Mary-Jane Matsolo, wearing tight jeans, gold high-heeled sandals, and a white t-shirt with navy blue block letters reading “HIV Positive,” strides to the front of the Johannesburg conference room. “I’m the one who will make you understand patent laws and intellectual property rights,” she says to the dozen people gathered before her. “It’s what I do, and I do it very well.”
At Matsolo’s prompting, everyone takes turns explaining why they are here. One after another, advocates for persons with mental illness, diabetes, epilepsy, and other diseases bitterly describe how the patients they represent—and sometimes even they themselves—cannot afford the medicine they need. A drug for depression and bipolar disorder is unavailable due to its price; the same goes for medicines to treat epilepsy, cancer, and reproductive health problems. “Most doctors never tell their patients that these medicines will help them,” says one advocate. “Why would they, if the people can’t get the treatment?” Others call out their agreement.
“OK, that’s good,” Matsolo reassures them. “That’s why we are here.” To start her presentation, she shows the group the back of her t-shirt. It reads, “Bad Patents = Death.”
Matsolo is a campaign officer for the South Africa-based Treatment Action Campaign, known as TAC. She was born Nomathansanqua Matsolo in Port Elizabeth, but her Facebook nickname is “Songbird.” This year, she released an album entitled “Soul of a Woman,” and the album’s lead single got some radio airplay in the Cape Town region. At home in front of a crowd, Matsolo’s chief role at TAC is educating the public about HIV/AIDS. To her, it is more than a job. A now-deceased older sister was HIV-positive, and Matsolo watched her struggle with both her health and the stigma that came with the disease. “Helping my sister and working with TAC turned me into a teacher, a fighter, a motivator,” she says.
The session in Johannesburg is part of the Fix the Patent Laws campaign. The campaign is a joint effort in South Africa by TAC and Médicins Sans Frontières, the Nobel Peace Prize-winning provider of treatment in some of the world’s most desperate settings. TAC and Médicins Sans Frontières, known here as MSF, have recruited experts to analyze the current law and have conducted media workshops explaining what is at stake. Protesters, some wearing blind-folds to demonstrate the lack of scrutiny of drug patent applications, have marched on the parliament building. But the pharmaceutical industry has lobbied the United States to hold back trade benefits with South Africa if it adopts new policies that do not strongly protect medicine patents. Meanwhile, in 2014, leaked emails showed that pharmaceutical companies planned to pay South African community organizations to demonstrate grassroots opposition to reforms that had been proposed in parliament. Now, that reform process seems to have stalled.
South Africa is just one country among many facing health crises due to patented medicines; the World Health Organization reports that more than one-third of the world’s population has limited access to needed medicines. Legal protection for patented drugs has been a sticking point for international trade agreements and is even an issue in the 2016 U.S. presidential campaign. But it is South Africa that is reliably described as “ground zero” in the struggle between the drug companies and access to medicines activists. The biggest reason for the designation is that South Africa was the site of the pharmaceutical industry’s most stinging defeat. And TAC was the organization delivering the blow.
TAC soon launched a campaign of civil disobedience, including illegally but openly importing a generic, and far cheaper, version of the AIDS medicine fluconazole.
ACCESSIBLE HISTORY
As she begins the training, Matsolo spends little time reviewing the history of activism for access to medicines. For everyone who lives in sub-Saharan Africa, it is a well-known story. At the turn of the twenty-first century, HIV/AIDS was rampaging across the continent. Recently discovered antiretroviral medicine was known to be a hugely effective treatment for the virus—it was so potent that its impact on patients was known as the Lazarus Effect. The medicine was in wide use in North America and Europe, but the high cost of the patented drugs meant that they were available to just one of every 1,000 Africans infected with HIV. South Africa was particularly hard hit, with HIV prevalence as high as 25 percent among women of childbearing age. In the year 2000, more South Africans died in their 30s and 40s than in their 60s and 70s.
TAC’s initial response was unimpressive. Its first effort, on Human Rights Day in 1998, consisted of just ten people fasting in front of St. George’s Cathedral in Cape Town, asking passers-by to sign a petition demanding that the government provide medicine for pregnant women with HIV/AIDS. But TAC had excellent organizational genes. Several of its founding members had been active in the anti-apartheid movement. And the group received further training from ACT-UP and other veterans of the passionate, dramatic U.S.-based AIDS treatment campaign of the 1980s and 1990s.
TAC soon launched a campaign of civil disobedience, including illegally but openly importing a generic, and far cheaper, version of the AIDS medicine fluconazole. TAC’s co-founder, Zackie Achmat, was HIV-positive and often ill. But in a dramatic decision that attracted international attention, Achmat risked his life by refusing to take antiretrovirals until they were widely available to South Africa’s poor. TAC became known for its spirited demonstrations, usually including the South African toy-toyi protest dance and chants around the theme of “Patients Over Patents.”
The iconic HIV-Positive shirts that TAC members and staff like Matsolo still wear were created when AIDS activist Gugu Dlamini was beaten and stoned to death after revealing her disease status on a radio show. Based loosely on the apocryphal story of the King of Denmark wearing a yellow star in solidarity with Jews during Nazi occupation, the HIV-Positive shirt is worn by those struggling with the disease and those who aren’t.
TAC was particularly effective at combining mass mobilization with legal action. When lawyers filed challenges to the high prices charged for patented medicines or argued for ramped-up government AIDS programming, the courtrooms were packed, and the streets outside were filled with thousands of singing, chanting demonstrators. When the International AIDS Conference was held in Durban in July 2000, TAC led over 6,000 protestors in a march to the site of the opening ceremonies, taking advantage of the international stage to pressure the drug companies and governments to respond to the pandemic.
TAC and global AIDS treatment activists raised the stakes. Since the United States was leading the charge against South Africa and Brazil, activists relentlessly heckled U.S. Vice President and 2000 presidential candidate Al Gore at his public appearances. They even interrupted Gore’s official campaign announcement in his hometown of Carthage, Tennessee, chanting “Gore’s Greed Kills,” until security kicked them out. Activists blocked traffic outside the Washington office of U.S. Trade Representative Charlene Barshekfsy. International media began following the story, and pressure increased on the corporations and the Clinton-Gore administration. On March 5, 2001, the day that oral arguments on the pharmaceutical industry lawsuit began in the High Court in Pretoria, TAC and other activists launched a “Global Day of Action” against the drug companies. Marchers in major cities carried signs saying, “Stop Medical Apartheid.” Others convened a mock court hearing in front of the offices of GlaxoSmithKline and Bristol Myers Squibb, finding the companies guilty of murder by blocking affordable drugs. The activists re-labeled the companies "GlobalSerialKillers" and "Big Murder Syndicate.”
TAC had created a public relations nightmare for the drug companies. Six weeks after the global protests, they dropped their lawsuit. Soon after, the United States withdrew all of its complaints against South Africa and Brazil. In November 2001, governments at a World Trade Organization ministerial conference adopted the Doha Declaration, affirming the rights of nations to take measures to reduce the cost of medicines in response to public health needs.
Continued protests by TAC forced the drug companies to allow generic manufacturing and use of their patented AIDS drugs in South Africa. A TAC legal challenge spurred the country’s government to create a broad HIV/AIDS treatment plan. Drug prices fell by as much as 90 percent. The resulting acceleration in treatment availability was breathtaking. In 1999, 20,000 South Africans were on antiretrovirals. Nearly three million are today. Globally, the President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria, initiatives of the Bush administration, now provide antiretroviral treatment for 16 million people.
It was a heady victory. The New York Times called TAC the most effective AIDS group in the world. During a visit to an HIV clinic in Khayelitsha, Nelson Mandela wore the organization’s HIV-Positive t-shirt. TAC was featured in the documentary “Fire in the Blood,” with the triumphant scene occurring when Zackie Achmat spoke outside the courtroom after the pharmaceutical industry dropped its lawsuit. “We have made the mightiest industry in the world shake in its boots!” Achmat yelled to the cheering crowd.
Greeff has seen young South African mothers with cancer go from treatable to terminal, waiting in vain for the medicine that would have cured them. “To me, this is a human rights issue,” she says.
FEAR FREE
A decade and a half later, the industry seems to be well past its fear of activists. Achmat and others have moved on from TAC. The historic gains of the HIV/AIDS treatment efforts have largely held firm, but they failed to spill over into other health areas. The most dramatic example is cancer, the longtime enemy of Linda Greeff.
A Cape Town-based social worker, Greeff was a 31-year-old mother of two young sons when she was first diagnosed with ovarian cancer. Surgeries to remove tumors and an eventual hysterectomy were successful in addressing the cancer, but she spent years struggling physically and emotionally. After her recovery, Greeff and another survivor founded the group People Living with Cancer. Like most disease-focused organizations, People Living With Cancer concentrated on non-controversial awareness programs and support services. It provided a toll-free advice line and a “cancer buddy” system matching survivors with the recently diagnosed. It happily accepted funding from drug companies. But Greeff grew increasingly disturbed. She saw too many cancer patients going without care, despite the existence of medicine that would ease their pain or even cure their disease. “I can’t sleep at night knowing there are people out there who cannot get the treatment they need,” Greeff says.
So she decided to attend this Fix the Patent Laws training, an exercise that she admits is forcing her out of her comfort zone. Greeff has always considered herself a helper, not an activist. The complexity of patent laws intimidates her, as does the prospect of challenging the government and multinational companies. It is not an unreasonable fear: as soon as Greeff tentatively began participating in public events that questioned patent drug pricing, her group lost some of its industry donations.
There have been significant advances in cancer medicines in recent decades. A particular area of growth is in the area of biologics, which are produced using living systems such as bacteria, or plant or animal cells. But new cancer drugs are still under patent in most countries, which translates into price tags that are unaffordable to the poor. Reminiscent of the HIV/AIDS pandemic of the 1990s, millions of cancer patients in the developing world now suffer without treatment.
Like most South Africans, Greeff watched TAC’s aggressive HIV/AIDS treatment demonstrations and litigation from afar. But now she believes her cancer advocacy has to follow this same path. “What they have done with HIV/AIDS—the mass mobilization, the legal expertise, the willingness to be radical if need be—we need to be doing that now, too,” she says.
Yet it is clear that this broader coalition cannot simply mimic TAC’s successful struggle for access to AIDS medicines. The messaging in that fight benefitted from a remarkably straightforward equation: HIV-positive patients with access to antiretrovirals lived long, healthy lives; those without the medicine died. In contrast, the current struggle, in South Africa and beyond, encompasses a dizzying array of medicines and diseases. Privately, organizers worry that it will be hard to recreate the clear moral consensus around all medicines. And there is this: although sharply discounting the price of AIDS medicines was not welcomed by the pharmaceutical industry, their eventual concessions amounted to a small slice of their profit margins. The Fix the Patent Laws’ broader challenge to the drug patent system is a frontal attack on the industry’s entire business model. “They know we are not going to be quiet now,” Greeff says. “And they have megabucks to fight us with.
A LONG TRIP
Matsolo decides that it’s time to explain the ground rules for the coming fight. “Who knows what TRIPS is?” she asks. Blank stares greet her. So Matsolo describes the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights, aka TRIPS. Signed by 123 countries, TRIPS transformed an uneven worldwide patchwork of intellectual property law into a blanket of standards mandating protection for holders of patents, copyrights, and trademarks. For patent holders, that protection features at least 20 years of government-granted monopolies on their products, during which time no other company or individual can manufacture or import these goods.
Among the governments that have fought for access to affordable medicines, India has been far and away the most successful.For medicines, TRIPS radically changed the status quo. In most societies, there was little precedent for patent monopolies to be granted to necessities like medicine. For example, Germany’s patent law of 1877 labeled medicines as “essential goods,” along with food and chemicals, and forbade any attempts to patent them. Well into the latter half of the twentieth century, countries such as Brazil, India, and Spain had strict limits on patenting medicines. But when the TRIPS negotiations began in 1986, more than half of the countries involved either had very limited patent protection for medicines or refused to grant them at all.
This had become an increasing problem for multinational pharmaceutical companies. Their industry, which once competed on the basis of manufacturing innovation and price, had come to rely on the profits of patented products. At one time in the mid-twentieth century, for example, Pfizer, had a full 33 percent of its global sales accumulated by just two patented drugs. So the industry pushed the U.S. government to make intellectual property protection a priority in all trade negotiations. It did not take the industry long to find willing partners on Capitol Hill and in the White House. Drug companies are reliably at the top of the U.S. lists in both lobbying expenditures and political campaign contributions. Not surprisingly, the United States was the most passionate advocate for TRIPS. Wielding its economic might, Washington offered incentives and threatened trade sanctions until even the most reluctant countries signed on.
Yet a few nations still insist on following policies that allow for access to affordable medicines. TRIPS includes some exceptions to its overall strong pro-patent terms, including permission for countries to issue compulsory licenses, which allow for generic production of medicines even if they are under patent. Among the governments that have fought for access to affordable medicines, India has been far and away the most successful. So Matsolo introduces the group in Johannesburg to Shailly Gupta, who helps lead MSF’s access to medicines campaign in India. Gupta is less flamboyant than Matsolo, but she speaks about medicines with the same no-nonsense intensity. Gupta hands out business cards with a picture on the back of a gleaming gold ring, with a single round pill in the spot where a diamond is usually placed. “Medicines should not be a luxury,” it reads.
Gupta explains that India’s resistance to patenting medicines has allowed its generic drug manufacturing industry to grow to the point where the country is known as “the pharmacy of the developing world.” Eighty percent of the generic medicine used in poor countries is made in India. The Indian government has set up strict criteria for patentability, and has issued compulsory licenses for the generic manufacture of several medicines, including a treatment for liver and renal cancer, which became 97 percent less expensive after a generic version was made available.
Indian law is particularly tough on the common pharmaceutical industry practice known as “evergreening.” Evergreening occurs when a new patent is granted for minor revisions or for new uses of an already patented medicine, thus extending the corporation’s monopoly control past the original 20-year period. “It’s just tweaking something on the drug and then going for a new patent on it,” Gupta says. Using South Africa as an example, Gupta shows the group how evergreening works: In South Africa, the company Novartis obtained a patent in 1993 for the drug imatinib, marketed by the company under the name Gleevec, which treats chronic myeloid leukemia. Before that patent was scheduled to expire in 2013, Novartis obtained two additional patents on the drug, one in 1997 for a new form of the compound and one in 2002 for the use of the drug to treat an HIV-related infection. The drug is now on patent in South Africa until 2022, 29 years after the original patent was granted.
The South African advocates nod. It is a story they know well. But, Gupta says, compare your situation with India, where evergreening is blocked by the country’s patent laws. In 2006, India’s government rejected Novartis’ application for patents on its secondary uses of Gleevec. Without secondary patents, the medicine costs 91 percent less than the South African version. When Gupta reveals the price difference, the South African advocates’ eyes widen. Gupta smiles, not quite able to hide her pride. In her country, 570 million people live on less than $1 per day, she says. Every penny that a drug price is lowered translates into saved lives.
Novartis fought the Indian patent decision, and the company’s court appeal mobilized advocates on both sides of the debate. Gupta and her MSF colleagues collected nearly half a million signatures on a petition demanding that Novartis drop the case. Thousands participated in street demonstrations in front of Novartis offices worldwide, often carrying huge inflatable pills and signs reading” “Novartis: Making a Killing in Profits.” In 2013, the India Supreme Court rejected Novartis’ challenge and upheld the country’s anti-evergreening rules.
Novartis’ appeal followed established court procedures. But the pharmaceutical industry’s vigorous lobbying for maximum patent protection has at times crossed over into ethically dubious territory. In January, 2014, a leaked email from Merck’s managing director for South and East Africa, revealed the existence of a plan by as many as two dozen pharmaceutical companies to direct $600,000 to fund South African front organizations that would create the illusion of grassroots opposition to patent law reforms. The ensuing “Pharmagate” scandal earned headlines across the country. South Africa’s health minister, Aaron Motsoaledi, angrily condemned the plan. “This document can sentence many South Africans to death. This is no exaggeration. This is a plan for genocide,” Motsoaledi told the newspaper Mail and Guardian. A cartoon in the Sunday Times depicted “Big Pharma” with three divisions: research, profits, and “Third World Genocide,” the latter led by a scythe-carrying Grim Reaper.
PATENTLY ABSURD
Advocates for access to medicines around the world are closely watching the Fix the Patent Laws effort in South Africa, but they say that the ultimate fix needs to be on a global scale. “We just have to get away from the thinking that the way to fund medicine research is through higher prices and the granting of monopolies,” says Jamie Love, an economist who directs the intellectual property advocacy group Knowledge Ecology International.
Love, a longshoreman-turned-staffer for Ralph Nader, has a blunt approach that has angered many pharmaceutical companies and sometimes even a few allies. But he is also a longtime collaborator with TAC, and he played a key role in the historic HIV/AIDS treatment victory. It was Love who convinced Indian generic drug manufacturer Cipla to make a dramatic 2001 pledge to manufacture and sell antiretroviral medicines at a cost of $1 a day. That offer of a 96 percent reduction from the patented price gained immediate international attention and helped ratchet up the pressure on both drug companies and governments.
Love and other advocates say that intellectual property law for medicines should be different from the law covering products like smart phones or flat-screen televisions. If a consumer cannot afford the patent-influenced price of the new iPhone or a high-definition TV, they say, that isn’t a moral challenge, like the one that comes with the impossibly high price tag on life-saving drugs. Many philosophers and economists agree, saying that the nations that labeled medicines a public good for generations pre-TRIPS were right. Jonas Salk, who invented the polio vaccine, refused to patent it, saying that it belonged to the people. The creator of the first synthetic malaria vaccine donated the patent to the World Health Organization.
Love regularly points out that even the United States, the world’s foremost promoter of maximum patent protection, ignores patent laws when the need arises. It has a lengthy record of issuing compulsory licenses for the production of military technology. When the country was in the grips of the anthrax scare of the fall of 2011, the government did not hesitate to threaten Bayer with a compulsory license for its patented drug ciprofloxacin, considered to be the best available treatment for anthrax exposure.
One matter is not in dispute: the pot at the end of the research rainbow is only filled with gold if the discovered medicine can be sold at profitable prices.Yet the question remains: Are patents necessary to incentivize research for new medicines? That is the long-time argument of the pharmaceutical industry. The companies admit that most medicines can be manufactured for pennies per dose, but they say that patent-protected pricing is essential for recouping their investment in research and development—a number that is hard to pin down. A Tufts University study estimated that it costs an average of $2.6 billion to bring a drug to market, but there is a distinct lack of transparency in the private cost figures, leading to other analyses pegging the cost at a fraction of that. Several state and federal lawmakers have proposed rules that would compel transparency in the cost of medicine research. Regardless of the true figure, advocates say, it is clear that drug companies spend more on marketing and sales than they do on research.
One matter is not in dispute: the pot at the end of the research rainbow is only filled with gold if the discovered medicine can be sold at profitable prices. Inevitably, that means pharmaceutical corporations devote the vast majority of their research to medicines that will be consumed by the comparatively wealthy. Researchers Adam Mannan and Alan Story have pointed out that the marketing costs of any of the current high-profile erectile dysfunction drugs far exceed the global investment in developing a vaccine for dengue fever, which poses a risk to 40 percent of the world’s population. And little wonder: Viagra doubled Pfizer’s stock price within days of its introduction.
Instead of spurring on drug research and development, the current patent system has been accused of inhibiting it. Patents have the effect of locking up knowledge, especially with the motivation under current law to pile up “packet thickets” to discourage potential competitors from entering the area.
It doesn’t have to be this way, Love insists. “The transformative change comes with de-linkage,” he says. De-linkage is the term Love and others use to describe a set of proposals that would break the connection between medicine prices and the costs of research and development. These include a variety of incentives such as grants, prizes, drug purchase commitments, and even crowd-funding of research. Many advocates push for a research and development treaty that would prioritize neglected diseases and ensure access to the resulting medicines. This reform doesn’t need to mean the end of the pharmaceutical industry, Love says “If you do the de-linkage right, with real rewards for innovation, the companies that are good at innovation will do just fine,” he says.
Nearly all of these reform proposals anticipate substantial government investment. But taxpayers, particularly in the United States, are already paying for the medicine research process. Globally, it is estimated that 30 percent of medicine research and development costs are shouldered by governments through entities like the U.S. National Institutes of Health, and another 10 percent by private philanthropy. Yet a 1981 U.S. law has insured that the patents for even publicly-developed drugs usually end up in the hands of private entities, meaning that taxpayers also pay for monopoly pricing at the back-end of the medicine development process.
A recent example has been provided by U.S.-based drug company Gilead, which prices its patented Hepatitis C drug sofosbuvir, marketed as Sovaldi, at $1,000 per pill, a 1,000 percent mark-up over manufacturing costs. This take-it-or-leave-it price tag has caused budget crises at the U.S. Veterans Administration, which is reportedly spending $1 billion on the Gilead drugs in the current fiscal year. State Medicaid programs face similar pressures paying the patent price, and have taken to rationing Sovaldi. Yet the drug’s development was actually funded by its customers, including the VA, before Gilead bought the patent. Government payments for the blockbuster drug pushed Gilead’s profit margin to nearly 50 percent in 2014.
Such examples seem to be building momentum for reform. In July, 118 leading U.S. cancer physicians co-authored an article in the journal Mayo Clinic Proceedings, decrying the average $100,000-plus annual cancer medicine cost. As many as one in every five of their patients don’t fill their prescriptions because of cost, they wrote. Ayalew Tefferi, a hematologist at Mayo Clinic and the first signator on the article, told the Wall Street Journal, “What we’re fighting is the greed.” The cancer physicians joined an increasingly loud chorus calling for the U.S. Congress to lift its ban on the Medicare program negotiating prices with drug companies. U.S. President Barack Obama ran for office under a pledge to allow the same kind of bargaining that keeps medicine prices lower in other nations. But the idea was abandoned on the path toward the Affordable Care Act. “Medicare is a guaranteed market,” Love says. “So the companies are saying, ‘Let ‘er rip.’”
On the global stage, nearly every non-U.S. party to the proposed Trans-Pacific Partnership resisted the U.S. Trade Representative’s push for maximum drug patent extensions. The World Health Organization and other international bodies are increasingly referring to medicine access as a basic human right. Some national courts are backing up that argument. This month, the World Trade Organization (WTO) is debating the fate of a waiver that allows the 48 least developed countries an exemption from complying with TRIPS’ drug patent rules. Reports indicate that the U.S. is arguing for only a temporary extension of the waiver that is set to expire on January 1, 2016, but virtually the entire international community, including the EU and major UN agencies, supports an indefinite extension. “I’m absolutely optimistic that there can be big changes, and soon.” Love says. “We just need to get the messaging right, and we need the political leadership to step up. I mean, the benefits are so obvious.”
THE NEXT FIGHT
Back in Johannesbug, Mary-Jane Matsolo is wrapping up the training. It has been a whirlwind tour through the TRIPS agreement, South Africa’s problems, and the legal models in India. “Are we still there?” she asks.
The advocates nod, but several look a bit dazed. “This is a steep learning curve for me,” Greeff admits later. “But it is good to be in a group: it is a lonely place to advocate on your own.” The group concludes its sessions by devising a plan to collect patient stories from their different disease areas, co-sign an editorial on patent law reform, and send letters to members of Parliament.
“These are exciting times, man,” Matsolo says later. “For years on these medicines issues, it’s been TAC, TAC, TAC. Now we can say, ‘Hello, it’s not just TAC speaking.” She continues, “Look, we know that pharma is a huge well-oiled machine. That means we need to be an even bigger well-oiled machine. Our job is to show people the connections. Because once they get it, the passion, the drive, the fight, the anger—they all come out. We are in the right, and we will be a force to be reckoned with.”
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