Interview: Brook Baker on Intellectual Property Rights, Free Trade, and Access to Medicines
By Katrina Geddes
When I first meet Northeastern University law professor Brook Baker, it’s a bitterly cold day in Boston. It’s a relief to escape into the warmth of Baker’s office, tucked away inside Northeastern’s Cargill Hall, where I am to meet with the prominent professor who focuses on intellectual property, access to medicines, and increasing the legal, economic, and policy response to the HIV/AIDS pandemic. Baker’s office is cluttered and cozy, decorated with personal photos, a large tribal rug, and South African ornaments.
The authority with which Baker discusses the core issues of the access to medicines movement reflects a lifetime spent chipping away at the block of pharmaceutical imperialism. He came to health activism after a stark realization about the reality of life in South Africa, where he initially intended to train the next generation of lawyers that would shape the post-apartheid nation. After learning that 26% of his female students would be dead within a few years due to lack of treatment for HIV, he became involved in campaigns for universal access to treatment and care for people living with HIV/AIDS. He has written and consulted on intellectual property rights, free trade and access to medicines with organizations such as the Global Fund to Fight AIDS, UNDP, WHO, OSI, UNITAID, Health GAP, and the Medicines Patent Pool. He also focuses on strategies for strengthening health systems, and improving health care delivery in developing countries.
Human rights: An absence of enforceability
We begin by discussing the competing paradigms of human rights and proprietary intellectual property (IP) rights. When I ask him why, in practice, IP rights trump human rights, he explains that human rights lack enforcement mechanisms. While IP rights are fiercely guarded by their owners, human rights, Baker says, “have no comparable enforcement mechanism. There’s no real sanction except naming and shaming. The naming and shaming reports come out all the time but don’t have much effect.”
“The right to health has historically been actualized in the judicial context,” Baker says, “but it can be usefully actualized in legislative battles, law reform battles, which try to achieve more structural change.”
In addition to the absence of enforceability, Baker explains that human rights “lack teeth against many of the main perpetrators who are private actors – international corporations who do the most structural harm to access to medicines.” The state-centric nature of human rights obligations allows non-state actors to escape sanctions for human rights abuses, including corporate action which impedes the right to health. Baker explains that efforts within the UN system to extend human rights obligations to corporations have been largely ineffective due to “the lack of enforcement mechanisms and the unresolved question of justiciability in national courts.”
Baker believes strongly that the right to health should continue to be grounded within the human rights framework, given the ability of non-state actors to avoid consequences for human rights violations. “I think we need to deploy [the human rights framework] strategically and correctly as a discourse, as a rallying cry and as one of the ways we build the social movement for the right to health.”
Baker notes that the access to medicines movement has deployed the human rights discourse very powerfully and with significant effect, particularly in terms of HIV. “When you win something like lower prices for [antiretroviral drugs] or when you defeat an effort to have a particular IP provision in a trade agreement, you are changing the actual structures that affect the right to health.” He believes that the social movement “has the teeth at present” and thinks that using the human rights discourse as the basis for social movements should continue to be the primary focus.
Historically, Baker says, health movements have focused on judicial interactions by taking cases to court, with limited effect. Increasingly, however, the social movement is maturing towards law reform through legislative rather than judicial means. He says this shift arises from a growing realization that many of the negative structural elements that affect the right to health arise from legislative sources. In line with this new approach, health activists in South Africa are currently trying to amend national patent laws to prevent evergreening by multi-national pharmaceutical corporations.
“The right to health has historically been actualized in the judicial context,” Baker says, “but it can be usefully actualized in legislative battles, law reform battles, which try to achieve more structural change.”
The patent system and inhibited access to medicines
Baker believes that the patent system is one of the most significant structures inhibiting access to medicines, as it obstructs the market entry of generic medicines and neglects non-profitable diseases. Baker claims that the current system “distorts research priorities towards medical conditions where maximum profits can be made.” This leads not only to neglected diseases, but to neglected populations. “Even when you have a disease that affects poor people and rich people,” Baker explains, “the focus will be on getting it to the rich people. There’s very little incentive to cater for poor populations.”
Increasingly, there have been calls for new R&D business models which provide alternative rewards for research and delink profits from product sales. Baker adds his voice to these calls. “Instead of everyone digging the same well and making the same mistakes, mainly because of secrecy, we could have more collaboration, the kind of things that made the Genome project work well—sharing resources—that would result in a cheaper research model and better therapeutic outcomes. It wouldn’t be this ‘all or nothing’ kind of system with a huge monopoly with excessive prices.”
For years, the pharmaceutical industry has justified its monopoly profits on the basis that such profits are necessary to recoup R&D expenditure. Baker disagrees. “Pharmaceutical companies spend almost two and a half times as much on marketing as they do on research and development.” Moreover, the marketing is designed not to better inform patients but to seize a greater share of the market. Pharmaceutical companies “don’t have to market their best medicine because doctors will prescribe it and patients will have heard about it. They spend all their money and all their sales force on trying to expand the use beyond the stated indication and trying to gain market share from the other blockbuster that got into the market first. They’ve got this slight advantage they can talk about and that’s what they send all their product detailers out to talk about. We have so much wastage in the system because people are trying to grab a portion of these blockbuster monopolies.”
Given these weaknesses in the patent system, why is the pharmaceutical industry still clinging to a broken model? “It’s the goose that keeps laying the golden egg for them,” Baker explains. “They’ve remained one of the most profitable industries. All the dinosaur industries don’t want to die, even if they don’t make much sense. They have more or less bought governments. You would say so in the US. And when you have the government supporting them and you have a very strong industry…” Baker shrugs, looking resigned.
TRIPS and tools for increasing access to medicines
I shift gears and ask Baker about the TRIPS agreement. Of the various flexibilities available under the agreement, what should developing countries be using to most effectively increase access to medicines? “I think there’s an array of tools,” responds Baker, “and they need to be used in a complementary way.”
“Some of the mechanisms that exist are hard to operationalize on a country by country basis. Cheap medicines are basically the result of aggregated markets. The reason you have low prices on AIDS medicines is that there were a lot of countries that could buy the cheap generics and there was PEPFAR and the Global Fund financing the purchases. So you had buying power, and lots of countries eligible for the low prices, you had a big market that incentivized generic entry, production efficiency and economies of scale. So from my perspective, if you want compulsory licensing to work, you need cooperation on a regional or global scale. You need lots of countries to cooperate on issuing licenses nearly at the same time, if the product is widely patented, so that you can create a large market that incentivizes generic entry and competition. It’s fine if you’re a big country like the US because you have a lot of people and a lot of purchasing power, so issuing a compulsory license on your own is effective. But if you’re in Botswana, a compulsory license means nothing, because a generic company is not going to come on board just to supply 2 million people.”
The 2005 insertion of TRIPS Article 31bis was designed to promote compulsory licensing by allowing developed countries to export low-cost generic drugs to poorer countries lacking manufacturing capacity. So why have few developing countries invoked their rights under Article 31?
“If you want compulsory licensing to work, you need cooperation on a regional or global scale.”
“Most countries don’t have ideal legislation with respect to the standards for issuing compulsory licences or the mechanisms for doing so,” Baker explains. “Most countries don’t have a good description of the full range of grounds upon which compulsory licenses can be issued, for example, excessive pricing, inadequate sources of supply, inability to make needed combinations, et cetera.”
The United States, by contrast, routinely issues compulsory licenses for the use of government-patented inventions. “The US has, in government-use licenses, the absolute easiest mechanism of all,” Baker says. “And they use it all the time. And no one ever talks about the hypocrisy of the United States having this very easy-to-use system that they use a lot when they’re complaining about anyone else who uses compulsory licensing anywhere else in the world. In the US, any government official or any contractor of the federal government can take and use a patent, subject only to notification and eventual payment of adequate compensation. The grounds are only that it’s for government use.”
Free trade agreements that threaten access to medicines
Lingering on the subject of the United States, we discuss two free trade agreements it is currently negotiating: the Trans-Pacific Partnership (TPP) and the Trans-Atlantic Trade and Investment Partnership (TTIP). Both agreements could potentially contain investor-state dispute settlement provisions which would allow US pharmaceutical companies to sue foreign governments for pro-public health measures that promote access to medicines but reduce pharmaceutical profits. Baker believes that the fear of foreign litigation would severely compromise the willingness of states to utilize TRIPS flexibilities such as patent reform and compulsory licensing, thereby eroding the public health policy space carved out by TRIPS. “If you thought that every time you made a patent decision, as Canada did invalidating two patents on Eli Lilly products, that not only would the company complain to the highest court in the land, but they might skip that step and pick three pro-industry arbitrators from the small international pool of such lawyers and try to win there … that’s a system that could have an interim effect on governments in terms of both the decisions they make and the regulations they undertake.”
“We know, for example, that the tobacco companies taking investor-state dispute settlement procedures against plain packaging are slowing down the effort to better regulate tobacco sales. The same thing could impact regulatory decisions about whether medicines should be given marketing approval or not; it could affect price control decisions, therapeutic formulary decisions, certain patent decisions.” If foreign governments are forced to spend millions of dollars defending their pro-public health measures against pharmaceutical expectations of profit, Baker warns, they will quickly run out of funds to do so.
He hopes that public campaigning will prevent investor-state dispute settlement provisions from being included in the TPP or the TTIP. He notes growing pressure in Europe from civil society and even some governments who think that investor state dispute resolution is a bad idea. Such provisions were initially included, he explains, because some countries lacked a judicial system that allowed investors to pursue their rights, so a separate system was necessary. “It was based on this theory that some banana republic was going to seize a business and not compensate the owner, and there would be no recourse in state courts. But the TTIP is being negotiated between the EU and the US. Does anyone seriously think that there aren’t adequate court remedies in the US and Europe with respect to illegal government decisions? Of course there’s plenty of legal opportunity to challenge them. But what businesses want is an extra-judicial direct claim against the state on an indefinite standard that gives them a great deal of leverage. It’s just a huge corporate power grab.”
“What we need now,” Baker says firmly, “is a movement that keeps the heat on with respect to the right to health and the right to medicine writ large across all disease categories and all medicines.”
Baker explains that developed countries can’t, on the one hand, acknowledge health as a human right and on the other hand, endorse a system that allows corporations to complain about a thwarted expectation of profit and force governments to abandon pro-public health measures. “That’s another example of the imbalance between the rights that exist in the trade regime and human rights,” Baker asserts.
He talks passionately about the importance of the social movement, given the lack of institutional power protecting human rights. “The Global Commission on HIV and the Law had a recommendation that there be a moratorium on rich countries seeking TRIPS-plus provisions in trade agreements with developing countries. Where has it gotten us? Not very far. We don’t have an institutional lever; we don’t have any institution of power that could stop developed countries from applying pressure on developing countries. It’s crazy to have to be defending the little bit of policy space that currently exists under international law.”
The World Health Organization, Baker says, “is not playing the leadership role it should. It’s politically timid about this, partially because of the governance role that rich countries play within it and also due to the influence of the pharmaceutical industry. It’s not playing the normative role it should.” He places more importance on the social movement for global health. “What we need now,” he says firmly, “is a movement that keeps the heat on with respect to the right to health and the right to medicine writ large across all disease categories and all medicines. What I like about working on IP issues is that it doesn’t just help people living with HIV; if reform is accomplished, it could potentially help anyone with any medical condition.”
Given everything Baker has seen and how far there is to go, it would be easy for him to surrender to bitterness and pessimism. On the contrary, he is convinced that the social movement for health can achieve what political institutions have failed to do – inspire people to fight for their right to health as human beings. As long as people like Brook Baker continue to fight, the rest of us have no excuse.
Katrina Geddes received her Master of Laws (LLM) from Cambridge University in 2014, specializing in international intellectual property law. She will be commencing a Master of Public Policy at Harvard University in August 2015, focusing on global health and access to medicines.
Photo: Northeastern University School of Law