Is Medicines NZ about to get US help to oppose Pharmac's TPP policies
By Richard Harman (author)
There were questions last night as to whether United States "Big Pharma" companies might be out to put pressure on the New Zealand Government to change some of its TPP policies on Pharmac.
New Zealand's "Big Pharma" lobby group, Medicines New Zealand has complained that the TPP is too tough on the pharmaceutical companies.
It argues that the way the Government is interpreting the TPP means that nothing has changed as far as Pharmac is concerned.
But TPP opponents here say that we can expect an upcoming high level US trade delegation here would enable the US to put pressure on the Government to move things in the direction wanted by Medicines New Zealand
In their submission to Parliament's Foreign Affairs Defence and Trade Committee on the TPP Medicines, New Zealand says recent dialogue with Government officials indicated New Zealand was taking a narrow interpretation of matters around intellectual property and transparency around medicines procurement.”
Medicines New Zealand chair, the former ACT MP Heather Roy said: “This seems, in most cases, to be at odds with the majority of TPP countries’ interpretations and positions and OECD norms, especially on IP provisions."
The submission says the New Zealand Government’s proposed two-y[G1] ear maximum limit for pharmaceutical patent term extension, including an unwillingness to take into account delays experienced in carrying out the necessary studies and clinical trials to establish the safety of the pharmaceutical substance, “is unacceptable to Medicines New Zealand.
“Furthermore, it is not in line with other TPP signatory countries such as Australia, USA and Japan (all up to five years).”
Medicines New Zealand is also complaining that the Government is fiddling the requirement to extend data protection on new biologically based “biologic” drugs from five to eight years.
"It does not represent an eight-year marketing protection period, only five years with other measures and market circumstances being proposed to reach an eight-year[G3] end point. “
“This is an extremely liberal interpretation of what actually constitutes robust data protection.”
But Australia appears to be going along the same lines as New Zealand with the former Trade Minister Andrew Robb saying that Australia would not need to change its laws to comply with the TPP biologics provisions.
Medicines New Zealand says it is not seeking an end to Pharmac but argues there is room for improvement in both the transparency of Pharmac decision-making processes and timeliness of funding decisions.
“Medicines New Zealand is not supportive of the New Zealand Government’s proposed interpretation of the Transparency Annex of the TPP.
“This represents no more than a status quo for the way in which Pharmac already makes funding decisions.”
Health Minister Jonathan Coleman was unavailable for comment last night but the Government is unlikely to be too phased by this submission.
The only worry would be if the United States Government were to take up the case promoted by Medicines New Zealand.
The Republican Senator Orrin Hatch who is chair of the Senate Finance Finance Committee will be an influential voice in the final decision by the US Senate to ratify the agreement and Hatch said he was concerned that negotiators failed to secure 12 years of protection for next-generation biological drugs, which could push companies to leave the industry, make it more difficult for innovators to recover investments made in new products and leave Americans subsidising cheaper medicines in other nations.
The U.S. campaigned for 12 years of protection to ensure incentive for innovation, while Australia and New Zealand pushed for five years to give patients access to cheaper medicine.
Hatch said the U.S. should not have agreed to Australia's "greedy" demands for a smaller monopoly period.
"At the end of the day, (the U.S. Trade Representative) may need to go back to the negotiating table and try again... The alternative to renegotiation may very well be no TPP at all," he said.
The TPP opponent Professor Jane Kelsey was ringing alarm bells on that yesterday with a statement picking up on a "Wolrd Trade Online" report that the US Trade Representative, Michael Froman, was sending "implementation teams" to Trans-Pacific Partnership countries to discuss how they will implement their obligations on intellectual property and other issues, as well as the capacity building they may require in order to meet them.
Professor Kelsey says ‘ “Implementation is code for the US making sure it gets what it wants, backed by its power to veto the TPPA’s entry into force if it doesn’t”
“I strongly suspect these fixes will involve administrative measures, not legislation, so there will be no public process even after the fact.”