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Patents are Killing Patients with Long Term Needs

By Karina Taylor

How much should it cost someone to be sick? Who should pay to keep them alive? These questions must be viewed from the perspective of health and economics, because both influence the answers. Health providers, focusing on care and recovery, want affordable treatment so patients will choose the best medical option instead of the cheapest one. Pharmaceutical companies, wanting to solve impossible medical problems while remaining profitable, price their products with the cost of development, as well as market value, in mind. In the case of specialty drugs — many of which treat lesser-known conditions or side effects, often for the remainder of a patient’s life — pharmaceutical companies often pass off even more of the cost to the consumer, since theirs is a niche market with specialized needs the company was willing and able to fill.

This at least was the defense of Turing CEO Martin Shkreli when he purchased the drug Daraprim, the brand name of the antiviral pyrimethamine, and increased the price-per-pill from $13.50 to $750 nearly overnight. An essential ingredient of the standard ACT combination that treats HIV and malaria, generic pyrimethamine is listed twice on the World Health Organizations’ list of essential medicines due to its use in the treatment of toxoplasmosis, a parasitic infection that can affect anyone with a compromised immune system, from babies in utero to patients of any autoimmune disease. 

The small number of Americans suffering from the diseases Daraprim treats was cited as the reason for the exorbitant price hike. The greater offense to the international medical community, however, was Turing’s purchase of Daraprim when its longtime status as an “orphan drug” (who have too small a market for countries to find profitable for further development) left costs low and generics plentiful for international consumers, who are often uninsured and rely on the help of states or non-governmental organizations for access to lifesaving medicines.

The ability to obtain affordable treatment, especially for long-term conditions, relies entirely on a patient’s nationality unless civil society intervenes. Wealthy Western countries have state controls in place to shield patients from the brunt of pharmaceutical costs. In the United Kingdom, the National Health Service directly negotiates rates on their patients’ behalf. In the United States, the federal 340b designation protects patients from the fluctuations of market pricing, no matter their insurance coverage. 

However, in many poorer nations, with unregulated drug markets and large long-term need populations, patients are fully exposed to market instability, and are left choosing between going without essential care and hoping for the intervention of NGOs. These range from regional operations, such as Africare and the Malaria Consortium, to far-reaching international organizations such as Medicines Sans Frontieres (MSF, or Doctors Without Borders). 

How those organizations obtain necessary drugs leads to the more serious issue of patent protections. Joanna Keenan, press officer for MSF’s Access campaign, explains that “more than 80 percent of the medicines procured by MSF Supply Centers are indeed generic. Wherever it is possible to purchase generic, we do, however in some countries, patents may prevent us from importing generic products so we would have to supply the brand name.”

So here’s a thought experiment: Patients in country A have an autoimmune disease that requires a combination of drugs that not only mitigate symptoms but support their compromised immune systems. Their treatment, as provided by an NGO due to their country’s inability to negotiate for better prices, is currently generic, produced in country B. A drug company in country C buys the generic’s patent, increasing the market price by 5,000 percent. Due a trade partnership between countries B and C, country B cannot legally produce the generics keeping patients alive in country A unless the NGO supplying them pays market price. Otherwise, country A is forced to illegally import the cheaper drugs that will keep their citizens alive.

The story of nations A, B, and C places the Daraprim controversy in a broader context of patents and pricing in the international pharmaceutical market. One of the loudest concerns surrounding the landmark Trans Pacific Partnership struck between the United States and a number of Asian countries — including India, home to one of the world’s most robust generic industries — is the effect the deal will have on the import and production of cheaper generic drugs throughout the region. In a statement, MSF expressed “dismay that TPP countries have agreed to United States government and multinational drug company demands that will raise the price of medicines for millions by unnecessarily extending monopolies and further delaying price-lowering generic competition.” Their disappointment is well-founded — the actions of companies like Turing may appear unconscionable but, under this and many other intellectual property protections, are completely legal. 

According to MSF’s Joanna Keenan, when patents block generic competition (referred to as a “patent buyout”), the options for many NGOs representing patients in need are provided by government efforts  “ranging from effective price negotiations accompanied by price transparency and when needed, the use of public health safeguards and flexibilities to introduce generic competition if a relevant drug is either unaffordable or not available.” He continues, “MSF also engages companies that hold patents to safeguard our patient needs, but ultimately safeguarding access is a responsibility which must be driven by governments and relevant inter-governmental institutions.”

Right now, the most that many NGOs can do is implore companies to do better by their neediest patients, or hope that market competition can resolve the issue. When pharmaceutical company Rodelis began pricing its newly-obtained tuberculosis drug out of a range accessible for many patients, the Chao Center that originally produced the drug reversed the transfer of ownership.  The Daraprim case took a recent turn for the better when Imprimis Pharmaceuticals in San Diego announced they would sell their pyrimethamine-containing alternative for $1, and that it “intends to launch several other low-cost alternatives to specialty generic drugs.” 

However, advocacy and crossed fingers are not enough. Civil society must be empowered to not only negotiate directly with manufacturers, as MSF does currently, but negotiate in place of nations too weak economically to obtain the best deal for their citizens. Such deals are usually made behind closed doors between nations in desperate straits on a variety of developmental fronts and companies fully aware that they hold all the cards before even coming to the negotiating table. NGOs, on the other hand, have their international presence and constant access to customers to bargain with, and nations with populations in need must set aside issues of sovereign pride and allow these organizations to negotiate on their behalf before footing the (hopefully smaller) bill. Unlike the ups and downs of the pharmaceutical market, representation at the bargaining table is something these governments can control, and the lives of their most vulnerable citizens depend on the outcome.

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Karina Taylor is editorial assistant at World Policy Journal.

[Photo courtesy of Chris Potter]

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