The Trans-Pacific Partnership (TPP) has effectively taken away affordable access to life-saving medicines and the country’s control over policymaking, Malaysian anti-TPP lobbyists say.

It also puts the Malaysian government at risk of being sued if it favours public interests over foreign investors under the investor-state dispute settlement (ISDS) provision.

On medicines, the patent protection period for biologic drugs, used in the treatment of cancer, diabetes and hepatitis C, among others, will see generic medicines take longer to come on the market, making affordable treatment difficult.

Klang MP Charles Santiago said early indications based on foreign media reports about the TPP agreement reached three days ago by the pact’s 12 members, showed that data protection for biologic drugs was for a period of five years on confidential clinical trials and a possible extension of three years under data exclusivity.

This meant Malaysia would be going from zero patent protection for biologics medicines here, to a five-plus-three year period.

“We are moving from zero to eight, which means the generic version can only appear after the eighth year.

“Malaysia’s position was five years but we conceded another three years to reach an agreement under US pressure.

“This simply means that Malaysians will not have access to affordable life-saving medicines, such as for the treatment of cancer,” Santiago told The Malaysian Insider.

Although Malaysia will not sign the agreement until it is debated and approved by Parliament, Santiago said the legislative body should object to signing the trade pact.

“This goes against what the government committed to the people.”

Asked about ensuring affordable medicines under the concluded agreement, the Ministry of International Trade and Industry (Miti) referred The Malaysian Insider to its statement issued in July this year in response to concerns about the TPPA.

The statement said patent-protection clauses in the TPPA were not very different from Malaysia’s current regulations, which provide patent protection for 20 years.

“In the TPP, countries would only be required to extend patent protection if there was unreasonable delay within the regulatory approval process. However, such extension can be avoided through efficient implementation. We strongly believe our current approval process is efficient and would not constitute an unjustifiable delay,” its statement said.

Addressing concerns about the higher price of medicines, Miti said the price of drugs would not be solely determined by patent protection, but there were other factors involved, such as “currency fluctuations, the cost of research and marketing budgets and current procurement practices”.

Waiting for details

The hope that Malaysia would be exempted from the TPP chapter on government procurement also did not materialise, Malay Economic Action Council (MTEM) chief executive Mohd Nizam Mahshar said.

The only thing left was the threshold level Malaysia had negotiated and its transition period before it moved into an open market regime.

Malaysia had wanted an exception so that it could continue to retain practices, such as set-asides, price preferences and offsets under its current policies, said Nizam.

But this is no longer the case under the concluded deal and neither does MTEM expect Malaysia to be excluded from the ISDS where government procurement was concerned.

Malaysia, Nizam said, had never objected to this from the beginning.

With no threshold factor set for state-owned enterprises, these companies would have to compete with foreign outfits with several decades of experience behind them, he said.

Miti, in its July statement, however, said “the TPPA does not prevent governments from pursuing and regulating legitimate public policy objectives, especially in areas such as national security, public health, environment and welfare”.

“There are a number of safeguards being negotiated to address the key concerns, including the avoidance of frivolous claims and challenges by investors.

“We are committed to ensuring that our core national policies, including the interests of the Bumiputeras, will be safeguarded,” it had said.

What was left to be seen was how the chapter on investment had been worded, Nizam said.

Story continues