|President Barack Obama|
The Obama administration is backing off of drug-price protections in the big Trans-Pacific Partnership treaty now under negotiation, The New York Times reports. But U.S. negotiators are still pressing for more power to get involved in government decisions on reimbursement rates.
Citing newly leaked documents, the newspaper says it's another case of branded drugmakers versus generics makers, activists and public health officials, who maintain that the treaty would push up government drug costs and force consumers to pay more for their meds.
The provisions are part of a "transparency" annex in the proposed trade agreement, which would cover 12 nations, but potentially affect drug costs in other countries as well because of reference pricing. An earlier proposal had referred to "competitive market-derived prices" and granted drugmakers the right to appeal reimbursements they considered too low.
That market-pricing language and appeals process are now gone, but trade negotiators appear ready to give drugmakers more power to influence government reimbursements, the NYT says, citing the leaked document.
|La Trobe University's Dr. Deborah Gleeson|
"It was very clear to everyone except the U.S. that the initial proposal wasn't about transparency; it was about getting market access for the pharmaceutical industry by giving them greater access to and influence over decision-making processes around pricing and reimbursement," Deborah Gleeson, a lecturer at the School of Psychology and Public Health at La Trobe University in Australia, told the Times.
It's true, however, that at least one of the TPP countries--New Zealand--zealously holds the line on drug costs and offers pharma little information about its consideration of new therapies. "There are no clear timelines for review, no sense of what a complete dossier is to get a fair review," PhRMA's Jay Taylor told the newspaper. "It's a question of basic due process."
As Taylor points out, "market access" is key for drugmakers trying to launch new products in various markets. Agreeing with governments on pricing can be a long and difficult process. But in some countries--such as England, where the National Institute for Health and Care Excellence (NICE) has a well-defined process--opportunities for drugmakers (and patients) to weigh in are built in.
One worry for public health groups is a provision that extends the drug-review rules to U.S. government health programs. While the Centers for Medicare and Medicaid Services already has a process that would comply with the proposed TPP rules, those rules could prevent U.S. lawmakers from changing rules that prohibit Medicare from negotiating prices with drugmakers.
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