E-DRUG: How to control pharmaceutical traders/brokers? (7)
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Dear Colleagues,
In the globalized international pharmaceutical market, the vulnerable
populations from poor and insufficiently regulated countries are facing more and more threats related to bad procurement policies and practices. A broad agreement is now arising from this E-drug debate that, when buying either active pharmaceutical ingredients (APIs) or final pharmaceutical products at brokers or international traders, it is often hard or even impossible to trace the origin of the purchased products, so that the final users are potentially exposed to medicines whose quality has not been ensured at some steps of the manufacturing, transport, storage and distribution cycle.
But if using these international traders brings so relevant risks for the
health of patients, why are they so frequently used? When and why do we
really need them?
Sadly, a possible answer may be "the price". In countries with severe
budgetary constraints, there is a strong pressure on getting the lowest
possible prices. International traders that operate in a sort of "grey area", which does not generally fall under the responsibility of any stringent regulatory authority, may be able to be very competitive, by procuring products whose price is "lower than possible", due to the poor enforcement of appropriate quality assurance measures.
The best strategy to avoid this kind of risk would then be to limit -or even avoid- the use of such intermediaries, and buy directly at approved
manufacturers or at authorized wholesalers, able to guarantee and prove the
quality of the products they supply.
However, for minimizing immediate risks, purchasers which still wish to use
international traders/brokers, should check a minimum of basic requirements, e.g. existence of a valid authorization to trade in pharmaceuticals, presence of a responsible pharmacist, presence of a quality assurance system, capability to trace the origin of the supplied products and to provide, on demand, certificates of pharmaceutical products and certificate of analysis per batch, etc. Even if, as noticed by the Moderator, verification "on paper" is never sufficient to assure quality, the lack of complete paper documentation is per se a reason to disregard a potential supplier of pharmaceuticals.
Purchasers should also become more and more willing to share information
about the quality of the pharmaceutical suppliers, including brokers: any
purchasers and medical staff who become aware of quality deficiencies, should immediately share this information with the competent bodies and authorities, and with any local actors who could be concerned/affected by the same problem. The lack of information-sharing is really a multiplier of risk for the patients.
Still, it is not correct to put the whole burden of quality checks on the
final purchaser/user, rather than on the competent bodies and institutions.
Pharmaceutical regulatory authorities should take full responsibility for all the medicines that are either marketed in their respective country, or
exported from their territory for marketing elsewhere (and this,
irrespectively of whether these medicines were manufactured in their country or they were "just" on transit). For stringent Drug Regulatory Authorities, in particular, there should be a moral imperative to check the quality of all medicines that are manufactured or transiting in the territory of their competence for being exported to poor-regulated countries and be used by vulnerable persons. This responsibility should include the control (including licensing and audit) of any brokers acting in their country, just as it is done for any national pharmaceutical establishments.
At the same time and with a long-term perspective, there is need to mobilize appropriate resources to strengthen DRAs in poor countries. The quality of medicines falls under the mandate of WHO, which in 2008 committed itself to develop and/or strengthen the capacity of national regulatory authorities to monitor the quality, safety and efficacy of health products (Global Strategy and Plan of Action of the WHO Intergovernmental Working Group on Intellectual Property, Public Health and Innovation, adopted by the 61st World Health Assembly in May 2008). It would be interesting to find out if any new actions have been already implemented, in the light of this WHA motion, to build on the capacity of DRAs in developing countries.
Raffaella Ravinetto, pharmacist,
Institute of Tropical Medicine Antwerp
rravinetto@itg.be
Sandrine Cloez, pharmacist
Sophie-Marie Scouflaire, pharmacist