Firedoglake founder interview on Democracy Now: bill includes garuntee monopology provision

[Political Heretic]

Democracy Now report, I just listened to on podcast - Firedoglake founder stats that the house bill includes a monopoly provision that guarantees drug companies the rights to all biological drugs, which she called the "drugs of the future."

She stated that the provision would make it illegal for these drugs to ever go generic and ensures that only rich people will have access to them (due to their enormous cost).

What's the other side of this - anyone familiar with this provision, biological drugs, or anything?

What about a bill passed in the name of health reform that grants drug companies a monopoly?

[Captain Hilts]

1. What's the status of getting rid of Ins. Companies' anti-trust exemption?

[sabrina 1]

8. That is in the House Bill.

I read a section of the bill yesterday and it was included.

[Cessna Invesco Palin]

2. Where is this in the bill? n/t

[Political Heretic]

4. Obviously that's what I'm trying to figure out.

It is nearly 2000 pages after all. This was reported, as I indicated, on Democracy Now and I'm trying to get more information about it.

Someone else said its a 12 year monopoly, not permanent. Not sure if that's true, or if it would make it ok or not, but some clear facts would be helpful.

[sabrina 1]

5. Okay, here's a link with some information

on the provision. http://www.essentialaction.org/access/index.php?/archives/205-Consumer-Health-Groups,-State-Legislators,-Experts-React-to-Vote-to-Add-Generic-Biotech-Drug-Proposal-to-Health-Care-Reform-Bill.html

It looks like the provision is for 12-15 years. But, Jane Hamsher had said that there is a loophole, which would allow the pharmaceutical companies to make slight changes to their products and they would then be able to extend their monopolies, making these drugs unavailable to ordinary people.

In the link above, I read pretty much the same thing:

Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, Tel: [phone] or Cell: [phone], [e-mail]

"The biogenerics proposal adopted today torpedoes the objective of health care cost containment. The Eshoo proposal only offers the illusion of price-lowering generic competition for biotech drugs like Roche-Genentech’s $72,000 per year cancer treatment Herceptin. By making cheap and easy tweaks to old biologic drugs, Big Pharma will be able to obtain near perpetual monopolies and keep affordable biogenerics from pharmacy shelves several decades after their patents expire.

Not sure is this only applies to specific, named drugs though.

[Ruby the Liberal]

7. It is a patent clause

[sabrina 1]

3. I don't think the provision is forever, I think it's for 12 years

[Ruby the Liberal]

6. You are likely talking about Jane Hamsher. She wants biologic

drugs (those created from live cells) to be under 7 (or less) years protection.

The Eshoo amendment to the House bill allots 12 years. Dr. Dean supports this as it is a very expensive and long-time development.

I do not have an opinion on it as I don't know all of the facts on both sides.

[sabrina 1]

9. Yes, I don't know anything about the development of drugs

or how much time it takes, so I cant' say if 12 years is too long or not. But there is a problem with the loophole allowing them to make slight changes and extend the patent protection forever, if that really is the case. If that's true and the cost remains as high as it is now, it would make those medications unavailable to a lot of people.

Otoh, how would it benefit the drug companies to restrict their market to few patients? Would they not be better off lowering the cost and making it possible for hundreds of thousands more people to have access to them?

Still, loopholes like this should be closed if the bill is to mean anything imo.

[robinlynne]

10. 12 extra years after the 20 years they already have.

[Political Heretic]

14. I don't have an opinion either for the same reasons. But thanks for the info.

[ThomCat]

11. Yes, we are going to see a two-tiered healthcare system

because of these meds. :(

If they really do grant a monopoly on biologicals then we're screwed. That can be the window through which health care will be undermined, no matter what we think has been accomplished.

How much would you sacrifice to get that med that is the only thing that will save your life? If only one company has it, you give them anything they want. If they demand that the health care system be changed so that it is more predatory and unfair again, that is what will happen.

[mmonk]

12. Here is some backup to Janes's claims from the UAEM and the

AMSA concernig Eshoo's claim Jane's claim is inaccurate:

"The clause Representative Eshoo refers to does appear on its face to exclude changes that result in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength from being eligible for a new 12-year exclusivity period. Unfortunately, her understanding of how the language operates is incorrect. The existence of the language in the bracket "(not including a modification to the structure of the biological product)"--actually does create a huge evergreening loophole. If you look closely at the tricky language of the sentence you will see that changes to biologics that result in new indications, routes, dosing schedules, delivery systems, strengths, etc., are ineligible for another 12- year exclusivity period under the Eshoo approach only if they come about without a modification to the structure of the product.

In other words, if a company makes a modification to the structure of the already approved biologic that results in a new indication or any of the other items listed, they will be eligible for a brand new 12-year exclusivity period. Unfortunately, because the term "structural modifications" is not defined, interpretation is open to a very wide range of possible changes that will qualify for a brand new 12-year monopoly, many of which are relatively simple and inexpensive to do, and which do not change a drug in any material way."

http://www.huffingtonpost.com/jane-hamsher/anna-eshoos-phrma-boondog_b_342622.html

http://fdlaction.firedoglake.com/2009/11/02/uaem-and-amsa-respond-to-rep-eshoo-point-by-point/">UAEM and ASMA Respond to Rep. Eshoo-Point by Point

[Political Heretic]

13. Thank you for this info, thanks to others providing info as well!

[mmonk]

15. Glad to help.

[Orwellian_Ghost]

16. K&R