Generics v. Big Pharma: A Latin American Legal Drug War

Latin America is the latest battlefield for the billions in the global showdown between smaller generic labels from the developing world and the major U.S. and European firms.

A pharmacy in Sao Paulo, Brazil
A pharmacy in Sao Paulo, Brazil
David Cornejo*

SANTIAGO Imagine a Mexican-style lucha libre wrestling match between pharmaceutical products. On one side is Kikuzubam, the molecule of the poor. His flashy challenger is Rituximab, produced by a wealthy pharma firm called Roche.

Kikuzubam taunts his rival, telling him he is just as tough. The judge gives him the first round when he says, "no need for clinical tests!"

But the rules change in the second round. The judge now demands testing. Kikuzubam starts feeling the heat. Some in the audience — Kikuzubam's fans in the public health sector who "love him, he's so cheap!" — boo the decision. The knockout blow comes later, when the judge removes Kikuzubam's licence. One, two, three, four ... The champion of the poor is down for the count.

For now, at least, Rituzimab, the fancy Swiss rival, is still king of the ring.

Welcome to the global fight between bio-technology and generics, which have now begun locking horns in the Americas. The prize? A huge and growing market in beating tough diseases.

The chief problem is a lack of rules. States are inclined to buy cheap copies with little certification. Big labs counter by taking their competitors to court. For now, labs, governments and patients are all maneuvering to protect their respective interests.

Until recently, big firms argued that biopharmaceutical products could not be copied. It turns out they were mistaken, and the battle has shifted to the rules governments should impose on copiers, whose products are entering the market as patents written in the past 20 years expire. That is where lobbying comes in — another area short on rules!

What lobbying by the drug firms does is delay discussion and approval of laws to regulate generics, says Juan-Manuel Anaya of the Colombian Rosario University's center for the study of autoimmune diseases. It can take strange forms: when Colombia's ambassador to the U.S., Luis Carlos Villegas, wrote to the Colombian Health Ministry in July 2014 to inform it of U.S. firms' "concerns" over a ministerial decision to regulate generics, the country's lawmakers were indignant. "Was he lobbying for those firms," asked one Colombian senator?

"Take it if it makes you happy"

As Andrés Felipe Cardona, head of the cancer NGO RedLANO, observes, governments also have their agenda, which is always to pay less. "The state doesn't care if the drug works or not. It sees who is charging less. Some countries, like Ecuador and Argentina, are completely lax and let any drug product can come in."

After its knockout last March, Kikuzubam was entirely withdrawn from the market. Roche, in the meantime, looks set to recover its licence. End of story? Not quite. Turns out there is a third player also wanting a piece of the action: Reditux, a generic made by Dr Reddy, an Indian laboratory.

Reditux is available in Ecuador, Peru, Chile and Bolivia. Labs distributing it have already accused Roche of trying a range of tricks to keep the product out of regional markets, in spite of public demand. Looks like the patients themselves are trying to enter the ring!

The lack of debate on biogenerics means that many physicians in Latin America are fuzzy about their qualities. When Laura Parilla had chemotherapy for breast cancer in Mexico City, relatives recommended she take Interferon to mitigate the effects. "I asked a doctor and, with total indifference, he told me "it won't do you any good or harm, take it if it makes you happy,"" she says.

Many doctors "have no idea" about the differences between patented and generic drugs, says Richard Salvatierra, head of the Americas Health Foundation. "Sometimes they change one for the other without the patient knowing." Patients are starting to demand access to generic drugs.

All eyes on Brazil?

This lack of debate is unusual considering how many Latin American leaders have had cancer. The list includes Venezuela's Hugo Chávez, who died in 2013, former Paraguayan President Fernando Lugo, Argentina's Cristina Kirchner and Brazil's Lula da Silva and Dilma Rousseff. After the latter had her lymphatic cancer treated with Rituximab, Brazilian patients went to court to demand it become available in public hospitals. The country is set to start producing its own version, as Rituximab's patent ended two years ago.

While experts see regulation as the solution, after Rousseff's illness, Brazil sought to make drug firms and copiers collaborate.

Brazil is currently the largest market for and biggest producer of generic drugs in Latin America, with government backing. Firms are encouraged to invest in making products whose purchase by public health authorities is increasingly assured, through PDPs or product development partnerships. "It will allow the country to make its own pharmaceutical products in Brazil," says Reginaldo Arcuri of BrasilPharma.

The big labs are observing Brazil even as they too have begun making generics. Their change of outlook is evident in their acceptance of Brazilian state initiatives to boost biogenerics. "It is a global and natural movement," says Vera Valente, head of biogenerics at Merck. "The firm decided to embrace the cause and formed its biosimilars division. If we don't do it, someone else will."

The first set of rules for biogenerics emerged from the European Medicines Agency (EMA) in 2005. The World Health Organization issued its own document in 2010, and American states used such texts to formulate their own regulations. There is no global set of norms for now, nor an oversight body to check products and their effects. In Latin America, generics function mostly under rules applied to patented drugs.

"Ask someone in a country if biosimilars are working and they tell you, "sure, nobody died from them"," says Richard Salvatierra. "But nobody knows their exact benefits."

But with changing perspectives, they are here to stay. When oncologist Jaime de la Garza headed Mexico's National Cancer Institute, he once chose a generic over a patented drug for being half the price. He recalls that a rep from the firm Bristol-Myers Squibb came to tell him the generic he had chosen over their product "is no good." Years later, says de la Garza, the rep was found working "in the firm making the copies and I asked him, why are you working in a firm that makes useless products? He said "the market changed.""

Ring the bell for round three!

*Marlene Jaggi in Sao Paulo and Camilo Olarte in Mexico City contributed to this item.

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The Food Truck, A Sign That The White And Wealthy Are Moving In

In San Diego, California, a researcher tracked how in the city's low-income neighborhoods that have traditionally lacked dining options, when interesting eateries arrive the gentrification of white, affluent and college-educated people has begun.

Balboa Park Spring Fling Food Truck festival

San Diego Food Trucks via Facebook
Pascale Joassart-Marcelli

SAN DIEGO — Everybody, it seems, welcomes the arrival of new restaurants, cafés, food trucks and farmers markets.

What could be the downside of fresh veggies, homemade empanadas and a pop-up restaurant specializing in banh mis?

But when they appear in unexpected places – think inner-city areas populated by immigrants – they're often the first salvo in a broader effort to rebrand and remake the community. As a result, these neighborhoods can quickly become unaffordable and unrecognizable to longtime residents.

An appetite for gentrification

I live in San Diego, where I teach courses on urban and food geographies and conduct research on the relationship between food and ethnicity in urban contexts.

In recent years, I started to notice a pattern playing out in the city's low-income neighborhoods that have traditionally lacked food options. More ethnic restaurants, street vendors, community gardens and farmers markets were cropping up. These, in turn, spurred growing numbers of white, affluent and college-educated people to venture into areas they had long avoided.

This observation inspired me to write a book, titled The $16 Taco, about how food – including what's seen as "ethnic," "authentic" or "alternative" – often serves as a spearhead for gentrification.

Take City Heights, a large multi-ethnic San Diego neighborhood where successive waves of refugees from places as far away as Vietnam and Somalia have resettled. In 2016, a dusty vacant lot on the busiest boulevard was converted into an outdoor international marketplace called Fair@44. There, food vendors gather in semi-permanent stalls to sell pupusas, lechon (roasted pig), single-sourced cold-brewed coffee, cupcakes and tamarind raspado (crushed ice) to neighborhood residents, along with tourists and visitors from other parts of the city.

Informal street vendors are casualties.

A public-private partnership called the City Heights Community Development Corporation, together with several nonprofits, launched the initiative to increase "access to healthy and culturally appropriate food" and serve as "a business incubator for local micro-entrepreneurs," including immigrants and refugees who live in the neighborhood.

On paper, this all sounds great.

But just a few blocks outside the gates, informal street vendors – who have long sold goods such as fruit, tamales and ice cream to residents who can't easily access supermarkets – now face heightened harassment. They've become causalities in a citywide crackdown on sidewalk vending spurred by complaints from business owners and residents in more affluent areas.

This isn't just happening in San Diego. The same tensions have been playing out in rapidly gentrifying areas like Los Angeles' Boyle Heights neighborhood, Chicago's Pilsen neighborhood, New York's Queens borough and East Austin, Texas.

In all of these places, because "ethnic," "authentic" and "exotic" foods are seen as cultural assets, they've become magnets for development.

Food vendor at outdoor international marketplace called Fair@44.

Fairat44 via Instagram

A call for food justice

Cities and neighborhoods have long sought to attract educated and affluent residents – people whom sociologist Richard Florida dubbed "the creative class." The thinking goes that these newcomers will spend their dollars and presumably contribute to economic growth and job creation.

Food, it seems, has become the perfect lure.

It's uncontroversial and has broad appeal. It taps into the American Dream and appeals to the multicultural values of many educated, wealthy foodies. Small food businesses, with their relatively low cost of entry, have been a cornerstone of ethnic entrepreneurship in American cities. And initiatives like farmers markets and street fairs don't require much in the way of public investment; instead, they rely on entrepreneurs and community-based organizations to do the heavy lifting.

In City Heights, the Community Development Corporation hosted its first annual City Heights Street Food Festival in 2019 to "get people together around table and food stalls to celebrate another year of community building." Other recent events have included African Restaurant Week, Dia de Los Muertos, New Year Lunar Festival, Soul Food Fest and Brazilian Carnival, all of which rely on food and drink to attract visitors and support local businesses.

Meanwhile, initiatives such as the New Roots Community Farm and the City Heights Farmers' Market have been launched by nonprofits with philanthropic support in the name of "food justice," with the goal of reducing racial disparities in access to healthy food and empowering residents – projects that are particularly appealing to highly educated people who value diversity and democracy.

Upending an existing foodscape

In media coverage of changing foodscapes in low-income neighborhoods like City Heights, you'll rarely find any complaints.

San Diego Magazine's neighborhood guide for City Heights, for example, emphasizes its "claim to authentic international eats, along with live music venues, craft beer, coffee, and outdoor fun." It recommends several ethnic restaurants and warns readers not to be fooled by appearances.

Longtime residents find themselves forced to compete against the "urban food machine"

But that doesn't mean objections don't exist.

Many longtime residents and small-business owners – mostly people of color and immigrants – have, for decades, lived, worked and struggled to feed their families in these neighborhoods. To do so, they've run convenience stores, opened ethnic restaurants, sold food in parks and alleys and created spaces to grow their own food.

All represent strategies to meet community needs in a place mostly ignored by mainstream retailers.

So what happens when new competitors come to town?

Food vendor at outdoor international marketplace called Fair@44.

Fairat44 via Instagram

Starting at a disadvantage

As I document in my book, these ethnic food businesses, because of a lack of financial and technical support, often struggle to compete with new enterprises that feature fresh façades, celebrity chefs, flashy marketing, bogus claims of authenticity and disproportionate media attention. Furthermore, following the arrival of more-affluent residents, existing ones find it increasingly difficult to stay.

My analysis of real estate ads for properties listed in City Heights and other gentrifying San Diego neighborhoods found that access to restaurants, cafés, farmers markets and outdoor dining is a common selling point. The listings I studied from 2019 often enticed potential buyers with lines like "shop at the local farmers' market," "join food truck festivals" and "participate in community food drives!"

San Diego Magazine's home buyer guide for the same year identified City Heights as an "up-and-coming neighborhood," attributing its appeal to its diverse population and eclectic "culinary landscape," including several restaurants and Fair@44.

When I see that City Heights' home prices rose 58% over the past three years, I'm not surprised.

Going up against the urban food machine

Longtime residents find themselves forced to compete against what I call the "urban food machine," a play on sociologist Harvey Molotch's "urban growth machine" – a term he coined more than 50 years ago to explain how cities were being shaped by a loose coalition of powerful elites who sought to profit off urban growth.

I argue that investors and developers use food as a tool for achieving the same ends.

When their work is done, what's left is a rather insipid and tasteless neighborhood, where foodscapes become more of a marketable mishmash of cultures than an ethnic enclave that's evolved organically to meet the needs of residents. The distinctions of time and place start to blur: An "ethnic food district" in San Diego looks no different than one in Chicago or Austin.

Meanwhile, the routines and rhythms of everyday life have changed so much that longtime residents no longer feel like they belong. Their stories and culture reduced to a selling point, they're forced to either recede to the shadows or leave altogether.

It's hard to see how that's a form of inclusion or empowerment.The Conversation


Pascale Joassart-Marcelli is a Professor of Geography and Director, Urban Studies and Food Studies Programs at San Diego State University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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