The Malta Medicines Authority has moved to reassure the public over the safety, quality, and effectiveness of generic medicines, following remarks by Opposition Leader Alex Borg suggesting a future Nationalist government would ensure medicines are of “good quality, not generics”.
In a statement issued on Sunday with the Superintendence of Public Health, the authority said it wanted to “allay any alarm” among the thousands of Maltese patients who rely daily on generic medicines.
The statement also echoed comments made last week in parliament by Health Minister Jo Etienne Abela, who had defended the use of generics as safe, effective, and regulated to EU standards.
Citing the European Medicines Agency, the authority underlined that a generic medicine “contains the same active substances as the reference medicine and is used at the same dose to treat the same disease”. The only differences between a generic and its branded equivalent, it said, may be in the product’s name, colour, or shape, but not in its therapeutic effect.
“Generic medicines are manufactured according to the same quality standards as all other medicines,” the statement said, noting that regulatory authorities conduct regular inspections to ensure good manufacturing practices are followed.
The authority also explained that generics must demonstrate bioequivalence to their brand-name counterparts, meaning they deliver the same amount of active ingredient into the bloodstream over the same period of time. “This ensures that a generic medicine works in the body in the same way as the originator,” it said.
Generic medicines produced in Malta and available to local patients “follow the same EU regulations for quality, safety, and efficacy as in all other European Union countries”, the authority said. It also highlighted that the World Health Organization endorses the use of generics for their safety, quality, and potential to make healthcare more affordable and accessible.
The statement urged the public not to be “alarmed by any statements which may wrongly infer any inferiority in the quality of generic medicines”, including those distributed through the Pharmacy of Your Choice scheme and the private market.