WHA Committee Bans IP Reference In Substandard And Falsified Medicines

The “delicious acronym SSFFC” – as described by Marie-Paule Kieny, assistant director-general for Health Systems and Innovation at the World Health Organization – will no longer be used by WHO to describe substandard and fake medical products, when a committee’s decision is adopted by the full World Health Assembly tomorrow. And key to this decision is that protection of intellectual property rights is not a competence of the UN health agency.

A committee of the World Health Assembly agreed on 29 May to replace the awkward term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC medical products) with “substandard and falsified medical products.”

This is “the final step” in removing intellectual property from the name of medicines of this type (IPW, WHO, 28 November 2016), said Michael Deats, the group leader for Vigilance, Spurious/falsely-labelled/falsified/counterfeit medical products at the WHO.

The change of the name was “one of the most controversial and challenging subjects to address.” according to Kieny.

This was a “horrible topic” a few years ago, Deats told Intellectual Property Watch. But now countries are “on the same page working together,” he said, adding, “I just want that to continue.”

Approval of New Name and Definitions

Member states agreed during the 65th World Health Assembly that the Member State mechanism on SSFFC medical products would use the term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” until the governing bodies of WHO could endorse a definition.

The fourth meeting of the Member State mechanism decided in November 2015 to establish a working group to refine the working definitions of SSFFC medical products. The report by the Director-General on Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products of 20 March 2017 sets out the new definitions as agreed during the fifth meeting of the Member State mechanism in November 2016.

Substandard products are “authorized medical products that fail to meet either their quality standards or their specifications, or both”, according to the 20 March report. Falsified products are “medical products that deliberately or fraudulently misrepresent their identity, composition of source.”

Unregistered or unlicensed medical products are “medical products that have not undergone evaluation and/or approval by national and/or regional regulatory authorities for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation,” according to the report.

Unregistered and unlicensed medical products are defined in the report because people often confuse them with substandard and falsified goods, according to Deats. The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) defines counterfeit goods as related to trademarks.

The WHO approaches substandard and falsified medicines merely from a public health perspective, Deats said. The report states that “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 term “counterfeit” is, therefore, no longer part of the name used at WHO.

Japan said during the discussion in committee that it would be inappropriate for the WHO to focus on intellectual property rights, as it does not have experience in IP. Japan emphasised that the change of the name does not mean that infringements of intellectual property rights will be tolerated. Counterfeit remains an important term to protect intellectual property rights, the delegate said.

The aim of legislation of countries and regions all over the world that deals with substandard and falsified medical products is very similar, but the used language is not the same, according to Deats. This leads to a “massive amount of confusion … especially confusion related to IP and the word counterfeit,” he said. The new name “clarifies the situation” and “makes sure that we all know what we are talking about,” Deats said.

More than 30 delegations took the floor in WHA committee A to express their support for the new name and definitions. According to the Philippines, the simplification will lead to a better understanding by the public. It is a remarkable and historical progress that has been achieved, the delegation of Tanzania said.

A lot of delegations emphasised the threat of substandard and falsified medicines to public health. Several delegations, including Sri Lanka and the members of the African region, presented their national plans to prevent and detect substandard and falsified medical products.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) stated that the reaching of consensus is “an important step forward.” The International Pharmaceutical Students’ Federation (IPSF) said, “Falsified medication contributes to distrust of government, health care systems, and health care professionals.”

Kieny said she hopes that all stakeholders, including academia, other international organisations, civil society and members of the industry, will adopt the new term.

Zimbabwe asked for further financial support to detect substandard and falsified medical products. Kieny said that the secretariat will continue to seek further resources to continue the work.

Kieny ensured that the WHO secretariat will continue to enhance monitoring and surveillance systems and support member states with the tools and capacity building to prevent, detect and respond to substandard and falsified medical products. The secretariat will also continue to support the strengthening of national regulatory systems, she said.

Review of the Member State Mechanism

The committee also noted a report of the review of the Member State mechanism on substandard/spurious/falsely-labelled/ falsified/counterfeit medical products. The review covers the period 2012-2016. Resolution WHA65.19 mandated the review of the Member State mechanism to be conducted in 2016. Decision WHA68 (12) delayed the review until 2017.

The review entailed an online survey for the primary stakeholders of the Member State mechanism and the interested nongovernmental organizations, key-informant interviews and a document review.

The review report states that the mechanism “continues to be relevant” as it plays a “critical role in raising awareness of SSFFC medical products and Member States would want it to continue.”

The main gaps in the working of the Member State mechanism were identified during the review process. These gaps include “an unfinished technical agenda, limited coordination processes among the different actors, an inadequate system of communication and dissemination of information between the mechanism and Member States.”

The mechanism is also “under-resourced, in part as a consequence of not being properly prioritized within WHO and among the actors of the mechanism,” it said.

“The diversity of initial political perspectives and expectations about the mechanism and the evolving operating procedures and governance structure were considered as factors that may have delayed the achievement of the objectives,” according to the review report.

Recommendations

The review report includes a series of recommendations and action items for some.

For instance, it recommends “the members of the Steering Committee of the Member State mechanism to revisit the current workplan, ensure outstanding activities within the workplan are completed, and consider plans and activities for the next phase.”

The second recommendation is the development of “appropriate processes for effective coordination, communication and dissemination of information on main action areas and outputs.” The report further recommends the members to “build and expand national capacity to address SSFFC medical products” and to “secure sufficient additional resources for the mechanism to achieve all of its objectives.”

The last recommendation is the “engagement of additional actors in the mechanism, including academia, manufacturers, nongovernmental organisations, civil society and related technical institutions at global, regional and country levels.”

Argentina said that it would welcome a report on the steering committee and the participation of the WHO as an observer. Argentina would furthermore welcome a presentation by the Executive Board before the next meeting.

The WHO secretariat will reply to the recommendations. The timeframe for the response is unknown, Deats said. The technical group that works on communication and awareness is a program of three years. The discussion of some of these issues are therefore going to continue for several years, according to Deats.

Elise De Geyter is an intern at Intellectual Property Watch and a candidate for the LLM Intellectual Property and Technology Law at the National University of Singapore (class 2017).

 

Image Credits: William New