[Ip-health] TWN Info: QSE Working Group divided, IMPACT Secretariat moves to Italy
ssangeeta at myjaring.net
Wed Mar 9 16:25:17 PST 2011
> TWN Info Service on Intellectual Property Issues
> 9 March 2011
> Third World Network
> www.twnside.org.sg <http://www.twnside.org.sg>
> QSE Working Group divided, IMPACT Secretariat moves to Italy
> Published in SUNS #7103 dated 8 March 2011
> Geneva, 7 Mar (Sangeeta Shashikant*) -- Deep divisions among Member States
> have resulted in the Working Group on Substandard/Spurious/Falsely-labelled
> /Falsified/Counterfeit (SSFFC) Medical Products of the World Health
> Organisation (WHO) ending its three-day meeting last week with a
> recommendation to the World Health Assembly (WHA) this year to extend its
> While there were differences among Member States over the many issues that
> were under discussion in the Working Group that met from 28 February to 2
> March, the conflict among Member States over WHO's relationship with the
> International Medical Products Anti-Counterfeiting Task-force (IMPACT) was
> particularly pronounced. Many Member States questioned IMPACT's legitimacy and
> insisted that WHO distance itself from IMPACT's activities.
> It has also emerged that the IMPACT's Secretariat, which was hosted by WHO in
> Geneva, is now (since September 2010) provisionally being hosted by the
> Italian Medicines Agency (AIFA), the national authority responsible for drug
> regulation, based in Rome.
> As mandated by World Health Assembly decision 63(10) of 2010, the Working
> Group met to discuss WHO's role in measures to ensure the availability of QSE
> (quality, safety and efficacy) and affordable medical products; WHO's role in
> the prevention and control of medical products of compromised QSE such as
> substandard/spurious/falsely-labelled/falsified/counterfeit medical products
> from a public health perspective, excluding trade and intellectual property
> considerations; and WHO's relationship with IMPACT.
> As Member States were unable to bridge their differences in the three-day
> meeting, a report (Doc. A/SSFFC/IGWG/5) of the discussions undertaken by the
> Working Group will be submitted to the upcoming World Health Assembly in May
> this year with recommendations on "Next Steps".
> The report to the WHA reflects areas of agreement, issues considered by the
> Working Group and the conflicting positions of Member States on a number of
> issues over which disagreements persisted, such as on WHO's relationship with
> IMPACT and the approach to terminology and definitions. The report also notes
> in the introductory section that "The Working Group decided to focus the
> discussion on identifying principles".
> As "Next Steps", the report states that "In view of the need for further
> deliberations in order to make specific recommendations", it "requests that
> the World Health Assembly consider extending the period set out in Decision
> 63(10) in order to allow the Working Group to complete its work as soon as
> possible, building on the work thus far achieved".
> It also states that "WHO should continue its programmatic work related to WHA
> mandates contained in resolution WHA 41.16, resolution WHA 47.13 and
> resolution WHA 61.21" and that "These resolutions are not related to IMPACT".
> It further adds that "Mechanisms adopted by WHO to fulfill its mandate should
> ensure transparency and inclusiveness in their conception and composition,
> avoiding the emergence of conflicts of interest in the actors involved and
> should guarantee oversight of its activities and accountability".
> WHO'S RELATIONSHIP WITH IMPACT
> According to some sources, examination of WHO's relationship with IMPACT
> consumed a significant amount of time of the Working Group, with discussions
> often being tense and bordering on the emotional.
> [WHO's involvement in IMPACT was tendentious even at the WHA. IMPACT is a
> multi-stakeholder initiative, initiated without a mandate from the World
> Health Assembly, with a heavy private-sector presence. The G8 countries and
> the European Union, among others, have identified IMPACT as an important
> initiative in the context of the Intellectual Property (IP) enforcement
> agenda, leading to concerns that WHO is being used as a front by IMPACT to
> validate its activities that are aimed at protecting IPRs].
> Discussions on the links that WHO should have with IMPACT split the Working
> Group into two camps, namely, one camp unequivocally calling for WHO to
> disengage from IMPACT, while the other supporting WHO's continued engagement
> with IMPACT. Supporters of IMPACT, however, did acknowledge the need to reform
> The Africa Regional Office (AFRO), in its statement at the meeting, qualified
> its support of IMPACT. It recommended that the mandate, role and status of
> IMPACT be redefined in accordance with the governance structure of the WHO to
> ensure accountability to Member States. It also called for transparency and
> participation in its decision-making processes, reporting mechanism and
> funding. It added that the composition of IMPACT should also be reviewed,
> pointing out that the five working groups were either chaired by developed
> countries or by the industry or by other organizations, with WHO playing a
> "peripheral role".
> According to some sources, AFRO's call for reform hit a dead-end, as it
> emerged that WHO had little authority over IMPACT and cannot "unilaterally
> change the terms of reference" of IMPACT.
> Some countries proposed the formation of an intergovernmental mechanism to
> replace IMPACT when looking into
> spurious/falsely-labelled/falsified/counterfeit (SFFC) medical products,
> removing "substandard" and placing it in a separate category of compromised
> QSE medical products.
> According to some delegates, several developing countries also requested Dr
> Margaret Chan, the WHO Director-General, to exercise her administrative
> authority to disassociate WHO from IMPACT. This request led Dr Chan to claim
> that WHO had already taken some steps to distance itself from IMPACT. She
> pleaded against the request, arguing that no single position had emerged
> regarding IMPACT, the delegates said.
> [Despite Dr Chan's assertion, WHO's links with IMPACT continue visibly. For
> instance, IMPACT's website is hosted by WHO, and Dr Carissa Etienne, the
> Assistant Director-General, Health Systems and Services of WHO, continues to
> Chair IMPACT's Planning Group. While WHO-IMPACT links continue, IMPACT's
> Secretariat, which was located in the WHO, is now provisionally being hosted
> by the Italian Medicines Agency (AIFA), the national authority responsible for
> drug regulation, based in Rome, as many Member States questioned its
> legitimacy and insisted that WHO distance itself from IMPACT's activities.]
> The distinct positions and proposals in the Working Group are reflected in the
> Working Group's report to the WHA: "Following a general discussion, there was
> no consensus on WHO's relationship with IMPACT. The positions ranged from
> disengagement from, to continued engagement, with IMPACT. Some Member States
> suggested a moratorium on WHO's involvement in IMPACT activities until this
> issue is duly assessed by the Working Group, while other Member States
> supported WHO's continued involvement. Some Member States proposed an
> intergovernmental mechanism to discuss the issue of SFFC. Some Member States
> acknowledged the need to reform IMPACT. However, it was noted that WHO cannot
> unilaterally change the terms of reference of IMPACT."
> The report further states: "Several Member States recognized that there have
> been benefits to some countries; several Member States, however, expressed
> their concerns about the controversial nature of the work of IMPACT and
> confusion between public health goals and commercial interests."
> (A developing-country delegate said privately that despite the lack of
> consensus on the WHO's relationship with IMPACT, the "political message" to
> the WHO Secretariat has been made clear.)
> TERMINOLOGIES AND DEFINITIONS
> According to some sources, some of the time of the Working Group was spent
> attempting to bridge differences over terminologies and definitions.
> The WHA Decision had not defined the scope of the term "medical products" and
> thus it fell on Member States to define it. The scope of "medical products"
> was one of the few areas on which agreement was reached in the Working Group.
> On this, the report notes: "For the purpose of this Working Group, it was
> agreed that the term medical products refers to medicines, vaccines and
> in-vitro diagnostics".
> According to some sources, several countries sought to expand the scope to
> include "medical devices". While the attempt was not successful, a footnote to
> the agreed definition of the Working Group leaves the option of expanding the
> scope to include medical devices in the future. The footnote states: "This may
> also include medical devices at an appropriate time in the future".
> Divergences also surfaced over the manner in which medical products with
> compromised QSE should be referred to. This was a contentious issue even at
> the 2010 WHA, which saw a group of developing countries voicing concern about
> WHO promoting an IP enforcement agenda under the guise of dealing with
> compromised medical products, calling for WHO to discontinue the use of the
> term "counterfeit". This was opposed by some other countries.
> [The only multilaterally agreed definition of "counterfeit" is in the TRIPS
> Agreement wherein the term refers to a specific category of trademark
> infringements. WHO's use of the term "counterfeit" to refer to QSE-compromised
> medical products led to concerns that WHO was conflating the issue of QSE with
> Intellectual Property Rights (IPRs).]
> The irreconcilable differences during the WHA were provisionally diffused with
> agreement to substitute the term "counterfeit medical products" with
> substandard/spurious/falsified/falsely-labelled/counterfeit medical products
> (SSFFC), pending agreement by the Working Group.
> The first meeting of the Working Group was not able to reach agreement on the
> The Working Group discussed use of the terms "substandard" and "falsified". On
> the former, discussion took place on the basis of a WHO definition developed
> by the Expert Committee on the Specification of Pharmaceutical Preparations in
> October 2010 as follows: "Substandard medicines are pharmaceutical products
> that do not meet their quality standards and specifications. Each
> pharmaceutical product that a manufacturer produces has to comply with quality
> assurance standards and specifications, at release and throughout its
> shelf-life, according to the requirements of the territory of use. Normally,
> these standards and specifications are reviewed, assessed and approved by the
> applicable national or regional medicines regulatory authority before the
> product is authorized for marketing."
> Use of the term "falsified", suggested by the WHO Secretariat in document
> A/SSFFC/WG/3 Rev. 1, received the support of Canada and the European Union in
> particular, with the former presenting principles in relation to "falsified"
> medical products, while the latter presented a legal definition for
> consideration of the Working Group.
> Elements proposed in relation to "falsified" medical products are reflected in
> the report: "With regard to falsified medical products, some Member States
> proposed the following non-exhaustive elements of a definition: a falsified
> medical product gives a false representation of its identity and/or source
> and/or record keeping for traceability; pretends to have been assessed and
> approved by the competent regulatory authority, pretending to be a genuine
> quality product; has an intention to deceive by a fraudulent activity; is
> falsified for profit motives, disregarding public health and safety; and that
> disputes concerning patents or trademarks must not be confused with
> falsification of medical products."
> However, with no consensus on the matter, the report simply notes:
> "Differences remained among Member States on the appropriate terms to be used
> to represent medical products of compromised quality, safety and efficacy".
> WHO'S ROLE IN ENSURING QSE AND AFFORDABLE MEDICAL PRODUCTS
> Deliberations on WHO's role in QSE matters also saw the Working Group divided
> over approaches to deal with the problem of proliferation of compromised
> medical products.
> The report of the Working Group captures these differences. Under the section
> on "WHO's role in measures to ensure the availability of quality, safe,
> efficacious and affordable medical products", the report notes: "Some Member
> States stressed that the improvement of access to affordable, quality, safe
> and efficacious medicines is an important element in the effort to prevent and
> control medicines with compromised quality, safety and efficacy."
> "Overall, WHO should continue to focus on and intensify its measures to make
> medical products more affordable, strengthening national regulatory
> authorities and health systems which includes national medicine policies,
> health risk management systems, sustainable financing, human resource
> development and reliable procurement and supply systems, and to enhance and
> support work on pre-qualification and promotion of generics, and efforts in
> rational selection and use of medical products. In each of these areas, WHO's
> function should be: information sharing and awareness creation; norms and
> standards and technical assistance to countries on country situation
> assessment; national policy development; and capacity building, supporting
> product development and domestic production".
> On "WHO's role in the prevention and control of medical products of
> compromised quality, safety and efficacy such as substandard/ spurious/
> falsely-labelled/falsified/counterfeit medical products from a public health
> perspective, excluding trade and intellectual property considerations", the
> report states: "Some Member States expressed their desire to set up an
> intergovernmental negotiating body to draw up legally binding instrument at
> the international level designed to prevent the manufacture, export, import,
> or trade of counterfeit medical products on international markets and in
> international trade and regulate and oversee supply and distribution
> [According to some sources, this proposal was rejected by several developing
> countries that argued that such an instrument would legitimise WHO's
> involvement in the various "anti-counterfeiting" initiatives (which is
> focussed on IP enforcement) when it should be focusing on QSE matters].
> The report further states: "Some Member States stressed that the improvement
> of access to affordable, safe and efficacious medicines is an important
> element in the effort to prevent medicines with compromised quality, safety
> and efficacy".
> The Working Group also "considered the future role of WHO" in dealing with
> substandard and SFFC medical products under the headings of "Information and
> awareness creation"; "Norms and standards"; and "Technical support to
> On each of the headings, the report elaborates on the issues considered:
> "Information and awareness creation: For substandard medical products, WHO
> should be a global convenor for information exchange and awareness creation,
> including through the International Conference of Drug Regulatory
> "In addition, for SFFC products, WHO should also promote and support awareness
> raising among regulatory authorities, political decision makers, health
> professionals and consumers; create a global surveillance and alert system,
> gathering and disseminating reliable and objective data on SFFC products; and
> act as a global convener dedicated to combating other SFFC products from a
> public health perspective".
> "Norms and standards: For substandard medical products, WHO should
> develop/update/promote tools and guidelines for quality assurance and GMP
> (Good Manufacturing Practice), especially addressing the issues of
> bio-equivalence and inter-changeability, bio-similars and COPP certificates.
> WHO should intensify activities on pre-qualification of products and quality
> control laboratories, including specialized laboratories as centres of
> "In addition, for SFFC products, WHO should develop/update/promote tools and
> guidelines for combating SFFC medical products, including tools for sampling
> and surveillance of the market and guidelines for good distribution practices
> for internet sales, importers and brokers".
> "Technical support to countries: For substandard medical products, WHO should
> continue the programme of supporting the assessment of national regulatory
> authorities, leading to plans of action for strengthening them and monitoring
> their progress. WHO should increase its efforts to build national and regional
> regulatory infrastructures and capacity, including the national capacity to
> implement and enforce the regulations. Technical assistance should focus on
> quality assurance, safety and pharmacovigilance systems. Technical support to
> national regulatory authorities should be expanded in the areas of good
> governance and transparency issues including use of IT-enabled systems, and
> strengthening national medicine quality control laboratories. WHO should also
> continue to support regional and sub regional harmonization initiatives and
> expand their scope to cover aspects of implementation and enforcement of
> regulations. Training programmes should focus on good manufacturing practice
> (GMP) and pharmacovigilance. In undertaking the above activities, WHO should
> intensify its international cooperation and its international cooperation and
> "In addition, for SFFC products, WHO should also assist countries in
> identifying gaps in national legislation and regulatory structures, training
> programmes, support to linking national regulatory structures with other
> national organizations involved in fighting SFFC medical products, and
> providing support for the establishment and accreditation of national and
> international quality control laboratories able to analyse SFFC medicines."
> (* With inputs from Heba Wanis and K. M. Gopakumar.) +
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