- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Medicine Access and Rational Use > Selection
(2015; 3 pages)
The Lancet: http://www.thelancet.com/
On Oct 21, WHO published the full report of the 20th Expert Committee on the Selection and Use of Essential Medicines, with its new WHO Model List of Essential Medicines (EML). The new list includes recently developed medicines for drug-resistant tuberculosis (bedaquiline and delamanid), a number of new cancer treatments (such as imatinib, rituximab, and trastuzumab), and, perhaps most controversially, new direct-acting antiviral drugs (DAA) for the treatment of hepatitis C (sofosbuvir, simeprevir, daclatasvir, ledipasvir, and ombitasvir). Several of these medicines are very expensive. For example, the new medicines to treat hepatitis C are priced up to US$95 000 per 12-week course of treatment, and their primary patents will only expire in 2024–30. Despite the ability of some payers and intermediaries to negotiate large discounts, even high-income countries are struggling to pay for broad access to these treatments.
It is not the first time that WHO has added expensive medicines to the Model List. In 2002, the agency included 12 antiretroviral medicines for HIV/AIDS that were patented in many countries, to focus global attention on a major global public health need and to stimulate interventions to expand access to these lifesaving medicines. These products were unaffordable for almost all countries at that time. The new Model List now expands further into other therapeutic areas.
The recent inclusion of new expensive medicines has raised many questions. Has the original concept of essential medicines lost its original relevance as a list of basic medicines for resource-constrained settings? Should the list include medicines not yet authorized by stringent regulatory authorities or not easily available? Should the list include medicines for off -label indications? Should the list automatically include any medicine mentioned in a WHO treatment guideline?