E-DRUG: MPedigree: combatting the sale of counterfeit drugs (4)
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Dear Dr. Pakenham-Walsh,
I note the letter by Dr. Jahnke to you:
http://tinyurl.com/nzqau9
I see that it grossly mischaracterises the mPedigree model and makes
unsubstantiated comments about the requirements for end-user participation
in policing the supply chain.
Dr. Jahnke has clearly not followed the efforts of mPedigree, or he would
have noted that:
1. MPedigree is multinational in intent, with active efforts in 6 countries
(ranging from Ghana to India) to create a pharmaceutical quality grid. As
capacity expands, there is no reason why the other developing countries can
not be brought on board seeing as GSM networks are currently the most
accessible and widespread technology infrastructure worldwide, particularly
for the poor and vulnerable. In many ways, the logistics of this operation
is similar to the mass vaccination efforts of yesteryear.
2. It is simply untrue that end users have no responsibility for taking
steps to protect themselves. This happens all the time. In many countries
citizens are exhorted to take note of features such as 'expirty dates' and
existing security features such as holograms. They are frequently advised to
be alert to new packaging designs, and to examine packs critically to see
that they have not been tampered with. Requiring that they verify the unique
number is no added burden, especially as the proposed service is free, quick
and reliable.
3. Nor is it the case that mPedigree ignores the vital role played by
national regulators. Indeed, a key component of the mPedigree effort to
create 'national electronic health resource systems' is ensuring that the
record systems of developing countries' health institutions migrate from
manual processing to electronic processing. As mPedigree works closely with
regulators in the maintenance of the electronic records, the issue of
database security does not arise except in the general context of regulatory
integrity, which in all fairness is the backdrop of all and any
interventionsin this and related areas, including in the case of Dr.
Jahnke's vaunted 'mini-labs'.
4. Whether or not medicines that bear codes will give the impression of a
'caste' system for medicines is a question the world already deals with in
relation to existing security features such as holograms, even though the
reliability of these features have long been known to be compromised. Where
an assessment has been duly made, and effectively communicated to the
population, that certain classes of medicines are violently prone to
counterfeiting, the need to have such medicines bear special codes does not
in any way preclude a general policy of augmenting the security of every
drug. It is simply a matter of prioritisation which is a general context in
all policymaking.
5. Dr. Jahnke raises the issue of cost, albeit on the back of a rather
sweeping statement. What is not in doubt is that counterfeit drugs
constitute a significant proportion of the trade in medicines. Every
counterfeit medicine successfully sold represents a loss of revenue to the
legitimate manufacturer which unfailingly is passed on to longsuffering
consumers. Indeed, even discounting the human and social costs,
counterfeiting represents such an assault on the revenues of businesses and
governments that a reduction in its prevalence can only lead to a reduction
in the general prices of medicines in the medium term.
6. The notion that 'static' - barcode, even if also unit-level, coding
implemented by pharmacists should prove sufficient to this difficult task is
clearly misconceived. Here in Ghana and elsewhere it is accepted that a
non-negligible percentage of pharmacists are complicit in the counterfeit
trade. Secondly, static barcodes are much easily duplicated than one-time
codes verified via SMS. Thirdly, the notion that scanners can be distributed
across the retail networks of poor countries clearly runs against the
observed reality in most developing countries. Lastly, the suggested barcode
method does not provide real-time intelligence in the way of reports and
alerts to regulators and other enforcers. Have those who suggest such
methods really observed the licensed chemical sales operations of countries
like Ghana and Nigeria?
7. On the issue of vans, one cannot dismiss the prospect that they have a
place in the laboratory operations of national regulators around the world.
But as a scale-led effort to dramatically reduce the scope of
counterfeiting, they clearly are much too expensive to play any role but a
complimentary one.
It is necessary that all proposed solutions to counterfeiting be assessed
not on their capacity to totally eliminate the incidence of cunterfeiting,
but on their realistic contribution to the reduction of prevalence. That
will require a generally more detailed and sophisticated analysis of their
pros and cons. It is in this spirit that I thought I'd briefly share my
thoughts.
Thank you all very much for your time.
Warm regards,
Bright Simons
MPedigree
bbsimons@mpedigree.net