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

H.E. Ambassador Xolelwa Mlumbi-Peter
European Union
70.   The European Union would like to read out the replies provided by Hungary to the questions raised by South Africa at the last TRIPS Council. 71.   Question 1 raised by South Africa: why has the Government of Hungary decided to rely on its emergency powers to issue a Government decree for public health compulsory licences? 72.   Hungary's reply: in connection with the COVID-19 pandemic, on 11 March 2020, the Hungarian Government declared special legal order (State of Danger) that lasted until 18 June 2020. During the State of Danger, the Government may adopt decrees by means of which it may, as provided for by a cardinal Act, suspend the application of certain Acts, derogate from the provisions of Acts and take other extraordinary measures. 73.   The pre-existing compulsory licence regime for public health purposes provided in the Hungarian Patent Act (Law No. XXXIII of 1995 on the Protection of Inventions by Patents, hereinafter mentioned as "HPA") was based solely on Regulation of the European Parliament and of the Council (EC) No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (hereinafter mentioned as "Regulation (EC) No 816/2006"). 74.   Besides this specific regime under Regulation 816/2006, the Hungarian patent law did not provide for a compulsory licence regime for public health purposes. The COVID-19 pandemic, as a situation of national emergency, created a risk that holders of patents or supplementary protection certificates valid in Hungary of medical products, active substances, procedures and equipment needed to fight the COVID-19 pandemic would not be able to ensure the required supply. Should voluntary mechanisms fail, compulsory licences could be an option to secure this supply. Therefore, a system that would handle domestic public health problems was deemed necessary and swift legislative action was required. The special legal order provided the most suitable and fastest framework to regulate the new regime of compulsory licences for public health purposes. 75.   Question 2 raised by South Africa: Section 1.4 of the Decree states the period for which a public health compulsory licence 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 license to import or manufacture patented medical products? 76.   Hungary's reply: the special legal order (State of Danger) was terminated on 18 June 2020, and thus Government Decree 212/2020 ceased to have effect on that day. There were no compulsory licences filed for or granted based on the Decree. 77.   Act LVIII of 2020 on Transitional Rules related to the Termination of State of Danger and on Epidemiological Preparedness made necessary modifications regarding the termination of the special legal order, including the modification of the Hungarian Patent Act (HPA), which came into force on 18 June 2020. This modification added the provisions on the public health compulsory license system to the HPA. 78.   Question 3 raised by South Africa: the public health compulsory license 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? 79.   Hungary's reply: The Government Decree 212/2020 provided for a regime of compulsory licences for public health purposes for the supply in Hungary. It did not amend the compulsory license based on Regulation (EC) No 816/2006 (Article 33/A of HPA) concerning the compulsory licences for export to countries with public health problems. Status of Hungary as an importer under Article 31bis of the TRIPS Agreement has also not changed. 80.   Question 4 raised by South Africa: what circumstances informed the government's decision to terminate the special legal order (State of Danger) on 18 June 2020? 81.   Hungary's reply: Hungary successfully completed the first phase of the fight against the coronavirus, following which Hungary was among the first EU Members to terminate the special legal order. The special legal order served its purpose, it helped in preventing the pandemic from reaching tragic proportions, because the Hungarian Government could take all the necessary measures in due time and could rely on the sacrifice and discipline of the Hungarian citizens. With the stabilisation of the epidemic situation, the termination of the special legal order was justified.
1. The Chair invited the Secretariat to report on notifications that the Council had received since its meeting in July 2020.
2. A representative of the Secretariat said that the Council had received the following notifications under Article 63.2 of the TRIPS Agreement:
a. Chinese Taipei had notified regulations governing the filing of patent and trademark applications by electronic means, as well as regulations governing the application for compulsory licences for musical works and related royalties;
b. Australia had notified a consolidated version of its Patents Act 1990, as well as the Intellectual Property Laws Amendment Act 2020, which implemented the Productivity Commission Response Part 2 and Other Measures;
c. Mexico had notified revisions of the Penal Code, as well as a Decree amending the Federal Law on Copyright regarding copyright protection in the digital environment;
d. The United States had notified their amended Plant Variety Protection Act and corresponding Regulations;
e. The United Kingdom had notified over 70 pieces of legislation that represent the evolution of the UKs law on trademarks and on designs since 1996;
f. Pakistan had notified its Geographical Indications Act 2020;
g. Myanmar had notified its new Plant Variety Protection Law;
h. Hong Kong, China had notified a Copyright Amendment Ordinance, which enhanced the Copyright exceptions relating to persons with a print disability in order to meet the standards under the Marrakesh Treaty;
i. Ukraine had notified amendments regarding its patent law reform, as well as amendments to strengthen rights to trademarks and designs, and to combat patent abuse;
j. Japan had notified a further revision to its Unfair Competition Prevention Act of 1993, which provided civil remedies against acts of unfair competition with respect to "shared data with limited access"; and
k. Slovenia had notified an Act Regulating Collective Management of Copyright and Related Rights.
3. He added that, Albania and Slovenia 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.
4. The representatives of Pakistan; Mexico; Australia; Hong Kong, China; Ukraine; Canada; Chinese Taipei; the United Kingdom; and the United States of America took the floor.
5. The Chair recalled that, at the July 2020 meeting, several questions had been asked regarding legislation notified by Canada and the European Union. She invited those two delegations to take the floor to respond to those questions or inform the Council of any follow up in this regard.
6. The representative of South Africa and the European Union took the floor.
7. The Chair noted that, notifications to the Council were 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. Article 63.2 obliged Members to notify any new or amended laws in the area of TRIPS. The same applied to the Checklist of Issues on Enforcement which had been established by the Council as an element of Members' notification obligations.
8. She encouraged Members to notify legislative changes made to implement the special compulsory licensing system to export medicines covered by the new Article 31bis of the TRIPS Agreement. More than 50 WTO Members, including most of the world's major exporters of medicines, had adopted implementing legislation that allowed them to use the System as exporters and/or importers. However, only 20 Members, including the European Union, had formally notified such measures to the TRIPS Council. The notification of all relevant laws and regulations could assist Members in preparing for the potential use of the System. This would also help the Secretariat in its efforts to provide informed technical support to Members in this area.
9. Finally, she welcomed the information provided by Members concerning their notifications, as well as the constructive exchange on Members' legislation we had under this agenda item.
10. The Council took note of the notifications and the statements made.
IP/C/M/96, IP/C/M/96/Add.1