EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE [ S.L.528.08 SUBSIDIARY LEGISLATION 528.08 EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE REGULATIONS 23rd March, 2018 LEGAL NOTICE 58 of 2018, as amended by Legal Notice 448 of
- The title of these regulations is the Exceptional Medicinal Treatment Committee Regulations. Citation.
- requires:- Interpretations. In these regulations, unless the context otherwise "Committee" means the Exceptional Medical Treatment Committee; "Exceptional Medicinal Treatment" means medicinal treatment provided in cases of diseases when the medicinal treatment is not on the Government Formulary List or is not according to the Government Formulary List policies; "Fifth Schedule" means an entitlement to free medical aid to their medical condition as suffered and subject to these persons satisfying the means test provisions as laid down in Part II of the said Schedule of the Social Security Act; "Government Formulary List" means a list of medicinal treatments available within the national health service as defined in the Availability of Medicinal Products within Government Health Services Regulations; Cap.
- S.L.458.
- "Minister" means the person responsible for the Ministry for Health; "Rare Disease" means any disease or medical condition or disorder that effects less than one per two thousand persons. 3.
(1)There shall be a Committee to be known as the Exceptional Medicinal Treatment Committee.
(2)The Committee shall assess requests for exceptional medicinal treatment in cases where such treatment is: (
- a)not listed on the Government Formulary List; (
- b)medicines are listed on the Government Formulary List but not according to protocol, indication or prescribed criteria; Exceptional Medicinal Treatment Committee. 1 2 [ S.L.528.08 Appointment of Committee. EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE (
- c)specifically branded medicines; (
- d)medicines for the treatment of Rare Diseases. 4.
(1)The Minister shall appoint the Committee which shall be composed of: (
- a)a Chairperson; (
- b)Chief Medical Officer or a representative of the Department of Policy in Health; (
- c)two Pharmacists one of which is from the Directorate for Pharmaceutical Affairs; (
- d)two Clinicians; (
- e)a representative of the Central Procurement and Supplies Unit within the Ministry for Health; (
- f)a Patient Representative.
(2)A secretary to the Board shall be appointed by the Minister who shall be a member of the public service.
(3)The Committee shall provide for any matter or procedure it may deem necessary for the better implementation of the functions of the Committee.
(4)The Committee shall be provided with an annual budget and moreover shall submit an annual financial report to the Permanent Secretary within the Ministry for Health supporting the decisions taken by the Committee. Duties of the Committee. Substituted by: L.N.448 of 2018. 5.
(1)The Committee shall receive applications for exceptional medicinal treatment from the Directorate for Pharmaceutical Affairs through an application in the form prescribed by the Chief Medical Officer.
(2)Applications for exceptional medicinal treatment: (
- a)which have not been previously approved for the requested indication, shall be submitted to the Directorate for Pharmaceutical Affairs by a Consultant in the medical class and endorsed by the respective Clinical Chair; (
- b)which have previously been approved for the same requested indication, shall be submitted to the Directorate for Pharmaceutical Affairs by a Consultant in the medical class and endorsed by the EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE [ S.L.528.08 3 respective Clinical Chair. The Clinical Chair can delegate authority to endorse these requests to the Lead Clinician; (
- c)for renewals or for a change in dose of an approved exceptional medicinal treatment, shall be submitted to the Directorate for Pharmaceutical Affairs by a Consultant in the medical class.
(3)The Directorate for Pharmaceutical Affairs will from their part file the submission and assessment to the Exceptional Medicinal Treatment Committee for appraisal.
(4)The applications submitted to the Committee shall be evaluated according to rules established by the Chief Medical Officer from time to time. 6.
(1)Urgent Cases shall be assessed by the Chairperson in consultation with at least one of the clinicians sitting on the Committee as well as one pharmacist sitting on the Committee. The Directorate for Pharmaceutical Affairs shall determine which treatment is deemed to be urgent thus requiring an urgent decision.
(2)The Committee may adopt and publish any necessary procedure to process urgent and critical submissions. Amended by: L.N. 448 of 2018.