Recent publications, information and events

32 WHO Drug Information Vol. 28 No. 1, 2014 Recent publications, information and events World malaria report: financing needed to sustain major progress The World Health Organization (WHO) has released its World malaria report 2013. The report shows major progress in the fight against malaria and calls for sustained financing to preserve past gains. Global efforts to control and eliminate malaria have saved an estimated 3.3 million lives between 2000 and 2012. Despite an increase in the global population at risk, new malaria cases have decreased by 29% and malaria deaths by 45% globally in that period. Access to WHO-recommended artemisinin-based combination therapies (ACTs) has risen more than fourfold from 2006 to 2012. Access to diagnostic testing has also increased in recent years. However, an estimated 3.4 billion people remain at risk of malaria, with around 80% of malaria cases occurring in Africa. Less than half of the population at risk had access to an insecticide-treated bed net in 2013, and millions of people stilllack access to diagnosis and quality-assured treatment. The roll-out of preventive therapies – recommended for infants, children under 5 and pregnant women – has also been slow in recent years. Malaria prevention and treatment requires continued financing. While the total international and domestic funding for malaria control has increased tremendously since 2000 to reach US$ 2.5 billion in 2012, it still falls short of the US$ 5.1 billion needed each year to achieve universal access to prevention and treatment interventions. Adequate and predictable funding is also needed to combat emerging parasite resistance to artemisinin, the core component of ACTs, and mosquito resistance to insecticides. WHO is currently developing a global technical strategy for malaria control and elimination for the 2016-2025 period. Reference: World Health Organization. World malaria report 2013. Geneva, Switzerland: WHO, 2013. WHO Prequalification: A quiet revolution in global public health A recently published article looks at the history of the WHO Prequalification of Medicines Programme, created in 2001. The Programme has improved the quality of life-saving medicines used today by millions of people in low- and middle- income countries. Although verifying medicines quality may appear a non- controversial activity, the Programme was initially criticized harshly for helping commercial generic producers gain access to markets until then dominated by originator companies. Today the Programme is respected globally for its solid and transparent standards that come out of an international consensus process with WHO Member States, and for its close collaboration with national drug regulatory agencies in both developing and wealthy countries. The article terms it “the strongest mechanism currently in place to create sustainable medicines regulatory systems in low- and middle-income countries”, and concludes 33 WHO Drug Information Vol. 28 No. 1, 2014 Recent publications, information and events that global health donors would be well advised to create a sustainable funding base for the continuation of its work, which is crucial to assure the quality of key medicines purchased with their finance. Reference: ‘t Hoen EFM, Hogerzeil HV, Quick JD, Sillo HB. 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. AIDS drugs for all: how global advocacy transformed pharmaceutical markets A recently published book looks back on how the global AIDS treatment advocacy campaign transformed pharmaceutical markets the history towards universal access to ARV treatment for all people living with AIDS. It describes how a product market was developed and altered to provide access to quality-assured, affordable medicines to treat HIV for all who need them. The book acknowledges the important role of the WHO Prequalification of Medicines Programme in assuring the quality of affordable generic products. WHO prequalification has proved to be one of the crucial enablers in an unparalleled social and political movement to fulfil the entitlement of every person to access to treatment as a human right. Reference: Kapstein EB, Busby JW. AIDS Drugs for All. Social Movements and Market Transformations. New York, USA: Cambridge University Press; 2013. Who are the originators of innovative medicines in the EU? Over 40% of innovative medicines and over 70% of new medicines for the treatment of rare diseases recommended for marketing authorisation in the European Union (EU) between 2010 and 2012 originated from small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships, according to an article authored by staff members of the European Medicines Agency (EMA). On the other hand, SMEs are underrepresented as marketing- authorization holders while the other types of organizations mentioned above are not involved at the stage of marketing applications at all. Acknowledging the role of SMEs as a motor of innovation for medicines, the EMA has a programme in place to support SMEs through all stages of medicine development. New platforms are also being set up that will facilitate the engagement with the academic world, further supporting the translation of innovation into successful developments in the interest of patients. Reference: Lincker H, Ziogas C, Carr M, Porta N, Eichler HG. Regulatory watch: Where do new medicines originate from in the EU? Nature Reviews Drug Discovery 13, 92–93 (2014) doi:10.1038/nrd4232. Medicines Patent Pool and Bristol- Myers Squibb sign agreement The Medicines Patent Pool (MPP) and biopharmaceutical company Bristol-Myers Squibb have signed a licensing agreement to increase access to a key HIV medicine, atazanavir, in 110 developing countries. This is the MPP’s first agreement covering a World Health Organization (WHO)- preferred second-line therapy. WHO estimates there will be over 1 million people on second-line treatment by 2016, and many more will need access to these therapies. WHO Drug Information Vol. 28 No. 1, 2014 34 Recent publications, information and events Previous agreements with Gilead Sciences and ViiV Healthcare have expanded access to WHO-preferred first- line treatments for adults and children. The Medicines Patent Pool works by creating a pool of relevant patents for licensing to generic manufacturers and other producers, facilitating the generic competition that brings down prices and can help to stimulate innovation. Medicines Patent Pool licensees are required to submit their products to either the WHO Prequalification Programme or to a stringent regulatory authority for evaluation. References: MPP and Bristol-Myers Squibb Sign Agreement to Further Expand Access to a Key HIV Medicine. 12 December 2013. Licences in the MPP, at http://www. medicinespatentpool.org/licensing/current- licences/ Report calls for cooperation to strengthen post-market surveillance systems The Safety Surveillance Working Group, a collaborative effort initiated by the Bill & Melinda Gates Foundation, has published a report that assesses the medicines and vaccines product pipeline and resulting demands on the regulatory systems in low- and middle-income countries. Based on that data analysis, the report outlines a strategy and implementation plan to strengthen post-market safety in these countries. The authors call for a coordinated international effort of policy makers, regulators, industry and health professionals to build sustainable safety surveillance systems. They point to the importance of cooperation and of leveraging existing infrastructure such as that offered by the WHO Programme for International Drug Monitoring, the WHO Global Vaccine Safety Initiative, the Brighton Collaboration and the CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Reference: Bollyky TJ, Stergachis A. A Report of the Safety and Surveillance Working Group. Seattle, USA: Bill & Melinda Gates Foundation; 2014. Events Annual ATC/DDD Methodology course The WHO Collaborating Centre for Drug Statistics Methodology announces its next annual course in ATC/DDD, to be held in Oslo, Norway, on 5-6 June 2014. The course is open to all interested parties. Basic knowledge in common medical terminology is recommended. The Anatomical Therapeutic Chemical (ATC) classification system, together with the Defined Daily Dose (DDD) as a technical unit of measurement, provides an effective tool to present and compare drug consumption statistics at international and other levels in drug utilization research. Reference: WHO Collaborating Centre for Drug Statistics Methodology [website] at www.whocc.no/courses/