Steve May: Courts should address prescription drug re-importation

Editor’s note: This commentary is by Steve May, a licensed independent clinical social worker who has worked in a variety of mental health and substance abuse agencies for the past 15 years. In addition, he served as national director of state affairs for the Hemophilia Association and has held a variety of leadership positions in the bleeding disorders community. He also is a Selectboard member in Richmond where he resides.

Lawyers will tell you that sometimes a case will bless you with good facts but bad case law. The opposite can also be true: You have bad facts in a case but on the merits of the law, your argument is strong. And as the saying goes, when you have neither, baffle them with brilliance. With that in mind, simply stated: It’s time.

In this moment when NAFTA and trade with Canada is a particular focus, we should take up the question of re-importation of prescription drugs. Prescription drugs are the only legal product that as Americans we are not allowed to procure, contrary to the idea of free trade and simpler movement across borders for people and labor. To hear it discussed, one can’t help but think that the Canadian medical system is in the dark ages of medicine, complete with leeches and sorcery masquerading as basic medicine. This leaves the FDA to act as protectors of the public trust, working to shield a band of rubes (aka American patients) from unscrupulous snake oil salesmen in white lab coats from Vancouver to Halifax.

Of course, we aren’t dopes and the prohibitions against large-scale purchasing of prescription medicines from Canadian pharmacies are not an effort led by Canadians. No, rather, this obstacle has been created by Big Pharma. The largest pharmaceutical drug purchaser in the country, the government of the United States, as a matter of law may not use the economy of scale created by the largest purchasing program under government control of pharmaceutical drugs, Medicaid and Medicare, to capture discounts and overall savings. There is a name for this kind of arrangement; it is called an unlawful restraint of trade.

Attempts to stop re-importation are equally disturbing. They are every bit as much an attempt to unlawfully restrain trade. American drug manufacturers are contracting with Canadian provinces to sell their drug products in Canada. Having sold them into the Canadian public health architecture, these same manufacturers argue that their own products now are of unknown provenance. And, as such, we the public need to be protected from this public health threat. An American product sold in Canada for return to an American purchaser is no different than one sold with the idea of it going to Europe or Uruguay. American companies don’t deliberately sell defective products at home or abroad.

The current Supreme Court is the most business friendly bench we have had in almost a century. That’s important because it is the ultimate authority that will apply the law in this case. The Supreme Court may decide that it has an interest in maintaining the free flow of products over America’s northern border. It also could choose to maintain the status quo. This question actually is more profound than one might expect. It actually strikes at the center of the American experience.

At the beginning, in writing the Constitution, the framers sought to create rules to address a whole set of concerns. One of the primary issues dealt with was trade. They viewed the movement of goods and services essential to the ultimate success of the republic. Trade was so critical to the framers that they wrote the commerce clause, which is designed to police trade over state lines. They actually went as far as to detail the reciprocity of contracts, and so a contract written between parties in Virginia is valid and enforceable in any and all of the other states.

Re-importation involves a clause in the North American Free Trade Agreement, NAFTA. Industry lobbyists convinced Congress to exempt a whole area — pharmaceuticals — from routine trade as prescribed under the terms and conditions of legislation, in this case a treaty duly passed by Congress and our neighbors.

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Circumventing NAFTA can’t be in step with the spirit of the commerce clause no less the letter of the law. Acting to stop any actor from using the power of markets to aid in an effort to drive down the cost of provisioning health care is foolhardy. Health care represents no less than one-sixth of our economy and Canada is America’s largest individual trading partner.

No one knows with certainty how the court system would react to such a case. We do know that in the absence of someone actually testing the law, nothing will change. The status quo seems to be in conflict with the spirit of the law at a minimum and potentially the letter of the law. This conflict raises a “question of law” which needs to be resolved. The question of re-importation from Canada and the effort to stop trade that artificially inflates the drug manufacturers’ profits deserves a resolution.

This court with its ingrained pro-business bias has a mixed history in cases where big business and the family shop are concerned. This is exactly the right vehicle and venue for this to be heard, good facts and good law be damned. More important than venue or vehicle or law even, these circumstances have ripened sufficiently to the point where at minimum our argument may be fit enough to receive a sympathetic hearing by the Supreme Court. All of this requires that we are ready to put the ball in play through actions designs to kick off a legal action of one kind or another.

Simply stated — we have good law. The intent of NAFTA and the constitutionally protected right to contract are adversely impacted by efforts to prohibit the sale of medications across borders.

According to government officials, the rationale for prohibiting the sale of drugs from Canada is “to protect the public” from inferior or unregulated drug products. In this case, we are discussing medications being resold by manufacturers to Canadian pharmacies regulated by the provinces and Health Canada. Canada is a first world country with a first world health care infrastructure. A blanket prohibition against drug re-importation hurts American patients by unnecessarily raising the cost of their care while acting to inflate profits for all drug manufacturers regardless of their nation of origin. Stockholders are being protected at the expense of patient care. These are good facts, sympathetic to patients.

Drug makers in creating a blanket prohibition created a system which is too rigid. If one wants to argue that Mexico and Canada aren’t the same — that the delivery of care is different and the circumstances in the two countries demand different things — that might be reasonable, but a complete prohibition on drug re-importation is not. The time for legal action is now.


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