Howdy, Stranger!

It looks like you're new here. If you want to get involved, click one of these buttons!

In this Discussion

Here's a statement of the obvious: The opinions expressed here are those of the participants, not those of the Mutual Fund Observer. We cannot vouch for the accuracy or appropriateness of any of it, though we do encourage civility and good humor.

    Support MFO

  • Donate through PayPal

Trans Pacific Partnership and Generic Drugs

edited June 2015 in Off-Topic
This is not political and I don't want this thread to become political. I'm simply highlighting one aspect of the TPP - that it appears to be negative/very negative for generic drugs.

There are quite a few more sources. Again, not being political just an FYI. Perhaps this is why you're seeing the bidding war in generics - Teva aggressively going after Mylan, Mylan going after Perrigo. Consolidation for strength in size/scale given the negative consequences of TPP for generics.

------------------
http://www.nytimes.com/2015/06/13/business/business-leaders-react-with-dismay-to-defeat-of-trade-bill.html

"He dismissed concerns that the pact could limit access to generic drugs, noting that the overwhelming majority of prescriptions filled in the United States were for generic medications, despite strong intellectual property laws in this country.

Generic drug industry officials hailed the vote, however.

Heather Bresch, the chief executive of Mylan, a generic drug maker, applauded the defeat on Friday by the House, saying it would give her more time to lobby against the trade pact.

She and other leaders in the generic drug industry have argued that the pact goes too far in protecting the patents of the brand-name drug industry and would block access to generic drugs around the world.

“I think it’s scary and dangerous that the president is looking for this kind of authority on a trade bill that I think has serious flaws in it,” she said. “It’s setting the global generic industry back 30 years.”

“I’m thankful for this reconsideration, and I’m going to use this window to try and educate and let our voice be heard,” she said."

--------------------

"n the case of pharmaceutical patents, the TPP appears to offer much stronger protections for drug companies than those set by TRIPS. Patents could be extended beyond 20 years, delaying the rate at which generics can come to market, for example. Poor countries would also have reduced ability to get brand-name drugs at generic costs. Medicare and other government programs around the world could also lose their bargaining power to get generic drugs at reasonable prices.

There are more provisions to beef up patents in ways that global health advocates fear will hurt patients. A wider range of drugs would be eligible for patents, including “me-too” drugs that don’t improve the effectiveness of existing drugs. Some surgical and diagnostic techniques could also be patented, meaning doctors could only use the methods if they paid the patent holder. Provisions that would protect data would also force drug manufacturers looking to introduce a generic drug to conduct their own safety and efficacy studies, which costs money and exposes patients to added risk."

http://www.healthline.com/health-news/would-the-trans-partnership-boost-drug-prices-and-endanger-access-061215#3
------------------------------------

"Trade agreements are negotiated by the office of the United States Trade Representative, supposedly on behalf of the American people. Historically, though, the trade representative’s office has aligned itself with corporate interests. If big pharmaceutical companies hold sway — as the leaked documents indicate they do — the T.P.P. could block cheaper generic drugs from the market. Big Pharma’s profits would rise, at the expense of the health of patients and the budgets of consumers and governments.

There are two ways the office of the trade representative can use the T.P.P. to maintain or raise drug prices and profits.

The first is to restrict competition from generics. It’s axiomatic that more competition means lower prices. When companies have to fight for customers, they end up cutting their prices. When a patent expires, any company can enter the market with a generic version of a drug. The differences in prices between brand-name and generic drugs are mind- and budget-blowing. Just the availability of generics drives prices down: In generics-friendly India, for example, Gilead Sciences, which makes an effective hepatitis-C drug, recently announced that it would sell the drug for a little more than 1 percent of the $84,000 it charges here.

That’s why, since the United States opened up its domestic market to generics in 1984, they have grown from 19 percent of prescriptions to 86 percent, by some accounts saving the United States government, consumers and employers more than $100 billion a year. Drug companies stand to gain handsomely if the T.P.P. limits the sale of generics.

The second strategy is to undermine government regulation of drug prices. More competition is not the only way to keep down the prices of essential goods and services. Governments can also directly restrain prices through law, or effectively restrain them by denying reimbursement to patients for “overpriced” drugs — thus encouraging companies to bring down their prices to approved levels. These regulatory approaches are especially important in markets where competition is limited, as it is in the drug market. If the United States Trade Representative gets its way, the T.P.P. will limit the ability of partner countries to restrict prices. And the pharmaceutical companies surely hope the “standard” they help set in this agreement will become global — for example, by becoming the starting point for United States negotiations with the European Union over the same issues."

http://www.nytimes.com/2015/01/31/opinion/dont-trade-away-our-health.html

etc etc etc.....

Comments

  • @MFO Members: Scott said, "This is not political " that's like saying let the fox guard the chicken coup !
    Regards,
    Ted
  • edited June 2015
    Well, I don't think that this need become political, in the sense of the two major political parties. But an examination of whose commercial ox is getting gored may be of interest. Personally, I find the discussions regarding the generic drugs to be very interesting.

    Perhaps I am incorrect (yet again), but I don't believe that the action so far actually directly involves the TPP, which is yet to be finalized. It's my understanding that Congress has now voted to give the president authority for "fast-track negotiation" involving all trade treaties, which means that if the president signs a trade agreement (such as the pending TPP), Congress still needs to ratify the treaty, straight "yes" or "no", but they may not amend it.

    Without the fast-track concession on the part of Congress, the president's negotiating position was at a great disadvantage, as his agreements could be later amended in a way that made the treaty unacceptable to other treaty parties. Pretty hard to make a good deal under those circumstances, as the other parties know full well that the US really cannot make a straightforward commitment that is not subject to later revision.
  • I think Old_Joe has it right. The big issue is the taking of power away from Congress on these treaty negotiations. I'm not sure what 0bama is trying to prove here. Perhaps he wants this done before he leaves office?

    If the generics issue is not reworked, drug prices will skyrocket which in turn will eventually raise costs for consumers and insurance. It seems totally bass ackwards to me.
  • Well, strictly speaking Congress voluntarily relinquished this particular power- it wasn't taken from them. As far as the politics go, it really isn't a straightforward D vs R situation- the power alignment on either side crosses both party lines for a variety of reasons, resulting in some rather unusual bedfellows.
  • Thanks OJ. I am away from the news for the last few days as we are traveling.
  • Hi @scott

    Thank you. Ramifications will continue, and some will be investible.

    You're already busy with investigations of your desire. I will only add that
    you may choose to find time to review N.A.F.T.A, G.A.T.T and W.T.O. which
    had birth during the Clinton era to continue to shape the new "trade" wheel on a global scale.
    This is as political, as I choose to offer, and the investment ramifications were and continue to be very dynamic.
    The wheel continues to turn.....

    Take care,
    Catch
  • As with all things, people will adapt to the situation. It just takes some time.
  • Big pharma seems to have done very well under the current patent system, and bad things are happening to the prices of many generic drugs over the past 2 to 3 years from my personal observations. The argument for outrageous prices for some newer drugs and biologics is that the prices need to be high to recoup development costs as well as cover the costs of failed potential products. Logically, one could assume that longer patent protection would result in lower initial costs for the drugs or treatments, since costs would be recouped with a longer protected patent. Or, one could simply reap bigger profits. Only the most naive optimist, or a pharmaceutical lobbyist would presume the former.

    The fix is already in, and the TPP will pass, and the rise in drug costs will be another "unintended consequence" of legislation regarded as essential at the time. You know, even if you "eat right" and exercise religiously (no, not just on Easter and Christmas), you'll most likely need some drugs, maybe a lot of them, in advanced age, so long as you look both ways even crossing one-way streets, so you'd better hope those drugs are affordable. With the boomers aging, the patent extension and reduction in generic availability may be even more of a disaster than the loss of jobs resulting from TPP. (Admittedly, I'm basing the presumed job loss on the effects of NAFTA, which Ross Perot predicted with his "The giant sucking sound is your jobs going south" comment in the presidential debates, which did become true for my small Indiana home town when the main factory moved to Mexico.)

  • The countries that have adopted socialized medicine have also instituted price controls on medicines. Our quasi-social system we have now might have to go that route in the future.

    My biggest gripe with big pharma during my pharmacy career was the pricing of the drug compared to the alternative. For example, a medicine that one could take to dissolve kidney stones would be priced in the hundreds. The reasoning was that it saved the patient from having the more expensive lithotripsy procedure. The cost of manufacturing was never involved. Same with TPA (Tissue Plasmogen Activator) which we charged $4000 for but it could take care of the clot versus the more expensive catheterization procedure.

  • edited June 2015
    American's do not like trade agreements in any form or shape. If you want political strategy, the "blame" has once again shifted to a politician that probably will never really need voter approval and set free all those politicians who might be unseated, in part, by a positive vote on the issue itself. If Obama finishes and signs it, this trade agreement will, with fast track, not bite anyone in the ballot.
  • Once again, folks: The president can sign any treaty he wants to, but per the United States Constitution the Senate must ratify that treaty.
  • That's certainly what they teach in civics classes, or whatever passes for them these days. 2/3 approval by Senate. Unfortunately, that's not the way the real world works. (To be honest, I'm still looking through this, I can't believe how convoluted it is.)

    NAFTA was an executive agreement, not a treaty. It was not put before the Senate for consent. Rather, Congress (House as well as Senate) passed a bill approving NAFTA. The Senate vote was only 61 in favor, so one can't bootstrap a ratification off of that vote.
    http://articles.latimes.com/1993-11-21/news/mn-59485_1_trade-pact

    Why Congress passed that statute, and what effect it had is some of what I'm still sorting out. Here's Politifact's take on executive agreements. It describes three different levels of Congressional approval - the NAFTA-like (statute), no approval, and something in between. It doesn't make clear what the import of these classifications is.

    For a more extensive discussion, including historical perspective, see
    http://www.press.umich.edu/pdf/9780472116874-ch1.pdf

    (From that paper: "It is a widely held misperception that the Senate ratifies treaties. Rather, the Senate consents to the treaty, as amended, and ratification awaits presidential action...")


  • edited June 2015
    Hi @msf

    As always, I am pleased to find your thoughts for all topics here; which you choose to add your common sense and wisdom of discovery.

    Relative to the GATT legislation, I found this to be a most disgusting circumstance; as the vote was during a "lame duck session". I suppose one could argue that the legislators in such a circumstance could say that they were able to vote with "their heart and a clear conscience." Sadly, they also won't be returning to the legislature to be concerned about their vote and implications.

    GATT and lame duck session, 1994, multi resources

    Note: I spent many hours providing printed data and home edited video distributions (congressional testimony) to attempt Michigan congressional members and Michigan auto union presidents and members to better understand forward implications regarding NAFTA and GATT. Note: I was not a member of any union.

    This was my last full blown social intercourse with members of congress from this state.

    I will now leave this subject lie in its place.

    Thank you again for your contributions.

    Take care,
    Catch
  • @catch22 - Thanks for the search link. A long but interesting page I found is at Congressional Quarterly (CQ) Almanac:
    http://library.cqpress.com/cqalmanac/document.php?id=cqal94-1102970

    It starts by saying that the deferral on voting until after the 1994 elections was due to parliamentary procedures by a minority trying to block passage. The final votes tend to lend credence to that thesis: 76-24 in the Senate (roll call), and 288-146 (roll call) in the House.

    It describes the opposition as: "a patchwork coalition similar to the one that had almost upset NAFTA in 1993: labor unions, environmental organizations, government reform groups, Ross Perot's United We Stand America populist movement, and such “America First” conservatives as Patrick J. Buchanan."

    It also sounds like the purpose of the statute that was passed was to implement the GATT agreement, not so much to grant approval (though implementation tacitly grants approval).
Sign In or Register to comment.