The recent decision by the European Union to sign the Anti-Counterfeiting Trade Agreement (ACTA) has been met with outrage by Europe’s citizens. People across numerous European cities have taken to the streets, protesting against the new laws and the consequences on internet freedom in particular. They’ve signed petitions en masse; two million signatures against the agreement were delivered to Brussels in early March. But there is a little-discussed, other consequence of ACTA: that millions of lives in the developing world hang in the balance from a lack of access to affordable medicines.
ACTA will adversely affect access to medicines. The principles behind ACTA – the enforcement of intellectual property rights – will provide a blank cheque for abuse that will see the likelihood of medicines being detained and generic producers, suppliers, and even users threatened with abusive court threats and litigation.
ACTA’s backers say the idea is to prevent the distribution of ‘counterfeits’, including counterfeit medicines. But what is a counterfeit medicine? The word is sufficiently loaded to warrant a closer look. Ostensibly, the word refers to fake medicines. Fake drugs are dangerous. They are produced – often with little or none of the lifesaving pharmaceutical ingredients, or worse, with harmful ingredients – with the intention to deceive people into believing they are a brand drug. They mimic its packaging in order to con the consumer.
This has nothing to do with generic medicines. Generic medicines are legitimately produced drugs – they are bio-equivalent, exact copies of an original drug but priced significantly less. Their price means they are a life-line, allowing people in the developing world to access treatment and enabling treatment providers – like Médecins Sans Frontières (MSF), or like donor governments through overseas aid – to scale up care to many, many more people. Around 80 per cent of the medicines MSF use to treat HIV are generic medicines.
The difference appears obvious. But ACTA is a deliberate attempt to confuse and conflate fakes and generics. Seemingly, ACTA is about stopping the trade in fake drugs. But its provisions mean that legitimate, life-saving generics could get caught up in drug seizures or be drawn into labelling disputes over trademarks, and other litigation.
We have already seen the effects of similar provisions in European customs regulations. Drug seizures in Europe have happened with alarming frequency – all legitimately produced generics being confused for fakes or on the mistaken suspicion of infringing on a trademark. ACTA’s proponents say this has been solved as the final text has evolved, but it is only a partial solution. The threat still remains in relation to drug labelling. An incident in 2009 illustrates the risks: customs in Germany seized a shipment of generic versions of an antibiotic, simply because a customs officer confused the international scientific name of the molecule with the trademark brand name of the drug produced by GlaxoSmithKline.
ACTA threatens to multiply these sorts of incidents. It would give power to customs authorities to detain or seize legitimate generic medicines – on even the mere suspicion of infringement of a trademark.
Who is at risk? Generic companies, for a start. ACTA threatens to make trade in generic medicines a risky enterprise, one that companies are reluctant to engage in. The lack of legal safeguards in the agreement encourages abuse, particularly given the commercial rivalry between multinational pharmaceutical companies and generic manufacturers.
Because ACTA widens the enforcement net far beyond customs, third parties that use those drugs – such as treatment providers like MSF – also stand to suffer, as they could be drawn into legal action. The proposed punishment for such violations is excessive.
But the price is ultimately paid by those dependent on lifesaving medicines. In many of the recent incidents, generic drugs were only temporarily stopped from reaching their destination, but even that small delay can be life-threatening. For many diseases like HIV or tuberculosis, a delay in patients receiving their drugs can mean they start to develop drug resistance and need to switch to more expensive alternatives. And if ACTA deters generic competition, then drug prices will rise, rationing treatment to those who can afford to pay.
Under international trade rules, countries must introduce intellectual property enforcement rules in relation to counterfeit labelling of medicines – when a label is deliberately copied with the intention of deceit. But critically, this sets a baseline and contains safeguards against abuse which gives countries the ability to still promote access to medicines. ACTA – and EU law in general – goes beyond what countries are required to do and creates new barriers to access medicines.
Europe is now stopping to think a little more on ACTA and is asking the European Court of Justice to check it is compatible with EU law. But this is an agreement intended to be rolled out to all developing countries, who will have no ability to change the text. Europe, along with the US and Japan, are already quietly pushing this same harmful agenda of one-sided enforcement on developing countries. Europe needs to pause and consider the effects ACTA will have, not just on itself, but also on the developing world; because the stakes are too high for it not to.
A woman receives a two month supply of high quality, affordable, generic antiretroviral medicines, which were sourced by the government of Malawi and distributed by MSF. November 2010.
As leaders from India and the EU met for a summit in Brussels, MSF, together with AIDS groups protesting in Africa, Asia and Europe, demanded the EU stop pursuing measures that undermine India’s role as producer of affordable life-saving generic medicines