[Ip-health] WTO TRIPS Council: South Africa considers strict patentability criteria to address abuses in the pharmaceutical industry

Thiru Balasubramaniam thiru at keionline.org
Thu Feb 7 09:56:37 PST 2019


https://www.keionline.org/29652
--WTO TRIPS Council: South Africa considers strict patentability criteria
to address abuses in the pharmaceutical industry
Posted on February 7, 2019 by Thiru

On 1 February 2019, the World Trade Organization (WTO) published a
submission (IP/C/W/651) by South Africa to the TRIPS Council on
Intellectual Property and the Public Interest: Promoting Public Health
Through Competition Law and Policy. The South African paper endeavors to
kickstart discussions at the TRIPS Council to examine “the linkage between
intellectual property and competition law…with specific reference to
exploitative excessive pricing and restrictive practices such as reverse
payment agreements, strategic patenting and more lately,the evolution of
niche pricing of off-patent pharmaceuticals.”

This paper is a follow up to a joint submission by South Africa, China,
Brazil and India in May 2018 on the ad hoc item, Intellectual Property and
the Public Interest: Promoting Public Health Through Competition Law and
Policy. For a read-out of previous discussions at WTO on intellectual
property and competition, please see Submission of China and South Africa
on Promoting Public Health Through Competition Law and Policy
<https://www.keionline.org/27930> and WTO TRIPS Council: South Africa asks
WTO members to share best practices to address excessive prices
<https://www.keionline.org/29163>. The new paper by South Africa will be
discussed at the next meeting of the TRIPS Council from 13 February 2019 to
14 February 2019.

South Africa highlighted the recent European Commission study, Competition
Enforcement in the Pharmaceutical Sector (2009 – 2017), while noting that
not all jurisdictions prohibited exploitative excessive pricing.

A recent publication of the European Commission entitled “Competition
Enforcement in the Pharmaceutical Sector (2009 –2017)” sheds light on the
efforts of European competition authorities to ensure affordable and
innovative medicine. It should be noted that not all jurisdictions prohibit
exploitative excessive pricing, however excessive pricing models may often
be indicators of underlying competition problems. Unlike the binding
minimum standards of intellectual property protection and enforcement
contained in the TRIPS Agreement, there is no equivalent international
legal instrument for competition law that would provide such minimum
standards of protection.

In terms of advancing the TRIPS Council discussions on intellectual
property and competition law, South Africa proposed the following guiding
questions. South Africa reiterated its commitment to share best practices
in relation to remedying excessive pricing and questioned whether “abusive
practices currently prevalent in the pharmaceutical industry” could be
addressed by “raising the bar of patentability requirements”.

   Guiding Questions 12. The questions are designed to build on previous
   questions circulated in document IP/C/W/643 and IP/C/W/649.Delegations are
   invited to share their experiences ofusing competition law regimes to
   address anti-competitive practices that affect access to medicines and
   medical technologies or to share challenges that they face in the
   enforcement of competition law issues that affect access to medicines or
   medical technologies.
   1.

   When dealing with exploitative excessive pricing in the context of
   anti-trust or competition enforcement in the pharmaceutical and medical
   technology sector, should competition/anti-trust authorities become quasi
   price regulators? What are the practices or guidelines that Members have
   followed to address exploitative excessive pricing in their respective
   markets with specific emphasis on actions undertaken by
   competition/anti-trust authorities?
   2. What examples of best practice can Members identify on the subject of
   the control and remedies for exploitative excessive pricing? Are there
   context-specific methodologies employed by Members for determining if
   prices are excessive, and what mechanisms are used to remedy and control
   pricing abuse?
   3.

   To what extent can abusive practices currently prevalent in the
   pharmaceutical industry be addressed through improving the patent system,
   by for example, raising the bar of patentability requirements or increasing
   registration fees? What have Members’ experiences been with these types of
   measures or other approaches that have been followed?
   4. Have any Members recently conducted market inquiries into the
   pharmaceutical sector to assess its impact on access to medicine or more
   generally the impact of the pharmaceutical sector on competition in
   particular market segments? If so, what were the findings and what remedial
   actions were recommended or taken?
   5.

   To what extent can technical assistance and capacity building contribute
   to the delivery of more effective policies by WTO Members in the field of
   competition law to address the abuse of intellectual property rights? What
   role can international organisations play in this regard, including the WTO?



-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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