Medicines for cancers in children: The WHO model for selection of essential medicines.

Pressures to include more cancer medicines in the WHO Model List of Essential Medicines (EML) pose challenges for the Expert Committee responsible for recommending changes to the list. How do medicines for cancer fit within a definition of essential medicines as those meeting the priority health needs of the population? Will identifying a medicine as "essential" offer some leverage to improve access to effective cancer medicines in low and middle-income countries (LMICs)? The addition of a number of medicines for the treatment of cancers in children to the Model List of Essential Medicines for Children (EMLc) in 2011 provides important insights into previous Expert Committee decision-making and offers a platform for future deliberations. As combination chemotherapy is required for effective treatment of many malignancies, a disease-based approach makes more sense than an agent-based approach. Inadequate financing to purchase essential medicines is a reality in many LMICs, thus a consideration of health impact is central to decisions on the selection and procurement of medicines. Inclusion in national EMLs should identify medicines that have priority for procurement in the public sector. This article will discuss some of the factors taken into account by the Expert Committee in developing the WHO EMLc. We argue that the disease-based approach coupled with the assessment of the magnitude of the clinical benefit provides an appropriate approach for considering further additions of medicines for pediatric cancers and for the review of the adult cancer section of the Model List.

WHO guidelines on biosimilars: Toward improved access to safe and effective products.

The World Health Assembly resolution on access to biotherapeutics in 2014 urges WHO and Member States to facilitate access to biotherapeutics while ensuring their quality, safety, and efficacy. While efforts to date have contributed to increased availability and better access to biotherapeutics, including biosimilars, huge gaps still remain, with lack of product access identified as a problem in many countries. A thorough review of the WHO guidelines on biosimilars issued in 2009 in view of technical developments, accumulated and emerging scientific evidence as well as experience in biosimilar evaluation since the release of the guidelines provided an opportunity to introduce greater flexibility and to reduce regulatory requirements in biosimilar development where possible. Based on the identification, draft revisions of the WHO guidelines were prepared with input from extensive consultation with various stakeholders and the broader public. The move toward a greater emphasis on quality and functional in vitro assessment enables the reduction of cost and timelines of development and supports streamlined regulatory approval as a first critical step toward product availability. This article includes the key updates that have been incorporated in the revised guidelines but are not restricted to these alone and should be read in conjunction with the guidelines.

Review of the quality of pediatric medications in developing countries.

The quality of essential medicines for pediatric populations in developing countries is largely unknown. This review examines quality studies (2000-2011) of medicines on the WHO Essential Medicine List for Children, the quality of a subset of pediatric formulations, and the association of these poor quality medicines with adverse clinical outcomes. We searched Embase, Medline, BIOSIS, and IPA using MeSH subject terms for quality measures, medicine formulations, and substandard medicines and combined these with 267 medicines, and 91 low-income and lower-middle-income countries. Seventy articles met our inclusion criteria examining the quality of 75 medicines from 28 countries. Content and dissolution tests were utilized most often. Results indicate that antibacterials, antifungals, and antiretrovirals were consistently of good quality. Quality tests on pediatric formulations were performed on 55 of 75 of the medicines studied and followed the general trend of quality results. Three studies were included that examined clinical consequences of substandard medicines-two cases of diethylene glycol poisoning and one case of substandard malaria drugs. We conclude that there is a need for more quality studies of pediatric formulations of essential medicines in developing countries and their clinical consequences.