The issue of counterfeit and substandard medicines is again not on the agenda of the World Health Organization Executive Board meeting in January, though sources say member states are being consulted about the issue by the secretariat.

At the Executive Board meeting in January 2009, a report on counterfeit medicines was rejected due to objections over the use of the term “counterfeit,” and the WHO director general told member states that she would prepare an updated report taking into account their concerns.

Counterfeit is a term of art under the World Trade Organization, where it is defined as a trademark violation. Several developing countries have objected to the use of the term in a health context, arguing instead that terms such as “falsified” or “substandard” medicines should be used in order to focus the debate more widely on public health issues, rather than use a term that could be misconstrued as related to intellectual property rights instead.

There is a further concern that counterfeit drugs will be confused with generic drugs, a concern which was exacerbated by several cases that came to light in 2009 of legal generic drug shipments from India being delayed in European ports on accusations of intellectual property rights violations.

The secretariat is still “insisting” on using the terminology, and is currently undertaking consultations with member states on how to handle the counterfeit drug issue, a Geneva-based diplomat said.

The WHO secretariat told Intellectual Property Watch that the term has been used in several resolutions of WHO’s annual decision-making World Health Assembly, as well as in WHO guidelines, dating back to “some time ago” and that therefore a permanent change in its use would “require a solid basis.”

The WHO is asking governments to provide definitions of “counterfeit” pulled from their national laws, several sources told Intellectual Property Watch. The deadline for these submissions is 20 December, the WHO secretariat told Intellectual Property Watch. The secretariat is preparing a “baseline/situation analysis” for a discussion on counterfeits that will be held at the World Health Assembly in May 2010.

A ‘frequently asked questions’ document on the WHO website, dated October 2009, says counterfeits are “defined differently in different countries.” The document is available here [pdf].

It also quotes a WHO-backed initiative, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) task force, which defines a counterfeit medicine as “one that is deliberately and fraudulently mislabelled with respect to identity and/or source,” and that can include incorrect, inactive, or insufficient ingredients. The ongoing consultations with member states have also invited comments on the IMPACT document, the secretariat said.

A “counterfeits fact sheet” document [pdf], dated July 2009 and appearing on the WHO website. may explain the use of this terminology. It claims “counterfeit medicines are more dangerous than substandard medicines,” even though they “may be less frequent.” This is because “their content can be dangerous (if, for example, they contain toxic materials) or lacking (as in the absence of active ingredient),” the document says.

“Even a single case of a counterfeit medicine is unacceptable since it indicates that the pharmaceutical supply system in which it was detected is vulnerable. Worse, it undermines the credibility of national health and enforcement authorities,” the fact sheet adds.

A Global Mechanism for Combating Counterfeit

A “global mechanism similar to the one used to control narcotic drugs should be created to control trade in counterfeit medicines,” the October document states, adding that counterfeit drugs affect the general public as well as “the sick and innocent consumers” and “deserve more attention.”

There are several measures governments must take domestically to combat counterfeit medicines, it adds. Among these actions are strengthening national drug regulatory authorities, including their cooperation with national law enforcement agencies such as “police, customs, and the judiciary.”

Internationally, information should be shared between “regulatory authorities, pharmaceutical manufacturers, national law enforcement officers, [and] international organisations such WHO, Interpol, World Custom Organization.” This cooperation can be aided, it adds, by “a common definition of counterfeit medicines,” which is perhaps what the current member state consultation is trying to achieve.

Nationally, the document says, medicines should have defined points of entry and their importation should be controlled “by issuing import permits and inspecting consignments at points of entry as necessary.” The market should be monitored to prevent both counterfeit and substandard medicines from getting to consumers, it adds.

History

The issue first came up in January 2009 in response to a report by IMPACT, which drew criticism from developing countries as its main participants were developed nations and pharmaceutical industry representatives.

It was decided at the time that the WHO secretariat would do further reporting on the issue, taking into account governments’ concerns, and report back at the World Health Assembly in May 2009 (IPW, WHO, 27 January 2009). However, the WHA was truncated so that state health representatives could go home and manage fears about a breaking H1N1 (or, swine flu) pandemic, and counterfeit medicines were left off the agenda.

But they came up anyway, as a line appeared in the WHO’s medium-term strategic plan detailing expected activities for the years 2008 through 2013 about helping members to implement the IMPACT report. Governments – notably Brazil, India, Suriname, and Thailand – objected as the counterfeit/IMPACT issue had not yet been resolved (IPW, WHO, 23 May 2009).

“If member states decide” that the problem should be called ‘substandard’ drugs, then “I have no problem,” WHO Director General Margaret Chan told Intellectual Property Watch in May, adding “WHO will not do the work of WIPO [World Intellectual Property Organization] or the WTO [World Trade Organization]” by becoming involved in IP.

The WHO secretariat told Intellectual Property Watch last week that the counterfeit issue will be handled at the 2010 World Health Assembly.