Access to medicines and intellectual property

1
Access to medicines and intellectual property

• Sanya Reid Smith
• Third World Network
• 11 April 2007
• Regional High Level Consultation on HIV and the
  Law
  
• Auckland

2
Overview

• Introduction
• Supranational obligations
• World Trade Organization (WTO) and its
  flexibilities
  
• Other relevant multilateral intellectual property
  treaties (Paris Convention, Patent Cooperation
  Treaty)
  
• Free Trade Agreements (FTAs)
• Bilateral Investment Treaties (BITs)
• Re-registration of patents

3
Introduction
4
Doctors without Borders, Untangling the Web of
Price Reductions
5
World Trade Organization (WTO)
6
WTO status
7
WTO Members

• Non-LDC WTO Members (Fiji, Papua New Guinea)
• Full Agreement on Trade-Related Aspects of
  Intellectual Property Rights (TRIPS)
  implementation required
  
• So must allow 20 years of patents on medicines,
  but can use TRIPS flexibilities to minimise the
  impact on affordability of medicines. Eg
  
• Avoid giving patents on new uses of existing
  medicines
  
• Set patentability criteria high to avoid allowing
  patents on variants of medicines
  
• Exceptions to patents, including Bolar working
• Compulsory licences/government use orders
• Government can allow someone other than the
  patent owner to make and/or import and sell the
  patented medicine for any reason, subject to the
  procedural conditions set out in TRIPS
• Some best practice examples a compulsory licence
  can be granted for any medicine to treat HIV/AIDS
  or its related conditions (Zimbabwe), at a
  royalty of 0.5 (Indonesia and Thailand) and the
  compulsory licence lasts until the patent ends
  (Indonesia)
• Parallel importation

8
WTO Members continued

• LDC WTO Members (Solomon Islands)
• Do not have to implement patents on medicines
  until 2016
  

9
Non-WTO Members

• Non-WTO Members Cook Islands, Federated States
  of Micronesia, Kiribati, Marshall Islands, Nauru,
  Niue, Palau, Tokelau, Tuvalu
  
• Countries in the process of joining the WTO
  Samoa, Tonga, Vanuatu
  
• Non-WTO Members are not required
• to have patents at all
• to have patents on medicines
• (subject to other treaties, see below)
• During WTO accession may be asked to agree to
  stronger intellectual property protection than
  TRIPS requires

10
Non-WTO Members continued

• If you have a patent law, you can repeal it
• You may have to still recognise existing patents
  until they finish depending on your own laws and
  other international treaties you have signed
  
• If you have a patent law and you want to keep it,
  you can make it more health oriented, eg
  
• No patents on medicines, or
• No patents on essential medicines, or
• Patents on medicines are only available for a
  short period and/or
  
• Allow instant automatic/easy cheap compulsory
  licences for medicines etc
  
• Although if you join the PC/PCT/PLT you will have
  some restrictions
  

11
Paris Convention (PC) Members

• PNG and Tonga are the only participants currently
  PC Members
  
• PC obligations re patents
• Incomplete protection, eg does NOT require
• Patents to be available for medicines
• Patents to last for 20 years
• Compulsory licensing procedural requirements in
  TRIPS
  
• PC is not very enforceable
• Can withdraw from PC 1 year after giving notice
• TRIPS incorporates most of PC and makes it more
  enforceable (as well as adding more protection
  for intellectual property rights)

12
Patent Cooperation Treaty (PCT) Members

• PNG is the only participant that is a PCT Member
• Basically makes it easier to patent in multiple
  countries
  
• WIPO data all countries but one who joined had
  increase in patent applications
  
• If grant at same rate, then more medicines will
  be patented
  
• Can withdraw from PCT 6 months after giving
  notice
  

13
Bilateral investment treaties (BITs)

• BITs have been signed with a number of Pacific
  countries. Some bilateral investment treaties are
  listed at
  
• http//www.unctadxi.org/templates/DocSearch____779
  .aspx
  
• www.paclii.org
• BITs may mean use of public health safeguards (eg
  those in TRIPS) could be expropriation and so
  require compensation because they usually have
  
• A broad definition of investment that includes
  intellectual property such as patents or the data
  used to give marketing approval to a medicine
  
• An expropriation provision without exceptions
• BITs usually allows the investor from the other
  country to sue the host government directly in an
  international tribunal
  
• BITs are NOT enforceable via trade sanctions

14
Free trade agreements (FTAs)

• North-South FTAs are more likely to
• Prohibit use of public health safeguards (eg via
  intellectual property chapter)
  
• Penalise use of public health safeguards (eg via
  investment chapter)
  
• Allow governments to sue each other at an
  international tribunal
  
• Allow tariffs to be put on the exports of the
  losing government
  
• Allow investors from the other FTA country to sue
  the host government at an international tribunal

15
Re-registration

• Non-WTO Members do not have to allow patents on
  medicines
  
• LDC WTO Members do not have to allow patents on
  medicines (yet)
  
• Some of these countries which do not have to
  allow patents on medicines may be doing so
  because
  
• Their law allows it
• They re-register patents granted elsewhere
  (including on medicines), eg Kiribati, Nauru,
  Samoa, Solomon Islands, Tuvalu, Vanuatu
  
• TRIPS does not require re-registration, so even
  WTO Members (eg Fiji) are not required to do it

16
Summary
17

• Thank you
• For more information and materials please do not
  hesitate to contact me at sanya_at_myjaring.net