AVAILABILITY OF MEDICINAL PRODUCTS WITHIN THE GOVERNMENT HEALTH SERVICES REGULATIONS

SUBSIDIARY LEGISLATION 458.31

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

REGULATIONS

6th March, 2009

LEGAL NOTICE 58 of 2009.

The title of these regulations is the Availability of

Medicinal Products within the Government Health Services

Regulations.

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

2.4

Strength

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

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

3.3

Date of issue of Authorisation

Expiry Date of Authorisation

4. Costing

Estimated Unit Cost

Euro

.

Include any further information on specific conditons and incentives

Total Cost per Patient (Annually or per Treatment Course)

Euro

.

(Please explain how this figure was reached)

The estimated number of patients who would require the medicinal product

(state how this information was derived).

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

mandatory and the Superintendent of Public Health reserves the right to

perform his evaluation)

mecicinal product (the Superintendent of Public Health reserves the right to

perform his evaluation)

5. Further Information regarding the Medicinal Product

Reasons for requesting the medicinal product to be considered for coverage

by the Government Formulary List

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

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.

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

communicate/sign on his behalf or

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 ......../............/............

(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 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

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

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.

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

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

Name of Marketing Authorisation Holder

Address

Telephone number

2. Costing

Present Price of Unit Cost to Government

Euro

Include any further information on specific conditions and incentives

Total Cost per Patient (Annually or per Treatment Course) Euro

(Please explain how this figure was reached)

The estimated number of patients who would require the medicinal product

(state how this information was derived).

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

mandatory and the Superintendent of Public Health reserves the right to

perform his evaluation)

mecicinal product (the Superintendent of Public Health reserves the right to

perform his evaluation)

3. Reasons for requesting price increase of the Medicinal Product

Reasons for requesting price increase of the medicinal product included in

the Government Formulary List

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

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.

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 ......................................

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES

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 ......../............/............

(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-regulation (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 one hundred and eightydays 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, 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 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, the following

provisions shall apply if an increase in the price of a medicinal

product is permitted only after prior approval 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, by the holder of a

marketing authorization to increase the price of a medicinal

product and that this is communicated to the applicant within

ninety 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 ninety 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 sixty 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

ninety days from date of request referred to in sub-regulation (2)

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 ninety 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 ninety 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 ninety 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 sixty

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.

AVAILABILITY OF MEDICINAL PRODUCTS

WITHIN THE GOVERNMENT HEALTH SERVICES