Fighting fake medicine, or fighting each other?

Substandard pills
It is now true that nothing is confiscated more often at the borders of the EU than fake medicine – not fake running shoes or fake handbags or fake watches, but medicines.
Professor Amir Attaran
At worst, taking substandard or falsified medicine can kill you; at best, you will receive no relief from the symptoms of your ailment, or no protection from a health threat. That is without the added risk that diseases may become resistant to treatment as a result of the use of illicit diluted drugs. The hazards seem obvious, so why is it possible to trade such medicines on the global market with impunity?

Pharmaceutical crime has been described as involving ‘the manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices’. According to Interpol, it ‘encompasses the counterfeiting and falsification of medical products, their packaging and associated documentation’.1

And therein lies the rub with tackling this problem. Previous attempts to address it at the international level have been thwarted by arguments about the implications of the word ‘counterfeit’, where there is a need to distinguish between intellectual property rights and compromised quality, safety and efficacy of medicines. The new moniker adopted by the World Health Organization (WHO) – ‘substandard/spurious/falsely-labelled/falsified/counterfeit medical products’ (SSFFC) – will, argue the authors of a recent report, only serve to compound the confusion.

This politicisation of the debate and other issues (such as arguments surrounding pharmaceutical pricing and financial interests) have so far impeded the creation of international legislation to criminalise the global trade in falsified medicines.

In a paper published last week in the British Medical Journal, lead author Professor Amir Attaran, Canada Research Chair in Law, Population Health and Global Development Policy at the University of Ottawa, criticised the lack of action on substandard and falsified medicines. He argues that this situation has resulted in countless deaths worldwide, and calls for an international treaty to address the various aspects of this problem.

In an interview with ScienceOmega.com Professor Attaran offered his perspective of the conflicted arena of international policy on the issue, and expressed his frustration at the lack of a non-governmental presence at the member states mechanism meeting taking place in Buenos Aires this week.

Policymakers attempting to tackle the problem of falsified pharmaceuticals will have to overcome numerous hurdles including the dearth of information that surrounds this issue. There are no global statistics to give a sense of the scope of the problem; data mainly consists of figures from regional and national customs authorities as well as case studies.

"It is crime after all, and criminals seldom report their activities fastidiously to the authorities," Professor Attaran said. "It’s always challenging to say how big the problem is, but we do have a few illustrative cases."

In the European Union, instances of illegal medicines being imported increased by 700 per cent between 2010 and 2011. This figure represents just a one-year shift, and only takes into account products seized as a result of intellectual property violations. The real scale of the problem, therefore, could be considerably worse.

"It is now true that nothing is confiscated more often at the borders of the EU than fake medicines – not fake running shoes or fake handbags or fake watches, but medicines," reiterated Professor Attaran.

Indeed, the researcher cited examples of cases worldwide – in developed as well as developing countries – in which falsified medicines and medical products have resulted in fatalities. Earlier this year, more than 120 people died in Pakistan as a result of taking heart medicine contaminated with a lethal overdose of an antimalarial drug. Currently, the death toll from an outbreak of meningitis in the United States caused by adulterated steroid injections stands at 33, with hundreds more remaining in hospital. Four years ago, at least 84 infants died in Nigeria after being given a teething mixture that apparently contained diethylene glycol – an ingredient also found in antifreeze and brake fluid.

"In July this year, authorities in West African countries carried out a customs operation in 16 major sea ports," Professor Attaran said. "It wasn’t a large, ambitious programme – it was only for a one-week period – but in that week they seized 82 million fake treatments."

The World Customs Organization reported that antimalarials, antibiotics, antiparasitics, cough syrups, contraceptives and infertility treatments were among the products seized in Operation VICE GRIP 2. Although there are accounts of fake medicines being sold in the past, countries now routinely trade medicines across borders. Allowing international trade without the proper mechanisms of global governance in place creates the opportunity for organised criminals to infiltrate supply chains, as Professor Attaran explained.

"Opening global markets to medicine is a good thing for the most part; it means more patients get access to more medicines, more cheaply," he remarked. "However, we haven’t been careful enough to put up defences against international organised crime alongside this opening up of the market. Criminals have worked out that it is very profitable and less risky to do this trade compared to, for example, smuggling cocaine or heroin. In most countries, medicine crime is barely punished."

According to Professor Attaran and his co-authors on the article, there are a number of reasons that it is proving so difficult to address the global trade in illegitimate medicines.

"Every country has its own drug regulatory authority, with the exception of very poor countries," explained Professor Attaran. "This is a massive problem for those countries; if you don’t have a regulatory authority, criminals are bound to take advantage. Even in countries that do have regulation, like the UK and Canada, the authorities have quite weak powers in some cases."

Even in developed countries, where medicine safety is generally better, national law can be quite lax concerning the falsification of medical products, as Professor Attaran explained with regard to Canada:

"Never in the country’s history has a person been sent to prison for fake medicine trading. A typical fine is about 2000 Canadian dollars; for serious criminals that is just the cost of doing business. We have very backwards laws at the national level in some countries, including Canada, which ought to know better."

The primary obstacle, however, is that this trade is legal. Somewhat perversely, the protocols of the Framework Convention on Tobacco Control (FCTC) mean that cigarette falsification is more tightly controlled than the falsification of medicines.

"In the space of global commerce, there’s no law at all covering this," Professor Attaran stated. "It is completely legal to trade fake medicines internationally."

A comprehensive global strategy to challenge the production of and trade in substandard and falsified medicines is necessary, the authors of the paper argue, if meaningful progress is to be made. All stakeholders must work together towards a shared goal if the required legal, financial and technical measures are to be put in place.

"We have a broad team consisting of lawyers, diplomats and members of various health professions – nurses, pharmacists and doctors included – all standing behind the recommendation that there needs to be a treaty on this issue. Treaties are how you make international law and they have a proven record of being able to criminalise seriously dangerous conduct in all countries.

"The internationalisation of criminal law is what has impeded crimes such as money counterfeiting, hijacking and international money laundering," Professor Attaran pointed out. "Countries signed a treaty in each of those cases that bound them to enforce the law no matter whose ox was being gored, and that has made all the difference."

The problem of definitions has plagued the establishment of a consensus among shareholders and among states. When an overly broad definition of ‘counterfeit’ is used, the field is open for accusations that those with an interest in enforcing intellectual property laws can fly the flag of ‘anti-counterfeiting’ in order to squeeze potential competitors from the market. ‘Counterfeit’ and ‘falsified’ do not necessarily mean the same thing, and access to cheap, generic medicines is important, especially in developing countries. The authors of the paper recommend an internationally agreed terminology in which ‘counterfeit’ is reserved for issues concerning intellectual property violation.

I asked how scientific research can help to address the issues surrounding fake and substandard medicines when so many other obstacles stand in the way of action. Professor Attaran expressed his belief that those in charge of funding streams are not interested because the science of tracing how existing treatments are being corrupted is ‘not sexy enough’.

"Scientific research is the most important thing; it’s top of the list as far as I’m concerned," he replied. "Unless we have clear evidence that the problem exists, why should anyone do anything about it?

"We do need additional research on the extent of the problem – particularly epidemiological research on who is affected and to what extent. Basically, collaborative research between the biomedical and criminological communities is needed."

Professor Attaran stressed the importance of funding bodies not shying away from marrying the two disciplines, as there are clear benefits to be reaped for public health and safety.

In terms of intergovernmental cooperation, some progress has been made. The International Medical Products Anti-counterfeiting Taskforce (IMPACT) was established in 2006, and a further working group was set up at the behest of the 63rd World Health Assembly in 2010. Little progress, however, was reported at the 64th WHA meeting, and so the 65th Assembly created a new ‘member state mechanism’, the functioning of which will be reviewed in three years time.

The first meeting of the member state mechanism began yesterday in Buenos Aires, Argentina, bringing together representatives of 100 or so countries. However, it is taking place without the presence of Professor Attaran and other non-governmental officials.

"Some of the professional health organisations involved in our paper – under the aegis of the World Federation of Public Health Associations – were denied permission by WHO to attend the meeting," Professor Attaran revealed. "As recently as a few months ago, they were welcomed to these meetings and no reason was given for the refusal on this occasion. I do have it from a confidential source in Geneva that the decision was taken at the request of India."

In light of their recommendations, I asked Professor Attaran what he hopes might be achieved at the Buenos Aires meeting this week. His response was mixed.

"I work closely with WHO and have great respect for the organisation, but they have adopted an unusually timid stance on this situation, which I think is down to bullying by certain countries – principally India," he said, stating his conviction that institutionalised corruption is largely to blame for hindering the creation and ratification of an international treaty targeting counterfeit and falsified medicines. 

Professor Attaran speculated that if the cynical calculation has been made by the government of India that its citizens are profiting from the manufacture and trade of illicit medicines, motivations for enforcing regulation and the law more strictly could be obfuscated.

"Of course there is a very good reason that this practice should be shut down; people are dying, and there is something that matters more than money."

Mounting forensic evidence suggests that India and China are the world’s leading suppliers of counterfeit medicines, of which it is supposed a large portion must also be falsified. Professor Attaran was keen to stress that it is not only these states that are to blame, and that not all pharmaceutical companies should be regarded with suspicion. However, as the United Nations Office on Drugs and Crime (UNODC)’s report on the globalisation of crime points out, a lack of accountability leaves the door open for organised crime – it is almost an invitation.

Earlier this year, an Indian parliamentary committee issued a scathing report which found that the Indian drug regulatory body – the Central Drugs Standard Control Organization (CDSCO) – is inadequately staffed and without the resources to fulfil its remit. The report also called attention to the conflict of interest between the agency’s powers of authorisation and its mandate to ‘meet the aspirations […] demands and requirements of the pharmaceutical industry’. Professor Attaran is of the belief that corruption is behind some of the irregularities discovered in the parliamentary investigation, and that these conflicts may also be brought to bear in international intergovernmental discussions on the topic.

CDSCO did not respond to ScienceOmega.com’s request for comment. Nor did WHO’s press office in Geneva, although the body has previously stated that it is the responsibility of individual member states to decide who can attend. A spokesman for the WHO Country Office for India noted the Ministry of Health and Family Welfare’s response in The Indian Express, and said the regional office had nothing further to add at that time.

"You couldn’t ask for a broader consensus than we have in this BMJ paper; we have lawyers, doctors, diplomats, pharmacists, the nurses of the world," reiterated Professor Attaran. "Countries just need to get on with it now, and if they’re not going to get on with it, we need to expose them and show that they are putting commercial interests ahead of lives."


1 Interpol, Pharmaceutical crime

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