Intellectual Property Protections Key to Medical Innovation, Economic Growth in Texas
United Nations bureaucrats want to mess with Texas.
The UN High-Level Panel on Access to Medicines recently recommended weakening intellectual property protections that drive and sustain biopharmaceutical innovation. Panelists hope their proposals will make it easier for foreign companies to create knock-offs of treatments researched, developed, and manufactured in America and distribute them around the world.
The Panel's misplaced focus on intellectual property resulted in a series of damaging recommendations that would suffocate medical innovation and stunt economic growth in Texas and across the nation -- all without helping patients one bit. Patents and other intellectual property protections are not barriers to access to medicines. The vast majority of treatments on the World Health Organization's Essential Medicines List are no longer protected by patents, yet millions of people around the world do not have access to them.
Innovation is expensive and risky. Bringing a new drug to market takes an average of a decade and costs roughly $2.6 billion. Additionally, only one out of every 5,000 promising compounds makes it out of the lab and through clinical trials to receive FDA approval. And just twenty percent of approved drugs ever turn a profit.
Strong IP protections allow inventors to profit from their rare successes by restricting copies for a limited amount of time. That's essential, especially given that these companies need to earn back not just the development costs of the successful drug, but of all the ones that failed too. Read More >>
Importation of Prescription Drugs: A Bad Idea
“Reimportation” of prescription drugs is back as an issue, but only because Democrats seek to distract from the effort to repeal and replace Obamcare, according to Politico. By importation we refer to the ability of American consumers to buy their prescription drugs from overseas rather than from domestic sources, and particularly to large-scale importation, such as US drug distributors sourcing their drugs from overseas.
There has always been some cross-border traffic on pharmaceuticals, as drug prices in Canada can be cheaper than in the US. But the Medicare Part D prescription drug benefit, which came into effect in 2006, has significantly reduced this traffic by making prescription drugs available to seniors at more affordable prices.
There’s a reason why such importation is illegal today under most circumstances, and that’s because of safety. The rate of counterfeit drugs in other countries is staggering, and the only way to keep the counterfeit problem from infecting the US drug supply is through the rigorous inspection and supply-chain regime maintained by the FDA. And the FDA has repeatedly told Congress that it cannot guarantee the safety of drugs entering the US from other countries such as Canada, since it does not inspect those facilities. And when the FDA has been permitted to inspect overseas facilities, the results haven’t been encouraging, such as the extensive and discouraging history of the FDA with Indian pharmaceutical manufacturer Ranbaxy.
Some on the free-market side of the political spectrum argue that importation of prescription drugs is simply a matter of “free-trade,” which at least up until the last few months has been a persuasive argument when presented to Republicans. But, as professor Richard Epstein notes in an IPI publication noted below, importation of prescription drugs is actually a perversion of free trade, in that it rewards other countries for their price controls and socialized medicine systems, rewards them for their disregard for the patents of American drug companies, and would likely create shortages of much needed drugs in poor countries as their drug supply was diverted back to the US. Read More >>
The Moral and Logical Vacuity of the Anti-Patent Crowd
Now, any clown can come up with an example of a bad patent. Priti has the nerve, however, to use Sovaldi as her example, which is where we are going with all of this.
What is Sovaldi? Sovaldi is a CURE for Hepatitis-C. It’s a revolutionary medicine. First you had Hep-C, and you suffered and you died early. Now, with Sovaldi, you can be cured of Hep-C.
I emphasize this because, before Sovaldi, the critics of the pharmaceutical industry were bashing the industry because it allegedly was focusing on lifestyle drugs for the rich West rather than trying to cure the diseases that plagued millions of people. Greed rather than trying to actually cure diseases. Then Sovaldi comes along and inconveniences their argument.
But you’ve got to hand it to Priti. She has nerve—almost certainly more nerve than you or I have. Because Priti can write something like this:
“We have evaluated Gilead’s patent portfolio and found that, based on US and international patent law, Gilead does not deserve any of its 27 patents for Sovaldi. Both the base and secondary patents for the drug are based on old science and commonly known techniques.”
Really? So there’s no cure for Hep-C. Someone invests millions of dollars and years of expertise and actually manages to invent a cure for Hep-C, but they’re not entitled to a single patent for such a revolutionary invention? Read More >>
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18 Months After the VA Scandal, Not Much Has Changed for Veterans
In this video from reporter Jason Whitely at WFAA-TV in Dallas-Fort Worth, IPI’s Dr. Merrill Matthews says not much has changed in the Veterans Administration 18 months after news of its VA hospital wait-time scandal first broke. Read More >>
Shkreli's Stupid Pricing Move Vindicates Rather Than Indicts Pharmaceutical Markets
The Real "Death Sentence": Limiting Data Exclusivity
Public Citizen is highlighting a cancer victim who is protesting at the Trans-Pacific Partnership (TPP) meeting in Atlanta.
Public Citizen quotes the protester as saying: "When you have breast cancer today, you can’t wait 8 years or 7 years or 6 years for a treatment to become available or affordable. When you have cancer, even a one-year delay in affordable medicine can be a death sentence. That is why we call this proposed provision of the TPP a ‘death sentence clause.’ If it passes, thousands of women like me will die waiting.” Read More >>
The Australia-U.S. Free Trade Agreement Did NOT Blow-up Australia's Pharmaceutical Benefits Program
Right now, literally as I type this, Australian trade negotiators are reportedly resisting U.S. demands for increased protection of pharmaceutical and biotech innovation in the Trans-Pacific Partnership (TPP) agreement. They are no doubt motivated by the warnings of Australian academics and researchers that Australia’s Pharmaceutical Benefits Scheme (PBS), which the Australian government uses to control drug prices, will be weakened or undone altogether by extending the period of data protection for biologics, among other provisions.
The sky-is-falling warning from these academic critics of the pharmaceutical industry is that protecting the products of innovation will necessarily result in dramatic price increases, which Australia (and Australians) will no longer be able to afford.
Interestingly, Australian academics made this exact same argument in 2003, warning Australia about the treaty that was then being negotiated, the Australia-U.S. Free Trade Agreement (FTA).
I have before me a copy of a paper published by The Australia Institute, entitled “A Backdoor to Higher Medicine Prices? Intellectual Property and the Australia-US Free Trade Agreement,” by Dr. Buddhima Lokuge, Dr. Thomas Alured Faunce, and Richard Denniss.
The paper predicted that the Australia-U.S. FTA would result in dramatic increases in the cost of prescription drugs in Australia.
“This paper examines five leading medicines near the end of their patent lives in Australia. Based on PBS expenditures for these drugs in 2003, we estimated the potential cost of likely changes to IP provisions under the FTA to the PBS and Australian taxpayers. The costs accrue over a four-year period from 2006 to 2009. . . . The ‘central case’ estimate is that the additional cost of these five drugs alone, as a result of IP provisions in the FTA, will be more than $1.12 billion with a lower estimate of $850 million and an upper estimate of $1.56 billion.”
But they were wrong then, and they’re likely wrong now. Read More >>
Australia Drug Prices Did NOT Increase After Australia-U.S. FTA
A piece in today’s Dominion Post (New Zealand) finds that warnings about higher drug prices as a result of free trade agreements are baseless, as least as far as facts are concerned:
“We can't assume medicine costs will increase if some patents or Intellectual Property protections are extended. Speculation about rising medicine prices under the TPPA mirror concerns Australians voiced over the U.S-Australia FTA. However, since signing the FTA in 2005, Australia's spend on pharmaceuticals has remained stable and the rate of expenditure has decreased. In 2006 Canada's pharmaceutical spend decreased after implementing an eight year data protection period. Similarly, after Japan increased data protection in 2007 to eight years, pharmaceutical spend decreased and health care spend increased by the year 2010.” Read More >>
TPP Critic Quigley Writes Article for Foreign Policy; Coordinates with Anti-IP Activists
On Monday, a writer named Fran Quigley had a piece published on the Foreign Affairs website that was highly critical of some of the provisions in drafts of the Trans-Pacific Partnership (TPP) agreement.
We’ll get around to dealing with the arguments in Quigley’s FP article in a separate blog post.
Quigley’s title of “Clinical Professor of Law in the Health and Human Rights Clinic” at Indiana University tells us much of what we need to know. If you merge health and human rights, you have already decided that access to every bit of the latest health care technology available is a human right, and if it’s a human right, it’s your right to have it for free, or for something very close to free.
That makes Quigley an activist more than an analyst of the provisions of the TPP. A look at his cv demonstrates that Fran is a social justice crusader, a proponent of the labor movement, and a neighborhood organizer type. Read More >>
Webcast Tonight: Merrill Matthews Speaks At Cancer Specialist Conference
IPI's Dr. Merrill Matthews joins ASCO, the world's largest conference of cancer specialists, tonight in Chicago to discuss the role research and development plays in fighting cancer and why innovation is critical for patients. Read More >>
So Do We Need Pharmaceutical Innovation, or Not?
Today in the Wall Street Journal, there is good op/ed about the threat of Ebola and other infectious diseases that urges us to invest more money in medical innovation.
There's also another op/ed complaining that cutting edge, innovative medical cures are too expensive, and that we need something apparently just short of price controls to do something about it.
So which is it? Do we want pharmaceutical and biotech companies taking risks and innovating new cures, such as Sovaldi, the new cure for hepatitis? Or not?
Ms. Ignagni's piece is particularly egregious. It's part of a campaign that she's behind to get the federal government to forceably lower the price of Sovaldi, a blockbuster new miracle cure for hepatitis C. Note the word "cure."
First, she writes as if concern over high drug prices is a recent phenomenon, which of course it isn't. I've been hearing statists complaining about high drug prices for the 20 years I've been doing public policy. In fact, the first paper I ever edited and published at IPI was on this very topic. The redistributionists have never understood why they can't have all their diseases cured and their pain alleviated without it costing anyone anything. They're always focused on the second order concern--how goods are distributed--without fully appreciating the first order concern--how goods come to be in the first place.
Distributing existing goods is easy--innovating a new product or service that never existed before, now that's impressive. But apparently not to Ms. Ignagni. Read More >>
ObamaCare Creates Some More Part-Timers
I was talking with a lady, who is probably in her late 50s, when she told me she was going to start looking for a different job. See, she’s a teller working in the branch of one of the country’s largest banks, and the bank is making some cutbacks, turning its full-time tellers into part-timers (at some branches anyway).
I asked the next question, but I was pretty sure I already knew the answer: How many hours was the bank willing to let her work? Under 30, she said, which just so happens to be ObamaCare’s dividing line between those who must be covered with employer-provided health insurance and those who don’t. Read More >>
A Way Around the Law
Health and Human Services Secretary Kathleen Sebelius has taken a lot of heat for asking--some would say shaking down--health insurance executives for money to help implement ObamaCare. So it has changed the messenger, but not the message. Read More >>
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