US Senators are due to begin today what is likely to be a long and bruising debate on its controversial health care reform bill.

On the evening of Saturday, November 21, House Majority Leader Harry Reid succeeded, on a 60-39 vote, in getting the merged Finance and Health, Education, Labor and Pensions (HELP) Committees’ health bills brought to the Senate floor for debate after the Thanksgiving break. 60 votes had to be won for the bill to proceed, and while the Senate is split 60/40 Democrat/Republican (plus two independents), three moderate Democrats – Mary Landrieu, Blanche Lincoln and Ben Nelson – agreed to vote for allowing the bill to proceed but said they would not support any final version that includes a “public option;” ie, government-run insurance plan set up to compete with private health insurers.

Sen Reid’s proposal currently includes such a public option, but it would permit individual states to opt out, unlike the version approved by the House of Representatives in its own health reform bill. Nevertheless, this provision – along with the Senate bill’s controversial proposals on abortion and illegal immigration – could stop the legislation ever getting to a final vote as, again, a minimum 60 votes in its favour will be required before that vote can even take place.

There could also be strong opposition to the provision in Sen Reid’s package to give branded biologic drugs 12 years’ protection from generic competition. The same provision appears in the approved House bill but, back in June, the White House stated that that no more than seven years’ exclusivity was necessary to strike “the appropriate balance between innovation and competition.”

Ohio Democratic Senator Sherrod Brown says he will work to get the current 12 years’ exclusivity reduced. “Biogenerics would save consumers and businesses billions of dollars by putting a stop to open-ended monopolies that produce windfall profits for drug makers. We have a choice between locking in excessive monopoly periods for Big Pharma or helping more patients get access to cheaper drugs,” Sen Brown has said.

Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA) has also attacked the 12 years' exclusivity as “egregious and unwarranted,” adding: “the Senate leadership had the opportunity to address the deficiencies of the House healthcare reform bill and to fulfill the Senate HELP Committee’s commitment to close down a major loophole known as ‘evergreening’ and deliver a more reasonable biogenerics pathway to consumers, labor, businesses, generic manufacturers, and employers. Instead, they have provided further hurdles to access more affordable medicines.”

Meantime, while both House and Senate bills would enable comparative effectiveness research, neither would require providers to use the findings of such research. The House proposal to require to the federal government to negotiate prices with manufacturers for drugs used in the Medicare prescription drug programme is not echoed in the Senate bill, but it does include a proposed amendment requiring greater disclosure on price and fee levels agreed between drugmakers and purchasers, and this has already drawn warnings from pharmacy benefit managers (PBMs).

The amendment, added by the Senate Finance Committee, would require PBMs that contract with health plans under Medicare to report to the government “information regarding the generic dispensing rate: the rebates, discounts, or price concessions negotiated by the PBM and the payment difference between health plans and PBMs and the PBMs and pharmacies. All disclosed information would be confidential, except for certain specific purposes,” it says.

The Pharmaceutical Care Management Association (PCMA), which represents PBMs, has “very strong concerns about the impact" of this disclosure language, PCMA chief executive Mark Merrett told Sen Reid in a letter last week.

“As the language currently stands, the level of detailed pricing information required to be disclosed by the provision – along with the limited protections for confidential information - will inevitably result in this information leaking into the marketplace,” Mr Merrett warns Sen Reid. “This in turn will allow competing drug manufacturers and pharmacies to learn what prices their competitors charge and raise prices accordingly – it would decrease, not increase, competition among them,” he adds.

This is just one of dozens of amendments which Senators will have to consider over the weeks and possibly months of debate on the bill. If it does make it to a final vote, the agreed bill must then be reconciled with the House version, creating compromise legislation which would then be sent to the President. However, his often-stated goal of getting a final health reform bill signed into law by year-end is looking increasingly unrealistic.