Exceptional Medicinal Treatment
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Exceptional Medicinal Treatment

The Exceptional Medicinal Treatment (EMT) Unit is responsible for processing requests for exceptional medicinal treatment, which is defined as a medicinal treatment which is not covered by an existing policy on the Government Formulary List.

In brief, an EMT Request Form​ endorsed by a medical consultant is submitted for an individual patient. The request is reviewed by the pharmacists within the EMT unit and a technical case report is presented to the Exceptional Medicinal Treatment Committee (EMTC). The EMTC was set up in line with the L.N. 58 of 2018: Health Act (Cap. 528): Exceptional Medicinal Treatment Committee Regulations, with the objective of evaluating the submitted applications and decide whether an EMT request should be approved or rejected as per Exceptional Medicinal Treatment Policy​.

 The EMT unit finally co-ordinates the supply of approved items with the Central Procurement and Supplied Unit (CPSU) and Pharmacy of your Choice (POYC) scheme by providing the necessary information to:

        I.   ​ Initiate the procurement process and, once stock availability is confirmed for a particular patient,

       II.   Ensure the necessary entitlement documents are in place for the medication to be collected. 

The process is illustrated here.​

Frequently Asked Questions      

  • ​Who can apply for exceptional medicinal treatment? 
EMT applications need to be submitted to the Directorate for Pharmaceutical Affairs (DPA) by a medical consultant.  
I. In case of an application for a drug/indication which has never been approved in the past, counter endorsement by the respective clinical chair is also required.

II. EMT which has previously been approved through the EMTC for the same requested indication, also require counter endorsement by the respective clinical chair, however the clinical chair can delegate authority to endorse requests to respective lead clinicians.

 III. No counter-endorsement is required for renewal or change in dose of previously approved treatment.

IV. A critical request is defined as a submission for medicinal treatment which, if not administered immediately, can result in life-threatening consequences for the patient and thus needs to be initiated with immediate effect. In this scenario, the medical doctor can endorse the request on behalf of the clinical chair/lead clinician/consultant in order for an emergency supply to be provided until the next working day of the respective department, after which the normal submission procedures are to be carried out.

  • Which forms needs to be submitted in order for an EMT request to be evaluated?
An EMT request form is required both for new requests and renewal of previously approved treatment. Information submitted on the form needs to be fully legible and contain all relevant information as to enable the compilation of a holistic review of the requested drug for the specific indication.
An ADR report needs to be submitted together with the EMT form in case of requests for specifically branded medicines.
  • How is the EMT request form submitted?
​Applications for new treatments, any renewals or change in dose can only be processed if submitted electronically via email address: dpa.emt@gov.mt.  No hard copies will be accepted.

  • How long do EMT requests take to be processed?
​The EMTC generally convenes every 4 weeks in order to discuss submitted EMT and make the necessary approvals or rejections. In some cases, further information is requested from the consultant which would then need to be resubmitted to the EMTC.

Urgent requests, which are defined as an EMT request which needs to be assessed before the next scheduled EMTC meeting, are generally submitted to the EMTC within the first working day following submission of application to DPA.

  • Is EMT stock readily available?
​No. Approvals for non-formulary items are procured on a named-patient basis. This means that stocks for each approved patient is bought separately as per dose and quantity specified on the EMT form.  Hence, before a new patient is started on treatment adequate stocks needs to be ensured so that treatment of previously approved patients is not compromised. Once stock availability is confirmed through CPSU, POYC are notified to issue out-patient entitlement documents.

Renewals of exceptionally approved medicines should be made at least 2 months in advance of their expiry in order to allow adequate time for processing and for additional stock to be purchased.  Any increase in dose requires DPA approval before being implemented.

  • Is the EMTC decision final?
​Decisions taken by the EMTC are final unless there is new evidence which was not previously available or considered. In such cases, the request can be re-submitted for re-consideration by the consultant through the EMT unit.