There are thousands of medicines on the market of varying usefulness, efficacy and price, and the possibility of obtaining medicines over the Internet has added to this plethora. How can you find your way around when you are in a position of responsibility and have limited resources at your disposal? The need for rationalisation had become obvious, and this is what the World Health Organisation (WHO) has tried to address.
The first WHO Model List of Essential Medicines was published by the WHO in 1977; since then it has been updated every two years or so as the scientific evidences and the market for medicines has expanded. The latest list dates from June 2019 and is the 21st list. Since 2007, the WHO has also published a separate list for children up to the age of 12; the 2019 list is the 7th since it was first published in 2007.
These lists identify the essential medicines that health systems around the world should provide access to for the entire population, in accordance with the Montreal Declaration on the Fundamental Right to Essential Medicines (Montreal 2005). This is a model list that can be adapted locally by the health authorities of different countries to meet their priority public health needs. The medicines selected must be essential to meet these priority needs and must present sufficient evidence of safety, efficacy, acceptable cost-effectiveness, and sufficient availability on the market.
Essential medicines, as defined by the WHO, are those that meet the health needs of most of the population. They must be available at all times in adequate quantities and appropriate formulations, at a price affordable to individuals and the community.
The main list corresponds to the minimum drug requirements of a basic healthcare system and indicates the medicines with the best efficacy, safety and cost-effectiveness for priority diseases. These diseases are selected on the basis of their current and estimated future importance to public health, as well as the availability of safe and cost-effective treatment.
More than 150 countries are currently using the WHO list to determine which medicines are best suited to their contexts and health priorities, so that they can draw up their own national lists of essential medicines.
In January 2020, the WHO launched a new, easy-to-access digital version of its Model List of Essential Medicines. This change will revolutionize the way this essential reference tool is used. The new electronic version allows the traditional WHO Essential Medicines List to be accessible on smartphones and computer screens as a comprehensive database that can be accessed free of charge online.
Most medicines on the WHO Model List of Essential Medicines are generic, and therefore no longer subject to patent legislation. However, some new medicines that are active against serious diseases that threaten public health may be included on the Model List but are still subject to patent law. This was a particular issue with the Covid 19 messenger RNA vaccines during the recent Covid 19 pandemic. In a forthcoming article, we will look at the legal options available to governments to circumvent this obstacle.
To address the lack of access to testing and screening services in many countries, the WHO has also published an annual Model List of Essential Diagnostic Products since 2018, listing the recommended in vitro diagnostic (IVD) products that must be available at the point of care and in laboratories in all countries to enable life-saving diagnoses to be made without delay. The 2021 edition includes the WHO-recommended COVID-19 diagnostic tests (PCR and antigenic), expands the range of tests for infectious and vaccine-preventable diseases and non-communicable diseases (such as cancer and diabetes), and contains a new section on endocrinology, which is important for reproductive and women’s health. For the first time, the list includes tests that should not be provided in countries, either because they are not cost-effective or reliable, or because newer, easier-to-use technologies have supplanted them.
Now, what about medical devices? In order to make progress towards the goal of improved global access to appropriate medical devices, the Priority Medical Devices (PMD) project, initiated by the WHO, has defined a health-based approach to medical devices. This process has not yet resulted in a genuine model list of PMDs.
The scientists appointed by the WHO to update the lists of essential medicines are regularly subject to pressure from pharmaceutical companies, which see the inclusion of their products on the list as a major source of revenue. The independence of these scientists is therefore crucial to guaranteeing the quality of their work.
The new African Medicines Agency, better known as the AMA, will be based in Rwanda! This was the decision taken at a meeting of the AU Executive Council in Zambia in 2022. “The WADA will play a key role in strengthening confidence in the quality of health products on the continent, promoting cooperation and mutual recognition in regulatory decisions and facilitating the circulation of health products“, said Sabin Nsanzimana, Minister of Health in the Rwandan Government. The new organization will facilitate pandemic preparedness. It will increase access to medicines. The agency will also support collaboration between regulators and help build resilient health systems.
