Title: WIPO National Workshop on Intellectual Property for Diplomats Sana
1WIPO National Workshop onIntellectual Property
for DiplomatsSanaa, Republic of Yemen20-21
March 2007
- The TRIPS Agreement
- and Public Health
- Roger Kampf
- WTO Secretariat
2- I.
- Overview
- Relevant TRIPS Provisions
- Transition Periods
3TRIPS Provisions ofDirect Relevance to Public
Health
- TRIPS Objectives and Principles
- Patents (incl. compulsory licences)
- Exhaustion
- Protection of Undisclosed Information
- Competition
- Measures against Counterfeiting
- Transition periods
4 Patent Table
- Art.27.1 Patentable Subject-Matter
- ? ? Exclusions Art.27.2 3
- Art.29 Patent Application
- ?
- Art.28 Rights conferred ? Exceptions /
- Limitations Art. 30 31
- ?
- Art.33 20 Years of Protection
5Article 30 Exceptions
- Exceptions may be provided if they
- are limited
- do not unreasonably conflict with normal
exploitation of the patent and - do not unreasonably prejudice the legitimate
interests of the patent owner, taking account of
the legitimate interests of third parties - Examples in national legislation
- Experimental use
- Use to develop test data required to obtain
marketing approval
6Article 31 Compulsory Licences
- Use of invention without authorization by right
holder - government use
- use by third parties
- not limited to specific purposes
- must meet certain conditions, including
- prior efforts to obtain voluntary licence
- exception public non-commercial use or national
emergency - predominantly for supply of domestic market
- exception adjudicated anti-competitive
practices - adequate remuneration paid to patent owner
- ? Doha Declaration / Para.6 System
7Exhaustion of Rights
- DS mechanism does not apply
- Except for national / MFN treatment obligations
- Effects in pharmaceutical sector
- ? Doha Declaration freedom to establish regime
which best fits domestic policy
considerations
8Article 39.3 Data Exclusivity
- Members are obliged to protect test data against
- unfair commercial use when
- marketing approval for pharmaceuticals or
agro-chemicals requires submission of undisclosed
data - new chemical entities are utilized
- origination of data involves considerable
efforts - information is not publicly available
- disclosure, unless
- disclosure is necessary to protect the public
- steps have been taken to protect the data against
unfair commercial use
9Transition Periods
- 1996 2000 2005 2013 2016
- ___?_______?_______?______?________?__
- ? ? ? ?
? - Industrialised DCs and DCs LDCs
1) LDCs - Countries Economies products
pharma - in Transition 1) not (patents
- previously test data)
- patented EMRs
- waived
- National treatment and MFN treatment obligations
apply as of 1996
10- II.
- The Doha Declaration on the TRIPS Agreement and
Public Health
11The Declaration General Statements
- Recognition of the gravity of the public health
problems...,especially those resulting from
HIV/AIDS, tuberculosis, malaria and other
epidemics - Recognition that intellectual property protection
is important for the development of new medicines
and recognize concerns about its effects on
prices - Agreement that the TRIPS Agreement does not and
should not prevent Members from taking measures
to protect public health. - Reaffirmation that TRIPS can and should be
interpreted and implemented in a manner
supportive of Members right to protect public
health and, in particular, to promote access to
medicines for all
12Content of the Declaration
- Guidance for disputes
- Clarification compulsory licences
- right to grant
- freedom to determine the grounds
- Clarification of emergency situations
- right to determine what constitutes a national
emergency of other circumstance of extreme
urgency - Clarification of exhaustion
- freedom to establish own regime
- Transfer of technology
- reaffirmation of Article 66.2 commitment
13Instructions for Further Work / Implementation
- Find expeditious solution to difficulties of
Members with insufficient / no manufacturing
capacities in pharmaceutical sector in making
effective use of compulsory licensing - ? General Council Decision of August 2003
(WT/L/540) Chairmans Statement (WT/GC/M/82,
para.29) - ? General Council Decision of 6 December 2005
(WT/L/641) - Protocol Amending the TRIPS
Agreement Chairmans Statement (WT/GC/M/100) - Extend LDC transition period as regards
protection and enforcement of patent rights /
undisclosed information in the field of
pharmaceuticals - ? TRIPS Council Decision extends LDC transition
period until 1/1/2016 (IP/C/25) - ? General Council Decision waives obligations
under Article 70.9 (WT/L/478)
14 - III.
- August 2003 Decision
- Implementation of Paragraph 6
- of the Doha Declaration on the
- TRIPS Agreement and Public Health
15What is the problem ?
- Members can issue compulsory licences for
importation / domestic production - Concerns
- availability of supply from generic producers in
third countries - mandatory patent protection for pharma products
as from 2005 in exporting countries with
important generic industry - Problem Art. 31(f) requires production under
compulsory licenses predominantly for the supply
of the domestic market of the Member
16Solution Paragraph 6 System (1)
- August 2003 Decision is about addressing health
problem in importing Member and legal problem in
exporting Member - Decision consists of three waivers and calls for
TRIPS amendment - General Council Chairmans statement
- Decision in effect since 30 August 2003,
terminates when amendment replaces it for each
Member
17Three Distinct Waivers
- Of 31(f) to exporting Members subject to
conditions on transparency and safeguards - scope and coverage diseases and products
- importing Members
- who is eligible
- notification requirements
- assessment of manufacturing capacities
- notification requirements applying to exporting
Members - safeguards against diversion
- Of 31(h) to importing Members provided paid in
exporting Member on same products - Of 31(f) to any LDC or developing country part of
RTA where at least half LDCs
18Difference BetweenTRIPS 1995 and Para.6 System
WTO Member with insufficient manufacturing
capacity for pharmaceuticals
- Art. 31(h) may be waived to avoid double
remuneration - special provisions for RTAs with 50 LDCs
- other Art.31 conditions continue to apply
19Other Elements
- Facilitation of transfer of technology
- Annual review substitutes review of waiver by the
General Council - Preservation of existing flexibilities
- including under Article 31(f)
- non-violation complaints not available
20Chairmans Statement
- Represents key shared understandings of Members
- Good faith use of the system
- All reasonable measures to prevent diversion
- Information on manufacturing capacities (how)
- Expeditious review in TRIPS Council and good
offices of DG or Chair of TRIPS Council - List of voluntary partial/full opt-out countries
21 - IV.
- December 2005 Decision
- Protocol Amending
- the TRIPS Agreement
22GC Decision WT/L/641 of6 December 2005
- Basis para.11 of August 2003 Decision which
instructed TRIPS Council to initiate work on
amendment by end 2003 with a view to its adoption
within 6 months - Adopts Protocol amending the TRIPS Agreement and
submits it to Members for acceptance - Protocol open for acceptance until 1/12/2007
- Takes effect upon acceptance by two thirds of
membership - ? Note that Paragraph 6 System as established
under August 2003 Decision continues to apply
until entry into force of amendment in a Member
23TRIPS Amendment
- Waivers of August 2003 Decision are transformed
into permanent TRIPS amendment - ? technical exercise, no changes in substance
to Paragraph 6 System - Inserts in TRIPS Agreement
- new Article 31bis consisting of
- 3 waiver provisions of August 2003 Decision
- non-application of non-violation complaints
- preservation of TRIPS flexibilities
- Annex setting out terms for using Paragraph 6
system - Appendix to Annex dealing with assessment of
manufacturing capacities (former annex to August
2003 Decision)
24Statements by ChairmanRecognition by MC
- Chairmans Statement
- re-read prior to adoption of GC Decision
- updates list of full opt-out countries
- Chairmans Statement on non-violation complaints
amendment without prejudice to overall question
of applicability of NVCs to TRIPS - Hong Kong MC in December 2005 Ministers welcome
work on TRIPS amendment to implement August 2003
Decision
25 26Implementing Legislation in Exporting Members
- Based on information shared in the TRIPS Council
- Norway, Canada, India, EC (in effect)
- Korea
- Switzerland (in process)
- China also adopted implementing legislation in
December 2005
27Use of Paragraph 6 System
- Possible reasons for absence of notifications so
far - generic medicines available outside patent system
- legislative changes in exporting countries recent
or not yet done - meant to address situation where non-predominant
limit proves restrictive - voluntary licences and reduction of prices
offered by patent owners - Remember system not to be used if
- local production
- voluntary licences
- no patents in exporting country
- exporting country not a WTO Member
28Concluding Remarks
- TRIPS forms part of the solution next to other
important factors infrastructure, national
health systems, procurement regimes, import
tariffs, etc. - Increased recognition of TRIPS flexibilities
- ? but need for each country to take the
necessary steps at national level to avail itself
of such flexibilities - TRIPS beyond Doha new rules ? What role for DSU
and FTAs ?
29Some References
- Doha Declaration on TRIPS and Public Health
(WT/MIN(01)/DEC/2) - Decision on the implementation of paragraph 6 of
the Doha Declaration on TRIPS and Public Health
(WT/L/540 and Corr.1) - Decision on an amendment to the TRIPS Agreement
(Protocol) (WT/L/641) - Decision on extension of transition period for
LDCs with respect to pharmaceutical products
(IP/C/25) - Decision on general extension of transition
period for LDCs (IP/C/40)