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Ten Years of the Doha Declaration The State of Implementation

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					Ten Years of the Doha
Declaration: The State of
Implementation
Geneva
14 November 2011

                            1
Declaration on the TRIPS Agreement
and Public Health, WT/MIN(01)/DEC/2
 ‘4. We agree that the TRIPS Agreement does not and should not
 prevent Members from taking measures to protect public
 health. Accordingly, while reiterating our commitment to the
 TRIPS Agreement, we affirm that the Agreement can and should
 be interpreted and implemented in a manner supportive of
 WTO Members' right to protect public health and, in particular,
 to promote access to medicines for all.
  In this connection, we reaffirm the right of WTO Members to
 use, to the full, the provisions in the TRIPS Agreement, which
 provide flexibility for this purpose.’


                                                                   2
WIPO Conventions
• TRIPS flexibility: not to comply with WIPO Conventions beyond
  those required by TRIPS
• Some WTO accessions (including by LDCs) require the joining of
  additional WIPO Conventions including unspecified/all WIPO
  Conventions in Vanuatu’s accession,
 http://www.keepandshare.com/doc/2914152/wtoaccpac-pdf-june-27-2011-
 4-42-pm-4-6-meg?da=y.
• Some developed country FTAs eg EFTA (eg with Egypt), EU (eg
  leaked proposal to ASEAN), USFTAs require the joining
  of/complying with TRIPS+ Conventions including the PCT



                                                                       3
Patentability standards
• TRIPS flexibility: defining patentability standards within Art 27
  TRIPS
  • Eg India’s s3(d) not inventions: ‘the mere discovery of a new form of
    a known substance which does not result in the enhancement of the
    known efficacy of that substance or the mere discovery of any new
    property or new use for a known substance or of the mere use of a
    known process, machine or apparatus unless such known process
    results in a new product or employs at least one new reactant;’
     http://ipindia.nic.in/ipr/patent/manual/HTML%20AND%20PDF/Manual%20o
     f%20Patent%20Office%20Practice%20and%20Procedure%20-
     %20html/Act/Section%203.htm
• US proposed text in TPPA: ‘the Parties confirm that: patents shall be
  available for any new forms, uses, or methods of using a known
  product; and a new form, use, or method of using a known product may
  satisfy the criteria for patentability, even if such invention does not
  result in the enhancement of the known efficacy of that product.’                4
  http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf
Patents on new uses
• TRIPS flexibility: not to have patents on new uses
• Some developed country FTAs eg EFTA (eg Korea), USFTAs (eg
  Morocco, US proposal in TPPA) require patents on new uses
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs should establish high patentability
  standards and provide for exclusions from patentability, such
  as new forms and new or second uses, and combinations, in
  order to address evergreening and facilitate generic entry of
  medicines.’
 http://www2.ohchr.org/english/bodies/hrcouncil/docs/11session/A.HRC.11.
 12_en.pdf

                                                                           5
Patents on diagnostic, surgical
and therapeutic methods
• TRIPS flexibility: Art 27.3(a): can exclude from patentability:
  diagnostic, therapeutic and surgical methods for the
  treatment of humans or animals
• Some developed country FTAs eg USFTAs (eg US proposal in
  TPPA) require patents to be available for diagnostic,
  therapeutic, and surgical methods for the treatment of
  humans or animals.




                                                                    6
Pre-grant patent opposition
• TRIPS flexibility: pre-grant patent opposition is allowed
• Some developed country FTAs eg USFTAs (eg Bahrain,
  Morocco, US proposal in TPPA) prohibit pre-grant patent
  opposition
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs should establish liberal pre-grant, post-
  grant opposition and revocation procedures, which can be
  taken advantage of by all concerned stakeholders, including
  patients’ groups.’




                                                                 7
Patent term extensions
• TRIPS flexibility: Art 33: 20 year patent terms are sufficient
• Some developed country FTAs eg EFTA (eg Chile, Korea), EU
  (eg proposal to ASEAN, India), US (eg CAFTA, US proposal in
  TPP) require patent term extensions beyond 20 years
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs should not introduce TRIPS-plus standards
  in their national laws. Developed countries should not
  encourage developing countries and LDCs to enter into TRIPS-
  plus FTAs’



                                                                   8
Compulsory licences
• TRIPS flexibility: compulsory licence grounds are not limited
  • Reaffirmed in Doha Declaration on TRIPS and Public Health 5(b):
    ‘Each Member has the right to grant compulsory licences and the
    freedom to determine the grounds upon which such licences are
    granted’
• Some FTAs such as US-Singapore restrict the situations in
  which compulsory licences can be used
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs need to incorporate in their national
  patent laws all possible grounds upon which compulsory
  licences, including government use, may be issued.’

                                                                      9
Parallel importation
• TRIPS flexibility: Art 6: parallel importation is permitted
  • Reaffirmed in Doha Declaration on TRIPS and Public Health 5(d):
    ‘The effect of the provisions in the TRIPS Agreement that are
    relevant to the exhaustion of intellectual property rights is to
    leave each Member free to establish its own regime for such
    exhaustion without challenge, subject to the MFN and national
    treatment provisions of Articles 3 and 4.’
• Some FTAs such as US-Morocco prevent parallel importation
• UN Special Rapporteur on the Right to Health ‘Developing
  countries and LDCs should adopt the principle of international
  exhaustion and provide for parallel importation with simplified
  procedures in their national laws.’
                                                                       10
Data protection
• TRIPS flexibility: Art 39.3: ‘Members, when requiring, as a
  condition of approving the marketing of pharmaceutical or of
  agricultural chemical products which utilize new chemical
  entities, the submission of undisclosed test or other data, the
  origination of which involves a considerable effort, shall protect
  such data against unfair commercial use.’
• Some WTO accessions (eg Cambodia, Vanuatu in transition
  period), USFTAs (eg CAFTA), EFTA FTAs (eg Lebanon, Tunisia)
  and EU FTAs (eg proposals to ASEAN and India) require data
  exclusivity
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs should not introduce TRIPS-plus standards
  in their national laws. Developed countries should not
                                                                       11
  encourage developing countries and LDCs to enter into TRIPS-
  plus FTAs’
Linkage
• TRIPS flexibility: no requirement to provide linkage
• Some WTO accessions (eg Cambodia, Vanuatu during
  transition period) and FTAs eg US-CAFTA require linkage
• UN Special Rapporteur on the Right to Health: ‘Developing
  countries and LDCs should not introduce TRIPS-plus standards
  in their national laws. Developed countries should not
  encourage developing countries and LDCs to enter into TRIPS-
  plus FTAs’




                                                                 12
Enforcement eg border
measures
• TRIPS flexibility: Art 51 only requires WTO Members to allow
  for suspension into free circulation when suspect importation
  of counterfeit trademark or pirated copyright goods
• Some FTAs eg EU proposals to ASEAN and India require
  suspension when suspect import, export, free warehouse of
  infringing patents (and other IP), EU-CARIFORUM EPA agree to
  collaborate to expand this to patents




                                                                  13
Transition periods
• TRIPS flexibility: Art 66.1 LDC transition period: ‘The Council for
  TRIPS shall, upon duly motivated request by a least-developed
  country Member, accord extensions of this period.’
  • Doha Declaration on TRIPS and Public Health 7: ‘We also agree that
    the least-developed country Members will not be obliged, with
    respect to pharmaceutical products, to implement or apply
    Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce
    rights provided for under these Sections until 1 January 2016,
    without prejudice to the right of least-developed country Members
    to seek other extensions of the transition periods as provided for in
    Article 66.1 of the TRIPS Agreement.’
• Vanuatu’s WTO accession: ‘Vanuatu confirmed that it would
  apply the Agreement on Trade-Related Intellectual Property
  Rights by no later than 1 December 2012‘
                                                                            14
• UN Special Rapporteur on the Right to Health ‘LDCs should
  make full use of the transition period’
UNAIDS, UNDP, WHO: 2011
• ‘UNAIDS, UNDP and WHO urge countries, where
  appropriate, to use the intellectual property and trade
  flexibilities set out in the World Trade Organization
  Agreement on Trade-Related Aspects of Intellectual Property
  Rights (TRIPS), and the Doha Declaration on the TRIPS
  agreement and public health, in order to reduce the price of
  HIV medicines and expand access to people most in need.’
‘proposed bilateral and regional free trade agreements could
  limit the ability of developing countries to use the TRIPS
  flexibilities. Governments in both developed and developing
  countries should ensure that any free trade agreements
  comply with the Principles of the Doha Declaration.’
   http://www.unaids.org/en/media/unaids/contentassets/documents/p
    ressrelease/2011/20110315_PR_TRIPS_en.pdf
WHO’s Commission on Intellectual Property
Rights, Innovation and Public Health:
some relevant recommendations
• In bilateral trade negotiations, it is important that the provisions in the
  texts respect the principles of the Doha Declaration.
• Bilateral trade agreements should not seek to incorporate TRIPS-plus
  protection in ways that may reduce access to medicines in developing
  countries.
• Re data exclusivity: A public health justification should be required for




                                                                                16
  data protection rules going beyond what is required by the TRIPS
  agreement.
• The Doha Declaration clarifies the right of governments to use
  compulsory licensing as a means of resolving tensions that may arise
  between public health and intellectual property, and to determine the
  grounds for using it. Developing countries should provide in their
  legislation for the use of compulsory licensing provisions, consistent with
  the TRIPS agreement, as one means to facilitate access to cheaper
  medicines through import or local production.

‘Public health Innovation and Intellectual Property Rights, April 2006
Recommendations from the UN Special
Rapporteur on the Right to Health (Grover)
‘States need to take steps to facilitate the use of TRIPS
 flexibilities.’
‘TRIPS and FTAs have had an adverse impact on prices and
 availability of medicines, making it difficult for countries to
 comply with their obligations to respect, protect, and fulfil
 the right to health.’
World Health Assembly resolutions

• Urged Member States to take into account in bilateral trade
  agreements the flexibilities contained in the Agreement on
  Trade-related Aspects of Intellectual Property Rights and
  recognized by the Declaration on the TRIPS Agreement and




                                                                   18
  Public Health adopted by the WTO Ministerial Conference
  (Doha, 2001);
       WHA Resolution 57.14
• Urged Member States to consider, whenever necessary,
  adapting ‘national legislation in order to use to the full the
  flexibilities contained in the Agreement on Trade-Related
  Aspects of Intellectual Property Rights (TRIPS)’
     WHA Resolution 56.27
Thank you



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