*José Serra, O Estado de S.Paulo
May 11, 2017 | 3:02 a.m.
In recent decades, technological advances in pharmaceuticals have brought enormous benefits worldwide. Life expectancy and quality of life have increased across all social classes. Better medicines not only prolong life, but also improve it.
This advance has tended to raise the costs of medicine, especially the latest technologies. This applies to medicines and other areas involving healthcare. And it is an international trend. The IMS Institute, an organization specializing in health studies, estimates that per capita spending on medicines nearly tripled in the United States from 1995 to 2014, after adjusting for inflation.
In Brazil, until the late 1990s, the price of brand-name drugs—reference drugs—was a barrier, sometimes insurmountable, to access to healthcare. Although the same substances were used in so-called similar drugs, there was no guarantee of bioequivalence, meaning that doctors were not sure that the effects of the substitute drug would be the same as those obtained from the reference brand. Competition was therefore virtually non-existent in the sector.
At the beginning of Fernando Henrique Cardoso's second term in office, in 1999, we decided to regulate and encourage the production of generic drugs—whose main property is precisely the guarantee of their bioequivalence to brand-name products. International experience had already shown that generics were capable of intensifying competition and lowering prices. It was necessary to act quickly so that millions of patients could undergo or continue their treatments, living with greater safety and comfort. That same year, we passed the Generic Drugs Law.
The law went far beyond simply “legalizing” the product, as it required companies not only to ensure bioequivalence, but also to adopt good manufacturing and safety practices, which had a huge impact on the quality of pharmaceutical production in Brazil. With the same purpose in mind, we created the National Health Surveillance Agency, Anvisa.
The price differences between generic and brand-name drugs are striking. I checked at a pharmacy in Brasília: the antiallergic drug fexofenadine hydrochloride (Allegra), in a package of ten 120 mg capsules, costs R$ 28 in its generic version, while the brand-name drug costs as much as R$ 43. For the antibiotic amoxicillin, in a package of 21 500 mg capsules, the prices are R$ 15.50 and R$ 61.50, respectively. Meanwhile, 28 20 mg capsules of the anti-ulcer drug omeprazole are sold for R$ 9.20, compared to R$ 75 for the reference brand.
It wasn't just consumers who benefited. Domestic pharmaceutical companies also benefited, with their share of the top ten laboratories in the sector rising from 4.7% in 1998 to 27% in 2016.
In addition to having much lower prices, generics also caused a drop in the price of reference brands. This trend was observed by Marislei Nishijima, a researcher at the University of São Paulo (USP), in a 2008 study. Marislei Nishijima also noted that the extent of the price drop depends on the number of generics with the same active ingredient on offer: the more generics for a given substance, the lower the prices.
This conclusion is extremely important. It is not enough for Anvisa to approve a single competitor. Several must be admitted to the market in order for prices to fall more aggressively. In fact, during the PT administrations, the queues for authorization of new generics grew. The processes began to take longer than reasonable. Thus, the momentum for price reductions cooled.
Even for state-of-the-art non-generic drugs—which have no competitors but are indispensable for the treatment of certain diseases—authorizations were unjustifiably delayed, causing harm to patients' health.
In 2012, a study by Interfarma showed that the time frame for approving drugs had increased progressively. For new drugs without generic or similar versions, the time frame had increased from 7 to 16 months. This was especially serious in the case of so-called biological drugs, which are essential in the treatment of degenerative and autoimmune diseases and various types of cancer. For generics, the situation was even worse. The delay could be more than two years.
Upon my return to the Senate in 2015, I proposed a bill, approved in 2016 – Law 13,411 – creating the concept of priority drugs, for which the maximum period for granting authorization became 120 days. Classification in this category is based on the novelty of the drug—the possibility of treatment not previously available—or, especially in the case of generics, on the price reduction that its introduction on the market may bring about.
Law 13,411 also establishes a maximum period of one year for Anvisa to decide on authorization requests that were submitted to the agency before the law came into effect.
Finally, there is a provision that provides for the dismissal of Anvisa's board of directors in the event of unjustified failure to comply with the deadlines set forth in the law for two fiscal years.
Although it came into force less than six months ago, Law 13,411 has had a positive impact on the market. The time required to process authorizations has decreased. Anvisa has implemented regulatory and management changes that have accelerated authorizations, especially by reducing purely bureaucratic steps. And in the technically essential steps, there have been productivity gains. Now, more qualified personnel need to be hired for the agency's drug management department, which handles authorization requests. This department has 120 employees and needs 50 more. This is not unreasonable, considering the enormous cost-benefit ratio for society.
Generic drugs continue to benefit the population. And increasingly so.
*Senator (PSDB-SP)
See original: http://opiniao.estadao.com.br/noticias/geral,os-genericos-continuam-fazendo-bem,70001772847