WHO Group Suggests New Name For Falsified Medicines, Dropping ‘Counterfeit’

A widely representative World Health Organization technical working group has recommended new terminology for substandard or falsified medicines, after years of sharp disagreement among WHO members that led to the tongue-twister: “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products. The working group recommends a simpler formula: kick out intellectual property rights by dropping the term “counterfeit” and just call the products “substandard and falsified.”

If agreed by the larger WHO membership, this definition would be expected to end a long battle over the word “counterfeit,” which generally relates to trademark infringement in legal circles, not an area of expertise for the health body.

Some developing countries, such as India, have pointed out that keeping the word counterfeit in the description might lead to a confusion which could lead to arbitrary detention of generic medicines at borders.

The informal technical working group on draft working definitions of substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products met on 22 November.

The working group was chaired by Maximiliano Derecho from Argentina and included representatives from Brazil, China, India, the United States, Ireland, Indonesia, Tanzania, Nigeria, and Spain, according to the WHO.

According to the 23 November report [pdf] of the informal technical working group, the group sought to come up with a simplified common global understanding and provide clarity in what is meant by an SSFFC medical product.

“[T]he term ‘counterfeit’ is now usually used in the context of protection of intellectual property rights. Substandard and falsified products are a public health issue and the focus should be firmly on protecting public health,” according to Michael Deats, group lead for the SSFFC Surveillance and Monitoring, Safely and Vigilance, Essential Medicines and Health Products at the WHO,

“In addition, the terms spurious, and falsely labelled were dropped as falsified includes all variations of deliberate and fraudulent misrepresentation,” he told Intellectual Property Watch.

The recommendation made by the informal technical working group were agreed at the plenary session of the 5^th Member State Mechanism meeting held in Geneva last week, he said.

The recommendation will now go to the World Health Assembly in May 2017 via the Executive Board, said Deats. The Board next meets in January.

“The recommendation is a very positive step and enables a common global understanding of what constitutes a falsified or substandard medical product,” he said. [I]t does not affect National legislation but ensures that there is clarity at the International level amongst all Member States.”

SSFFC was used as a provisional description, until a simpler definition could be endorsed by the governing bodies of WHO, it said. Alternatives were nearly agreed more than a half-decade ago, but stalled acrimoniously despite research showing support then for changing “counterfeit” to “falsified” (IPW, WHO, 3 March 2011). Also, in the past, India in particular as a major generic drug producer has expressed concern about confusion in the public mind between counterfeits and legitimate generics.

The terms of reference of the Member State Mechanism on SSFFC medical products “expressly exclude the protection of intellectual property rights from the mandate of the mechanism, and therefore, the same criteria shall be used in the definitions to be used in its deliberation and work,” the report said.

“In the context of medical products, the term ‘falsified’ appears to adequately include all the various types of deliberate misrepresentation of a medical product in such a way which enables the specific exclusion of intellectual property rights,” the working group found.

William New contributed to this article.

 

Image Credits: drugs.com