The Doha Declaration @ 20: The quest for solutions to overcome access barriers created by the TRIPS Agreement

In our mini-series to mark the 20th anniversary of the 2001 Doha Declaration, we turn to a lawyer and economist who worked as a consultant to the World Trade Organization (WTO) during the process leading up to the agreement on the declaration. Dr. Carlos Correa also attended the ministerial conference itself in 2001 in Doha, along with all the key actors. He is now the Executive Director of the South Centre, an intergovernmental organisation of developing countries, and continues to work with their governments on issues around intellectual property and public health.

Why did the Doha Declaration happen — where did it all start?

Well, the main reason for the process that led to the adoption of Doha Declaration was the HIV/AIDS crisis in Africa. South Africa attempted to implement a couple of so-called ‘flexibilities’ from the TRIPS Agreement in order to be able to get hold of affordable antiretrovirals for people living with HIV, and this resulted in litigation initiated by 39 multinational pharmaceutical companies against the South African government. If successful, this litigation would have limited the capacity of the South African government to act in the context of that epidemic and provide affordable treatment to people living with HIV. So that really was the trigger, I would say, of the Doha Declaration process.

The African group clearly took the lead in putting this issue on the table in WTO. For the first time, there was a discussion on the relationship between the TRIPS Agreement and health, and this led to the initiative of clarifying that the TRIPS Agreement could and should be implemented in a manner compatible with access to medicines to all — as stated in paragraph 4 of the final Doha Declaration.

But more broadly, Doha was the outcome of a concern by African countries and developing countries as a whole about the implications of the implementation of the TRIPS Agreement in relation to health even beyond the HIV pandemic — a concern that intellectual property could become a barrier for access to medicines.

So the Doha Declaration was created in response to concerns from developing-country governments about the TRIPS Agreement?

Unfortunately, in the negotiation of the TRIPS Agreement at the WTO, the health ministries and health authorities did not participate; hence many of them were not really aware about the implications of the TRIPS Agreement for public health, in particular, because the TRIPS Agreement obliged all the WTO members to provide patent protection for pharmaceuticals. This was not the case before the TRIPS Agreement entered into force.

Dr. Carlos Correa

What was your role at this time?

In the process of the negotiation and after the TRIPS Agreement was signed, I tried to indicate the consequences that the agreement would have on public health and the problems that the implementation of the TRIPS Agreement would bring about in terms of access to pharmaceuticals. But I was also one of the first to point to what were called in the Doha Declaration itself — ‘flexibilities’ in the TRIPS Agreement.

My main argument was that the TRIPS Agreement was there, and it would have been very difficult to change it because it had been just adopted. But I argued that the TRIPS Agreement provisions allow for some policy space to member countries. And these ‘flexibilities’ could be used to mitigate the impact of the legal monopoly granted by patents, for instance, and thus reduce the negative impact the TRIPS agreement might have.

Was it a tough process to get the declaration adopted even though the final outcome was positive?

It was without doubt a victory for developing countries. There was quite a significant consensus in the developing countries at the WTO about the urgent need to find the way for applying the TRIPS Agreement in a manner compatible with the achievement of public health objectives.

On the other hand, there was strong opposition from the United States in particular. The US is the host to very strong pharmaceutical companies. There are also many in Europe, some in Japan, but the US was a significant opponent to the idea of making a declaration like this that, in their view, would weaken the protection by intellectual property provided to pharmaceuticals. So that was perhaps one of the main diplomatic issues; but at the conference in Doha, the situation of the US was weakened significantly because the Doha ministerial took place a couple of months after the attacks of September 11.

As a result of this event, to cut a longer story short, the US was considering at that very time the need to use a compulsory licence for anthrax treatment in the context of concerns that a wave of biochemical terrorist attacks were imminent in the US. This turned out not to be the case but then at the WTO the comparison was made between a few casualties, a few deaths, that had had occurred in the US, against the millions of people who could be deprived of access to medicines in Africa or in other developing countries, because of the implication of this TRIPS agreement.

Protesters demonstrate outside the Supreme Court in Pretoria, South Africa, in 2001, as the pharmaceutical industry faced off in court against the South African government. The 39 drug companies were attempting to sue the government over using ‘flexibilities’ around intellectual property rights in a move that would have denied people living with HIV/AIDS access to affordable antiretroviral medicines in South Africa.

What impact has the Doha Declaration had?

It was an important achievement for developing countries to have it confirmed that the TRIPS Agreement can be interpreted in a manner that mitigates the impact of monopolies that are accorded through intellectual property rights. It also had a specific impact on the way legislation around intellectual property was enacted in many countries subsequently.

A concrete example is the work that was done around amending India’s national patent law. This law was shaped in a way to comply with the TRIPS Agreement but also to enshrine the flexibilities highlighted by Doha in a way to protect public health. For instance, the law in India sets out the right to oppose patents as well as to issue compulsory licences and other flexibilities. Some other countries too have incorporated these flexibilities into their own national patent laws over time.

Any regrets over how things have evolved after Doha?

Actually during the negotiations, there were compromises made so that the absolute primacy of public health over commercial interests was not fully reflected in the declaration nor made a legally binding rule. And in the years that followed, we would have expected the Doha Declaration to have had a wider impact in more countries. However, some developing countries have not yet made full use of the flexibilities in the TRIPS Agreement for a variety of reasons, though we are trying to change this.

Moving forward today, how does the story of the WTO TRIPS Waiver now under discussion fit into the work that was done around Doha?

The need for the waiver means that even the interpretation of the provisions of the TRIPS Agreement in the context of public health needs, may not be enough in cases like an emergency — such as this current pandemic.

For instance, the fact that you can grant compulsory licences isn’t enough because you need to act fast and yet in order to implement them, you need time. There are procedures to be followed. You need to act collectively in such an emergency and to take action at the global level; this is why a waiver is needed. You also need to provide legal certainty for manufacturers that they won’t be sued if they push ahead with manufacturing products — as fast as possible, and this certainty can be provided by the waiver.

Currently, the likelihood for the waiver being adopted is uncertain — what lessons could be learned from the Doha negotiation process?

You can make perhaps a parallel between the Doha Declaration and the waiver. The Doha Declaration was a deal-breaker at that [2001] WTO conference. What I mean is that developing countries were not ready to sign a final declaration for the conference if there was no outcome in relation to public health. The adoption of the Doha Declaration actually allowed the whole conference to be successful in terms of adopting a new work programme. As the developing countries were so strong about having this declaration, they were not willing to move forward in other areas if there was no agreement on this. The Doha Declaration was a key issue at that ministerial conference, and for developing countries, was a sine qua non to move forward.

What if there is no positive outcome for the supporters of the Waiver?

There will be however some positive outcomes, such as putting on the table again a reform that was introduced to the TRIPS Agreement as a consequence of the Doha Declaration, through the addition of a new article — Article 31bis. The TRIPS Agreement was amended to introduce a new provision on compulsory licensing. But this new article is cumbersome, difficult to implement. Because of the waiver discussions, this is now something that will definitely get the attention it needs to make it a workable mechanism.

But in the bigger picture, if there is no positive outcome, I think there may be a stronger demand for changes in the system. The WTO would not be able to show that in a situation of emergency like this it is possible to adopt the means needed to mitigate the situation. So, I think that the next step would be to look at how to change the system. Therefore, for those who would like to preserve it as is, it will be preferable to get an agreement on this waiver.

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MSF Access Campaign — Medicines Are Not a Luxury

This blog is a place to reflect on our experiences working for access to medicines. For the official MSF Access Campaign website please visit msfaccess.org.