The 14th model essential medicines list (EML), prepared by the WHO expert committee in March 7-11, 2005, has been published recently (July 2005) and is available on the WHO medicines web site (www.who.int/medicines/organization/par/edl/expcom14/eml14_en.pdf). The delay in publication is caused by the objection to the list reportedly by the USA, probably as it contained 2 medicines (mifepristone and misoprostol) that may be used in, inter alia, safe abortion (www.essentialdrugs.org/edrugs). WHO has managed to delicately balance in keeping these 2 medicines in the new list while adding a comment/footnote linked to mifepristone and misoprostol, “where permitted under national law and where culturally acceptable”. The 14th model list contains 306 individual medicines, 14 less than preceding list (2003 EML). WHO revises the model list once in 2 years and in the past 28 years, 14 times revisions in the list have been carried out.
The WHO EML represents the most compelling international compilation of essential medicines for public health. Compiling a list of EML was begun in 1975, in the wake of WHA’s call on focusing attention on essential medicines of good quality at reasonable cost. Since its first publication in 1977, the WHO EML has been established successfully in majority of the people worldwide for their priority health needs with affordable, effective and safe medicines. The first model list identified 208 individual drugs and thereafter some medicines are deleted, added and a few reinstated. The simple logic behind deletion is that a medicine that is safe today may become questionable as a result of new findings and spontaneous ADR reporting. The list has been attracted much debate from different groups – one side the NGOs and consumer activists and the other side the pharmaceutical industry. The complaint by the industry is too much restriction for inclusion a new medicine in the list, and the NGOs have been critical for little attention paid to AIDS, malaria and other tropical diseases of least developed nations. Over the years although the structure and principle of the WHO model EML remained largely unchanged, albeit criteria for selection of an essential medicine have evolved a drastic change from an experience-based to evidence-based method. The name of the list, 2003 onwards, has also changed, from essential drugs lists (EDL) to essential medicines lists (EML). WHO now publishes clear explanations and evidence for all decisions (selection, deletion and changes etc.).
The 2005 WHO model EML
What are essential medicines? According to WHO, essential medicines are those that satisfy the priority health care needs of the population. They are selected with regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. The details of 2005 EML committee report for 14th model EML is available at: www.who.int/medicines/organization/par/edl/expcom14/14Expcom_ReportFinal-unedited_040705.pdf. This reflects transparency of whole process of publishing present EML. This 14th edition EML has drawn much attention due to the inclusion of 2 progesterone antagonist (mifepristone/misoprostol regimen) for medical abortion in the first nine weeks of pregnancy. Nineteen medicines/items have been removed from previous list and 9 have been added to the present list (Table 1). Eighteen changes are carried out in the items on the model list. These changes include adding square box next to medicines, removal of footnote on future review, addition of footnote that will be reviewed at next meeting, change of section name and division of subsection etc. In addition, a few applications for inclusion in the list have been rejected.
Click to view the salient features of the 2005 WHO EML
How essential is the 14th model EML?
There are uncountable numbers of different medicines available; many of these are similar in therapeutic action, however, some may be more expensive and more side effects than others. Apart from, there are medicines which are known to be ineffective or harmful, but which are commercially available. In this scenario, WHO EML is the definite answer for making decision of selecting right medicines. Incredible though it may sound, medicine formulations, just about 530 (2005 EML) to satisfy priority health care needs of the population, are about 10000 currently available in India. It is a paradox that many non-essential and, even adulterated medicines are available yet have a shortage of essential medicines. WHO EML and its essential medicines strategy programme continues to be a hope of patients’ straightforward requirements of medicines that are effective, reasonably safe and accessible. However, in post-TRIPS era, it is a challenge on access to medicines in developing countries where many are TB carrier, and burdened by malaria, filaria, leprosy, diabetes, asthma and life-threatening infections, and need to be addressed.
(The author is with Department of Pharmacy, Annamalai University, Annmalainagar 608 002 (TN) Email: cdl_scbasak@sancharnet.in