[Ip-health] 8 November 2016 - TRIPS Council - India's intervention on the Paragraph 6 Mechanism

Thiru Balasubramaniam thiru at keionline.org
Mon Nov 14 03:51:40 PST 2016


Submitted by thiru on 14. November 2016 - 13:43

On 8 November 2016, India delivered the following statement on Review under
Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the
Doha Declaration on the TRIPS Agreement and Public Health.

India’s Interventions at the TRIPS Council meeting (08-09 November 2016)

Agenda Item 7: Review under Paragraph 8 of the Decision on the
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health

Mr.Chairman, India attaches high importance to the Doha Declaration on
Public Health, the Paragraph 6 System as established under the 2003 waiver
decision and the 2005 Protocol Amending the TRIPS Agreement. India had
notified its acceptance of the Protocol in March 2007. We would like to
congratulate Papua New Guinea, Peru and Belize who have deposited their
instrument of acceptance of the Protocol since the last TRIPS Council
meeting held in June 2016. So far, over 64 per cent of WTO members have
submitted their instruments of acceptance for the TRIPS protocol and 5 more
members have to submit their instruments of acceptance for entry into force
of the 2005 Protocol Amending the TRIPS Agreement.

Mr.Chairman, we have always been of the view that the Doha Declaration on
TRIPS and Public Health constituted a major landmark in the short history
of the WTO because it recognized the primacy of public health needs and the
preparedness of the Organization to take up the problems faced by the poor
in developing countries. Along with several other Members, India had worked
relentlessly on the Doha Declaration and the Decision. The Decision
established a framework for special compulsory licences, which is an
additional flexibility aimed at enabling exports of medicines to WTO
members with insufficient or no manufacturing capacities in the
pharmaceutical sector. However, the export of HIV/AIDS medicines by the
Canadian pharmaceutical company Apotex to Rwanda in September 2008 had been
the first and only use of the system so far.

Mr.Chairman, the experts at the side-event held during lunch time today has
broadened our understanding on the various aspects of the Paragraph 6
System, especially on the implementation of the Paragraph 6 System so far,
the challenges and opportunities involved as well as ways of improving the
system to make it effective and meaningful.

Ms. Yuanqiong Hu, Medicines Sans Frontiers mentioned they were the
organisation who imported ARV medicines for AIDS/HIV treatment in Rwanda
from Canada under paragraph six mechanism. The process took upto three
years due to time taken by the Apotex company in Canada to get regulatory
approval, time taken to negotiate with originator companies etc. They could
supply ARV medicines available from Indian generic companies before they
could get the supplies from Apotex company.

The Canadian Representative said that Canadian Access to Medicines Regime
(CAMR) is the first to implement the paragraph six system waiver and
allowed Apotex, a generic manufacturer to supply medicines. The company has
made loses from the order as it supplied at a cost of 39 US cents per pill
and informed that they will not venture into supplying of medicines under
para six mechanism waiver in the future.

Mr. Denis Broun, representative of CIPLA company, a generic producer said
that so much red-tape was built into the paragraph six system for it to
fail. He mentioned they will never come forward to manufacture under the
special compulsory license as they cannot achieve operations of scale,
requirements of special labelling and markings, creation of a special
website, remuneration to patent holder etc. They urged for more simpler and
faster procedures.

Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate
Institute of International and Development Studies said that Para six
system is not a good system and should be renegotiated before it enters
into force as the System is not workable in the current form. She said that
patenting in exporting countries like India is on the rise as it is
implementing the patent system, and the need for workable para six system
has risen.

Based on the experts opinion at the side-event held today, we reiterate our
concern that the Paragraph 6 System is too complex, cumbersome and
administratively unwieldy for further use. I conclude by quoting the
recommendation on the special compulsory license by the UNSG HLP on Access
to medicines in its report release in September this year. The
recommendation was also endorsed by many experts at the side-event held
today afternoon. Recognizing the Para 6 system as complex and cumbersome,
the UNSG High Level Panel on Access to Medicines has recommended that “WTO
Members should revise the paragraph 6 decision in order to find a solution
that enables a swift and expedient export of pharmaceutical products
produced under compulsory license. WTO Members should, as necessary, adopt
a waiver and permanent revision of the TRIPS Agreement to enable this

Thank you Chair.

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