Trade Minister Todd McClay says he sees no reason why big pharmaceutical firms would stop supplying new medicines in New Zealand as they have always done, despite threats from lobby group Medicines New Zealand over the government's stance on intellectual property protections under the Trans-Pacific Partnership agreement.
Medicines New Zealand chair Heather Roy, a former consumer affairs minister, has indicated drug companies may not bother to register drugs here unless the government makes more concessions on the TPP.
The threat comes ahead of a one-man delegation from the US Trade Representatives' Office arriving in New Zealand reportedly to talk about implementation of the agreement which requires the US to sign to go ahead.
Some drug companies were already not making products available in New Zealand if they didn't get Pharmac funding because the private market was so small, though Roy couldn't say how many had done so.
The government's stance on TPP IP protection "would mean that more companies would consider doing that, which is not helpful for clinicians wanting to prescribe those medicines or for patients who would have no access to them in New Zealand and would have to seek alternatives offshore," she said.
Medicines NZ's recent submission to Parliament's Foreign Affairs Defence and Trade Committee on the TPP medicines clauses said dialogue with government officials indicated New Zealand is taking a narrow interpretation on IP matters and medicines procurement.
The government's proposed two-year maximum limit for pharmaceutical patent term extension, including an unwillingness to take into account delays experienced by the patentee in carrying out necessary studies and clinical trials, is unacceptable and not in line with other TPP signatory countries' perspectives or positions, the submission said.
The other key issue is an increase from five to eight years in the data exclusivity period for biologics, which include many new and expensive medicines such as the cancer drug Keytruda. Data exclusivity refers to protecting clinical trial data submitted to regulatory agencies from use by competitors and is a different type of monopoly protection to patents.
It was a key battle in the TPP negotiations with the US wanting 12 years and New Zealand wanting to maintain five years. The final wording of the TPP text is fairly ambiguous as it contains two options around biologics, one stating at least eight years' protection of clinical trial data and another saying at least five years' protection along with other measures to deliver a comparable outcome in-market.
I see no reason drug companies would not continue to register their medicines in New Zealand as they've always done.
Medicines NZ claims the government is taking "an extremely liberal interpretation" that effectively would mean "for biologics it doesn't represent an eight-year marketing protection period, only five-year with...other measures and market circumstances being proposed to reach an eight-year point."
"This is an extremely liberal interpretation of what actually constitutes robust data protection," Medicines NZ said, and would effectively mean the status quo in New Zealand.
McClay reiterated in an emailed statement that "TPP is not up for renegotiation".
He said all parties had agreed to keep in touch during their ratification processes, so it was not unusual that the US would send someone to New Zealand.
"It is normal for countries to take an interest in how other countries bring treaty obligations into effect. Any meetings would be at official level, not ministerial," he said. "I see no reason drug companies would not continue to register their medicines in New Zealand as they've always done."
He said discussion with the US, led by the Ministry of Foreign Affairs and Trade, is likely to focus on information about process and timelines for both countries' ratification.
"New Zealand has been clear how it will meet the obligations under TPP, including in the National Interest Analysis, " he said. "We are equally interested in how the US is implementing the obligations in TPP that will assist New Zealand exporters."
McClay would also hold ratification discussions with a number of TPP countries while in Peru for APEC next month.
TPP critic Jane Kelsey said last week that the visiting representative from the US Trade Representatives' Office is trying to "fix" problems that mean the deal doesn't have support in Congress.
US Trade Representative Michael Froman this month said intellectual property was a major point of discussion with other governments, making particular mention of New Zealand's proposed legislation on patent term extensions.
Kelsey said she was more concerned about pressure to change the protection for biologics, given the Republican chair of the Senate Finance Committee Orin Hatch, who decides if and when the TPP implementing legislation proceeds, has hardened his stance saying eight years is not enough and he now wants 12 years. Froman has said the Obama administration was still "developing ideas" for how to resolve the Republicans complaints that the TPP's required market exclusivity period for biologic drugs was too short.
Kelsey said she strongly suspects any required "fixes" from the US would involve administrative measures in New Zealand rather than being included in TPP legislation.