TPPA - did minister mislead public on medicine costs?

by Koh Jun Lin     Published 12 Nov 2015    Source : Malaysiakini

Opposition members of the parliamentary caucus on the Trans-Pacific Partnership Agreement (TPPA) have accused International Trade and Investment Minister Mustapa Mohamed of misleading the public on its impact on the cost of medicines.

They said that while Mustapa told the public that Malaysia had only been granted a five-year protection period for clinical trial data, the TPPA actually stipulates two options.

These being that TPPA partners may either provide an eight-year data protection or a five-year protection data accompanied with other measures that would have the same effect as an eight-year data protection period.
“This leaves room for the US to continue to pressure countries to use administrative delays to keep affordable medicines off their market for an equivalent period of time.

“Whatever the mechanism used, the effect would be the same: rising costs and delays in access,” TPPA caucus member Nurul Izzah Anwar told a press conference at the PKR headquarters in Petaling Jaya today.

The TPPA’s clinical data exclusivity clauses prevent pharmaceutical companies from using test data from their competitors to apply for government approval to sell the same drugs for a period of time which, in effect, provides the company which first marketed the drug with a temporary monopoly on its sale.

The impact is most significant for an emerging class of drugs known as biologics which do not always qualify for patent protection.

Klang MP Charles Santiago said biologics have shown promise in treating ailments such as cancer, AIDS, and rheumatism, but could cost up to RM5,000 each.

In contrast, the ‘generic’ versions of these products (known as biosimilars) cost only about RM50, but TPPA’s data exclusivity clauses would keep them out of the market until the protection expires.

Malaysian law currently provides a five-year data exclusivity period for conventional drugs, but there is no such provision for biologics.

Different picture

Kelana Jaya MP Wong Chen said the New Zealand government already acknowledges that TPPA would raise medical costs, and Malaysia should follow suit.

Nurul Izzah also said that Mustapa had wrongly dismissed claims that TPPA would allow extensions of patents of old but modified medicines.

She insisted that the terms of the agreement allow for patent extension applications up to another 20 years, which could open the door to ‘patent evergreening’.

As it is, she said, Malaysians already pay between 30 and 148 percent higher prices for the same medicines compared to their Australian counterparts, due to an absence of a medicine pricing policy in Malaysia.

“To assuage fears, the International Trade and Industry Ministry has said that the TPPA will not allow for patent extension, and that the government has agreed to extend this privilege to biologics, completely dismissing the importance of affordable medicines to the people of Malaysia.

“However, the TPPA text paints a very different picture,” she said.