Health Services Regulations, 2009

L.N. 58 of 2009

MEDICINES ACT

(CAP. 458)

Availability of Medicinal Products within the Government

Health Services Regulations, 2009

IN exercise of the powers conferred by article 106 (d) of the

Medicines Act, the Minister for Social Policy has made the following

regulations:-

The title of these regulations is the Availability of Medicinal

Products within the Government Health Services Regulations,

2009.

Regulation 6 (1)

Ref. No. __________________

Form T01

Application to the Superintendent of Public Health for the consideration of a

medicinal product to be covered by the Government Formulary List as per the

Government Health Services (Medicinal Products) Regulations, 2009.

This application is to be filled in clearly and completely, otherwise it will be returned and

will not be considered. The time lines for the decision specified in the legislation apply

once the application is validated and accepted.

1. Details of Applicant

1.1

Name of Marketing Authorisation Holder

1.2

Address

1.3

Telephone number

2. Details of Medicinal Product

2.1

Product Name

2.2

Active Ingredient

2.3

Pharmaceutical form

B

2.4

Strength

2.5

Method and Route of Administration

2.6

Proposed pack size/s to be placed on the Government Formulary List

2.7

Indications for which the product is being requested [indications should be covered by locally

approved Summary of Product Characteristics (SPC)].

2.8

Posology / Dosage regimen (as covered by SPC)

2.9

Duration of treatment course (where applicable)

2.10

Pharmacotherapeutic Group

ATC Code ____________________

Pharmacotherapeutic Group ____________________

3. Authorisation Status

3.1

Authorisation of the medicinal product in Malta (tick where applicable)

3.1.1

Authorisation in accordance with procedures laid down in Regulation (EC) No 726/2004 of the European

Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation

and supervision of medicinal products for human and veterinary use and establishing a European Medicines

Agency, as amended.



3.1.2

National Marketing Authorisation [also includes products approved through the Mutual Recognition

Procedure (MRP) and the Decentralised Procedure (DCP)]

3.2

Authorisation Number

B

3.3

Date of issue of Authorisation

3.4

Expiry Date of Authorisation

4. Costing

Euro

.

4.1

Proposed Unit Cost to Governmentt

Include any further information on specific conditions and incentives

Euro

.

4.2

Total Cost per Patient (Annually or per Treatment Course)

(Please explain how this figure was reached)

4.3

The estimated number of patients who would require the medicinal product

(state how this

information was derived).

4.4

Pharmaco-economic evaluation of the medicinal product (this is not mandatory and the

Superintendent of Public Health reserves the right to perform his evaluation)

4.5

Superintendent of Public Health reserves the right to perform his evaluation)

B

5. Further Information regarding the Medicinal Product

Reasons for requesting the medicinal product to be considered for coverage by the Government

Formulary List

Comparison of this medicinal product to similar or alternative medicinal products or other

treatments available on the market

Comparison of this medicinal product to other medicines on the Government Formulary List in

terms of

Innovation

Therapeutic effectiveness/improvement

Cost and economic evaluation

Cost-effectiveness

Safety

Efficacy

Impact on quality of life

Availability and versatility of medicinal product

Other

List any information about the product which is being attached

Approved SPC

Authenticated copy of Marketing Authorisation

Literature to substantiate any information given

B

I, hereby confirm

i)That to the best of my knowledge and belief, all the particulars I have given in this

application form and all the documentation submitted, are correct and complete.

ii)I am fully aware that the list of medicines available within the Government Health

Services is by ATC classification and that the medicinal product will be considered

by its active ingredient and not as a proprietary/branded product.

iii)I am aware of the criteria that apply through the legislation (Social Security Act, Cap.

318, article 23; Availability of Medicinal Products within the Government Health

Services Regulations, 2009).

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

In the case where the applicant, for the purpose of this application, would like to

nominate a person authorised to

a) communicate/sign on his behalf or

b) act fully on his behalf,

there shall be provided details of the nominee and the type of authorisation available..

B

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

Signature of Nominee

Name in BLOCK LETTERS

Date _______________________

For office use only: Application received on ___/___/___

B

(1) The primary objective of these regulations is the

promotion of public health by ensuring the availability of adequate

supplies of medicinal products at a reasonable cost in Government

Health Services.

(2) These regulations shall apply where the holder of a

marketing authorisation, hereinafter referred to as “the applicant”,

wishes to apply for the inclusion of a medicinal product on the list

of medicinal products covered by the Government Health Services,

hereinafter referred to as “The Government Formulary List”.

(3) These regulations shall be without any prejudice to

the power of the Superintendent of Public Health to

(a) include any medicinal product in the Government

Formulary List;

(b) apply pricing measures to any pending and new

applications for the introduction of medicinal products.

Regulation 7 (a)

The Criteria which are taken into account by the Superintendent of Public Health,

the Committee and any experts with which they consult in deciding whether or not

to include a medicinal product on the Government Formulary List

The registration status of the medicinal product in Malta.

Entitlement to free medicines shall be as specified in the Social Security Act, Cap.

318, article 23 and the Fifth Schedule Part II to the same Act regarding Diseases and

Conditions in respect of which Free Medical Aid may be accorded, as well as

medicinal products required for the provision of care within Government Institutions.

A medicinal product or a category of medicinal products to treat conditions which fall

outside the scope of the Government Health Services may be entirely excluded from

the Government Formulary List.

Diagnostic and other requirements for the prescription, use and monitoring of the

medicinal product particularly if additional costs are incurred. The possibility for

monitoring the use of the medicinal product and the outcome of treatment. The fact

that patients were started on treatment or were part of a clinical trial does not affect

the decision for inclusion of a medicinal product on the Government Formulary List.

The value, extent and relevance of the information and evidence available about the

medicinal product particularly in terms of innovation, therapeutic effectiveness and

improvement, safety, efficacy, impact on quality of life, availability and versatility of

medicinal product, cost-effectiveness, comparison to other available medicines and

other treatment modalities.

Cost and economic evaluation such as the conditions for the supply, prescription, use

and monitoring of the medicinal product, affordability by the national health services

and the social and epidemiological impact shall be taken into account in determining

the coverage of a medicinal product by the Government Health Services

The Superintendent of Public Health, the Committee and any experts with which

they consult in deciding whether or not to include a medicinal product on the

Government Formulary List reserve the right to take into account other criteria as

they may deem necessary.

B

The Superintendent of Public Health shall be responsible

for the implementation of these regulations and shall be assisted by

the Government Formulary List Advisory Committee, hereinafter

referred to as “the Committee”.

Regulation 11 (2)

Ref. No. __________________

Form T02

Application to the Superintendent of Public Health for the consideration of a price

increase for a medicinal product included on the Government Formulary List as per

the Government Health Services (Medicinal Products) Regulations, 2009.

This application is to be filled in clearly and completely, otherwise it will be returned and

will not be considered. The time lines for the decision specified in the legislation apply

once the application is validated and accepted.

1. Details of Applicant

1.1

Name of Marketing Authorisation Holder

1.2

Address

1.3

Telephone number

2. Costing

Euro

.

2.1

Present Price of Unit Cost to Government

Include any further information on specific conditions and incentives

Euro

.

2.2

Total Cost per Patient (Annually or per Treatment Course)

(Please explain how this figure was reached)

B

2.3

The estimated number of patients who would require the medicinal product

(state how this

information was derived).

2.4

Pharmaco-economic evaluation of the medicinal product (this is not mandatory and the

Superintendent of Public Health reserves the right to perform his evaluation)

2.5

Superintendent of Public Health reserves the right to perform his evaluation)

3. Reasons for requesting price increase of the Medicinal Product

B

Reasons for requesting price increase of the medicinal product included in the Government

Formulary List

Comparison of this medicinal product to similar or alternative medicinal products or other

treatments available on the market

Comparison of this medicinal product to other medicines on the Government Formulary List in

terms of

Innovation

Therapeutic effectiveness/improvement

Cost and economic evaluation

Cost-effectiveness

Safety

Efficacy

Impact on quality of life

Availability and versatility of medicinal product

Other

List any information about the product which is being attached

Approved SPC

Authenticated copy of Marketing Authorisation

Literature to substantiate any information given

I, hereby confirm

That to the best of my knowledge and belief, all the particulars I have given in

this application form and all the documentation submitted, are correct and

complete.

I am fully aware that the list of medicines available within the Government Health

Services is by ATC classification and that the medicinal product will be

considered by its active ingredient and not as a proprietary/branded product.

I am aware of the criteria that apply through the legislation (Social Security Act,

Cap. 318, article 23; Availability of Medicinal Products within the Government

Health Services Regulations, 2009).

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

B

In the case where the applicant, for the purpose of this application, would like to

nominate a person authorised to

a)

communicate/sign on his behalf or

b)

act fully on his behalf,

there shall be provided details of the nominee and the type of authorisation available..

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

Signature of Nominee

Name in BLOCK LETTERS

Date _______________________

For office use only: Application received on ___/___/___

B

€1.86

(1) The Government Formulary List Advisory Committee

shall consist of

(a) a chairperson;

(b) two pharmacists who are also public officers;

(c) two clinicians from amongst the medical consultants

who are public officers;

(d) a patient representative;

(e) a legal advisor who is a public officer;

(f) two economic advisors.

(2) The Chairperson and the members of the

Committee

(a) shall be appointed by the Minister responsible for

health for a period of two years;

(b) may resign their office at any time by giving notice

in writing to the Minister.

(3) The Minister may at any time remove the Chairperson

and, or any of the members of the Committee appointed according

to sub-article (2), on grounds of disability to perform their functions,

bankruptcy or neglect of duty.

(4) The quorum necessary for meetings of the Committee

shall be the Chairperson and not less than half the other members

Provided that the Committee may act notwithstanding

any vacancy among its members.

(5) Before reaching a decision the Committee may

consult any experts it deems necessary.

(6) The decisions of the Committee shall be taken by a

majority of votes of members present at the meeting. The Chairperson

shall have an original vote and, in the case of equality of votes, also

a second or casting vote.

(7) The Superintendent of Public Health, the members

of the Committee and any experts shall declare their interest, and

the Minister shall have the right to refuse any committee members

or experts on the basis of conflict of interest.

(1) The Government Formulary List shall include a list

of medicinal products by the International Non-proprietary Name

(INN). The products in this list shall be classified according to the

Anatomical Therapeutic Chemical (ATC) classification.

(2) The Government Formulary List shall not include

proprietary names of products, unless in exceptional circumstances

where patient safety is compromised.

(3) The Government Formulary List shall include

conditions specific to coverage within the Government Health

Services in terms of entitlement to free medicines, supply within

the Government Health Services (primary and secondary care, use

in specific clinics or hospitals), prescriber criteria and use within

the Government Health Services (specific prescribers, conditions

for prescribing, protocols, therapeutic guidelines or clinical

guidelines).

(4) Products which are not classified as medicinal

products in terms of the definition of the Medicines Act may be

included on the Government Formulary List.

(1) An applicant may request that a medicinal product

be included in the Government Formulary List. In such cases the

applicant shall forward a separate application to the Superintendent

of Public Health in accordance with the requirements laid down

by the said Superintendent, as specified in the application form in

Schedule I to these regulations.

(2) Any decision on the inclusion of a medicinal product

on the Government Formulary List and the reference price to be

paid for such product by the Government Health Services shall be

taken through a single administrative procedure, which procedure

shall not exceed 180 days from date of application.

(3) The applicant shall furnish the Superintendent

of Public Health with adequate information. If the information

supporting the application is inadequate, the time limit set in the

preceding sub-paragraph shall be suspended and the applicant shall

be notified of such detailed information as may be required.

Any decision not to include a medicinal product in the

Government Formulary List shall be communicated to the applicant

and it shall contain

(a) a statement of reasons based upon the criteria in

Schedule II to these regulations, including, if appropriate, any

expert opinions or recommendations on which the decision is

based;

(b) information about the remedies available to the

applicant under the laws in force and of the time limits allowed

for applying such remedies.

(1) Any decision to exclude a medicinal product from

the Government Formulary List, shall contain a statement of reasons

based on objective and verifiable criteria. Such decision including,

if appropriate, any expert opinions or recommendations on which

the decisions are based, shall be communicated to the person who is

responsible therefore.

(2) Any such person as may be responsible shall also be

informed of the remedies available to him under the laws in force

and the time-limits allowed for applying such remedies.

Any decision to exclude a category of medicinal products

from the Government Formulary List shall contain a statement of

reasons based on objective and verifiable criteria and be published

in an appropriate publication to be determined by the Superintendent

of Public Health.

(1) Any decision made under regulations 7, 8 and 9

of these regulations may be appealed from before the Government

Formulary List Appeals Committee, hereinafter referred as “the

Appeals Committee”.

(2) The Appeals Committee shall be composed of the

following members, who shall not be public officers

(a) a Chairman nominated by the Minister responsible

for health from among legal practitioners;

(b)

a medical practitioner;

(c) a pharmacist.

(3) All members of the Appeals Committee shall be so

appointed for a term of three years and may be re-appointed for a

further term or terms.

(4) The Appeals Committee shall, upon an application

to that effect by the person concerned, meet to hear and decide upon

a decision reached by the Government Formulary List Advisory

Committee.

(5) An appeal to the Appeals Committee shall be filed

within the peremptory term of twenty days from such a decision .

(6) The Appeals Committee shall regulate its own

procedure and levy such fees as may be prescribed.

(7) In exercise of its function under this regulation, the

Appeals Committee may appoint experts to relate on any matter

before it.

(8) The decisions of the Appeals Committee shall be in

writing and shall be deemed final and conclusive and shall not be

subject to review by the ordinary courts of law except on points of

law.

(1) Without prejudice to regulation 14 of these

regulations, the following provisions shall apply if an increase in the

has been obtained from the Superintendent of Public Health acting

on the advice of the Committee.

(2) The Superintendent of Public Health shall ensure

that a decision is adopted on an application submitted, in accordance

with the requirements laid down under Schedule III to these

regulations, by the holder of a marketing authorization to increase

the price of a medicinal product and that this is communicated to the

applicant within 90 days of its receipt.

(3) The applicant shall furnish the Superintendent

of Public Health with adequate information, including details of

those events intervening since the price of the medicinal product

was last determined, which in his opinion justify the price increase

requested.

(4) If the information supporting the application is

inadequate, the Superintendent of Public Health shall forthwith

notify the applicant of what detailed additional information is

required and take their final decision within 90 days of receipt of

this additional information.

(5) In case of an exceptional number of applications,

the period may be extended once only for a further period of 60

days. The applicant shall be notified of such extension before the

expiry of the period.

(6) In the absence of such a decision within the

abovementioned period or periods, the applicant shall be entitled to

apply in full the requested price increase.

Should the Superintendent of Public Health decide not to

permit the whole or part of the price increase requested, the decision

shall contain a statement of reasons based on objective and verifiable

criteria and the applicant shall be informed of the remedies available

to him under the laws in force and the time limits allowed to apply

for such remedies.

(1) The Minister responsible for health may request that

the price being charged by the holder of the marketing authorization

be reviewed according to the exigencies of the Government Health

Services.

(2) The Minister responsible for health shall furnish the

holder of the marketing authorization with adequate information

which, in his opinion, justifies the review in the price being charged

to the Government Health Services.

(3) The holder of the marketing authorization shall

within 90 days from date of request referred to in sub-regulation

(2) hereof provide a reasoned decision to the request made by the

Minister responsible for health.

(1) In the event of a price freeze imposed on all

medicinal products or on certain categories of medicinal products

by the Minister responsible for finance in consultation with the

Minister responsible for health, the Minister responsible for finance

shall carry out a review, at least once a year, to ascertain whether

the macro-economic conditions justify that the freeze be continued

unchanged. Within 90 days of the start of this review, the Minister

responsible for finance shall announce what increases or decreases

in prices are being made, if any.

(2) In exceptional cases, a person who is the holder of

a marketing authorization for a medicinal product may apply for

a derogation from a price freeze if this is justified by particular

reasons. The application shall contain an adequate statement of

these reasons.

(3) The Superintendent of Public Health shall ensure

that a reasoned decision on any such application is adopted and

communicated to the applicant within 90 days. If the information

supporting the application is inadequate, the Superintendent of

Public Health shall forthwith notify the applicant of what detailed

additional information is required and take his final decision within

90 days of receipt of this additional information.

(4) Should the derogation be granted, the Superintendent

of Public Health shall forthwith publish an announcement in the

Gazette of the price increase allowed.

(5) Should there be an exceptional number of

applications, the period may be extended once only for a further

period of 60 days. The applicant shall be notified of such extension

before the expiry of the initial period.

Nothing in these regulations shall preclude the

Superintendent of Public Health from applying any controls and

conditions in the case of the procurement and supply of any medicinal

product that is covered by the Government Health Services.

The Availability of Medicinal Products within the

2007. Government Health Services Regulations, 2007 are hereby

revoked.

B