In November 2001, the World Trade Organisation (WTO) summit in Doha concluded with a number of agreements, including the famous declaration "on public health", which was universally welcomed. This declaration can be summarized by its Article 4, which states: "The TRIPS agreement does not and should not prevent members from taking measures to protect public health."
This declaration has important political and legal implications. For the first time since its creation, the WTO recognizes a hierarchy of values, the primacy of public health over free trade, and more specifically that medicines are not like any other commercial product. Other articles of the Doha Declaration are more explicit in recognizing that States can exploit safety clauses within TRIPS (compulsory licenses and parallel imports).
Compulsory licenses provide an essential balance within the patent system, allowing governments to override a private monopoly when necessary for the public good, for example if the patent holder abuses their dominant position, or in case of public health need (refusal or incapacity of the patent holder to sell their medicine in a country, inaccessible price, and so on). The legitimacy of compulsory licenses is clearly affirmed in the Doha Declaration. This recognition is crucial since, after the full implementation of the TRIPS agreement, the possibility of obtaining quick access to generics will depend on the possibility of issuing compulsory licenses.
Some countries lacking a local industry will not be able to exploit this safeguard, as this mechanism is foreseen by the TRIPS agreement only for a predominantly domestic market. WTO Members recognized this problem at Doha and tasked the TRIPS Council to propose a solution before the end of 2002. The TRIPS Council will meet on 25 June in Geneva.
The TRIPS agreement imposes a policy of intellectual property copied from those of industrialized ones. Until the signing of the WTO agreements, the organisation of patents was based on the Paris Convention, to which adherence was voluntary, and which did not oblige the patenting of all technological domains, nor to provide a minimum period of patent protection. The TRIPS agreement generalizes patents for a minimum of 20 years to all sectors.
Developed countries took their time before adopting patent legislation, often waiting until their industrial ability had reached a certain level. These countries adopted patents in three steps : absence of patents, patents on processes, then patents on products and processes. Through the TRIPS agreement developed countries have succeeded in preventing developing countries from taking this stepwise approach.
The application of the TRIPS Agreement is leading to a reinforcement of the market monopoly and the disappearance of sources of affordable medicines from other countries like Brazil and India. From now on, compulsory licenses and parallel imports represent the only means of escaping from excessive prices.
These safeguards are not a concession made to developing countries, but are part of a panoply of measures used by developed countries. The US and Canadian governments did not hesitate for an instant during the anthrax scare of Autumn 2001 in considering the use of Indian ciprofloxacin (an anthrax antibiotic), even though this drug is patented by Bayer.
Compulsory licenses are precisely described and framed within the TRIPS Agreement. The patent holder is always compensated. As such, we are very far from a situation of intolerable losses to the global pharmaceutical market - for whom sub-Saharan Africa for example represents less than 2% of the global pharmaceutical market.
The possibility of issuing and exploiting compulsory licenses is a fundamental indicator of the balance within a patent system. Currently the TRIPS Agreement benefits least those countries that are least-advantaged. This is both a paradox and a profound injustice.
WTO members took a first step to resolving this problem in Doha. What measures are now taken should be judged on their effectiveness in resolving public health problems, in a just and equitable way, without discrimination between countries.
But the process is unequal. The measures proposed today by industrialized countries are accompained by numerous conditions which render the process too bursdensome for the countries that need them : industrialized countries have only put forward proposals with the greatest reticence, even ill-will. The 'Spirit of Doha' has been completely forgotten, and the political opening that was won half a year ago risks being ruined.
Ellen't Hoen, is the co-ordinator of the Globalisation project within Médecins Sans Frontières Access to Medicines Campaign. Pierre Chirac is a consultant for the campaign.
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