Pharmaceutical companies wary of drug agency’s new tactics
A battle broke out
at the National Food and Drug Administration and Control, NAFDAC’s
conference room on Friday, between two companies marketing different
technologies for the same purpose of permanently eradicating the
distribution of counterfeit drugs in Nigeria.
Sproxil’s Mobile
Authentication Service (MAS), which utilises the SMS platform and
GlobalPCCA’s Pentesta, which employs Radio-frequency identification
(RFID) are similar in that they empower the consumer to quickly
determine the genuineness or otherwise of the drug they are buying.
Each product’s
presentation won a fair share of supporters among the participants
drawn from pharmaceutical companies and associations; and NAFDAC now
has the task of endorsing one.
However, Paul Orhii, NAFDAC’s Director General, prefers that “each pharmaceutical company makes its choice.”
“We won’t force
anything down your throat. Go and meet with the two companies and come
back to tell us your decision,” Mr Orhii said when participants started
expressing fears that NAFDAC may ‘anoint’ one of the products.
But the national
president of the association of pharmaceutical importers on Nigeria,
Nnamdi Obi, delivered the bottom line. “I am confused by the two
presentations,” he said, “I want NAFDAC to choose the best technology
that is most affordable to Nigerians.” Mr Obi’s confusion takes root
from a potential weakness in the MAS revealed by GlobalPCCA’s Fola
Daniel.
MAS requires that
consumers send a security code attached to each drug through SMS to
Sproxil’s server for authentication, but Mr Daniel said there is a
technology called “Net Hawk mobile phone tool” which can usurp the MAS
technology by cloning GSM cells, and the equipment, according to him,
costs less than N100,000.
Though, Sproxil’s
Chike Asiodu attempted to play down the potential threat, saying the
cost of cloning about 900,000 GSM cells in Nigeria will be practically
impossible, Mr Daniels, citing the example of his friend’s father,
insisted it is already being used by some kidnappers in the country.
X-ray of the MAS
The fact that MAS
technology was introduced to NAFDAC by mPedigree, which has
successfully implemented it in Ghana, but NAFDAC chose Sproxil, a
company that was not part of the national committee that drafted the
implementation guideline for the technology, is breeding distrust among
pharmaceutical stakeholders that spoke to NEXT.
“We have been at
this thing since around 2008. NAFDAC has dragged its foot till now that
Sproxil all of a sudden appeared,” said a representative of a major
pharmaceutical company at the conference. “I just hope they can
implement it properly.” In fact, Charles Akinsete, the public secretary
of Nigerian Representatives of Overseas Pharmaceutical Manufacturers
(NIROPHARM) referred to the technology as mPedigree, in an interview
with NEXT.
But according to industry stakeholders, the concern is more on effective implementation rather than on the implementer.
“I believe in this
technology because it’s effective and does not require manufacturers to
purchase any equipment. Also, it can be used anywhere there is GSM but
I must confess I don’t like the politics surrounding it,” said a
pharmaceutical boss.
What is wrong with the MAS implementation?
There are three key
issues that may undermine the MAS technology as it is being implemented
now. In an email response to NEXT’s enquiry, Tomi Davies, a director in
Sproxil said, “Sproxil Technology uses: Direct access to all MNO SMSC
in Nigeria for SMS through our local partner TextNigeria, Cloud
Computing applications and servers hosted by Amazon in the USA, and
24×7 Local Call Centre for participating consumers by ConSol (same
centre used by LASG for emergency calls).” NEXT’s investigation,
however, showed that such a project requires a dedicated data centre
and not just a hosting agreement that is not legally binding on Amazon.
Sections 3, 4, and
5 of Amazon Web ServicesTM Customer Agreement imply that the company
can terminate or suspend the services rendered to a customer “for any
reason or for no reason, at our discretion at any time.” Should
anything go awry, Amazon cannot be invited for questioning.
Secondly, the
security codes are issued by Sproxil, using asymmetrical technology and
printed in Nigeria. Upon arrival of the drugs in Nigeria, Biofem will
attach the security cards and this model bothers industry stakeholders.
“Nobody else has
the mandate or competence to determine if a particular product is
original except the one who made it,” said the pharmaceutical boss, “so
Sproxil will have to get the drug manufacturers to imprint the security
codes from source, else it is difficult to convince me that some of the
cards will not go on fake drugs by the time all the drug manufacturers
and distributors adopt the technology.” This is where Sproxil may meet
a big challenge, as it will take more that a presentation to get the
drug manufacturers to do this. It will take legislation at the national
and organisation levels for it to work.
“Looking at it from
the perspective of the umbrella organization that my company belongs to
in Nigeria, once it becomes a matter of deliberate policy of the
umbrella organization, my company will most likely participate,” said
Oladiran Rotimi, the group product manager of CiplaEvans
pharmaceuticals limited, a member of NIROPHARM.
Usifo Augustine,
Biofem’s product manager said that the ultimate plan is to get the
drugs coded right from source but Merck Sante, the French company that
manufactures glucophage, in an email response to NEXT’s enquiry, sent
by Gangolf Schrimpf, the Corporate External Communications manager of
Merck, declined to answer whether it will be ready to code the drug
right from source; though it confirmed it’s awareness that glucophage
is being used by Spiroxil as a guinea pig experiment in Nigeria.
The third issue is the one raised by Sproxil’s rival. “The GSM
companies have to come out and assure us that they are legally involved
in this project and that the technology is secure,” said the
pharmaceutical boss. “This should not be taken as a get-rich-quick
means. It should be seen as a social project because human lives are at
stake here.” “I would have expected a more convincing report from the
GSM companies, like an activity chart showing how long the
authentication process takes.” Sproxil’s presentation simply said that
735,153 packs of glucophage were labelled with PIN numbers under the
trial period and 22,638 SMS messages were received from 6,761 unique
consumers.
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