In April 2015, The WHO Expert Committee, tasked with the review and update of the WHO Lists of Essential Medicines for adults (EML) and children (EMLc), recommended the addition of 36 new medicines to the EML, and of 16 to the EMLc. It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers
by Raffaella Ravinetto*
Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine
WE HAVE A DREAM: UNIVERSAL EARLY ACCESS TO INNOVATIVE, LIFE-SAVING MEDICINES
The inclusion of antiretroviral medicines in the WHO Model List of Essential Medicines (EML) represented in 2002 an important step in the path toward getting universal access to medicines for HIV/AIDS. Even if the overarching goal is not reached yet, the inclusion of ARVs in the WHO EML gave a strong message that these medicines must be available to all those in needs, because of their safety and efficacy for treating an otherwise deadly disease, and irrespectively of their price. The inclusion of antiretrovirals in the WHO EML slightly preceded the launch of other key-initiatives, such as the WHO Pre-qualification project (1) and the Global Fund, aimed respectively at giving guidance on the choice of quality-assured generics, and at facilitating the universal access to life-saving medicines for HIV/AIDS, malaria and tuberculosis.
More than a decade after this milestone event, the 20th meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines made in April 2015 other “essential” choices. The Expert Committee, tasked with the review and update of the WHO EML for adults and of the Model List of Essential Medicines for children (EMLc), recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list), and of 16 to the EMLc (five to the core list and 11 to the complementary list). The new essential medicines cover a wide range of conditions, including multi-drug resistant tuberculosis, extensively drug resistant tuberculosis (XDR) and pre-XDR, HIV/AIDS, viral hepatitis, cancer, cardiovascular diseases, and contraceptive products (2, 3). Some of the choices made by the Expert Committee, are in line with the principle that early access to innovative, life-saving medicines should be universal.
The case of viral hepatitis The new EML sub-section for hepatitis C includes six oral direct-acting antiviral (DAAs) medicines: daclatasvir, ledipasvir + sofosbuvir, ombitasvir + paritaprevir + ritonavir with or without dasabuvir, simeprevir, and sofosbuvir, chosen on the basis of “comparative efficacy, increased tolerability and the potential public health impact”.
The high prices of these medicines are making their access extremely challenging not only in middle- and low-income countries (LMICs) (4), but also in some high-income countries (5), and could have discouraged their inclusion in the EML. Conversely, according to the WHO, “the very high cost of hepatitis C medicines was considered and the Committee recommended that WHO take actions at global level to make these medicines more accessible and affordable”. This decision strongly underlines the need to ensure access to DAAs for all those in need. It is now hoped that it may trigger other international initiatives to upscale the access to DAAs, just as it happened 13 years ago with antiretrovirals. Noteworthy, a few months before the new EML was issued, the WHO Pre-qualification had already expanded its scope to hepatitis C (6), as a first step to provide reliable guidance on quality-assured generic versions of these medicines.
The case of cancer medicines Hepatitis C is, like HIV/AIDS, malaria and tuberculosis, an infectious disease, and so far the focus of most “access” initiatives has been on transmissible diseases, whether present worldwide or mainly/ exclusively prevalent in LMICs. But LMICs are not exclusively of mainly hit by infectious diseases, and the morbidity and mortality of non-transmissible diseases such as cancer, cardiovascular diseases and diabetes, are steadily increasing. For instance, according to the WHO, more than 60% of world’s total new annual cases of cancer occur in Africa, Asia and Central and South America, and these regions account for 70% of the world’s cancer deaths. Ensuring universal access to anti-cancer medicines thus represents a major ethical challenge for the international community (7).
The EML Committee has recommended the addition to the EML of 16 medicines for cancer, and it has endorsed the use of 30 medicines for the treatment of specific cancers. Among the recommended medicines there are some high-cost medicines (including imatinib, trastuzumab and rituximab), for which the possibility of universal access may also be put at stake by intellectual property issues and high prices. Their inclusion in the EML underlines that early access to innovative essential medicines should be seen as a human right irrespectively of whether they are costly or not, and irrespectively of whether the concerned diseases have or have not a potential for epidemics.
It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers.
1) ‘t Hoen EFM, Hogerzeil HV, Quick JD, Sillo H. A quiet revolution in global public health: the World Health Organization’s Prequalification of Medicines Programme. Journal of Public Health Policy 2014; doi:10.1057/jphp.2013.53
2) 19th WHO Model List of Essential Medicines (April 2015) . Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf
3) WHO Model List of Essential Medicines for Children (April 2015). Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EMLc2015_8-May-15.pdf
4) Kamal-Yanni M. Hepatitis C drug affordability. Lancet Global Health 2015; 3: e73-e74
5) Brunetto MR et al. Reducing the price of new hepatitis C drugs in the Tuscany region of Italy. BMJ. 2015 Jun 24;350:h3363
6) 12th Invitation to manufacturers and suppliers of medicinal products for HIV infection and related diseases, including treatment for hepatitis B and C, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team – Medicines Last accessed on 5th July 2015 at http://apps.who.int/prequal/info_applicants/eoi/EOI-HIV-v12.pdf
7) ‘t Hoen E. Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. A report prepared for Oxfam, 2014.
 The core lists present a list of “minimum medicine needs for a basic health‐care system, listing the most efficacious, safe and cost‐effective medicines for priority conditions”, while the complementary lists present essential medicines “for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed”.
*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.
After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).
Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health.