Health officials at this week’s World Health Assembly in Geneva have been battling over how to best combat the growing problem of counterfeit medicines.
According to the Pharmaceutical Security Institute, more than 2,000 incidents involving counterfeit drugs were reported worldwide by police and customs authorities in 2009 – up nine per cent on the previous year – but the true scale remains unknown.
India and Brazil, which are big producers of generic medicines, say concerns about counterfeit drugs are being hijacked by pharmaceutical firms keen to protect their patents against legitimate generic competitors.
Together with Latin American and African developing countries, the two nations this week urged the World Health Organization (WHO) to end its International Medical Products Anti-Counterfeiting Taskforce (Impact) partnership, established in 2006, which includes groups that represent the interest of pharmaceutical firms.
“What we object to is a group of private companies, with the help of the WHO secretariat, waging war in this organisation against generic medicines,” Brazil’s ambassador Maria Nazareth Farani Azevedo said in a speech.
“Emerging and developing countries believe there is a readiness to reinforce intellectual property laws and the monopolies of the pharmaceutical industry under the guise of the fight against counterfeits,” Patrick Durish, head of health projects for the Berne Declaration non-governmental organisation, told swissinfo.ch.
But the WHO rejects the accusations and will not be drawn into overseeing intellectual property.
Hendrick Hogerzeil, director of the WHO’s essential medicines programme, denied the UN agency had a hidden agenda to strengthen intellectual property rights, adding it had a very clear goal.
"We do not want any counterfeit discussion to block the trade in what we call legitimate generic medicines and WHO is not going in IPR [Intellectual Property Right] enforcements,” he said.
“We go for the public health and leave the other thing to WIPO (World Intellectual Property Organization) and WTO (World Trade Organization) and the countries themselves."
Hogerzeil went on to condemn the European Union for seizing Indian generic drugs in transit for patent violation, describing it as an “improper unfortunate use of counterfeit legislation”.
Several shipments of generic drugs bound for Latin America and Africa have been seized or halted while on transit in the EU, the first dating back to 2008.
This has resulted in a trade dispute at WTO, with Brazil and India filing separate complaints again the EU for violating international trade rules.
Experts warn that the manufacture and sale of counterfeit medicines is growing in complexity, scale and geographic scope, with many bought over the internet.
Counterfeit medicines, part of billion-dollar criminal activities, are often stashed in cargos that go out of their way to disguise their country of origin.
A WHO report said in rich countries counterfeit drugs were mainly "expensive hormones, steroids and anti-cancer medicines and pharmaceuticals related to lifestyle".
But in developing countries, especially Africa, counterfeit products were commonly available to treat life-threatening conditions such as malaria, tuberculosis and HIV/Aids, it said.
Late night negotiations
Health officials in Geneva pored over two draft resolutions before the official end of the assembly late on Friday night.
One text, backed by a number of developing and emerging countries including India, asks the World Health Assembly to set up an intergovernmental working group to examine the issue of counterfeit drugs, including the relationship between the WHO and Impact.
Another, put forward by the EU and Switzerland, proposes a less binding consultation process without negotiation.
In the end, the Health Assembly accepted the intergovernmental working group, which is to be open to all member states. The proposal emphasised that the group should restrict itself to public health issues only. Intellectual property or trade issues will not form part of its remit, the WHO said in a statement.
The working group will make specific recommendations to the 64th World Health Assembly in 2011.
“It’s not a simple struggle – everyone agrees that it’s a big health problem,” Durish said ahead of the decision. “But we don’t think reinforcing intellectual property rights will help; it will rather lead to more legal generic drugs being wrongly assimilated with illegal counterfeits.”
The north-south polarisation over counterfeit drugs seems to be getting stronger and emerging countries like Brazil, India and China are key to resolving the issue, he added.
Simon Bradley, swissinfo.ch with agencies
According to the US-based Centre for Medicines in the Public Interest, counterfeit drug sales will reach $75 billion (SFr77.1 billion) globally in 2010, an increase of more than 90 per cent from 2005.
Officials do not suspect counterfeit drugs are being made in Switzerland but that the country serves as a transit point.
Often a counterfeit drug may appear to come from a European country when in fact the online operation may be based in Africa and the labs in Asia. Most believe criminal organisations are behind the sales.
The problem of counterfeit medicines was first addressed at the international level in 1985 at the WHO Conference of Experts on the Rational Use of Drugs in Nairobi. Since then WHO has adopted a number of resolutions to deal with the issue and in 2006 it launched an international anti-counterfeiting taskforce (Impact).
But getting governments and law enforcers around the world to work more effectively to counter the problem has proved hard.
That may be changing. On October 11, 2009, former French President Jacques Chirac launched an initiative to combat counterfeit medicines. The so-called "Cotonou Declaration" is the first step of a worldwide campaign aimed at raising awareness of the problem and persuading governments to impose tougher penalties and improve routine testing of medications. The larger goal is to establish an international convention on counterfeit drugs.
Since 2008 Switzerland has been involved in the negotiation of the Anti-counterfeit Trade Agreement (ACTA), which critics view as an opaque club of rich states.