Emma Back and Alix Beith, consultants to the CGD Drug Resistance Working Group, contributed to this post.
There’s a lot of attention being paid to the counterfeit drug trade at the moment. Former President of France, Jacques Chirac, recently chaired a meeting with West African leaders to discuss how to crack down on counterfeiting. Meanwhile, the Wellcome Trust and the American Pharmaceutical Group held an Opinion Formers' conference on counterfeit medicines (presentations here); the International Federation of Pharmaceutical Manufacturers and Associations produced a brief on the issue; and Roger Bate has continued to draw attention to counterfeits and other drug quality issues in developing countries, including through his book Making a Killing. And this is all on top of the WHO-hosted IMPACT initiative on counterfeits, which started in 2006.
This attention is fully justified. Counterfeit drugs kill – and they do it while shaking people’s confidence in governments’ ability to protect the health of their citizens. The Pharmaceutical Security Institute, an industry supported non-profit, identified 1,834 incidents of known counterfeiting in 2008. While some counterfeits are close copies of the original drug, most are not, and many contain no active ingredients at all. The result for the patient is prolonged illness and even death, with the risks particularly high for children suffering an acute febrile illness, such as malaria.
But the public health risks go beyond such immediate suffering. Drugs that contain a little – but not enough – active ingredient, or that include only one active ingredient where a combination is needed for effective therapy, present ideal conditions for microbes to mutate in response to the drug. The drug resistance that results creates a huge additional cost, threatening the usefulness of quality-assured products for all prospective patients.
Drug manufacturers share responsibility with regulatory authorities for providing safe, quality-assured drugs and for tracking their continued effectiveness. Pharmaceutical companies should be more actively engaged in efforts to ensure that the drugs that reach patients are what they say they are. While there are examples of industry investing in this area – as GSK did through the Alexander Project when they had investments in antibiotics to protect – more is needed.
The CGD Drug Resistance Working Group’s draft report recommends development of industry-wide standards for pharmaceutical companies and distributors to encourage them to pay attention to quality issues that affect drug resistance beyond the manufacturing stage, as they package, store, and distribute their products. Such standards might also cover post-marketing surveillance activities, and the information provided to healthcare providers and patients, for example through promotional materials or package inserts.
Another part of the answer is to strengthen national drug regulatory agencies so they are better equipped to stem the circulation of substandard and counterfeit products on their markets. The CGD draft report recommends using regional regulatory networks to facilitate the sharing of data on substandard and counterfeit products as well as other information relevant to drug resistance.
For now, the attention of politicians, national drug regulators, global health agencies, and pharmaceutical companies is focused on tackling counterfeiting. But as they meet, they must keep drug resistance and other public health impacts uppermost in their minds. Counterfeiting is a crime. But its victims go beyond the companies whose intellectual property has been stolen and the procurement agencies whose resources are being wasted. The victims are sick patients everywhere, now and in the future – and substandard products of every type, not just counterfeits, present a risk. Sadly, every day we wait to address this problem, the number of victims grows.