E-DRUG: How to control pharmaceutical traders/brokers?
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Dear E-druggers,
Is there a missing link in the control of the global pharmaceutical
trade?
We control starting materials (QC lab), manufacturing sites (GMP
inspections), finished products (medicines registration), pharmaceutical
companies (codes of conduct, licenses, prequalification), procurement
agencies (new WHO guidelines in TRS 937 annex 6), wholesalers (GDP),
pharmacies (licenses), pharmacists (professional register, ethics) etc,
but the international traders or brokers seem to escape control.
Obviously there are many ethical, honest and good-willing traders, who
provide useful procurement services. But how can we be sure?
We could insist on licensing them. This needs to be done by a competent
authority in the country where the trader/broker is based. Such a
country may be far away. Do we trust that far-away authority? How do we
verify that their certificate is genuine? And, how can one assess the
quality of their operations and the products they trade in? Is there a
professional global trading association which can set standards, and do
peer-review? Should we develop GTP? (Good Trading Practices).
What could we then inspect if the medicines are not there, but we find
an office with a computer, fax and telephone?
OK, let's control their products then! But how can we check these if
their traded products are never entering their own warehouses, let alone
the country where the trader is based? Traders often buy products
somewhere else, outsource their production, or ship the (uncontrolled?)
products directly from supplier or source to the target country.
National Medicine laws focus on products, premises, people or processes,
rather than on distant procurement services. Medicine laws are national,
and it is difficult to "license" someone who is outside the country. OK,
agents or importers could be licensed in the importing country.
What can be done in the exporting country? These countries often have an
economical interest to facilitate exports so are not likely to be
"difficult" if the products are exported to far-away countries. This
does not only apply to developing countries but equally to the European
Union, where national authorities do not really check the export of
medicines.
How to control the "no-man-land" between the exporting and the importing
country? Free trade zones are growing rapidly, and are not popular if
they start checking the quality of temporarily stored medicines. Do we
know the temperature in sea-containers where the medicines are stored,
maybe for months?
What can the buyers do? Obviously, they could insist on the documents
that document the whole drug supply chain from raw material to finished
product. They can and should insist on having the name/place of
manufacturer on the label. But how to assess that this is a true
statement? How to assess that Certificates of Origin and even
Certificates of Pharmaceutical Products (so-called CPPs) are authentic?
Brokers might not like to disclose their sources (as otherwise the
customer might cut out the middleman, and buy directly from the original
supplier). So the names on certificates are sometimes erased or changed,
labels are replaced, products are repackaged into new containers,
documents may even be made up. It happens that at the receiving end the
buyer has no way to be sure that the product delivered was the one
originally ordered (from manufacturer X in country Y).
Importing countries could of course insist that all imported products
are registered. But WHO surveys have shown that many developing
countries do not have the capacity, skills or even political will to
invest in strengthening Drug Regulatory Authorities. And the
international community has not (yet) seen this as a priority issue, so
little support is going towards Regulatory Authorities. Brokers can
therefore easily target countries where the regulatory controls are
weak, and circumvent strict controls.
Regular wholesalers or suppliers might sometimes be reluctant to deliver
products to developing countries or war zones as payments are slow or
unreliable. Brokers can offer credit if the price is higher. So in the
end, consumers in those countries run the risk of paying higher prices
for products of uncertain origin and unknown quality.
We think that the honest and good-willing traders should be transparent,
and be prepared to reveal their sources and disclose the information
about the medicines they trade in. But how to establish the difference
between the good and bad guys? Should the regulatory authorities in the
countries where the offices of the traders are based play a role in
ensuring that traders comply with the ethics and good practices in
medicines supply? WHO to develop GTP? Self-control by an international
pharmaceutical traders organization?
The debate is open: tell us about your experiences with traders/brokers,
both the good and bad ones and how you make sure that they perform with
the delivery of good quality medicines. Trading companies are also
invited to react.
Regards
Wilbert Bannenberg, public health physician (wjb1610@gmail.com)
Rob Verhage, pharmacist (verhager@gmail.com)