On 14 February 2018 and 16 February 2018, the World Trade Organization (WTO) conducted a Trade Policy Review (TPR) of Malaysia. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The TPRM takes place in the “Trade Policy Review Body which is actually the WTO General Council — comprising the WTO’s full membership — operating under special rules and procedures”. (Source: WTO, Trade Policy Reviews: Brief Introduction). The Chair of the Malaysia TPR was H.E. Ambassador Juan Carlos González (Colombia); the discussant was H.E. Ambassador Claudio de la Puente (Peru). Malaysia’s delegation was led by Mr. J. Jayasiri, Secretary General of the Ministry of International Trade and Industry (MITI).
On Thursday, 26 April 2018, two months after the Trade Policy Review of Malaysia was held, the WTO secretariat released the addendum to the minutes of the meeting which “contains the advance written questions and additional questions by WTO Members, and replies provided by Malaysia.” (Source: WT/TPR/M/366/Add.1). Of particular interest are the perspicacious questions posed by Brazil and Ukraine in relation to Malaysia’s September 2017 issuance of a compulsory license on sofosbuvir, a medication used for the treatment of hepatitis C.
In their written questions, Brazil and Ukraine referred to the WTO secretariat report prepared in advance of the Trade Policy Review of Malaysia (WT/TPR/S/366); the report published in December 2017 states:
3.174.Compulsory licensing provisions are applied to patents, layout designs of integrated circuits, and copyrights and related rights. There have been no changes to provisions on compulsory licensing, and no compulsory licences have been granted since 2014.
KEI contacted the WTO secretariat to clarify its assertion in its TPR report for Malaysia that “no compulsory licences have been granted since 2014”; the WTO secretariat responded that the text of this particular paragraph was prepared in the summer of 2017 prior to Malaysia’s issuance of a compulsory license in September 2017.
Brazil’s written questions and Malaysia’s answers are reproduced below.
3.3.8 Intellectual Property Rights
Page 75 (Para 3.174)
According to paragraph 3.174, no compulsory licences have been granted in Malaysia since 2014. However, there reports in the media stating that in September, 2017, the Malaysian government approved the use of Rights of Government under Patent Act 1983 (Act 291) for the patented invention of Sofosbuvir, a hepatitis C medicine. In that regard, please answer:
Questions:8.
Can you confirm this information? If confirmed, was the decision based on the Doha Declaration on the TRIPS Agreement and Public Health (…“the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all” and it is reaffirmed “the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose”)?
Answer: The implementation of the compulsory licence under the Rights of Government is based on the existing provision of Patents Act 1983 and in accordance with the Doha Declaration on the TRIPS Agreement.
9.How many additional hepatitis C patients are expected to receive treatment after the approval of the use of Rights of Government?
Answer: Based on a report in 2010, it is estimated that 453,700 Malaysians were infected with viral Hepatitis C with 2,000 newly diagnosed patients per year. The treatment plan is being finalized since the Sofosbuvir tablets are yet to be available. It is expected that 1,500 Hepatitis C patients will receive treatment in 2018, as compared to only 500 patients who were treated with other Hepatitis C drugs before the approval of the use of Rights of Government.
10.Were there any challenges encountered by the Government of Malaysia in implementing the use of Rights of Government for Sofosbuvir?
Answer: The implementation is still at an initial stage.
11.Does the Government of Malaysia intend to use the system provided for by Article 31bis of the TRIPS Agreement, which entered into force on 23 January, 2017?
Answer: The decision on this issue is based on the current provision of the Patents Act 1983 and the TRIPS Agreement.
Ukraine’s written questions and Malaysia’s answers are reproduced below.
3.3.7 Intellectual property rights
3.3.7.1 OverviewPages 74 -75
(paragraphs 3.171, 3.174) According to the Report “Malaysia ratified the Protocol Amending the TRIPS Agreement on Public Health in December 2015. … There have been no changes to provisions on compulsory licensing, and no compulsory licences have been granted since 2014.”
It is also mentioned in Para 2.7 (page 23) of the Report that “Treaties or international legal instruments (including WTO agreements) are not implemented automatically; appropriate national legislation is required to give the treaty force of law domestically.”
Questions:
10. In view of the entry into force of the Protocol Amending the TRIPS Agreement (on 23 January 2017), could Malaysia kindly inform on national implementing measures providing for special compulsory licences and its scope (for export or import of medicines)?
Answer: Malaysia has submitted the acceptance of the Protocol Amending the TRIPS Agreement in December 2015. Hence, Malaysia is amending the Patents Act 1983 to include the provision of the Article 31bis of TRIPS Agreement.
11.What competent authorities are responsible for initiation and making decision relating to the grant of compulsory licences to address public health problems according to Malaysian legislation?
Answer: Initiation to invoke compulsory licensing due to public health concern is under the jurisdiction of Ministry of Health(MOH). Granting of compulsory licensing comes under the Ministry of Domestic Trade, Co-operatives and Consumerism (MDTCC) which is the competent authority as provided under the Patents Act 1983.
12.Who may apply for the grant of the compulsory licence to use the patented invention concerning medicines and how is the process of cooperation between applicants and responsible authorities organized?
Answer: Any person can apply for compulsory licenses under Patent Acts 1983. The process of cooperation between applicants and responsible authorities is provided under Part X (Compulsory Licences) Section 49 to 54 of Patents Acts 1983. The procedures are provided under Regulation 38 to 42 of Patent Regulations.
13.Are there any pre-grant conditions and requirements on remuneration to the patent holder?
14.If so,could Malaysia, please, also describe the relevant legislative provision concerning pre-grant conditions and remuneration?
Answer: Details regarding compulsory licenses are provided under Section 49 to 54 of Patents Acts 1983. With regard to compulsory licenses under Rights of Government, it is provided under Section 84 of Patents Act 1983.
15.Considering Press Statement of Minister of Health of Malaysia of 20 September 2017 (available at:https://goo.gl/SaznZu), could Malaysia, please, clarify the state of play of the implementation of the decision to initiate the Rights of Government to exploit the patented invention of Sofosbuvir?
Answer: MDTCC and MOH are working closely on the implementation of the decision to initiate the Rights of Government. Malaysia is currently finalizing the procurement of generic Sofosbuvir tablets.
16.Has Malaysia examined the possibility of using the system, set out by the Protocol Amending the TRIPS Agreement, while making above mentioned decision?
Answer: The decision on this issue is based on the current provision of the Patents Act 1983.