Letter asking WHO review of the Essential Drugs List (EDL)

Jamie Love has written to the World Health Organisation asking them to review the asking the Essential Drugs List (EDL). OF the 312 medicines on the list, only 14 are protected by patents which would suggest that patents are not blocking access to essential medicines in developing countries. The trouble is that cost is one of the key factors in determining whether a particular drug is "essential." So large numbers of patented drugs don't make the list because they are too expensive. There is a good reason for including cost as a factor because the list is designed to avoid high priced (less cost effective) patented medicines. But an unintended side affect of this is that even drugs which developing countries would have a right to make cheaper generic versions of under compulsory licence, are not making the list because the cost of the patented rather than the generic version is what it taken into consideration in deciding whether it should be on the list. Love says:

"Drug industry representatives have used the WHO EDL to argue that rigid intellectual property protections are not a barrier to essential medicines, because “no” patented medicines are “essential” according to the WHO.[2] Of course this is a distortion; many patented medicines currently not on the EDL would be included were they available at generic prices – for instance the most recent list includes no patented anti-cancer drugs, and the core list includes no anti-cancer drugs whatsoever. The existence of a WHO “Essential Medicines List” which clearly does not contain many truly essential medicines may be confusing for public health officials and others and provide rhetorical fodder to those who oppose intellectual property flexibilities for health...

Patented medicines currently available only at prohibitive prices may nonetheless offer the “potential for cost-effective treatment” as countries have the opportunity to legally produce or import generic versions. More critical to the evaluation of cost effectiveness under the emerging system is the true marginal cost of production, which bears little or no relationship to the market price in developed countries.

We believe that it is more appropriate that the Essential Medicines List reflect the opportunity that many countries have to obtain currently patented drugs at generic prices by assessing cost-effectiveness not only on the basis of current market prices, but also on the basis of potential generic prices if countries were to avail themselves of their right to exercise TRIPS flexibilities, including the granting of compulsory licenses. Developing countries in particular might stand to benefit from a model WHO Essential Medicines List that does not exclude essential patented medicines by ignoring the potential that those drugs could be obtained more cheaply. A welcome side-effect of this change would be an “Essential Medicines List" that more fully reflects the range of truly essential medicines, where essential reflects both the need for treatments and the costs of meeting those needs unburdened by patent rents.

We recognize that the current WHO Essential Medicines List (EDL) is designed to avoid high priced (less cost effective) patented medicines, that some national laws that reference the EDL create obligations for public outlays, and that these outlays may not be justified at the higher prices for patented medicines. The WHO could easily address this problem by creating a category within the EDL for medicines that are essential "if available at generic prices," an option that is clearly relevant for many developing countries."

Essential reading.