Conclusion: Fix the Patent Laws

Patent law has been a battleground for access to medicines. Patent law helps influence what knowledge we produce, and who benefits from this knowledge. Patent law, in short, reflects what—and whom—society values.

However, South Africa’s current patent law neither aligns with the government’s constitutional obligations nor its developmental needs. Patents, in theory, are supposed to incentivise innovation by rewarding inventors with an exclusive right to sell their product. Because this exclusive right is so powerful, many countries make sure that patents are only granted to genuine innovation—but not South Africa.

In South Africa, all patents are freely granted as long as the applicants meet the most basic of procedural requirements: filing the right paperwork and paying the right fee. The result is predictable. ⁶⁷ Between 2003 and 2008, Brazil, a country with a strong substantive examination system, granted 278 pharmaceutical patents. South Africa granted 2442 pharmaceutical patents, in 2008 alone. These undeserving patents restrict competition, block introduction of more affordable generics, and artificially keep medicines out of reach for patients.

What the system does, then, is to prioritise the profits of foreign patent-holders over the health of people living in South Africa. A recent study found that less than 10% of the patents granted in the country between 2005 and 2015 were filed by South Africans. ⁶⁸ The system is flagrantly inconsistent with the government’s constitutional obligation to take reasonable steps to advance the right to access healthcare services.

It does not have to be this way. A UNDP study highlighted how South Africa could reform its intellectual property laws to accelerate treatment access. ⁶⁹ For example, South Africa could replace its lengthy and bloated compulsory licensing laws, with easy-to-use, simplified procedures that are public- health friendly.

In 2009, the Department of Trade and Industry (dti) announced it would undertake IP reform. A series of delays then plagued the process: false starts, leaked policies dripping with the influence of industry, and many unfulfilled promises of forthcoming bills. Nine years later, there are no new laws.

While a recently finalised policy offers hope, the government must introduce and adopt bills as urgently as possible. In doing so, they must show the political courage to withstand threats from industry and foreign governments.

The attacks have been many. In 2014, a leaked document showed industry plans to delay the policy and fund “experts” that would downplay public health concerns. The ensuing scandal, known as Pharmagate, led to a sharp response. The Minister of the Health called the industry plot tantamount to “genocide.” ⁷⁰ In 2015, the American Chamber of Commerce in South Africa sought to tie South Africa’s eligibility for trade benefits to abandoning its proposed patent reforms. US pressure then reportedly stalled the process—an eerie reminder of the battle over HIV medicines in the 2000s (see Taking on Goliath: the PMA Case). Jonathan Berger, a former senior researcher at SECTION27, does not think pharmaceutical companies have learned much. After all, he says, their business model remains the same.

“They’ve learned that they have to be smarter about their PR. Some of their messaging may have changed. But it’s still the same [flawed principles]: we need patent protection, the system works.”

The Fix the Patent Laws campaign (FTPL), launched by TAC, SECTION27, and MSF on 11 November 2011 – the 10th anniversary of the Doha Declaration – has led the fightback. FTPL, which now includes 40 organisations, has analysed draft policies, highlighted gaps in medicine access, and marched to demand action. Most importantly, its creation has re-energised the access to medicines movement in South Africa and focused attention towards the structural barriers to medicine access, recognising that case-by-case victories will not be enough.

In February 2017, FTPL launched the Tobeka Daki Campaign for Access to Trastuzumab. The campaign was named after Tobeka Daki, a brave and courageous activist with HER2+ breast cancer who was denied a chance to live because she was unable to afford the cancer medicine she needed. In March 2016, Tobeka told her story in front of the United Nations Secretary-General’s High-Level Panel on Access to Medicines. Tobeka then led a picket at the International AIDS Conference, and again in front of Roche’s offices in Sandton to protest the high price of trastuzumab. A few months later, the cancer spread to her spine and Tobeka passed away.

It is too late to save her life. But the government should urgently adopt intellectual property reforms that protect public health to save the thousands more who still need medicines. In September 2016, the UN High Level Panel released a report recommending that countries use all available public health safeguards—or TRIPS flexibilities—in their patent law. ⁷¹

In August 2017, the government finally took an important first step, releasing a draft policy that incorporated many of these health safeguards. FTPL welcomed the policy, and a thousand of its members marched to Pretoria to urge the release of a bill. For Zackie Achmat, who decades ago launched the struggle for treatment, the policy was a “a realisation of all the things that people died for in South Africa.” ⁷² A group of US civil society organisations then sent a letter urging the US government and industry not to interfere with South Africa’s efforts to promote access to lifesaving medicines.

Then, in May 2018, the government released a promising final intellectual property policy. FTPL welcomed the policy as an important milestone in the process of reforming South Africa’s patent laws, but urged the government to adopt legislation without delay to give meaning to the policy.

What kind of intellectual property reforms South Africa actually adopts will shape the well-being of thousands of people living in South Africa—and beyond. A strong, pro-public health patent law could embolden other countries. Internationally, South Africa must continue its farsighted leadership. Following the recommendation of the Global Commission on HIV and the Law, South Africa must call for suspension of TRIPS for essential health technologies, such as medicines and diagnostics. ⁷³ As the Special Rapporteur in the field of cultural rights recently stated, “where patents and human rights are in conflict, human rights must prevail.” ⁷⁴

Tshabalala agrees. “People are dying of cancer, but cancer medication is still under patent. You have to pay thousands and thousands of rands to access it. That is not fair.”

Beyond Patents

Fixing patent laws will not solve the problems inherent in patents. Patent protection, for example, does not drive innovation when the treatments may not be profitable, such as for antibiotic-resistant bacteria, or neglected tropical diseases. Hundreds of thousands of people remain afflicted with diseases that have no effective treatment.

In 2017, the Minister of Health Dr Aaron Motsoaledi noted: “We must come up with innovative research and development models, such as The Life Prize . . . which delinks the cost of R&D from the final cost of medicines.” ⁷⁵ South Africa should continue to advocate for alternative research and development models, such as delinkage, which proposes incentivising R&D through grants, subsidies and cash prizes instead of patent monopolies that permit excessive pricing. ⁷⁶ And it should back up this global leadership with funding for these initiatives, as well as increased spending on basic research. South Africa must invest in the drugs—and models of drug development—of tomorrow. It cannot remain trapped in the market logic of intellectual property.

Nearly twenty years ago, a call for universal access to HIV treatment seemed revolutionary. It was deemed impossible by many. But over time, civil society and government worked towards that vision, overcoming intense international pressure to increase medicine access. After a decades-long struggle, voluntary licenses have provided a band-aid solution.

Stephen Lewis, the former UN Secretary-General’s Special Envoy for HIV/AIDS in Africa, thinks the progress has been extraordinary. But, he says, not everyone has been held accountable. “The one thing which is missing is the pharmaceutical industry. We have not learned to bring these bastards down. . . That’s the next big battle.”

Now more than ever, we need to strike at the root of the injustice. South Africa must fix its patent laws, and commit to a rights-based global innovation system that puts people before profits. Thousands of lives depend on it.