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Big Pharma alliance Gabriel Levitt  –  Mar 22, 2017 1:29 AM

Hi, I’m Gabriel Levitt from PharmacyChecker, the company maligned by Mr. Horton. There’s time enough for us to defend ourselves down the road but here’s what I wrote on CircleID, http://www.circleid.com/posts/20160912_protecting_online_access…. I think you’ll see that Electronic Frontier Foundation is aligning itself with online access to safe and affordable medication and that that’s pretty cool!

I’ll just note that LegitScript is allied with the pharmaceutical and U.S. pharmacy industries and their agenda on the issue of online pharmacies. This is not my opinion but fact. LegitScript, Eli Lilly and the National Association of Chain Drugstores stared Alliance for Safe Online Pharmacies in 2009; a group that supported the Stop Online Piracy Act.

Simply put, 45 million Americans did not fill a prescription in 2016 because of cost. A few million Americans buy real medication from international online pharmacies each year. The drug companies don’t want them to. I believe a full airing of this issue is finally coming to light, which is great and long overdue.

Three questions for John Horton Jeremy Malcolm  –  Mar 23, 2017 9:00 PM

I don’t have time for a full rebuttal of this post just now, but here are three simple questions for John Horton.

1. Isn’t it true that no matter how demonstrably safe an overseas online pharmacy is and despite its compliance with all laws that are legally enforceable against it, it can’t even theoretically satisfy LegitScript’s Internet pharmacy verification standards if it ships into the USA?

2. Who has the responsibility to shut down an online pharmacy (to use your terminology)—is it:

(a) the regulators of the country where the pharmacy operates from, it has has infringed its laws;
(b) the regulators of a country into which it ships product, if it has infringed its laws; or
(c) private companies that it has dealings with, for violating LegitScript’s private verification standards?

3. Isn’t it true that LegitScript verified pharmacy Walgreens was also charged with illegal sales of medicines and agreed to pay a record $80 million to settle the charges? Isn’t Walgreens also a “criminal enterprise”, under your definition?

Three Answers for Jeremy Malcolm (and Three Questions) John Horton  –  Mar 24, 2017 9:45 PM

Hi Jeremy, Thanks for your questions! See below. 1. I think you may be misunderstanding what’s legally enforceable when it comes to the practice of pharmacy or the dispensing of drugs. The subtext of your question (as I read it, at least) is: if an entity shipping drugs into Country A is physically domiciled outside of Country A, the laws of Country A aren’t legally enforceable. That’s incorrect, both legally and in practice. Under the laws of every country I’m aware of, any person or business dispensing pharmaceuticals within or into that country – irrespective of the dispensing entity’s physical location – is subject to the laws and regulations of the country into which they are shipping drugs. In the US, that includes the US Food, Drug and Cosmetic Act (e.g., 21 USC 353(b), et seq.), all 50 state regulatory schemes requiring pharmacy licensure, and several others. For a summary of laws and regulations in about 20 countries most commonly targeted by internet pharmacies, if of interest, feel free to review the laws and regulations summarized in our co-authored guide for banks and payment providers at https://usa.visa.com/dam/VCOM/global/support-legal/documents/online-pharmacy-guide-for-acquirers-vbs-18-apr-2016.pdf. Being physically domiciled outside of those jurisdictions doesn’t mean you don’t have to comply with those laws – unless, of course, you don’t ship to the country in question, in which case, of course you don’t need to worry about that country's laws. To illustrate this: if US laws were not enforceable against CanadaDrugs and Andrew Strempler, which are and who was outside of the US, how would they have been indicted and convicted (respectively)? As to our standards, we require compliance with applicable laws and regulations. Consistent with what I’ve explained above, “applicable” means not only the jurisdiction where the entity is located, but any jurisdiction into which the entity dispenses drugs. At present, prescription drug importation into the US directly to individuals is illegal (as is the case in just about every country). That’s a fact, by the way -- not mere opinion. It’s also illegal, everywhere, to sell prescription drugs without requiring a valid prescription. And so on. As to our program, think about it this way: a credible verification program should, among other things, help verify whether the entity in question is complying with applicable laws and regulations; suggesting that a verification service is supposed to ignore applicable laws and regulations is not, in my view, a credible suggestion for how a verification program is supposed to operate. So hey, want to get LegitScript certified? Not hard. Operate legally. 2. The three options you’ve presented don’t quite capture how this all works. In the payments industry, online ads industry, private carrier industry, hosting industry, domain name registration industry, etc., there are terms and conditions between the customer and the service provider. These are enforceable contracts. Those Terms and Conditions (nearly) always prohibit use of the companies’ services in furtherance of illegal activity. When a customer uses the services in furtherance of criminal activity, they are in breach of those agreements, and the remedy is typically termination of services. In the domain name industry and the payments industry, there are additional layers of contractual requirements put on the registrar or registry, and on the bank or payment provider, by ICANN and the card brands, respectively. (In the interests of brevity, I won’t go into all of those here.) The short version: for a registrar or payment provider not to take certain actions against customers engaged in illegal conduct can be a breach of their accreditation or acquiring license agreements. As to the options you’ve presented, regulators certainly may play a role in some cases. However, there’s no law (anywhere) that says a company can’t enforce their own terms and conditions unless they have a court order or a note from a regulator. Companies, as a matter of routine, are able to use common sense and expert resources to determine whether there has been a violation of their terms and conditions. As to your third option, I think that you are missing the point. It’s not that the rogue online pharmacies fail to meet our standards (although that’s true). It’s that they violate companies’ terms and conditions – in the case of rogue online pharmacies, by virtue of failing to comply with applicable drug safety laws. Which sometimes has dire consequences. 3. What I find most disturbing about this question is that it supports my point about your alignment with PharmacyChecker and CIPA. I think I’ve read this one a few times from Gabe@PC, but I’m not sure I’ve ever seen anyone else ask it. In general, your blogs and arguments make it appear as if CIPA and PharmacyChecker are feeding you talking points – hence my blog about your alignment with them. But anyway – putting that aside, to answer your question, it’s a straightforward difference: Walgreens’ business strategy isn’t predicated on operating illegally. Rogue internet pharmacies’ (and CIPA members’) business strategies are predicated on operating illegally – their entire business plan centers around continuous illegal conduct. To be sure, Walgreens’ behavior shouldn’t be overlooked, but it doesn’t follow that Walgreens’ fundamental business plan relies on ongoing illegality. By the same token, if any of the “Canadian” online pharmacies wanted to start operating legally, hey – I’d be thrilled, and we’ll classify them legitimate. But "legitimate" doesn't mean I hide out offshore and pretend that I can ignore drug safety laws where I do business, or plaster maple leaves all over my website then ship drugs from some non-Canadian location. Questions for you: 1) Do you think drug safety should be regulated or unregulated? 2) Does it bother you that the drugs sold by CIPA members are usually not from a Canadian pharmacy, or often from any pharmacy at all, but are transshipped through warehouses in Barbados, Turkey and other locations as part of an unregulated supply chain? 3) If a company can readily tell that a domain name is used in furtherance of dangerous, illegal activity – let’s take silkroad-pharmacy.com as an example – is it your position that registrars, banks, payment providers, etc. should continue providing services even when they know that their services are being used for criminal activity?

Crime and punishment Gabriel Levitt  –  Mar 25, 2017 12:33 AM

John - Forget about the Internet for this one question. Should it be illegal for someone who is sick to travel to another country to obtain needed medication that is unobtainable due to price where they live -- and bring that medicine back home?

Re: Three Answers for Jeremy Malcolm (and Three Questions) Jeremy Malcolm  –  Mar 24, 2017 11:25 PM

As to your answers:

1. As you know, Strempler only became subject to U.S. law because he was physically in Miami at the time he was arrested.  If you insult the King of Thailand on your blog and then you fly through Bangkok, you might get arrested too.  Do that mean that you were breaking the law when you blogged about the king in your bedroom in Portland?  For readers who want a more impartial account of the Canada Drugs case, read here: http://www.cnbc.com/2015/08/19/canada-pharmacy-charged-in-78m-drug-export-scheme.html.

2. You didn’t actually answer the question.

3. No, I wrote my first article on this topic before I’d ever spoken to Gabe or anyone from CIPA.  After it came to their attention they got in touch with me, but once again, I wrote the two follow-up articles on my own initiative, they neither requested nor reviewed them until after they were published.

Your questions:

1. I addressed this in my last post.  I said that there may be some merit to regulating cross-border sales of medication, but there is obviously a massive conflict of interest in this being undertaken by bodies with close links to U.S. Big Pharma such as ASOP, CSIP and LegitScript.

2. No, but if securing the supply chain were your real concern, look at how this works in Europe.  Or look at the innovations around supply chain certification that are going on with blockchain.  There are lots of other ways to secure the supply chains than to cut off patients’ access to affordable medication.

3. A content host is entitled to apply their own policies and terms of service, which may in turn be determined by industry or supplier requirements.  But they should not be compelled to delete any content without a court order.  See the Manila Principles on Intermediary Liability at https://www.manilaprinciples.org.

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