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Commercial considerations result in hundreds of drug withdrawals in Brazil

As a result of lack of commercial interest, pharmaceutical companies operating in Brazil have withdrawn from the market old and cheap medications, some of them essential and without substitutes.

Of the 1,748 drugs cancelled between May 2014 and June 2017, 63% were for commercial motivations, the second rise recorded on the website of Anvisa (Agência Nacional de Vigilância Sanitária). Other reasons (37%) referred to changes of factory location, problems with an active ingredient, etc. Almost a fifth (17%) were reactivated later. The industry must inform Anvisa at least six months beforehand of any cancellations and where there is no alternative a year before.

The pharmaceutical companies claim that there has been a shift-change in prices motivated by government politics. The federal government says the prices of these drugs have been revised. In oncology there is a big preoccupation with this situation because across the treatment interruption of drug access could accelerate the growth of the tumor and reduce the chances of a cure.

According to Dr Maria Inez Gadelha, diretor of the department with special attention of the Ministry of Health, many patients have remained “orphans” of these drugs. "The majority of these drugs are integrated into chemotherapy schemes which cure cancer, whilst the new antineoplastics, almost in their totality, only treat the patients palliatively," she said.

Dr Gadelha says that at least 30 medications for cancer have been discontinued since 2014 or run the risk of being removed, amongst those drugs for treatment of tumours of the bladder, lungs and leukemias. "Many of these remedies were developed from the 1950s, do not have patents and, because they are cheap, the industry no longer has interest in producing them."

Patient Vera Maria Pinho de Oliveira, already feels in her skin the effects of this lack. She has had lymphoma since 2009 treated with the medication Leukeran(chlorambucil). "It was the only one [treatment] capable of keeping the illness controlled," she said.

Since November the medication, which used to cost R$ 38, has disappeared from the pharmacies of Belo Horizonte (MG), where she lives. She has tried to find it in other states but without success. It was only after six months of trying that she was able to buy four boxes directly from the laboratory and received a donation of another three .

In the period without the drug she used high doses of corticoid to control the illness. "I had an allergic reaction, I gained weight, I could not sleep and had to take other remedies to control these symptoms," she told us.

The manufacturer, UK pharma major GlaxoSmithKline (LSE: GSK), says that the cessation was temporary and communicated this to Anvisa. Also that, together with the pharmaceutical comany Aspen, a new manufacturer of Leukeran, it is working to regularize the offering.

Paradox for patients

For Angelo Maiolino, president of the Brasilian Association of Hematology, Hemotherapy and Cellular Therapy, it means that patients with cancer today live a paradox: they suffer difficulties in accessing older and cheaper drugs, because of the lack of interest of the pharmaceutical companies, and also the new because of the high cost.

Mr Maiolino cites another example of a drug which disappeared from the market: melfalano, used to treat múltiple myeloma and essential in marrow transplant, had its production interrupted this year.

He stated that the remedy has no substitute and its unavailability prejudices the treatment of many patients diminishing their chances of a cure. "Although not ethical, absurd and almost criminal to imagine the lack of a medication so imperative, the industry is not obliged to produce it. Not here nor in other countries," he said.

The drug, also from GSK, ceased production in the whole world and, after international pressure, returned to production last January, but there is still a shortage. Dr Gadelha says that anothet laboratory is waiting for authorization from Anvisa to produce melfalano.

For Merula Steagall, president of Abrale (Associação Brasileira de Linfoma e Leucemia), the Ministry of Health is only going about "putting out fires...They must prevent the discontinuation of availability and act in a preventative manner."

Pediatric oncologist Vicente Odone says that another preoccupation is the quality of drugs imported in substitution for the discontinued traditional ones..."The country does not have big centers for quality control of medications which confirm the safety and effectiveness of what is coming in," he stated.

Pharma company views

The pharmaceutical laboratories claim that the interruption of some remedies in the country occurs many times more through the lag in prices caused by government politics than through commercil motives.

"Many times the firms wish to make determined products, including essentials, but the price authorized by the government does not cover the costs of production," says Nelson Mussolini, presidente-executive of Sindusfarma (Sindicato Paulista da Indústria de Produtos Farmacêuticos).

In these circumstances, according to him, it is the responsibility of the government for the fact that a product remains unavailable to the patient, not the industry. "In Brasil, it is the government which has the final word over the offer of medications in the market, to determine the price of products, permitting only an annual readjustment, also defined by the government," he said.

As a note, trade group Interfarma (Associação da Indústria Farmacêutica de Pesquisa) remembers that, after the termination of a patent for a medication, there is an emergence of companies which come to make new versions. "Therefore, when a company decides to discontinue it it does not neccessarily mean it disappears from the market, since similar and generic versions exist."

The note goes on to say that the very decision to discontinue a medication does not mean that the company will cease to produce therapies against the same illness. "It is common for medications to be substituted by new molecules, capable of treating the same illnesses with greater effectiveness and safety."

Secondly Interfarma notes that, in a smaller number, there are cases in which unique medications, without generic versions, are discontinued. "This generally occurs because the cost of the inputs rises more than the cost of the product itself, causing the company to discontinue its production line, impacting the viability of the final product."

Revised prices

The Ministry of Health says that, through a provisory measure, it has already authorized a revision of prices for those drugs at risk of withdrawal from the market and without alternative therapies coming to the market.

The action has a practical effect in the market of penicillin and other medications. The Ministry says it is investing R$6.4 billion ($1.94 billion) in a new political move to stimulate development of the national industry.

There were 56 items selected for partnerships of technology transfer and 115 for technology orders. Amonst the oncology drugs which may be discontinued, 10 are on a priority list.


Source: https://www.thepharmaletter.com/

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