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crucial HIV medicines.49 Brazil adopts an additional mechanism to ensure higher scrutiny, where
prior consent of the National Sanitary Supervision Agency (ANVISA) is required before a patent
application relating to medicine is reviewed by the patent office.50
51. Traditionally, opposition proceedings were limited to competitors and governments.
Lately, they have been broadened to include interested persons such as civil society
organizations and patients’ groups. This is particularly important when generic companies may
not have an interest in opposing a patent on a medicine of public importance.
52. Ensuring higher scrutiny of patent applications before a patent is granted and of patents
that have been granted can be a useful tool to limit the impact of patents on medicines.
7. Pro-competitive measures
53. Article 40 of TRIPS specifically recognizes the adverse effects of licensing conditions or
practices relating to intellectual property rights (IPRs). It therefore allows member States to
identify in their national laws licensing conditions or practices which may constitute an abuse of
IPRs and have an adverse effect on competition. The South Africa Competition Commission for
example, has held that the practice of a pharmaceutical company in not granting licences to
generic companies amounts to an abuse of dominant position.51 As such, note should be taken of
reports of competition authorities of developed countries detailing anti-competitive practices in
the pharmaceutical sector.52
54. The use of anti-competition law can be an important tool to promote access to medicines.
TRIPS article 31 for example allows a relaxation of certain restrictions, such as prior negotiation
with patentees and predominantly domestic use, relating to compulsory licences which may be
useful to remedy anti-competitive practices.
55. While this report does not specifically further explore use of anti-competition laws, there is
a need for countries to adopt and effectively apply pro-competitive measures allowed under
TRIPS to prevent or remedy anti-competitive practices having a bearing on the use of patented
medicines.
49
N. Ford and others, “The role of civil society in protecting public health over commercial
interests: lessons from Thailand” The Lancet, vol. 363, No. 9408 (February 2004), p. 560.
50
Brazil, Law No. 10.196 of February 2001.
51
South Africa Competition Commission media release No. 30, 2003.
52
See, for instance, European Union (EU) Directorate-General for Competition, Pharmaceutical
Sector Inquiry - Preliminary Report, 28 November 2008.
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