Dr Clive Ondari, Coordinator of Access to Medicines, Department of Essential Medicines and Health Products, World Health Organization
In the second half of our exclusive interview, Dr Clive Ondari addresses WHO medicines policies and promotes greater efficiency in health systems, medical products and technologies for the future
In what ways is the work carried out by the Department of Essential Medicines and Health Products (EMP) working towards the World Health Organization’s (WHO’s) strategic objective of improving access, quality and use of medical products and technologies?
WHO’s strategic objective of improving access, quality and use of medical products and technologies seeks to enable countries to ensure that the medicines in their markets are safe, effective and quality assured and that they achieve optimal value for money in their expenditure for these products.
Through expert committees and a number of partnerships, we develop and update global norms and standards on quality, methodologies on medicine-related information and evidence, carry out capacity building in various aspects of the medicines chain at country level, especially in the area of national medicine regulation and control, as well as procurement and distribution. We are responsible for the development of International Non-proprietary Names (generic names) for new active pharmaceutical substances, assessing priority medicines for UN procurement through the WHO/UN Prequalification of Medicines Programme, advising the Commission on Narcotic Drugs on the scheduling of controlled medicines, as well as maintaining chemical reference standards.
Our activities have enabled the treatment of over 4 million HIV/AIDS patients with quality-assured medicines at affordable pricing. With the WHO/Health Action International (HAI) survey methodology, availability and affordability have been measured in over 50 countries as part of MDG monitoring.
Long-term medicine supply strategies are important to ensure that essential medicines are accessible and readily available, though these are absent in many countries. How do you support the development of efficient medicines supply systems?
Adequate human resources, sustainable financing, comprehensive information systems, and coordinated healthcare partners and institutions are vital in ensuring uninterrupted availability and accessibility of essential medicines. Long-term supply strategies are needed in order to ensure that the key elements for effective supply systems are in place; often these strategies are absent in many countries, especially in sub-Saharan Africa.
WHO has developed tools to assess the medicines supply management systems in countries in a drive to identify strengths of the systems on which to build, and weaknesses to be addressed in order to improve service delivery. We provide technical guidance and advocates for secure and efficient medicines supply systems to improve availability of and access to essential medicines.
To what extent does EMP work on national constitutional commitments and legal enforcement of access to essential medicines as part of the right to health?
The right to the highest attainable standard of health (referred to as the right to health) was first reflected in the WHO Constitution in 1946 and then reiterated in the 1978 Declaration of Alma Ata and in the World Health Declaration adopted by the World Health Assembly in 1998.
EMP has developed the access framework that has enabled the implementation and monitoring of the commitments of governments – in the context of essential medicines and related products and as stated by the Committee on Economic, Social and Cultural Rights, General Comment No. 14 in 2000. The critical components of this framework are: (i) Availability – available in sufficient quantity; (ii) Sustainable Financing which ensures affordability – economic accessibility; (iii) Reliable Delivery Systems with the capability to ensure the appropriate quality; (iv) Rational use – to ensure safe and effective use as well as optimal use of resources.
Additionally, EMP has reviewed and reported in international journals court proceedings that have demonstrated how states can be held accountable to their commitments to the right to health of their citizenry. The access framework facilitates the reporting on how states are moving progressively towards achieving their set targets.
How much input does EMP have on the development and implementation of medicines policies within Member States?
EMP has published guidance on how to develop and implement comprehensive national medicines policies. Over 100 countries have developed their policies based on this guidance and thousands of professionals from developing and developed countries have been trained in the various critical aspects of managing the pharmaceutical sector including quality assurance, good manufacturing, pricing, supply management and promoting rational use.
We promote the systematic implementation and monitoring of national medicine policies to reflect government commitment and achievements, update and create new policy guidance documents on priority issues, promote country-level integration with health systems, harmonise national policies among regional economic blocks, and develop policies for simple pharmaceutical systems in post-emergency situation.
Additional work is focused on improving pharmaceutical surveys indicators and household surveys to measure performance of the national pharmaceutical systems and to create a package of country data. These data are vital in order to improve planning and monitoring of the effectiveness of country programmes.
What do you see as the greatest challenge to WHO’s mission for greater access to high quality medical products and technologies?
The challenges to WHO’s mission for greater access to medicines that are safe, efficacious and of assured quality are similar to those faced by the health systems in many countries. These are primarily adequacy of reliable and sustainable financing and human resources. The efforts of WHO cannot succeed if the implementation at the country level is inadequate and/or insufficient.
The World Health Report 2006 highlighted the crisis in human resources for health. The development, production, distribution and appropriate utilisation of medicines, as well as the supportive functions of regulation, operational research, and training, all require the involvement of competent pharmaceutical professionals. A survey on human resources for the pharmaceutical sector carried out in four African countries – Ghana, Nigeria, Sudan and the United Republic of Tanzania – concluded that there was uneven distribution of workers between urban and rural areas, inadequate motivation of workers especially in the public sector, limited production capacity of training institutions and poor or no retention strategies. More needs to be done to improve both the numbers and the competences of workers.
Of the 10 leading sources of inefficiency in health systems cited by the World Health Report 2011, six of these are related to the pharmaceutical subsector. These include underuse of generics and higher than necessary prices for medicines; use of substandard and counterfeit medicines; inappropriate and ineffective use; overuse or supply of equipment, investigations and procedure; inappropriate or costly staff mix, unmotivated workers and health system leakages: waste, corruption and fraud.
The current WHO Medium Term Strategic Plan is due to come to an end in 2013. How do you think that the next Strategic Plan will affect EMP? Do you think that you will be maintaining your current position, or moving into slightly different areas?
As we draw to the end of the current WHO Medium Term Strategic Plan, lack of access to medicines and health products continues to cause many deaths and much suffering globally. This is due to factors such as inadequately managed pricing, limited health financing, poor supply management and weak regulatory and enforcement systems for medicines. Research, development and financing for many health commodities are still inadequate, particularly for medical products with small markets. The weak regulatory environments have resulted in increased production and distribution of sub-standard and counterfeit products, which combined with widespread irrational use of medicines, contribute to the growing risk of antimicrobial resistance. EMP’s programme of work will be dictated by these prevailing priorities as well as existing obligations within international treaties and agreements.