The definition of biologics is being stretched to include many medicines produced by old-fashioned technologies. Extra monopoly years would be claimed on medicines 'derived from a biological system' - that is, from anything that was once alive, plant or animal. Using plants or animals is hardly ground-breaking new scientific technology - it dates back at least to the 1800s with aspirin and the first vaccine. The early decades of the 1900s used plant or animal technologies to give us penicillin, insulin, digoxin and morphine.
The US, on behalf of the large pharmaceutical companies, is asking for blood, too - literally, along with tissues and cells. The human body produces amazing molecules and many people generously make a gift of their blood. What's not used for immediate transfusions is converted and used for a host of conditions. All new blood extracts and products would be caught up in the biologics definition.
They want every new vaccine, too, from ebola to rheumatic fever. Irrespective of technology, gene or old-fashioned, each new vaccine would be called biologic.
Let's put the numbers into context. The US Department of Agriculture reported that eliminating all agricultural tariffs and quotas by all TPPA countries (best case scenario) would give a 0.01% gain in GDP gains to NZ by 2025. That's an extra $23 million - about the same as the lost savings from just one year extra monopoly for the gene technology medicines.
That's before you multiply this by further years of monopoly or add in the new medicines scooped into the biologics definition although they are manufactured by old technology. And that's before you add the extra medicine costs the Prime Minister has admitted will come from concessions already made.
This has impact far beyond the 12 TPPA countries. Other investment deals in the wings (such as the Regional Comprehensive Economic Partnership) would likely cross-fertilise with the TPPA. That would apply the 'more-costly-for-longer' biologics definition to old-technology medicines for some of the most impoverished nations in the globe.
Currently the TPPA countries range from nil to 12 years' monopoly for biologics (New Zealand gives five years for all new medicines, old technology or gene technology). Little wonder Médecins Sans Frontières/Doctors Without Borders has labelled the TPPA "the most harmful trade agreement ever for access to medicines".
I'm not against trade, but we have to be clear what's being traded away. Minister Tim Groser recently said he was "not emotionally in the space of wanting to leave the party". His emotions must not lead him to give in to demands that expand the definition or monopoly time given to biologic medicines.
The leaked text shows that New Zealand has already given in on other aspects of patent law that will, as the Prime Minister says, put up the price of medicines. In his determination to secure a deal, the Minister must not give away biologics too.
Dr Gay Keating is a Wellington-based public health specialist and researcher.
