XVIII International AIDS Conference: patents and access to medicines

The XVIII International AIDS Conference has been taking place this week in Vienna and I would recommend a terrific talk by Ellen ‘t Hoen, Senior Advisor UNITAID Medicines Patent Pool, 'A proposal for change: Managing patents to ensure access to AIDS medicines for all'

"Ten years ago, the world prepared to gather in Durban, South Africa, for the first International AIDS conferenceto be held on the continent most devastated by this terrible disease. At the time, the statistics were grim: only one in a thousand African people in need could get access to AIDS treatment, because the drugs were only available from originator companies who owned the patents on these medicines.  They came with a paralysing price tag of US$10,000 to US$15,000 per patient per year.

Through an immense joint mobilization of people living with HIV/AIDS and their organisations, their doctors and nurses, civil society, dedicated ministries of health, donor governments, and pharmaceutical companies, we have achieved today what most delegates at Durban thought impossible: access to AIDS treatment for more than 4 million people in the developing world...

The AIDS crisis and all its actors have caused a radical change in how we approach intellectual property in the field of medicine. This is reflected in legislative and policy changes, and changes in pharmaceutical companies’ business practices...

Before TRIPS, pharmaceutical patent policies and practices were diverse. For example, many countries did not consider patents on products such as medicines and food to be in the public interest and half of the countries actively excluded pharmaceutical (product) patenting altogether. This included a number of European countries such as Spain and Norway.

The WTO rules put an end to this when it required all member countries to introduce 20 year patents on medicines. As part of the WTO package, it was not possible for countries to opt out of TRIPS while becoming a member of the WTO, and the following years saw a wave of IP reforms in most developing countries to meet the requirements of the TRIPS Agreement. The policy space countries once enjoyed to design IP systems in line with their own development needs and priorities was rapidly shrinking...

In the late nineties, the potential effect of the changing IP rules on access to medicines was little understood, and interest in IP issues among the public health community was still rare.

A couple of things changed that:

In 1998, 39 drug companies and their representative body sued the new democratic South African government over amendments to its Medicines Act, which aimed to make low cost medicines more readily available. The companies asserted it was both unconstitutional and not compliant with the TRIPS Agreement...

Big Pharma vs. Nelson Mandela provided shock therapy. It was a call to action that pulled many different actors onto the stage.

In 1999 at the UN in Geneva, a group of NGOs and AIDS activists held a conference titled ‘compulsory licensing of AIDS drugs.’...

This caused a great deal of concern among the patent holders.

Thailand and Brazil were the first developing countries with AIDS treatment programmes that embraced the notion of universal access. They both heavily relied on the ability to produce low cost medicines in government facilities, illustrating the enormous cost reductions that could be achieved. (e.g., Thai fluconazole for 0.29 USD vs. 11 USD Guatemala negotiated price from originator, a 38-fold difference)...

Then, in April 2001 after a global and domestic public outcry under the leadership of the South African Treatment Action Campaign, the 39 drug companies dropped their case against the South African government. The landscape had dramatically changed. Access to medicines and the need to revisit the patent rules that govern them had become part of a larger political agenda and was no longer the exclusive domain of trade negotiators.

In November 2001, governments at the WTO Ministerial Conference – in an unprecedented move – adopted the Doha Declaration on TRIPS and Public Health. The Doha Declaration made clear that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.” This represented the first significant push back to the relentless march to strengthen private IP rights without regard for societal consequences in poor countries...

The 500-word Doha Declaration on TRIPS and Public Health has been essential in making low cost medicines available on a large scale...

When India became compliant with TRIPS in 2005, it incorporated public health safeguards in its Patents Act...

The AIDS crisis has been an engine for change – not only in thinking about IP and Health -

• but also in the way health care is delivered through task shifting...
• in the role of civil society in decision making in global health...

Market competition for the early generation of generic ARVs resulted in prices per patient per year dropping by 99% over the past decade. Drugs that used to cost $10,000 per year are now widely available for $67 per year.

So, what is the problem?

First, the cost of treatment is increasing again because new AIDS medicines are likely to be patented in developing countries and thus more expensive. Even in India, the new ARVs are likely to be patentable...

Second, increasing numbers of people will need access to new generation treatments. These treatments in general are more widely patented and more expensive...

Third, we still need to expand access to first line medicines to people that do not benefit from them today...

Fourth, we need to be able to respond to new scientific knowledge and evidence; we need to find ways of making key products affordable and available on a wide scale...

Fifth, we are faced with a serious financial crisis that risks setting back the treatment achievements of the last 10 years."

It's a complex and hugely important story, very well told. We often hear of the "copyright wars" and entertainment industry struggles to protect their revenues. Indeed I've been pretty focussed on just that for the past couple of weeks, drafting a chapter on the Digital Economy Act for a book on the nature of information (a substantive draft of which I finally despatched to the editors yesterday, though all the tedious tidying up and formatting of references and bibliography etc. still need to be done). Yet this question of access to medicines is an illustration that the need for a balanced intellectual property landscape transcends stories of the hordes of the mass unwashed 'music thieves' on the internet and really can be a question of life or death. Highly recommended.