Medics attack TPP's longer biologics data protection

Medical Association chairman Dr Steve Childs

The Trans-Pacific Partnership's longer data protection for biologic pharmaceutical makers will push up the cost of the fastest growing primary health treatment in the country, the Medical Association says.

Biologic drugs account for more than 40% of new pharmaceutical products being developed and proposals in the TPP to extend the length of time manufacturers can retain the data in producing those products will delay the introduction of cheaper alternatives, Medical Association chairman Steve Childs told Parliament's foreign affairs, defence and trade select committee.

The trade and investment pact between New Zealand, the US, Japan, Canada, Mexico, Chile, Peru, Australia, Malaysia, Vietnam, Singapore, and Brunei proposes two options on biologics allowing for either eight years' data exclusivity, or at least five years protection plus additional measures to deliver extra market protection. New Zealand has a five-year data protection period.

In an oral submission on the TPP Dr Childs said his organisation, which represents medical professionals, is unsure what those additional measures would mean, and the Medical Association's fears a longer protection period will delay the process to develop generic alternatives to those biologics drugs.

"You're extending your cost monopoly for the producer of the products of the most expensive primary treatment that we offer. It is a concern," Dr Childs said. "It is the future – it is going to be the vast majority of healthcare we're going to provide."

The period covering biologics' data exclusivity was a major sticking point in the TPP's negotiations with the US pushing for a 12 year period, and a one-man US Trade Representatives' Office delegation coming to New Zealand is being seen as another attempt by the agreement's biggest partner to press its case as American policymakers increasingly oppose ratifying the deal.

Last week, Medicines New Zealand, which lobbies on behalf of drug companies, told the committee some firms won't bother supplying New Zealand with certain drugs if government funding through Pharmac wasn't available due to the small size of the private market.

While it didn't oppose the TPP outright, the Medical Association said it also had some concerns over the ability of investors and other states to sue the government if it introduced health policy or regulations that another party didn't like, and also the increased the administrative cost of introducing more transparency to Pharmac.

The association requested officials undertake an independent analysis of the agreement to look specifically at how it will affect the health sector. 


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TPP does not require NZ to impose additional data protection for biologic medicines. The "other measures" apply to market protection "taking account of local circumstances". The Government is on record as saying there will be no change to NZ's current practices as a result of TPP. Public health is also excluded from the ambit of TPP's investor state dispute settlement mechanisms and the additional costs to Pharmac's operations, which do not affect on its core role, are marginal at best.

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Isn't extension of protection from disclosure/publication of biologics and extensions of patent terms *specifically* covered in the TPPA? And also, what happens if a suit is brought by a pharmacuetical corporation nonetheless sues the gov't - who determines whether or not that suit is "excluded from the ambit"? The NZ courts? The ISDS secret courts, where we'll never even hear the case is going ahead? And how do you measure "marginal" for additional costs? Enough to make them unaffordable to some whose lives depend on them? Enough for the NZ taxpayer to afford for the greater good? You're backing the wrong side, Stephen.

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The TPP does have two options, what will NZs decision be around adoption? Their comments around no change appeared to be focussed on consumer costs, rather than not increasing government burden behind the scenes.

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