Malaysia objects to patent terms in free trade agreement

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Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the Trans-Pacific Partnership (TPP) Free Trade Agreement. This time, the Malaysian Health Minister, Dr Datuk Seri Liow Tiong Lai, has spoken out against terms in the agreement which seek to extend the patent periods of medicines produced by foreign companies.

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The TTP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, US and Vietnam. The aim of the agreement is to expand the flow of goods, services and capital across borders.

However, the agreement has drawn criticism and provoked public protests in the past in part due to the secrecy of the negotiations and a number of controversial clauses in draft agreements that have been leaked to the public, with some believing that it will lead to decreased access to medicine.

The Malaysian Health Minister believes that certain terms in the agreement pertaining to patents are ‘not fair’ and would in effect make health care less affordable to the public. He told The Sun Daily that ‘according to the agreement, if a medicine is launched in the US, and then three years later it is launched in Malaysia, the patent would start from when it is launched here and not when it was launched earlier in the US.’

This is not the first time the TPP has been accused of hindering access to medicines. Proposed provisions in the TPP for 12 years of biologicals exclusivity have also been criticised [1].

The US Generic Pharmaceutical Association (GPhA) has also expressed its concerns over the TPP negotiations. GPhA believes that the intellectual property provisions being proposed for inclusion in the TPP agreement would hinder competition and access to generic medicines [2].

In the latest leaks it appears that the US is demanding aggressive intellectual property provisions that go beyond what international trade law requires. Malaysia’s main objection to this is that the existing patents on medicines would be extended for another five to 10 years or more, on top of the current requirement of 20 years. These patent extensions would mean that generics companies would not be able to produce more affordable generic drugs during this period.

The next negotiating round of the Trans-Pacific Partnership will take place in Leesburg, VA, USA, from 6–15 September 2012.

Related article

Debate over biosimilars exclusivity period in free trade agreement

References

1.  GaBI Online - Generics and Biosimilars Initiative. More debate over the exclusivity period for biologicals in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 17]. Available from: www.gabionline.net/Biosimilars/General/More-debate-over-the-exclusivity-period-for-biological-in-the-US

2.  GaBI Online - Generics and Biosimilars Initiative. Caution over IP provisions for biologicals in TPP [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 17]. Available from: www.gabionline.net/Biosimilars/News/Caution-over-IP-provisions-for-biologicals-in-TPP

Source: Office of the United States Trade Representative, Public Citizen, The Sun Daily

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