EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE REGULATIONS

EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE

SUBSIDIARY LEGISLATION 528.08

EXCEPTIONAL MEDICINAL TREATMENT

COMMITTEE REGULATIONS

23rd March, 2018

LEGAL NOTICE 58 of 2018, as amended by Legal Notice 448 of

2018.

The title of these regulations is the Exceptional

Medicinal Treatment Committee Regulations.

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;

EXCEPTIONAL MEDICINAL TREATMENT COMMITTEE

(c)

specifically branded medicines;

(d)

medicines for the treatment of Rare Diseases.

(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.

(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

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.

(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.