[Ip-health] DeLauro and Colins on March-In, and reasonable terms earlier this year

Peter Pitts ppitts at cmpi.org
Wed Dec 14 07:24:52 PST 2016

To this point, according to an article in Health Affairs, "… drugs with public-sector patents accounted for only 2.5 percent of US prescription drug spending."
On Dec 14, 2016, at 10:17 AM, Jamie Love wrote:

> https://www.gpo.gov/fdsys/pkg/CHRG-114hhrg21343/pdf/CHRG-114hhrg21343.pdf
> From this hearing:
> WEDNESDAY, MARCH 16, 2016.
> --------------
> DRUG COSTS Ms. DELAURO. Taxpayers provide more than about $30,000,000,000
> annually for NIH’s research. Dr. Collins, you have said that NIH conducts
> the basic science that ‘‘fosters innovation, ultimately leads to effective
> ways to treat complex medical conditions.’’ And yet, in so many cases,
> taxpayer-funded research leads to drugs that are sold back to the taxpayers
> at exorbitant prices.
> Example. UCLA led to a patent for Xtandi, a drug to treat prostate 26
> cancer. The drug now costs patients $129,000. The same costs patients in
> other countries about a third of that amount.
> Look, I realize the pharmaceutical companies invest their resources. They
> bring a new drug to market. They should profit from that innovation. But
> what I want to know is why U.S. taxpayers are getting gouged for drugs that
> wouldn’t exist without the significant investment of U.S. taxpayers.
> Can you better explain why U.S. taxpayers are paying for biomedical
> research on the front end and paying exorbitant prices at the back end? And
> I will just say that 50 of my colleagues and myself have sent a letter to
> you and to Secretary Burwell, requesting that the NIH and HHS assert
> March-in rights when taxpayer-funded research leads to a patented product
> that is not available to the public on reasonable terms.
> What are reasonable terms? A drug shouldn’t cost $129,000 for people to get
> access to it.
> Dr. COLLINS. Well, I know this is a topic of great interest, and well it
> should be. And certainly, my heart goes out, as all of us do, to patients
> who are in need of a therapeutic which is outside of their financial means
> to be able to gain access to, and that really ought to be the thing that
> drives us trying to come up with better solutions.
> I would say with regard to March-in rights, we read the letter carefully.
> You saw the response from Secretary Burwell. NIH does, in fact, have the
> ability to march in if reasonable terms are not being met and if we have
> intellectual property that is attached to that particular product.
> Ms. DELAURO. What is a reasonable term?
> Dr. COLLINS. Well, that is very much where it gets down to the
> nitty-gritty, doesn’t it? And we have looked at that situation several
> times in the past, and have not felt like we reached reasonable terms. But
> we are totally open to considering that on a case-by-case basis, and we
> will be glad to do that with other products that are brought forward for
> our consideration. We get it that this is a serious issue.
> Ms. DELAURO. And let us have further conversation. And I have gone over my
> time. I thank you, Mr. Chairman.
> ​=================
> Later in the same hearing, DeLauro says that a va​ccine for Zika should be
> affordable, relevant since the NIH and the Army are licensing Zika vaccine
> patents.
> ​=================​
> ​Ms. DELAURO. I would like to continue this conversation to look at breast
> cancer particularly. And I might just ask you to take a look at the Wall
> Street Journal this week. Bristol, and this is Bristol-Myers Squibb bets
> against Precision Medicine. I would ask you to take a look at it and tell
> us, you know, what Bristol-Myers Squibb is thinking about or talking about
> when we are trying to move in this direction.
> Ah, I have got 4 seconds left. La-da-da. All I will just say is, and this
> is to Dr. Fauci, if, one, I want to make sure that any vaccine that we deal
> with for Zika is going to be available and affordable for people. This is
> this reasonable terms issue. But secondly, I will just offer my view. I
> think it is critical for us to deal with supplemental emergency resources
> in order to address this issue and this problem. You are right. I will tell
> you that 46 we are now sending blood products to Puerto Rico in response to
> a Zika outbreak. What happens when we are looking at a blood supply that is
> potentially going to be difficult or people are not going to understand the
> safety of a blood supply with regard to Zika, and what kind of problems
> that is going to cause here in the U.S.?
> And let me just tell you, American women are not going to—they are going to
> be outraged if we are not doing something about them and about their
> ability to be pregnant and to bring a child to term. So thank you for the
> great work that you are doing in this area. I have another question, but
> that is okay. [Laughter.]
> Mr. COLE. Well, I am not sure that was a question, but it was——
> Ms. DELAURO. Genetically modified mosquitoes. Are they—is it— genetically
> modified mosquitoes? Mr. COLE. I am going to ask the gentlelady to take
> that one for the record. Ms. DELAURO. Okay. All right. Thank you. ​
> -- 
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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