Patents and access to medicines

The patent system

In recent decades, the Western pharmaceutical industry has built its success on the patent system. Most medical breakthroughs are carried out by academics with government funding, while companies bear the costs of expensive clinical trials. Under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – result of a very successful corporate lobbying campaign-, inventors are granted patents for the 10 years with exclusive rights to make and sell the drugs, recovering their costs by charging high prices. Only after the expiry of the patent can generic drug companies launch their chemically identical versions at cheaper prices.

The system has worked reasonably well in the developed world, with national health systems and insurers picking up the price of patented medicines for most patients, allowing drug companies to reinvest the profits in future research. But it has run into difficulties in poor countries, where expectations for treatment clash with modest state support for health. Few individuals are able to pay for their own drugs.


Flexibility and Compulsoty licences

In 2001 the Doha Declaration on the “TRIPS Agreement and Public Health” allowed governments certain “flexibility” to issue compulsory licences for medicines for public health reasons.

If a local government can't afford a pertinent patented drug, it can issue a compulsory license to produce it even before the patent has expired. Compulsory licensing enables the supply for not commercial use of cheaper generic versions of patented medicines without the permission of the patent owner. A country that issues a compulsory license can produce or import it from another country. This is completely legal, and in fact the United States and the EU have used compulsory licenses many times.

Very few developing countries have exercised their rights to compulsory licensing, because of the pressure from the USA and EU under the influence of their pharmaceutical companies. Malaysia was the first country to implement compulsory licensing in 2003 to treat more AIDS patients.

While the big pharma says that the compulsory licensing provision can be invoked only in the case of ‘national emergency’, healthcare NGOs say governments can use this provision liberally in ‘public interest’. The Doha declaration did not mentioned the flexibilities were only for HIV/AIDs medicines.

The pressure that the EU and the US are doing on countries that have decided on Compulsory Licenses (CL) means that the WTO Health agreements signed are worthless.

The last two decades of the 20th century saw a scientific revolution in the development of antiretroviral drugs for Aids. But a lot of pressure was needed to translate these clinical advances into accessible treatment for HIV patients across the developing world. Now the same thing is happening for heart diseases and cancer as the prize of the new medicines are enormous. Eribitux, one of the most expensive cancer drugs ever made, costs $17,000 a month. But the cancer drust is Zevalin, a $24,000-a-month treatment for a relatively rare type of lymphoma.

Some countries (Thailand, Brazil) are taking action to ensure broader access to medicines, by issuing compulsory licenses on the patents so they can get generic drugs. This is the most important access battle on access to medicines that’s going on.


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