INTELLECTUAL PROPERTY: TRIPS AND HEALTH
Members’ laws implementing the ‘Paragraph 6’ system
In order to implement the 2003 waiver and 2005 decision to amend the WTO’s intellectual property agreement, a number of Members have changed their laws.
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 alphabetical order individual Members’ formal notifications to the TRIPS Council. A number of other WTO Members have also put implementing legislation in place. However, given that the relevant measures have not yet been notified to the TRIPS Council, they are not reproduced below.
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.
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Legislation as notified to the TRIPS Council
Updated: 24 January 2022
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
- Australia: Schedules 1 and 2 of the Intellectual Property Laws Amendment Act 2015 and Schedules 1 and 2 of the Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation 2015 provide the legal basis to act as an exporting Member — notifications IP/N/1/AUS/P/11 and IP/N/1/AUS/P/12
Botswana: Sections 31 and 32 of the Industrial Property Act, Act No.8 of 2010 provide the legal basis to act as an exporting Member, including under the RTA waiver of the 2003 Decision, as well as an importing Member — notification IP/N/1/BWA/I/3
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, IP/N/1/CAN/P/7 and IP/N/1/CAN/P/12, and document IP/C/W/464
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.
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
- Cuba: Article 54.5 of the Decree-law No. 290 on Inventions and Industrial Designs of 2011 provides the legal basis to use the System as exporter and importer — notification IP/N/1/CUB/D/1
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
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
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
Jordan: Articles 22 and 23 of the Amended Patent Law number 28 of 2007 provide the legal basis to act as an exporting Member — notification IP/N/1/JOR/P/2.
Kazakhstan: Article 11 of the Law on Patents of the Republic of Kazakhstan No. 427-I of 16 July 1999, as amended up to Law of the Republic of Kazakhstan No. 378-V of 31 October 2015, provides the legal basis to act as an exporting Member — notification IP/N/1/KAZ/P/1.
- New Zealand: Articles 171 to 178 of the Patents Act 2013 No 68 provide the legal basis to act as an exporting Member — notification IP/N/1/NZL/P/5.
- 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
Oman: Section 13 of Royal Decree No.67/2008 on Industrial Property Rights and their Enforcement for the Sultanate of Oman provides the legal basis to act as an exporting Member — notification IP/N/1/OMN/I/2
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
- Rep. of Korea: Article 107 of the Patent Act and provides 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. Further details, including the procedural requirements for medicines to be exported or imported pursuant to Article 107 of the Patent Act, as well as the calculation of remuneration, are laid down in Presidential Decree No. 22306 of 26 July 2010 on “Provisions Regarding the Expropriation and Implementation of the Patent Right” — notification IP/N/1/KOR/P/7.
- Russian Federation: Amendments to Part 4 of the Civil Code introduced Article 1360.1. It permits the use of an invention for the production and export of pharmaceutical products without prior authorization of the right holder in accordance with the Russian Federation's obligations under international agreements — notification IP/N/1/RUS/P/3.
- 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
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
- Chinese Taipei: Articles 90 and 91 of the Patent Act as amended in 2013 provide the legal basis to act as an exporting Member — notification IP/N/1/TPKM/P/3
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Updated: 28 February 2011
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.
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