Dec 08, 2018 Volume 392 Number 10163 p2413-2514
Mariângela Simão, Veronika J Wirtz, Lubna A Al-Ansary, Suzanne Hill, John Grove, Andrew L Gray, Claudia Nannei, Lisa Hedman, Pamela Das, Hans Hogerzeil
Access to affordable, quality-assured essential medicines is a prerequisite for effective universal health coverage.1,2 Efforts to ensure comprehensive access to essential medicines have been hindered by a dearth of information. Most monitoring efforts have focused on measurement of a prespecified list of essential medicines in health facilities. Measures of affordability in private and public health facilities have relied on periodic surveys, usually by non-governmental organisations (NGOs) or academia3 The quality of medicine products and of prescribing practice, as well as patients’ use of essential medicines, have been assessed even less often. Pharmaceutical expenditure in the public and private sector is not prioritised in national systems, and is rarely reported.4 Without systematic data reporting on national pharmaceutical expenditure, there is a lack of attention to access to essential medicines in major reports such as the World Health Statistics.5 The 2015 Millennium Development Goals Task Force report concluded that tracking progress on access to essential medicines was impossible, given the absence of country-level data.6, 7
When target measurements are used to improve access, a robust monitoring and accountability system is needed—eg, the three-step framework recommended by Paul Hunt, former UN Special Rapporteur on the Right to Health, that involves appropriate collection of data, independent review, and the necessary corrective action.8 The Lancet Commission on Essential Medicines Policies made an initial proposal for such a framework.1 Independent review and corrective action are important components of an accountability mechanism, as shown by UNAIDS’ HIV progress reports9 and work in reproductive, maternal, newborn, child, and adolescent health.10
Members of the Lancet Commission on Essential Medicines Polices and WHO have discussed options for such a framework. A global accountability mechanism for monitoring access to essential medicines must take account of major global trends—eg, strengthening patient-centred primary health care; efficient country-led horizontal health systems, including prevention and treatment of non-communicable diseases; systems of risk-sharing, pre-payment, and social health insurance; and greater attention to the quality of care, the quality of health products, the skills and attitudes of health workers, and cost-effective treatment. Civil society is also demanding better data collection, transparency, and systems of accountability to promote equity and good governance.11 Greater reliance on routine data facilitated by new technologies, including mobile applications, should enable countries to generate timely information on a continuous basis.
The focus of accountability should move away from measuring only availability of medicines towards the effectiveness, quality, and efficiency of patient-centred comprehensive primary care services, which encompasses equitable access to essential medicines. To advance this agenda, indicators are therefore needed that are sensitive to differences in access on the basis of gender, ethnicity, education, residential location, and wealth quintile. WHO has already provided resources to assist national programmes in applying an equity lens.12, 13 Under the aegis of WHO, medicine access indicators should now be developed in close collaboration with member states, academia, and civil society, consisting of a small set of screening indicators supported by more detailed diagnostic and progress indicators.
Further high-level discussions between WHO, the Lancet Commission, other UN agencies, and NGOs have led to the identification of four priorities to ensure the development of a global Accountability Mechanism for Access to Essential Medicines (abbreviated as 2A2M). First, high-level political support is needed through the definition of the accountability structure and operating mechanisms, taking into consideration the roles and responsibilities of national governments, academic partners, and civil society. Second, the strategic generation, analysis, and use of prioritised data for decision making is vital, with a strong focus on national capacity building and leveraging existing technical support programmes. Third, technological advances in data collection must be adopted, building on the principles of the Health Data Collaborative and existing data platforms and recognising variability in national digital maturity. Finally, global advocacy is needed to ensure the engagement of all relevant technical and financial contributors at national and international levels.
A global accountability mechanism for access to essential medicines that is nationally applicable and feasible will take several years to achieve. However, experiences in HIV and reproductive, maternal, newborn, child, and adolescent health have shown that it can be done, provided a clear political mandate and the necessary financial and technical resources are ensured, together with country leadership and the engagement of civil society and academic institutions.
VJW reports grants from Sandoz International GmbH and from the International Federation of the Pharmaceutical Manufacturer Associations outside the submitted work. HH reports personal fees from WHO, Health Action International, and Access to Medicines Index 2018, outside the submitted work. PD is Senior Executive Editor, The Lancet. We declare no other competing interests. The authors alone are responsible for the views expressed in this Comment and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated.