The world’s medicine supply is under attack. From Pakistan, where 120 patients died of a fake heart medicine, to the United States, where 32 patients are dead and hundreds are hospitalized due to contaminated steroids, regulators are finding their defenses overwhelmed by shoddy drug companies and even organized criminals who make fake drugs containing no active ingredients. Probably at least 100,000 people die every year from substandard and falsified medicines for cancer, heart disease, infectious diseases, and other ailments.
This week, about 100 member countries of the World Health Organization will meet in Buenos Aires to strengthen defenses against the carelessly substandard and fraudulently falsified medicines. In order to make progress, a number of hurdles will have to be passed. Most are commonsensical, as our research team consisting of health, law and diplomacy professionals published this week in the British Medical Journal.
First, countries need to agree which medicines are good and which are bad. To date, they have failed to agree on this. That holds them back, both in safeguarding the quality of genuine medicines and criminalizing falsified (often inaccurately called “counterfeit”) medicines. (Falsified medicines are fake; counterfeit medicines infringe on intellectual property rights.)
In the past, rich countries and western pharmaceutical companies often seemed more interested in protecting their intellectual property from counterfeiting than protecting the victims of deadly falsified medicines. This infuriated poorer countries and generic medicine companies, but never more so than when enforcement actions against falsified medicines inappropriately branched out to criminalize real generic medicines.
To get around this problem, countries have to agree that protecting intellectual property and public health are two different things. Intuitively this makes sense: most of us, surprised to discover a person killed by fake medicine, would demand justice for the murder, rather than shriek in horror that intellectual property had been violated. Adding or subtracting from intellectual property laws would not achieve the desired outcome. Criminalizing falsified medicines would.
But criminalization has to be fair or it turns oppressive. There is a big difference between honest drug companies who sell an accidentally substandard medicine, and organized criminals who sell a deliberately falsified colon and breast cancer drug containing nail polish remover. But legally speaking, countries have yet to agree on defining terms like “falsified” and “substandard.” So long as countries cannot define the problems they must fight, and which medicines are wrongful in which ways, criminals will continue to slip through loopholes, and honest companies, pharmacists and doctors just might find themselves prosecuted unjustly.
With definitions in hand, countries must agree on the legal steps they will take cooperatively to increase medicine quality. Then these steps have to be put into a treaty, where they will be legally binding.
Why a treaty? There are several reasons.
First, some countries are havens for medicine crime. Two Canadian businessmen, Nathan Jacobson and Andrew Strempler, sold medicines by fraudulent means or laundered the money. Yet shamefully, Canada did not prosecute or extradite them, and other countries had to. A treaty would assist the police and prosecutors in all countries to cooperate against criminals like these men. For that reason, a treaty against fake banknotes has existed for almost a century; one for fake medicines is overdue.
Second, countries need to cooperate on technical standards for medicine quality and safety in international trade. The reason you can dial a phone number or board an aircraft in country X, and talk with or land safely in country Y, is that there are treaties on telephone systems and aircraft safety upon which all countries agree. Those legally binding technical agreements cannot make phones and airplanes perfect, but no agreements would be worse. Similar agreements are needed for internationally traded medicines, both to ensure that they are manufactured to good quality and to harmonize new technologies like bar-coding to authenticate the real medicines. The alternative is a global market where good and bad medicines mix, and each country uses a different authentication technology to discern them, ultimately making medicines less tradable and more expensive.
Third, developing countries need help to bring better quality medicines to their people. Today, two-thirds of countries have no medicine regulation agency at all or incomplete regulation. That is not surprising: the US and most of Europe only acquired medicine regulation between the 1930s and 1960s after snake oil salesmen and dangerous products had victimized them. Now that the emerging countries are consuming more medicines, they too are victims, and need to acquire the skills and technologies of medicine regulation.
The richer, more advanced countries should help, out of altruism surely, but also self-interest: fully 80% of medicines and their ingredients consumed in the United States come from abroad, often developing countries. Simply put, either we help fix their medicine quality problems, or we swallow them with a glass of water.