We wish to refer to your article “A Christmas wish fulfilled” published in page 12, The Sun on Tuesday, 29 December 2015.
In the article, there was one paragraph related to the Trans-Pacific Partnership Agreement (TPPA) and we would like to address your claims as follows:
The TPPA has been signed
We have not signed the TPPA. The negotiations were concluded on the 5th of October 2015, but as we have repeatedly said before, the decision whether or not Malaysia becomes a party to the TPPA will only be made after it has been discussed and voted in the special parliamentary sitting scheduled at the end of January 2016.
The TPPA is the final nail in the coffin as it extends the patent expiry period for up to 20 years
Our current policy is to provide 20 years of patent protection for pharmaceutical drugs, consistent with the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The claim that the TPPA extends the patent expiry period for up to 20 years is therefore incorrect.
If what you meant was patent can be extended beyond 20 years, we wish to clarify that it will only be extended if there is an unnecessary delay in patent or marketing approval. Article 18.46 (3) of the TPPA stipulates that “If there are unreasonable delays in a Party’s issuance of patents, that Party shall provide the means to, and at the request of the patent owner shall, adjust the term of the patent to compensate for such delays”.
However, Malaysia's current process of marketing approval for drugs is efficient – it takes 245 days on average. Hence the likelihood of patent extension should not arise.
The TPPA will keep affordable life-saving drugs out of reach
Malaysia has had a pharmaceutical data protection process in place since 2011, where the test data will be protected for a period of 5 years. However, the regulation on data protection in Malaysia has a condition that must be complied by the innovator. The innovator has to apply for registration of pharmaceuticals in Malaysia within 18 months from the date the drug obtained its first marketing approval in any other country.
Such a condition was introduced to encourage pharmaceutical companies to market their new drugs early into Malaysia. It will enable Malaysians to have early access to innovative drugs and also create a pathway for more affordable generic drugs to be brought into the market early. This same condition is also applicable to biologics data protection.
The TPPA therefore does not require us to extend the patent expiry period to 20 years. The TPPA by itself will not keep affordable life-saving medicine out of reach as Malaysia has negotiated to maintain our current policy of an access window which requires the innovators to introduce their drugs into our country within 18 months after receiving their first marketing approval in another country. If they fail to do so, their drugs will not qualify for data protection in Malaysia.
Datuk J. Jayasiri
Deputy Secretary-General (Strategy and Monitoring)
Ministry of International Trade and Industry
4 January 2016
About MITI :
The Ministry of Commerce and Industry was established in April 1956 then was renamed as The Ministry of Trade and Industry in February 1972. On 27 October 1990, the Ministry was separated into two Ministries which are; Ministry of International Trade and Industry (MITI) and Ministry of Domestic Trade and Consumer Affairs (KPDN).
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Last Updated 2016-01-05 16:40:57 by Azuna Hasbullah atau Abd Rahman