E-DRUG: Sri Lanka Regulatory Authority assures price control (6)
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Dear Professor Weerasuriya
It is a good case as they have reversed their prices back down and accepted
to forfeit the 'huge' profits. Though I believe that part of promotional
costs of medicines in the private sector respond to 'user preferences' and
'willingness-to-pay' in the higher socio economic classes (including the
political elite, expat communities and tourists).
They seek out preferred brands to cope with individual, sometimes clearly irrational, 'health' demands. Indeed as in 'what the market bears', which can, by its asymmetric nature in varying degrees be dissonant or at odds with public health goals.
I see all the time that pharmacies offer a tablet, capsules or a syrup
from Thai, South-Korea, or French origin from the shelf, registered
together with the less costly alternative from China, Viet, Lao, Thai...
origin on the counter, also registered. It is then really up to the
customers' purchase power and preference and this plays out only in the
middle/higher classes but not in poor communities as long as
cheaper alternatives for the same medical condition are for sale on that
pharmacy counter.
Coincidentally this morning I read a thread from an expat on social media asking other expats in Vientiane, in which pharmacies in town she can find Flemex (mucolytic) OTC tablets because other (generic) brands do not work 'well' for her.
'May I know where can I buy this medicine please? [picture Flemex] Couldn't find it in the pharmacy near me, instead they gave me a different brand but it didn't work well for me'.
Clearly this person will be paying more from her pocket to get the brand
she wants because she can apparently afford it, perceived value for money.
I foresee that the price cuts will somehow benefit the affluent class more
than it does for the poor communities. Just my opinion.
The low cost quoted for mebendazole tablets manufactured within Sri Lanka
is 'comparable' to international prices offered by accredited procurement
organizations. Accredited meaning that their QA/QC systems have been
approved by international donor organizations and (UN) institutions. Given
an assumed volume of 6+ million de-worming tablets needed per year, the SL
Government supply saves between 50-90K USD maybe 100K USD (my own
calculation) compared to the international market. This translates to
something like 5 to 10 cents less expenditure per household for STH
prevention (my own estimation again but almost certainly less than a dollar
per year). On the other hand, as to your point, surely there is no reason nor a justification for a poor household, to pay x times more for mebendazol or other imported essential medicines in the private sector, i agree that - that is just not an accessible medicine and overall does not
help sustainable development.
The suggestion of introducing a cap in this case at LKR 10.00 on the retail price seems thus a reasonable intervention. But with alternatives in the market and no shortages, the question is were poor communities purchasing the same imported tablets at LKR40.00 anyway?
Otherwise regardless of whether the Cost Effectiveness aspect in the
private sector is a mandate of the NMRA or another Economic Authority/UHC
unit, it sits fine with me as long as all (generic) products will pass the
same QES barrier first - compliant with internationally accepted
criteria -. Like the procurement professionals say: 'we never look at the
price of goods, works or services, if we are not satisfied with the
documented evidence of quality offered'.
A quality statement from a manufacturer like for example: '...guided by the World Health Organization experts on current good manufacturing practices' does not pass the test (for me) to ensure that international standards are in place or that batch-to-batch consistent quality is independently confirmed on a daily basis with actual periodic independent GMP inspections conducted and published by for example the WHO PQ project or a similar institution.
The latter, committing to foreign GMP inspections being totally very relevant is obvs voluntary for a domestic manufacturer whereas it becomes
increasingly required for those sources aiming at international markets.
See for instance GPO in Thailand and the Model QA System (MQAS) for
International PA's issued by the WHO. Of course you know all this better
than me.
The Government Pharmaceutical Organization (GPO)in Thailand (that exports products) is WHO Prequalified.
<https://extranet.who.int/prequal/sites/default/files/WHOPIR_GPO30May-02June2017.pdf>
I recall your earlier message that there are 'so, no issues with quality'
of low-cost mebendazole tablets used in the Sri Lankan Government Health
Services because these domestic manufactured tablets have contributed to
the decline in the prevalence of helminths in Sri Lanka and actually have
been a major contribution to the elimination of STH as a public health
problem in the country.
This is of course particularly important for the at-risk communities living in urban slums and the plantation sector where out-of-pocket payments (OPP) for essential medicines should ideally not exist at all. However, simply because selected regions remain at high or intermediate risk of ongoing helminth transmission, the improved water supply, sanitation and better personal hygiene in other parts of the country can over time have played a (much) larger role in cuttingre-infection cycles and in achieving that elimination.
The actual impact i.e. to measure or infer the consistent efficacy of mebendazole tablets administered once or twice per year, based on national helminth prevalence data is therefore a challenging task at best. External certification such as Prequalification of the manufacturer and the product may offer a more direct way to assure consistent product quality when it comes to low-cost medicines. National State Manufacturing Corporations should have that ambition in their strategy, would you agree?
Periodic deworming practice in Sri Lanka: Is it based on Sri Lanka Journal
of Child Health, 2017; 46(4): 307-311
Either way, my thanks for the discussion on this.
Two other elements coming to mind, on which one could perhaps shed a light
on (from the SL situation), is agreeing on fair retail prices with the
import agents or domestic manufacturers, by:
- applying differentiated wholesale margins in the private sector to account for costs of (shipping/importing), GDP storage in country and scale of inland GDP distribution. And post marketing activities (qualified
pharmacist's supervision, use of inventory management systems that allow full batch traceability, implementation of quality monitoring, pharmaco-vigilance and periodic dossier updates).
- using (dis)incentives schemes in a tiered structure for annual regulatory retention fees
with kind regards
Pascal Verhoeven
MSc.Pharm, MPH
Laos
Pascal Verhoeven <verhoeven.pascal@gmail.com>