A/HRC/23/42
the price of a specific medicine in one or several countries is used as a benchmark to set or
negotiate the price of medicines in a given country. Regrettably, some developing countries
select developed countries, with higher medicines prices, as reference countries, resulting in
substantially higher medicines prices. For example, in 23 developing countries, public
sector prices for generic medicines were 1.9 to 3.7 times higher than even the international
reference price (calculated at the median price of multi-sourced medicines offered to
developing countries by different suppliers) and for originator brands, 5.3 to 20.5 times the
international reference price.33 To secure the lowest price for medicines and enhance
affordable and equitable access to essential medicines, purchasing States should therefore
select reference countries whose level of economic development is similar to theirs.34 If
States use high-price countries for referencing, they should adjust the benchmark price to
the levels of local income per capita when setting prices.
24.
The Special Rapporteur was informed that pharmaceutical companies adopt various
methods to reduce price transparency in order to work around any loss incurred from ERP.
They introduce their products in high-price markets first, to be used as reference countries,
thus maximizing the price. Additionally, transparency is reduced when companies list high
prices in a country while granting discounts and rebates on the condition of
confidentiality.35
25.
Under the right to health, access to information includes providing consumers with
information on the prices of medicines. This has been a good practice adopted in some
States, which require by law that the maximum retail price of medicines be printed on
medicine packages.36
26.
About half of the surveyed States use TRP to set the ceiling price of medicines. TRP
is applied generally in developed countries, where the reimbursement price of a medicine is
fixed at the average or lowest price of other drugs in its therapeutic class that are available
on the internal market. Manufacturers may price their medicines at a higher level and if the
patient decides to purchase a medicine which is not covered by the reimbursement limit,
they will have to pay the difference. States informed the Special Rapporteur that they
offered alternatives to companies to set their prices below that limit, thus avoiding the extra
cost to the patient. TRP allows doctors and patients to select the lowest price medicine from
a range of alternatives within a therapeutic group, improving consumer awareness about
options available and thereby helps increase transparency in the market.
27.
States also exercise other forms of direct regulation through cost-based pricing,
which is based on actual costs of production, a profit margin and a percentage, fixed or
regressive, towards distributors’ mark-ups. Determining actual costs of production,
however, requires reliable and documented evidence of actual local costs of production,
which is difficult to obtain given the global dimension of pharmaceutical production.
Alternative methods to determine costs of production have included proxies, for example
tax paid on manufacturing costs through excise returns and customs duties on landed costs
of active pharmaceutical ingredients (APIs).37 Transparency in providing costs of
production is important to ensuring fair pricing of medicines, while allowing for a profit
33
34
35
36
37
Alexandra Cameron et al, “Medicines Prices, Availability and Affordability”, in The World Medicines
Situation 2011 (World Health Organization, 2011), pp. 5-6.
A/HRC/20/15/Add.2, p. 12.
Jaime Espin et al, “External Reference Pricing” (see Note 33 above), p. 22.
WHO, “Public-Private Roles in the Pharmaceutical Sector: Implications for equitable access and
rational drug use”, Health Economics and Drugs Series, No. 005 (1997), pp. 61-62.
Sakthivel Selvaraj and Habib Hasan Farooqui, “India: Draft Drug Policy 2011: Legitimising
Unaffordable Medicine Prices?”, Economic and Political Weekly, vol. XLVII, No. 46 (2012), pp. 1317, p. 14.
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