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NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

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Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE

SUBSIDIARY LEGISLATION 465.74

NATIONAL ANTIMICROBIAL RESISTANCE

COMMITTEE REGULATIONS

12th May, 2023

LEGAL NOTICE 105 of 2023.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

The title of these regulations is

the

National

Antimicrobial Resistance Committee Regulations.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

In these regulations, unless the context otherwise

requires

"Act" means the Public Health Act;

"antimicrobial resistance" means when bacteria, viruses,

fungi and parasites change over time and no longer respond to

medicines, making infections harder to treat and increasing the

risk of disease spread, severe illness and death. As a result of

drug resistance, antibiotics and other antimicrobial medicines

become ineffective and infections become increasingly difficult

or impossible to treat;

"AMR" means antimicrobial resistance;

"Committee" means the National Antimicrobial

Resistance Committee established by regulation 3.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

There shall be established a committee that shall be

known as the National Antimicrobial Resistance Committee.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

(1)

The Committee shall be appointed by the

Superintendent of Public Health and shall be composed as follows

(a)

a chairperson;

(b)

a representative of the Chief Medical Officer;

(c)

a representative of the Chief Veterinary Officer;

(d)

a representative from agriculture;

(e)

a specialist in Microbiology and, or Bacteriology;

(f)

a specialist in Public Health Medicine;

(g)

an environmental health practitioner;

(h)

a specialist in Infectious Diseases Medicine;

(i)

two (2) specialists in Family Medicine - one in

NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE

public and another in private employment;

(j)

two (2) pharmacists - one in public and another in

private employment;

(k)

two (2) veterinary surgeons - one in public and

another in private employment;

(l)

a nurse actively involved in infection prevention

and control within a hospital setting; and

(m)

a member from the general public.

(2)

There shall be a secretary to the Committee who shall be

appointed by the Superintendent of Public Health.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

The Committee shall serve as the national Intersectoral

Coordinating Mechanism for the coordination of the implementation of

the Strategy and Action Plan for the Prevention and Containment of

Antimicrobial Resistance in Malta through a OneHealth approach.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

It shall be the duty of the Committee to

(a)

advise the Superintendent of Public Health on

measures necessary to minimise antimicrobial resistance;

(b)

develop and update the Strategy and Action Plan

on Antimicrobial Resistance in Malta through a OneHealth

approach;

(c)

coordinate strategies to ensure continued

effectiveness of antimicrobial agents used in the treatment and

prevention of infectious diseases in humans and animals;

(d)

monitor the implementation of the National

Strategy and Action Plan on Antimicrobial Resistance through a

OneHealth approach and advise on implementation actions

where necessary;

(e)

promote effective infection prevention and control

programmes within healthcare institutions;

(f)

ensure that the impact on safety and quality of care

is considered in all decisions;

(g)

develop and recommend strategies to comply with

EU legislation as well as draw up and disseminate guidelines

and standards on appropriate antimicrobial use, optimal dosing,

administration and monitoring in line with accepted best

practice so as to guide antimicrobial therapy as well as infection

prevention and control;

NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE

(h)

promote effective education on antimicrobial

resistance, prudent use of antimicrobial agents and antibiotic

stewardship, as well as infection prevention, to professionals in

human health, animal health and the general public;

(i)

tender all such advice as may be requested by the

Superintendent of Public Health.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

(1)

The Committee shall coordinate the establishment

of surveillance systems to analyse trends in antimicrobial resistance

and antimicrobial utilisation using data in human and animal health, as

well as analysing healthcare associated infections caused by resistant

micro-organisms or otherwise.

(2)

By virtue of the powers conferred by article 8 of the Act,

the Committee shall act as an authorised body and collect, from any

relevant entity, appropriate information concerning antimicrobial

resistance, data on the consumption, distribution and dispensing of

antimicrobial agents used in the treatment and prevention of infections

in humans and animals, as well as incidence of healthcare associated

infections and the processes needed for their prevention.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

The Committee shall regulate its own procedure.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

(1)

The Committee shall aim to have the widest

possible representation.

(2) The Committee shall establish working groups on key

areas covered by the National Strategy and Action Plan on

Antimicrobial Resistance.

(3)

Members of working groups shall be co-opted by the

chairperson of the Committee, after consultation with the

Superintendent of Public Health.

(4)

Every working group shall be chaired by a Committee

member.

Laws of Malta — Subsidiary Legislation 465.74 — NATIONAL ANTIMICROBIAL RESISTANCE COMMITTEE REGULATIONS

(1)

The Committee shall provide the Superintendent

of Public Health with an annual report of its activities as well as

regular updates on progress achieved and milestones reached, in the

implementation of the national Antimicrobial Resistance Strategy and

Action Plan.

(2)

The Committee shall also prepare and disseminate a

national AMR report for Malta on a minimum biennial frequency. The

report shall include all relevant data that is critical to follow the impact

of the implementation of the national AMR strategy and achievement

of targets within the action plan.

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