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People Living With Hepatitis C—Victims of Patents

22.7.2014

This post is being published simultaneously on the 3.500 Millones blog. It was written by David Hammerstein (@DaHammerstein), who is a member of the Transatlantic Consumer Dialogue and also an activist working to protect the rights of consumers and patients. An earlier version of the post was published on the author’s own blog.

 Activistas indios demandan el acceso a tratamiento contra hepatitis C. Foto: ITPC

Private patents are responsible for the exorbitant price of many drugs, including sofosbuvir, a medication used to treat infection with the hepatitis C virus.

Product patents grant the owners market exclusivity for a certain period of time (ranging from 15 to 20 years), thereby allowing them freedom to fix prices at will. The aim of such protection is ostensibly to provide incentives for innovation. The resulting high prices bear little relation to the actual cost of research and development and none whatsoever to the marginal costs of production; prices are determined solely by the business interests of large pharmaceutical companies. A single sofosbuvir tablet costs €2.50 to produce and its price on the market is €650. A three-month course of treatment for a single patient costs €55,000.

This situation affects between 130 and 150 million people in the world. Since almost 99% of those affected (including Spanish patients) have no access to this treatment, it is shocking to observe the lack of any vigorous response on the part of our political institutions and those responsible for protecting public health interests against the abusive policies of an American corporation. Even though health is a universal common good, the price of a drug that saves lives is fixed solely on the basis of the business opportunity it represents in a particular market at a particular time.

The individual’s right to health must take precedence over the monopolies of pharmaceutical companies and exorbitant prices. Hundreds of thousands of Spanish patients infected with the hepatitis C virus and tens of millions of patients worldwide deserve the best treatment available. Even the Spanish public health authorities have stated that they will not purchase sofosbuvir at the current price—a price that the US pharmaceutical company Gilead can set as high as they wish because they enjoy a patent-based market monopoly.

While an outlay of €55,000 for a three-month course of treatment could empty the coffers of any public health system, no self-respecting government responsible for defending the common good is obliged to accept such abusive practices. If the government really wants to defend public health it has a number of tools at its disposal to undermine the dominant position of the pharmaceutical company and significantly reduce the price of the drug.

1. A compulsory licence. Any government can initiate the process for issuing a “compulsory licence” that would allow third parties to manufacture a generic version of sofosbuvir. The World Trade Organisation (WTO) Doha Agreement on Intellectual Property and Public Health allows countries to limit intellectual property rights if such a step is necessary to protect public health. Any government can use the flexibility afforded by international law to licence a third party drug manufacturer to produce a generic form of sofosbuvir for sale at a much lower price or can authorise the import of a generic version from another country. Under article 31 of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a country can issue a compulsory licence that allows a third party to produce the patented product or process without the consent of the patent owner.

2. Opposing the patent. Following the example of India, any government can challenge the legality of the sofosbuvir patent by filing an opposition on the grounds that the drug lacks the novelty required to warrant patent protection. The sofosbuvir molecule was previously patented as a drug for treating cancer.

3. Agreements with other countries to make joint purchases for public health systems. It would be possible to make an agreement with other European countries to purchase the drugs jointly in order to strengthen our negotiating position. However, what we have seen to date is precisely the opposite attitude: even France’s proposal for setting a maximum price for sofosbuvir in Europe was rejected by both the European Union and the Spanish government in a show of extreme passivity in the face of the power wielded by pharmaceutical companies.<0}

4. Joint negotiation with other countries to buy out the patent or pay for a licence that would authorise a third party pharmaceutical company to produce and market a generic version.  Egypt has reached an agreement with India to import generic sofosbuvir at a price 100 time lower than the price demanded by Gilead in Europe.

5. Delink (disassociate) biomedical innovation from the cost of production and marketing. There is a broad social and scientific movement in favour of new models of innovation driven by real health care needs instead of merely by market demands. In this new model, public funds would be used to incentivise the most urgent medical research on diseases such as hepatitis C, cancer and HIV/AIDS in exchange for public control of the intellectual property. This model would make it possible to produce universally available and accessible generic drugs.

People infected with the hepatitis C virus are also the victims of patents. And solutions for the problem do exist.

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