The Formulary is the minimum list of essential drugs for the basic health care system. It includes the most effective, safe and cost-effective drugs for priority diseases. Priority diseases are selected based on current and perceived future public health implications, and the potential for safe and cost-effective treatment.
The term “essential drugs” has been widely used since 1975, when the World Health Assembly adopted the concepts of “essential drugs” and “national drug policy”. In 1977, the World Health Organization (WHO) first published the WHO Model List of Essential Medicines (hereinafter referred to as the WHO Model List), designed to help other countries develop their own national lists. In the Almaty Declaration adopted in 1978, the provision of essential drugs is recognized as one of the elements of primary health care. Today, the concept of creating a list of essential drugs as drugs that meet the priority needs of the health system has gained widespread acceptance. According to this concept, essential drugs should be available in the required quantity, appropriate (established) dosage forms in the presence of guaranteed quality and at a price affordable for the patient and the community. The number of countries that have created national lists has already exceeded more than a hundred (some countries additionally create lists at the provincial or state level). In this publication, we invite readers to understand what role the list of essential drugs plays and what is necessary (from the point of view of WHO) for the proper application of this concept.
Before the first edition of the WHO Model List appeared in 1977 in some developed and developing countries (there were about a dozen in total), steps had already been taken to compile national lists of essential medicines. In particular, in Ceylon (now Sri Lanka), as early as 1959, a list of drugs for procurement in the public sector was compiled, and one of the first lists of essential medicines was created in Tanzania (1970). Today, more than 150 countries have regularly updated national lists of essential medicines.
The first edition of the WHO Model List (1977) included 204 drugs, and the current 20 version (2017) is twice as much as 433. The WHO Model List is updated every 2 years, as new data on efficacy and safety appear, the prevalence of diseases, new treatment methods are being developed.
Speaking about the evolution of the list, important additions cannot be circumvented, such as the inclusion of fixed-dose combinations (FDC) of drugs for the treatment of tuberculosis (1988), antiretroviral drugs (2002), a number of vaccines (2007), and also the division of antimicrobial drugs into 3 categories – ACCESS, WATCH and RESERVE (2017).
It should be noted that since 2007 a list has also been published for children under 12 years old (WHO Model List of Essential Medicines for Children). Today is its 6th edition.
To ensure the availability of essential medicines, various mechanisms can be used to reduce the manufacturer’s selling price (Ex-manufacturer¬ Price), for example, setting price caps, introducing an external reference pricing system (International Reference Pricing). However, it should be borne in mind that the final cost of the drug for payers also includes the distributor’s margin. In this regard, the final price even for generics with the lowest selling price of the producer may be higher than the reference price. In low- and middle-income countries, where the private sector provides a significant share of healthcare costs, patients buy drugs in retail, where prices can be even higher. According to a WHO study from 2007–2012, the cost of generics in the private sector is on average 5 times higher than reference prices.
Providing an opportunity to get a medicine at a lower price is another approach that is used to increase accessibility, as well as reduce the cost of treatment for patients. But such an approach alone cannot provide full and timely access of the population to the main medicines. An effective system for the provision of medical services depends on a number of interrelated factors related to financing, infrastructure, the procurement and supply system, and the proper use of drugs. It is important to pay attention to each of them, which will increase accessibility in the long-term and fully reveal the possibilities of the concept of essential drugs.
How does WHO decide to include the drug in the Formulary?
Applications for inclusion of a medicinal product in the Formulary are considered by the WHO Expert Committee on the Selection and Use of Essential Medicine, which consists of 8-12 people.
The assessment is based on:
- evidence of disease prevalence;
- clinical research data on the effectiveness and safety of the drug;
- analysis of economic feasibility from the point of view of the cost-effectiveness ratio.
The reason for the exclusion of the drug from the Formulary may be unacceptable adverse reactions or the availability of analog drugs with a higher safety profile or effectiveness.
Many countries use the Formulary as a guide when developing their own national lists, “tailoring” it to fit the needs of the population, priority diseases and the particularities of the national health system. Of course, approaches in different countries are different.
The WHO Model List contains only the names of the drugs, recommended dosages and dosage forms, while the national lists of some countries (particularly South Africa) also contain standard treatment guidelines.
Some countries additionally create updated lists at the provincial or state or even city level. For example, Brazil has lists at the country level (RENAME), states (RESME), and cities (REMUME).
In contrast to the WHO approach, which is based on evidence-based and evidence-based evidence, China, for example, uses an expert-based approach. 2 expert groups are formed: the first evaluates and offers candidate drugs for inclusion in the national list, and the second votes and approves the list.
It should be noted that many countries create only a national list, without specific recommendations regarding the rational use of essential drugs. Nevertheless, it is very useful to have special manuals. It is important to consider that ensuring the availability of essential medicines for the population depends on a number of interrelated factors related to financing, infrastructure, the procurement and supply system, and the proper use of drugs. It is important to pay attention to each of them, because an insufficient level of financing, an inability to correctly assess demand (need), supply disruptions, etc. will not contribute to increased consumption of essential drugs.