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PRIVATE PATENTS AND PUBLIC HEALTH

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promote the public interest in sectors of vital importance to their socioeconomic<br />

and technological development, provided that such measures<br />

are consistent with the provisions of this Agreement.”<br />

Developing countries also obtained transition periods for the<br />

implementation of the TRIPS Agreement to allow them to reach a certain<br />

level of economic development before being bound to the norms of<br />

TRIPS. Today only the WTO’s least-developed country (LDC) members<br />

continue to enjoy such transition periods.<br />

The 2001 Doha Declaration strengthens the notion even further that<br />

the TRIPS Agreement should serve a greater public good. It further<br />

expands the freedom countries have to implement TRIPS in a manner<br />

that takes into account specific needs with regard to health and access to<br />

medicines.<br />

The TRIPS Agreement sometimes specifically mentions the term<br />

‘flexibility’, for example in Paragraph 6 of the preamble, which says “[…]<br />

the special needs of the least-developed country Members in respect of<br />

maximum flexibility in the domestic implementation of laws and<br />

regulations in order to enable them to create a sound and viable<br />

technological base.”<br />

But all of these clauses do not take away from the fact that the TRIPS<br />

Agreement obliges countries to give up much of the diversity and<br />

flexibility in IP law and practices that existed beforehand. ‘Flexibilities’ is<br />

a term used to refer to the remaining room to manoeuvre when<br />

implementing the TRIPS Agreement.<br />

The term flexibilities gained greater meaning in the context of the<br />

TRIPS and public health discussions that commenced in the early 2000s<br />

and has since then come to refer to policy space available in IP law to<br />

protect public health.<br />

The World Intellectual Property Organization (WIPO) secretariat has<br />

identified the following flexibilities in the context of public health:<br />

• Compulsory licences and government use;<br />

• Exhaustion of rights (parallel importation);<br />

• Research exemption; and<br />

• Regulatory review exception (Bolar-type exception; that is, an<br />

exception to facilitate regulatory approval of generic medicines by<br />

allowing use of patented material before the end of the patent term).<br />

4<br />

CLOSING THE POLICY SPACE: TRADE AGREEMENTS <strong>AND</strong> TRIPS-PLUS MEASURES<br />

TRIPS leaves, however, larger policy space than the areas listed above,<br />

and allows for a degree of differentiation in the implementation of its<br />

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