Justification for applying article 20

Abstract

Access to medicines is an ongoing dynamic process which demands a proactive response by the authorities to ensure a timely availability of medicines to patients. It is a multi-faceted system that requires several branches of institutions for the safe and quality medicines to go from the manufacturing plant to the hands of the consumer. The regulation of marketing authorizations of medicines is geared to ensure the safety and efficacy of medicines that reach the public. The Malta Medicines Act of 2003 provides the provisions when it comes to medicinal products made available in the Maltese market. Article 20 of the Medicines Act with the title Marketing Authorization Relating to Medicinal Products is used to grant a permit of some medicinal products in the Maltese market for use in situational circumstances.

The methodology is divided into two parts. Part I presents the process undertaken to evaluate the existing role of Article 20 of the Medicines Act of 2003. Justifications for applying for Article 20 were identified on this section thru a developed and validated questionnaire. Part II presents the process undertaken to produce a systematic procedural on the process of applying for Article 20. A draft of standard operating procedure was developed.

The stakeholders that served as respondents consisted of six (6) from the Central Procurement and Supplies Unit, one (1) from the Office of the Superintendence of Public Health, and six (6) from Suppliers of medicines in Malta. The common justification they have stated involved the unavailability of the medicinal product or alternatives of the concerned medicine in the Maltese market. The reason for the unavailability is due to a number of reasons such as shortage due to increase in demand, temporarily unavailable from the manufacturer, unprecedented emergency that affect the access to the medicine. Another shared justification from the respondent’s is the interest of public health. In Part II, information gathered from the discourse with the different agencies was used to systematically lay out the current procedure. The systematic proceeding presented a operating procedure that allowed a better understanding on the roles and responsibilities of the stakeholders.

The stakeholders share in their conviction a great value of Article 20 of the Medicines Act. The stakeholders gave reasons that share the commonality of “public interests” particularly urgency in the need for the medicine and the specific need of patients for these medicines. The respondents have cited these two reason as the main motive as to why the procurement sector stakeholders have used the Article 20 marketing authorization route rather than the other marketing authorization routes. The analysis made through the data provided by the stakeholders it is indicative that the use of Article 20 of the Medicines Act of 2003 is justified and used as per the standard operating procedure.