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Medicines Act (Cap. 458) Availability Of Medicinal Products Within The Government Health Services Regulations, 2009 (Ln 58 Of 2009 )

VERŻJONI ELETTRONIKA

B 877

IN exercise of the powers conferred by article 106 (d) of the Medicines Act, the Minister for Social Policy has made the following regulations:-

Products within the Government Health Services Regulations,
2009.

(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.

(a) a chairperson;

Title.

Scope.

Responsibilities.

The Committee.

B 878 VERŻJONI ELETTRONIKA
(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.

(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.

(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.

B 879

The Government

Formulary List.

Application.

Decision not to include.

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(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.

Decision to exclude specific medicinal products.

Decision to exclude a category of medicinal products.

Appeals from decisions.

(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.

(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.

(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.
B 881

Price increase.

B 882 VERŻJONI ELETTRONIKA
(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.

Statement of reasons.

Price renegotiation.

Price freeze.

(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.

(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.

B 883

Superintendent of Public Health may apply controls.

Revokes L.N. 165 of

2007.

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B 888 VERŻJONI ELETTRONIKA

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 889

Signature of Applicant

Name in BLOCK LETTERS

Date

Signature of Nominee

Name in BLOCK LETTERS

Date

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

B 890 VERŻJONI ELETTRONIKA

Regulation 7 (a)

• 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

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B 894 VERŻJONI ELETTRONIKA

• Other

List any information about the product which is being attached:

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 895

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 896 VERŻJONI ELETTRONIKA

Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper <.. image removed ..>

Prezz/Price

€1.86