E-DRUG: WHO PQ now charging application fees (6)
[There are small countries eg Pacific Island Countries, with small capacity who
aim to REGISTER products that meet necessary standards so they can control
import quality. However they rely on certificates of assessment from countries
with strong regulatory capacity or WHO PQ or WHO Certification scheme
The idea that every country in the world must have its own self-standing
capacity to individually register every novel and generic medicines - in
essence that there should be 200+ parallel assessments of what is
essentially the same evidence seems wasteful of scare resources. There
are epidemiological and demographic differences between countries that
might require differential weighing of benefit/risk in particular
circumstances that might justify some additional review, but it seems like
those would be the exception rather than the rule. Given scarce economic
and human resources in most low- and middle-income countries why would we
want them to squander those resources on duplicative assessments.
Admittedly, there is some capture of drug regulatory authorities in rich
countries and drug companies currently cook the books in some of their
submissions. However, there is no evidence that drug regulators in low-
and middle-income countries will be any less susceptible to administrative
capture, outright corruption, or falsification of submissions.
I doubt that we can or should go to a single assessment - a global
registration system - in part because some double-checking is probably
desirable and we want to avoid imposition of platinum-level regulatory
standards that innovators will use to deter registration of generic
equivalents. But surely there is something to be said both for regional
harmonization/mutual recognition systems and for a strong role for WHO
prequalification while such regional systems are being established.
Things best done locally should be done locally and that probably includes
facility inspections and pharmacovigilance. If scarce administrative
resources were devoted to regulating and inspecting manufacturers and
distributers and if product integrity/safety were confirmed throughout the
supply chain, low- and middle-income countries would be getting the most
out of their investments.
It sometimes seems like a matter of pride to have independent capacity,
but it can come at a very high - even prohibitive - cost, and it can leave
countries with less to spend on what can only be done in country and on
health system strengthening and service delivery more broadly.
Professor Brook K. Baker
Northeastern U. School of Law
Affiliate, Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
Senior Policy Analyst Health GAP (Global Access Project)
Alternate NGOs Board Member UNITAID