Intellectual Property and the 90-90-90 Crisis

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AO Blog 22.09.14 shutterstock_152365001The 20th International AIDS Conference (AIDS2014) held in Melbourne this year called for countries to work together towards the latest target of “90-90-90” including the reach of antiretroviral therapy to 20 million people by 2020.

Therefore, it was not surprising that AIDS2014 thrust the spotlight on intellectual property and its ability to thwart the new global targets.

In the Jonathan Mann memorial lecture, the Hon. Michael Kirby commented:

“Without changing the global laws on intellectual property, people will die needlessly. It is as simple as that. Someone must tell those who will not act- the practical facts of life in our world. They cannot expect taxpayers in other countries to shell out, indefinitely, huge funds for antiretroviral drugs if they simply refuse to reform their own laws and policies to help their own citizens”

Addressing the practical inability of current intellectual property regimes to ensure medicines reach those in need is crucial to living in a 90-90-90 world.

What is ‘intellectual property’ and how does it relate to ARV access?

Intellectual Property: property rights attached to creations of the mind which include works such as inventions, literary and creative works, designs and symbols, names and images used in commerce. Countries control their particular intellectual property scheme.

Commerce: Exchange of goods and services.

Patent: A patent is a right that is granted for any device, substance, method or process that is new, inventive and useful. A holder of a patent means they hold a legally enforceable exclusive right to commercially exploit the invention for the duration of the patent.

Generic medicines/drugs: Often referred to as copied medicine. This is where medicine is produced and copied of brand-name drugs that exactly have the same bio-equivalence.  A generic medicine can only be legally produced if it is not under a patent or the patent period has expired.

Intellectual property rights (the right to patent a pharmaceutical, for example) have been criticised for creating medical monopolies which in turn, simply make pharmaceuticals unaffordable for many people in low and middle-income countries.

Intellectual property allows the protection of a new substance from being copied or used for a certain time. Just like in any other commercial dealing, the inventor sets the price to sell the product.

But what about creators of essential medicines such as antiretrovirals?

And what about developing countries that do not have the economic means to purchase and subsidise expensive patented medicines?

Many people in low and middle-income countries cannot afford or cannot access essential patented ARV’s due to the exorbitant cost stemming from intellectual property rights of patent holders.

The intellectual property scheme attempts to strike a balance between the right of innovators to protect and exploit their creation and the right to adequate and affordable healthcare.

Striking the right balance is critical to achieving the 90-90-90 goals. Strict and inflexible patent protection threatens the development of international trade in generic medicines. International agreements have attempted to help regulate strict patent policy. Agreements such as the TRIPS Agreement 1994, Doha Declaration 2001, and the WTO General Council Decision 2003 attempted to clarify the position and foster access to essential medicines. The TRIPS agreement (and later affirmed in the  Doha Declaration) allowed for countries to have flexibilities in patent protection including mechanisms such as policy options and safeguards to provide access to essential medicines in developing or least developed countries.  In practice, countries could still protect patents but also provide opportunity for low and middle income countries to expand access to low cost essential pharmaceuticals. However, in practice these flexibilities (or rights balancing) are not taken up for a variety of reasons and pressures.

Will Australia lead the way?

As one can imagine, intellectual property is a technical area of law with a whole range of competing rights and issues. It is complex, technical and seems foreign. In a developed country with (for the most part) an accessible public health system, lack of access to ARV’s or the inability for our country to acquire them seems like a problem oceans away.  In reality; it isn’t oceans away-one can just look to our Medicare ineligible population who do not have access to subsidised ARVs.

Within the mess of intellectual property Australia does seem willing to at the very least, to make sure we are compliant with our international declarations (Doha, TRIPS, WTO).

In the AIDS2014 Legacy Statement all Australian Health Ministers committed to continue to demonstrate global leadership in the response of HIV. Whether a coincidence or not, the government has introduced the Intellectual Property Laws Amendment Bill  which aims to make it easier for Australian businesses to provide assistance to countries that are unable to obtain essential medicines from other countries.  If this bill passes, it will send a clear message. In saying this, two questions arise:

And what about those who are not Medicare eligible?

Will other countries that have a stronger pharmaceutical manufacturing base follow suit and amend their intellectual property laws, too?

Unless these two questions are examined and appropriate actions undertaken, the only role intellectual property will have in the 90-90-90 goal is ensuring these ambitious targets are not met.