Countries need to act against fake and substandard medicines

The world’s medicine supply is under attack. From Pakistan, where 120 patients died after taking fake heart medicine, to the United States, where 32 patients died and hundreds were hospitalised because of contaminated steroids, regulators are finding their defences overwhelmed by shoddy drug companies and organised criminal groups that make fake drugs containing no active ingredients. It is estimated that at least 100,000 people die every year from substandard and falsified medicines for cancer, heart disease, infectious diseases and other ailments.

This week, delegates from about 100 member countries of the World Health Organisation are meeting in Buenos Aires with the aim of strengthening defences against substandard and fraudulent medicines. The meeting is extremely important, but to make progress a number of hurdles will have to be overcome. Most of these are commonsensical, as our research team, including professionals in health, law and diplomacy, argued in a paper entitled ‘How to achieve international action on falsified and substandard medicines’ just published in the British Medical Journal. (Unfortunately, the authors won’t be able to attend the meeting since the WHO has caved to demands from India that nongovernmental experts should not be admitted.)

In Buenos Aires, the delegates first need to agree which medicines are good and which are bad. Their failure to agree on such matters has impeded progress both in safeguarding the quality of genuine medicines and in criminalising falsified ones. Rich countries and western pharmaceutical companies have often seemed interested more in protecting their intellectual property from counterfeiting than the victims of deadly falsified medicines. This has infuriated poorer countries and generic medicine companies, especially when efforts to rein in falsified medicines began targeting genuine generic medicines.

To get around this problem, countries need to agree that protecting intellectual property and public health are two different things. Intuitively this makes sense: Most of us, learning that a person was killed by fake medicine, would demand justice for murder, rather than shriek in horror that intellectual property had been violated. Adding or subtracting from intellectual property laws won’t achieve the desired outcome. Criminalising falsified medicines will.

But criminalisation has to be fair or it turns oppressive. There is a big difference between honest drug companies that sell accidentally substandard medicines, and organised criminals who sell a deliberately falsified colon and breast cancer drug containing nail polish remover. Legally speaking, however, countries have yet to agree on terms like ‘falsified’ and ‘substandard.’

Unjustly prosecuted

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 will find themselves prosecuted unjustly. Once they have agreed on definitions, countries must next agree on the legal steps they will take together to improve the quality of medicines. These steps then must be put into a treaty to make them legally binding.

Why an international treaty? There are several reasons.
First, a treaty will foster cooperation among police and prosecutors in the signatory countries as they go after criminals selling fraudulent drugs. A treaty against fake bank notes 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 to which the 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 at high standards, and to harmonise new technologies like bar-coding to authenticate 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 to 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 United States and most of Europe only acquired medicine regulation between the 1930s and 1960s, after snake-oil salesmen and dangerous products had victimised 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: Some 80 per cent of medicines and their ingredients consumed in the United States come from outside the country, often from developing countries. Simply put, either we help fix their medicine quality problems, or we swallow them with a glass of water.

(Amir Attaran is a researcher at the University of Ottawa, and Roger Bate is a resident scholar at the American Enterprise Institute)
NYT