drugs” and “generic drugs”.
By analyzing the data of the type of commercialized product in the pharmaceutical chains, we can stablish that 93.15% of the earnings correspond to the sales of brand name drugs and 6.85% to the sales of generic ones. The sales figures of generic drugs is low, considering that 30 years ago this occupied 3% of the market. This indicates that, although the organic law of health in force in the country obligates the doctors to prescribe generic drugs, the doctors do not do it accordingly or the patients access the drugs through the aggressive and excessive market of the pharmaceutical industry.
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THE MARKET´S RESPONSE

The capacity that the offer has to determinate the demand of drugs is determined by the marketing strategies of the produces and providers of drugs, as well as the incentives and benefits given to the doctors and pharmacies (16-18). In many cases, this doctor-prescriber-pharmaceutical industry relationship turns into a problem when the prescribed medicine is not necessarily the most effective or the most cost-effective.
In this context, the most sold drugs in the country are not necessarily related with the epidemiological morbidity that the Ecuadorians suffer and that take them to health units. The WHO has described that more than half of the prescribed drugs are dispensed or commercialized in an inappropriate manner. This has generated an excessive, insufficient or inadequate use of the over the counter drugs and or the prescribed ones. The WHO advises the countries to execute national programs for the rational use of drugs. In other words, it is procured to incentive that “The patients receive the appropriate drugs for their clinical need, with doses adjusted to their particular situation, during and adequate period of time and worth the minimum possible cost for them and for the community” (1, 19).
Related to this guidelines and to the constitutional principles, since the year 2006, the National Policy of Drugs (PMN) is in force in Ecuador. The PMN is directed to universalize the access to generic drugs in order to assure its availability to the whole population. The Basic Drugs National Frame (CNMB) is a compendium where the drugs considered essential are found. The presence of this drugs is related to the epidemiology of the country, Table 2 has the antibiotics that occupy the first place in number of active ingredients and pharmaceutical formulas included in the CNMB.
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Tabla 2. Estructura del Cuadro Nacional de Medicamentos Básicos IX Revisión.

In the ninth revision of this document there are 397 active ingredients registered corresponding to 533 pharmaceutical forms, 725 concentrations and 755 items consistent with the epidemiological profile of the country (6.20).
The regulation in force establishes that the pharmacies can commercialize over the counter and prescribed drugs. Under this conditions, the country´s most sold prescribed product on a private level during 2012 was a medicine for the treatment of asthma and the most commercialized over the counter product was an anti-inflammatory medicine (14).
One must consider that the spending on health is 40%, despite the strong intervention in health from the State. Although the price of drugs in the last five years has increased 12% globally (12.5% brand name and 0.86% generic), this economical stimuli for the consumer seems not be and incentive for the consumption in general (1, 10, 15, 20).

THE PRESENT ROLE OF THE STATE

The Ecuadorian pharmaceutical market composition is the result of the interrelationship between the enterprises that integrate the pharmaceutical industry and their interaction with the State Institutions “institutional market”, the Private Health Institutions and the community play a fundamental role referring to the private market. In this last two, the pharmaceutical enterprise sector confronted some changes introduced by the National Government referring to topics such as the fixation of prices through an Interministry Price Committee. The Ministries of Public Health, Productivity and Industries, Social Development Coordination, Production Coordination, Employment and Competitively intervene in this decrees as well as the management and dispensation of the pharmaceutical products and the population access to them (5, 10).
In Ecuador, the national Government established the National Plan of the good living, which contains twelve peremptory national objectives for the State, of which one of their goals makes reference to "Improve the quality of life of the population", where the health is the Foundation for achieving this aim (4.21).
To meet this objective and considering the pharmaceutical industry as a cornerstone of development. In 2009, the national Government created by Executive Decree ENFARMA EP, the only public entity dedicated to the research, production, import and direct marketing of most of drugs using human, veterinary and agricultural inputs.
In this context, ENFARMA EP has created several projects such as the construction of a pharmaceutical complex, a vaccine production plant, a natural products Research Centre, a biotechnology development centre, a pilot plant and a center of clinical trials.
In this regard, and while the projects are completed, ENFARMA EP have an important role in the marketing of pharmaceutical products in Ecuador, facing a near future where the macro production of this company would fill more than 100 essential drugs, at low cost and high quality for a population Ecuadorian and regional. In turn, ENFARMA EP proposes to take up the challenge of promoting a development based on the discovery of active ingredients of human, veterinary or agricultural use mainly coming from our mega-biodiverse country, process known as bioprospecting and strengthen a strategic development of this field axis as it is biotechnology.
Bioprospecting is an important tool, however it is necessary to establish mechanisms, strategies and rules that optimize the process of obtaining new knowledge and technologies. In the case of natural products for the pharmaceutical research is necessary to perform a search and comprehensive selection of resources of therapeutic value, to subsequently perform its scientific validation; since, in many cases there is no scientific information that supports the therapeutic use of certain species.
Finally, it is important to note that the simple establishment of a public company has managed to lower the cost of drugs, either through better prices, compulsory licenses, approvals with friendly countries or pharmacological products on-demand registration.

CONCLUSION

The role of drugs both in the prevention of disease and the restoration of health is undisputed, however the misuse of it can result in a major health problem pubic, bulking thus public expenditure on this item. In this complex scenario health authorities face major challenges in the exercise of the rectory on the marketing of drugs it due to a very large, poorly distributed market and in continuous growth as well as the variety of pharmaceutical products, therefore it is necessary to abide to the drugs control policy both free consumption as well as of prescription , the continuous use of the best evidence to thus optimize resources, as well as the use of therapeutic equivalent with best profiles pharmacoeconomic than many of the drugs trade. Finally, recognizing the critical role that a public company with a social vision per turn commercial, can provide for the benefit of the country in the field of production, research and marketing of these products.

REFERENCES

3 requirements:

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