TWN Info Service on Intellectual Property Issues (Jul13/06)
24 July 2013
Third World Network

WHO: Slow progress in Open Ended Working Group on SSFFC medical products

Geneva, 24 July (K M Gopakumar and Sangeeta Shashikant) – The Open Ended Working Group to identify actions, activities and behaviours that result in sub-standard/spurious/falsely labelled/falsified /counterfeit (SSFFC) medical products is making slow progress.

The two-day meeting of the Working Group meeting is taking place in Geneva on 23-24 July 2013.

[The Member State Mechanism (MSM) on SSFFC at its first meeting on 19-21 November 2012 in BuenosAires, Argentinadecided to convene an Open Ended Working Group. The 65^th World Health Assembly in May 2012 had established MSM “for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” in accordance with the goals, objectives and terms of reference.The MSM is the outcome of a process started in 2008 to clean up WHO’s engagement in so-called “counterfeit” medicines. Developing countries raised objections against WHO’s counterfeit program due to its conflation of quality of medicines with intellectual property protection and enforcement.]

The Working Group is primarily considering a proposal form Brazil submitted on Objective 4 of the MSM during its first meeting.  Objective 4 states: “To identify actions, activities and behaviours that result in “substandard/spurious/falsely labelled/falsified/counterfeit medical products” and make recommendations, including for improving the quality, safety and efficacy of medical products”.  Apart from Brazil, India and UK submitted non-papers to contribute to the deliberations.

The work program agreed at the first meeting of MSM sets two activities under objective 4. These are: (a) “Identify the activities and behaviours that result in SSFFC medical products being prevented and controlled due to the health risk they present to the population; (b) Identify those activities and behaviours that fall outside the mandate of the mechanism and separate them from the list of activities and behaviours aforementioned”.

The list of activities and behaviors circulated by the Secretariat on the evening of 23 July shows the following status where the words in square brackets indicate no consensus yet:

• Manufacturing medical products in establishments that are not authorized by the health authority;
• Manufacturing medical products [or their packaging or their labelling] without registration or approval by the health authority.

Discussions on the following activities contained in the list also showed lack of agreement and therefore parts of those activities and behaviors are still in brackets:  

“Modifying accompanying information for the batches of medical products, and changing their packaging or extending the expiration date of the products [with the intention to] [that] mislead[s] the end-user or purchasing authorities];

or

Modifying and/or acquiring medical products or its packaging and literature [with the intention to] [that] mislead[s] the end-user or purchasing authorities];

Reproducing [, without authorization of national health authorities,] registered medicines or their packaging or their labelling [without authorization of the health authority];

[–Lacking adequate bar coding and unique identification of medical products.]

or

[- Lacking compliance to labelling requirements of the respective drug regulatory authority.]

or

[- Manufacturing medical products without complying to [effective] labelling requirements of the health authority.] (add footnote to define “effective”)

 Importing, [exporting,] distributing [(including transporting)], supplying, selling [, (including internet sales)] and storing medical products without compliance to [local] [national] [health] regulations; …”

Apart from the above mentioned bracketed list the Secretariat Document contains a few more activities and behaviour mentioned in the Brazilian non-paper.

The Secretariat, based on the 23 July morning discussion, circulated a document that contained a set of activities and behaviours in the afternoon to serve as the basis for discussion. However, Member Sates rejected that paper and used the list of activities contained in the non-paper of Brazil instead.

The United Kingdom on 24 July morning also circulated a non-paper containing a list of activities and behaviours that result in SSFFC medical products during manufacturing and distribution. The UK non-paper contained many activities and behaviours discussed in the list circulated on 23 July evening.

The main purpose of Brazil’s non-paper is to identify the activities and behaviours that negatively impact on the quality, safety and efficacy of medicines. This proposal achieves relevance in the absence of an agreed definition or understanding with regard to SSFFC products. Therefore Brazil’s non-paper avoided using the words “sub-standard/spurious/falsely labelled/falsified /counterfeit”.

Some delegates are of the view that the identification of activities and behaviors resulting in SSFFC products can lead to the definition of products to be covered under SSFFC. However, many developing countries view that any future definition on SSFFC should not include the term “counterfeit” because it is associated with intellectual property.

According to Brazil’s non-paper “The description of the activities and behaviours that negatively impact the quality, safety and efficacy of medicines may assist health authorities in identifying the agent and the irregular product. More than a concept, the identification and characterization of these activities and behaviours enables the assessment of the risk to the population, as well as measures that can be adopted to prevent and control these activities and behaviours and these irregular products”.

The paper focuses on “What activities and behaviours should domestic health authorities (with the support of WHO) prevent and control?” It does not focus on “What products should domestic health authorities (with the support of WHO) prevent and control.”

According to the paper the identification of activities and behaviours is limited to those “activities and behaviours that put the health of the population at risk”. The expectation of the proposal is that “The identification of the elements of the activities and behaviours to be prevented and controlled could contribute to the definition of the scope of the Member State mechanism to deal with SSFFC”.

Further, the paper provides an illustrative list of activities and behaviours that put at risk and/or damage public health. The list covers activities and behaviours in manufacturing and distribution. The activities and behaviours at the stage of manufacturing are divided into two viz. activities and behaviours by the holder of the health registration, and activities and behaviours by a third party (practised by agents who do not hold title to the health registration of medicine). The paper clarifies that the term “registration” refers to the health registration of medicines and not trademark registration.

The illustrative list of activities and behaviours by the holder of a health registration at the manufacturing stage is as follows:

• Produces medicines that violate the registered formula, either in relation to the active ingredient (e.g. medicines without active ingredient, or with incorrect concentrations of active ingredients) or in relation to excipients (e.g. risk of ineffectiveness or toxicity);
• Fails to comply with good manufacturing practices (GMP);
• Modifies the packaging, without complying with health regulations and without authorization from the health authority;
• Repacks the product in order to circumvent inspection activities or modifies the expiry date of the product;
• Modifies the manufacturing process of medical products, without the authorization of the health authority, jeopardizing the therapeutic activity of the medicine;
• Fails to implement good manufacturing practices whether by recklessness, negligence or malpractice (e.g. an accidental mix of components/inputs/active principles or packaging material).

The illustrative list of activities and behaviours by third parties without health registration in manufacturing stage are:

• Manufactures medical products in establishments that are not authorized by the health authority;
• Manufactures medical products without registration or approval by the health authority;
• Steals batches of medical products and changes their packaging with the purpose of hindering the tracking and tracing of batches or extending the expiration date of the products;
• Reproduces registered medicines or their packaging without authorization of the health authority;
• Substitutes the contents of the medical product using an authorized packaging.

The illustrative list of activities and behaviours at the stage of product distribution are:

• Imports, exports, distributes, transports, stores and commercializes medical products without authorization from the health authority;
• Fails to comply with the best practices of distribution, transportation and storage of medical products, as set out in the national health regulations;
• Imports, exports, distributes, transports, stores and commercializes medical products without health registration;
• Imports, exports, distributes, transports, stores and commercializes medical products that have been purchased from unauthorized companies or are of unknown origin;
• Changes the dates of manufacture and of expiry on the medical product’s packaging;
• Fails to implement good practice in the distribution, transportation or storage of medical products, whether by recklessness, malpractice or negligence.

Lastly, Brazil’s non-paper also proposes the list of activities and behaviors that are not relevant for the SSFFC discussion. It provides the following examples: “the conflict regarding ownership of patents, i.e., it does not matter to this discussion whether a producer is a patent holder or not. What matters is whether or not a producer holds a valid health registration and authorization to operategranted by the health authority. Moreover, trademark infringement is a violation of a private right and does not relate to health regulation and the protection of public health”.

India’s non-paper builds upon the Brazilian paper.  The important feature of the Indian paper is that it proposes identification of a list of medical products with compromised quality, safety and efficacy prior to the identification of activities and behaviours that result in the medical products with compromised quality, safety and efficacy.  The India paper avoids the use of the words “sub-standard/spurious/falsely labelled/falsified /counterfeitproduct” in the “absence of an agreement on the use of terminologies and definitions as well as the diverse use and understanding of the different terminologies at the domestic level”. It provides an exhaustive list of products with compromised quality, safety and efficacy viz. products which:

• do not satisfy the quality standards and specifications set by National Drugs Regulatory Authority (DRA) and poses a health risk to the population.
• do not satisfy the Labeling and Packaging requirements and other information required by the national DRA.
• deviate from the Storage, Transportation and Distribution requirements set by the national DRA and poses a health risk to the population
• extremely deviate from the requirements of Good Manufacturing Practice (GMP) guidelines set by the national DRA
• are produced, sold, distributed or imported without a license or authorization from the DRA.

According to the paper, the list should guide the identification of specific activities, actions, and behaviors as required by Objective 4. Further, the paper also states that the list could also assist in dealing with Objective 9 (“To further develop definitions of substandard/spurious/falsely-labeled/falsified/counterfeit medical products”) that focuses on the protection of public health.

The paper further states that “to ensure a focused identification of activities, actions and behaviors, it is proposed that such identification should be on activities, actions and behaviors that directly result in compromised medicines in the lit and which pose health risk to the population”.  The paper agrees with Brazil’s paper on focusing on activities and behaviours which pose health risk to the population.

The illustrative list of activities and behaviours identified in India’s paper is as follows:

• Production and marketing of medical products without active pharmaceutical ingredient;
• Production and marketing of medical products with extreme deviations from the specifications set by national DRA such as excessive amounts of active ingredients or inadequate amounts of active ingredients;
• Use of contaminated raw materials, which poses a public health risk, for the production of medical products. Raw materials refer to the active pharmaceutical ingredient or excipients or adjuvants included in the formulation of any given dosage.
• Providing wrong, insufficient or misleading labelling, packaging and other information relating to the medical products which results into compromised Quality, Safety and Efficacy such as with regardto ingredients, the international non proprietary name (INN),track and trace, indications, contraindications, required dosage, pharmacological action,date of manufacture, expiry date, place of manufacture, side or adverse effects, precautions for consuming the medicinesor drug-drug interactions.
• Failure to implement good manufacturing practices (GMP) set by the national DRA resulting in extreme deviations (e.g. accidental mix of components/inputs/active principles or packaging material).
• Distribution or sales of medicines after the expiry date.
• Manufacture, marketing and sale of medical products without a license or authorization from DRA.

Further, the paper states that “the mandate of the MSM is to address the issue of SSFFC from a public health perspective, excluding trade and intellectual property considerations. Intellectual property rights (e.g. trademarks, patents) are private rights and violation of such rights does not relate to health regulation and the protection of public health. Compromises of quality, safety and efficacy should be treated within the drug regulatory framework and not through intellectual property framework and tools”.

The paper also observes: “It is important to acknowledge that standards and specifications pertaining to quality, labeling, packaging, storage, transportation, distribution, manufacturing, import, export and marketing, varies from country to country. Therefore the list of actions, behaviors and activities should be in the context of national regulatory requirements”.

The paper also calls for taking into consideration of WHO’s ongoing work in the area of quality, safety and efficacy of medicines.

Discussions are in progress and the Working Group is expected to finish its work today (24 July).  The meeting of the Working Group will be followed by an informal consultation to finalise the remaining part of the work program of the MSM.