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.

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All labels observed (3)

Label	Occurrences
2003 WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health	1
2005 TRIPS amendment on public health (Article 31bis) canonical	1
TRIPS public health amendment	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)]

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
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 ⓘ linked to: General Council of the World Trade Organization
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 ⓘ TRIPS public health amendment ⓘ linked to: 2005 TRIPS amendment on public health (Article 31bis)
appliesTo	WTO member states ⓘ linked to: World Trade Organization member states
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 ⓘ
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 ⓘ
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 ⓘ linked to: 2005 TRIPS amendment on public health (Article 31bis)
partOf	Agreement on Trade-Related Aspects of Intellectual Property Rights ⓘ 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

Referenced by (3)

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) ⓘ

2005 TRIPS amendment on public health (Article 31bis) → alsoKnownAs → TRIPS public health amendment ⓘ

linked to: 2005 TRIPS amendment on public health (Article 31bis)

2005 TRIPS amendment on public health (Article 31bis) → originatesFrom → 2003 WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health ⓘ