Through a document, made public last July, Mozambique’s National Drug Regulatory Authority (ANARME) has prohibited the circulation and consumption of drugs branded LAURODERME and other related drugs for containing, in their composition, harmful chemical substances (4-tertbutylbenzyl propionaldehyde, Zinc pyrithione).
According to ANARME, the prohibition of the commercialization of these drugs in Mozambique aims to protect public health.
The Citizen Observatory for Health (OCS) analyzed the measure adopted by ANARME and found some aspects that need clarification.
“The company Medis Farmacêutica, representative of Bardacci Portugal, will proceed with the voluntary reception of LAURODERME brand products that contain in their composition the substance tertbutylbenzyl propionaldehyde”, the document says.
Taking into account the above quote, the OCS considers “incoherent” the removal of these products by a private entity, in the Mozambican market, as it is a matter of public health. In other words, the National Health System (SNS) should roll up its sleeves and start a campaign to collect these (and other) medicines that are harmful to human consumption.
In fact, this problem raises a debate behind the management and conservation of medicines by the SNS, considering that a large part of the health units in Mozambique, especially in rural areas, do not have adequate conditions for their conservation.
the competent entities. The entities themselves should carry out a work of collection of these drugs, taking into account that there are health institutions (pharmacies) that, for dishonesty and profit, may continue to market the same drugs, thus harming human health – a public health problem.
Several surveys carried out by OCS point out that Mozambique is a country that depends mostly on external support for the functioning of the health sector. The 2020 amount, for example, represents a quarter of what would be needed to meet the Millennium Development Goals (MDGs) in the order of US$60.00, and corresponds to only 6% of what is needed to meet the same goals by 2030 (US$271.00).
This figure (US$ 15.41) is also below the average for Africa (US$ 32.00 per capita). This means that health spending is not keeping up with the trend of population growth. (Read fully: https://www.observatoriodesaude.org/depreciacao-do-metical-e-subida-do-preco-de-combustivel-agravam-custos-no-sector-da-saude%EF%BF%BC)
Thus, the OCS considers the destruction of medicines a regrettable issue, and therefore calls for greater supervision of products entering the national market, with the need to carry out a prior monitoring work in the process of their acquisition, observing aspects related to quality, validity and conservation.
It makes no sense for a needy health system to waste pharmaceuticals, although the destruction of these products is necessary and urgent. The waste of these inputs, in a country that has a high demand for medicines, is an incongruity.
Observing the urgent need to destroy the drugs of the branded LAURODERME (which contains harmful substances 4-tertbutylbenzyl propionaldehyde, Zinc pyrithione), the following question arises: after the drugs have been withdrawn from the market, what mechanism will be used for their destruction?
According to article 8 of the law no 18 of February 2003, “it is forbidden to deposit in the national soil or subsoil, as well as to throw into the water or the atmosphere, toxic or polluting substances, outside the legally established limits.”
Therefore, observing the legal instruments, the same question persists: considering that the collected drugs will be incinerated, how will the environmental pollution be avoided?
ANARME’s position addresses only the prohibition of the circulation and availability of these drugs, but does not explain how they will be destroyed, although the same law states that in these cases “it is necessary to define the legal framework in which the management of resulting polluting substances should be processed.”
The destruction of pharmaceuticals is important, but the preservation of the environment must be guaranteed, at the risk of solving one problem by causing another. In the same vein, ANARME should speak publicly about the following questions: what mechanism will be used by users to denounce pharmacies that still sell the same drug? What sanctions are foreseen against those people who, even after the prohibition of circulation of the drugs in question, would have continued to market them?
Considering that LAURODERME’s products circulated in the national market, would they not have harmed someone’s health? If they have caused damage, who is responsible for the damage to someone else’s health? How will the injured parties proceed to contest the inappropriate consumption of these drugs which, due to some negligence, have circulated in pharmacies?