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Registering essential medicines

Uganda lags behind Kenya as experts advise East African countries to prioritise their essential medicines for drug registration

| THE INDEPENDENT | Governments should ensure that the regulatory agencies responsible for registering medicines prioritise and restrict the registration of medicines to only those that are on the lists of essential medicines. In tandem with standard treatment guidelines, this would help healthcare professionals to prescribe them appropriately. It would also ensure that priority medicines are available to the population.

This is the recommendation of experts from Makerere University Kampala and Newcastle University and the Royal Free Hospital, London, UK. The experts make the recommendations in an article titled ‘East African countries should prioritise their essential medicines for drug registration’ that was published in mid-November in The Conversation which publishes online stories written by academics and researchers.

The article announced findings of their study entitled ‘Registration of antimicrobials, Kenya, Uganda and United Republic of Tanzania, 2018’. The authors were Prof. Allyson M Pollock, Moses Ocan; a lecturer, and Petra Sevcikova; a researcher.   Rosanna Lyus, a junior doctor contributed to the work.

“Lack of registration of essential medicines may promote the use of non-essential medicines and, in less regulated markets, the use of unlicensed forms of a drug,” the experts say.

According to them, medicines circulating on the market without an approval from the national regulatory agency are illegal, do not enter the market through reputable channels, and may not meet necessary quality standards. The use of these unregistered medicines can lead to treatment failure and contribute to drug resistance if a treatment course contains only a fraction of the correct dose, or the medicine is so badly made that the active ingredients are not dispersed properly.

The researchers chose to focus on antimicrobials because antimicrobial resistance is a global problem. It develops when disease-causing organisms adapt to survive treatment with antimicrobial medicines, and as a result those medicines no longer work. Resistance is fuelled by inappropriate use of medicines: when the wrong medicine, dose or treatment length is used for a particular condition.

For these medicines, then, it’s particularly important to be guided by lists that narrow down the thousands of existing products. And the right medicines must be made available through registration. If they are not available, people might die for want of treatment.

Prioritising medicines

The World Health Organisation (WHO) introduced an essential medicine list in 1977. The document presented a compilation of essential medicines that could be adapted to countries and served as a guideline for establishing national lists.

The following year, 1978, the World Health Assembly passed a Resolution urging Member States to establish national lists of essential medicines and adequate procurement systems. In that same year, the Declaration of Alma-Ata was adopted at the International Conference on Primary Health Care, Alma-Ata, Kazakhstan.

The Declaration expressed the need for urgent action by all governments, all health and development workers, and the world community to protect and promote the health of all the people of the world. It was the first international declaration underlining the importance of primary health care and to include the provision of essential medicines and vaccines as a major component of primary health care.

The aim was to help countries prioritise which medicines to make available for public use. Every two years the WHO publishes a model list which countries use to develop national lists of essential medicines.

Most low- and middle-income countries have adopted and adapted the WHO model list concept and developed their own essential medicine lists in line with their disease and treatment priorities. These lists of a few hundred medicines make it easier for governments to choose what to procure from the many thousands of medicines on the market.

The lists are developed alongside standard treatment guidelines to help healthcare professionals prescribe the right medicines in the right doses for the right length of time. Therefore, essential medicine lists are an important tool for ensuring that the right medicines are available and are used in the right way.

According to the experts, however, the lists are only part of the system. Medicines on the list also have to be registered for use in a country and the pharmaceutical industry has to apply to register its products. After approval by regulatory authorities, they are listed on national drug registers. But there appear to be mismatches between lists of essential medicines and lists of registered medicine products in some countries.

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