Internet pharmacies are often unregulated and growing in number. Can you provide a quick summary of the current situation in terms of numbers, growth and the types of activity they undertake?

LegitScript currently maintains the world’s largest (as far as we know!) database of Internet pharmacies. At any one time there are typically between 25,000 and 75,000 active Internet pharmacies in existence, and that is a conservative estimate.

Of these, only about 1% - 2% are legitimate. Another 4% - 6% fail to meet our standards, but for relatively minor reasons. The remaining 92% - 95% are “rogue”, by which I mean that they are engaged in the knowing and intentional violation of drug safety and pharmacy laws as their business strategy.

“Rogue” Internet pharmacies engage in multiple types of illicit and dangerous behavior, but there are three overarching “big problems” that we currently see with rogue Internet pharmacies.

a. Lack of a prescription requirement. A classic problem with rogue Internet pharmacies is that they sell prescription drugs without requiring a prescription. This is just as important to patient safety as drug authenticity, because the very reason that a drug is designated as “prescription only” is that in order to be used safely, it requires some degree of medical supervision.

b. Sale of unregulated drugs. This can range from chemical equivalent drugs that simply have not been tested, to expired drugs, to outright counterfeits with toxic ingredients.

c. Lack of appropriate pharmacy licensure. Sometimes, there is no pharmacy involved in the distribution chain at all. However, rogue Internet pharmacies often supply drugs that of course must come from somewhere, so a pharmacy licensed in some jurisdiction may sometimes be involved. In these cases, the pharmacy is typically only licensed in a foreign jurisdiction where they make sure not to violate any laws (meaning, they won’t ship to an address there) but will dispenses drugs carte blanche into a jurisdiction where they are not authorized to practice.

Any of the “big three” violations above are serious; but typically, rogue Internet pharmacies are engaged in all three types of violations.

Although this sounds dramatic and somewhat out-of-control, how does the architecture of the internet provide opportunities for controlling the situation and reigning in the culprits?

There is sometimes a misimpression that the Internet has no rules. Although the enforcement of these rules is spotty, Domain Name Registrars, as a condition of their accreditation by the Internet Corporation for Assigned Names and Numbers (ICANN), are required to adhere to a policy that states domain names may not be used for unlawful purposes.

If this happens a domain name is used in furtherance of illegal activity the domain name registrars have the authority to suspend the domain name, essentially shutting down the website.

In cases where the illegal activity is obvious; such as where the website is engaged in “all three” of the violations described above, there is no justification for a Registrar to continue knowingly allowing its domain name registration services to be used in furtherance of clearly criminal activity. In cases where the only reason for the website’s existence is to sell counterfeit drugs and/or drugs without a prescription, etc., suspending the domain name is very much the right thing to do.

This means that the rogue Internet pharmacy problem is not hopeless. Registrars are key to solving the problem. Rogue Internet pharmacy operators look for “safe” domain name registrars; they cannot survive if Registrars do what GoDaddy, Directi and others have done, which is prohibit the misuse of their registration services. However, this is unlikely to happen if ICANN is nonchalant about Registrars knowingly permitting their Registration services to be used in the furtherance of unlawful activity.

As an example, can you provide some data on how successful your company LegitScript has been in this arena?

LegitScript is steadily making progress in working with search engines, Domain Name Registrars, ISPs and other third parties to prevent the use of those companies’ services by rogue Internet pharmacies. We currently assist Google by conducting “sweeps” of the company’s prescription drug and Internet pharmacy online advertisements. We’ve helped the company dramatically reduce the incidence of rogue Internet pharmacy advertisements. To be clear, the rogues will always try to slip through the filters; however, we typically identify them within a day or two after they first appear, or even just a few hours, and the ad is removed.

We have also succeeded in finding ways to work with some Registrars who have decided that it’s not responsible to allow their services to be used in furtherance of illegal activity. GoDaddy and Directi are two leaders on this front, and we regularly help them and others identify rogue Internet pharmacy domain name registrants.

Monitoring the Internet and issuing stop orders is one approach to tackling the problem, but in some ways it is “shutting the stable door after the horse has bolted”. How can national policy and other tools help enhance patient safety and prevent them buying products from unregulated on-line outlets?

Our national (including governmental) response, by this I do not only refer to the US but most countries worldwide, lags behind rogue Internet pharmacy operators, who are highly motivated to stay a step ahead.

First, enforcement agencies and regulators need to make clear to third parties such as payment processors, Registrars, ISPs, and other potential facilitators that the knowing facilitation and/or knowing profiting from rogue Internet pharmacy activity will itself be considered a problem. Here, the word “knowing” is important: it is not reasonable to hold third parties accountable if they are unaware of the problem, but once they are, they cannot simply turn a blind eye.

Second, here in the US and also elsewhere, it is important to address head-on, typically via legislation, the question of what constitutes the valid exercise of telemedicine, and what constitutes a “valid prescription.” Is it acceptable for a physician who never physically examines a patient, and only reads an online form that the patient filled out, to dispense a prescription drug on that basis alone? Before the Internet, this was rarely an issue; now, it is a critical question. However that is answered, there must be bright lines as to what is acceptable and what is not.

Third, each country should make available a master “White List” of approved Internet pharmacies allowed to dispense prescription drugs within or into that country. Full transparency is absolutely critical: after all, a legitimate Internet pharmacy has absolutely no reason to remain anonymous, either as to the identity of the dispensing pharmacy or as to the domain name registrant. To be clear, this is a list that identifies both the dispensing pharmacies, as well any website that facilitates orders for the pharmacy. Whether directly compiled by a government agency or outsourced to a third party, some sort of registration and publication is important, not merely for patients to verify that the pharmacy website is legitimate, but also to give third party facilitators like search engines and Registrars helpful information about who are legitimate actors and who are not.

Finally, the traditional methods investigation, arrest and prosecution, and on the prevention side, patient education remain important and absolutely indispensable. But those traditional methods are all-too-often relied upon as the sole strategy by governments who are still applying 1990s offline techniques to fight 2010 cybercrime.

Given that the Internet is here to stay, what do you think the long term strategy should be? Do you think even legitimate and regulated Internet pharmacies exacerbate the problem?

I do not think that legitimate Internet pharmacies exacerbate the problem. Websites that safely, legally and transparently fill prescriptions for patients should be welcomed.

If one steps back and looks at the Internet pharmacy market from a distance, what is the most obvious characteristic? The fact that the market is overwhelmingly full of bad actors ; 92% - 95% of the market in our estimation. Until that is cleaned up, the legitimate Internet pharmacy market will not reach its full potential. That has understandably reduced consumer confidence in Internet pharmacies as a whole. But imagine an Internet where most, or even all, Internet pharmacies were legitimate, dispensed genuine medications in response to a valid prescription and were appropriately licensed.

The long-term strategy needs to be one centered around Internet compliance as well as traditional enforcement methods. As I argued above, traditional enforcement and regulation are a critical element, but cannot be the sole basis of an international strategy: there will always be another country where bad actors can hide. Governments and companies need to understand that there is a “parallel” world of Internet enforcement that holds Registrars and website owners accountable via the ICANN framework. The only way to permanently effectuate a solution is to operate within this framework, too.

The members of the public of developed nations seem to be drawn in to on-line pharmacies, as seen in the recent survey commissioned by Pfizer, UK. Are you surprised by this, and what do you think the future holds as more and more people come on line in developing nations in Africa and Asia for example?

If one looks at the prevalence of counterfeits in many developing nations, some members of the public there perhaps feel that they simply have nothing to lose by going online. After all, if 30% - 50% of prescription drugs in a particular country are adulterated, expired or counterfeit, then online pharmacies claiming to be Canadian (even if actually operated out of Russia) may seem like a safe bet.

Yet there is one very simple truth: the operators of rogue online pharmacies are also rational economic actors. They are in it for the money. Consequently, it should come as no surprise that most rogue Internet pharmacy websites directly target countries where the public has more disposable income, such as the US, Canada, Japan, Germany, and so forth. Indeed, a great irony is that some rogue Internet pharmacies refuse to accept orders from third-world countries (or some of them) because they are afraid of a fraudulent payment transaction.

Ultimately, however, the positive news of increased Internet access globally will inevitably be seen as a business opportunity by rogue Internet pharmacy operators. That is precisely why this is and will remain a truly global problem that requires cooperation among all nations and all participants in the Internet infrastructure to address.