The New York Times published a new article on the TPP negotiations today (July 31, 2015). What is being called the final negotiating session is underway in Maui. However the Times reports that “dozens of issues remain unresolved”. One of these is the US push to extend exclusivity periods for pharmaceuticals and to free up pricing so that pharmaceutical companies can set any price that “the market will bear” as they like to say.
The US is apparently pushing the extension of exclusivity (Data Protection as they call it) to 12 years and citing the biosimilar legislation in the US which gave biologicals 12 years rather than the long standing 5 years the Hatch-Waxman gave to small molecule drugs. The report states that US negotiators are saying that they can’t go against the 12 years in current US law, conveniently ignoring the fact that the vast bulk of pharmaceuticals in the US have only 5 years of exclusivity.
According to the report Australia is leading the push back against this exclusivity and are holding a firm line at the existing 5 years. Australian negotiators point out that it takes “6 or 7 years to develop complex biologicals” so the real period of protection is significantly longer than the period of “data protection”. In many countries development cannot begin until patents expire and you cannot file until exclusivity expires.
The report states that “Observers to the negotiations say the 12-year data-protection window almost certainly will be scaled back to five to seven years, a move that will probably satisfy neither the pharmaceutical firms and their allies nor the activists pressing to overturn the whole patent system.” The reference to “activists” is to groups who believe that everyone should have access to life saving drugs and so think there should be no patents on drugs.
Australia for its part points out that in countries where the majority of pharmaceutical costs are covered by a national health scheme the much higher costs that would come from a longer period of data protection would come directly from the taxpayers of those countries and go to largely American pharmaceutical companies. They are holding firm on the current 5 years stating that Australian lawmakers will not support anything longer. This serves to point out the big problem here, in the US the cost of pharmaceuticals is paid by private insurance companies who don’t really care how much they cost (they make a profit anyway) whereas in countries like Australia the cost is paid by taxpayers who do really care how much they cost.
With luck we will not have to wait much longer to find out what the compromise will be in the final agreement, but somewhat longer to see which countries will vote to support their entry into the TPP.
