Hepatitis C: ganan las patentes, pierden los pacientes

Hepatitis C: the Patents Win, the Patients Lose


This post was written by David Hammerstein (@DaHammerstein), (@DaHammerstein) of the Transatlantic Consumer Dialogue in response to a recent announcement that the Spanish Government has agreed to buy a specific drug for the treatment of hepatitis C. In an earlier post, the same author reflected on how patents influence the treatment of this disease. This post was published simultaneously in the 3.500 millonesblog published by the Spanish newspaper El País.

Pastillas de Simeprevir. Foto: Andrew Karpenko, University of Washington.

Effective and relatively simple treatments exist that could cure the millions of people affected by the hepatitis C virus. But it is not true that all of these patients will be cured with the drug simeprevir, as was suggested by a recent article in El País announcing the Spanish government’s  decision to purchase simeprevir for its public health system. On the contrary, what civil society in Spain and elsewhere desperately needs is a fair and affordable price that would make universal treatment possible—and that price would be very different from the exorbitant €25,000 per course of treatment that the Spanish government has agreed to pay the manufacturers of simeprevir. At that price, treating just one-third of the people in Spain who are infected with the virus would cost the country’s taxpayers over €7,500 million.

As if that were not bad enough, simeprevir—a drug sold by the pharmaceutical company Janssen for the treatment of the hepatitis C virus—also has significant disadvantages compared to another drug called sofosbuvir.

Simeprevir is suitable for the treatment of a smaller subgroup of patients with hepatitis C infection than sofosbuvir, and its use in patients with severe disease is complicated by adverse effects caused by required complementary treatment with another drug. Unlike sofosbuvir, simeprevir must be taken daily as part of a combination regimen that also includes ribavirin and an injection of pegylated interferon; the interferon therapy has serious side effects and is contraindicated in a large group of patients, including people who have HIV/AIDS. Another important consideration is that simeprevir—the drug the Spanish government has agreed to buy—is only effective against certain genotypes of the hepatitis C virus. Sofosbuvir is effective against a larger number of genotypes and, since it does not require complementary interferon therapy, can be used to treat many patients currently not eligible for treatment. According to some researchers, a combination of sofosbuvir and simeprevir is one of the most effective regimens for the treatment this infection. However, this combination is currently inaccessible due to the high cost of both of these patented products.

Since simeprevir has a more limited application than sofosbuvir, why did the Spanish government choose to buy it? In my opinion, the purchase is a smokescreen that is being used to divert attention from the conspicuous weakness of the position currently held by Spanish, European and international institutions, who are incapable of obliging the pharmaceutical company that holds the patent for this drug to reduce its exorbitant prices. Patents make it possible for companies to charge disproportionately high prices for their products. The resulting high cost of treatment represents an insurmountable obstacle to a certain cure for most of the more than 150 million people in the world affected by the hepatitis C virus, which causes a million deaths every year. The announcement published in this newspaper gave the misleading impression that the problem of curing hepatitis C would be “resolved” by the government’s purchase of simeprevir. Unfortunately, with the purchase of this expensive drug we are still very far from achieving universal access to the best treatment available. It is unacceptable that due to the aberrant model imposed by private and monopolistic pharmaceutical patents that the public is forced to pay 1,000 times more for a tablet than it costs to produce it. The current prices are arbitrary, unfair and immoral, and they bear no relationship to the actual cost of the company’s investment in researching and manufacturing the product.

There has been a worldwide outcry calling for a reduction in the outrageous price of the other drug—sofosbuvir, patented by the pharmaceutical company Gilead Sciences, which costs €55,000 for a three-month course of treatment. As a cure for hepatitis C infection, sofosbuvir has clear advantages over all the other available alternatives. Unfortunately, tens of millions of people in the world infected by the virus (and hundreds of thousands of Spanish patients) are still waiting to receive effective treatment for their disease, which they cannot access due to the high price of the drug. Despite the preposterous cost of sofosbuvir, which excludes most patients from treatment, sales of the drug to wealthier patients who are able to pay have garnered profits of nearly 3,000 million for Gilead ... in just the last three months. According to an analysis undertaken by researchers at the University of Liverpool, the production cost of each tablet is a few cents, but Gilead sells them for 650 each. Even if a manufacturer charged €1 per tablet (€100 per treatment), a generic version of the drug would generate substantial profits for the company. If we do not radically change the current model for biomedical innovation—a model dominated by the concept inappropriately called "intellectual property"—generic versions of this product will not come onto the market until 2025 or 2030.

The Spanish government’s failure to take any action on an issue that affects the health needs of the general public is scandalous. If the European Union can set standards of transparency and impose stringent price caps on services like mobile phone roaming charges, should essential medicines not be subject to similar treatment?

It is neither sensible nor decent that the “fair price” of a drug that can save many lives should be fixed on the basis of a purely commercial negotiation between a government, such as that of Spain, and a pharmaceutical company. Or that the price should be imposed for purely commercial reasons by a company that enjoys a monopoly because it holds the patent. It is unacceptable that the common good should be forced to its knees by the private business interests of a pharmaceutical company. The only acceptable policy response is to ensure that both drug prices and the whole process of medical innovation be adapted to meet the universalist demands of the right to health services, a condition that must be established by public institutions rather than by the vagaries of disparate actors and financial profits in the market.

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