2005 TRIPS amendment on public health (Article 31bis)
E616453
TRIPS Agreement amendment
World Trade Organization rule change
international intellectual property law instrument
The 2005 TRIPS amendment on public health (Article 31bis) is a World Trade Organization rule change that allows countries to export patented medicines made under compulsory licenses to nations lacking sufficient pharmaceutical manufacturing capacity, in order to improve access to essential drugs.
All labels observed (1)
| Label | Occurrences |
|---|---|
| 2005 TRIPS amendment on public health (Article 31bis) canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T6733862 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: 2005 TRIPS amendment on public health (Article 31bis) Context triple: [Doha Declaration on the TRIPS Agreement and Public Health, influenced, 2005 TRIPS amendment on public health (Article 31bis)]
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A.
Doha Declaration on the TRIPS Agreement and Public Health
The Doha Declaration on the TRIPS Agreement and Public Health is a 2001 WTO ministerial statement affirming that intellectual property rules should not prevent members from protecting public health and ensuring access to affordable medicines.
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B.
World Health Organization Model List of Essential Medicines
The World Health Organization Model List of Essential Medicines is a periodically updated catalog of the most effective, safe, and cost-efficient medicines deemed essential for meeting the priority health needs of populations worldwide.
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C.
Agreement on Trade-Related Aspects of Intellectual Property Rights
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a key international treaty that sets minimum global standards for the protection and enforcement of intellectual property rights among World Trade Organization members.
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D.
GATT 1994 Article XXI
GATT 1994 Article XXI is the World Trade Organization provision that allows members to take trade-restrictive measures they consider necessary for the protection of their essential security interests.
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E.
Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: 2005 TRIPS amendment on public health (Article 31bis) Target entity description: The 2005 TRIPS amendment on public health (Article 31bis) is a World Trade Organization rule change that allows countries to export patented medicines made under compulsory licenses to nations lacking sufficient pharmaceutical manufacturing capacity, in order to improve access to essential drugs.
-
A.
Doha Declaration on the TRIPS Agreement and Public Health
The Doha Declaration on the TRIPS Agreement and Public Health is a 2001 WTO ministerial statement affirming that intellectual property rules should not prevent members from protecting public health and ensuring access to affordable medicines.
-
B.
World Health Organization Model List of Essential Medicines
The World Health Organization Model List of Essential Medicines is a periodically updated catalog of the most effective, safe, and cost-efficient medicines deemed essential for meeting the priority health needs of populations worldwide.
-
C.
Agreement on Trade-Related Aspects of Intellectual Property Rights
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a key international treaty that sets minimum global standards for the protection and enforcement of intellectual property rights among World Trade Organization members.
-
D.
GATT 1994 Article XXI
GATT 1994 Article XXI is the World Trade Organization provision that allows members to take trade-restrictive measures they consider necessary for the protection of their essential security interests.
-
E.
Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
- F. None of above. chosen
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
TRIPS Agreement amendment
ⓘ
World Trade Organization rule change ⓘ international intellectual property law instrument ⓘ |
| addresses | public health problems affecting developing and least-developed countries ⓘ |
| adoptedBy | World Trade Organization General Council NERFINISHED ⓘ |
| adoptionDate | 2005-12-06 ⓘ |
| allows |
export of patented medicines produced under compulsory licences
ⓘ
regional trade agreements of developing or least-developed countries to use the system jointly ⓘ |
| alsoKnownAs |
Article 31bis of the TRIPS Agreement
NERFINISHED
ⓘ
TRIPS public health amendment NERFINISHED ⓘ |
| appliesTo | WTO member states NERFINISHED ⓘ |
| beneficiariesInclude |
least-developed country WTO members
ⓘ
other WTO members with insufficient or no pharmaceutical manufacturing capacity ⓘ |
| concerns |
access to medicines in developing countries
ⓘ
compulsory licensing of pharmaceutical patents ⓘ |
| createsExceptionTo | requirement that production under compulsory licence be predominantly for the supply of the domestic market ⓘ |
| criticizedFor |
complex procedural requirements
ⓘ
limited practical use by WTO members ⓘ |
| designedTo | balance patent protection with public health needs ⓘ |
| enteredIntoForce | 2017-01-23 ⓘ |
| entryIntoForceCondition | acceptance by two-thirds of WTO members ⓘ |
| field |
global public health policy
ⓘ
intellectual property law ⓘ international trade law ⓘ |
| implementedBy | Annex to the TRIPS Agreement on the implementation of Article 31bis NERFINISHED ⓘ |
| influenced | national legislation on compulsory licensing for export in several WTO members ⓘ |
| legalBasisFor | export of pharmaceutical products made under compulsory licence ⓘ |
| legalForm | amendment to Annex 1C of the WTO Agreement ⓘ |
| linkedTo | Doha Declaration on the TRIPS Agreement and Public Health NERFINISHED ⓘ |
| modifies | Article 31 of the TRIPS Agreement ⓘ |
| originatesFrom | 2003 WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health NERFINISHED ⓘ |
| partOf |
Agreement on Trade-Related Aspects of Intellectual Property Rights
NERFINISHED
ⓘ
World Trade Organization legal framework ⓘ |
| permits | importation of generics produced under compulsory licence from other WTO members ⓘ |
| purpose |
to implement the 2001 Doha Declaration on the TRIPS Agreement and Public Health
ⓘ
to improve access to essential medicines in countries with insufficient or no pharmaceutical manufacturing capacity ⓘ |
| replaces | 2003 WTO waiver on exports of medicines under compulsory licence ⓘ |
| requires |
measures to prevent re-exportation of products supplied under the system
ⓘ
notification to the WTO by exporting members granting compulsory licences under the system ⓘ notification to the WTO by importing members using the system ⓘ publication of information about quantities and destinations of products supplied under the system ⓘ remuneration to patent holders by exporting members granting compulsory licences ⓘ special labelling or marking of products supplied under the system ⓘ |
| scope | pharmaceutical products needed to address public health problems ⓘ |
| subjectOf |
WTO notifications by importing and exporting members
ⓘ
debates on access to medicines and intellectual property ⓘ interpretative discussions in the WTO TRIPS Council ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: 2005 TRIPS amendment on public health (Article 31bis) Description of subject: The 2005 TRIPS amendment on public health (Article 31bis) is a World Trade Organization rule change that allows countries to export patented medicines made under compulsory licenses to nations lacking sufficient pharmaceutical manufacturing capacity, in order to improve access to essential drugs.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
Doha Declaration on the TRIPS Agreement and Public Health
→
influenced
→
2005 TRIPS amendment on public health (Article 31bis)
ⓘ