Understanding Brazil’s generic drug regulations

. Sep 26, 2018
generic drugs law brazil health care Brazil has a generic drugs law since 1999

Earlier this week, a Brazilian federal court issued an injunction which stripped U.S. pharmaceutical producer Gilead Sciences of its patent over Sofosbuvir, a medication used for the treatment of hepatitis C and sold under the brand name Sovaldi. Higher courts are still to uphold the decision, but the decision already paves the way for cheaper generic drugs.

Last week, Brazil’s National Intellectual Property Institute (INPI) granted the American company the patent, establishing that only Gilead would be allowed to produce the drug in Brazil. Sovaldi has proven to be effective against serious liver diseases, but Gilead was criticized for marketing a drug initially priced at USD 1,000 a pill in the U.S. For the INPI, however, “anticompetitive strategies” and “outrageously high prices” should influence discussions about intellectual property.

The case’s judge begged to differ, stating that preserving Gilead’s patent goes against the country’s goal to eradicate hepatitis C by 2030 – as generic medications could cost as little as six times less than the original drug, according to the decision. It would also damage the public health care system’s budget, as buying Sofosbuvir from a single licensed manufacturer could represent over BRL 1 billion in costs.

The case of Gilead’s hepatitis drug sheds some light on Brazil’s regulations concerning generic drugs. Here, we will explain how these rules work.

</span></p> <h2>Brazil&#8217;s 1999 generic drugs law</h2> <p><img loading="lazy" class="alignnone size-large wp-image-9091" src="é_Serra_como_ministro_da_saúde-1024x719.jpg" alt="josé serra minister of health brazil health care" width="1024" height="719" srcset="é_Serra_como_ministro_da_saúde-1024x719.jpg 1024w,é_Serra_como_ministro_da_saúde-300x211.jpg 300w,é_Serra_como_ministro_da_saúde-768x539.jpg 768w,é_Serra_como_ministro_da_saúde-610x428.jpg 610w,é_Serra_como_ministro_da_saúde.jpg 1672w" sizes="(max-width: 1024px) 100vw, 1024px" /></p> <p><span style="font-weight: 400;">By the late 1990s, the Brazilian market offered two types of drugs: those which were initially launched by big pharmaceutical companies (usually of foreign capital), and the so-called &#8220;similar drugs,&#8221; which were copies traditionally made by local small or medium-sized companies competing on the fringes of the medication market.</span></p> <p><span style="font-weight: 400;">In 1999, the federal government approved the Generic Drugs Law, aiming to guarantee patients&#8217; access to quality products that were more affordable and less dependent on the will of a small number of companies. A February 1999 law enforced strict regulations on generic drugs, which had to prove they had the same efficiency as the products they were intended to replace.</span></p> <p><span style="font-weight: 400;">The law also established that doctors could no longer prescribe the commercial name of a drug, but rather the substance they wanted patients to use &#8211; thus giving them the option to buy a generic version. In purchases for the public health care system, the preference must always be for the least expensive available option.</span></p> <h2>The impacts of generic drugs on Brazil</h2> <p><span style="font-weight: 400;">Since the law passed, the generic drugs market boomed. The number of such medications prescribed in Brazil has jumped by 65 percent as of 2015. These less expensive options (which are 35 percent cheaper, on average) now amount to 34 percent of the 115 million prescriptions issued in Brazil between February 2017 and 2018. </span></p> <hr /> <p><img loading="lazy" class="alignnone size-large wp-image-9088" src="" alt="generic drugs law brazil health care" width="1024" height="683" srcset=" 1024w, 300w, 768w, 610w, 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></p> <hr /> <p><span style="font-weight: 400;">According to Brazil&#8217;s National Agency of Sanitary Surveillance (Anvisa), generic drugs accounted for 70 percent of the 4.3 billion pharmaceutical units produced in Brazil last year. Today, there are 6,300 such medications in Brazil, being put on the market by 120 laboratories. The generic drugs market generated BRL 8.6 billion in revenue in 2016 &#8211; and the number of registered drugs jumped by 82 percent over the past five years to 882. </span></p> <p><span style="font-weight: 400;">Investments from the federal government bear much of the responsibility for this success, as the Ministry of Health has been the biggest advertiser for off-brand medications. &#8220;The generic drugs policy in Brazil was extremely effective &#8211; both from the standpoint of increasing access [to health care] and of creating an important national pharmaceutical industry,&#8221; says Jarbas Barbosa, Anvisa&#8217;s president. </span></p> <p><span style="font-weight: 400;">Of the top 20 companies of the generics sector, 16 are Brazilians &#8211; and three of them are state-owned (Fundação Oswaldo Cruz, Fundação para o Remédio Popular, and the Vital Brasil Institute).</span></p> <hr /> <p><img loading="lazy" class="alignnone size-large wp-image-9089" src="" alt="generic drugs law brazil health care" width="1024" height="377" srcset=" 1024w, 300w, 768w, 610w, 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></p> <hr /> <p><img loading="lazy" class="alignnone size-large wp-image-9090" src="" alt="" width="1024" height="420" srcset=" 1024w, 300w, 768w, 610w, 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></p> <hr /> <h2>Patients love generic drugs. Doctors, not so much</h2> <p><span style="font-weight: 400;">A 2011 survey by Proteste, an organization focused on consumer experience and satisfaction, showed that Brazilian patients quickly grew fond of generic drugs &#8211; mostly for the savings they represent. A survey showed that 83 percent trusted this type of medication. Among doctors, however, 46 percent showed concerns for their efficiency &#8211; and almost half thought they were more susceptible to counterfeiting.</span></p> <p><span style="font-weight: 400;">In 2016, </span><a href=""><span style="font-weight: 400;">Proteste</span></a><span style="font-weight: 400;"> carried out a new survey on the matter only among doctors. Their findings changed a lot. Fifty-eight percent of doctors said they frequently prescribed generic drugs &#8211; and only 4 percent never do. However, 91 percent of doctors complain they don&#8217;t have enough information from Anvisa about the properties of these drugs &#8211; relying exclusively on the feedback they get from patients.

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