1. To what extent are TRIPS flexibilities embedded in areas outside patent protection well understood? If so, how are Members implementing such understandings in their national and regional laws?
479. TRIPS flexibilities as to the method of implementing TRIPS obligations allow WTO Members different ways to transpose into national law that the TRIPS Agreement simply articulate but does not define. For example, in the field of enforcement the TRIPS Agreement allows WTO Members to resort to their own legal system and practices to implement enforcement obligations.
480. TRIPS flexibilities with regard to standards of IP protection in Malaysia include exceptions and limitations provided for, but not limited to, under the copyright and industrial property laws in Malaysia. For example, copyright protection incorporate flexibilities where it allows exceptions for visually and hearing-impaired people.
2. What are the likely difficulties that Members may face in dealing with a changing technology landscape where embedded IP rights may affect the dichotomy between IP rights as private rights and the public interest dimensions recognized in the TRIPS Agreement?
481. The relevant IP laws on protection of technology provide sufficient flexibility in dealing with a changing landscape where embedded IP rights may affect the dichotomy between IP rights as private rights and public interest.
482. The main challenge is generally to strike a balance in providing an IPRs framework that can assure adequate protection of IPRs that is not considered, as under- or over-protection of IPRs which may undermine the larger economic strategy of a country. However, in certain circumstances, there may be cases in which private interests in IPRs must be subordinated to more compelling public interests. Many countries, for example, are facing increasing social and financial difficulties a consequence of public health and epidemic disease.
483. Another difficulty that Members may face in dealing with a changing landscape is that the impact of IPRs itself is dependent on the types of technology. For example, the role of IPRs in the process of development in the pharmaceutical industry is very different to the role of IPRs in the mobile phone industry.
3. What are the benefits and limitations of initiatives such as voluntary licenses and pledges to access much needed technology to deal with the COVID-19 pandemic?
484. When patent holder companies issue voluntary licences for patented medicines, they enable other manufacturers to develop generic versions of these medicines. This helps to support supply, increase affordability and improve access to ensure an inclusive and sustainable healthcare to our wider society. In Malaysia's view, the limitation of voluntary licensing which is based on countries economic developments. Due to COVID-19, many countries are faced with challenges in addressing the high cost of medicines and technologies required in mitigating this pandemic.
485. Malaysia welcomes discussion among WTO Members on the implications of intellectual property rights over the technologies and products required for mitigating COVID-19 pandemic with the aim of ensuring that IP rights including patents, industrial designs, copyright and trade secrets do not create barriers to scaling up research, development and supply of technologies necessary to mitigate COVID-19.
4. Are there circumstances where trade secrets can be shared more broadly? If so, what are those circumstances? Would national or international health pandemics fall within this category?
486. WTO Members have a considerable flexibility to define which situations trade secrets can be shared, provided that such situations are consistent with the WTO TRIPS Agreement.