Author: Roberta Paduan

Source: Exame, 22/08/2008

During the month of August, 16 people with the AIDS virus spent two days voluntarily admitted to a hospital in Campinas, in the interior of São Paulo, receiving a medication and taking blood tests every hour. The result of this battery of tests will reveal whether a drug under development at the Rio de Janeiro laboratory Farmanguinhos, an arm of the Ministry of Health, is absorbed by the patients' organisms in the same amount and within the same period as the drug it tries to replicate, Efavirenz, belonging to the multinational Merck . The analysis of the tests, which should come out at the end of September, is a test of fire for the state laboratory and, above all, for the federal government. In May 2007, under the allegation that Merck charged Brazil more than twice the price paid by Thailand, the Ministry of Health suspended the purchase of Efavirenz, decided to import cheaper generic versions of the drug and promised that in one year , would start production in the country. Four months after the period announced by the government, the start of the manufacture of the drug - an antiretroviral of the anti-AIDS cocktail - is still uncertain. If the tests with the patients are successful - which did not happen in the first attempt, carried out earlier this year - the pills should start to reach the patients in the first half of 2009. The delay in relation to the initial schedule can reach one year .

Problems in clinical trials and delays in drug development also occur in the world's largest laboratories. However, in this case, some elements increase government accountability. To import the generic Efavirenz and start the development of the drug in the country, the government resorted to a controversial resource provided for in international trade legislation: the compulsory license. This appeal is a patent breach admitted in extreme cases, such as Merck's alleged abuse. In order to maintain the supply of the drug to HIV carriers, the government started importing generics manufactured in India, which until recently had not adhered to the international treaty on respect for intellectual property and which therefore developed the drug despite the original still having a patent. in force. The measure was controversial. "This type of episode erodes the image of the country, which still tries to assert itself as complying with international rules", says Ricardo Mendes, from Prospectiva, a consultancy specialized in international relations. At the other end are those who support actions like the one taken against Merck. "The pharmaceutical sector is one of the most likely to exercise economic abuse, because, in some situations, it uses patent protection to maintain the benefit of exclusivity," says economist Lia Hasenclever, a specialist in the pharmaceutical sector.

Controversies aside, the fact is that the government is in the spotlight. In addition to using a controversial resource, the Ministry of Health has promised something it has so far failed to deliver. The delay in the production of Efavirenz has raised doubts about the technical and managerial capacity not only of Farmanguinhos but of public laboratories in general. With the exception of Cuba, the Brazilian model of state-owned pharmaceutical industries is unparalleled in the world. There are 19 public laboratories here - the oldest of them is from the Army, created by Dom João VI after his arrival in Brazil in 1808. There seems to be a consensus that such a network of official laboratories is at least an exaggeration. “'Farmobras' is a delay,” says Gonzalo Vecina Neto, a professor at the Faculty of Public Health at the University of São Paulo and former president of the National Health Surveillance Agency. "The government has no competence to produce drugs and should close most of these laboratories." Only four of the 19 state-owned drug manufacturers are responsible for 75% of the total medicines produced by the public network.

The anachronism and inefficiency of the state laboratory network was demonstrated by a study coordinated by economist Lia Hasenclever. "In general, government laboratories do not have technological or managerial skills to justify their existence," says Lia. “They were not created to innovate and they also cannot be agile because they are tied to the rules of public tenders and tenders.” The official laboratories themselves are uncomfortable with the current situation.

"I buy raw material, the heart of the medicine, just as I buy a paper package", says Ricardo Oliva, president of the Association of Official Pharmaceutical Laboratories of Brazil and superintendent of Furp, a laboratory in the state of São Paulo. By law, purchases must be made by bidding where the lowest price wins. It takes time. It is also vital, in the case of complex products, to take into account aspects such as product quality. “It is very difficult to maintain competitiveness with such archaic management systems”, says Oliva. Part of the delay with Efavirenz, in fact, can be credited to bureaucratic obstacles in the public system. After the approval of the active ingredient of the medicine - developed by a consortium formed by three private companies, Nortec, Cristália and Globe -, Farmanguinhos decided to introduce a change in the final formulation of the pill. The change was made because one of the ingredients would have to be imported and, for that, go through the bureaucracy rite. “We wanted to save the import time by using another input,” says Eduardo Costa, superintendent of Farmanguinhos. "But, as it didn't work, we had to import and go back to the original formula." That vaingue alone took seven months.

Promised but did not deliver

Understand the imbroglio surrounding Efavirenz - anti-AIDS drug whose patent was broken by the government - and the causes of the delay in its production in state laboratories

2006

November

The government starts negotiations with the Merck laboratory to reduce the price of Efavirenz, one of the drugs in the anti-AIDS cocktail. Brazil pays 138% more than Thailand

2007

May

Without reaching an agreement with Merck, the government decrees the compulsory license of the drug. The appeal, provided for in international law, allows the country to import generic drugs. Minister José Gomes Temporão announces that Farmanguinhos, from the federal government, and Lafepe, from the state of Pernambuco, will produce the drug in one year

January

The active principle of Efavirenz (whose production has been delegated to three Brazilian companies) passes all tests. Farmanguinhos and Lafepe begin to develop the final product

2008

April

The drug does not pass the bioavailability test done to prove that the drug spreads throughout the body in doses and in the same time periods as the Merck product. Farmanguinhos and Lafepe have to redo the formulation

August

The tests with the second version of the drug begin to be carried out with volunteer patients. Results are expected in September. If all goes well, the first batches of Efavirenz will be delivered by June 2009. The delay can reach one year

The creation of the state structure is rooted in the distortions of the economy and the country's regulatory system. The national pharmaceutical industry was slow to develop for a number of reasons. The historical price control - still existing today -, the low purchasing power of the population and the lack of an intellectual property protection policy did not stimulate investments in the sector for a long period. The consequences were low production and high prices. At the same time, the Union and several states started to produce medicines under the justification that many private laboratories did not have reliable quality. More recently, the evolution of the competitiveness of the national industry and the advent of generics, which made medicines considerably cheaper, eliminated many reasons for the existence of these laboratories. An analysis of the Farmanguinhos catalog, for example, shows that only six of the 66 products that leave there make sense. “With the exception of drugs against malaria and tuberculosis and some antiretrovirals, the rest have several manufacturers and could be purchased by the government at a lower cost,” says Vecina Neto.

The federal government itself seems to have realized the need to reformulate the network, but it knows that dealing with this hornet's nest is not easy - most laboratories belong to state governments. “From now on, only those who are adapted to the new vision of the ministry will be able to obtain resources”, says the head of Health, José Gomes Temporão. In the last five years, the Ministry of Health has invested R $ 318 million in official laboratories. According to Temporão, these institutions will have to produce medicines considered strategic, contribute to the development of new production processes and have an ongoing management modernization project. "The laboratories are important for the government to maintain assistance programs, but they have to undergo adjustments", says the minister. This year, the Union will spend 5,2 billion reais on the purchase of medicines. The Ministry of Health does not know how much of this amount is spent on the purchase of drugs from official laboratories. The anti-AIDS program alone consumes R $ 1 billion in medicines, of which 350 million are purchased from the public network.

Some measures recently adopted show some progress. Last year, the ministry delegated to the municipalities the purchase of medicines, previously centralized in Brasília, opening space for them to seek medicines in the private network. "This should greatly improve efficiency and even eliminate the most inefficient," says Lia Hasenclever. Another initiative was the determination that the BNDES only release resources to official laboratories that accept to be submitted to the scrutiny of an independent consultancy. The objective is for the consultancy to evaluate everything from the type of medication to be produced to the management improvements adopted. It is a start - but it will take much more to air the state's system of medicine production.