The purpose of medicines regulation is to protect consumers and patients by ensuring the medicinal products placed on the market are safe, effective and of high quality and by ensuring that pharmaceutical activities are carried out according to established standards.
The Medicines Authority regulates medicinal products and pharmaceutical activities and disseminates objective and unbiased information as relevant to different stakeholders.
Effective medicines are capable of treating and curing diseases.
However, they can also cause adverse side effects, which, in some instances, can be serious and possibly even dangerous. Legal provisions require that a marketing authorisation is essential for a medicinal product to be placed on the market.
Pharmaceutical companies need to demonstrate that a medicinal product is of the required quality, safety and efficacy and rigorous procedures of evaluation are followed before a medicinal product is granted a marketing authorisation.
This evaluation for market-ing authorisation entails the need for proof that the medi-cine has a positive benefit-risk balance, that is, the medicine does more good than possible harm.
After authorisation, medicinal products continue to be monitored to ensure this positive benefit-risk balance is maintained when the medicine is used in clinical practice. Over the past decade, there have been global efforts to provide effective systems for the monitoring of the safety of medicinal products. Pharmaceutical companies need to submit safety updates on authorised medicines. Adverse drug reactions encountered by patients are reported to regulatory authorities. This information on adverse drug reactions is pooled into a European database and is monitored and evaluated. If, during the lifetime of a product, it is realised the product has additional adverse effects to what was expected at the time of marketing authorisation or that the benefit-risk balance is considered to be negative, the medicinal product may have its authorisation varied or even revoked.
Medicines regulation is intended to ensure medicinal products on the market are of the required quality throughout their shelf life. Inspections are conducted on all operators carrying out activities along the supply chain: manufacturers, importers, wholesale dealers and pharmacies to ensure standards of good practice are implemented and maintained. Sampling and testing of medicinal products is done on packs taken up from different points along the supply chain. Enforcement action is taken whenever there is breach of regulations.
Medicines regulation protects the consumer from harmful, dubious and counterfeit (fake) medicines throughout the entire supply chain. Counterfeit medicinal products are products manufactured or tampered with fraudulently. Counterfeit medicines can be ineffective, of poor quality and potentially harmful and can result in therapeutic failure, exacerbation of disease and, possibly, death. Some counterfeit products are produced in such a way that makes them look exactly like the product manufactured by the authorised manufacturer, to the extent they cannot be distinguished from each other if not through chemical testing of the medicine.
If any operator within the supply chain does not adhere to the stipulated standards counterfeit products can end up at the patient. In Malta, no counterfeit products have been found within the regulated supply chain. However, when buying over the internet, patients would be bypassing the local regulated supply chain. There are substantiated concerns relating to the high risk of supply of counterfeit medicines through sale of medicines over the internet, particularly through sites that are not regulated. The World Health Organisation estimates that 50 per cent of medicines available from sites that conceal their physical address are counterfeit.
The Medicines Authority provides information on medicinal products.
A list of all medicinal products authorised to be placed on the local market can be found at www.maltamedicineslist.com.
This list enables patients to search by product name (to know the different strengths and dosage forms available for a specific product) and by active ingredient (to know the different products available on the market for a specific active ingredient). Patient leaflets as authorised by the Medicines Authority for all products having a marketing authorisation in Malta can also be accessed and downloaded.
Patients should refer to their doctor and their pharmacist as the primary source of information and advice about medicines, particularly as applicable to the individual patient’s specific circumstances and needs.
The Medicines Authority gives information on aspects relevant to medicines through the website www.knowyourmedicines.gov.mt and publishes information material.
An information leaflet – Things You Need To Know About Your Medicines/Il-Mediċini Tiegħek: X’għandek Tkun Taf – can be obtained from pharmacies.
The Medicines Authority can be reached through helpline 2343 9111 (from 9 a.m. to noon) and knowyourmedicines.info@gov.mt.
www.knowyourmedicines.gov.mt
Dr Vella Bonanno is CEO of the Medicines Authority.