Transcript WIPO National Workshop on Intellectual Property for Diplomats Sana’a, Republic of Yemen 20-21 March 2007 The TRIPS Agreement and Public Health Roger Kampf WTO Secretariat.

WIPO National Workshop on
Intellectual Property for Diplomats
Sana’a, Republic of Yemen
20-21 March 2007
The TRIPS Agreement
and Public Health
Roger Kampf
WTO Secretariat
1
I.
Overview:
Relevant TRIPS Provisions
Transition Periods
2
TRIPS Provisions of
Direct Relevance to Public Health
•
•
•
•
TRIPS Objectives and Principles
Patents (incl. compulsory licences)
Exhaustion
Protection of Undisclosed
Information
• Competition
• Measures against Counterfeiting
• Transition periods
3
« 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
4
Article 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
5
Article 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
6
Exhaustion 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
7
Article 39.3: Data Exclusivity
• Members are obliged to protect test data
against:
– unfair commercial use when:
• marketing approval for pharmaceuticals or agrochemicals 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
8
Transition Periods
1996
2000 2005 2013
2016
___ _______ _______ ______ ______
__ __
↓
↓
↓
↓
↓
Industrialised
Countries
1)
DCs and
DCs
Economies
products
in Transition 1) not
previously
patented
LDCs 1)
LDCs
· pharma
(patents &
test data)
· EMRs
waived
National treatment and MFN treatment obligations apply as of
1996
9
II.
The Doha Declaration on the TRIPS
Agreement and Public Health
10
The 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
11
Content 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
12
Instructions 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);
Chairman’s Statement (WT/GC/M/82, para.29)
⇒ General Council Decision of 6 December 2005
(WT/L/641) - Protocol Amending the TRIPS Agreement;
Chairman’s 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)
13
III.
August 2003 Decision:
Implementation of Paragraph 6
of the Doha Declaration on the
TRIPS Agreement and Public Health
14
What 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“
15
Solution: “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 Chairman’s statement
• Decision in effect since 30 August
2003, terminates when amendment
replaces it for each Member
16
Three 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
17
Difference Between
TRIPS 1995 and Para.6 System
WTO Member with
manufacturing
capacity
Government /
competent authority
Patent ⇒
compulsory
licence
Generic
Manufacturer
TRIPS 1995
Art. 31(f): no export
of predominant part
of production
WTO Member
with insufficient
manufacturing
capacity for
pharmaceuticals
PARA.6 SYSTEM
Art. 31(f) may be waived if:
- notifications are made
- special marking/labelling of
exported products
- other conditions are met
Art. 31(h) may be waived to avoid double remuneration
 special provisions for RTAs with 50% LDCs
 other Art.31 conditions continue to apply

18
Other 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
19
Chairman’s 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
20
IV.
December 2005 Decision:
Protocol Amending
the TRIPS Agreement
21
GC Decision WT/L/641 of
6 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
22
TRIPS 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)
23
Statements by Chairman
Recognition by MC
• Chairman’s Statement:
– re-read prior to adoption of GC Decision
– updates list of full opt-out countries
• Chairman’s 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
24
V.
Final Remarks
25
Implementing 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
26
Use 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 nonpredominant 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
27
Concluding 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 ?
28
Some 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)
29