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QSE Working Group divided, IMPACT Secretariat moves to Italy
08 มีนาคม 2554
Date: 8 March 2011
Source: TWN Info
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 mandate.
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
IMPACT.
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
DrMargaret 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 aboutWHO 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
matter.
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
networks".
[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 countries".
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
Authorities".
"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".
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"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
excellence."
"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 collaboration".
"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."