Taking on Goliath: the PMA Case

When President Nelson Mandela signed an amendment to the Medicines Act in 1997, few could have imagined that the law would not take effect for another seven years. 9 The Amendment Act, which aimed to bring down soaring medicine prices, quickly became the centre of an international firestorm.

The pharmaceutical industry, backed by the US government, launched a full-frontal assault, arguing that the law violated their patent rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The Pharmaceutical Manufacturer’s Association (PMA) joined 40 multinational and national drug companies in a lawsuit challenging the Act before the High Court of South Africa. 10 Central to the industry’s concerns was Section 15C of the Act, which in part allowed imports of patented medicines from other countries, a process known as parallel importation

“There was such resistance. We were actually shocked,” says Director General of Health Precious Matsoso, who helped draft the law.

As the lawsuit dragged on in court—the application was delayed by more than three years—the PMA also enlisted the muscle of the US government. The US Ambassador wrote a letter to the South African government criticising Section 15C of the Act. The United States Trade Representative (USTR) put South Africa on a Special 301 Watch List, and withheld trade benefits. 11

Ellen t’Hoen, then-an intellectual property adviser at Médecins Sans Frontières (MSF), says the case was a rallying point. “Overnight that made the world realise that there was something really, really incredibly wrong.”

Treatment activists launched their own response. US activists targeted US Vice-President Al Gore for his role in pressuring the South African government. They began disrupting campaign events, yelling “Gore’s Greed Kills.” A year later, South Africa was removed from the Special 301 Watch List, and US President Bill Clinton recognised the rights of African countries to pass TRIPS-compliant legislation to combat the AIDS epidemic. 12 (In a potential reversal of this policy, industry recently tried to use South Africa’s eligibility for US trade benefits under Africa’s Growth and Opportunity Act as a bargaining chip to undermine South African intellectual property reform, (see Fix the Patent Laws). Still, the PMA decided to continue the lawsuit. In January 2001, TAC announced it would seek to join the case.

The Treatment Action Campaign was launched just a few years earlier. On 10 December 1998, Zackie Achmat gathered 10 people on the steps of St. George’s Cathedral to call for access to affordable HIV treatment.

A week before, Achmat had made a call for action at the funeral of a prominent gay rights activist who had HIV: “Join our hands to fight the drug companies. . . Don’t talk to us of a partnership of care and compassion. Talk to us of a partnership that will save lives.”

Speaking at Tseko Simon Nkoli’s memorial, Achmat would launch a struggle that helped bring life-saving medicines to millions of people. At one point, Achmat even refused to take HIV treatment until it was available to everyone in the public health system. But in 2001, a legal intervention for TAC was a new, untested strategy. TAC was trying to turn “a dry legal contest into a matter about human lives.” 13

Justice Cameron discussing the impact of ARVs on his life.

It worked. TAC’s application to join was vigorously opposed, but once TAC was admitted, resistance crumbled. TAC successfully argued that the case was “not about intellectual property of these companies” but rather the “human rights of people who live with HIV in South Africa,” recalls Mark Heywood.

TAC did not just join the case in court. It also rallied protesters, and helped organise demonstrations around the world to call on pharmaceutical companies to withdraw the case. On March 5th, 2001—TAC’s Global Day of Action—5000 people marched past the Pretoria High Court and gave a memorandum to the US Embassy. Public awareness grew. The three strategies of litigation, mobilisation, and education increasingly came to define the work of TAC. “We empowered people to take on pharmaceutical companies on their own grounds as equals,” says Heywood.

In the US, activists continued to push for access. They secured a historic pledge from a pharmaceutical company to not enforce its patent on a key medicine in Africa. 14 An Indian generic company, working with US activists, then announced that it could bring the price of ARVs down to US $1 a day, making universal HIV treatment a possibility for the first time. 15

Achmat recalls the “amazing” global solidarity. “MSF mobilised internationally. Activists in India and Brazil helped us. ACT-UP Paris occupied a pharmaceutical company office in Paris for three full days and shut them down,” he says. “We had ordinary people across all these countries, we had churches, we had unions, we had everybody supporting us.” 16

Confronted with rising public and legal opposition, the PMA crumbled under pressure and withdrew its claims in 2001.

The PMA’s withdrawal represented a remarkable victory for treatment activists. It provided proof that the world’s most powerful multinational companies could be held accountable, and demonstrated the importance of treating health as a human right. 17 “Without the South African court case, we would not have had the Doha Declaration,” says t’Hoen, referring to the landmark document affirming that the TRIPS agreement should be interpreted in a manner supportive of access to medicines for all. (see The Promise of Doha).

More broadly, the early success showed the value of litigation, mobilisation and education to a newly emerging health and human rights movement. This would prove vital to subsequent battles for access. Strengthened by this victory, the alliances formed between treatment activists from around the world continue to this day. Activist networks share resources, knowledge and strategies to hold the pharmaceutical industry accountable.


Justice Cameron reflecting on what made TAC successful.

Although the withdrawal of the case appeared to pave the way for increased access to ARVs, the South African government had other plans. Following the victory, Minister of Health Tshabalala-Msimang said that it was not government policy to use ARVs, nor would it be for the foreseeable future.

Driven by relentless campaigning, South Africa has since then made significant progress in introducing ARVs (see Denialism, Defiance, and Durban). South Africa now has the largest HIV treatment programme in the world, with 4.2 million people on ARVs. 18 Working with international partners, the government has slashed the prices of HIV medicines, and prioritised scaling up its HIV response.

But even today, the potential of the Act largely remains unrealised: twenty years after its enactment, Section 15C of the Act has never been used to import cheaper medicines. Some ARVs may now be affordable, but many medicines remain out of reach for thousands of people. The reality is that the amendments to the Medicines Act largely left the Patents Act untouched. Section 15C was a small part of a solution to much a larger problem. While we won the battle, the war has been lost.

For Director General Precious Matsoso, the uneven progress is troubling. “I find it to be sad. In this day and age, after we had won regarding HIV/AIDS, the cancer patients are now sentenced to death again”.

The PMA case spurred a global movement that pushed governments to put people over patents. Since then, South Africa has consistently championed its right to use TRIPS flexibilities in international forums, such as the World Health Organization. 19 Twenty years later, South Africa must finally put its words into practice, and change its patent laws (see Fix the Patent Laws).

  2. Notice of Motion in the High Court of South Africa (Transvaal Provincial Division), Case No. 4183/98.
  3. Simon Barber, U.S. Withholds Benefits Over Zuma’s Bill, Africa News (July 15, 1998), available at http://allafrica.com/stories/199807150119.html.
  4. William Fisher & Cyrill Rigamonti, The South Africa AIDS Controversy: A Case Study in Patent Law and Policy, THE LAW AND BUSINESS OF PATENTS (2005), available at https://cyber.harvard.edu/people/tfisher/South%20Africa.pdf.
  5. Mark Heywood, “Debunking “Conglomo-Talk”: A Case Study of the Amicus Curiae as an Instrument for Advocacy, Investigation and Mobilisation, 5 LAW, DEMOCRACY & DEVELOPMENT (2001).
  6. Daryl Lindsey, Amy and Goliath (2001), available at https://www.salon.com/2001/05/01/aids_8/.
  7. Sarah Boseley, Big Pharma’s Worst Nightmare (2016), available at https://www.theguardian.com/society/2016/jan/26/big-pharmas-worst-nightmare.
  8. Achal Prabhala, Zackie Achmat: Private Sector, Not The State, Stalling Access To Medicine, Huffington Post (2017), available at https://www.huffingtonpost.co.za/2017/12/03/zackie-achmat-new-patent-policy-is-a-realisation-of-all-the-things-people-died-for_a_23295428/ .
  9. Mark Heywood, “Debunking “Conglomo-Talk”: A Case Study of the Amicus Curiae as an Instrument for Advocacy, Investigation and Mobilisation, 5 LAW, DEMOCRACY & DEVELOPMENT (2001).
  10. UNAIDS, RIGHT TO HEALTH (Nov 20, 2017), p.48, available at http://www.unaids.org/en/resources/documents/2017/20171120_right_to_health.
  11. See South Africa’s Statement on Access to Essential Medicines at WHA (May 26, 2014), available at http://www.fixthepatentlaws.org/?p=886.