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PRIVATE PATENTS AND PUBLIC HEALTH

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ead in the light of the object and purpose of the Agreement as<br />

expressed, in particular, in its objectives and principles.<br />

b) Each Member has the right to grant compulsory licences and the<br />

freedom to determine the grounds upon which such licences are<br />

granted.<br />

c) Each Member has the right to determine what constitutes a<br />

national emergency or other circumstances of extreme urgency, it<br />

being understood that public health crises, including those relating to<br />

HIV/AIDS, tuberculosis, malaria and other epidemics, can represent<br />

a national emergency or other circumstances of extreme urgency.<br />

d) The effect of the provisions in the TRIPS Agreement that are<br />

relevant to the exhaustion of intellectual property rights is to leave<br />

each Member free to establish its own regime for such exhaustion<br />

without challenge, subject to the MFN [most favoured nation] and<br />

national treatment provisions of Articles 3 and 4.”<br />

The use of the term “include” in the first sentence of this paragraph<br />

makes it clear that the flexibilities in implementing TRIPS are not limited<br />

to those listed in the Doha Declaration. Paragraphs 4 and 5(b) identify<br />

compulsory licensing as a key measure for developing countries to limit<br />

the exclusive rights of patent holders and to identify alternate sources of<br />

medicines, whether through local production or importation. It<br />

strengthens countries’ rights to use compulsory licensing and is<br />

unambiguously clear on the fact that there are no limitations as to the<br />

grounds for issuing compulsory licences. Paragraph 5(c) reiterates<br />

countries’ freedom to determine what is a national emergency or<br />

circumstance of extreme urgency. This clause is important because TRIPS<br />

waives certain procedural requirements, such as prior negotiation with<br />

the patent-holder, if a compulsory licence is issued in a situation of<br />

emergency or urgency. It does not mean that a compulsory licence can<br />

only be applied in cases of emergency or urgency. This is a common<br />

misunderstanding regarding TRIPS.<br />

Paragraph 5(d) resolves once and for all the question of whether TRIPS<br />

authorises parallel trade by noting that TRIPS leaves “each Member free<br />

to establish its own regime for such exhaustion without challenge.”<br />

Parallel importation refers to the import and resale in a country,<br />

without the consent of the patent holder, of a patented product that has<br />

been legitimately put on the market of the exporting country. The sale of<br />

the patented medicine is deemed to “exhaust” the patent holder’s rights.<br />

2<br />

TURNING THE TIDE: THE WTO DOHA DECLARATION ON TRIPS & <strong>PUBLIC</strong> <strong>HEALTH</strong><br />

34

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