Motor Vehicles (Driving Licences) (Amendment) Regulations, 2018

L.N. 16 of 2018

TRAFFIC REGULATION ORDINANCE

(CAP. 65)

AUTHORITY FOR TRANSPORT IN MALTA ACT

(CAP. 499)

Motor Vehicles (Driving Licences) (Amendment) Regulations, 2018

IN EXERCISE of the powers conferred by article 54 of the

Traffic Regulation Ordinance and by article 43 of the Authority for

Transport in Malta Act, the Minister responsible for Transport,

Infrastructure and Capital Projects, after consultation with the

Authority for Transport in Malta, has made the following regulations:-

The title of these regulations is the Motor Vehicles (Driving

Licences) (Amendment) Regulations, 2018 and these regulations shall

be read and construed as one with the Motor Vehicles (Driving

Licences) Regulations, hereinafter referred to as "the principal

regulations".

Regulation 2 of the principal regulations shall be

renumbered in it’s entirety as regulation 2(1) and immediately

thereafter there shall be added the following new sub-regulation

"(2) These regulations transpose the following

(a) Directive 2002/24/EC of the European

Parliament and of the Council relating to the type approval

of two or three-wheel motor vehicles;

(b) Directive 2006/126/EC of the European

Parliament and the Council on driving licences as amended

by Commission Directive 2009/113/EC of 25 August,

2009;

(c) Commission Directive 2011/94/EU of 28

November, 2011 of 25 August 2009 amending Directive

2006/126/EC of the European Parliament and of the

Council on driving licences;

(d) Commission Directive 2012/36/EU of 19

November, 2012, of 19 November 2012 amending

Directive 2006/126/EC of the European Parliament and of

the Council on driving licences;

(e) Council Directive 2013/22/EU, of 13 May 2013

adapting certain directives in the field of transport policy,

by reason of the accession of the Republic of Croatia;

(f) Commission Directive 2013/47/EU of 2

October, 2013, of 2 October 2013 amending Directive

2006/126/EC of the European Parliament and of the

Council on driving licences;

(g) Commission Directive 2014/85/EU of 1 July,

2014 of 1 July 2014 amending Directive 2006/126/EC of

the European Parliament and of the Council on driving

licences;

(h) Commission Directive (EU) 2015/653 of 24

April, 2015 amending Directive 2006/126/EC of the

European Parliament and of the Council on driving

licences; and

(i) Commission Directive (EU) 2016/1106 of 7

July 2016 amending Directive 2006/126/EC of the

European Parliament and of the Council on driving

licences.".

The Eighth Schedule to the principal regulations shall be Amends the

Eighth Schedule

amended as follows

to the principal

regulations.

(a) item 5 thereof, under the heading ‘Cardiovascular

Diseases’, shall be substituted by the following

"Cardiovascular conditions or diseases can lead to a sudden

impairment of the cerebral functions that constitutes a danger to

road safety. These conditions represent grounds for establishing

temporary or permanent restrictions to driving.

1 For the following cardiovascular conditions, driving

licences may be issued or renewed for applicants or drivers in the

indicated groups, only after the condition has been effectively

treated and subject to competent medical authorisation and if

appropriate, regular medical assessment

(a)

Group 1

(i) brady-arrhythmias (sinus node disease and

conduction

disturbances)

and

tachy-arrhythmias

(supraventricular and ventricular arrhythmias) with history

of syncope or syncopal episodes due to arrhythmic

conditions;

(ii) tachy-arrhythmias

(supraventricular

and

ventricular arrhythmias) with structural heart disease and

sustained ventricular tachycardia (VT);

(iii) symptomatic of angina;

(iv) defibrillator implantation or replacement or

appropriate or inappropriate defibrillator shock;

(v) syncope (a transient loss of consciousness and

postural tone, characterised by rapid onset, short duration,

and spontaneous recovery, due to global cerebral

hypoperfusion, of presumed reflex origin, of unknown

cause, with no evidence of underlying heart disease);

(vi) acute coronary syndrome;

(vii) stable angina if symptoms do not occur with

mild exercise;

(viii) percutaneous coronary intervention (PCI);

(ix) coronary artery bypass graft surgery (CABG);

(x)

stroke/transient ischemic attack (TIA);

(xi) heart failure: New York Heart Association

(NYHA) I, II, III;

(xii) heart transplantation;

(xiii) cardiac assist device;

(xiv) valvular heart surgery;

(xv) malignant hypertension (elevation in systolic

blood pressure ≥ 180 mmHg or diastolic blood pressure ≥

110 mmHg associated with impending or progressive organ

damage);

(xvi) congenital heart disease;

(xvii) hypertrophic

cardiomyopathy

if

without

syncope;

(xviii) long QT syndrome with syncope, Torsade des

Pointes or QTc > 500 ms.

(b)

Group 2

(i) brady-arrhythmias (sinus node disease and

conduction

disturbances)

and

tachy-arrhythmias

(supraventricular and ventricular arrhythmias) with history

of syncope or syncopal episodes due to arrhythmic

conditions;

(ii) brady-arrhythmias: sinus node disease and

conduction

disturbances

with

second

degree

atrioventricular (AV) block Mobitz II, third degree AV

block or alternating bundle branch block;

(iii) tachy-arrhythmias

(supraventricular

and

ventricular arrhythmias) with structural heart disease and

sustained ventricular tachycardia (VT) or polymorphic

nonsustained (VT), sustained ventricular tachycardia or

with an indication for a defibrillator;

(iv)

symptomatic of angina;

(v) permanent

pacemaker

implantation

or

replacement;

(vi) syncope (a transient loss of consciousness and

postural tone, characterised by rapid onset, short duration,

and spontaneous recovery, due to global cerebral

hypoperfusion, of presumed reflex origin, of unknown

cause, with no evidence of underlying heart disease);

(vii) acute coronary syndrome;

(viii) stable angina if symptoms do not occur with

mild exercise;

(ix) percutaneous coronary intervention (PCI);

(x)

coronary artery bypass graft surgery (CABG);

(xi) stroke/transient ischemic attack (TIA);

(xii) significant carotid artery stenosis;

(xiii) maximum aortic diameter exceeding 5.5 cm;

(xiv) heart failure: NYHA I and II provided that the

left ventricular ejection fraction is at least 35%;

(xv) heart transplantation;

(xvi) valvular heart surgery;

(xvii) malignant hypertension (elevation in systolic

blood pressure ≥ 180 mmHg or diastolic blood pressure ≥

110 mmHg associated with impending or progressive organ

damage);

(xviii) grade III blood pressure (diastolic blood

pressure ≥ 110 mmHg and/or systolic blood pressure ≥ 180

mmHg) (applies to group 2 only);

(xix) congenital heart disease.

5.2 For the following cardiovascular conditions, driving

licences shall not be issued or renewed in the indicated groups

(a)

Group 1

(i) peripheral vascular disease — thoracic and

abdominal aortic aneurysm when maximum aortic diameter

is such that it predisposes to a significant risk of sudden

rupture and hence a sudden disabling event;

(ii)

heart failure: NYHA IV;

(iii) valvular heart disease with aortic regurgitation,

aortic stenosis, mitral regurgitation or mitral stenosis if

functional ability is estimated to be NYHA IV or if there

have been syncopal episodes;

(iv) Brugada syndrome with syncope or aborted

sudden cardiac death.

(b)

Group 2

(i)

implant of a defibrillator;

(ii) peripheral vascular disease — thoracic and

abdominal aortic aneurysm when maximum aortic diameter

is such that it predisposes to a significant risk of sudden

rupture and hence a sudden disabling event;

(iii) heart failure: NYHA III and IV;

(iv) cardiac assist devices;

(v) valvular heart disease in NYHA III or IV or

with ejection fraction (EF) below 35%, mitral stenosis and

severe pulmonary hypertension or with severe

echocardiographic aortic stenosis or aortic stenosis causing

syncope; except for completely asymptomatic severe aortic

stenosis if the exercise tolerance test requirements are

fulfilled;

(vi) structural and electrical cardiomyopathies —

hypertrophic cardiomyopathy with history of syncope or

when two or more of the following conditions present: left

ventricle (LV) wall thickness > 3 cm, non-sustained

ventricular tachycardia, a family history of sudden death

(in a first degree relative), no increase of blood pressure

with exercise;

(vii) long QT syndrome with syncope, Torsade des

Pointes and QTc > 500 ms;

(viii) Brugada syndrome with syncope or aborted

sudden cardiac death.

Driving licences may be issued or renewed in

exceptional cases, provided that it is duly justified by

competent medical opinion and subject to regular medical

assessment ensuring that the person is still capable of

driving the vehicle safely taking into account the effects of

the medical condition.

Other cardiomyopathies

5.3 The risk of sudden incapacitating events shall be

evaluated in applicants or drivers with well described

cardiomyopathies (for example arrhythmogenic right ventricular

cardiomyopathy,

non-compaction

cardiomyopathy,

catecholaminergic polymorphic ventricular tachycardia and short

QT syndrome) or with new cardiomyopathies that may be

discovered. A careful specialist evaluation is required. The

prognostic features of the particular cardiomyopathy shall be

considered.

5.4 The Authority shall have the right to restrict the issue

or renewal of driving licences for applicants or drivers with other

cardiovascular diseases."; and

(b) paragraph (ii) of Group 1 of item 6 thereof, under the

heading "Diabetes Mellitus", shall be substituted by the

following

"(ii) An applicant or driver with diabetes treated

with medication which carries a risk of inducing

hypoglycaemia shall demonstrate an understanding of the

risk of hypoglycaemia and adequate control of the

condition. Driving licences shall not be issued to, or

renewed for, applicants or drivers who have inadequate

awareness of hypoglycaemia. Driving licences shall not be

issued to, or renewed for, applicants or drivers who have

recurrent severe hypoglycaemia, unless supported by

competent medical opinion and regular medical

assessment. For recurrent severe hypoglycaemias during

waking hours a licence shall not be issued or renewed until

3 months after the most recent episode. Driving licences

may be issued or renewed in exceptional cases, provided

that it is duly justified by competent medical opinion and

subject to regular medical assessment, ensuring that the

person is still capable of driving the vehicle safely taking

into account the effects of the medical condition.".

€0.63