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Opinion

Will the Next U.S. President Let Access to HIV Drugs Be Hijacked in the Name of Free Trade?

April 13, 2016

Anna Forbes

Anna Forbes

Can you name one issue on which Doctors Without Borders, amfAR and Public Citizen agree with Hillary Clinton, Bernie Sanders, Ted Cruz and Donald Trump? In one way or another, they all oppose the Trans-Pacific Partnership (TPP), a giant free trade agreement among twelve countries that border the Pacific Ocean, including the U.S. that could have a drastic impact on the global HIV epidemic.

After five years of secret negotiations, TPP was finalized and the details were publicly released last October. Often called "NAFTA on steroids," the 5000-page agreement is the largest multi-country trade deal in history. President Obama has already signed the TPP, but the U.S. is not bound by it unless Congress passes it. Since Congress voted last June to "fast track" the agreement, it cannot debate or amend it further, only put it to a pass or fail vote.

TPP is really big. The Harvard AIDS Initiative estimates that it could shape 36% of the global economy. And TPP could happen soon. It may be introduced during Congress' "lame duck" session, the time between the November election and the January 2017 seating of the new Congress. (Here are the candidates' specifics reasons for opposing it.) But what does it have to do with HIV?

Chapter 18 of the agreement is on intellectual property (copyrights, trademarks, patents, etc.) including pharmaceutical patents. Currently, patents have different lifespans in different countries. But under TPP, these would not only be uniform, but also longer in most cases. A generic version of a drug cannot be sold in a country until after the drug's patent expires in that country. So, longer lifespans for pharma patents means longer waits for generics. This is huge for people living with HIV.

According to FDA, competition between generic and branded drugs lowers drug prices substantially, often by 50% or more. Globally, about 90% of the drugs used to treat people with HIV are generics. TPP passage would mean that generic drugs are prevented from competing with expensive brand-name medicines for a longer time and drug prices stay higher.

The introduction of generic antiretrovirals (ARVs) was by far the main driver of the 100-fold price reduction in the cost of HIV treatment in sub-Saharan Africa. In 2000, about 70,000 Africans received ARVs. By 2011, over six million people in the region were getting ARVs (almost all generics). Brian Honermann of amfAR has said of the TPP, "Had these sorts of provisions been in place, we wouldn't have had the explosion of medications that made the scale up of antiretroviral therapy in Africa possible."

Despite all this progress, an estimated 20 million people living with HIV are currently untreated worldwide. We are less than halfway to the goal of universal HIV treatment, and TPP passage would defeat our progress toward it.



Why Aren't We Talking About This More in the HIV World?

There are three factors. First, TPP is so large and complex that it is difficult to hold media attention on its Chapter 18 provisions. Second, President Obama endorses TPP. Since we (more or less) trust his judgment on HIV issues, it is difficult to think that he is wrong on this one. Third, the TPP's new pharma provisions apply primarily to biologics. Today's ARVs are not biologics, so people assume that TPP will have little impact on HIV medications. That's not entirely accurate.

First, a quick review of essential terms. Currently, most drugs are assembled from non-living chemicals. A "biologic," however, is a drug prepared in a living organism. These terms indicate how the drugs are made rather than what they do. Milk, for example, is to "biologic" as Gatorade is to "small molecule."

A pharmaceutical "patent" protects a particular molecule from competition. A "generic" drug is an identical molecule produced by a manufacturer who does not hold the patent or trademark. It can be produced when the generic manufacturer gets a license from the patent holder, when the patent expires, when the generic manufacturer is in another jurisdiction or for other reasons.

Although drugs produced by biologic methods have some kinds of patent protection, the process is less straightforward because a biologic is not a specific molecule. It is a product better defined by what it does than by what it is. If two drugs have the same essential function in a given context they are called "bio-similar." (Nutritionally, cow's milk and soy milk, for example, are "bio-similar" to mother's, but you can't call either a generic version of the other or of mother's milk.) Because of this conceptual shift from what a drug is to what it does, manufacturers want protections for biologics that are easier to enforce than patents.

Right now, U.S. biologic manufacturers automatically get twelve years of "market exclusivity" for a product. This means protection from competition for that period regardless of patent status and in addition to any patent protections. Other countries have looser rules. For example, biologics get eight years of market exclusivity in Japan and Canada but none at all in many other TPP countries. After failing in their demand for 12-year exclusivity in all countries, U.S. negotiators settled for requiring TPP member countries to select either a five-year or eight-year exclusivity period under different sets of "market harmonizing" rules. The upshot? Compared to patents, these "exclusivity grants" let manufacturers keep a broader range of competition out of the market for about the same length of time and at a lower enforcement cost (i.e., lawyer's fees). So it's good for the manufacturers. Is it good for us?

There are some potentially important HIV-specific biologics in the pharma pipeline right now. For example, monoclonal antibodies (MAbs), a biologic, can protect monkeys from SHIV (the primate version of HIV) for weeks or months if they are injected before or shortly after viral exposure. If successful in humans, this could provide us with pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) administered by injection every few weeks or months.

Unlike an ARV, a biologic MAb "directly engages a person's immune system to change the course of an HIV infection." Functional cure researchers are investigating whether they could help purge viral reservoirs sites by facilitating the "elimination of replication-competent virus." Some vaccine researchers think biologics may be able to teach the immune system to produce its own broadly neutralizing antibodies against HIV.

Microbicidal "cocktails" made of MAb combinations have been shown to protect against multiple sexually transmitted infections, including HIV. One such combination appears to prevent both HIV and HSV8, a herpes strain that facilitates HIV acquisition. It is going into human trials now, formulated as a vaginally inserted film (think breath-fresheners strips). Next up is testing it in a long-lasting vaginal ring.

If the U.S. Congress passes TPP, it will both restrict access to and boost the prices of these and many other medicines. Doctors without Borders says that "the TPP is threatening to cut off the lifeline that generic drugs provide for people living with HIV/AIDS and many other diseases" including cancer, tuberculosis and hepatitis C (HCV). For a vivid picture of the different generics make, consider the fact that Solvadi (sofosbuvir, a cure for HCV) costs $84,000 in the U.S. and $1000 (for the whole treatment) in India where the generic is available.


Want to Stop This?

Call both your senators and your congress member and ask them to vote "no on TPP." You can get their numbers by going to www.govtrack.us/congress/members and entering your address. With three phone calls, you can join millions of Americans in opposing the TPP.

You can also talk about TPP and the negative impact it will have at every presidential campaign event you attend. Bird-dogging candidates about this will engage them and their surrogates in reminding voters of the dangers of the TPP. After all, how can we talk about ending AIDS if we don't insist on putting people's lives ahead of corporate profits?

Anna Forbes is a Washington, D.C.-based writer, organizer and activist working in HIV/AIDS since 1985. Now an independent consultant focused on women's needs with regard to HIV, her current and recent clients include the Sero Project, SisterLove, GNP+, the Positive Women's Network - USA, the International AIDS Society, IAVI, UN Women and the Global Network of Sex Work Projects.


Copyright © 2016 Remedy Health Media, LLC. All rights reserved.


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