CIPA & Legit Script conflicts

LegitScript
Posts: 20
Joined: Thu Jun 17, 2010 12:51 am

RE: CIPA & Legit Script conflicts

Post by LegitScript » Mon Jun 25, 2012 5:36 am

Just a quick note. Came across this thread and we are formulating a few points that we hope will be helpful in response to EvilFantasy's questions. Good questions. Stay tuned.

evilfantasy
Posts: 3940
Joined: Thu Dec 25, 2008 4:08 am

RE: CIPA & Legit Script conflicts

Post by evilfantasy » Mon Jun 25, 2012 5:44 pm

By me criticizing the FDA you say I really have another agenda in this topic but YOU keep referring to them as the top authority. How can I not respond using the FDA as a point of reference to make my point?

If a pharmacy in any country is shipping out any type of goods to an American address and it is not breaking that countries laws, who is really at fault. The company or the person who ordered the goods?

There are laws in place allowing the import of prescription drugs from Canada.

[url=http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVIIIImportsandExports/ucm107064.htm t=_self]SEC. 804. [21 USC §384] Importation of Prescription Drugs[/url]
(b) REGULATIONS.--The Secretary, after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.

(c) LIMITATION.--The regulations under subsection (b) shall--

(1) require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 505 (including with respect to being safe and effective for the intended use of the prescription drug), with sections 501 and 502, and with other applicable requirements of this Act;

(2) require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); and

(3) contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs.
And more...

[url=http://www.ehow.com/about_6646860_legality-citizens-buying-canadian-drugs.html t=_self]The Legality of US Citizens Buying Canadian Drugs[/url]
Controversy Regarding Current Laws

The FDA restrictions regarding prescription drugs are based on the stated aim of ensuring prescription drugs taken in the U.S. are safe, genuine and of high quality. Counterfeiting of prescription drugs is a known problem both within and outside the U.S., however, and Canadian drugs are generally considered to be of equal quality and safety as U.S. prescriptions. Although importing Canadian drugs remains technically illegal, several states--Nevada, Minnesota, Illinois and Wisconsin--have run state-sanctioned programs that help U.S. citizens purchase cheaper prescriptions from other countries. The legal confusion regarding prescription drug imports has led to calls for changes to U.S. law.

Guest

RE: CIPA & Legit Script conflicts

Post by Guest » Mon Jun 25, 2012 9:21 pm

Edit =
verbum sat sapienti

































Guest

RE: CIPA & Legit Script conflicts

Post by Guest » Mon Jun 25, 2012 9:39 pm

<quote user="superhero58">

Stay on topic
Read the thread subject and the first post, and when replying to the post, make sure it is relevant. Periodically review your previous postings to ensure that the information is still accurate.

https://www.mywot.com/en/forum/4908-forum-guidelines

As far as I see this is over !

Cya!
[/quote]

This is not a Police State.
Evilfantasy started this thread and he is just replying.
I see nothing wrong with it.

Self control, please
Thank you


LegitScript
Posts: 20
Joined: Thu Jun 17, 2010 12:51 am

RE: CIPA & Legit Script conflicts

Post by LegitScript » Tue Jun 26, 2012 12:23 am

Hi everyone,

Thought we’d join this discussion. Sorry that it took us a little while. EvilFantasy, thanks for the questions.

So, you’d probably expect that thecanadianpharmacy.com will ship you drugs from a Canadian pharmacy, right? To be very precise, you’d probably expect the following:

* The website will send you drugs from a pharmacy that is licensed and legal in Canada (and physically located in Canada).

* If you fill a prescription with that website, you get the same thing that a Canadian resident would get if they walked into a pharmacy in Canada, or that is subject to the same drug safety protections that Canadian residents enjoy.

In short, you probably think: “Hey, this is totally a legit pharmacy in Canada –– yeah, maybe it’s not supposed to ship to the US, but that’s just a jurisdictional technicality!” (Indeed, your post on Mon 25 Jun 2012 at 05:44:51 PM UTC indicates that you believe that the drugs are imported from Canada, and are equivalent to what you’d get if you walked into a Canadian pharmacy.)

Not quite. Here’s why. Let’s talk first about the who, then let’s look at the what.

First, who is CIPA run by? You might expect that an organization that certifies Internet pharmacies would be impartial –– a third-party organization without conflicts of interest. However, CIPA appears to be operated by employees of the Internet pharmacies it monitors. It’s up to you whether you believe that sort of a system to be credible and reliable. Here is the board of directors for CIPA, and their affiliations. (The names can be confirmed at the Canadian government’s Industry website at https://www.ic.gc.ca/app/scr/cc/CorporationsCanada/fdrlCrpSrch.html?locale=en_CA; the affiliations are based on our research.)

* Len Hillary, Pharmacist at CanadaDrugs.com, etc. See: http://ca.linkedin.com/pub/leonard-hillary/10/509/477
* Ankur Arora, PharmaWest Pharmacy (includes NorthwestPharmacy.com, etc.). See http://ca.linkedin.com/pub/ankur-arora/13/177/133
* Dawn Polley, Granville Group (includes onlinecanadianpharmacy.com, etc.). See http://ca.linkedin.com/pub/dawn-polley/8/793/a65.
* Troy Harwood-Jones, CanadaDrugs.com legal counsel. See http://www.canadadrugs.com/patient_services/article/82/.
* Amarjit Mann, Solaris Worldwide (includes BlueSkyDrugs.com, etc.). See http://www.solarisworldwide.com/business.html
* Mark Scott. (There are a couple of different Mark Scotts out there, so not sure –– but there is a Mark Scott who is or has been a pharmacist for GlenwayPharmacy.com.)

All of those websites and businesses are CIPA-approved. So, if you ask, Who runs CIPA? Is it an impartial third-party? The answer is, Well, the certification organization is run by the entities that get certified. Either all but one, or all, members of the CIPA board works for one of the online pharmacies that CIPA is supposed to certify and regulate. So, if you thought CIPA represented government agencies or impartial third-parties, that’s demonstrably and provably untrue.

Second, why did we put the word “Canadian” in quotes? Because CIPA online pharmacies aren’t really “Canadian” in the way that you might expect (and in the way described earlier in our post). To be sure, they might be registered Canadian companies, and might be owned or operated by (or employ) individuals with a pharmacist’s license in Canada. But despite that, the drugs are not the same ones sold to Canadians by licensed Canadian pharmacies (by which we mean, they are not subject to the same supply chain and safety regulations and oversight). In fact, in many (most?) cases, the drugs don’t go through Canada at any point in the transaction like they would if you were a Canadian customer. Rather, if the transaction comes from the US or elsewhere outside of Canada, CIPA-approved websites generally divert drugs to the US via locations India, Turkey, and other locations via Barbados or similar transit points. Sometimes the drugs are also routed to a pharmacy in a “safe country” for labeling purposes, but again, the drugs aren’t really from that pharmacy or part of that approved supply chain –– it’s just for the labeling. Yet, the entire message of CIPA-approved websites is that these are “Canadian” Internet pharmacies.

To read an excellent description from a UK judge about how this works, see page 2 and 3 (paragraph 7) of oami.europa.eu/pdf/natcourt/Lilly.pdf.

Why would they do this? Marketing is one reason. US residents are a huge target market, and the assumption is that a pharmacy in Canada (or the UK, etc. –– a “safe” country) is going to be safe and regulated. By contrast, it is much tougher to market a “Turkish Internet pharmacy” or “Indian Internet pharmacy” to someone in Topeka, Kansas. So the “Canadian” marketing is used on the website, even though the drugs aren’t coming from the Canadian pharmacy in the same way that they would if you walked into a physical Canadian pharmacy. But on the surface level, the business can show that it “has” a Canadian pharmacy license...and even operates a licensed pharmacy in Canada, even though the drugs aren’t necessarily coming from there. Which leads people to mistakenly assume that the prescription drugs are actually being imported from a Canadian pharmacy, and are the same drugs (that is, subject to the same safety regulations and oversight) that a Canadian resident would get.

It is reasonable to ask if this would fly if CIPA were run by impartial third-parties or government regulators. Our opinion is that it probably would not.

Here’s another point. Some CIPA-approved websites don’t even ship to Canada at all, since the drug supply chain wouldn’t be legal if those drugs were shipped to Canadian residents. (Prescription drug importation directly to patients is illegal in Canada.) A rhetorical question, perhaps, but does that make any sense –– a “Canadian Internet pharmacy” that won’t ship to Canada?

Then again, does this matter? Our opinion is that it does. You’ve got CIPA websites like cheapodrugs.com (which, by the way, is a CIPA pharmacy but cannot ship to Canada, see http://www.cheapodrugs.com/faqs/35-do-you-ship-to-canada-), which is registered to Tom Haughton in Barbados, whose supply chain has been publicly tied to counterfeit drug sales; despite that, his website is and continues to be CIPA-approved. And the allegations of CanadaDrugs-related businesses (that is, not the website itself but other businesses under the corporate umbrella) selling counterfeits have been documented in the news recently. And RxNorth.com, allegedly selling counterfeits in 2006, was CIPA-approved –– which makes sense, since Andrew Strempler, arrested a few weeks ago in connection with RxNorth’s counterfeit drug activity, helped found CIPA. The list goes on. It’s not just a legal technicality –– rather, there are real, serious, factual reasons to be concerned about drug safety.

In terms of the difference between LegitScript’s “unapproved” and “rogue” designations, AlphaCentarui was close, but let us explain in a bit more nuance.

It’s true that several CIPA members ALSO have brick-and-mortar pharmacies in Canada, actually serving Canadians. But that’s not really a relevant point if that’s not where the drugs (or most of the drugs) they are sending to non-Canadian residents come from. (On a basic level, it can be thought of as a bifurcated supply chain based on who the customer is.) The reason that we designate some illicit websites as “rogue” and some as “unapproved” (and most or all CIPA websites as “unapproved”) is mostly because the CIPA websites do require a prescription. Generally –– there are exceptions to this, but it’s mostly true –– rogue websites are doing the “big bad three” things wrong: a) failing to require a prescription, b) not operating with any pharmacy licenses at all; and c) not adhering to a safe, regulated, legal drug supply chain. In the case of CIPA websites, they do require a prescription, so our “unapproved” category is generally reserved for cases in which we cannot accurately refer to it as violating those three fundamental principles. Also, most online enforcement (e.g., by Registrars) is focused on the lack of a prescription requirement, so it’s a helpful way of distinguishing between websites that require a prescription and those that do not.

Let’s be clear-eyed about what’s going on here: these faux-Canadian Internet pharmacies aren’t altruistic non-profits; they are for-profit, profitable businesses that exist to make a profit, like any other business. In fact, they are very canny, for-profit businesses who have found a smart business strategy with high profit margins and effective –– but in our opinion, deceptive –– marketing, part of which includes CIPA designation and implies that the drugs are “from” a Canadian pharmacy.

Finally, there’s an important policy point that is a subtle but important difference. The issue, in our view, isn’t fundamentally about importation. (We couldn’t care less about importation per se.) The issue is about whether a drug supply chain is regulated for safety and authenticity. (Which we think is a very important question.) So in direct answer to your question: LegitScript does not approve CIPA websites because the drug supply chain is not subject to adequate oversight for safety and authenticity, and in our opinion, the marketing is deceptive, since the drug supply is not really “Canadian” in the way that we think most customers would expect based on the websites’ marketing, domain names and content. And, we do not view CIPA as an impartial certification system because it is not run by impartial third parties, but rather by the organizations that are being certified.

EvilFantasy, hopefully this addresses your questions, at least from LegitScript’s point of view.

MysteryFCM
Posts: 4912
Joined: Mon Jul 14, 2008 4:47 pm

RE: CIPA & Legit Script conflicts

Post by MysteryFCM » Tue Jun 26, 2012 12:35 am

@LegitScript,
Great to see you guys here ;o)

LegitScript
Posts: 20
Joined: Thu Jun 17, 2010 12:51 am

RE: CIPA & Legit Script conflicts

Post by LegitScript » Tue Jun 26, 2012 12:59 am

Thanks, @MysteryFCM!

evilfantasy
Posts: 3940
Joined: Thu Dec 25, 2008 4:08 am

RE: CIPA & Legit Script conflicts

Post by evilfantasy » Tue Jun 26, 2012 1:17 am

<quote user="mysteryfcm">
@LegitScript,
Great to see you guys here ;o)[/quote]

Ditto! And again, I do not think I was ever bashing LegitScript and if I came off that way then please do not take offense to what I have said. Any company is open to scrutiny, even LegitScript. I was also not bashing the FDA. I believe my criticism was fair and quite frankly nobody can tell me to just trust any big corporation, government or not. If you do then that's on you.

<quote user="legitscript">It’s true that several CIPA members ALSO have brick-and-mortar pharmacies in Canada, actually serving Canadians. But that’s not really a relevant point if that’s not where the drugs (or most of the drugs) they are sending to non-Canadian residents come from. (On a basic level, it can be thought of as a bifurcated supply chain based on who the customer is.) The reason that we designate some illicit websites as “rogue” and some as “unapproved” (and most or all CIPA websites as “unapproved”) is mostly because the CIPA websites do require a prescription. Generally –– there are exceptions to this, but it’s mostly true –– rogue websites are doing the “big bad three” things wrong: a) failing to require a prescription, b) not operating with any pharmacy licenses at all; and c) not adhering to a safe, regulated, legal drug supply chain. In the case of CIPA websites, they do require a prescription, so our “unapproved” category is generally reserved for cases in which we cannot accurately refer to it as violating those three fundamental principles. Also, most online enforcement (e.g., by Registrars) is focused on the lack of a prescription requirement, so it’s a helpful way of distinguishing between websites that require a prescription and those that do not.[/quote]

This is an important statement and actually the basis of my thinking when starting this topic. If Canadian residents are using these legal pharmacies and Americans are crossing the border to get these legal prescriptions filled and they are getting the Canadian equivalent of FDA approved medication, all the while at WOT the scorecard is red and the comments state that this is a rouge pharmacy then the WOT rating system on pharmacies is flawed. We are misleading Canadian residents and Americans who may use the WOT add-on and need to know if the pharmacy is trusted by "the masses".

I get what LegitScript is about, used the website as a point of reference and will continue to do so. Don't think for a second I don't or won't. If anyone is missing my point in the original post then I'm sorry because I have explained it more than once. I am/was ultimately questioning the WOT system for rating pharmacies. Not all laws are not set in stone and that is proven time and again in the court systems. Lawyers, judges and citizens all interpret the law differently. It doesnt matter what a law states because any statement can be called into question.

I think I have come to a conclusion with the help of LegitScript describing the gray areas to me. Thanks again. My mindset on this issue I will keep to myself for now. Thanks also to Superhero and AlphaCentauri. Jazspeak had a great idea IMO also. You all put some information out there I had not found myself. Not that I'm agreeing with anyone and I never wanted this to be an argument. I'm just as entitled to my opinion, questions and suspicions as the next guy or gal is and as always I hold no hard feelings towards anyone. It's an Internet forum and I don't let forum disagreements get to me. I learned not to do that loooong ago.


PharmacyChecker
Posts: 59
Joined: Thu Dec 16, 2010 5:30 pm

RE: CIPA & Legit Script conflicts

Post by PharmacyChecker » Tue Jun 26, 2012 1:45 pm

This is really a great conversation.

For the record, it’s to LegtiScript’s credit that they do not classify international online pharmacies that sell to Americans as rogue when they find such websites are meeting certain safety criteria, such as the prescription requirement. To bring to light real and even potential dangers of ordering drugs online to help consumers is what this should all be about.

@Legitscript - I'm pleased to read that your greatest concern is the safety of the drug supply chain when it comes to online pharmacies rather than “importation” per se. In theory, if you could determine that non-U.S. online pharmacies that sell to Americans were operating very safe mail-order pharmacies, from Canada and other countries as well, would you be willing to change your program's criteria to approve such safe international online pharmacies?

LegitScript
Posts: 20
Joined: Thu Jun 17, 2010 12:51 am

RE: CIPA & Legit Script conflicts

Post by LegitScript » Tue Jun 26, 2012 8:08 pm

Hi @PharmacyChecker,

Of course -- but that's a strongly qualified "of course." Our concern is that the drug supply chain be regulated (that is, regulated with legal oversight with some enforceability). If, for example, the FDA under existing law certified certain avenues of importation as safe (as existing law empowers them to do, as you know) and basically said, "We view this supply chain, which is imported directly to the customer, as safe, legal and constituting FDA-approved drugs, and we are able to regulate this supply chain for authenticity and safety" no problem with that on our end. (But the FDA hasn't said that, of course.) It's not importation per se that we have a problem with -- it's a drug supply that falls outside of a regulated, closed, transparent supply chain. So, when we say that drug importation has to be legal for us to approve websites engaged in importing directly to customers (and by legal, for the US, we mean FDA-approved; for other countries, approved as legal by the equivalent government authority providing drug safety oversight, whether that includes importation or not), it's not just a blind adherence to legal technicalities; rather, we think that that's actually a really important structure that websites need to operate within. But again, it's not importation itself that we care about per se. It's about the closed, regulated, transparent supply chain designed to prevent and dissuade drug supply with authenticity problems. (We also care that the dispensing pharmacy be appropriately licensed in jurisdictions that require it, which would be another hurdle for many foreign suppliers, but perhaps not an insurmountable one if importation were legal federally.)

The second reason why we'd feel it be important for importation to be legal before we'd approve websites engaged in direct importation to the customer is for liability reasons. Our position is that we would neither want to recommend nor facilitate activity that is considered not to be legal, particularly in cases where a substandard drug is received.

So, in sum, we're basically agnostic on importation itself becoming legal -- obviously, there are some potential positives and negatives to the policy itself depending on how its structured. We oppose business practices that result in a supply chain for drugs that puts patient health and safety at risk, and would consider any unregulated supply chain (which, in our view, is what all CIPA-approved websites are engaged in) to constitute such a risk.

@LS

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