Generic drugs often become available earlier in other countries and that means greater affordability. Generally, it’s a violation of a drug companies’ intellectual property rights when a company sells a generic in a country before the patent has expired. But what happens if you import a generic version of a drug, one that is lawfully-made and sold in a country where it is available but still on patent here, to fill a prescription? Are you committing an intellectual property violation?
According to a side agreement (of the General Agreement on Tariffs and Trade) among countries party to the World Trade Organization, called TRIPS (Trade-Related Aspects of Intellectual Property Rights), countries are not obligated to enforce IP laws for small importations of goods, which include pharmaceuticals.
You can find this in Part III, Enforcement of Intellectual Property Rights, Article 60:
De Minimis Imports
Members may exclude from the application of the above provisions small quantities of goods of a non-commercial nature contained in travelers’ personal luggage or sent in small consignments.
The “above provisions” refer to enforcement actions against intellectual property violations that involve goods crossing borders (in person, by plane, sea, through the mail, etc.). If you read closely, it includes the word “may.” That means, in theory, you could be accused of an IP violation, but I know of not a single instance of that happening to an individual importing a medicine for personal use.
What is clear is that there’s general agreement (no pun intended) that individuals should not be subject to IP enforcement actions for importing a product for personal use. When it comes to a life-saving medicine, this seems like common decency – even natural law.
Tagged with: article 60, intellectual property rights, patent, TRIPS, WTO
Azar is proposing a discussion about allowing imports of single-source drugs to lower costs
Yesterday, Health and Human Services Secretary Alex Azar announced that he was tasking FDA Commissioner Scott Gottlieb with forming a working group to explore how drug importation could be used to lower prices. See Gottlieb’s remarks on the proposal.
The crux of the proposal is very narrow. Azar is considering allowing imports of foreign versions of off-patent medicines that only one manufacturer (also referred to as “single-source” drugs) is selling in the U.S. market. That would be a drug without any competition where the company with the marketing license jacks the price. Keep in mind that he has simply called for a working group to discuss it.
I’m getting asked a lot of questions about this proposal and realize that many people, including well-informed journalists and policy professionals, don’t really get this.
People who already import medicines, through buying them online or carrying them home from Canada to save money may also be confused!
So, to help any and all understand what HHS and the FDA are considering when it comes to drug importation, below are some important takeaways. My general take, as noted in the Washington Post, is that it’s a step in the right direction (if it goes forward), and it could help educate the public about greater potential benefits to larger scale importation.
- This is not legalizing buying cheaper, FDA-approved meds from retail pharmacies in Canada online or otherwise.
- Millions of Americans already benefit from importing lower-cost, safe and effective medicines for personal use. They do this despite the existing federal prohibitions and scare tactics employed by industry-funded groups to deter such purchases. To do so safely, they stick to credentialed online pharmacies, such as those verified by PharmacyChecker.com. Today, Roger Bate, who is affiliated with the American Enterprise Institute, wrote: “All the FDA has to do is allow Pharmacy Checker to do its job and tell the American people about it.”
Tagged with: Alex Azar, Daraprim, emflaza, gleostine, Roger Bate, Scott Gottlieb, single source
The relentless deluge of Big Pharma bunk in the media continues. Dr. Kristina Acri, an associate professor of economics at Colorado College, recently published an op-ed in a local Colorado newspaper – The Pueblo Chieftain – called “Drug importation bill a poison pill.” Dr. Acri is against a state bill supported by Congressman Jared Polis (D-CO), who is also running for Governor, that would allow the wholesale importation of lower-cost medication from Canada. This bill is similar to one recently passed in Vermont, which came from drug importation model legislation created by the National Academy for State Health Policy.
The Pueblo Chieftain did not include that Dr. Acri has worked for the Pharmaceutical Researchers and Manufacturers of America. She is also known as a staunch supporter of the drug industry’s intellectual property rights agenda.
Congressman Polis was given ample opportunity to respectfully refute Dr. Acri’s stance in his own op-ed called “A safe way to lower drug costs.” I liked his op-ed. Feel free to read both of their positions, but one thing he wrote about Dr. Acri’s piece was wrong: “I very much appreciate Dr. Acri offering a constructive, fact-based critique that enriches our community’s discussion of this important issue.” Her piece was decidedly not fact-based, and it needs to be called out. Let’s break it down.
First, she writes: “A study by the Organization of Economic Co-Operation and Development showed that counterfeit drugs accounted for 2.5 percent – or $461 billion— of the world drug market in 2013.” I looked at that report, and it states that in 2013 international trade in counterfeit and pirated goods (not just drugs) “represented up to 2.5% of world trade, or as much as $461 billion.” That section is referring to total world trade – not solely pharmaceuticals. That total includes all counterfeit products ranging from “high-end consumer luxury goods such as watches, perfumes or leather goods, to business-to-business products such as toys, pharmaceuticals, cosmetics and foodstuffs.” Over the years, the industry has plucked numbers out of thin are on the topic of counterfeit drugs, getting “facts” to stick in the media, but this one really took the cake.
See the study for yourself: https://read.oecd-ilibrary.org/governance/trade-in-counterfeit-and-pirated-goods_9789264252653-en#page12. (more…)
Tagged with: colorado, Congressman Jared Polis, Dr. Kristina Acri, nashp, state importation bill
In its wisdom and activist spirit, Vermont has a new law on the books allowing for the wholesale importation of FDA-approved drugs from authorized wholesalers in Canada. Canadian wholesale pharmacies sell many brand-name drugs at much lower costs than their U.S. counterparts. This could help patients pay lower prices at local pharmacies and the state to save money on its pharmacy bills.
Some people (oh, I don’t know, ones sponsored by Big Pharma) are saying that the drug importation program is illegal. Let me tell you why that’s ridiculous – and I’m using a kind word. The new law does not allow pharmacies in Vermont to import medication from Canadian wholesale pharmacies; at least not yet. Instead, Vermont will ask permission from the U.S. Department of Health and Human Services to implement an importation program. It will try and prove to the department that its program will be safe and compliant with federal law. If the Secretary of Health and Human Services certifies the program, which is permissible under current law, only then will Vermont bear the fruits of its labors and begin importing from Canada.
I wrote more extensively about similar legislation introduced in Utah, which passed the House but failed to make it through the Utah Senate. Here’s that analysis: Rep. Norman Thurston’s Utah Drug Importation Bill. It explains, mostly, what this bill is and is not.
What’s amazing and motivating is that Vermont passed this bill 29-0 in the Senate, and 141-2 in the House. Vermont is not putting up with pharma’s bull on importation anymore.
Word up, Vermont!
Tagged with: Vermont
Today, President Trump will be talking about drug prices and his administration’s plan to help Americans better afford prescription drugs. By permitting importation of affordable medication, the administration has a chance to really strike a populist chord and a positive one.
It’s been said that the president is going to talk about trying to force other countries, such as Canada, to raise drug prices. Instead, why not expressly allow Americans to access those lower prices through importation? It was one of the solutions offered by Trump during his campaign.
The millions of Americans, across all parties, who already import medication to fill prescriptions will wildly applaud the administration for doing so.
Can Trump use executive authority on drug prices? Yes. Under current law, the Secretary of Health and Human Services, Alex Azar, can permit individuals to import medication for personal use right now. The Secretary can also make it lawful for companies to import FDA-approved drugs at wholesale pharmacies in Canada.
America is united against high drug prices. It seems we’re only waiting for POTUS to catch up.
Tagged with: Alex Azar, executive authority, trump
It’s widely known that Americans buy medications from Canada and other countries because the prices are much lower. What many people do not know is how people are doing this.
Even our foremost scholars on the issue of U.S. pharmaceutical prices don’t know. In an article published in the prestigious British Medical Journal (BMJ), readers are informed that:
“A modest proportion of U.S. citizens travel to Canada and Mexico to purchase lower priced prescription drugs.23”
That footnote – 23 – links to a 2016 Kaiser Family Foundation Health Survey, which includes the question:
“Have you or another family member living in your household ever bought prescription drugs from Canada or other countries outside the United States in order to pay a lower price, or not?”
Eight percent of respondents said that they had, which is about 20 million Americans, but the survey did not ask how they did it.
The data is far from perfect. I looked at several data sources when I wrote a report in 2015 called Online Pharmacies, Personal Drug Importation and Public Health. In one analysis of an FDA survey in 2012, I estimated that about six million Americans were purchasing medication from outside the U.S. over the Internet. I believe that figure is somewhat inflated. (more…)
Tagged with: Aaron Kesselheim, BMJ, CDC, Daraprim, Kaiser Family Foundation, lomustine, Ravi Gupta