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Additional flexibilities have been made available to WTO Members under
the 2003 Decision,
as well as the 2005
Protocol Amending the TRIPS Agreement
which transposes the 2003 waiver into a permanent amendment of the TRIPS
Agreement. These flexibilities are intended to deal with the
difficulties that WTO Members with insufficient or no manufacturing
capacities in the pharmaceutical sector face in making effective use of
compulsory licensing under the TRIPS Agreement.
The additional flexibilities are optional, not mandatory. To take
advantage of them, a number of WTO Members have adopted domestic
implementing laws or regulations which incorporate the Paragraph 6
System in their respective legal frameworks. As explained here,
the adoption of such legislation follows the normal domestic legislative
and regulatory processes and is distinct from the acceptance of the
Protocol Amending the TRIPS Agreement.
Among the WTO Members with implementing laws or regulations, three
categories can be observed, i.e. those Members that have implemented the
System to act exclusively either as exporters or importers, and those
Members that have put in place laws or regulations allowing them to act
both as exporters or importers under the Paragraph 6 System.
Below is an overview of relevant changes to domestic legislation in
order to implement the Paragraph 6 System, listing in chronological
order individual Members’ formal notifications to the TRIPS Council.
Additional information on certain Members’ implementing legislation was
shared at the TRIPS Council’s meeting of 27 October 2010. It can be
found in Section 2 of the Annex to the
TRIPS Council’s Report to the General Council on the Annual Review of
the Paragraph 6 System.
Legislation as notified to the TRIPS Council back to top
Updated: 28 February 2011
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Norway: Amendments to Sections
49 and 50 of the Patent Act of 15 December 1967 No.9 and to Patent
Regulations of 20 December 1996 No.1162 provide the legal basis to act
as an exporting Member — document
IP/C/W/427
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Canada: Amendments to the Patent
Act and Food and Drugs Act, as well as the Use of Patented Products for
International Humanitarian Purposes Regulations provide the legal basis
to act as an exporting Member — notifications
IP/N/1/CAN/P/5,
IP/N/1/CAN/P/6 and
IP/N/1/CAN/P/7, and document
IP/C/W/464
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India: Section 92-A of the
Patents (Amendment) Act 2005 provides the legal basis to act as an
exporting Member — notification
IP/N/1/IND/P/2
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European Union/European Communities:
Regulation (EC) No 816/2006 of the European Parliament and of the
Council of 17 May 2006 on Compulsory Licensing of Patents Relating to
the Manufacture of Pharmaceutical Products for Export to Countries with
Public Health Problems provides the legal basis for EU Member States to
grant compulsory licences for export of patented medicines —
notification
IP/N/1/EEC/P/5
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Hong Kong, China: the Patent
(Amendment) Ordinance No.21 of 2007 provides the legal basis to act as
an exporting Member, as well as importing Member in situations of
extreme urgency — notifications
IP/N/1/HKG/P/1/Add.6 and
IP/N/1/HKG/17
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Switzerland: Articles 40d and
40e of the consolidated version of the Federal Law on Patents for
Inventions of 1 July 2008 and the Ordinance on Patents for Invention
provide the legal basis to act as an exporting Member. Further terms and
conditions are addressed by Article 111 of the Patent Ordinance —
notifications
IP/N/1/CHE/P/9 and
IP/N/1/CHE/4
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Philippines: Section 93-A of the
Republic Act No. 9502 (also known as the “Universally Accessible Cheaper
and Quality Medicines Act 2008”) and Rule 13 of the Implementing Rules
and Regulations of Republic Act No. 9502 provide the legal basis for the
grant of a special compulsory licence for the import of patented drugs
and medicines, as well as for their manufacture and export —
notification
IP/N/1/PHL/I/10
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Singapore: Sections 2, 56, 60,
62 and 66 of the Patents Act 2005 Revised Edition provide the legal
basis to act as an importing Member in situations of national emergency
or other circumstances of extreme urgency — notification
IP/N/1/SGP/P/Rev.1
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Albania: Article 50 of the Law
No.9947 of 7 July 2008 on Industrial Property provides the legal basis
to act as an exporting Member — notification
IP/N/1/ALB/I/2
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Croatia: Articles 69a to 69h of
the amended Patent Act of 2009 provide the legal basis to act as an
exporting Member — notification
IP/N/1/HRV/P/2
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China: Articles 50, 53 and 57 of
the amendment to the Patent Law of the People’s Republic of China, which
was adopted on 27 December 2008 and entered into force on 1 October
2009, provide the legal basis to act as an exporting Member. In
addition, Article 49 provides the legal basis to act as an importing
Member in situations of national emergency or other circumstances of
extreme urgency, or if public interest so requires — notification IP/N/1/CHN/P/2. Further details, such as the definition of a pharmaceutical product, are addressed in chapter V of the Revised Rules for the Implementation of the Patent Law — notification IP/N/1/CHN/P/3.
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Rep. of Korea: Article 107 of
the Patent Act and Presidential Decree No. 23306 of 26 July 2010 on
“Provisions Regarding the Expropriation and Implementation of the Patent
Right” provide the legal basis to act as an exporting Member, as well as
an importing Member in situations of national emergency or other
circumstances of extreme urgency — notification
IP/N/1/KOR/P/4.
Also back to top
Updated: 28 February 2011
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Japan: At the annual review of
the Paragraph 6 System in October 2010, the delegation of Japan also
reported orally to the TRIPS Council on the domestic rules which
constitute the basis for it to act as an exporting Member under the
System. The Guideline for Administering Award System and Article 93 of
the Japanese Patent Act (notification
IP/N/1/JPN/P/8),
which provides for the grant of non-exclusive licences for reasons of
public interest, were referred to as the legal basis for the grant of
compulsory licences in accordance with international obligations,
including the TRIPS Agreement, the 2003 Decision and the Protocol
Amending the TRIPS Agreement, and thus for the purposes of the System.
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NOTE ON EU/EC:
On 1 December 2009, the Treaty of Lisbon amending the Treaty on European
Union and the Treaty establishing the European Community (done at
Lisbon, 13 December 2007) entered into force. On 29 November 2009, the
WTO received a Verbal Note (WT/L/779) from the Council of the European
Union and the Commission of the European Communities stating that, by
virtue of the Treaty of Lisbon, as of 1 December 2009, the European
Union replaces and succeeds the European Community
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