KUALA LUMPUR, Nov 14 — Pressure is set to mount on Putrajaya over the controversial Trans-Pacific Partnership Agreement (TPPA) after whistleblower group WikiLeaks released portions of the secretive trade deal that support fears it may force Malaysians to pay more for medicine.
According to the draft of Intellectual Property (IP) Rights chapter published online by WikiLeaks, the United States — seen as the key driver of the deal — is pushing for a five-year ban against the introduction of generic equivalents to patented medicine.
This would also apply from the date a drug undergoes marketing approval in the signatory state, rather than from the date it was originally patented.
In Article QQ.E.16 titled “Submission of Information or Evidence Concerning the Safety or Efficacy of a New Pharmaceutical Product”, it was proposed that a country shall not “authorise a third person to market a same or a similar product” in its territory for at least five years from the date of the approval given to the original product.
This may prolong the period that cheaper generic versions of the drug cannot be made available, a fear that members of the medical fraternity and opposition lawmakers opposed to the murky trade deal have previously voiced.
Malaysia was among the countries opposed to the proposal, together with Australia, Peru, Vietnam, New Zealand, Chile, Singapore, and Brunei.
The same section of the draft also sought for the same moratorium to apply to any similar generic medicine produced in territories aside from the signatory state without consent from the original producer.
The US also wanted a three-year ban to unbranded versions of patented medicine that contained a previously-approved chemical ingredient but is undergoing approval.
Articles in the document concerning US pharmaceuticals were followed by a blank placeholder for a specific provision applying to “biologics”, suggesting that the restrictions could be broadened even further by the US in later negotiations.
“Biologics” refer to organic medical products, such as medicinal vaccine, cells or tissues created through biological processes instead of through chemical synthesis.
In the US and European Union, almost all biologics are brand-named since generic versions—called “biosimilars”—were previously not authorised due to the complexity and difficulties in making them identical to the original producer’s version.
In August, Putrajaya vowed to reject any proposal that would block Malaysians from accessing affordable medicine in the agreement, noting widespread concerns raised over a likely surge in healthcare prices should the trade deal be formalised.
Local resistance to the TPPA has been such that it has united often-opposed groups and personalities — including former prime minister Tun Dr Mahathir Mohamad and archrival Datuk Seri Anwar Ibrahim — under the umbrella of fighting Malaysia’s inclusion in the agreement
Critics have regularly raised concern over costlier healthcare from the TPPA, among others, saying the free trade agreement would enable pharmaceutical giants to patent medicines and obtain longer exclusivity.
The exposé by WikiLeaks yesterday comes as chief negotiators of each country are set to meet in the decisive summit in Salt Lake City, US on November 19 to 24.
The 95-page, 30,000-word chapter on copyright, patents and other intellectual property issues was obtained after the last round of TPPA meet in Brunei between August 26 and 30, and contains annotations detailing each country’s negotiating positions, unlike previous leaks.
WikiLeaks also noted that while Australia is the nation most likely to support US negotiators’ hardline position, countries such as Malaysia, Vietnam and Chile are the ones most opposed.
“If instituted, the TPP’s IP regime would trample over individual rights and free expression, as well as ride roughshod over the intellectual and creative commons,” WikiLeaks editor-in-chief Julian Assange said in a separate statement.
“If you read, write, publish, think, listen, dance, sing or invent; if you farm or consume food; if you’re ill now or might one day be ill, the TPP has you in its crosshairs.”
The TPPA is a free trade agreement that has been negotiated by the US, Malaysia and nine other nations as part of the larger Trans-Pacific Strategic Economic Partnership since 2010.
Critics allege that the agreement has since been co-opted by powerful corporations to allow them to trample over existing consumer, worker and environmental rights in signatory countries.
Up until yesterday, it had not been definitively known how much — if any — of the allegations against the agreement were true.
WikiLeaks is an international whistleblower organisation that rose to prominence in 2010 when it released troves of confidential US diplomatic cables that revealed political intrigue, espionage and other — often embarrassing — revelations involving American embassies across the globe.
According to the draft of Intellectual Property (IP) Rights chapter published online by WikiLeaks, the United States — seen as the key driver of the deal — is pushing for a five-year ban against the introduction of generic equivalents to patented medicine.
This would also apply from the date a drug undergoes marketing approval in the signatory state, rather than from the date it was originally patented.
In Article QQ.E.16 titled “Submission of Information or Evidence Concerning the Safety or Efficacy of a New Pharmaceutical Product”, it was proposed that a country shall not “authorise a third person to market a same or a similar product” in its territory for at least five years from the date of the approval given to the original product.
This may prolong the period that cheaper generic versions of the drug cannot be made available, a fear that members of the medical fraternity and opposition lawmakers opposed to the murky trade deal have previously voiced.
Malaysia was among the countries opposed to the proposal, together with Australia, Peru, Vietnam, New Zealand, Chile, Singapore, and Brunei.
The same section of the draft also sought for the same moratorium to apply to any similar generic medicine produced in territories aside from the signatory state without consent from the original producer.
The US also wanted a three-year ban to unbranded versions of patented medicine that contained a previously-approved chemical ingredient but is undergoing approval.
Articles in the document concerning US pharmaceuticals were followed by a blank placeholder for a specific provision applying to “biologics”, suggesting that the restrictions could be broadened even further by the US in later negotiations.
“Biologics” refer to organic medical products, such as medicinal vaccine, cells or tissues created through biological processes instead of through chemical synthesis.
In the US and European Union, almost all biologics are brand-named since generic versions—called “biosimilars”—were previously not authorised due to the complexity and difficulties in making them identical to the original producer’s version.
In August, Putrajaya vowed to reject any proposal that would block Malaysians from accessing affordable medicine in the agreement, noting widespread concerns raised over a likely surge in healthcare prices should the trade deal be formalised.
Local resistance to the TPPA has been such that it has united often-opposed groups and personalities — including former prime minister Tun Dr Mahathir Mohamad and archrival Datuk Seri Anwar Ibrahim — under the umbrella of fighting Malaysia’s inclusion in the agreement
Critics have regularly raised concern over costlier healthcare from the TPPA, among others, saying the free trade agreement would enable pharmaceutical giants to patent medicines and obtain longer exclusivity.
The exposé by WikiLeaks yesterday comes as chief negotiators of each country are set to meet in the decisive summit in Salt Lake City, US on November 19 to 24.
The 95-page, 30,000-word chapter on copyright, patents and other intellectual property issues was obtained after the last round of TPPA meet in Brunei between August 26 and 30, and contains annotations detailing each country’s negotiating positions, unlike previous leaks.
WikiLeaks also noted that while Australia is the nation most likely to support US negotiators’ hardline position, countries such as Malaysia, Vietnam and Chile are the ones most opposed.
“If instituted, the TPP’s IP regime would trample over individual rights and free expression, as well as ride roughshod over the intellectual and creative commons,” WikiLeaks editor-in-chief Julian Assange said in a separate statement.
“If you read, write, publish, think, listen, dance, sing or invent; if you farm or consume food; if you’re ill now or might one day be ill, the TPP has you in its crosshairs.”
The TPPA is a free trade agreement that has been negotiated by the US, Malaysia and nine other nations as part of the larger Trans-Pacific Strategic Economic Partnership since 2010.
Critics allege that the agreement has since been co-opted by powerful corporations to allow them to trample over existing consumer, worker and environmental rights in signatory countries.
Up until yesterday, it had not been definitively known how much — if any — of the allegations against the agreement were true.
WikiLeaks is an international whistleblower organisation that rose to prominence in 2010 when it released troves of confidential US diplomatic cables that revealed political intrigue, espionage and other — often embarrassing — revelations involving American embassies across the globe.
No comments:
Post a Comment