Political stand-offs 'holding back efforts to fight counterfeits'

One would imagine medicines counterfeiting should be a fairly uncontroversial issue - after all it concerns a criminal activity that places the health of people around the world in jeopardy. In recent months, however, political agendas have undermined efforts to tackle the trade.

The seizures of generic medicines in transit from India to markets in Africa and Latin America at EU borders have played a key part in politicising the medicines counterfeiting issue and shifted attention away from strategies to restrict the activity and safeguard public health.

"There has been considerable debate about whether counterfeiting of medicines is in fact an IP issue, " said Philip Stevens of the International Policy Network at a press conference held earlier this week to highlight the emerging controversy.

The meeting took place just as details started to emerge of another seizure case, this time in France. On this occasion reports are that the shipment of anti-platelet drugs were in transit from India to Venezuela and were stopped on suspicion of patent violation.

The conflation of IP and trademark infringement or misrepresentation of products lies at the heart of the debate, but it must be remembered that "patent protection is very different from trademark protection," according to IPN's Julian Harris.

Medicines counterfeiting "should be about misrepresentation and obtaining redress, areas in which there is much more focus on protecting patients than defending innovation and other arguments related to IP," he argued.

Sadly, in many countries it is legally impossible for patients injured by misrepresented medicines to obtain redress against the culpable people involved in the crime, he said.

Fears about patent protection issues should not be explicitly used to stop genuine anti-counterfeiting efforts, continued Harris, noting that this has clearly been the case with the IMPACT consortium, which has brought together the World Health Organisation, Interpol, NGOs and industry in an attempt to combat counterfeiting.

The process of IMPACT has been "stifled" over the last two years on the grounds that a definition of counterfeiting it developed was designed to conflate counterfeiting with generic medicines. However, a year ago IMPACT revised the definition and excluded any mention of patents, even going so far as to add a footnote saying explicitly that patent infringement was not included.

"We have to move on from using this issue as a pro- and anti-IP football," he said.

Roger Bate of the American Enterprise Institute noted that one of the key problems with the EU seizures is that shipments are not being released quickly enough. The law indicates that consignments which are eventually passed should be released within 20 days, but has been as long as four months.

"If there are seizures of legitimate generics and they are turned around within 20 days, there is less of an impact," said Bate, pointing out that one should remember that 3 million dangerous treatments have been intercepted by this activity over the last year.

It is also important to place the EU seizures in the proper context, according to Harris. Recently-released EU data suggest that 90 per cent of seizures are for trademark infringement, while just 6 per cent are for patent infringement.

Given those figures, it should be possible to prevent seizures of legitimate generic medicines without giving into the will of counterfeiters, he said.

He referred to the concerns about the decision by a UK High Court earlier this year to release a shipment of counterfeit Nokia phones on the grounds that they were not 'in the course of trade', as this ruling suggests it would be acceptable for customs to wave on a shipment of counterfeit medicines that could cause serious health problems in their destination market.

Meanwhile, bickering over definitions of counterfeiting and substandard medicines is "somewhat futile," according to Harris.

"The legal handling of counterfeiting is determined by interpretations of law in national courts," he said, pointing to concerns about the linking patent infringement with counterfeiting in bills recently unveiled in Uganda, Kenya and even India. 

Despite the controversy, it should be possible to reach some sort of consensus that patent infringement is a separate issue to trademark infringement or other activities such as misrepresentation, according to Harris.

He conceded, however that there are overlaps between the two that cause problems, for example where a patented design for pharmaceutical packaging can be considered to be integral part of a brand's identity.

"A lot of policy people do not take these nuances into account," said Harris. "But the legal complexities are important, and failing to consider them is one reason that political stand-offs are taking place."

Meanwhile, Bate believes that while various parties are able to deliberately link counterfeit drugs with other issues such as access to medicines, patent laws and trade agreements, there will be no resolution.

"I don't see these issues resolving rapidly. I wish I could be more optimistic," he said.