Info Service on Health Issues (Nov15/07)
WHO: Expert working group on SSFFC definitions established
Geneva, 23 November (K M Gopakumar) – The World Health Organization’s work on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has taken a step forward.
The WHO Member State Mechanism (MSM) established a working group on working definitions in a decision taken at its 4th meeting held on 19-20 November at the WHO Headquarters in Geneva.
The primary objective of the expert working group is to refine the working definitions used by the WHO for the surveillance and monitoring of SSFFC medical products. Even though the working definitions do not use the term “counterfeit” the definition of falsified medicines could include medical products infringing intellectual property rights.
According to the MSM meeting report, the working group of experts will be from national and regional regulatory agencies and they will work on refining the working definitions. The modalities of the working group and budget implications, along with an update on the existing working definitions, would be submitted to the MSM Steering Committee by the WHO Secretariat at its meeting in March 2016.
The report of the MSM Steering Committee held on 26September 2015 did not explicitly recommend the establishment of the working group. The report stated: “It was proposed that the Steering Committee recommend to the Member State Mechanism that technical experts be identified to work with the Secretariat to review the comments received on working definitions used in the SMP (surveillance and monitoring project) and make recommendations for consideration”.
Third World Network (TWN) learned that even though the decision to establish the working group was taken in the morning of 20 November the ambassador of Monaco questioned the decision during the drafting at the MSM meeting. The report of the meeting captures the decisions and conclusion of the meeting. During the drafting of the report the ambassador said that there was no decision to establish the working group and the decision was to request the Secretariat to submit modalities of the working group and budget estimation by March 2016 and it is for the Steering Committee to take further decisions in this regard.
This was contested by many Member States who pointed out that there was a decision to establish the working group. One developing country delegate told TWN that the ambassador of Monaco was not present in the morning of 20November when the MSM meeting took the decision on establishment of the working group. The ambassador justified her position stating that even though she was absent she has notes of the meeting from her colleague. The drafting of the report took more than 3 hours.
WHO’s working definition on falsified medical product states: “A visually imitated medical product and/or its packaging purporting to be licensed by a national medicines regulatory authority (NMRA)”. The term ‘visual imitation’ is too vague and can include trademark infringement.
Many working definitions currently used by WHO’s surveillance and monitoring mechanism goes beyond substandard, spurious, falsely labeled or falsified medical products. Apart form falsified medical products WHO also uses the following working definitions to capture data on SSFFC medical products. These terms are: suspected falsified medical product, substandard medical product, suspected substandard medical product, intentionally manufactured substandard medical product, diverted medical product, stolen medico product and unlicensed edictal product. This can result in projecting inflated data on SSFFC medical products (http://www.twn.my/title2/health.info/2015/hi151106.htm)
This expert working group is also expected to provide clarifications on different terms used to identify quality-compromised medicines. Currently different international and national agencies are using different terminologies to refer to medicines with compromised quality. WHO uses the terms substandard, spurious, falsely labeled, falsified, and counterfeit. While INTERPOL uses ‘counterfeit’ the World Customs Organization uses the term ‘illegal medicine’. The UN Office on Drugs and Crime (UNODC) prefers ‘fraudulent medicine’ and the Global Fund to Fight against TB and Malaria uses the term ‘fake medicine’. There is no existing legal definition for any of the terms used by these international organizations.
The absence of legal definitions has provided a favorable condition for pharmaceutical transnational corporations (TNCs) and their developed country partners to conflate quality issues of medicines with intellectual property (IP) enforcement. By linking IP enforcement with quality issues TNCS and developed countries are aiming at placing Drug Regulatory Agencies (DRA) as a gatekeeper of IP protection and to enforce IP using public money.
The working group on definitions is supposed to offer a long-standing solution to the description of medical products with compromised quality. Recently UNODC suspended its work on developing a model law on fraudulent medicines until a definition of fraudulent medicine is agreed upon by the WHO (see http://www.twn.my/title2/health.info/2015/hi151003.htm).
One of the objectives of the MSM established under the World Health Assembly resolution (WHA 65.19) is to further develop definitions of “substandard/ spurious/falsely-labelled/falsified/counterfeit medical products” that focus on the protection of public health”.
Even though WHA 41. 16 refers to spurious, counterfeit, falsely labelled and sub-standard medical products WHO does not have a definition approved by its governing bodies. Until 2010 WHO used a working definition used in a WHO-IFPMA joint workshop in april 1992 on counterfeit medicines to refer to counterfeit medicines (IFPMA is the International Federation of Pharmaceutical Manufacturers & Associations).This was not approved by any WHO expert group or governing body.
The WHO-IFPMA definition on counterfeit medicine states: “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging”.
The word counterfeit has a specific meaning in the context of intellectual property. Therefore this definition creates confusion and implicitly includes intellectual property rights.
The definition does not explain the word identity. From a pubic health perspective identity of drugs means the international non-proprietary name (INN) of a drug. In the absence of an explanation it can also mean the trademark or trade name of the drug. Thus this definition encompasses intellectual property elements. As a result, a drug consisting of a correct active ingredient but having a close similarity with another trademark or trade name can be termed as a ‘counterfeit’ drug.
The 1992 WHO-IFPMA workshop viewed the issue of counterfeit as an intellectual property issue. The workshop report recommends: “Counterfeiting is an international problem which needs to be addressed by the implementation of international laws. A sound legal framework is provided by the proposed anti-counterfeiting provisions in the draft GATT–TRIPS agreement (General Agreement on Tariffs and Trade-Aspects of Intellectual Property Rights including Trade in counterfeit Goods), which is based on effective international trademark protection supported by effective enforceable sanctions and penalties (including imprisonment). (See page 14 of the workshop report: http://apps.who.int/medicinedocs/documents/s16244e/s16244e.pdf)
(The pharmaceutical industry succeeded in getting the United States, the European Commission and Japan to push for the inclusion of an intellectual property agreement in the Uruguay Round of trade negotiations. What ended up as the TRIPS Agreement originated as a draft from industry.)
The International Medical ProductsAnti-Counterfeiting Taskforce (IMPACT) initiative, which WHO is part of, proposed another definition. IMPACT defines ‘counterfeit medical product’ in the following way: “A medical product is counterfeit when there is a false representation in relation to its identity, history or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging”.
The IMPACT definition expands the scope of counterfeit by including false representation with regard to identity, source and history, to the product, its container or other packaging or labelling information.The definition does not give any explanation on these terms. These terms clearly target the issues related to intellectual property protection. For instance, a medical product becomes counterfeit irrespective of correct information with regard to source and identity if the product or packet carries the same colour schemes of another medical product. A product may even be classified as counterfeit when the shape of the product is similar to a competing product. This is important especially in the light of the broadening scope of trademark into non-traditional areas like taste, shape, colour, touch and feel, smell etc.
There was another incident which clearly brought out the IP enforcement agenda behind WHO’s programme on counterfeit medical products. The Secretariat circulated a draft resolution at the 124th meeting of the WHO Executive Board (EB) in December 2008. The draft resolution in its preamble stated that “Recognizing that disputes about, or violations of intellectual property rights are not to be confused with counterfeiting”. (http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14-en.pdf)
The next day the Secretariat brought out a corrigendum which stated: “Please note that the sixth preambular paragraph of the draft resolution addressed to the Health Assembly should read as follows: Recognizing that disputes about, or violations of, patents are not to be confused with counterfeiting” (http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14Corr1-en.pdf). Thus the corrigendum makes it clear that trademark infringements would be treated counterfeit medicines and that these compromise the quality, safety and efficacy of medicines.
Since the Secretariat is in charge of developing the modalities for the consideration of the Steering Committee, the scope of the newly established working group would be clear only after the meeting of the Steering Committee.