Five Big Ideas for the Global Struggle Against Fake Medicines

02/07/2013 11:50 | Updated 31 August 2013

Fake and counterfeit medicines and medical products, and their harmful impact on global health, are receiving more global attention. These are medicines that can kill or maim rather than heal, and in many countries, especially in the Global South, make up more than 20% of all medicines in supply.

Using "Google News" results trends over the last three years one can crudely calculate that international press coverage of the subject is surging at a rate of more than 120% a year. Whatever the actual figures, there is no doubt that more editors, and presumably therefore more people, are more aware of the problem than ever.

It is remarkable then how weak global action to address this problem has been. Some might even say that in certain important respects there has been retrogression.

For instance, the main taskforce of the World Health Organisation (WHO) dedicated to the problem, the IMPACT, has been disowned by the WHO, because of suspicion in the developing world that it has been hijacked by western corporations and interests. And though efforts have been made to set up a successor entity concerns remain over the coherence of the global response to the problem.

So, in the 30 years that the WHO, as the primary global public health entity, has been prioritising this issue, we have gone from a period of growing global cooperation to the current situation where notwithstanding greater public awareness:

1. We no longer have consensus at the highest inter-governmental levels on even the definitions to use in describing these dangerous, unapproved, medicines; and

2. We no longer have an authoritative estimate of the scale of the problem at a global level.

It is unremarkable then, considering the lack of consensus on such basic matters, that growing international awareness of the problem has not led to more action.

Rather than quibble in endless meetings, and instead of focussing on the search for academic consensus, the world community can move to a more "project-based" response by scaling up existing pockets of effective consensus, such as the commitment by most stakeholders to a "patients' rights" and "public safety" framework for taking action globally against the proliferation of these harmful medicines.

Below we propose 5 broad "projects" that the global health community can engage around in a practical, measurable, way.

1. A Global Access to Safe Medicines Index

The process of developing indicators to assess the situation in different countries in order to arrive at a global index of some sort should re-direct the conversation to more concrete local concerns, sparking practical debate about what countries ought to be doing in order to solve the problem, whilst at the same time highlighting gaps in global cooperation. A great example of how indices have fostered useful, behaviour-impacting, discussion is the "doing business reports" issued in variants by the World Bank and the World Economic Forum.

2. An International Patient Sentiment Survey

If all the interest in the subject of counterfeit and unapproved medicines was to convert into greater activity on the ground, there is no doubt that individual patients are likely to become better sensitised about the risks they face from these dangerous products. Compare, for instance, the 50% plus awareness rate pollsters Gallup found in 15 African countries in 2010 with the 2% awareness rate TNS found in the UK. Without corresponding assurance from the authorities in cleaning the health system, patient confidence will slump. This interesting see-saw effect - of rising sensitisation and potential falling confidence - needs careful management, which in turn requires empirical tracking in the form of a sentiment survey. Once can take some interesting lessons from the Transparency International Corruption Survey, which relies on the evolving perception of business people who do business in countries under evaluation. A "case-study repository" of fake medicines incidents providing an end-to-end overview of these events should also supply the human-interest stories necessary to enhance the quality of broader public awareness.

3. A Pharmaceutical Quality Infrastructure Blueprint

The German government, through agencies like the GIZ and BMZ, has, in conjunction with some UN bodies such as UNCTAD and UNIDO, have been trying to spearhead international action on the provision of support to pharma companies in developing countries especially to produce good quality drugs. This is particularly essential to the fight against sub-standard (as opposed to imitated or falsely labelled) medicines and the wider issue of medicines accessibility. It is easy however to over-simplify the issue into simply one of capital and skills for local manufacturers. But where ports are creaky, regulators are corrupt, cold chains do not exist, and laboratory technician courses at local polytechnics are weak, the entire supply chain of medicines, whether produced locally or overseas, becomes compromised. In some countries, storage conditions are so bad and clearance procedures so murky that active pharmaceutical ingredients (APIs), which are mostly imported, deteriorate even before they get to the factory or warehouse. It is a total quality infrastructure issue.

4. A Global Charter on Safe Medicines

Some experts believe that only a global treaty can activate true global cooperation on this issue. Such a treaty can harmonise enforcement action and stop criminals from exploiting gaps between nations and loopholes in local regulations. Some like Professor Amir Attaran point to the ludicrousness of the current situation where a global treaty for the control of tobacco is enabling the possible traceability of these killer-products internationally, while life-saving medicines continue to lack such a global tracking system. The truth however is that given the current confusion at the WHO level, it is unclear how such a treaty can be laid at the UN level. Meanwhile, regional conventions in Europe may be pre-empting a treaty, and may even motivate some emerging markets/powers to obstruct a single global convention. Rather than a treaty, a charter that can be adopted voluntarily by different countries and societies as a source of shared norms and model legislation, but does not need to scale UN politics, may stand a better chance of beginning the process that can eventually lead to a global treaty.

5. An API Intelligence System

Most small and medium-scale producers of medicines simply do not have the capacity to police their own supplier network effectively. A global intelligence sharing system on suppliers of APIs, chemical signatures, as well as blacklists and whitelists, that all manufacturers, generic or branded, can openly share, can help curb the supply of sub-standard pharmaceuticals.

Bright Simons is honorary Head of Research at IMANI, a think tank in Accra, and the inventor of Africa's home-grown ICT-based response to the counterfeit medicines crisis: www.mPedigree.Net