Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Xolelwa Mlumbi-Peter

37.   We thank the Secretariat for the overview of notifications received under this agenda item. As rightly pointed out some of the notifications overlap with the list of verified measures which was published by the Secretariat. South Africa wishes to raise some questions on COVID-related notifications under agenda item 2. We look forward to studying Australia's notification and the short explanation of the amendment. Also, the intervention from Canada has been well noted. We have some further questions regarding Canada's notification. The EU also discussed the notification of Hungary about which we also have some questions. For brevity I will focus only on a few questions and submit the remainder in writing.

Canada: document IP/N/1/CAN/30 (Canada: Laws and Regulations)

a. Does the scope of the amendment allow compulsory licenses to be sought by the Minister of Health for purposes of importing generic versions of patented medical products to respond to public health emergencies? b. The amendment limits the duration of the compulsory licenses to a maximum of one year. As is now apparent, pandemics and other public health emergencies can go on for much longer, how will Canada address this gap? Can the compulsory licenses be renewed or can the Minister of Health reapply for a new compulsory licenses to cover the same products? Would this not disrupt access during an emergency? c. Do patent holders have the right to apply for an injunction or any other relief that may halt implementation of the compulsory licenses sought by the Minister of Health? d. Why has Canada limited the right of a Minister of Health to apply for and be granted a compulsory license only in situations of public health emergencies? How will the Minister of Health address patent challenges in other situations of public health need in Canada?

Hungary: document IP/N/1/HUN/3 (Hungary: Laws and Regulations)

38.   The TRIPS Agreement reaffirmed by the Doha Declaration on TRIPS and Public Health recognize that each WTO Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted. The right to issue compulsory licenses, be it to address public health or any other national concern, should be a common feature in national patent legislation. a. Why has the Government of Hungary decided to rely on its emergency powers to issue a Government Decree for public health compulsory licenses? b. Section 1(4) of the Decree states the period for which a public health compulsory license is granted shall not last longer than until 31 March 2021. Given that the COVID-19 challenge is expected to continue for a number of years, and shortages are likely, what other provisions exist in Hungary's patent law that will allow Hungary to issue compulsory or government use licenses to import or manufacture patented medical products? c. The public health compulsory licenses decree allows exploitation of patented inventions presumably including importing from other countries. How will the opt-out of Hungary as an eligible importing country in connection with the 30 August 2003 and Article 31bis mechanism impact the utility of Hungary's public health compulsory license decree? d. What circumstances informed the Government's decision to terminate the special legal order (State of Danger) on 18 June 2020?

The Council took note of the notifications and the statements made.
4.   The Chair invited the Secretariat to report on notifications that the Council had received since its meeting in February 2020.
5.   A representative of the Secretariat said that the Council had received the following notifications under Article 63.2 of the TRIPS Agreement:
a. The European Union had notified regulations relating to the implementation of the Regulation on the European Union Trademark; and a Regulation and a Council Decision relating to the European Union's accession to the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications;
b. Japan had notified consolidated versions of its Design Act, its Patent Act, its Trademark Act and its Copyright Act;
c. Mexico had notified its declaration of protection of the denomination of origin "Pluma";
d. the Kyrgyz Republic had notified government decrees, regulations and rules relating to traditional knowledge, and to patenting rules for selection achievements, electronic computer programs and databases;
e. Chinese Taipei had notified its Trade Secrets Act;
f. Canada had notified its Bill-13, providing for certain measures in response to COVID-19;
g. Thailand had notified consolidated versions of its Trade Secrets Act, the Copyright Act and the Trademark Act;
h. The Kingdom of Saudi Arabia had notified its amended Copyright Law and related implementing regulations;
i. Hungary had notified a government decree on public health compulsory licences and transitional rules regarding epidemiological preparedness; and
j. Hong Kong, China had notified an amended trademark Ordinance and its National Anthem Ordinance of 2020.
6.   He added that, under Article 69, Belize, Qatar, the Kingdom of Saudi Arabia, and Tonga had provided information on contact points for the exchange of information and cooperation on trade in infringing goods, under Article 69 of the TRIPS Agreement.
7.   Chile had notified a contact point for technical and financial cooperation, under Article 67 of the TRIPS Agreement.
8.   He noted that some of the above-mentioned notifications were included in the list of IP-related COVID-19 measures. This non-exhaustive list of intellectual property measures was compiled and maintained by the WTO Secretariat from official sources and from Member's inputs. The most recent inputs were from Greece, Switzerland and the Russian Federation. The list was updated continuously, and the most recent version could always be accessed on the WTO website. It represented an informal situation report and an attempt to provide transparency with respect to measures related to intellectual property rights (IPRs) taken in the context of the COVID-19 crisis.
9.   He drew delegations' attention to two developments in the area of documentation procedures:
a. A new document series had been created for the circulation of Members' reports to the TRIPS Council. The IP/C/R/[MEMBER]/- series would comprise reports and reviews submitted by individual Members to the TRIPS Council, from 2020 onwards. This included reports and responses relating to geographical indications (TRIPS Article 24.2), biotech patenting and related issues (TRIPS Article 27.3(b)), incentives for technology transfer (TRIPS Article 66.2), and technical cooperation (TRIPS Article 67); and
b. The WTO Secretariat's Central Registry of Notifications (CRN) sends out annual reminders to Members identifying unfulfilled annual notification obligations across all WTO Agreements. In the context of TRIPS, the notification obligations under Article 63.2, 67, and 69 – namely to notify legislation, responses to the enforcement checklist and information on contact points – were on-going obligations, which required action whenever new legislation entered into force, or when the contact point details changed. In light of this, CRN reminders would now be sent to all Members covered by these obligations, indicating that these notification obligations applied "as appropriate". By sending such regular reminders, CRN invited Members covered by these provisions to regularly verify that they are up-to-date with their ongoing notification obligations under Article 63.2, Article 67 and Article 69.
10.   The Chair invited delegations that had notified new or revised legislative measures or submitted updates to their Enforcement Checklist to inform the Council about the key points of their notifications. This had become a well-established practice, followed by many delegations at recent sessions of the Council. It provided valuable insight into the notifications provided and promotes awareness and transparency.
11.   The representatives of Australia; Canada; the European Union; South Africa; Chinese Taipei; Thailand; Japan; the Kingdom of Saudi Arabia; and Mexico took the floor. The representative of Hong Kong, China requested that his statement be included in the record of the meeting.
12.   The Chair noted that, while the pace of notifications to the Council had increased in recent years, they were still not keeping up with the actual development of laws and regulations relating to TRIPS. She recalled that Article 63.2 was not a one-off requirement. It was a core element of the TRIPS transparency arrangements, and a central part of the Council's substantive work. It obliged Members to notify any new or amended laws in the area of TRIPS, including those recently adopted to address the COVID-19 pandemic. That requirement included the notification of legislative changes made to implement the special compulsory licensing system to export medicines covered by the new Article 31bis of the TRIPS Agreement. The notification of all relevant laws and regulations could assist Members in preparing for the potential use of the system. It would also help the Secretariat in its efforts to provide informed technical support to Members in this area. She urged Members to complete any outstanding initial notifications and to keep up to date with notifications on subsequent amendments. The same applied to the Checklist of Issues on Enforcement which had been established by the Council as an element of Members' notification obligations.
13.   Finally, the e-TRIPS Submission System was available for Members to notify their laws, and to make other required submissions to the TRIPS Council, through the click of a button. The e-TRIPS System not only facilitated the submission of information by Members, it also permitted digital access, consultation and analysis of this information through the e-TRIPS Gateway, an easy-to use interface to search and display information related to the TRIPS Council.
14.   The Council took note of the notifications and the statements made.
IP/C/M/95, IP/C/M/95/Add.1