As the country with the largest population in Latin America, Brazil is a market that the pharmaceutical industry cannot afford to overlook (Figure 1 and Figure 2). In recent years, the Latin American region has featured to an ever-greater extent in the global plans of pharmaceutical companies and Brazil is seen as a key market to help drive this growth.
"Many pharmaceutical companies have their manufacturing bases in Brazil and quite a few have their regional headquarters here," explains John Anderson of Rio de Janeiro´s Pro-Cardiaco Hospital, who previously headed up GlaxoSmith-Kline´s Brazilian operations. "It serves as a useful base for operating in the Southern Cone area of Latin America particularly within the Mercosur trading bloc"
Mercosur—a.k.a. Mercado Común del Sur (Common Market of the South)—is an ambitious economic integration project, which includes Argentina, Brazil, Paraguay and Uruguay1. It has also established various trade agreements with other South American countries. At present, Mercosur accounts for approximately 60% percent of South America's Gross Domestic Product and represents an area where 64% of the region's population lives1.
What makes Brazil of interest is that, despite its obvious attractions, pharmaceutical companies have found it difficult to operate in both in terms of sales and R&D. Brazil has often been described as an emerging healthcare market, but this terminology can understate the need to have a sophisticated strategy in order to benefit from the opportunities that exist. As Mr. Anderson highlights, patience is the key to the Brazilian market: "In the 1970s a number of U.S. companies became disheartened when they did not see an immediate return and left the market. It was a decision they regretted, particularly as it cost them a lot of money to re-establish themselves in Brazil. A long-term strategy combined with a careful evaluation of the economic and political climate is necessary for success to re-establish themselves in Brazil and the rest of Latin America."
Bill Sprigings, a regional international trade adviser (Healthcare & Life Sciences) for UK Trade & Investment, has seen similar challenges for British companies trying to enter the Brazilian market. "Brazil offers great opportunities for British healthcare product exporters, but it is not for the novice," he concludes. "This is no place for the 'me too.' Products need to be innovative and ideally designed to both reduce treatment costs and improve clinical outcomes."
In general terms the Brazilian pharmaceutical market has a potentially large consumer base as the population is growing and aging rapidly (see Figure 1). For example, between 1970 and 1991, the Brazilian population grew from 93.1 million to 146.8 million—an increase of nearly 58%2. However (or resultingly), Brazil has been described as a country that exhibits some of the most profound social inequalities to be found across the world. According to figures from the UK's Department for International Development Health Resource Centre, across Brazil there is a 63.4% degree of income inequality3.
"The country has both areas of affluence and areas of poverty," comments Dr. Paulo Wrobel, Adviser on Trade Promotion at the Embassy of Brazil in the UK. "This means that the opportunities in the Brazilian market are varied depending on a company's area of interest. About 85% of the population now live in cities and so urbanization is having a great impact on society." The changing epidemiological profile of the population has been accompanied by a rise in chronic diseases, particularly viral, cardiovascular, respiratory and metabolic conditions, and yet there remains a persistence of diseases associated with poverty and social inequality2,3,4.
Even the largest multinationals with years of experience of operating in a range of countries have found Brazil to be an extremely challenging market due to the political climate. This is because access to medicines issues have taken center stage in Brazilian healthcare and so the government has taken a tough approach to pharmaceutical expenditure and intellectual property. "Affordability is seen as one of the main problems in Brazilian healthcare at the moment," explains Dr. Wrobel.
This viewpoint is shared by Andrea Palluch of Kyowa-Hakko. "Many people among the economically active population do not earn much more than the minimum wage and not everyone in the population pays taxes," she comments. "This means that if medicines are not provided by the government, the majority of Brazilians will not have money to pay for them."
As Rodrigo Alberto Correia da Silva, founding partner of the law firm Correia da Silva e Mendonça do Amaral Advogados, outlines, "Brazil is now characterized by heavy government intervention in the area of healthcare products and services. Medicines have their prices fixed once a year through government analyses of market power and inflation. The decision is often seems more political then technical." Mr. Correia da Silva has worked with a number of industry organizations in the healthcare sector and is both chairperson of the Health Business Committee of The American Chamber of Commerce in Brazil and a Member of the Health and Legal Committee of the British Chamber of Commerce in Brazil.
Following years of underinvestment, in recent times the Brazilian government has become highly focused on improving the country's healthcare system. A key step forward was the Constitution of 1988 that created a new health system, the Sistema Único de Saúde (SUS – the Single Health System)5,6. The SUS brought together a number of healthcare institutions and hospitals across the nation under a single body of control for the first time5,6. In 1990, Brazil's Congresso Nacional (National Congress) passed additional legislation, which detailed how the new system would operate5,6.
Despite the changes that have been implemented since the establishment of the SUS, the healthcare situation in Brazil looks set to change slowly rather than dramatically. As Mr. Correia da Silva points out, Brazil faces a variety of healthcare challenges—some which are similar to those seen in other countries and others that are more specific and domestic in origin. "Around the world healthcare expenditure is rising, due to increased life expectancy and the cost of new technologies," he explains. "For Brazil the impact of these problems is made worse by poverty and the continuing failure of the government's healthcare system."
"There are about 180 million people in Brazil, but the government health budget remains fairly small," adds Dr. Laura Luchini, executive director of Eurotrials Brasil. "About 50 million people have health insurance that covers their health needs, but the remaining citizens rely on the public health system and this offers an inconsistent pattern of health care. The service can vary widely according to several local factors, such as the city or the area where the hospital or primary care unit is located."
In 2002, Brazil's healthcare spending as percentage of GDP was only 5.2%. This put it behind countries such as Argentina (8.0%), Chile (6.0%) and Mexico (5.5%)7. Brazil's per capita spending on healthcare was estimated at $50 per annum, which put it far below the $500 recommended by the World Health Organization7. However, as funding levels rise in Brazil the importance of managing this spending will become important. "Administrative efficiency and the distribution of funds have to be improved so that many hospitals across Brazil are able to provide the types of service that they should," remarks Mr. Anderson.
The financial problems that afflicted Brazil between 1999 and 2002 cast a shadow over the ambitious plans of those who wished to reform the healthcare system. Following the January 1999 devaluation of the Brazilian currency, the real, public spending was cut and emergency taxes were brought in to cut the national debt, which was over half of GDP8,9. Financial difficulties in neighboring Argentina and Uruguay only served to prolong any recovery in the Brazilian economy. At one point during August 2002, Brazil's currency lost 13% of its value8,9. The economic problems naturally affected the funding of healthcare and this had implications for the pharmaceutical market.
"The prices of medicines had been increasing gradually since 1994 and the public were becoming more and more concerned about this situation. Many had no access to privately bought drugs and depended on a sometimes limited Government distribution system," says Mr. Anderson. "The economic situation effectively added wood to the fire, bringing about renewed price controls for medicines and accelerating the arrival of generics." The commercial implications for pharmaceutical companies were dramatic. In 2002, Brazil's pharmaceutical net sales were estimated at $3.9 billion, whereas in 2001 they had been around $5.7 billion10.
These problems resulted in Mexico surpassing Brazil as the leading pharmaceutical market in Latin America (Figure 2). However, the economic situation in Brazil now appears to be more positive. "Despite the turmoil of the past years, the economy is set to grow by 3.5% through 2005," comments Dr. Paulo Wrobel. "Brazil now has a trade surplus of around $35 billion, which acts as a cushion to protect the economy. Inflation is between 5-6% and that is quite good by Latin American standards." The improvements appear to be reflected in a rebounding of the pharmaceutical market. IMS Health reported that in the 12-month period leading up to February 2005, sales through retail pharmacies in Brazil rose by 19%, surpassing the 9% sales increase seen in Mexico and the 13% increase in Argentina11. The most popular therapeutic categories in terms of sales were cardiovascular, central nervous system (CNS) and alimentary/metabolism11.
The government hopes that it will be able to maintain the economic recovery so that it can deliver its promises on healthcare. "Brazil still faces difficulties in improving its hospital infrastructure and ensuring their maintenance," says Ms. Palluch. "Some hospitals still lack sufficient numbers of staff to deliver a good service to patients" (Figure 3). Dianary Oliveira of LIBBS Farmacêutica Ltda. would like to see other weaknesses in Brazil's healthcare system addressed. "There should be more emphasis on preventive medicine," he believes. "We also need to ensure that physicians are not underpaid for their work within the healthcare system."
It is the long-term prospects that have encouraged pharmaceutical companies to commit themselves to Brazil. About 20% of the 370 established pharmaceutical companies in Brazil are foreign, mainly European or U.S., and it is estimated that they control about 70% of the internal pharmaceutical market (10). These companies also have a prominent place within Brazilian industry as a whole. For example, in 2003, Pfizer, Schering, Boehringer-Ingelheim, Bristol-Myers Squibb, Novartis and Organon were featured in a list of the top 100 companies to work for in Brazil12. The prestigious list is compiled on an annual basis by the Brazilian magazine Guia Exame12. Reporters from the magazine, who visited the companies nominated, based their results on employee surveys and an independent audit. Pharmaceutical companies have featured in this annual top 100 list since it was started seven years earlier12. Only 60 companies that appeared in the 2002 listings retained their place for 200312.
Companies must be officially authorized to operate in Brazil and their products must be registered with Agencia Nacional de Vigilancia Sanitaria (ANVISA) (Table 1). A number of international companies have established themselves in the market and have sought acquisitions. For example, the government emphasis on cost containment policies has recently attracted the attention of several international generics manufacturers.
|Table 1: The Philosophy of ANVISA
|Technical Regulation||Introduction of sanitary regulations assure consumers of the quality and safety of pharmaceutical products||Registration, inspection, sanitary surveillance|
|Economic Regulation||Introduction of policies to reduce the market power of the pharmaceutical industry and to increase consumer access to pharmaceuticals||Price controls, market monitoring, access policies, policies to encourage use of generic products|
ANVISA has visibly increased the number of generic applications that it has approved13. In public hospitals, doctors are required to prescribe generically and the government has been running a public campaign to educate consumers about generics. The official backing of generics has also been seen in the approval process. "The mix of the Brazilian market has changed," explains Mr. Anderson. "Branded products always had copies in Brazil, with these often being about 20% lower in price than originator products, but the market was cut up in a fairly defined manner. However, there is a lot of sensitivity about pricing and so new generics have emerged, with much lower prices."
Many would welcome changes in ANVISA's current approach to pricing. "I would like to see our regulatory authorities change their mind set to create healthy competition in the market and allow self-regulation to solve price problems," argues Mr. Correia da Silva. "This would help speed up authorizations, decrease bureaucracy and corruption and lessen the need for market intervention."
Multinational pharmaceutical companies have found it difficult to predict the outlook for the Brazilian market because of the tough line that the government takes over the pricing of branded products. The government describes its pricing approach as a negotiation process to determine a mutually acceptable agreement, but in many cases pharmaceutical companies believe they have few options but to agree to what is proposed. Although the government's policies are unpopular with the pharmaceutical industry, the resurgence of the Brazilian pharmaceutical market suggests that it is unlikely that companies would actively seek to shift their R&D investment elsewhere.
Although affordability of medicines has always been an important public issue, the government's tough approach to pricing essentially originates in its response to the AIDS pandemic. While other countries around the world have suffered delays in the political decision-making on how to tackle the AIDS crisis, Brazil took bold steps from the beginning, which are widely seen as having been successful5,14. Its National STD/AIDS Program (NSAP) set out to make AIDS treatments available free of charge to all citizens who needed them through the country´s public health care system15. This process began in the early 1990s and was strengthened by a 1996 Presidential Decree. This was backed by a public campaign to warn people about AIDS and World Health Organization data show that the number of AIDS cases reported each year has dropped since 1998 (Figure 4).
In 1998, approximately 90,000 Brazilian patients received antiretroviral treatments through the public health system, which represented over 70% of all the patients undergoing treatment within the major countries of Latin America15. Official figures show that between 1995 and 1999, the number of deaths in Brazil due to AIDS decreased by 38%15. In São Paulo, which accounted for 22% of AIDS cases in the country, death rates dropped by 54% between 1994 and 1999. Furthermore, the expenditure on antiretroviral AIDS treatments appears to have been compensated, to a large extent, by reduced hospitalization rates due to opportunistic infections. Brazil's Ministry of Health estimates that approximately 146,000 hospitalizations were avoided in the period of 1997-1999, allowing the country to save around $422 million15.
Having recently returned from the HOSPITALAR exhibition16, held in São Paulo, and through visits to local hospitals and research institutions, including the world-leading Oswaldo Cruz Foundation (Fundação Oswaldo Cruz - Fiocruz)17, Bill Sprigings was impressed by Brazil's dedicated approach. "Brazil has readily accepted the challenges it faced in the curbing of the spread of HIV/AIDS," he comments. "Every infected patient has received anti-retroviral drugs, leading to a halving of the prevalence rate over the last five years to around 0.6%."
Brazil's domestic pharmaceutical sector, particularly the organization Fiocruz, has been key to maintaining the supply of antiretrovirals. "Fiocruz is part of a huge industrial complex set up a number of years ago to develop the technology necessary for the production of modern medicines," explains Dr. Wrobel. "It now has a lot of experience in this area." In fact the involvement of Brazil's domestic pharmaceutical industry in tackling AIDS has led to newfound confidence in its capabilities and many companies are pursuing R&D projects in a range of disease areas. The country now has one of the most sophisticated domestic biopharmaceutical industries within Latin America. "Biotech R&D is expanding in Brazil because of the country's great biodiversity and the know-how in bio research from Brazilian Universities," Mr. Correia da Silva contends.
There is no doubt about the results of Brazil's anti-AIDS strategy, but it has not come without controversy14,17,18. In particular, the government decided to exploit a time lag until international patent rules applied in Brazil in order to produce its own generic versions of antiretroviral drugs. This has meant that a generic version of an antiretroviral combination cocktail that sold for $10,000 to $15,000 a year in the U.S. cost $3,000 in Brazil14,19. However, this approach brought it into dispute with pharmaceutical companies and the U.S., which complained to the World Trade Organization (WTO). On a global basis, the laws relating to pharmaceutical patents are in principle regulated by the WTO's Agreement on Trade-Related Aspects of Intellectual Property rights (TRIPS)14. There has been considerable debate as to what flexibilities are offered by TRIPS for countries dealing with serious health crises. Like Brazil, South Africa has also looked at setting aside international guidelines on intellectual property, stating that the enormity of the AIDS crisis gave it "medical emergency status"14.
More recently the government has threatened to break the patents of particular drugs, if the company concerned with its exclusive manufacture refused to lower its prices. In August 2001, there was controversy when Brazil's health minister threatened to strip Roche pharmaceutical's patent on the anti-AIDS drug Nelfinavir after six months of negotiations failed to lower the price. By manufacturing the drug locally, the minister estimated that the price could be reduced by 40%. Although Brazil has manufactured generic versions of anti-retrovirals, it was the first time it had openly threatened to strip a patent14,19.
Official figures show that the price of antiretroviral drugs has decreased steadily over the past decade, with the most dramatic price reductions relating to medications manufactured within Brazil, both by private companies and by national laboratories. Between 1996 and 2000, prices of drugs produced within Brazil, fell on average by 72.5%, while the prices of imported drugs dropped on average by 9.6% during the same period15. In 1999, 47% of antiretroviral medications were produced inside the country (92% from national laboratories and 7% from private companies) and 53% were purchased from multinational pharmaceutical companies15. Although there has been considerable media attention concerning the Ministry of Health's plans to produce several drugs internally under license, pricing agreements have actually been reached with a number of multinational pharmaceutical companies. This has made it more economical for the government to continue importing the drugs.
Although Brazil's direct approach to dealing with the AIDS crisis has not found favor with the pharmaceutical industry, it has heavily influenced the establishment of anti-AIDS programs in other countries. "Brazil's approach is widely seen as a success abroad," comments Dr. Wrobel. "There is considerable discussion on so-called south-south cooperation regarding AIDS and other diseases predominantly affecting developing countries. Countries such as Mozambique have been looking to Brazilian companies that have a growing experience in generic production."
Brazil is not only an important pharmaceutical market, but is also an important center for R&D (Figure 5), particularly clinical research. In principle the Brazilian market could cater to several types of international companies wishing to carry out research.
Ms. Palluch believes that the multiethnic nature of the population could prove advantageous. "In Brazil you will find descendants of native Indian, European, Asian and African ancestry. The diversity of cultures and eating habits in different regions could be beneficial when seeking results to extrapolate to a 'worldwide' scenario that is closer to reality."
"Brazil's huge population means there is a high incidence of developed and developing countries' diseases," states Dr. Luchini. "Furthermore, for companies working in niche areas, this situation increases the chances of finding individuals with rare diseases. Even if a few treatment options may be available, there are reference sites that have the relevant patient contacts."
"In many ways Brazil has an ideal environment for clinical drug development," believes Dianary Oliveira. "It has a multiethnic population, low development costs, qualified professionals and CROs." Despite continuing intellectual property controversies, he believes that the environment for patents has been strengthened. "Since 1997, when Brazil joined the World Intellectual Property Organization, the patent situation has improved for the pharmaceutical industry and this will improve the conditions for clinical research."
There is wide agreement that the relevant conditions for high quality clinical research exist in Brazil. "There is a high level of professionalism, expertise and experience amongst our medical doctors and nurses," contends Ms. Palluch.
"Several physicians have performed post-grad training abroad (mostly U.S. and Europe) and so clinical practice in reference hospitals is aligned with internationally recognized clinical guidelines," concurs Dr. Luchini. "At major universities, physicians have already been trained in GCP and are experienced in multicenter international clinical trials run to U.S.-IND or EU guidelines." Brazil has around 205 physicians per 100,000 of the population, which represents a potentially large pool of investigators for clinical studies20 (Figure 3). Dr. Luchini believes that there is a growing interest in clinical research within the Brazilian healthcare community: "Sponsors will find that less experienced investigators and site staff are enthusiastic to receive training. They view global clinical trials as a professional growth opportunity, because of the resulting international exposure to first class research and to internationally recognized Investigators."
Brazil also has a defined regulatory environment. The first enforced regulations concerning human research date from 1996, and are based on International Ethical principles (such as the Declaration of Helsinki). This defined the composition and roles of Institutional Ethics Committees (IEC), and also created a National Ethical Commission on Research (CONEP), to supervise the IECs. ANVISA also has a defined process for the regulation of clinical trials approvals and drug importation licenses. Yet just because there is a defined process does not imply efficiency as observers point out.
"Healthcare professionals together with the pharmaceutical industry should make every effort to change the minds of the regulatory authorities in respect of clinical trials," states Ms. Palluch. "Brazil could effectively lose out on conducting international clinical trials because of the delays caused by the centralized and bureaucratic procedure."
"The current regulatory environment for clinical trials is complex as there is a double track IEC-CONEP and ANVISA process," comments Dr. Luchini. "What we have experienced is that the approval process takes between four and six months to be accomplished, from final protocol to drug on site. Fortunately, as sites are well trained and highly motivated, patient inclusion is fast and compensates for the eventual delay to achieve First Patient First Visit."
"The original thinking behind ANVISA was to have an agency along the lines of the U.S. FDA, but unfortunately it does not have the Resources to operate in this way," concludes Mr. Anderson. "It can only change if there is the necessary political commitment."
Another problem is official and public attitudes towards clinical research. "There has been an element of paranoia amongst certain ethics committees that Brazilian subjects are being used as guinea pigs," comments Dianary Oliveira. In 2004 ANVISA started revising its regulations, outlining particular concerns regarding volunteer recruitment for clinical trials that are run at Brazilian centers21.
Perhaps more worryingly for the pharmaceutical industry, the subject of clinical trials was recently covered in the popular Brazilian soap opera "America," where a character volunteered to take part in a clinical study22. Ms. Palluch warns that such coverage should not be casually dismissed. "It is important to understand what a dramatic effect this can have on public attitudes given the audience that these types of programs achieve in Brazil, where they often appear at prime time," she explains. "It is going to be interesting to see how this issue is tackled by the writers. Yet more importantly, it shows that if we are to prove that the guinea pig concept of clinical research is outdated then clinical trial professionals must work hard to overcome any public prejudices towards medical research involving human subjects".
Given the difficulties of operating in the Brazilian market one might wonder why companies would persist in trying to succeed. However, it is worth remembering that pharmaceuticals remain in demand and that even established markets have their own operating difficulties. "People should always keep in mind that Brazil remains a large and growing market," suggests Mr. Anderson. "If you can set yourself up in defined areas and work at it you can achieve success. There are a few leaders in certain segments who have been thorough in applying their local knowledge. The key to the market is focus, discipline and a long term view."
One of the issues for the pharmaceutical industry at the present time is demonstrating that its research is geared towards helping alleviate the major healthcare problems in Brazil. "We need to get past the view that the pharmaceutical industry is simply intent on exploiting Brazil as an emerging market," argues Ms. Palluch. Other observers echo this viewpoint. "Pharmaceutical companies must drive their business in a responsible way and be aware of their social role," says Dianary Oliveira.
"The pharmaceutical industry can work for the benefit of the Brazilian people," adds Mr. Correia da Silva. "Its overriding image to the public should be as the fighter of disease."
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