Response to Issues Raised By YB Nurul Izzah

On data protection for biologics

 

1. MITI would like to respond to YB Nurul Izzah’s statement which appeared in the Malaysian Insider, alleging that MITI Minister has been misleading the public on data protection under the TPP.

2. The point that needs to be corrected is that the TPP does provide for a 5-year data protection for small molecules (referred to in the article as conventional drugs).

3. For biologics, the TPPA recognizes that the protection for biologics can be achieved through different means. The TPPA provides options for counties to choose from: to provide 8 years of data protection, or in the alternative, countries can choose to provide 5 years of data protection, along with other measures while recognizing market circumstances for biologics. These measures and circumstances may include existing regulatory and patent approval for biologics and biosimilars. Malaysia chose the alternative option of providing 5 year data protection, which reflects Malaysia’s existing regime in providing data protection for conventional drugs.

4. The agreement on data protection on biologics will be reviewed in 10 years. The TPP further allows a reasonable transition period for countries to implement. For Malaysia, we have 5 years from the date of entry into force of the Agreement, which means that the TPP provision on biologics will take effect only after 5 years after entry entry force.

 
 

On extension of patents for old but modified medicines

 

5. It has been explained a number of times before to the Parliamentary Caucus members as well as other stakeholders, but we would like to repeat that the issue of ‘modified’ medicines is consistent with Malaysia’s current practice.

6. We would like to again clarify that all discoveries, including new uses (or mischievously referred to by YB Nurul Izzah as ‘modified’), will meet the strict scrutiny of the patent office for novelty and obvious use. Regardless of whether subsequent patents relating to the known product can be applied for, no later-granted patents can extend the term of an earlier one. What this means is that each application and the protection granted is based on its own merit of novelty and new use and shall not be construed as an extension of the existing patent period.

 
 

On claim that the New Zealand government has said TPPA will increase medicine price

 

7. The main documentation that the New Zealand government have put out on TPP is the intellectual property fact sheet which can be found here at:   http://tpp.mfat.govt.nz/assets/docs/TPP_factsheet_Intellectual-Property.PDF

8. It is clear that there are no comments by the New Zeland government acknowledging that the TPP will lead to the increase in the price of medicines.