“Using Competition Law to Promote
Access to Health Technologies”
Access to Innovation: Making Generic Versions of
Newer ARVs Affordable
24 July 2014
Melbourne, Australia
Mandeep Dhaliwal, Tenu Avafia & Catherine Kirk
HIV, Health and Development Group, UNDP
Global Commission on HIV and the Law
• Broad range of issues on HIV and
law
• Bad laws & practices hinder
effective AIDS responses e.g.
TRIPS plus, anti-counterfeiting law
• Good laws exist and must be
replicated
• 6 key recommendations on IP and
treatment access
• 6.3.4 Countries must proactively
use other areas of law and policy
such as competition law, price
control policy and procurement
law which can help increase
access to pharmaceutical
products
UNDP guide on competition law
• Covers
– Competition law under
international law
– Anticompetitive behaviors and
remedies
– Market dominance and market
definition
– Challenges facing developing
countries
• Includes
– Model provisions principles for
inclusion in national legislation
being developed
– Country case study examples
Sample of anti-competitive practices
in the pharmaceutical sector
• Patent thickets to extend
monopolies (1300 patents
and applications in EU for
individual medicine)
• Excessive or spurious
litigation at the Patent
Office or Health Agency
• Restrictive licensing
practices
– Exclusive grant-back
clauses in licensing
agreements
– Pay for delay
• Abuse of dominance
– Excessive/predatory pricing
– Denying a competitor access
to an essential facility
– Exclusionary act
• Market collusion
– Carving up markets
– Price fixing
• Merging/acquiring generic
competitors in large MICs
India, Brazil, Egypt others
Advantages and challenges of using
competition law to increase treatment
Advantages
• Less multilateral regulation
with competition policy
• More flexibility in TRIPS than
patent laws
• Broader range of interested
parties can use competition
law
– Civil society/Patient groups
– NGOs
– Generic companies
Requirements/challenges
• Under-utilized flexibility,
insufficient information on
using competition law
• Can require complex enabling
legislation and regulations
• Capacity constraints at
competition authorities
• National level policy
coherence
• Developing countries more
susceptible to market
concentration
Using competition law to increase treatment in
South Africa
• Section 49 of the Competition Act of South Africa’s allows
“any person” to submit a complaint to commission
• People living with HIV lodged a complaint against GSK and BI
for excessive pricing of select ARVs, leading to the premature
deaths
– Hazel Tau and Others v GlaxoSmithKline and Boehringer Ingelheim
• Competition Commission found anticompetitive behaviour
present. On grounds:
– excessive pricing, and
– denying competitor access to an essential facility
• Out of court settlements with the companies resulted in
reduced royalties (from 30 % to 5%)
More examples from South Africa
• 2005: Competition law was again used by TAC
against BMS differential pricing on Fungizone.
– Result: 90 per cent price reduction
• 2007: Complaint by TAC and AIDS Law Project
of excessive pricing on Efavirenz
– Eventually, granted royalty-free licenses for
efavirenz to 6 South African generic
manufacturers.
Conclusion
• Access to health technologies is a fundamental human
right.
• Competition remains underutilized public health TRIPS
flexibility
• Cut and paste model from developed to developing
countries not recommended
• Policy coherence is essential between competition,
patent, drug regulatory, procurement officials to build
stronger competition frameworks.
• Competition law should form part of the toolkit used by
countries in developing sustainable treatment policy
responses.
THANK YOU
Mandeep Dhaliwal
United Nations Development Programme
[email protected]