Healthy Domains Revisited: the Pharmaceutical Industry
Users scored an exciting victory over copyright-based censorship last month, when the Domain Name Association (DNA) and the Public Interest Registry (PIR), in response to criticism from EFF, both abruptly withdrew their proposals for a new compulsory arbitration system to confiscate domain names of websites accused of copyright infringement.
But copyright enforcement was only one limb of the the DNA's set of Registry/Registrar Healthy Practices [PDF]. One of the other limbs of these practices was a process for "streamlining complaint handling from illegal or 'rogue' online pharmacies." Although the target is different, the mechanism is much the same: allowing a self-interested private entity to request the cancellation of domain names associated with websites that it alleges infringe its rights.
How and Why Big Pharma Blacklists Overseas Pharmacies
The treatment of online pharmacies in the Registry/Registrar Healthy Practices is even more unbalanced than in the copyright proposal, in that decisions on whether a domain name should be confiscated would not be made by an independent arbitrator, but by reference to an opaque blacklist maintained by big pharma trade groups the Alliance for Safe Online Pharmacies (ASOP) and LegitScript. These blacklists use the loosest of definitions of "illegal online pharmacy" in order to depict licensed overseas pharmacies as rogue, even if they supply original branded medicines and require a prescription, unless they are also licensed in the country of each and every online customer.
Why can't overseas pharmacies just obtain foreign licenses to avoid being blacklisted, then? Because, at least in the case of U.S. sales, that would mean they could only dispense medicines sourced within the U.S. from the manufacturer, at the world's highest prices. In other words, it is literally impossible for a foreign-dispensing pharmacy to obtain a license that would keep them off the ASOP and LegitScript blacklist.
Now, it may well be that there should be some international mechanism to regulate overseas pharmacies sending prescription medicines into countries where they are not licensed. EFF doesn't take a position on this because it's outside of our area of expertise, but it's worth noting that there are several similar initiatives already in place, focused on cases that pose a high risk to consumers, such as the criminal trade in fraudulent medicines.1
In contrast, ASOP and LegitScript call all overseas pharmacies that dispense medicines to the U.S. "illegal", regardless of whether they dispense fraudulent or authentic medicines. This is misleading because although it may be against U.S. law for Americans to import medicines from overseas, the pharmacies sending such medicines are not subject to U.S. law. Provided that they comply with the laws in their own countries, such as by maintaining professional licenses and sourcing authentic medication, they are breaking no laws that apply to them. Calling them "illegal" and blacklisting them along with vendors of fraudulent medicines is a misleading tactic at best.
Shadow Regulation Gets Big Pharma What the Law Won't
This explains why big pharma has fallen back on Shadow Regulation as a way of getting what they want, by putting pressure on pliant Internet intermediaries such as domain registries and registrars who are neither qualified, nor perhaps particularly interested, in distinguishing between fraudulent drug peddlers and licensed pharmacies whose only crime is being based outside of the U.S. By setting up their own front organization ASOP as judge and jury, and Internet intermediaries like the domain name registries as executioners, big pharma is able to effectively maintain a stranglehold on online sales of prescription medicines that they could never get under national or international law.
That doesn't mean that online trade in medicines needs to be an unregulated free-for-all. There may be some merit in the DNA's idea of a cross-border framework of cooperation on online medicine sales. But the DNA's big mistake was in allowing big pharma to write the rulebook. If a set of practices on online pharmacies is to be developed, this should be done through an inclusive, balanced and accountable process. This means including all affected stakeholders, so that a balance can be struck between the private interest of patent monopolists and diverse public interests such as access to affordable medicine and maintaining a free and open Internet.
The outcome of such a conversation probably wouldn't look much like what we see in the DNA's Registry/Registrar Healthy Practices—which are quite literally lifted holus-bolus from a document of the ASOP/LegitScript mouthpiece Center for Safe Internet Pharmacies (CSIP). A more balanced set of guidelines might, for example, provide a channel for Internet intermediaries to ensure that consumers have accurate information about the provenance of the pharmaceuticals that they buy online, and assist law enforcement authorities in obtaining information about online pharmacies that dispense fraudulent medicines.
Meanwhile, it's not as if there are no safeguards already in place for purchasers from online pharmacies. We already mentioned one independent pharmacy watchdog in our last piece on this topic; PharmacyChecker.com. In addition, there are self-regulatory guidelines that many reputable online pharmacies follow, such as those of the Canadian International Pharmacy Association (CIPA). (EFF is presenting on Shadow Regulation at CIPA's AGM today, and our presentation is linked below.)
Without even acknowledging the existence of such existing best practice initiatives, the DNA's Registry/Registrar Healthy Practices would have Internet intermediaries hand the reins of Internet content regulation over to big pharma. There is no better illustration of what a dangerous precedent this sets than in the Healthy Practices themselves, which would have granted similar content censorship powers to copyright monopolists, if we hadn't stopped that proposal first. Even if well-meaning, Shadow Regulation will always be inclined to have unintended consequences such as these, because of its deliberate exclusion of Internet users and the public at large.
We called it out before, and we're calling it out again: the Healthy Domains Initiative remains unhealthy for the Internet, and the DNA needs to go back to the drawing board.
- 1. Big pharma has long tried to dishonestly conflate this with international trade in safe generic and branded medicines, by describing them both using blanket phrases like "counterfeit drugs". However they suffered a setback last year, when the World Health Organization (WHO) ruled that it would henceforth use the terminology substandard and falsified in its work on public health concerns around fraudulent medicines, signalling that the WHO has no designs to become an international patent enforcement body.