Trans-Pacific politics

Pharma and biotech companies weighing political responses to TPP deal

The biopharma industry is again at the center of a massive political dispute, this time over the Trans-Pacific Partnership. After fighting and losing a battle to persuade or force the rest of the world to adopt 12 years of biologics exclusivity, biotech and pharma CEOs are focused on shoring up support in the U.S., where presidential candidates are pummeling them as profiteers.

U.S. Trade Representative Michael Froman announced last week that TPP sets a five-year minimum period of exclusivity augmented by regulatory and administrative requirements that could further delay biosimilars launches for an unspecified period.

When President Obama last week summoned drug company CEOs to the White House to discuss TPP, they expressed their anger and bewilderment with the deal, according to people who were briefed on the meeting.

After five years of negotiations, with elections looming in many TPP countries creating intense pressure to finalize the treaty, Australia was willing to walk away rather than accept an increase over the five years of biologics exclusivity it currently provides.

The U.S. was not willing to kill the deal over a biologics exclusivity policy that President Obama has resisted at home. Instead, the U.S. agreed to ambiguous language that mandates no changes to Australian law, but that could be interpreted to require it to implement unspecified measures that would add up to eight years of effective exclusivity.

Ironically, Hillary Clinton is citing the treaty's alleged benefits to drug companies as one of the main reasons for her opposition to TPP (see "Hillary's TPP Strategy," page 2).

While public discussions about TPP have focused on its effects on markets for biologic drugs in Australia, Japan and other U.S. trading partners, the public statements and private lobbying of drug companies and their trade associations are in fact primarily targeted at the U.S.

BIO and PhRMA have rallied political support for a global 12-year exclusivity period because they feel that acknowledging the acceptability of a shorter period anywhere, under any circumstances, could undermine their position in the U.S., biotech and pharma company lobbyists told BioCentury.

Pushing past the public posturing, in

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