The Obama administration is taking actions to address the illegal sale of counterfeit prescription drugs online. These efforts can benefit patients who could fall victim to rogue online pharmacies, but may also limit access to safe and affordable medication provided by non-U.S. international online pharmacies, many based in Canada. Millions of uninsured and under-insured Americans have purchased prescription drugs through, and relied on, such websites to afford medicine.
Last Monday, the White House Intellectual Property Enforcement Coordinator (IPEC), Victoria Espinel, stated that her office was in discussions with Google, Go Daddy, American Express, and Microsoft about cracking down on online pharmacies, and that an announcement about IPEC’s plans moving forward will be made within weeks. This statement seems to be a follow-up to a late-September meeting held by IPEC, which brought together domain registrars and registries to discuss voluntary protocols to combat the sale of non-controlled counterfeit medication online. As we reported, the Internet Corporation for Assigned Names and Numbers (ICANN) notably declined its invitation to attend this meeting, and at least one of its attendees, Go Daddy general counsel Christine Jones, as reported on Domain Incite, communicated that intellectual property protection was not discussed and voluntary protocols were not agreed to. Jones also shared her understanding that an “FDA solution” might be used to combat counterfeit drugs being sold online. Espinel’s statement last week suggests the same.
Recent FDA actions do suggest that a crackdown on rogue online pharmacies is underway. During one such initiative, called Operation Pangea III, the FDA and Interpol targeted 294 drug-selling websites and has suspended or curtailed the operations of 274 of those websites. Shutting down rogue online pharmacies protects patients, but will the U.S. Government extend these actions to safe international online pharmacies to the detriment of public health?
Unfortunately, the administration’s position on online pharmacies is guided by the recommendations of the Alliance for Safe Online Pharmacies, an alliance of mostly U.S. pharmaceutical and pharmacy stakeholders. ASOP calls for the U.S. government to coordinate with ICANN and registrars to shutdown “illegal” online pharmacy sites to fulfill ICANN’s contracts with registrars; contracts that require the latter to prohibit Internet access to domain registrants that operate unlawfully. It also calls for search engines to delist illegal pharmacy sites from organic search results. And in doing so, it appears that ASOP is not only targeting dangerous rogue online pharmacies, but would also like to see safe, non-U.S. online pharmacies that export prescriptions to Americans shutdown on legal technicalities, not because of safety.
Using the word “illegal” to describe which sites should face enforcement action, and not using the words “rogue” or “unsafe”, for instance, is purposeful and geared toward getting government to change its compassionate and pragmatic position of the past decade to a policy calling for strictly enforcing certain drug importation laws to the detriment of American patients. When Americans import prescription drugs online for their own use from non-U.S. pharmacies, they violate federal law, which bans personal drug importation; when non-U.S. pharmacies export prescriptions to Americans they may violate state and federal laws governing prescription sales. However, many view personal drug importation as, de facto, decriminalized because people are neither arrested nor prosecuted for the practice and, with few exceptions, orders always reach patients. Moreover, reputable non-U.S. pharmacies selling to Americans are operating legally within their own jurisdiction and fall outside the reach of U.S. laws.
Notwithstanding the “grey” legality of the industry, take down protocols against safe and affordable online pharmacies represent a threat to public health because prescription drug utilization for chronically ill patients is price elastic. A study by the National Consumers League concludes that for Americans with chronic illnesses, cost is the number one reason for skipping medication. Furthermore, a survey released in 2008 by Harvard University School of Public Health, USA Today, and the Kaiser Foundation found that four in ten Americans, around 120 million people, say they have trouble paying for drugs, skip prescriptions, or cut pills because of cost.
A decade of experience and studies show that the international online pharmacies that follow safe standards – most importantly by requiring valid prescriptions and dispensing from licensed pharmacies – function just the same as domestic mail-order pharmacies. The difference is that, due to price controls in other countries, international online pharmacies sell popular brand name drugs at prices 70% lower than domestic pharmacies. With tens of millions of prescriptions filled through international online pharmacies, few adverse health affects have been reported, as noted by the FDA. And reports, including one in the peer-reviewed Public Library of Science One, conclude that verified sites, domestic or international, sell genuine medication and require a prescription. Today, the lead author of this report, Roger Bate, from the American Enterprise Institute, made a strong free-market argument calling for the formal decriminalization of personal drug importation.
Corporate profit, not safety, is the reason pharmaceutical companies lobby against personal drug importation. A shareholder report by drug giant Pfizer defended an increase of its CEO’s compensation by extolling his actions to prevent the legalization of drug importation both directly and through other groups. After all, in the early 2000s, pharmaceutical companies challenged the safety of drug importation from Canada, while taking the action of cutting supplies to Canadian pharmacies that serviced American patients. Were they trying to save the American people from their own less expensive products?
That the White House is taking action against online pharmacies through the IPEC indicates its concern about intellectual property rights and potential profit loss to pharmaceutical intellectual property holders. However, public statements made by high-ranking U.S. officials suggest that concern for public health is the primary reason for the government’s attention to online pharmacies, not intellectual property rights. Indeed, this was even communicated by Vice President Joseph Biden during a conference announcing the administration’s policy on intellectual property enforcement. In a speech, delivered as keynote speaker at a Partnership for Safe Medicines conference on October 8th, 2010 (one sponsored by large pharmaceutical companies), FDA Commissioner Margaret Hamburg stated that public safety, and not intellectual property, would drive its enforcement priorities. By these standards, denial of access to safe and affordable medications online to uninsured and under-insured Americans would be incongruous with America’s goals.
Personal drug importation expanded during the Bush administration, which staunchly opposed its legalization. Now it faces its demise under the Obama administration, even though Senator and presidential candidate Obama vociferously supported and voted for legalization, as did former Congressman and Chief-of-Staff, Rahm Immanuel. Additionally, former Governor Kathleen Sebelius, now Secretary of Health and Human Services, enrolled Kansas in a drug importation program, which allowed residents to order from pre-approved online pharmacies shipping drugs from Canada, Ireland, and the United Kingdom.
In the final analysis, if the White House recommends “voluntary protocols” to ICANN, domain registrars, and search engines, or actions by federal agencies – such as the FDA – that shut down dangerous and deadly rogue online pharmacies, then the public health is served. In complete contrast, efforts by the government, pharmaceutical companies, and groups they fund, that end up curtailing access to or shutting down safe and affordable online pharmacies, will result in fewer Americans getting the medication they need.
In the future, all Americans may have health insurance that adequately covers their prescription drug costs and they will not need or want to purchase medications from outside the U.S. President Obama has certainly worked to make that a possibility. Or, although unlikely, foreign pharmaceutical markets will move away from price controls toward a freer market, which might result in lower, more affordable U.S. drug prices. But right now, with almost 51 million Americans uninsured, any actions to stop safe personal drug importation are unjust harmful, and should be viewed as unacceptable.
