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The impact of trips agreement on access to medicines in developing countries: legal challenges faced by the pharmaceutical industry particularly in India
Kamini Shanmugaiah1.
The impact of intellectual property rights in particular patent
relating to public health has posed numerous challenges faced by
developing countries who are members of World Trade Organisation
(WTO). This paper examines the impact of TRIPS Agreement (Trade
Related Intellectual Property Rights) in relation to developing
countries in general with specifi cation made to India. Signifi cant
changes brought about by the TRIPS fl exibilities in particular usage
of compulsory licensing and Bolar provision have to a certain extent
benefi ted the developing countries in the fi eld of public health during
national emergency. The TRIPS fl exibilities by way of amendment
have helped countries that (do not possess manufacturing
capacities) to import medicines. Some developing countries even
utilised TRIPS fl exibilities in an aggressive manner to enforce their
right to have access to medicines from other countries for the benefi t
of their citizens. Further, TRIPs fl exibilities have helped developing
countries to manufacture generic products to make it affordable to
the people. This paper specifi cally examines the impact of the TRIPS
Agreement on Indian generic pharmaceutical industry and the
legal challenges faced by Indian pharmaceutical industry after the
implementation of product patent regime effective from 1 January
2005. The Patent Amendment Act 2005(India) will be looked into
especially on the controversy in respect of Section 3(d) of the Patent
Amendment Act 2005(India) on the requirement of patentability.
The new Section 92A of the Patent Amendment Act 2005(India)
on the grounds to invoke compulsory licensing will be analysed to
see whether Indian government has applied restrictive or broad
approach, as compulsory licensing is certainly an important legal weapon for India to manufacture affordable generic medicines.
The current challenges faced by India on data exclusivity provision
often described as the TRIPS PLUS standard is impliedly stated in
Article 39.3 of the TRIPS Agreement on undisclosed information.
India needs to achieve legal certainty in complying with the TRIPS
Agreement and also bearing in mind the TRIPS-PLUS standards
before adopting those TRIPS provisions into its patent law legislation
in order to promote innovation and to achieve public health as well
as to serve the interest of the developing countries.
Affiliation:
- Universiti Utara Malaysia, Malaysia
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Indexation |
Indexed by |
MyJurnal (2021) |
H-Index
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1 |
Immediacy Index
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0.000 |
Rank |
0 |
Indexed by |
Scopus 2020 |
Impact Factor
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CiteScore (0.2) |
Rank |
Q4 (Law) Q4 (Sociology and Political Science) |
Additional Information |
SJR (0.164) |
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