[Ip-health] WHO: Socio-economic impact study of SSFFC medicines is “propaganda”, says South

Mirza Alas mirzalas at gmail.com
Fri Nov 27 09:04:08 PST 2015


*WHO: Socio-economic impact study of SSFFC medicines is “propaganda”, says
South *


Geneva, 20 November (K M Gopakumar) – A socioeconomic impact study on
substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical
products by the World Health Organization secretariat comes across as
propaganda findings, according to several developing countries.

The study, based on a United States proposal and which is currently in
progress, makes an estimate of annual purchase of substandard and falsified
medicines at USD 50 billion.

This figure of USD 50 billion is arrived at on the basis of 13.7% of
estimated prevalence of substandard and falsified medicines.

These findings are contained in a one-page executive summary shared with
WHO Member States that does not reveal the methodology used to reach
figures on prevalence. The fourth meeting of the WHO Member States
Mechanism (MSM) on SSFFC discussed this on 19November in Geneva.  The MSM
meeting concludes on 20November.

(The MSM was established through a World Health Assembly resolution to
guide WHO's activities on quality, safety and efficacy of medicines without
conflating it with intellectual property enforcement.)

The USD 50 billion is calculated using the prevalence data that the
executive summary states as follows: “… if the 13.7% prevalence figure is
applied to the overall medicines market in low and middle income countries.”

The estimation of prevalence of substandard and falsified medicines is
reached using data from 97 publicly available peer reviewed field studies.
On limitations of the study the executive summary states: “with the
limitation that most of the studies were conducted in Africa and Asia, and
predominantly on anti-malarial and antibiotic medicine …”

(In fact the African study is titled “Survey of the quality of selected
antimalarial medicines circulating in six countries of sub-Saharan Africa”
which is very limited:
www.who.int/medicines/publications/WHO_QAMSA_report.pdf)

It further states, “Methodological challenges prevent the extrapolation of
this figure beyond the scope of data, particularly given the gaps in the
literature from certain regions (e.g. higher income countries) and
therapeutic classes (e.g. medicines for non-communicable diseases).

Interestingly, with all these limitations the executive summary concludes
that, “it is nonetheless possible to estimate the minimum size of annual
purchases of substandard and falsified medicines at USS 50 billion”.

The executive summary also states that “based on the aggregated data form
field studies, out of specification (one type of substandard) appears to be
a significant problem, although falsified medicines have also been
reported”. However the document provides only the USD 50 billion figure as
annual purchases of substandard and falsified medicines. It does not give
any breakdown of substandard and falsified medicines.

The executive summary also does not provide any details of the 97 publicly
available peer reviewed studies used for the initial findings. It is not
even clear at this point if the Secretariat and authors of the study would
provide enough details about these studies.

Third World Network (TWN) learned that an expert meeting was organised on
11-12 November to discuss the study. The executive summary was shared with
the experts only on 12November.  As a result there was only a little
discussion on the executive summary at the experts meeting. The note of
record of the meeting does not reflect any discussion on the USD 50
billion.  The one-page executive summary was shared with Member States’
missions in Geneva only on 18 November, which scuttled all possibilities of
seeking specialist opinion from capitals.

[The lead author of the study is Dr David Evans, Former WHO Director for
Health Systems Financing Department. Members of the expert working group
are: Lou Garrison (University of Washington, USA), Tomas Pippo Anmat
(Director, Health Economics Department, Ministry of Health, Argentina),
Ricardo Cavazos (Federal Commission for the Protection Against Sanitary
Risks, Mexico), Erika Veiga (Brazilian Health Surveillance Agency),
Catherine Goodman (London School of Hygiene and Tropical Medicine, UK,
Anban Pillai (National Department of Health, South Africa), Anreas Seiter
(World Bank)  and Budiono Santoso (Yogyakarta academy of Sciences,
Indonesia.]

Irrespective of the lack of time to study the executive summary many Member
States especially Brazil and Argentina questioning the findings at the MSM
meeting on 19 November. A delegate told TWN that the discussion on the
topic took more than two and a half hours during the afternoon session from
2 to 5 pm.

Member States asked the lead author of the study, Mr. David Evans, to
explain the methodology to reach the USD 50 billion figure. Member States
also stressed the need to explain the methodology of the study and its
limitations. Further, questions were also raised on the feasibility of
using data from different sources especially for extrapolation purposes.
Member States also asked about the criteria for the inclusion and exclusion
of data.

Many Member States repeated their demand to fully exclude private data and
data of studies financed by the private sector including the pharmaceutical
industry. Queries were made to the lead author about the definition of
substandard medicine and falsified medicine.

Suggestions also came up to list as annexures assumptions and limitations
on the data used for the study. One Member State pointed out that SSFFC is
a global issue and not the problem of developing countries only.

The opinion of the WHO legal advisor was sought on whether the study needs
the approval of the MSM for publication. The legal advisor responded that
there is no such practice of seeking approval of governing bodies to
publish technical work.

However, a new time line has been agreed to finalise the study. According
to the new time line the draft will be shared towards the end of March 2016
for the comments of Member States. The final document would be ready by
June 2016 after incorporating the comments from Member States.

Several Member States told TWN that they are very concerned that the study
would be used for propaganda purposes to push an intellectual property (IP)
enforcement agenda by conflating quality, safety and efficacy of medicines
with IP.

In the past WHO, citing data from industry sources, declared that the
prevalence of counterfeit in developing countries was 10% to 30 %, with
selected states of the former Soviet Union having a prevalence of more than
20%.

In 2006 a WHO–IMPACT document titled “Counterfeit: An Update on Estimate”
stated: “… many developing countries of Africa, parts of Asia, and parts of
Latin America have areas where more that 30% of the medicines on sale can
be counterfeit. Other developing markets, however, have less than 10%;
overall, a reasonable estimate is between 10% and 30%; - many of the former
Soviet republics have a proportion of counterfeit medicines which is above
20% of market value – this falls into the developing country range.” (
http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf
)

(IMPACT is the International Medical Product Anti-Counterfeit Taskforce, a
multi-stakeholder platform for intellectual property enforcement dominated
by pharmaceutical industry interests. In 2011 the IMPACT secretariat was
shifted out of WHO due to opposition from many Member States.)

As developing country Member States started questioning the source of data
and methodology the WHO Secretariat had to back out from this propaganda
data. In 2008 the WHO Secretariat stated, “It is impossible to obtain a
precise estimate of the proportion of counterfeit medical products on
national markets” (
http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14-en.pdf). Then it gave
other statistics to defend its IP enforcement agenda.

The above document stated: “ … the number of incidents detected in 2007
increased to more than 1500, that is more than four cases a day. Even minor
cases concern at least one production batch, which amounts to thousands of
tablets. The 2007 figure represents roughly a 20% increase over that for
2006 and a 10-fold increase over 2000”.

Of late both assertions turn out to be wrong. WHO had carried out two
studies that were published in 2011. The first study looked at selected
antimalarial medicines in six Sub-Saharan Africa countries. The second
study looked at the quality of anti-tuberculosis medicines circulating in
selected former Soviet Republics.

The first study collected 935 samples and after various verifications
selected 306 samples for laboratory testing. Finally only 267 samples were
fully tested. The finding states: ‘… 28.5% of them failed to comply with
specifications. Although non-compliance with pre-established criteria
cannot be directly related to a risk for patients' health, such a high
failure rate indicates a substantial problem in the quality of
antimalarials present in distribution channels. Focusing only on extreme
deviations from specifications (as defined in this report), which are
likely to be associated with health implications, the failure rate reached
11.6%.”

Further the study stated: “Eight of 29 samples failing content testing
(including seven of 22 ACTs) deviated from the declared content by more
than 20%. Two samples in the survey were missing one of the APIs altogether
(one ACT and one SP). It was not investigated whether these samples were
counterfeits. However, one of them was suspicious, as it contained only 9%
of the second API (active pharmaceutical ingredient) and tablet appearance
differed from another sample from the same manufacturer. However, it can be
concluded that, despite a high proportion of substandard samples collected
in this survey, the proportion of medicines missing active ingredients was
low”.

(ACT refers to Artemisinin-based combination therapy while SP is
Sulfadoxine/pyrimethamine.)

Regarding counterfeit the studystated: “One of the objectives proposed in
the survey protocol was to estimate the proportion of counterfeit ACT and
SP products at different points of the regulated and informal distribution
system. However, it was recognized that confirmation of substandard
products as counterfeits is a very complex activity going beyond the scope
of quality testing and therefore could not be fully executed.”

Thus WHO’s claim on provenance of counterfeit found in Africa has little
evidence at least in the area of antimalarials.

The second study found “overall 33 samples (11.3%) failed to meet the
specifications set for the survey. Focusing only on extreme deviations from
specifications, the total failure rate reached 1.0%”.  Regarding
counterfeit it stated, “No sample was suspected to be of a spurious,
falsely-labelled, falsified or counterfeit product.”

Thus the studies do not provide any indication to support the publicly
circulated information of scale of counterfeit medicines.

In 2012 WHO initiated a project on surveillance and monitoring of SSFFC
medical products.  This project was initiated with financial assistance
from European Member States. The project is using the terminology SSFFC
medical products without any shared understanding on these terms viz.
substandard, spurious, falsified, falsely labelled and counterfeit
medicines. According to the Secretariat “as of September 2015, 826
suspected SSFFC medical products have been reported from 78 Member States”.
(http://www.who.int/medicines/regulation/ssffc/surveillance/en/)

These alerts need to be assessed and validated through independent
analyses. These 826 alerts in the last three years are far below what WHO
stated in 2008 i.e. more than 4 alerts per day. The surveillance and
monitoring project was started in 2012.

The Secretariat recently shared the working definition of SSFFC medical
products in use for the surveillance medical products.  The project uses
the following terms for capturing the data: Falsified medical product,
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.

Diverted medical products are defined as “genuine Quality medical products
diverted from intended supply route. No guarantee of standards of
distribution and storage”.

Stolen medical products are defined as “Quality medical products or
packaging that have been stolen from a manufacturer, distributor, retailer
or health facility”.

How these products *per se* constitute an SSFFC product is not very clear.
These two categories do not necessarily compromise the quality of
medicines. The inclusion of diverted product as SSFFC medical product in
effect criminalises parallel importation, a flexibility under the Agreement
on Trade-related aspects of Intellectual Property Rights (TRIPS).

It also goes against WHO’s Global Strategy and Plan of Action on Public
Health, Innovation and Intellectual Property, which encourages use of
flexibilities in the TRIPS Agreement to ensure access to affordable
medicine.

The definition of falsified medicine can still be interpreted to include
intellectual property infringements especially trademark infringements.
Falsified medical product is defined as “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.

Not surprisingly, the surveillance and monitoring project with the above
mentioned broad definitions has not provided any information publicly on
how many of these alerts were finally verified and classified into the
following categories: falsified, substandard, unlicensed, diverted and
stolen medical products.

The current study (with its one-page executive summary discussed yesterday
on 19 November) is not collecting samples from the field and verifying the
data. Instead the study relies on already published studies. The main issue
here is that the definition of collecting data varies in each study. Even
WHO’s own surveillance mechanism covers diverted and stolen products and if
the authors of the study include these as SSFFC medical products the study
would necessary come up with an inflated figure like USD 50 billion.

Similarly all substandard medical products would not lead to adverse health
consequences. It is only the extreme deviations that have the potential to
result in adverse health consequences.  It is not entirely clear that the
authors of the study would take a public health-oriented approach or just
include all out-of-specification products for the health and socioeconomic
impact assessment. According to an observer, inclusion of all of the
specifications for impact assessment can be termed as “a manufacturing of
evidence to serve the purpose of donors”.

This study is based on a proposal first tabled by the US. According to this
proposal “the objective of the economic impact study is to provide
information and quantify the cost and socioeconomic impact of falsified and
substandard medicines and establish the return on investment from
strengthening regulatory systems to secure the health products supply
chain”.

The study has the following research aims:

·         Estimate the health and economic cost of poor quality and
falsified products (measuring direct and indirect costs) using the
available published and unpublished literature and databases.

·         Determine the costs of implementing, scaling up and supporting
alternative options for strengthening regulatory interventions to reduce
the health and economic impacts of SSFFC medical products, with the
geographical focus of this work depending on the available data.

·         Assess the possible benefits of alternative options for
strengthening regulatory systems.

·         Make recommendations for how countries could seek to try to
identify the health and economic costs of SSFFC medical products in their
own settings.

The US proposal had the following research aims:

   1. Estimate the economic cost and impact of poor quality and falsified
   products (measuring direct and indirect costs)
   2. Determine the cost-effectiveness of specific regulatory interventions
   (as a health technology) to prevent the economic impact of poor quality
   products using case studies that are representative of the country or study
   population
   3. Conduct a cost-benefit/return on investment analysis for alternative
   options for strengthening regulatory systems.


http://www.twn.my/title2/health.info/2015/hi151106.htm



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