Part 1: Let’s just import what we need!

This is a common attitude among the public and politicians. The American Association of Retired Persons endorses it and is organizing a grassroots campaign to support the idea. It saves all the work in trying to actually fix the problem—or does it?

It is common for retirees in Sun City, AZ, to carpool down to Mexico for their medications every month or two to save money. In my hometown of Youngstown, OH, day-trips by bus are organized to take Americans to Canada for their prescription drugs. The Internet has a proliferation of advertisements and spam e-mails for cheap prescription drugs. Why should Americans have to pay top dollar? (The answer is we shouldn’t—but don’t stop reading here.)

While it might be all right to go to another First World country to purchase medication, it is not all right to run off to the Second or Third World to do so. Before anyone thinks this unfair, consider that one of the top issues each year at the World Health Organization’s Annual Assembly is the problem of counterfeit products, whether fake, “watered” down or substituted, and the problem is increasing.

"..Increasingly easy access to sophisticated technologies such as those for printing and manufacturing, have made it more difficult for governments and other concerned parties to combat counterfeiters of medical products effectively…the extent of counterfeiting is impossible to quantify…Counterfeiting affects all medical products: from medicines and pharmaceutical ingredients to medical devices and diagnostics…Counterfeit products have been detected in most of WHO’s Member States and in all its regions. Cases have involved widely used medicines such as atorvastatin [Lipitor] and paracetamol [Tylenol], limited use medicines such as growth hormone, paclitaxal [Taxol], and filgrastim [Neupogen], erectile dysfunction medicines and medical devices such as contact lenses, condoms, surgical mesh and diagnostic test strips used by diabetic patients to monitor their blood glucose concentrations. Both expensive products and cheap ones, generic and branded products are being counterfeited with the result that they appear in community pharmacies and hospitals, as well as other less regulated settings.

Although organized crime and individuals acting alone have been associated with the manufacture and/or trade in, counterfeit medical products, in most cases the counterfeit products appear to have been internationally traded between previously unconnected groups or individuals. This fact puts an equal responsibility on importing and exporting countries.

Many factors of varying importance between Member states contribute to creating an environment where the manufacture of, and trade in, counterfeit medical products can thrive:

• Governments’ unwillingness to recognize the existence or gravity of the problem

• Inadequate legal framework and penalties

• Weak administration and coordination, with measures not focused on fighting counterfeiting

• Ineffective control of manufacturing, import and distribution of medical products

• Ineffective collaboration among bodies and institutions, such as health authorities, police, customs and the judiciary, involved in regulation, control, investigation and prosecution

• Ineffective collaboration and exchange of information between the public and private sector

• Insufficient collaboration and exchange of information

Besides the ubiquitous corruption, several other socioeconomic factors, many of which are specific to some countries, or particular areas inside a country, undermine efforts against counterfeiting:

• National drug policies that prioritize economic over public health aspects of medicine manufacturing, with the result that exporting takes priority over compliance with good manufacturing practices.

• Extreme fragmentation of distribution channels involving an unnecessarily large number of transactions, thereby increasing the opportunities for counterfeiters to infiltrate the normal distribution system

• Existence of “extraterritorial” trade zones which largely escape from regulatory and enforcement oversight and goods and their accompanying documentation can be manipulated

• Inadequate access to health services and reliable pharmaceutical supply channels that creates opportunities for “informal operators” who establish “informal supply systems” purportedly to meet populations’ real needs

• Absence of or insufficient social security coverage in countries that do not regulate prices; the resulting search by patients for better prices often leads to fierce competition among vendors and opens opportunities for counterfeiters who can offer unbeatable prices

• Illiteracy and poverty, which puts patients at a particular disadvantage

• Unregulated Internet trade, where unscrupulous sellers can hide their identity and the true origin of traded medical products

• Third-party manufacturing, which, if not properly and carefully supervised, may lead to the unauthorized use of manufacturing techniques and packaging materials." [ Counterfeit medical products. Report by the Secretariat – WHO. 61st World Health Assembly. Provisional agenda item 11.13, April 7, 2008]

This post is an excerpt from Healthcare Solved - Real Answers, No Politics.