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

2. Relevant TRIPS Provisions
Overview:
Relevant TRIPS Provisions
Transition Periods

3. 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

4. ↓ « Patent Table » ↓ ← Exclusions: Art.27.2 + 3
Art.27.1: Patentable Subject-Matter
↓ ← Exclusions: Art
Art.29: Patent Application ↓
Art.28: Rights conferred ← Exceptions /
Limitations: Art
Art.33: 20 Years of Protection

5. 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

6. 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

7. 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

8. Article 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

9. Transition Periods
_________________________________
↓ ↓ ↓ ↓ ↓
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. The Doha Declaration on the TRIPS Agreement and Public Health
II.
The Doha Declaration on the TRIPS Agreement and Public Health

11. 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

12. 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

13. 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 (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)

14. Implementation of Paragraph 6 of the Doha Declaration on the
III.
August 2003 Decision:
Implementation of Paragraph 6
of the Doha Declaration on the
TRIPS Agreement and Public Health

15. 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“

16. 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

17. 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

18. Difference Between TRIPS 1995 and Para.6 System
WTO Member with manufacturing capacity
Generic Manufacturer
Government / competent authority
WTO Member with insufficient manufacturing capacity for pharmaceuticals
TRIPS 1995
Art. 31(f): no export
of predominant part
of production
PARA.6 SYSTEM
Art. 31(f) may be waived if:
- notifications are made
- special marking/labelling of
exported products
- other conditions are met
Patent ⇒
compulsory
licence
Art. 31(h) may be waived to avoid double remuneration
special provisions for RTAs with 50% LDCs
other Art.31 conditions continue to apply

19. 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

20. 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

21. IV.
December 2005 Decision:
Protocol Amending
the TRIPS Agreement

22. 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

23. 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)

24. 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

25. V.
Final Remarks

26. 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

27. 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 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

28. 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 ?

29. 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)