On Monday, 27 March 2017, Knowledge Ecology International (KEI) delivered the following oral statement to the Open Session of the 21st Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines. The program for the open session can be found here.
KEI submitted two applications to the 21st WHO Expert Committee on the Selection and Use of Essential Medicines – 1) a proposal for the inclusion of enzalutamide on the WHO Model List of Essential Medicines for the Treatment of Metastatic Castration Resistant Prostate Cancer and 2) a proposal for the inclusion of trastuzumab emtansine (T-DM1) on the WHO Model List of Essential Medicines for the Treatment of HER-2 Positive Locally Advanced or Metastatic Breast Cancer.
Statement of Knowledge Ecology International: WHO 21st Expert Committee on the Selection and Use of Essential Medicines
27 March 2017
Dear members of the Expert Committee,
Traditionally, the World Health Organization (WHO) has defined essential medicines as those that “satisfy the health care needs of the population…and are intended to be available within the context of functioning health systems at all times…and at a price the individual and the community can afford [Emphasis added].”
In 2015, the WHO announced the inclusion of costly treatments for hepatitis C, cancer (including trastuzumab and imatinib) and tuberculosis (including bedaquiline and delamanid) on the WHO Model List of Essential Medicines (EML), reflecting the importance of their clinical benefits, even though in many countries, the prices were high, due to patent and other IPR protections.
As the Committee once again deliberates the inclusion of medically effective but costly medicines, it is time to more explicitly acknowledge the need to address the practical issues that governments face. Resources are limited, and expensive drugs can divert resources from more cost effective products. It is not surprising that many dedicated public health professionals are opposed to including expensive patented drugs on the EML. It is also not surprising that many patients and patient advocates chafe at the paucity of newer drugs on the EML.
The WHO Expert Committee ask been asked, several times, to create a category in the EML for products that would be essential, if available at affordable prices.
New medicines are expensive due to policies, not physics, chemistry or biology. A policy to grant an IPR monopoly, through patents, data exclusivity or other IPR mechanisms, is designed solely to induce investments in R&D. Countries can regulate or eliminate monopolies, and some do. India broke the monopoly for sorafenib, for example, because of excessive pricing. As countries wrestle with affordability issues, they can seek technical assistance from the WHO or other entities in order to use lawful pathways to ensure treatments are affordable and widely available — including through the granting of compulsory licences.
If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically effective drugs affordable.
KEI is completing a review of 56 new anti-cancer drugs approved by the US FDA from 2010 to 2016. 45 of the new drugs received a priority review status by the US FDA. None of the 56 new drugs are on the WHO EML.
In a different analysis, KEI looked at the 28 drugs with unique active ingredients the US National Cancer Institute (NCI) identified as approved by the FDA to treat breast cancer. Of the 28, 18 were registered from 1953 to 1998, and of these, 12 are included in the current 2015 version of the WHO EML. Ten were registered from 1999 to 2016, and of these, none are included in the WHO EML.
A system of medical guidance that is consistently ignoring or excluding new drugs for cancer needs to be reformed, and new options for dealing with affordability and access are needed if we are serious about achieving equality of health outcomes.
In conclusion, we suggest that the Expert Committee create a working group to address the complex and rapidly evolving challenges posed by cancer; this standing group could help identify treatable tumours of public health relevance and prioritize and identify the medicines used to treat these tumours, and also begin to evaluate and contribute to proposals to delink R&D incentives from drug prices, because this is the fundamental policy change that is needed.