Exceptional Medicinal Treatment Committee Regulations, 2018

L.N. 58 of 2018

HEALTH ACT

(CAP. 528)

Exceptional Medicinal Treatment Committee Regulations, 2018

IN EXERCISE of the powers conferred by article 30 of the

Health Act, the Minister responsible for Health, has made the

following regulations:-

(1) The title of these regulations is the Exceptional

Medicinal Treatment Committee Regulations, 2018.

(2) These regulations shall come into effect on such date as the

Minister for Health may by notice in the Gazette appoint.

In these regulations, unless the context otherwise requires:-

"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;

"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.

(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;

(c)

specifically branded medicines;

(d)

medicines for the treatment of Rare Diseases.

(1) The Minister shall appoint the Committee which shall Appointment of

Committee.

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.

The Exceptional Medicinal Treatment Committee shall

Duties of the

Committee.

(a) receive applications for Exceptional Medicinal

Treatment from the Directorate for Pharmaceutical Affairs;

(b) the applications shall be submitted to the Directorate

for Pharmaceutical Affairs by a Medical Consultant and

endorsed by the respective clinical chair of the respective

Department at Mater Dei Hospital, through an application in the

form prescribed by the Chief Medical Officer;

(c) the application shall be received by the Directorate

for Pharmaceutical Affairs who will from their part file the

submission and assessment to the Exceptional Medicinal

Treatment Committee for appraisal;

(d) the applications submitted to the Exceptional

Medicinal Treatment Committee shall be evaluated according to

rules established by the Chief Medical Officer from time to time.

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.

€0.27