Dr Clive Ondari, Coordinator of Access to Medicines, Department of Essential Medicines and Health Products, World Health Organization


Whilst drug development is essential, implementing guidelines to ensure that medicines are available, safe and responsibly administered is equally important, especially in low-income countries, as Dr Clive Ondari spells out in the first of a two-part exclusive interview


How would you define the role of the Department of Essential Medicines and Health Products (EMP) within the World Health Organization (WHO)?

The Department of Essential Medicines and Health Products contributes to strengthening health systems by providing support to countries in improving access to, and use of, safe, effective and quality-assured medicines. This is achieved through the work we do to develop and update norms and standards and the provision for technical support. Through advocacy we raise awareness of the need for the improvement of regulatory and delivery systems to ensure that medicines reach those who need them according to the principles of essential medicines.

To improve regulatory and licensing procedures and advance research and development for missing essential medicines and health products, we have established numerous partnerships. Part of our responsibility is also to publish information and guidelines to support policy makers and healthcare workers in providing the right medicines.

We help countries set and agree on their medicines priorities, draw up and implement plans, and monitor and evaluate them. Moreover, collaboration between countries to improve quality, selection and use, and to increase availability and affordability of medicines is encouraged. We promote transparency and efficiency, and advocate a coordinated, multi-stakeholder approach that involves the private sector, civil society, academic and other partners.

80 per cent of deaths occurring due to noncommunicable diseases (NCDs) take place in low- and middle-income countries, where access to medicines is generally poor. How is the EMP working towards improving access to medicines to prevent such deaths in these countries?

Cost-effective medicines to treat many of the noncommunicable diseases (NCDs) are available and in mostly low-cost, generic forms. Unfortunately, these medicines remain inaccessible and unaffordable to many who need them, especially in low- and middle-income countries where the prevalence of NCDs are increasing.

The major burden of disease related to NCDs cannot be reduced without equitable access to essential medicines. While primary prevention of NCDs is a key objective, treatment of existing cases (secondary prevention) is also needed and widely expected by patients. Medicines are an essential component for the treatment of cardiovascular diseases, diabetes, chronic obstructive pulmonary disease including asthma, many cancers (including palliative pain treatment) and depression.

Scaling up access to NCD medicines is critical to global efforts to ameliorate the burden of NCDs and also in achieving the Millennium Development Goals (MDGs). Low public sector availability of essential medicines is often caused by a lack of public resources or underbudgeting, inaccurate demand forecasting, and inefficient procurement and distribution. This forces patients into the private sector, where generic medicines are often two to three times more expensive. Chronic treatment puts an enormous and continuous financial strain on household budgets.

Many policy options exist to address these problems and to achieve, for NCDs, the same three main objectives that are valid for any general essential medicines programme: equitable access (rational selection, affordable prices, sustainable financing and reliable systems); assured quality and safety; and quality use by prescribers and consumers. EMP has been working for over 30 years in these areas and will continue to support countries in their renewed commitments to tackle the burden of NCDs.

Currently, there is a great deal of concern about the rise in antimicrobial resistance and its implications, such as death, poorer quality of life and expense to healthcare systems. How are you working to address this issue?

WHO works at local, national, and international levels to build capacity, provide technical guidance, and catalyse political commitment to address the threat of antimicrobial resistance. The goals are to ensure the provision of high-quality and effective antimicrobials for patients today and the preservation of the life-saving power of antimicrobials for future generations.

The World Health Assembly has issued a series of resolutions identifying antimicrobial resistance as a public health priority and directing WHO secretariat to support Member States and international efforts to address antimicrobial resistance and to promote the rational use of antimicrobials.

WHO provides technical guidelines to support antimicrobial resistance containment and assists countries in the establishment of the necessary infrastructure to support national medicines policy, health services, and surveillance capacity. A policy package has been developed to support countries in combating antimicrobial resistance and calls for: (i) Commitment to a comprehensive, financed national plan with accountability and civil society engagement (ii) Strengthening of surveillance and laboratory capacity (iii) Assurance of uninterrupted access to essential medicines of assured quality (iv) Regulation and promotion of rational use of medicines, including in animal husbandry, and ensure proper patient care (v) Enhancement of infection prevention and control (vi) Fostering of innovations and research and development for new tools.

The WHO estimates that of all medicines prescribed, dispensed or sold, half of these are inappropriate for the patient. What are you doing to encourage more rational use of medicines?

Rational use of medicines refers to the correct, proper and appropriate use of medicines. Rational use requires that patients receive the appropriate medicine, in the proper dose, for an adequate period of time, and at the lowest cost to them and their community.

Irrational use, which is overuse, underuse or misuse of medicines, harms people and wastes resources. More than 50 per cent of all countries do not implement basic policies to promote rational use of medicines. In developing countries, less than 40 per cent of patients in the public sector and 30 per cent in the private sector are treated according to clinical guidelines.

A combination of healthcare provider education and supervision, consumer education, and an adequate medicines supply is effective in improving the use of medicines, while any of these interventions alone has limited impact.

WHO advises and works with countries in several ways. For example, we help to develop and implement policies through evidence-based clinical guidelines to guide training, supervision and supporting decision, lists of essential medicines used for medicine procurement and insurance reimbursement, elimination of financial incentives that lead to improper prescribing, such as prescribers selling medicines for profit to supplement their income, regulations to ensure that promotional activities meet ethical criteria and adequate funding to ensure availability of medicines and health personnel.

We also build structures, such as national bodies to coordinate policies on medicine use and monitor their impact. Drug and therapeutics committees in districts and hospitals to monitor and implement interventions to improve the use of medicines are also included in this.

Education is also important and we help to provide problem-based training in pharmacotherapy and prescribing in undergraduate curricula, continuing medical education as a requirement of licensure and public education about medicines. Finally, WHO helps to make independent and unbiased information about medicines publicly available for health personnel and consumers.

The most effective approach to improving medicines use in primary care is a combination of education and supervision of health personnel, consumer education, and ensuring an adequate supply of appropriate medicines. Any of these alone have limited impact.

WHO has developed guidance and support for the implementation of these measures over the last 30 years and will continue to monitor global medicines use and pharmaceutical policy. We are dedicated to providing policy guidance and support to countries to monitor medicine use and to develop, implement and evaluate national strategies to promote rational use of medicines and deliver training programmes to national health professionals on how to monitor and improve medicines use at all levels of the health system.