A/HRC/11/12
page 11
requires them to update their IP standards, which in turn involves a complex set of reforms to
redraft and update existing laws.32 It also requires considerable increase in the financial and
human resources allocated to IP issues.33
B. TRIPS flexibilities and their implementation
25. TRIPS provides flexibilities that WTO member States can use. Article 1 establishes the
core principle that member States can determine the appropriate method for implementing
TRIPS within their own legal system and practice. Furthermore, the objectives and principles of
TRIPS emphasize the balance of rights and obligations and provide the basis for countries to
utilize the flexibilities and adopt IP protection at the national level to meet their social and
developmental needs. Article 8 specifically provides that member States may, in formulating or
amending their laws and regulations, adopt measures necessary to protect public health. The
Declaration on the TRIPS agreement and public health (Doha Declaration) adopted by the WTO
Ministerial Conference in 2001 recognized concerns over the effect of IP on medicine prices and
reaffirmed the right of member States to use TRIPS flexibilities to achieve public health needs
and promote access to medicines for all.
26. Countries have varied in the extent to which they have implemented TRIPS flexibilities.
While some countries lack sufficient awareness about the full use of flexibilities and have
limited technical capacity to implement them, others have not sufficiently streamlined their
patent laws to facilitate use. Furthermore, pressure from developed countries has played a
prominent role in shaping the implementation of TRIPS flexibilities in developing countries and
LDCs.
27. From a right to health perspective, developing countries and LDCs should be enabled to
use TRIPS flexibilities. More particularly, their national laws should incorporate the flexibility
to:
(a)
Make full use of the transition periods;
(b)
Define the criteria of patentability;
(c)
Issue compulsory licences and provide for government use;
(d)
Adopt the international exhaustion principle, to facilitate parallel importation;
(e)
Create limited exceptions to patent rights;
(f)
Allow for opposition and revocation procedures.
In addition, countries need to have strong pro-competitive measures to limit abuse of the patent
system.
32
Ibid., p. 11.
33
Ibid.
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