Innovation and Clinical Research in Brazil
Innovation and Clinical Research in Brazil S ﾃグ
E D I T I O N S
PAU LO, O C TO B E R 2010
S P E C I A L S V O LU M E
I I
H E A LT H
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G E N E R A L C O O R D I N AT I O N
Octávio Nunes Institutional Communication Manager
Missieli Rostichelli Institutional Communication Assistant
Phone: (55 11) 5180-2395 missieli@interfarma.org.br C O M M U N I C AT I O N L I A I S O N
Burson-Marsteller Selma Hirai Phone: (55 11) 3040-2403 (Burson-Marsteller) Phone: (55 11) 5180-2305 (Interfarma) selma.hirai@bm.com EDITORIAL PROJECT
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63,000 copies PHOTOS
Interfarma Database A B O U T I N T E R FA R M A
Interfarma – Pharmaceutical Research Industry Association – is the entity that gathers the pharmaceutical industries installed in Brazil responsible for promoting and stimulating research and development of new medications. Founded in 1990, Interfarma gathers 36 laboratories that represent 57% of the Brazilian market in medication. In September 2010, the association changed its bylaws and began to represent national companies and researchers.
Innovation and Clinical Research in Brazil
Because I am the size I see myself and not the size of my height FERNANDO PESSOA
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Innovation and Clinical Research in Brazil
Introduction Urgent and deep improvements in Brazil’s public health system have become the population’s major demand. During the election campaign to choose the new government, opinion surveys revealed that concern about medical care, hospital admissions and access to medication is the main anguish of the Brazilian population, greatly out-distancing public safety, ranked second. Curiously, the population’s demand for health results in part from Brazil’s advances and in part from its difficulties. As other important problems such as inflation, employment and economic stability are being overcome, our public health shortages become more visible and incomprehensible. At the same time, we have historically coexisted with results that fall short of what is needed in governments from every period, region and political position. It is true we have much to celebrate as a country. We have expanded vaccine coverage, increased the number of health agent teams, reduced infant mortality rates, raised the s life expectancy. However, we continue to lack resources, management and innovation in many other segments of public health. And in this aspect, Brazil’s development has curiously become a generator of new problems. As we combated and improved in public health, our country’s profile of diseases advanced, demanding more complex solutions. Before we were able to get rid of dengue fever or the lack of sanitation, hypertension, diabetes, the s—called diseases of progress, of aging and of urbanization were here to stay.
The leaders who take office in 2011, regardless of position or party, will have a challenge in common: the population has elected health a priority. And it expects concrete results. Interfarma, an Association that represents the Pharmaceutical Research Industry, understands that any advance in terms of public health shall first of all demand a constructive, rational and unbiased debate, because no attempt at a solution will resist partisanship, backward points of view or the search for consensus, without which public policies become fragile and efforts useless. As its contribution, Interfarma has sought to stimulate debate in an open, democratic and pluralistic manner. It has held seminars, begun to publish Reports on the fundamental issues of public health and it has participated in every area of initiatives that contribute towards our authorities. This publication on Clinical Innovation and Research is part of this effort and this vision. It contains data, opinions and arguments about the role Brazil could play in Innovation, the difficulties that hinder it from assuming a more important role and the paths the next government can study related to the subject. Sincerely,
Eloi Bosio
Antônio Britto
Chairman of the Board
CEO
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Brazil, Land of Opportunities
There is a lack of private initiative
Brazil has advanced in innovation, but it could be many steps ahead if it applied itself firmly to the task. The excellence of some of its research and development centers, as well as the evolved scientific foundation and knowledge the country generates, is important. In agribusiness, biofuels, the automotive and aeronautical sectors, mining and information and communication technology, the country stands out. However, it could be more, and could generate new wealth, if Brazilian innovation was also competitive in other areas and Brazil decided to enter the global research and development chain with determination.
A country’ patent request process is directly related to its capacity for innovation. Despite the extremely favorable scenario, Brazil is only ranked 23rd in patent requests in the WIPO – World Industrial Property Organization ranking, with 496 requests. This ranking is an indicator of companies and institutions that request a deposit in some international institute. In Brazil, the INPI – National Industrial Property Institute – has registered nearly 25 thousand requests for patents in all areas. But a patent registered here does not guarantee protection abroad. Some specialists credit this small number of patent deposits abroad and the difference in comparison to deposits in the INPI in large part to timidity and a lack of business culture.
Brazil has countless instruments to be among the top countries in innovation: it is the 7th biggest economy in the world; international reserves are kept at a good level; the banking system has proven its efficiency; it has political and social stability, and; it has the cleanest energy matrix in the world. The positive profile continues: Brazil has one of the largest domestic markets in the world; it is one of the major exporters of foods, and; it was able to establish a totally diversified foreign market. Add to this scenario, qualified institutions and personnel, as well as national and multinational companies in conditions to speed up the innovation process in every sector. This has not occurred with the speed and vigor of other countries, more daring and engaged in the concept of innovation. Without citing the biggest economies, some countries, like Singapore and South Korea have raised the innovation banner. They have an aggressive attitude in this area and are thus standing out in the global picture, says Antônio Britto, CEO of Interfarma – Pharmaceutical Research Industry Association. “Ambition is lacking. Although it has advanced, Brazil is still timid in relation to its size and the role it needs to perform. If we compare what the country was doing with what it is doing, it has advanced, but Brazil is not the only one in this race If we increased our speed from 20 to 50, others out there increased it from 80 to 120. So, we are less daring and aggressive than the others, despite the improvement,” says Britto.
Area specialists say this is most probably uncertainty and insecurity on the part of business owners in face a government that took too long to define and guarantee instruments for protecting innovations. “The system for protecting industrial inventions is one of the fundamental elements for stimulating research and development in search of new technologies,” affirms Gert Dannemann, director of the Dannemann Siemsen Institute for Intellectual Studies and Property. The Institute director says the success of countries like Germany, which became the second largest global exporter due to the quality and high technology of its products, stems from the guarantee the country’s laws give patents. Ricardo Camargo Mendes, from the Prospectiva – International Business and Public Policies – consultancy, says Brazil’s patent legislation is advanced and in compliance with international treaties, but he says the rhetoric from some of Brazil’s representatives abroad sometimes disqualifies any right to intellectual protection, especially
What do the scientists think “The consequence of this is low investment by companies in research and development,” says Carlos Henrique de Brito Cruz, scientific director at FAPESP – Research Support Foundation of the State of São Paulo – and former dean of Unicamp – University of Campinas.
Innovation and Clinical Research in Brazil
in the area of medication, which ends up driving outside companies away. “It is common for us to receive multinational business leaders asking whether Brazil has industrial protection laws,” says Mendes. These arguments can be observed in the numbers. According to data from the Ministry of Science and Technology, the companies invested 0.5% of GDP – Gross Domestic Product - in innovation in 2009. In some countries, investment in research is four times higher than in Brazil.
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Law deficiencies are in their enforcement Patent requests stop in the long waiting line at the INPI due to a lack of structure and technicians For some specialists, if legislation advanced, its enforcement by INPI still depends on agility and investments in human resources. According to the analysts, the law was much more comprehensive and innovative than the body’s capacity to enforce it. Today, the institute has 270 patent examiners, including senior, junior and regularly hired personnel that are in training, a period that can take from two and a half to three years.
The eye of the researcher “Business investment in research in the most developed countries is three to four times greater than it is in Brazil,” says the FAPESP scientific director, Carlos Henrique Brito Cruz. In South Korea, that number jumps to 1.6%, and in Japan and the United States, to 2%. Altogether, Brazil invested the equivalent of 1.1% of GDP in innovation, 0.6% on the part of the government. This is a much lower percentage when compared to Korea and Singapore, which invested 2.5%, and OECD - Organization for Economic Cooperation and Development countries, plus China and Russia, with 2.3% on average. These numbers also explain why, in Brazil, patent deposits at the INPI and European and American bodies by universities correspond to 58% of the total, whereas in the United States and in developed countries “90% of the registrations are made by companies”, says Brito Cruz.
Júlio César Castelo Branco Reis Moreira, advisor to the INPI patent directorate, says that number of examiners is not sufficient to handle the federal government’s institutional strategic planning goal, which is to reach 2014 making at least one exam of all requests deposited in 2010. “We have areas in INPI today examining deposits from 2004 and 2005,” says Reis Moreira. “In critical areas, such as electronics, where the shortage of personnel is greater, we are still examining the end of 1999 and beginning of 2000.” According to the Institute, the pharmaceutical sector is following along at the same pace as the others, although it has received more attention lately. “Today there are 75 examiners handling the drug area, 70% with PhDs. We believe that is a sufficient number to handle the requests in this area and reduce the backlog,” -says Reis Moreira. According to the Institute, on average, Brazil takes four years to analyze a patent request, twice the time consumed by European and American bodies. The process, which is common to the patent system in most developed countries, demands that once presented, the request be kept secret for 18 months. After that quarantine, the patent applicant has another 18 months to confirm whether he wants his request analyzed or not. That means, says Reis Moreira, that when a request is at the INPI since 2000, it is late since 2003, the year it was put on the list for analysis. That period is called a backlog.
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Fewer PhDs, less training
“The fact that an institution owns a patent guarantees it the correct use of that invention.” In the last year determined, USP and Unicamp deposited 1006 patents at the INPI, more than all the other university institutions together.
If on one hand, companies face bureaucracy and certain
Another fact recalled by Fapesp scientific director Brito Cruz is the small number of PhDs working at companies. While here only 23% of them are in the production sector, in South Korea that percentage jumps to 54%, and in the United States to 80%. “Brazil needs to further increase training in basic science and the preparation of people at universities. It needs to accelerate training for applied research and technological development at companies,” says Brito Cruz.
contradictions in the processes that should provide incentives for innovation, the universities could expand their space if they adopted a greater “patent culture and learned to have patents”. “There is still great difficulty at USP (University of São Paulo) and Unicamp (University of Campinas), for example, in transforming scientific production into protection,” observes Luiz Fernando Reis, director of the Institute for Teaching and Research at Hospital Sírio-Libanês, one of the country’s references in research and health care.
Scientists agree there is resistance on the part of companies in hiring researchers, but, on the other hand, on the university benches there is still an important shortage of PhDs and Post-PhDs, precisely those at the top of knowledge. Brazil graduated nearly 11 thousand PhDs
Revenue versus Innovation In some aspects, it is the Industrial Property Law that hampers innovation. In others, government bodies are the problem. But there is also the Internal Revenue’s de-stimulating action in the case of the Technological Innovation Law. Regulated by decree in October 2005, the law was viewed as a big push in the sense of driving and stimulating new technologies. It stipulates “incentive measures for innovation and scientific and technological research in the productive environment aimed at achieving the country’s technological autonomy and industrial development." One of the instruments created by the law to facilitate research was the Income Tax deduction for the following year of spending on innovation during the current year. “Well regulated and well designed, the law could greatly increase investments in innovation,” says Ricardo Mendes, of Prospectiva. "Not paying taxes to develop a new technology is interesting for everyone. Many other countries do that, like
China and Singapore, for example, countries that are attracting much investment in research.” However, in Brazil, from the Internal Revenue perspective, “it is the one that determines what is and is not innovation, not the INPI,” says Mendes. If it decides it isn’t, the company has to pay what it did not collect, plus interest and fines. “Many companies, including large multinationals, do not use the Innovation Law out of fear the Internal Revenue will have another interpretation, fear that its research will not be seen as an innovation. So, to avoid that liability, they end up not taking the chance,” says Ricardo Mendes. “This creates a climate of great insecurity, defeating the good part of the law, because innovation is often not a tangible product." In the opinion of the Prospectiva director, the country could be at the same level as the other BRICS if there were not so many obstacles and if the incentives were properly informed and used.
Innovation and Clinical Research in Brazil
in 2008 and wants to reach 16 thousand in 2011. In absolute numbers, the result is expressive and the country is at a level similar to England, India and South Korea. However, in relative numbers, the situation is quite different. Brazil graduates 5 PhDs per group of one hundred thousand inhabitants, compared to 12.1 in Japan, 13.6 in South Korea, 14 in the United States, 24 in the United Kingdom and 30 in Germany (see Figure 1).
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Figure 1. Number of PhDs graduated each year, per 100 thousand inhabitants. Country Brazil
% 5.0
Japan
12.1
South Korea
13.6
United States
14.0
United Kingdom
24.0
Germany
30.0
Percentage of PhDs working in industry Country
What do the specialists say “At this moment, Brazil faces three fundamental problems: the first is the formation of critical mass; the second is time, because transformations do not take place overnight; and the third - which must be initiated - is to draw up inductive policies and put them in operation,” underscores public health physician Gonçalo Vecina Neto, corporate superintendent of Hospital Sírio-Libanês. Vecina was also director of the Central Institute of the Hospital das Clínicas in São Paulo, the largest medical center in Latin America, and president of Anvisa – National Health Surveillance Agency. Paulo Hoff, oncologist and director of Strategies at the Oncology Center of Hospital Sírio-Libanês, says it is no longer possible to work in isolation without exchanging information and experience. “You should try to reinvent the wheel,” affirms Hoff, also clinical director of the Octávio Frias de Oliveira Cancer Institute of São Paulo, of USP’s College of Medicine. “Great human developments were the result of a sum of efforts. We want to be part of that sum. Today, we already have areas of excellence where we are at the same level as developed countries. We are improving and the difference is getting smaller and smaller, but I think it is process that will still take a few decades for our whole to be equivalent to the more developed countries,” adds the oncologist.
%
Brazil
23.0
South Korea
54.0
United States
80.0
Source: Fapesp, Capes, OECD
Publications One indicator that shows Brazil’s evolution in innovation is the number of scientific publications produced by the country; nearly 30 thousand papers in approximately 10 thousand indexed journals, ranked 15th in the world, and 2.6% of the global total. In 1981, this participation didn’t reach 0.5%. China, for example, publishes 8.4% of the world’s papers, and its production grew sixty-fourfold between 1981 and 2008. Source: Prospectiva Consultoria
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The Sírio-Libanês model of ‘inventing’ One of the country’s cutting-edge hospitals, the Sírio-Libanês is among the reference institutions chosen by SUS - Single Health System - for investing in professional training and research. This fact, which gives the hospital the status of philanthropic with the respective fiscal benefits, has been permitting the application of R$ 10 million per year in research, besides its own budget of R$ 5 million in this area. The hospital maintains the Institute of Studies and Research, IEP, and its portfolio includes at least half a dozen “inventions” in the patent process. The institution has just protected an endoscope internationally in the European Community. It has also already patented a pectide, a biomolecule, and it is going to test a low frequency laser for sterilizing oral cavity infections, very common in patients who undergo chemotherapy. Behind this innovative spirit, Luiz Fernando Reis, director of the IEP, cites Sírio Libanês’s differential: “a policy of intellectual protection approved by the hospital's Board”. “The researcher assumes the commitment that the hospi-
Brazil advances without celebrations Even with the evolution in patent requests abroad, Brazil’s total barely exceeds 1% in comparison to American requests. Brazil advance 5.1% in international patent deposits with 496 in 2009, compared to 472 in 2008. This result is more expressive when compared to 2005, when Brazil had 270 requests. Between 2005 and 2009, international patent registration by Brazilian institutions increased nearly 84% according to WIPO – World Intellectual Property Organization. “Our gap is so great that any increase seems bigger than it really is. Even considering
tal owns any invention made within the institution. We establish rules for remuneration and we have something that is little disseminated in Brazil. You cannot get proper protection for a product if you don’t have proper documentation, on how you got to that point. Laboratory notes of every phase and of every registry are extremely strict and rigorous so the invention cannot be contested later." Reis says the option and investment in research and teaching permit “holding on to great talents and cutting-edge doctors”, because they are in constant update mode and involved in research. “Most of the hospital’s professionals have strong academic ties and this environment feeds excellence. Without an academic environment, a hospital becomes a mere reproducer of technology. With this environment, it generates knowledge. Today, we have 46 clinical studies taking place inside the hospital.”
the advances, it is still very little,” says the president of Biominas, Eduardo Emerich. Although it almost doubled the number, Brazil’s deposits represented only 1.08% of the American total, for example. “We cannot compare with the United States. There, you learn to be an entrepreneur in school, to transform technology and innovation into product. Brazil is heading that direction, but that type of learning has yet to be established,” explains Emerich. The country would need to invest very much in innovation to bridge the gap between those in front in this area or to get close. In China, for example, and always in China, expansion exceeded 215% between 2005 and 2009, to 7906 in 2009, and 29.1% when compared to 2008 (see Figure 2). “Over recent years, the government has invested a lot to transform China into a high-tech country. They have a lot of money and political power. When the government decides it is going to head a certain direction, it
Innovation and Clinical Research in Brazil
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A sign that even in times of crisis, protecting and preser-
really does,” explains Emerich, for whom Brazil’s policy for stimulating innovation is too encompassing. “When it is too broad, the resources, regardless of how great – and that is not the case; they are scarce - cannot do everything. Maybe we should discuss areas of priority. Many countries, like Canada, did that and it has worked,” says the president of Biominas.
ving intellectual property in the international context is important and necessary. The United States still leads the ranking with almost one-third of the deposits in 2009, or 46,079, a 10.8% drop compared to the year before. Among emerging countries, Brazil lags far behind South Korea with 8,049 requests in 2009 and a 1.9% increase over 2008. East Asian countries continued to grow, despite the global
Effects of the crisis
crisis. Japan, ranked second in number of registrations, grew 3.6%, with 29,807.
Taking into account all of the countries and sectors, there was a 4.5% drop in the total deposit of patents between 2008 and 2009, falling from 163,247 to 155,900, according to WIPO, an entity that does not conduct patent registrations and analyses, but promotes them when a company or institution wants their invention protected in other countries. WIPO general director Francis Gurry says the drop was already expected due to the international crisis, but nevertheless it was smaller than recorded in previous experiences.
With a total of 122 out of 142 countries who signed the PCT – Patent Cooperation Treaty – emerging countries represent 14% of the total number of registered patents, with China and South Korea responsible for 10%. Brazil is ranked ahead of Mexico (193) and Poland (174), but lags behind emerging competitors: India (835) and Russia (662). In the set of nations that are part of the WIPO classification, Brazil is ahead of 127 countries (see Figure 2).
Figure 2. World ranking of patent deposits. País
2005
2006
2007
2008
2009*
Participation over total for 2009
Variation over 2008
46,857
51,296
54,037
51,653
45,790
29.4%
-11.4%
1
United States
2
Japan
24,870
27,023
27,748
28,785
29,827
19.1%
3.6%
3
Germany
15,987
16,734
17,824
18,853
16,736
10.7%
-11.2%
4
South Korea
4,689
5,946
7,065
7,901
8,066
5.2%
2.1%
5
China
2,512
3,937
5,465
6,128
7,946
5.1%
29.7%
6
France
5,756
6,264
6,570
7,074
7,166
4.6%
1.3%
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United Kingdom
5,095
5,092
5,539
5,514
5,320
3.4%
-3.5%
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Netherlands
4,504
4,550
4,422
4,339
4,471
2.9%
3.0%
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Switzerland
3,294
3,613
3,814
3,749
3,688
2.4%
-1.6%
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Sweden
2,887
3,333
3,658
4,136
3,667
2.4%
-11.3%
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Italy
2,349
2,702
2,948
2,885
2,718
1.7%
-5.8%
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Canada
2,320
2,573
2,847
2,913
2,572
1.6%
-11.7%
13
Finland
1,893
1,844
1,994
2,223
2,173
1.4%
-2.2%
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Australia
2,001
2,003
2,053
1,946
1,800
1.2%
-7.5%
15
Israel
1,461
1,599
1,747
1,905
1,578
1.0%
-17.2%
23
Brazil
0.3%
1.7%
Total Deposits Source: WIPO - *Estimate
270
334
397
472
480
136,753
149,669
159,949
163,247
155,900
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Biggest slice from companies In the WIPO classification, American companies have 29.4% of total patent registrations; followed by the Japanese, with 19.1%; Germans, 10.7%; Koreans, 5.2%; and Chinese, 5.1%. The Organization points to four Japanese companies among the top ten with the biggest number of PCT applications in 2009. First is Panasonic Corporation, with 1,891. Huawei Technologies of China is second with 1,847. The top ten companies alone, in number of registrations, account for 13,363, or 8.56% of the total. Each of these companies, alone, has more registrations than 121 countries, individually, including Brazil. Those companies tied to telecommunications and
Worst position among the BRICs Brazil drops sharply in innovation ranking when compared to Russia, China and India, say researchers The most recent world ranking for innovations places Brazil in 68th compared to 50th in 2009. On this scale, Iceland, Sweden and Hong Kong are the three most innovative centers in the world. Among Latin Americans, Brazil ranked 7th, losing to countries like Costa Rica, Chile and Uruguay. When compared only to the four BRICs (Brazil, Russia, China and India), the country was ranked third in 2009, but fell to last place on 2010. This information is part of the third reports conducted by the world business school, Insead, in partnership with the Confederation of Indian Industry, CII. The 2010 edition of the Global Innovation Index has a specific chapter on Brazil, which is treated as “a Latin American success story”, estimating that “by 2014, the country should be the fifth largest economy in the world, passing Great Britain and France.” The study, published by the news agency, BBC Brazil, calls attention
electronic equipment dominate the list of industries with the greatest number of application. The only one tied to a university research center, Regents, of the University of California, appears in 40th, with 321, and a 26% drop compared to 2008. When adding the pharmaceutical (12,200 registrations), fine organic chemistry (8,841) and biotechnology (7,446) we get 28,487 applications, or 18.3% of all registration requests. Together, they exceeded those areas where there are more investments in the market.
to the country’s perspectives, highlighting “deep-water oil exploration, tropical agriculture and manufacturing of regional aircraft”. Insead and CII believe Brazil has an advantage in relation to the other BRICs, despite its last place ranking. “Contrary to China, (Brazil) is a democracy. Contrary to India, there are no insurgents, no ethnic and religious conflicts, and no hostile neighbors. Contrary to Russia, it exports more than just oil and weapons and it treats foreign investors with respect,” says the report. Another fact calls attention: one out of every eight Brazilian adults has already tried to open a business. However, the study registers the obstacles to innovation in Brazil, especially social inequity. Brazilian infrastructure is worse than China’s and South Korea’s. Analysts defend that Brazilian innovation would benefit greatly if intellectual property protection was stronger in the country. The report also states that the government’s role in stimulating innovation and its policies in this sense "lack coherence and those institutions responsible for managing the innovative processes, such as the INPI - National Institute for Industrial Property – still have bureaucratic and inefficient tendencies”. The study classified 132 countries based on 60 different indicators, such as patents per million inhabitants,
Innovation and Clinical Research in Brazil
investments in research and development, broadband Internet and cell phone users and average time for opening a business in the country. The study also tried to measure innovation’s impact on social well-being, including data on spending on education, per capita GDP – Gross Domestic Product and the GINI index for social inequality.
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In Brazil, little enthusiasm in the National Congress Most Brazilian congressmen consider intellectual property a fundamental factor for the country’s development, but the theme is little discussed in Congress
Advantage of the Small Iceland, Sweden, Hong Kong and Denmark lead this year’s edition of the report. The Global Innovation Index highlights the fact the top ten in its ranking are relatively small nations, “each with less than 0.3% of the world population”. In Insead’s and CII’s analysis, smaller populations can make public policies more effective. The United States, which led the study last year, fell to 11th place. The study points to the drop in investment in innovation and the recent economic crisis among the main causes. Singapore, ranked seventh, also deserved a special chapter. The country’s “impressive success” is described as a consequence of government action. Public investment in education, research and the technological industry made Singapore the innovative country it is today, according to the study. “Governments should interfere to formulate efficient rules in relation to patents, copyrights and problems with piracy,” affirm the analysts. The report concludes that “today’s leaders are not necessarily tomorrow’s leaders. Therefore, innovation can – and generally should – eliminate obstructions to catalyze the process.”
A survey conducted by Ibope in 2009. Involving 100 congressmen, at the request of the Brazil Intellectual Coalition – a group of companies and representative entities such as the Federation of Industries of the State of São Paulo (Fiesp) and the Brazilian Intellectual Property Association (ABPI) – reveals that most of the Senators and Federal Deputies consider the intellectual property issue a fundamental factor for development. However, 90% of the congressmen say the Congress debates intellectual property and innovation themes very little. Only 26% of the deputies and senators interviewed cited “technological innovation” as a “window of opportunity” for Brazil’s development. The numbers also reveal that the congressmen consider investment in infrastructure (64%) more important for Brazil than technological innovation and scientific research (19%). It is also important to point out that the last item saw a drop compared to 2008, when 30% of those interviewed said the application of resources to research would represent a window of opportunity for the country. Only 15% of those interviewed said they were well aware of Brazilian legislation that deals with intellectual property. But when questioned, they revealed little knowledge concerning the theme. Only 3% cited the Technological Innovation Law of 2004, which creates incentives for companies to invest in research and new technologies as an important mechanism for development. Forty-one percent actually said they were unaware of legislation about intellectual property, and the number of congressmen who declared having any interest in the matter fell from 54% to 44% between 2008 and 2009. “The lack of knowledge and inconsistency in opinions and perceptions about intellectual property appeared as the main result in the survey, repeating the 2008 sce-
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nario. Even among congressmen who declared interest and knowledge about intellectual property, incoherent perceptions and opinions on the subject were observed.” Despite the results, or perhaps because of them, a movement of concern can be seen in Congress, which is creating the Parliamentary Front for Innovation and Intellectual Property to debate the matter institutionally and politically.
Development that is slow and lacking in learning Brazil invests and has untied some knots in research, but it cannot repeat its errors of the past, advise specialists. If the number of patents grew little and the policy of innovation has still not taken off, this is because of policies still found in the business environment. The country had no laws that guaranteed intellectual property for a long time, and furthermore, economic instability and the abrupt opening of the market after 1991 did little to stimulate innovation. “For many years, business owners did not think about innovation because they could make a lot of money with copies. What has changed now is that if they don’t innovate, they won’t move forward. Outside Brazil, if there is no patent, companies will not even begin to negotiate. “If you have no patent, you have nothing,” explains Eduardo Emerich, president of Biominas. “Today we have an open and stabilized economy, but the involvement with innovation and research on the part of companies is still slow and in need of learning,” says Carlos Henrique de Brito Cruz, scientific director at FAPESP – Research Support Foundation of the State of São Paulo. Specialists say the country is on the right path by launching lines of credit through the BNDES – National Bank of Economic and Social Development, creating sector funds and stimulating research through development agencies like FINEP - Financer of Studies and Projects, the FAPs, funds and foundations for rese-
arch assistance and support. Although the horizons are still distant, the country is beginning to look at robotics and combinatory chemistry. It has been untying knots in many areas and investment in research and innovation has been ceasing to be a “risk contract” to become necessary and healthy policy for good business.
Health Complex In the health area, despite the obstacles, there is direction. Brazil invests in biotechnology, which has already resulted in vaccines, growth hormones and many other drugs; and genetic engineering, as has been taking place in some centers of excellence. The Federal Government has focused on innovation and medication production areas in Brazil with fiscal incentive programs and financing, creation of specific laws and development of partnerships with foreign companies for the transfer of technology, the so-called Public-Private Partnerships or PPPs for Health, through a program called the Industrial Complex for Health. “We are working on guaranteeing market for national pharmochemical companies and strengthening public laboratories and industries installed in Brazil, whether national or foreign,” says the Secretary of Science, Technology and Strategic Inputs of the Ministry of Health, Reinaldo Guimarães. Part of the multinational industry that invests in the research and development of new drugs considers the initiative correct. João Sanches, director of corporate affairs for MSD, of the US, says that in the past, initiatives in this sense were punctual and today Brazil has a favorable regulatory and innovation environment that will permit the country to “make quantum leaps in the future” in the pharmaceutical sector. That is also good for industries. “Nearly 80% to 90% of growth in the global pharmaceutical market in coming years will come from emerging markets, of which Brazil is part, and it will be between the eighth and sixth largest market in the world in a few years. It is very important for companies to participate in this market,” says Sanches.
Innovation and Clinical Research in Brazil
Example of waste If Brazil has potential and global companies seek opportunities here, the specialists expect the country to at least stop repeating the errors of its recent past. At the beginning of the decade, Brazil missed the chance to have a new therapy center for treating diseases considered neglected and of high incidence, such as dengue fever, malaria and tuberculosis, very common here as well. Novartis of Switzerland, which idealized the center, set up the Novartis Research Institute on Tropical Disease in 2003, in Singapore, a country that focuses on attracting new technologies.
nities that are being wasted because of bureaucracy
“That episode is an example of waste. We have informed the government that we are before opportu-
medication and technologies. That is the challenge
and because, although the country has improved, Brazil’s attitude still falls short of what is necessary,” observes Antônio Britto, CEO of Interfarma. “Brazil has been successful in expanding its capacity in producing vaccines and some basic medications. This is clearly important from the social perspective, from the technological perspective and from the economic perspective, but it is just a beginning. The big challenge is how to develop capacity to generate innovation and attract research in more complex before us today,” adds the executive.
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Clinical Research
arch, when conducted with the participation of foreign companies, needs the approval of three different bodies: the ERCs – Ethical Research Committees – which are tied
Just as innovation is essential for many sectors of the
to each university of research center engaged in the trial;
economy, clinical research is a gateway to new technolo-
CONEP – National Commission on Ethics in Research, a
gies in health. Likewise, Brazil has enormous potential,
collegiate body tied to the National Health Council that
but it misses countless opportunities. For example, clini-
also gathers the ERCs; and ANVISA - National Health
cal trials have grown in the country in the recent past. In
Surveillance Agency, which provides health approval and
1996, when the ethical regulations on researching new
evaluates research safety and methodology aspects.
medications on human beings was defined, there were only 30 requests for drug test authorizations protocoled at the Ministry of Health. At a given moment, Brazil accelerated its pace to hold new clinical studies, registering 1822 clinical studies conducted in the country. Potential medications against cancer, diabetes, cardiovascular disease and AIDS lead the trial rankings.
When it is sponsored by national companies, clinical research receives simplified treatment and needs to be approved only by the local ERC and ANVISA. “This creates discrimination between research plans based on the origin of capital and not on ethical norms or protecting the patient, which is the subject of the study,” says Gustavo Kesseltring, director of operations at the Clinical
Clinical study numbers grew indicating Brazil would
Research Center at Hospital Alemão Oswaldo Cruz and
begin to experience a different and positive reality in
former president of the Brazilian Pharmaceutical Medici-
relation to attracting new trials. However, in the opinion
ne Society. In the pharmaceutical industry, it is precisely
of specialists, Brazil did not grow, keeping its world par-
the global companies that contribute the greatest volume
ticipation at lower levels compared to other countries.
of resources, being responsible for 95% of the research
“From 2006 to 2009, South Korea’s participation in Cli-
conducted in the country.
nical Trials in the world rose from 0.5% to 1%; India went from 0.7% to 1.5%; and China from 0.7% to 0.9%, whereas, in that same period, Brazil remained stationary at 1.2%, according to the Brazilian researcher at MIT – Massachusetts Institute of Technology – and scholar in the globalization of clinical trials, Fabio Thiers. More than 100 thousand Brazilian are estimated to have participated in clinical trials. Nearly 550 medical institutions and research centers in Brazil are qualified for testing medication. However, this participation falls far short of patient needs and the country’s potential Of the $40 billion invested annually in clinical research, Brazil has receiving little more than US$ 139 million.
Delays and oversights According to data released by the Good Clinical Practice Journal in March 2006, the average delay to decide on clinical research in the world was 8.86 months. In the United States and France, time spent on authorization was only 3 months. In Canada, proceeding took four months. In Argentina, 6 months. But it Brazil, it oscillated between 10 and 14 months. “Since research today is global and
Brazil is equipped with an excellent network of research
multicentric, when Brazil decides to grant authorization,
centers and it has scientists with internationally recog-
the opportunity has already passed it by,” says Kesselring.
nized expertise, as well as large reference hospitals. But
“The country has been discarded from shorter clinical
clinical research is facing a series of obstacles to expand,
trials, because the risk of authorization not arriving in su-
mainly of a regulatory nature. The country is the exam-
fficient time is very big,” says the Brazilian, Fabio Thiers,
ple in the world where authorization for clinical rese-
researcher at MIT (see Figure 3).
Innovation and Clinical Research in Brazil
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Figure 3. Approval of clinical research* Countries
Average
United States, France and Canada
3 to 4 months
Argentina
6 months
Chile
4.5 months
Colombia
3 a 4 months
England
5 months
Russia
5 months
Australia
4 months
Brazil
10 to 14 months
World
8.6 months
Source: Good Clinical Practice Journal * In 2008
Outside the timeline Add to that an extremely bureaucratic process, where errors in filling out forms or the omission of data return the protocols to the starting line after months of proceedings. Over the past six years, according to estimates by Abraco – Brazilian Association of Representative Organizations for Clinical Research – Brazil has let investments of more than US$ 200 million slip away, although it has more than 300 thousand active doctors and more than 600 ethics committees in clinical research installed.
A molecule is born The value chain for innovation in health gathers multiple players. It is estimated that US$ 800 million to US$ 1 billion are needed for a molecule to become a medication approved for consumption. Of course, cost varies in accordance with the disease. For an active principle to leave the laboratory and reach pharmacy shelves, another
Fundamental step Excess regulation in Brazil makes expansion unfeasible. Despite their qualification, Brazilian medical centers and hospitals conduct little more than 1.2% of total global clinical trials. In order to place a medication in the market, a laboratory invests on average nearly 50% of the total sum for developing the composite, with an emphasis on the safety factor. The other 50% is invested in researching molecules in order to arrive at a stable and promising composite, where the failure rate for a drug in phase III of clinical trials jumped from 30% to 50% in the 1990s. The Clinical Trial is a fundamental step in development of a new drug. Increasingly bigger multicentric studies are currently needed. The reason is that launching a medication demands strict safety standards. Studies are conducted in several countries where the new medication is put in contact with different ethnic populations, providing safety to patients and a better evaluation of the new drug.
ten thousand molecules are discarded along the way. Universities and study centers play a fundamental role, investing in basic research, from which ideas sprout for the emergence of new drugs; preparing professionals qualified to work in the pharmaceutical industry; and participating in clinical trials. The development of drugs itself is driven by the research centers and pharmaceutical industries, which are also responsible for investments in marketing, production and distribution of medications.
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What do the specialists say Over the past few decades, a movement in health research has been observed on a global scale geared towards the hospital patient. Paulo Hoff, clinical director of the Octávio Frias de Oliveira Institute of Cancer of the State of São Paulo (Icesp), underscores there is consensus concerning two important points: the need to drive clinical research, always on behalf of the patient, and to follow strictly ethical criteria. “This is not a case of getting into Manichaeist discussions because everyone agrees with the essential. It is necessary to stimulate the development of drugs that save lives, just as it is essential to promote research in an ethical manner,” he says.
Bureaucratic culture According to Professor Paulo Hoff, the delay in approving clinical protocols has to do with Brazil’s bureaucratic and notarial tradition, where the processes are extremely valorized and accumulate. “This is a characteristic of our culture. Try to open a micro enterprise in Brazil. It is much more complicated than in many countries. This same delay is embedded in our research system,” he says. According to Hoff, the idea is not reduce the ethics or control of clinical trials, but rather speed up the process, making it as fast as it is in other countries. “When it was drawn up, the system has duplicity in evaluations, mainly involving new medications developed by multinational companies. Our studies take longer to be evaluated than in Canada, Australia and United States, and we cannot say those countries follow looser ethical criteria than we do. The result is our loss of competitiveness,” affirms the researcher. Each multicentric study is estimated to involve seven to eight different research centers in each country, where the average is 20 countries. That means CONEP reevaluates protocols that have already been submitted for scrutiny and for approval by more than one hundred ethics committees.
Antônio Britto, CEO of Interfarma, explains that Brazil was included in the world circuit of research due to the size and quality of its hospitals, research centers and scientists and the great ethnic and demographic diversity. “But rules, like those in Brazil, for authorizing clinical research do not exist anywhere else in the world. This bureaucracy and delay only exist here,” says Britto, who adds the systems needs to be restructured and strengthened so Brazil can take advantage of the opportunities of participating in major global scientific studies. “Brazil needs to have more interest. We are no longer just a country with third world diseases. The aging population, the so-called progress diseases like cardiovascular problems, cancer and diabetes, have drastically changed the epidemiological profile. Now we need to worry about advancing to cover these needs. And today such opportunities exist.”
Efficiency in check The need for developing new drugs is emblematic in the case of cancer. “Brazil has 500 thousand cases of the disease per annum and a significant number die due to lack of efficient treatment. For many patients, the opportunity to participate in a clinical trial is everything we have to offer," says the doctor, Paulo Hoff. “There is no guarantee the clinical trial will bring a cure, but it can give hope. It may give more time with the family. Society needs to offer more efficient treatment, that guarantees more productive lives,” he says (see figure 4).
What do the specialists say “We are experiencing a blackout in the country’s clinical study system,” says Charles Schmidt, vice-coordinator and professor of the graduate program in clinical research at the College of Medical Sciences at Santa Casa in São Paulo. “The system needs to be decentralized. That way, it would be more apt to discuss issues and make decisions. Although it claims to be a transparent entity, CONEP is centralized in Brasília and the chance of a researcher to be face to face with an evaluator is very restricted," he affirms.
Innovation and Clinical Research in Brazil
The fight against cancer offers great arguments for intensifying Brazil’s participation in clinical trials, but research in a series of other diseases with high incidence and mortality are equally needed, such as AIDS, hepatitis, cardiovascular disease and diabetes. “Degenerative diseases of the nervous system, like Parkinson’s and Alzheimer’s also tend to become more common with aging populations and will require greater research efforts,” says Gustavo Kesselring. In the case of Alzheimer’s, current treatment is effective in only 30% of patients. “We still need to improve efficacy 70% against the disease. Where will that 70% come from? Research. How? Conducting clinical trials,” affirms the doctor. In the opinion of the doctor Jorge Kalil, head professor of clinical immunology and allergy at the College of Medicine of the University of São Paulo and director of the immunology laboratory at the Heart Institute (InCor), Anvisa - National Health Surveillance Agency – has a very important role as a regulator, inspector and controller of the system. “But it needs to begin to promote more development, to be quicker in approving projects. Speed is competitiveness,” says Kalil, adding that clinical research empowers professionals, improves observation of patients, of medications and of new applications for
Figure 4. Efficacy of current treatments with medications. Desease
Percentage
Cancer (all types)
25%
Alzheimer’s
30%
Urinary incontinence
40%
Hepatitis C
47%
Osteoporosis
48%
Rheumatoid arthritis
50%
Migraines (prophylaxis)
50%
Migraines (acute)
52%
Diabetes
57%
Asthma
60%
Cardiac arrhythmia
60%
Schizophrenia
60%
Depression
62%
Source: Brian B. Spear, Margo Heath-Chiozzi and Jeffrey Huff, Clinical Application of Pharmacogenetics, Trends in Molecular Medicine (May 2001)
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already existing medications. “It allows us, in our project for innovation, to bring more quality to our work.” Kalil advocates the decentralization of CONEP, particularly due to the growth of research activity in the country. “It needs to regulate, inspect, but not approve everything, because it takes too long, and then we miss the opportunity.” The doctor observes that the less competitive Brazil is in clinical research the longer it takes for cutting edge medications to be available in the country, resulting in losses to medical science and patients. As an example, Kalil cites the successful treatment against cancer received abroad by Brazil’s vice-president José de Alencar. “He had to go to the United States because (treatment) was not available here due to the delay in approving protocols. If we were faster, industry would invest more in clinical research in the country. The more we have, the more we attract new investments and more knowledge.”
Research saves lives An Australian study on cancer conducted in 2008 sought to determine the potential effects of regulatory inefficiency in clinical trials. The researchers, led by David Christie, of the East Coast Cancer Centre, in Queensland, estimated that for each month of delay in beginning clinical trials on cancer 30 Australian lives were potentially lost, on average. The calculation was based on survival improvement data for patients with cancer over the past 10 years (1% per year, according to estimates) that could be attributed to improvements in treatment resulting from clinical studies. Since the annual mortality rate for cancer in Australia is approximately 36 thousand patients, the authors estimated that every month 30 patients do not die as a result of therapeutic advances obtained from clinical trials. Delays in beginning these studies entail a loss of opportunity to extend the lives of 30 patients every month.
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Opportunities for Brazil and for Brazilians Brazil’s inclusion in the clinical trials route permits access to new technologies and innovative treatment Brazil’s inclusion in the route of clinical trials is pointed out as advantageous for several reasons. The biggest beneficiary is the patient. He gains access to innovative treatment that would only be available later and receives high level medical follow-up sponsored by the industry that develops the medication. Other advantages include the chance given doctors to learn proven methodological standards and the opportunity granted institutions to receive financial funds. “We are gaining qualification. Today, we are included in protocols from the initial phases and we have become important co-stars,” affirms Paulo Hoff. Participating in clinical trials qualifies the country to produce the so-called translational research that unites scientists and doctors to test advances and hypotheses still in experimental stages in basic research on human beings. For the government, the gains include the possibility of reducing the trade balance deficit. National empowerment in clinical trials is also an indispensable condition for controlling the efficacy and quality of products offered in the domestic market. It is also a path for developing research in national industries.
An old debate The Ministry of Health has made clinical trials a priority in the health research agenda since 2004, when the 2nd National Conference on Science, Technology and Innovation in Health established a set of recommendations to quality health research. At that time, a debate was already proposed in the medical and scientific communities in the sense of speeding up CONEP procedures, as well as a review of resolutions in effect. The Conference also suggested conditioning CONEP approval only on relea-
sing resources, and not on the acceptance and judgment of processes. The priority established resulted in gains in the qualification of public hospitals for conducting clinical essays. An example is the structuring of clinical research at university hospitals, which today are part of the National Network for Clinical Research. The network’s objective is to permit teaching hospitals from several places in the country to gain competence in conducting clinical trials. The emphasis, in this case, is the demands from public health, testing medications, procedures and mechanisms for diagnosing diseases of interest in the SUS – Single Health System. “The Network’s objective is to increase the conducting of clinical research in the country, respecting the vocation of each institution, but at the same time inducing the development of projects geared towards health problems defined as priorities by the national health policy,” said Reinaldo Giumarães, Secretary of Science, Technology and Strategic Inputs of the Ministry of Health, in an interview. But almost nothing has advanced in terms of proceedings for clinical trial processes. Due to technical problems in the Datasus system, the promise made in 2007 to establish the Brazil Platform, a national computerized database for records of research on human beings, which would permit computerizing all procedures made by the ERC/CONEP System, including implementation of electronic files to replace the printed documents used today, has still not been made feasible.
Lacking competitiveness A study conducted in 2006 by Cristiane Quental, researcher at the Oswaldo Cruz Foundation, sought to evaluate national qualification in clinical trials and provide subsidies for policies and actions capable of supporting the innovation process in the pharmaceutical industry. The study revealed a consensus: practically everyone affirmed that the country could meet a greater demand for trials if not for the time it took for a protocol to be approved in the ERC/CONEP system, so that national centers miss out on opportunities to countries in Eastern
Innovation and Clinical Research in Brazil
What do the scientists say Head professor of ophthalmology at Unifesp – Federal University of São Paulo, Rubens Belfort Júnior, observes that it would be desirable for the country to participate in earlier phases of trials. “It is a fact that the industry ends up bringing 2nd or 3rd level of importance research. For researchers, it is ideal to participate in phases that truly add knowledge,” he says.
Europe, Latin America and Asia. “No one questions the ethical principles, but a management shock is lacking,” according to the study. The researcher believes it would be ideal to delegate some autonomy to ERCs to decide. “Not all the ERCs, but those that demonstrated competence, with CONEP overseeing,” she says.
Hope in new drugs Obstacles in conducting a greater number of clinical trials in the country do more harm to the lowincome population. The trajectory of São Paulo businessman Eduardo Marafanti, 58, summarizes patients’ hopes in clinical trials. In 1999, Marafanti was stricken by a sudden loss in physical resistance as a result of chronic myelogenous leukemia. At the time, options were restricted to a medulla transplant - discarded due to a lack of compatible donor - and a therapy with the drug Interferon, which in his case, had no effect. The businessman was given at most one year of life by his doctor. He read in the newspaper that American doctor Brian Druker was recruiting volunteers for a study involving a new medication. “The risks were enormous, but the certainty of death was on the table, so the risk was welcome,” he says. Since he had the means, he went to the United States and got one of the last openings - there were 200 – to participate in the clinical trial. It was successful and Marafanti resumed his normal life with treatment. After a five year remission period, a phase during which there are no signs of the disease, but it cannot be considered a cure, his organism stopped responding to
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the medication and the disease returned. A sample of his medulla, taken when he was in remission, saved him from the crisis. After the medulla transplant, he began treatment with another experimental drug, which made the disease regress. In 2008, in face of another relapse, he began treatment with another medication, which has been ensuring him good quality of life ever since.
Daring initiatives The issue is confronted in a proactive manner in other countries. A government ad in Australia in 2009 announced the importance of clinical trials for the country, calling for the pharmaceutical industries and explaining why Australia wanted to be number 1 in the world in steering investments in clinical research. In 2007, an ad from Chile in an American journal promoted a seminar to be held in Boston that was going to promote the country’s clinical research industry. The objective was to attract American companies and take clinical research to Chile, a country with a predictable and efficient regulatory environment. Another ad from 2008 invited Americans to a meeting that would discuss strategies for implementing clinical research in India, China and southeast Asia. The site for Germany’s Ministry of Education and Research defines clinical research as a national high-tech strategy In an example from South Korea, government, academia and industry jointly developed a platform to create infrastructure and develop medication through clinical research. In 2004, they defined their objective: become the seventh market for the world’s pharmaceutical industry by 2015, today they are 11th. Among the initiatives by South Korea’s Ministry of Health to achieve that goal is, once again, clinical research, defined as an industry with high added value in knowledge.
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The case of an illustrious citizen Marafanti’s story has a happy ending, but the restrictions to clinical research in the country end up punishing patients from the lower income brackets since they do not have the resources to travel abroad and participate in clinical trials. Charles Schmidt, of the Santa Casa de Misericórdia of São Paulo, cites the example of politician and businessman José Alencar, vice-president during the Lula government’s two terms, who has been fighting cancer since 1997 and has undergone multiple surgeries. In 2009, he joined a research protocol at MD Anderson hospital, a center of excellence in oncology in the United States, and he was able to keep the disease under control thanks to an innovative approach using chemotherapy drugs. “Brazilian patients could have the same benefit is this medication had been tested in the country, but unfortunately, it is not available," he says. Schmidt adds that he has seem victims of various diseases, especially certain types of cancer, be deprived of treatment that could have prolonged their lives. “The patients get desperate and some of them even seek out treatment abroad that is completely unethical and criminal, like those brain stem injections offered in China.” That is not what happens in developed countries. An example that has become a symbol of hope is American cyclist Lance Armstrong , today 39, who became famous after winning the Tour of France seven times running, from 1999 to 2005, after recovering from cancer of the testicles with metastases in the brain and lungs. The diagnosis came in 1996. According to doctors, his chances for survival were only 40%. Armstrong underwent two surgeries and participated in two clinical trials. “I owe my life to research against cancer and all the patients who participated in clinical trials for cancer before me,” says Armstrong. “Lance Armstrong and thousands of youths, treated annually for cancer of the testicles, are examples of how clinical trials can benefit many patients,” says Stephen D. Williams, director of the Cancer Center at Indiana University in the United States.
Global studies Health professionals are not the only ones aware of the importance of clinical research and the obstacles it faces in Brazil. A researcher at the Massachusetts Institute of Technology (MIT), Brazilian Fabio Thiers, was co-author of a study published in 2008 in the prestigious scientific magazine, Nature, on the globalization of clinical research. He says that over the past fifteen years, the inclusion of several emerging countries in the itinerary for international clinical trials was due to a set of factors. On one hand, the ease of communication resulting from the Internet broke through barriers and showed researchers from central countries that there were also quality professionals capable of participating in multicentric studies in peripheral countries. On the other, in this period there was also a notable increase in clinical research around the world, with the need for including new centers. “This developed an infrastructure for clinical research in several countries.” According to Thiers, today we are experiencing a second phase of this process in which the existence of a certain expertise will not be sufficient to guarantee countries a leading role in clinical research. “An intensification of international clinical trials is projected and the countries interested in participating and calling the attention of the sponsors will have to invest in new research centers and greater professionalization of researchers,” he affirms. Thiers' study confirms the tendency of growth of emerging countries in Eastern Europe, Asia and Latin America in participating in international studies financed by industry, although the developed countries still preserve the largest portion - two-thirds of this market will be divided among five countries: United States, Germany, France, Canada and Spain. Emerging countries have 17% but grow unequally. Thiers underscores that although Brazil shows weaknesses in this race, there is lots of room to grow. “A recent official document from the American government underscored that in research centers like those in Brazil, there is a higher proportion of patients in clinical trials than in central countries, demonstrating that we have good capacity for participation,” he says. Thiers also underscores that the interest of pharmaceutical industries in approaching emerging countries follo-
Innovation and Clinical Research in Brazil
ws a world trend. “Companies are forced by shareholders to have solid strategies in emerging countries,” he affirms. If there is interest in the market, companies offer, in the case of clinical trials, an important contribution, which is the opportunity for the researchers to work in a high value-added activity. “You are training doctors in accordance with international standards and bringing high technology.”
Paths to innovation Specialists point to the best paths for Brazil to be more daring and competitive Brazil has good and advanced legislation in intellectual property protection, some of the most sophisticated and world-renowned research and development centers in several areas and a body of notable scientists. However, it is taking very slow steps towards innovation. Specialists say it needs to move faster and to invest in innovation in more sectors. They suggest a more daring attitude by the country so it can advance in this area and become more competitive. The suggestions include more incentive for education, aimed at training more scientists, greater involvement and investment by the government and business and more articulation among universities, government and companies to transform innovation into goods for society as a whole. The government also has to contribute by further improving labor legislation, reducing bureaucracy, reducing the tax burden and most of all implementing inductive and defined policies geared towards innovation in Brazil. These instruments are pointed out by specialists as efficient for promoting sciences and their application in the country. All these issues must also be broadly ensured by representatives of the government so the image of a Brazil that “can change its rules at any moment” changes abroad. In the clinical research area, there is a convergence of opinions between specialists and doctors in relation to the need for giving a less operational and more supervisory role top CONEP – National Commission on Ethics in Research – and giving Anvisa – National Health Surveillance Agency – and the ERCs – Ethics in Research
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Committees – the task of evaluating and approving clinical trials with foreign medications, as already occurs with national research. Charles Schmidt, of the Santa Casa de Misericórdia of São Paulo, says decentralization,
Lack of regulation generates excesses The issue of regulatory obstacles in Brazil has been the object of studies and evaluations by attorneys and law specialists. According to Angela Kung, specialist in the regulatory area for medications and biotechnology at the Pinheiro Neto law office in São Paulo, there are several gaps in the legislation and in the structure for controlling research that conspire against the legal safety of clinical trials in the country. As an example, she cites CONEP’s demand that sponsors guarantee research participants ample access to medications. “If that isn’t accepted, the study is not authorized. But that means the company will be obliged to provide that drug even if it doesn’t presented the desired effects and the protocol is interrupted, which makes no sense Providing a product without registry is a crime. According to Angela, a law would be necessary to regulate clinical trials in Brazil. “But no one questions that because they are afraid the Courts will say CONEP does not have the competence and order the clinical trials interrupted, which would be a disaster,” she affirms.
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which is in force in rich and emerging countries, is the best way out to provide greater agility to research. Antônio Britto, CEO of Interfarma – Pharmaceutical Research Industry Association – believes the solution is simple. “Simply ensure that, without detriment to ethics which must always preside over any clinical research, Brazil has rules that are more efficient and more adjusted to world rules, because the world takes much less time to decide on clinical research than Brazil.” Britto also observes that the ERC / CONEP systems must invest in infrastructure, contracting of personnel and qualifying professionals. The government is studying the regionalization of CONEP’s activities to reduce the slow pace of research proceedings. “CONEP is going to replicate in four or five states and thus the time for approving and reviewing protocols will be cut in half,” says Reinaldo Guimarães, Secretary of Science, Technology and Strategic Inputs of the Ministry of Health in the seminar “Paths for the Financing of and Access to Health Care,” held in June 2010 by Interfarma.
Legal security The creation of a new and more effective regulatory framework is also pointed out as essential for clinical trials to gain speed in Brazil. “There are flagrant illegalities in resolution 196, which created the ERC/CONEP system,” says Charles Schmidt. “It is a resolution in the field of bioethics, which in practice functions like a law, although it has never been voted in Congress. It harms the principle of isonomy by giving different treatment to national and foreign companies and it creates a structure above justice and the President of the Republic, because it is responsible for creating norms, executing them and punishing,” he says. Attorney Angela Kung says the structure for evaluating and supervising ethics in research needs to be the target of legislation discussed and approved by Congress, and not only the National Health Council. “It would be a way to provide legal security to those who want to conduct research in Brazil and to consider the opinions of all parties involved, without Manichaeism,” she affirms.
Innovation and Clinical Research in Brazil
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Innovation and Clinical Research in Brazil
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