Accessibility to generic medicines on the Maltese market

Abstract

As the price of innovative and complex therapies increases, availability and access to generic medicines is critical for the sustainability of healthcare systems. The aims of this study were to identify available generic medicines on the Maltese market and to develop and validate a questionnaire to assess the perception of the general public regarding accessibility to generic medicines.

Two drug classes were selected for the purpose of this study: drugs for oncology and drugs acting on the nervous system. Innovator drugs for oncology are expensive and nervous system drugs are widely prescribed in Malta and not broadly represented on the national health service scheme, requiring patient out of pocket payment. All authorised products as listed by the national competent authority were reviewed, and generic products available for each active ingredient and the corresponding dose and pharmaceutical forms were analysed. A questionnaire was formulated and validation with an expert panel was carried out.

For oncology, 159 generics for 15 originators are available, namely: Alkylating agents (n=16), antimetabolites (n=63), plant alkaloids (n=26), cytotoxic antibiotics (n=18), and other antineoplastic agents (n=36). The majority of generic oncology drugs are available as parenteral dosage forms (n=139). For nervous system drugs, 467 generics for 114 originators were available, namely: Antiepileptics (n=104), antipsychotics (n=146), hypnotics, sedatives and anxiolytics (n=65), antidepressants (n=128), central nervous system stimulants (n=8), and drugs used in addictive disorders (n=16). The majority of generic drugs for nervous system disorders are oral preparations (n=435). There were 9 originators for oncology drugs and 60 for nervous system drugs which did not have generic counterparts. Results showed that for oncology drugs, antimetabolites had the most generics available, while alkylating agents had the least. Drugs for nervous system disorders were generally well-represented, with antipsychotics having the greatest number of generic products available. The questionnaire developed focused on assessing perception of access to generic medicines. Overall, the panel agreed that the questionnaire is concise, quick, and easy for the patients to reply. Through this study the available generic medicines on the Maltese market for oncology drugs and for drugs acting on the nervous system were identified and a tool to understand the perception of generic medicines and accessibility by patients was developed.