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April 18, 2016
The region of Latin America is currently experiencing what it is like to have a legal drug war on its soil as smaller generic labels from the developing world take on major pharma firms from the US and Europe. With billions at stake, bio-technology and generics have locked horns in the Americas in the bid to gain a foothold in a huge and growing market in beating tough diseases.
In spite of the Latin America public health sector being in favour of the Mexican produced Kikuzubam, the fancier and more expensive Swiss rival, Rituximab produced by Roche is today, king of the ring. With a more relaxed set of pharmarules in Latin America, states are more inclined to buy cheaper copies of western drugs even if they have less certification. However, in doing so, the large, western pharmaceutical companies are taking their competitors to court as happened with Kikuzubam and Rituximab. The result more often than not, as was the case with Kikuzubam in March 2014, involves the cheaper, generic lab having its licence revoked and the product withdrawn from the shelves. As pharmaceutical labs, governments and patients continue to move in different directions in order to protect their respective interests, a pharmaceutical war is beginning to rage in Latin America.
Until recently, large pharma labs argued that biopharmaceutical products could not be copied however it turns out that they were wrong. The battle has therefore shifted to the rules that Latin American governments should impose on copiers whose products are entering the market as previous patents written in the past 20 years begin to expire. This environment has resulted in lobbying, another area where Latin America is rather more relaxed than the developed countries of the larger pharmaceutical companies. The lobbying by the drug companies delays the discussion and approval of laws to regulate generics and this can create rather strange occurrences. For example, in July 2014, the Colombian Ambassador to the United States wrote to the Colombian Health Ministry to voice US pharma firms concerns over a ministerial decision to regulate generics. The result was obvious with Colombia’s lawmakers all up in arms.
While Latin American governments receive such concerns voiced by ambassadors, it runs in direct conflict to their agenda which is to pay less. Many governments in developing countries might not even care if the drug works better or worse than the western equivalent, but instead the price of the drug is what is important. Some countries such as Argentina and Ecuador have extremely lax rules, allowing any drug product into the country’s market.
With Kikuzubam withdrawn entirely from the market and Roche set to recover its licence, the story looks set to hit another bump in the road for the wealth Swiss pharma company. A third player from India looks set to enter the frame with a generic called Reditux. Already available in Bolivia, Chile, Ecuador and Peru, many Reditux distributing labs are already accusing Roche of trying a number of tricks to keep the product from entering regional markets in spite of public demand. With price driving decisions and a lack of debate on biogenerics, many physicians in Latin America do not have a clear understanding of the differences between patented and generic drugs and their qualities. It is not uncommon for a doctor in Latin America to change one drug for the other without disclosing the information to the patient as demand for access to generic drugs rises in the region.
After President Dilma Rousseff had her cancer treated with Rituximab, Brazilian patients went to court to demand its availability in public hospitals. With Rituximab’s patent ending 2 years ago, Brazil is set to start producing its own version of the drug. Brazil is the largest market and producer of generic drugs in Latin America, receiving government backing as the country seeks to make drug firms and copiers collaborate. In doing so, big pharma companies are being encouraged to invest in making products whose purchase is becoming increasingly assured by public health authorities. This will allow the country to make its own pharmaceutical products in Brazil. The large western pharmaceutical firms are keeping a close watch on Brazil as they too have begun to make their own generics with their evident change of outlook in their support of Brazil’s initiatives to boost biogenerics. While there is no global set of norms or body to check products and their effects, Latin America’s generics function mainly under the same rules applied to patented drugs. However, with a changing market and perspectives, it may not be long before biogenerics receive the same scrutiny.
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