Patent protection and the access to essential medicines

by Florian Vogt

Diseases like HIV/AIDS, Malaria or Tuberculosis have reached apocalyptic levels in many developing countries, especially in the sub-Saharan region and millions of infected people in these countries have no access to adequate treatment. This lack of access to essential medicines can be seen as one of the most important factors which contribute to this disastrous situation.

However, assessing the dimension and the horrible effects of the pandemic threats seems easy compared to finding coherent explanations for this development. Many western NGOs and governments of developing countries claim to have identified a simple reason for this disastrous situation: the international system of patent protection comprised by the WTO and its “Treaty on Trade-Related Aspects of Intellectual Property Rights” (TRIPS).

Patent protection is a way to assure that an invention (in this context mostly a newly developed active agent which can be used for the production of drugs) is not commercially used by third parties without permission of the inventor. The protection of intellectual property rights has its roots in the early beginnings of the industrial age when the financial aspects of inventions became more and more important. It is widely recognized that this basic principle of modern law helped to boost innovation, both for companies and private inventors, and is still the main incentive to risk high expenditures for the development of new products. The protection is geographically limited to the state which grants the patent and has a time restriction of 20 years.

Concerning active agents for medicines, the inventing company is not directly allowed to market its invention due to time and money-consuming approval testing. These necessary admission procedures lead to an additional financial burden and reduce the prevailing protection time to 8-12 years. Thus, patents limit the free access to inventions temporally and geographically for third parties. These principles form the basis of mentioned TRIPS-system which has 150 member states today.

This system is relatively unsensational as long as it is about “normal” inventions – and not about medicines which decide upon life and death. As mentioned above, many protagonists blame the TRIPS to also limit the access to essential medicines for the affected poor in developing countries. This assumption brings a special ethical dimension into the discussion because it implies that the existing legal system of patent protection hinders the production, introduction and distribution of cheap drugs in developing countries and thereby is directly responsible for evitable millionfold deaths.

The lack of access to essential medicines is unquestionably an intolerable shame which needs to be eradicated quickly and permanently. Thus, one has to look for the underlying factors of the current situation. Blaming the international treaty system for the suffering of millions of poor people is of course an easy and convenient way to mobilise public protest. But can it really explain the reason for this grievance?

Maybe a short look on some remarkable (but often omitted) facts would help to get a clearer picture: 95% of the medicines which the World Health Organisation (WHO) considers indispensable (“WHO essential drug list”) have never been or are no longer protected by patent rights. In many developing countries, patent protection on a lot of medicines against HIV, Malaria or Tuberculosis does not exist at all: Only 15% of the antiretroviral drugs used in the fight against HIV/AIDS are patent protected in the African states.

In the case of other severe diseases with high prevalence in developing countries, these rates are even lower: 12 of the 13 most effective anti-Malaria drugs are not protected in any African state – with the one resting drug being protected in only 5% of these states. And not even 1% of the medicines used in the therapy of Tuberculosis falls under patent laws in developing countries; for medicines against the sleeping sickness this rate is even under 0,5%.

These figures show that the rate of patent protected medicines for HIV/AIDS, Malaria, Tuberculosis and other malicious diseases with pandemic prevalence in developing countries is indeed very low. Furthermore, the TRIPS-system contains some important features to meet the special needs of developing countries. Together with the “Doha- Declaration on TRIPS and public health” in 2001 and the Amendment of December 2005, developing states obtain a bunch of possibilities to ensure that the access to essential medicines is not restrained by inter national patent laws.

The declaration made clear that the TRIPS-system shall not hinder the member states to protect their public health and that its legal interpretation should not weaken the rights of the states to ensure the access of the population to medicines. The least developed member countries already benefit from long transition periods until 2016. This time-frame can be extended which means that these countries will not have to abide by the patent protection of the TRIPS in the predictable future.

All member states can issue compulsory licences if the owner of a patent refused to offer the medicine on the national market to reasonable prizes. In the case of national emergency compulsory licences can even be granted without prior contact of the owner of the patent. The affected states can define themselves what they consider as an emergency or other matter of exceeding urgency; e.g. the AIDS pandemic which has reached alerting dimensions in certain African countries. These licences not only allow these countries to produce formerly patent protected medicines cheaply for its own market, but also to import them in case the member state does not have its own generics industry.

The figures mentioned above make clear that patent protection cannot be the main reason for the poor access to essential drugs in developing countries. The then listed instruments of the treaty and the Dohadeclaration show that the existing system possesses the necessary flexibility to meet the needs of the developing countries.

The failing supply of the population (better: of certain groups within the population) in a country which is affected by a health crisis is the outcome of a highly complex combination of social, political and economic factors and cannot be reduced to one single “external evil” as many NGOs and also government assert. They come along with the absence of a functioning national health care system, poor infrastructure, war and/or unstable political situations, missing education and prevention, lack of human resources, high custom duties (import taxes make up to 35% of the price of antiretroviral medicines in developing countries!) and of course the general consequences of economic poverty and un development.

The impact of TRIPS on the failing access to essential medicines in developing countries is by far overvalued. On the contrary, patents play a central role in the development of new drugs as it gives security and incentives to invest huge resources in precarious research projects. Without patent protection only a fraction of the existing research activities would take place. On an international level, the TRIPS finds an adequate balance of interests between the need for legal protection and the needs of the developing countries, apart from the fact that the large majority of the relevant medicines do not even fall under its regulation.

Thus, a reduction of the problem to the international legal system undermines an open discussion and consequently constructive solutions to this pressing issue. For this purpose, concerted and long-lasting activities have to be pressed ahead by the international community. In this process patent protection should be considered part of the solution, not part of the problem.