Hellen Berger

The health ministry of Brazil recently signed an agreement with US-based Bristol-Myers Squibb to obtain its patented production technology in order to locally develop the antiretroviral drug atazanavir sulfate. The drug is used, together with others, to treat HIV-infected patients in Brazil.  

The process of transferring the drug's production technology will take place until the end of 2016, while domestic production is planned to begin by 2017, according to the country's health ministry. Before the patent for atazanavir (held by Bristol-Myers Squibb) expires by the end of 2017, Brazilians will be trained by experts at the company's USA-based facility on how to produce the drug. The drug will be produced at a Rio de Janeiro-based pharmaceutical plant named Farmanguinhos, operated by Oswaldo Cruz Foundation (Fiocruz). 

Atazanavir is distributed to approximately 45,000 patients by the public health system, which corresponds to approximately 20% of all the HIV-infected patients cared for under this system. According to data from the health ministry, the government of Brazil spends approximately R$86 million ($41.4 million) annually to purchase the drug abroad. When atazanavir, which is taken daily by patients, starts being produced domestically, the country is expected to save a total of R$385 million ($185.3 million) in five years, the ministry added. 

Starting in 2013, the drug will be distributed nationwide inside locally-produced packaging. Output from the new domestic plant will add one more drug to the locally-produced drug list for HIV-infected patients, totaling up to 11 drugs produced in Brazil from the 20 medications offered at no cost to HIV-infected men and women in Brazil. According to government figures, some 127 million capsules will be produced annually in Brazil by 2017.  

Atazanavir is a protease inhibitor. This class of drugs is used to treat or prevent infection by viruses. Atazanavir is administered in combination with two other antiretroviral agents to prevent the risk of developing drug-resistant mutated viruses.   

According to the Oswaldo Cruz Foundation (Fiocruz), the plan is to meet at least 50% of the demand for atazanavir sulfate by 2015. Fiocruz says this deal guarantees that Farmanguinhos will set a final price for the drug that is 5% lower than the current price.  

The Brazilian government will not pay for the technology but guarantees purchasing the drug from Bristol-Myers Squibb until the end of the deal in 2017. According to the health ministry's AIDS department, this is the first deal of its kind for developing domestic production of a drug whose patent has not yet expired.  

The Brazilian Interdisciplinary Aids Association (ABIA) disagrees with the details of the deal and has questioned the need for the government to pay such a high price for a drug that will only be produced in 2017. The health ministry, on the other hand, says that prices will drop gradually. Minister Alexandre Padilha has publicly defended new deals with private laboratories in order to maintain the local HIV/Aids treatment program, which cares for approximately 217,000 Brazilians.   

Zidovudine (AZT), one of the first drugs to treat HIV, was made free for all Brazilian patients in 1991. In 1996, when antiretroviral treatments were developed, the drugs were offered for free to local patients, causing national AIDS mortality rates to decline, as observed by the 1992 International Conference of AIDS. By 2002, figures from the Brazilian health ministry showed that the drugs had helped to save more than 1.1 billion people by preventing deaths and hospitalisations.  

According to the World Health Organisation (WHO) guidelines of 2010, the levels of treatment coverage in Brazil were more typical of a developed country than a middle-income nation such as Brazil. Specialists, as well as WHO, say that Brazil's program success is based on the fact that the country has produced various AIDS drugs locally. Currently 50% of the drugs offered by the public health program are produced domestically.   

Brazil has complied with the international Agreement on Trade Related Aspects of Intellectual Property (TRIPS) since 1996, which limits the production of generic drugs that have been patented abroad. However, various generic drugs produced in Brazil were patented before the agreement and can be legally copied (1). 

In other cases, such as for atazanavir, Brazil has obtained the drugs internationally and was forced to put pressure on the pharmaceutical companies to lower their prices. In order to force price drops, the country has used a clause found in the TRIPS agreement, whereby "compulsory licenses" are given to developing countries, allowing them to produce generic versions of drugs when the government considers it to be a public health emergency.  

The government had never actually issued a "license" despite obtaining price reductions. However, in 2007, Brazilian President Luiz Inacio Lula da Silva announced that the country would issue a compulsory license for a drug named efavirenz, patented by Merck. The decision received mixed reaction. AIDS activists supported the decision, while Merck, as well as other pharmaceutical firms, said the move was unfair and could impact new investments in drug research and production in Brazil.  

On the other hand, there is no doubt that the move has saved lives, while analysts say that the tactics have influenced the market globally by increasing competition and driving costs down. A publicity poster released earlier by the health ministry said, "Local manufacturing of many of the drugs used in the anti-AIDS cocktail permits Brazil to continue to control the spread of AIDS. The drugs industry sees this as an act of war. We see it as an act of life."  

is a business writer based in São Paulo, Brazil. 

Articles

The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.

Report from Brazil January 2013

Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told 

. The organization publicly released a draft proposal on this policy on June 4, 2012 and the public had 60 days to comment.   

There is no set timing, however, for the process, according to Anvisa's regulatory and health surveillance specialist Simone de Oliveira Reis Rodero, as several steps are needed before the actual publication of the new requirements. 

Flickr/JoÃ£o Luiz Pacheco Vieira GalvÃ£o-Brazil/GoiÃ¡s/GoiÃ¢nia/Getty Images 

According to information from the Pharmaceutical Trade Union of the State of São Paulo, Sindusfarma, drug manufacturers are currently responsible for the quality of excipients included in the drugs they produce. Currently, says the Union, the sector lacks specific rules for such products and the pharmaceutical industry uses only a portion of the overall excipients produced in Brazil (other sectors such as health and beauty products use them as well). Many producers may not be interested in complying with all requirements coming from the pharmaceutical industry. The discussion is likely to continue as the industry and regulators debate competing interests and opinions.  

Anvisa is responsible for developing standards, authorizing pharmaceutical company operations, and for supervising the quality of pharmaceutical excipients used in drug prducts. Anvisa does this through health inspections to ensure compliance with quality controls in the drug-manufacturing process. Rodero added that Anvisa has started a database of active pharmaceutical excipients from companies that manufacture, import, export, fractionate, stock, expedite, distribute, and pack such products. "Good manufacturing practices for pharmaceutical drugs do not include their pharma excipients as criterion for manufacturing differs," says Rodero.  Therefore, a set of clear rules is being suggested to regulate the excipient sector, Rodero says.   

"The norms are not being requested by international organizations. The need came up due to the lack of regulation, which makes the harmonization process difficult during inspections. We requested that health authorities in countries that hold technical cooperation agreements with Brazil to send information on how excipients are treated regarding local norms and authorizations," says Rodero, adding that the responses are now being evaluated and the data consolidated.     

The draft proposal, made public on June 4, 2012, was written based on documents from the International Pharmaceutical Excipients Council

Europe, the World Health Organization, and the US Pharmacopeial Convention, revealed Rodero.   

According to Anvisa, because excipients can affect the final quality of a given drug, the establishment of an "ResoluÇão da Diretoria Colegiada" (RDC—Anvisa's Collegiate Board of Directors Resolution) is important for minimizing health risks involved during the manufacturing process. Standardizing GMPs and practices for the Brazilian sector, qualifying suppliers, and strengthening local producers are part of the goal as well, states the health authority. Excipients used in pharmaceuticals may act as antiadherents, binders, coatings, disintegrants, fillers, flavours, colors, lubricants, glidants, sorbents, preservatives, and sweeteners, according to pharmaceutical data from Anvisa.  

According to Rodero, the need for local producers of excipients to comply with quality requirements is important to increase public health safety because excipients can generate side effects or affect the final pharmaceutical product. Excipients in drugs sold in Brazil were responsible for cases of adverse drug reactions (ADR) in adults and children, according to a study conducted in 2004 by the Federal University of Ceará.  

Brazil's pharmaceutical industry professionals are asking whether a pharmaceutical resolution for excipients would affect producers. If approved, established companies would have a period of one year to comply with the new rules.  

According to Anvisa, changes would facilitate issuance of authorizations and health licenses, because standards would be put in place and minimum quality requirements needed for guaranteeing the quality of excipients would be absolutely clear. However, Brazil's National Pharmaceutical Laboratories Association (ALANAC) protests: "ALANAC supports any and all regulation initiatives as long as they improve the quality of the feedstock used in producing [pharmaceutical] drugs and [only] if it can stimulate industry competition and the development of local production," said Henrique Uchió Tada, executive technical director for ALANAC.   

"Anvisa's public consultation number No. 31/2012 on an RDC resolution for GMPs of pharmaceutical excipients defines that rules will only be applied to the local production, however, most of the excipients used in the pharma industry are imported," complains Tada. According to Tada, the association fears that the real objective of having an RDC—achieving quality assurance—will not be obtained if the rules only apply to excipients produced locally.    

Just like the RDC for pharmaceutical drugs, for example, which is valid for local and imported medicaments, "We understand that this proposal...should also be valid for products manufactured abroad," says Tada.    

According to the director of ALANAC, similar rules for excipients are not applied by other countries' health authorities as the GMP for pharmaceutical drugs already require that industry suppliers be qualified and guarantees quality controls during all production processes, he adds.    

 is a business writer based in São Paulo, Brazil.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

Report from Brazil September 2012

In the past decade, a few million Brazilians out of the country's 200-million population have stepped out of poverty due to the growing economic stability. During the same period, the government allowed generic drugs to enter the domestic market, including through public-health systems, and streamlined regulatory registration of generic drugs. 

 (JEREMY WOODHOUSE/DIGITAL VISION/GETTY IMAGES) 

Similar to many markets, generic drugs in Brazil are produced and sold for an average of 50% less than brand-name drugs.  These lower prices, along with the opening of the market, have greatly boosted the generic-drug sector in Brazil, with an average annual growth rate of 30% over the past 10 years, according to Odnir Finotti, executive president of the Brazilian Generic Drugs Industry Association, Pró Genéricos, based in São Paulo.

With innovator-drug patents increasingly reaching expiry, additional generic products have entered the Brazilian market in the past two years. These include generic versions of atorvastatin, rosuvastatin, sildenafil, quetiapin, and valsartan, which now represent around 15% of the sector's income, according to Pró Genéricos. These popular generic drugs are used to treat illnesses such as high cholesterol, erectile dysfunction, pulmonary arterial hypertension, bipolar disorders, high blood pressure, and congestive heart failure.  

As a result, the country's generic-drug market grew by 32.2% in terms of sales volume between 2010 and 2011 alone, reaching R$8.7 billion (approximately US $5.05 billion), according Pró Genéricos. The country sold 581 million units of generic drugs in 2011 compared with 439 million units sold the previous year. 

Additional innovator patents are expected to expire by 2017, including Pfizer's antipsychotic drug ziprasidone and sirolim, an immunosuppressive drug produced by Wyeth used in organ transplants.  

According to Pró Genericos' industry data, most generic-drug markets around the world have reached around 60% of the market share in terms of units sold. In the US, that share is approximately 74%.  

"If we add total domestic sales of generics plus the sales of biosimilar drugs, [these products] would hold around 60% of the country's market share in terms of units sold," says Finotti.    

In Brazil, "biosimilar" drugs are those sold under the brand name for which the drug's patent has expired, but which have not had bioequivalence tests done. Such drugs in the country are not considered interchangeable and therefore are not labeled as generics.  

Pró Genericos' expects generic-drug sales alone to reach 35% of the domestic market share in terms of units by 2015. According to IMS Health, the generic-drug market in Brazil has reached 20.5% of share in financial terms considering the sector's income in Reais.  

"We still have a long way to go before considering our generic drug market consolidated," adds Finotti. "We are just starting." 

To gain market strength, larger domestic or global pharmaceutical companies, most installed in Brazil, have been eying smaller generic-drug laboratories for acquisitions and to promote mergers. At the same time, they have had to reduce costs in areas such as research, management, and sales, says a pharma analyst and economist.  

According to the analyst, brand-name drugs have lost market share to generic drugs in the last years, forcing larger laboratories to cut costs and find alternatives as their margins drop.  

Future opportunities lie in generic versions of non-controlled drugs as well as medications that treat coughs and colds, says the São Paulo-based analyst. 

Hellen Berger is a freelance writer based in São Paulo.

Brazil's generic-drug market is growing steadily.

Report from Brazil March 2012

Opportunities for growth as well as favorable regulatory measures within the pharmaceutical market in Latin America are making the region more attractive than ever. According to IMS Health, the entire Latin-American region is expected to grow to $51.3 billion by 2014.  

Photo: Joseph Sohm-Visions of America / Getty			

"Latin America's pharma market in general has shown a growth trend similar to Asian markets in terms of sales, around 12% to 16%," says Carlos Kiffer, operations director for GC2, a pharmaceutical R&D company based in São Paulo, Brazil. 

Demand for pharmaceuticals and other products is increasing across the region, despite the global credit crisis, according to the Economic Commission for Latin America and the Caribbean (ECLAC), a United Nations organization with headquarters in Santiago, Chile. As a result, Latin American countries are expected to grow in total approximately 4.7% this year, projects ECLAC. In 2010, the region grew 5.9%.  

This economic performance is attracting global attention. Trade and manufacturing practice are also playing a role in the region's success. For example, the seven largest Latin American countries—Brazil, Mexico, Venezuela, Argentina, Colombia, Chile, and Peru—have all become signatories to international trade treaties such as the Trade-Related aspects of Intellectual Property Rights (TRIPS) treaty. Brazil and Mexico have been applying GMPs in their pharmaceutical industries for years. These practices are positive factors for investors, according to Carlos Kiffer, who also works as a researcher for the Federal University of São Paulo.   

Brazil, in particular, has the largest pharmaceutical market in Latin America and "leads in terms of gross sales with an average of $12 billion per year," according to Kiffer. The country's R&D market represents approximately 5% of total gross sales, he adds.  

This year looks good so far. IMS Health projects the pharmaceutical industry in Brazil alone will grow approximately 10% and report total revenues of $25.6 billion in 2011. By the year 2015, the market is projected to reach $32.8 billion, according to Business Monitor International (BMI).  

Brazil's potential lies in its population of nearly 200 million inhabitants, many of whom are just gaining access to private healthcare and generic drugs. During the past decade, the government has put controls into place to end sky-rocketing inflation, consolidated its economy, and opened the door to goods and services for millions of Brazilians, many of whom had been living in poverty. As a result of the changes, private healthcare firms based in the southeast of Brazil—the most developed region of the country—have reported double-digit growth in profits in the past few years.  

Government measures regarding fiscal adjustments have increased Brazil's competitive edge and boosted investments from the private sector as well. According to BMI, imports of goods produced outside South America, including pharmaceuticals, are expected to drop due to legislation passed in 2010 (Law number 12.349/2010). The new law gives preference to goods and services provided by domestic or foreign companies installed within the Mercosur economic bloc. Mercosur, also known as the Southern Common Market, is made up of Argentina, Brazil, Paraguay, and Uruguay. Bolivia, Chile, Colombia, Ecuador, and Peru have associate-member status in the bloc.  

"We therefore expect growth in the generic-drug sector to outpace the rest of the industry, especially in terms of sales volume," according to a February 2011 BMI report titled, Industry Trend Analysis.  

Generic-drug sales in Brazil represented 17.2% of the pharmacy sector by value and 21.3% by volume in 2010. The sector is expected to increase to around 25% by 2015, according to industry data. 

Market consolidation is underway as well. Recent acquisitions of domestic firms by giant multinationals have changed the local market considerably. And despite growing market share by foreign investors, growth and opportunities for smaller biotech firms are still expected, primarily because of the country's rich biodiversity,  according to Brazil's National Pharmaceutical Laboratories Association. 

Mexico has the second largest pharmaceutical industry in Latin America, with average gross sales around $9 billion per year, according to Kiffer. The R&D market in Mexico, like Brazil, corresponds to approximately 5% of the country's total gross sales, he explains.  

Looking ahead, Mexico's annual growth rate for the pharmaceutical industry is projected to be 11.7% between 2009 and 2014, and will likely reach close to $14.9 billion, according to BMI. 

According to Kiffer, Mexico's pharmaceutical market plays a relevant role in Latin America because it is located in North America and is closer to the US than any other Latin American country. The proximity allows Mexico to do business with the US and use the logistics infrastructure available in the region, adds the researcher.  

"Mexico has been developing its infrastructure and logistics for research, while good quality universities and [recently] improved pharma regulations offer opportunities," says Kiffer. 

The country's business environment has indeed become more competitive, according to IMS Health. The Mexican government, for example, abolished requirements for pharmaceutical companies to establish a local plant in order to obtain import permissions. As a result, public and private customers are no longer forced to purchase medicines from drug manufacturers that have plants operating in the country.  

In addition, according to Espicom Business Intelligence, the number of people accessing public healthcare in Mexico is expected to increase as the country implements universal healthcare coverage. The change could slow down growth in the private pharmaceutical sector, but will likely increase the sale of generic drugs. In fact, generic-drug spending is projected to comprise 7.5% (by value) of the total drug market in Mexico by 2014, according to BMI.  

To prepare for this growth, the country lowered its import tax rate and is supporting generic-drug company license deals with multinational firms. The government is also collaborating more with the US FDA, including by simplifying authorizations for imported products into Mexico. Additional improvements include the introduction of regulations aimed at controlling the quality of generic drugs in the country. 

Although Mexico is technically trailing behind other countries in Latin America with regard to the generic-drug sector, it is expected to continue to outrank overall pharmaceutical markets in many other countries in the region.  

Hellen Berger is a business correspondent based in São Paulo, Brazil.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

Report from Latin America

João Geraldo Ferreira, president and CEO of GE Brasil, announced at the end of 2010 that Brazil was prepared to host high investments. Ferreira's optimism for Brazil is based on the country's positive outlook for the near future as it prepares to stage the World Soccer Cup in 2014 and the Olympic Games in 2016.  To meet the growing demand for quality drugs, blood byproducts, and vaccines and to answer the call from the World Health Organization's (WHO) that all countries  have their own blood byproduct and vaccine (or blood-derived products) production, the São Paulo State government has built a human blood plasma facility using GE Healthcare technology.  

 PHOTO: MAURICIO SIMONETTI, GETTY IMAGES			

The unit will operate under international GMPs and be located within the Butantan Institute*, in São Paulo. "Plasma is the liquid portion of our blood and each country has its own characteristics with different antibodies," explains Elizabeth Martins, scientist and project leader for Butantan Institute. "We live in a tropical country, therefore, we have antibodies raised against diseases found in a tropical environment ... that is why the World Health Organization has asked each country to produce its own blood plasma products, because they are adequate for that specific country," she added. 

WHO states that developing countries will only be able to create affordable and sustainable supplies of blood-derived products by using plasma collected from their own population, according to WHO data from Oct. 2009.     

According to GE, approximately 90% of the blood derivatives used in Brazil are currently imported. Fundação Butantan will produce 30% of Brazil's need, potentially providing a return on investment and running costs within five years.   

According to Martins, each country has been asked to be responsible for their own immunobiological products, while another recommendation states that countries should produce their own hemoderivatives. 

To date, the São Paulo government has invested approximately R$70 million ($41 million) to build the plant. The Butantan Foundation has spent an additional R$50 million on the engineering project and equipment, says Martins, and will devote more funds to get the plant operational. The facility is being developed with the supporting expertise and technology of GE Healthcare, especially in the area of purifying proteins taken from plasma. The São Paulo government has signed a contract to purchase GE's healthcare technology services.  

Martins expects the plant, which should process 150,000 liters of plasma/year, to be operational by mid-2012 with product commercialization to begin in 2013. Bidding has begun among Brazilian firms to develop, according to specific standards, additional equipment and systems.  

From the government's point of view, investment in pharmaceutical production is a key strategy for ensuring that the country is self-sufficient in plasma derivatives and vaccines. With approximately 200 million inhabitants, large volumes of biopharmaceuticals are necessary, and specialists believe it is risky for the country to depend largely on imports of such products.  

"Helping drive down cost, improve quality, and increase access to healthcare is our core business strategy," says Olivier Loeillot, Enterprise Leader of Life Sciences at GE Healthcare. "In this project for Butantan, we have brought GE Healthcare's biotechnology, design, and engineering expertise to bear on exactly these key issues in the provision of plasma products to the people of Brazil," Loeillot adds. Part of WHO's call to action is also based on the fact that global healthcare emergencies, such as pandemic swine flu, can greatly affect individual countries' ability to treat its citizens should large volumes of immunobiolocal products become scarce or difficult to obtain. 

Moreover, closure of private Brazilian plasma companies in 2001 due to irregularities related with plasma commercialization, which is banned in Brazil, created an urgent need to regain access by establishing a national plasma fractionation facility. Recently, GE's plans for Brazil include additional collaboration between the company and the Brazilian government on various infrastructure projects, including those tied to the World Cup and Olympic Games. According to individuals working on the project, the strategy is to shift focus of key global markets from the US to other countries, especially to emerging markets.  

 * The Butantan Institute, based in in São Paulo, produces plasma products and vaccines according to strict international standards. The Fundação Butantan (Butantan Foundation) was established in 1985 to promote cost-effective production of vaccines for Brazilians. Butantan is one of the five centers chosen by WHO for its task force to fight disease around the world. The institute produces more than 50% of the vaccines used in Brazil and 80% of all vaccines used in the national vaccination program. With a surplus production capacity and a strong research and development program, Fundação Butantan has attracted international projects in biologicals.  

Brazil develops its first national plasma fractionation plant.

Report From Brazil March 2011

On April 19, 2010, Brazil's regulatory health authority, Anvisa, revised its good manufacturing practice (GMP) requirements, replacing standards that had been in place since August 2006. The GMPs apply to pharmaceutical products negotiated within the Mercado Común del Sur/Mercado Comum do Sul (Mercosul or Mercosur), the regional trade agreement that includes Argentina, Brazil, Paraguay, Uruguay, and Venezuela. (Bolivia, Chile, Colombia, Ecuador and Peru currently have associate member status.)  

 PHOTO: JEREMY WOODHOUSE, DIGITAL VISION, GETTY IMAGES			

The purpose of GMPs is to establish minimum requirements and standard practices to be followed in the manufacturing of drugs. Anvisa's revised GMP document, known as RDC 17, which applies to all drugs manufactured domestically for human use, took effect upon publication in April 2010. The document addresses quality, sanitation and hygiene, qualification and validation, products and contracts, and more. The primary updates affect computer-system validation and periodic product revision. Other specific changes address biological products, water for pharmaceutical uses, sterile products, and herbal medicines, according to the Rio de Janeiro Pharmacy Council.  

"The quality of a certain drug is directly related, among other aspects, with practices used during its production," said Anvisa Inspection Manager Marcelo Vogler. "These rules are fundamentally important for Anvisa because they guarantee certain quality requirements for drugs available in the local market." 

"The [GMP] rules are a result, mainly, of [global] disasters and catastrophes caused by faulty production practices as well as bad use and commercialization of pharmaceutical drugs," explains Vogler.  

During the 20th century, inspection problems and quality issues with pharmaceutical drugs led to many deaths and serious health injuries.  

One of the first major crises involved the use of elixir sulfanilamide. The ingredient was improperly used in a drug product and caused a mass poisoning in the United States in 1937. This incident, among others, led to the passing of the 1938 US 

 to secure the supply chain of these products. In Brazil, the act was introduced mainly as a consequence of the Mercosur trade pact and the need to consolidate trade practices, according to Anvisa. 

Then, in 1961, the sedative Thalidomide was withdrawn after it was discovered to cause birth defects in children whose mothers took the drug during pregnancy. Said to be "one of the biggest medical tragedies of modern times," the thalidomide case led to much stricter testing requirements for drugs worldwide.   

"The Mercosur pact brought the need to establish a package of harmonized rules between the members in order to support the process being developed," explained Vogler.  

Why revise the GMPs now? According to Vogler, all revisions to Brazil's pharmaceutical GMPs, including the most recent RDC 17 resolution, are based on international references, including standards set by the World Health Organization (WHO).   

"WHO revises its recommendations periodically and, consequently, we follow such recommendations, and that is why there was the need to revise our national document as well," said Vogler.  

"The main changes [to RDC 17] regard the need to 'Validate Computerized Systems' related with the process of production of pharmaceutical drugs," says Henrique Tada, technical regulatory manager in Brazil for the National Pharmaceutical Laboratories Association (Alanac) in Brazil.  

According to Tada, the revised GMPs on computer validation and product revision are beneficial because they force pharmaceutical companies to comply with quality controls in order to supply the local market with high quality drugs. The changes will also help bring Brazil's pharmaceutical drug manufacture in line with regulatory standards of the most developed countries. (The revised GMP on validating computer systems used in the production of drugs will involve additional costs for companies and as a result, will not be enforceable for three years.) 

"By complying with international practices, it is easier for domestically based pharmaceutical companies to [perform] export activities, especially national firms that have been growing steadily," adds Alanac's Tada. 

Other positive changes in the revised GMPs, according to specialists, are related to the global harmonization of procedures and the sharing of relevant information among international regulatory bodies. According to Anvisa, Brazil regularly collaborates with other regulatory and surveillance bodies with regard to information-sharing about inspections.  

"Brazil, as a member of the Mercosur trade pact, participates actively in activities ... by sharing data and harmonizing procedures and rules," says Vogler. For example, Anvisa works regularly with the Pan American Network for Drug Regulatory Harmonization (PANDRH). The network was established in 1999 "to support processes on drug regulatory harmonization," according to the US Food and Drug Administration website. Participants in PANDRH include national authorities in the Americas, pharmaceutical interest groups, industry, and academia.  

Although the Brazilian pharmaceutical industry does not participate in quality systems and analytical-testing activities as called for by the International Conference on Harmonization (ICH), notes Tada, Anvisa bases its technical guidelines on those of ICH.  

Hellen Berger is a business writer based in São Paulo, Brazil. 

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.