We can’t end AIDS without tackling patent abuse

Despite significant scientific advancements for HIV, along with global and national commitments to ‘end AIDS’, hundreds of thousands of people will die from HIV-related illnesses in 2020. Many will be children.

Despite that the treatment to save lives exists, 13.4 million people living with HIV don’t have access to it.

Despite that the prognosis for a person diagnosed with HIV is now, in theory, better than it ever has been, in reality that depends on where you live and who you are.
Affordable, optimal HIV treatment is far from equitable.

Science and promises won’t end AIDS – unless we also tackle the patent problem.

The rise of the patents

Patents on medicines have been rising significantly since 2005.
The situation now is that too many medicines are over-patented and over-priced.
Gram for gram, a HIV medicine can cost more than gold.

It’s not just HIV treatment that’s affected. The University of Liverpool examined each drug on the World Health Organization’s (WHO) list of essential medicines. The research looked at cost of production, which also allowed for manufacturing, formulation, packaging, taxation and a 10% profit margin. It found a significant gap between the cost and the price of most medicines on the list.

Aren’t high prices due to research and development (R&D)?

No.

The R&D argument is flawed.

The pharmaceutical industry frequently repeats that high prices are due to R&D, while at the same time remaining notoriously un-transparent about these costs. The industry is also the third most profitable in the world, making it irrefutable that the industry has gone beyond merely recouping costs and making a ‘healthy’ profit. It’s not exaggerated to call it profiteering, and the evidence is clear to see in annual reports, CEO’s salaries and bonuses for ‘blockbuster drugs’ (medicines that bring in more than $1 billion in sales every year).

It’s also worth noting that there are other sources of investment that contribute to the R&D of medicines. This includes public money and philanthropic investments, yet this is not anywhere close to being proportionately reflected in the resulting patents and prices.

The current patent system is broken

The system of granting pharmaceutical patents and permitting a 20 year monopoly period was intended, firstly, to reward disclosure of inventions to promote science, and secondly to promote genuine innovation, including medical breakthroughs. You could expect that such a system would ensure that companies could re-invest, so that the cycle of incentive and innovation keeps moving.

The problem is:

Patents are often granted despite a lack of innovation or novelty.
They don’t end after 20 years, instead they are ‘evergreened’.
And granting patents hasn’t increased innovation, it has slowed it.

New patents are growing at an alarming rate… while the cycle of incentive and innovation is being slowed.

All too often companies are getting away with extending their monopolies by applying for multiple, overlapping patents, with minor changes, on the same drug.

If you consider that pharmaceutical companies are profit-led, why would a business race to invest in new drugs when it has been permitted to make millions or billions from existing research? The abuse of the patent system, and the ease with which it has been committed around the world, has reduced both the incentive and the innovation.

Who is most affected by the patent problem?

Middle-income countries (MICs) are home to the majority of people living with HIV and many of these countries are bucking the global trend, which reflects an overall decrease in new HIV infections, and instead, the rate here is rising.

One impact of a middle-income classification for a country is that they are frequently left out of pricing deals or voluntary agreements for medicines. In parallel with this it is typical to see funding reduced or withdrawn from health and development agencies.

This leaves MICs with a dual burden of high prevalence and high costs.

Over-pricing as a result of unmerited and extended monopolies puts a huge strain on health budgets. While in theory a government may commit to universal access, in reality the budget may not stretch.

If patent abuse continues, and with it the growing treatment gaps, it won’t be realistic to expect to achieve a sustainable HIV response in countries with this dual burden of prevalence and price.

The patent problem extends well beyond HIV, most essential treatments for conditions from hepatitis to dementia to TB to cancer are affected. With regards to HIV, pediatric drugs have particularly suffered from a lack of innovation and investment, due to a ‘limited market’. Children living with HIV are simply not profitable enough.

What we want to achieve in 2020

Civil society has been, and will continue to be, instrumental in challenging intellectual property (IP) barriers and working towards our overall goal: affordable, optimal treatment for all.

Our focus is on HIV, Hep C and TB medicines in middle-income countries. We will continue to work in solidarity, across countries and across diseases and tackling other barriers to access, including stigma and discrimination. Actions that will be implemented by our IP experts and treatment activists will include:

Working to improve patent law, so patentability standards are stricter, and evergreening patents are not granted. This includes engaging with governments to advocate for the full incorporation of TRIPS flexibilities into national law, and for proactive use of these flexibilities.
Challenging unmerited patents, through pre- and post-grant patent oppositions, to prevent or revoke costly monopolies. Patent oppositions help support the role of overwhelmed patent offices, and civil society plays a role in building patent examination expertise.
Ensuring exemptions are upheld. For example, ‘least developed countries’ do not have to grant patents on drugs until 2033, and other exemptions exist.
Demanding the more routine use of compulsory licences and other flexibilities afforded to countries under the TRIPS Agreement. The Sustainable Development Goals (SDGs) reaffirm the right of countries to use TRIPS flexibilities, SDG3b explicitly refers to this.
Advocating for the use of the Bolar provision and the legalization of parallel imports nationally so more affordable, generic versions of essential medicines can be accessed sooner.
Continuing to use innovative approaches such as buyers clubs.
Blocking the threat that free-trade agreements (FTAs) pose to access to medicines. Civil society will advocate strongly to keep TRIPS Plus language out of any agreements.

While civil society has proved pivotal in this area, action by governments in middle-income countries and global health and development agencies is also critical.

Global health and development agencies must provide technical and political support to MICs and encourage the use of TRIPS flexibilities as part of their efforts to expand access to affordable medicines. This must include specifically funding activities supporting and promoting the use of TRIPS flexibilities at national level including civil society’s work in this area. Given the importance of tackling the HIV, Hep C, TB and other epidemics in middle-income countries, global agencies should consider determining funding and health interventions on a public health-oriented basis instead of relying on income-based classifications.

Governments in middle-income countries must lead efforts to make full use of TRIPS flexibilities, including enshrining them into national law and proactively using them. Governments must work together with civil society against political and legal pressure, and reject any TRIPS-plus measures that may impact access to medicines.

You can read our recommendations for global agencies and governments in more detail in our joint report, with Frontline AIDS, The problem with patents.

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