Saturday, 7 November 2015

Our Worst Fears Confirmed – Mohd Nizam Mahshar

Kamal Salih Comments: 
Nizam has consistently taken the position as point-man for those opposed to the TPPA recently negotiated by the 12 governments of the Pacific Region.  He is chairman of the lobby group Bantah TPPA (Against TPPA).  He is also the Executive Director of MTEM (translation: Malay Economic Action Council) a research body set up under the National Malay Chamber of Commerce and Industry.  The following article is a propo the position taken by the Council.  



The disclosure of the finalised texts of the Trans-Pacific Partnership (TPP) agreement has confirmed our worst fears about the purported 21st-century agreement.

Despite what governments and cheerleaders claim, our concerns have not been overblown, and it only goes to show what happens when we allow a select few – their every move monitored and driven by multinational commercial interests – to craft a deal behind closed doors.

Given that we will be legally bound to follow the TPP – or face trade or other sanctions should we be found in violation – the prospects are dire.


The intellectual property chapter will jeopardise access to affordable medicines.

It enables drug companies to press for patent term extensions beyond the standard 20 years, to compensate for any "unreasonable" time a patent office or drug regulatory authority takes to approve a patent application or grant marketing approval.

Patent term extensions will significantly delay the entry of cheap generic medicines into the market.

Generic companies will be prevented for five years from registering an equivalent generic version of a patented drug for market approval based on originator company data, thereby curbing the supply of cheaper drugs.

While Malaysia already has this market exclusivity provisions, these have various safeguards, while the TPP locks this in.

Data exclusivity extends to the new generation of "biologics" medicines (medicines derived from proteins isolated from pants, animals and micro-organisms) that have been developed to treat human diseases and conditions, such as vaccines, cancer medicines and therapies such as insulin.

Under the TPP, Malaysia must provide five years' data exclusivity for biologics. Malaysian law currently does NOT have data exclusivity for biologics and therefore will have to be amended to incorporate this.

The number of years of biologic exclusivity has led to such high prices that even in the US, the Obama administration has repeatedly sought to reduce the number of years of biologic data exclusivity in that country.

"Evergreening" of already existing monopolies will happen through market exclusivity if a "new" medicine is an old drug that has been found to be usable for a condition other than that which it was originally developed to treat, or for old medicine that has been found to be usable for a different population of patients.

A pharmaceutical company can also seek exclusivity for new combinations of an old drug and a new chemical entity.

The investment chapter overrides national sovereignty, allowing foreign investors to sue the government directly and preventing government from protecting citizens’ interests.

It provides for overly-wide definition of "investment" that extends the coverage of the foreign investor rights, exposing the government to challenges and multi-million dollar compensation over their actions and policies.

The definition of "investor" is also overly wide, allowing corporations from non-TPP countries to sue under the chapter’s investor-state dispute settlement (ISDS) system.

Rights will be granted to foreign investors that are not granted to domestic firms, such as the ability to challenge and demand compensation in an international court, which is a system that is lopsided in favour of private commercial interests.

There are some provisions meant to improve on certain procedural aspects of the ISDS regime, but there remains no solution to the problem of the lack of an appeals mechanism, or the lack of a vigorous code of conduct for the ISDS judges that is comparable to most domestic judicial systems.

Although Malaysia has signed investment agreements containing ISDS provisions as far back as 1959, the situation today is vastly different.

Multinational corporations today wield far greater power, some of which have individual budgets exceeding that of entire countries. The scope and depth of investment provisions today provide for the enjoyment of rights, but no obligations, by multinational companies.

We have listed above just a few aspects of the TPP as finalised by the Malaysian government and its 11 other "partners in crime". Over the next few days, we will analyse and state our position on other aspects of the TPP.

These few aspects are however enough to confirm our worst fears, and we call on the government, for the sake of Malaysia and her future generations, not to sign the agreement.

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