Unsafe Pills: WHO’s solution to substandard medicines may only make things worse

Combatting counterfeit medicines starts with better drug regulatory authorities, not a focus on intellectual property rights, says a new report released in conjunction with a World Health Organization meeting on fake drugs.

February 3, 2011

Canadians who have visited poor communities in developing countries are often struck by the easy availability of prescription medicines. A wide variety of remedies are sold by street vendors and in corner stores, with no need for a doctor’s note and with only the untutored vendor’s suggestions as to dosage and side effects.

Studies show in some countries nearly half of the common medicines on sale, such as anti-malarial drugs, do not meet World Health Organization quality standards. Pills may contain the wrong type or concentration of active ingredient, or they may have deteriorated during distribution, and thus become ineffective or dangerous. Or they may simply be fakes.

In Canada and other wealthy countries, national drug-regulatory authorities authorize medicines for use and monitor the market to remove any poor-quality, falsified, or unregistered medicines.

According to the WHO, some 30 percent of developing countries are unable even to maintain a registry of medicines, and cannot effectively monitor for substandard pills, with devastating consequences for patients and for public health.

While strengthening national regulatory capacity is the urgent and logical way forward, the WHO, at the behest of a number of medicines-exporting countries and some members of the multinational pharmaceutical industry, has started down a very different path.

The WHO-affiliated International Medical Products Anti-Counterfeiting Taskforce (IMPACT), with drug industry sponsorship, has focused attention on knock-offs: medicines that are intentionally misrepresented as the product of a brand-name manufacturer.

Using the real public health threat posed by substandard medicines as a justification, the taskforce is pressuring developing countries to adopt stricter intellectual property rules as the best remedy for poor-quality medicines.

Targeting that small subset of the problem cannot be relied upon to ensure patient safety, especially when evidence suggests that the vast majority of substandard and falsified medicines are unrelated to criminal trademark infringement.

Of even greater concern, the new IP enforcement rules being proposed would create new barriers to quality generic medicines, which are a lifeline for millions of patients in poor countries. IMPACT wants an expansive definition of counterfeit medicines that confuses counterfeits with generics, and overemphasizes police action on intellectual property rules.

The consequences could be starkly seen in the European Union, where the proposed rules have already been adopted. Over the past two years, at least 19 shipments of safe, quality generic medicines from India and Brazil, intended for patients in developing countries, were seized in transit in European ports and not allowed to continue to their destinations.

Some of the world’s poorest countries, including Kenya and Uganda, are being pressed to adopt faulty anti-counterfeit laws, or have already done so, supposedly to safeguard their medicine supply. These laws would endanger access to affordable generic medicines to treat HIV/AIDS and other diseases.

Policies that reduce generic competition can also undermine efforts to improve public health, because they drive up the price of medicines. High medicine prices are often a key reason why low-income households buy medicines from unregulated outlets, where they may be cheaper but of inadequate quality or falsified.

Developing countries would be wise to remain focused on public-health measures to ensure that all medicines within their borders meet acceptable standards of quality.

Some developing countries have successfully built national drug regulatory authorities, including Brazil’s ANVISA, which emerged only a decade ago and now effectively guarantees medicine quality in the country.

Lower income countries, such as Tanzania for whom a full-fledged regulatory authority is a long-term project, are trying innovative approaches like a database of unregistered medicines traced to pharmaceutical outlets, as well as public information campaigns.

Substandard medicines are a serious threat to billions of people living in poverty. Canada ought to offer developing countries its substantial expertise in drug regulation, and use its seat on the WHO executive board to derail the mistaken approach of using intellectual property law enforcement to address a public health problem.

Mark Fried is Oxfam Canada's Policy Coordinator.