The finalised texts of the Trans-Pacific Partnership (TPP) agreement confirm its worst fears about allowing a select few driven by multinational commercial interests to establish a deal behind closed doors, a group against the trade deal said today.
Bantah TPPA said the deal would jeopardise access to affordable medicines, adding that its concerns regarding the agreement had not been overblown.
“[The intellectual property chapter] enables drug companies to press for patent term extensions beyond the standard 20 years and compensate for any ‘unreasonable’ time a patent office or drug regulatory authority takes to approve a patent application or grant marketing approval,” the group’s chairman Mohd Nizam Mahshar said in a statement today.
“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.”
Nizam added that under the agreement, Malaysia must provide five years’ data exclusivity for biologics but said these terms had led to such high prices that even in the United States, the government had repeatedly sought to reduce the number of years of biologic data exclusivity.
Data exclusivity extends to the new generation of “biologics” medicines developed to treat human diseases and conditions, such as vaccines, cancer medicines and therapies such as insulin.
Nizam also warned of the “evergreening” of existing monopolies which he said would happen through market exclusivity if a “new” medicine was actually an old drug found to be useable for a condition other than the one it had been developed to treat.
Likewise, old medicines could be found useable for a different population of patients, or pharmaceutical companies could seek exclusivity for new combinations of an old drug and a new chemical entity.
“The finalised texts… confirm our worst fears,” he said.
“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 TPP document was uploaded to International Trade and Industry Ministry website earlier this afternoon.
The agreement is scheduled to be tabled and debated in Parliament at a special sitting early next year.
Twelve countries – Australia, Brunei, Canada, Chile, Japan, Mexico, New Zealand, Peru, Singapore, the US, Vietnam and Malaysia – concluded the TPP negotiations in Atlanta on October 5.
Detractors of the controversial deal say it will cause negative economic growth and have implications on the country’s sovereignty as it will remove the country’s control over policymaking.
They also fear that the deal will put the government at risk of being sued if public interest is prioritised over foreign investors.
However, Putrajaya has brushed aside opposition, saying that the pact will provide more choices for consumers and boost a healthy competition between local and foreign producers in the local market. – November 5, 2015.