AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE MINIMUM HEALTH AND SAFETY REQUIREMENTS FOR IMPROVED MEDICAL TREATMENT ON BOARD VESSELS
Date: 1991-02-27
Institutions: European Commission
Subjects: crew, medical device, medicinal product, occupational health, vessel

COMMISSION OF THE EUROPEAN COMMUNITIES 

C0M(91)  65  f i n al 

-  SYN  278 

Brussels,  27  February  1991 

Amended  proposa I  for  a  Counc iI  D irect i va 
on  the  minimum  health  and  safety  requirements 
improved  medical  treatment  on  board  vessels 

for 

(presented by the Commission pursuant  to Article  149(3) 
of  die  liEC-Treaty) 

EXPLANATORY MEMORANDUM 

Proposal  for a Council Directive on the Minimum health and safety 

requirements for  improved medical treatment on board vessels. 

Following the opinion of the Parliament on a first reading, issued on 

25.1.1991, the Commission  is forwarding to the Council an amended 

proposal  for a directive pursuant to Article 149(3) of the EEC Treaty. 

The amended text mainly strengthens provisions  in three areas: 

Improvements have been made with regard to the types of medical 

supplies to be carried and Member States are now required to 

quant i fy such supplies.  Spec i f i c prov i s i ons have a I so been laid 

down governing arrangements for checking supplies. 

Provisions have been  introduced on equipping  life rafts and life 

boats with minimum medical  supplies.  Finally, for some categories 

of vessels, the amended proposal  requires a sick bay to be made 

available for medical  treatment and the presence of a doctor among 

the crew. 

New requirements have been  introduced on the management of medical 

supplies, and  in particular their renewal and maintenance. 

The article on the provision of medical advice by radio for workers 

on board has been redrafted to give further details of how the 

system should work and what  its purpose is. 

The Commission's amended proposal  thus has the same general structure 

and objectives as the  initial proposal, but develops and clarifies some 

of the more  important provisions. 

-  1  -

I n i t i al  prejmeJ  by  the  Commission 

Proposal  for a Council  Directive on the 
minimum  Health and safety  requirements for 
Improved medical  treatment on board 
vessels 

Amended proposa! pursuant 
EEC 

A r t i es 14S>?: 

(Where no alternative version  !a gr/en 
this column, the text  h 

in 

THE COUNCIL OF THE EUROPEAN  COMMUNITIES, 

Having  regard  to the Treaty  establishing 
the European  Economic Community and in 
particular  Article 118A thereof. 

Having  regard to the Commission's  proposal 
drawn up after  consultation with the 
Advisory  Committee on Safety, Hygiene and 
Health  Protection at Work, 

In cooperation with the European 
Pari lament, 

Having  regard to the opinion of the 
Economic and Social  Committee, 

Whereas the Commission  communication 
(88/C28/02) on its programme  concerning 
safety, hygiene and health at work (1) 
envisages measures to ensure medical 
treatment  at sea; 

Whereas a vessel  is a workplace which 
requires  special  attention on account of 
its mobility,  its geographical  isolation, 
and the potentially  high  risks to the 
safety and health of the workers on board; 

Whereas a vessel  is a workplace which 
requires special  attention on account of 
its mobility,  its geographical  isolation 
and the wide  range of risks to the safety 
and health of the workers on board; 

Whereas  there  is a need for vessels to 
have on board  adequate medical  equipment 
and medicines, properly maintained and 
checked at regular  intervals, to permit 
the effective  treatment of the crew and, 
in certain  cases, avoid  disembarkations at 
sea or diversions of vessels, which are 
not only  costly but can also delay 
treatment; 

Whereas,  in order  to improve medical 
treatment  at sea, It is desirable to 
promote  training  in and information on the 
use of medical  supplies and of the various 
remote medical  consultation  facilities; 

.  - ...  0 —  2  -

initial  proposal  by  the Commission 

Amended proposal  pursuant  to Article  149(3) 
EEC 

Whereas there  is a need  to provide for 
additional measures for medical  assistance 
at sea  in order  to take account of 
technological  and medical  progress and 
thus ensure better  protection of  the 
health and safety of  the workers, 

HAS ADOPTED THIS DIRECTIVE: 

Definitions 

Article 1 

For  the purposes of  this Directive, the 
following terms have the meanings 
hereafter  assigned  to them: 

vessel : 

any vessel  flying the flag of a Member 
State, which  is operated  at sea or  in 
adjacent waters accessible to sea-going 
vessels and  is publicly or  privately 
owned, excluding warships and p'easure 
boats used for non-commercial purposes. 
Vessels fall  into four categories in 
accordance with Annex  I; 

worker: 

any person who  is employed or  retained 
in whatever  capacity on board a vessel, 
including trainees and apprentices, but 
excluding pi lots; 

medical  supplies: 

medical  equipment  and medicines, 
including any antidotes that may be 
required under  the terms of Article 
3(1); 

antidote: 

a substance or means used  to prevent or 
treat a harmful  effect or effects, 
direct or  indirect, of one or more 
substances  included  in the  list of 
dangerous substances  in Annex  III. 

Medical  supplies 

Article 2 

-  3 -

Initial proposal  by the Commission 

Amended proposal  pursuant  to Article  149(3) 
EEC 

Member  States shall  take the measures 
necessary  to ensure that  the vessels under 
their  jurisdiction always have at  least 
one medicine or one  item of medical 
equipment  in each of  the categories set 
out  in Annex  II for  the category of vessel 
to which they belong. 

The quantities to be carried must  take 
account of  the nature and destination of 
the trip and the number of crew members. 

The contents of  the medical  supplies shall 
be detailed on a checklist  as shown  in 
Annex V. 

Member States shall  take the measures 
necessary  to ensure that: 
a)  vessels always have medicai  supplies of 
the type specified  in Annex  M  for tho 
category of vessel  to which they 
belong.  The quantities of medicines 
and médical equipment  to be carried 
must  take account of  the features of 
the trip  (distance, ports of  call, 
destination, duration, etc),  the 
type(s) of work  to be carried out 
during the trip, the nature of the 
cargo carried and  the number of crew 
members.  The contents of  the medicai 
supplies shall  be detailed on a 
checklist as shown  in Annex V; 

b)  all  vessels have, for each of their 

life rafts and  life boats, a water 
tight medicine chest whose contents 
fulfil  the requirements  laid down in 
Annex  II for category D vessels. The 
contents of  these medicine chests sha 
also be detailed on the checklist 
referred  to  in (a); 

c)  all vessels of more than 500 gross 

register  tonnes with a crew of  15 or 
over on trips of more than three days 
duration have a sickbay where medical 
treatment  can be provided under 
satisfactory, hygienic conditions. 

d)  any vessel with a crew of  100 or more 

engaged on  international voyages of 
more than 3 days' duration carries a 
doctor on board. 

Dangerous substances 

Article 3 

Member  States shall  take the measures 
necessary  to ensure that: 

1) any vessel  under  their  jurisdiction 

carrying any of the dangerous 
substances  listed  in Annex  III has 
medical  supplies, including the 
appropriate antidotes  listed  in Annex 
II, and that to this end  its captain  is 
kept  informed of  the dangerous 
substances  loaded on board,  in order  to 
protect  the health and safety of the 
workers; 

Initial proposal  by the Commission 

- 4 -

Amended 
EEC 

proposal  pursuant  to Article 149(3) 

2) for  ferry-type vessels, whose 

conditions of operation do not always 
allow them to know well enough  in 
advance the nature of  the dangerous 
substances being transported, all  the 
antidotes  listed  in Annex  II are 
carried on board.  However, on a 
regular  route where the crossing  is due 
to  last  less than two hours, the 
antidotes may be  limited to those which 
have to be administered within a period 
of time not exceeding  the duration of 
the crossing. 

Allocation of responsibilities 

Management of medical supplies 

Article 4 

Member States shall  take the measures 
necessary  to ensure that: 

1) the provision and replenishment of all 
the medical  supplies of any vessel 
under  their  jurisdiction are undertaken 
at the responsibility and exclusively 
at the expense of  the owner, without 
any expense to the workers; these 
supplies are to be placed under  the 
responsibility of  the captain of the 
vessel who may, without prejudice to 
this responsibility, delegate the use 
and maintenance of  the supplies to one 
or more workers specially designated by 
reason of  their competence; 

2) the medical  supplies are maintained  in 
good condition and replenished where 
necessary, as soon as port conditions 
permit. 

2)  the medical  supplies are maintained  in 

good condition and replenished and/or 
renewed as soon as possible and  in 
every  instance as a priority part of 
normal  revictua11ing procedures. 

Initial proposal  by the Commission 

Amended proposal  pursuant  to Article 149(3) 
EEC 

- 5 -

3)  In an emergency, any medicines not 
available on board are obtained  as 
quickly  as possible  for  the workers 
concerned. 

Information and  training 

Article 5 

Member  States shall  take appropriate 
measures to ensure that: 

1) the medical  supplies are accompanied  by 

a guide to their use,  including 
instructions  for  the use of  the 
antidotes required  pursuant  to Article 
3; 

2) during their  professional  maritime 

training all persons  intending  to work 
on board are given  instruction  in the 
medical  and emergency measures  to be 
taken  immediately  in the event of an 
accident or serious emergency; 

3) the captain and  the worker or  workers 
to whom he delegates  the use of  the 
ship's medical  supplies pursuant  to 
Article 4 of  this Directive  have 
received  special  training, taking  into 
account  the specific risks and needs 
connected with  the different  categories 
of vessels and  in accordance with  the 
general  guidelines set out  in Annex  IV. 

Article  6 

The Member  States shall  designate one or 
more centres to provide any data which may 
be required  to  improve emergency  treatment 
for crew members.  The transmission system 
used must ensure that such data  remain 
confidential. 

In order  to ensure  that workers receive 
better emergency  treatment, the Member 
States shall  designate one or more  centres 
to provide workers on board with medicai 
advice by radio free of  charge 

Doctors providing  their  services for  these 
centres shall be trained  to familiarize 
them with  the special  conditions obtaining 
on board vessels. 

In order  to provide  the best  possible 
advice, the centres may, with  the agreement 
of the workers concerned, keep details of 
personal  medical  data.  Such data shall 
remain confidential. 

Initial proposal  by the Commission 

Amended proposal  pursuant  to Article  149(3) 
EEC 

- 6 -

Member  States shall  take appropriate 
measures to ensure that a competent 
authority carries out  annual  checks on all 
vessels under  their  jurisdiction to 
determine whether  the medical  supplies 
carried comply with  the minimum 
requirements  laid down  in this Directive 
and whether  the checklist provided  for  in 
Article 2 has been filled out correctly. 
When carrying out  such checks, the 
competent authority shall  also ensure that 
the supplies are kept  in suitable 
conditions and  that  they have not passed 
their expiry dates, where appropriate. 

Inspection 

Article  7 

Member  States shall  take appropriate 
measures to ensure that a competent 
authority carries out annual  checks on 
vessels under  their  jurisdiction to 
determine whether  the medical  supplies 
carried correspond  to the checklist 
provided  for pursuant  to Article 2. 

all 

Adaptation of  the Annexes 

Article  8 

For  the purpose of making  technical 
changes to the Annexes of  this Directive 
in the  light of  technical progress, 
changes  in  international  regulations or 
specifications and new findings  in this 
field, the Commission shall  be assisted by 
a committee composed of  the 
representatives of  the Member  States and 
chaired by the representative of  the 
Commission. 

The representative of  the Commission shall 
submit  to the committee a draft of  the 
measures to be taken. 

The committee shall  deliver  its opinion on 
the draft within a time  limit which  the 
chairman may  lay down according  to the 
urgency of  the matter. 

The opinion shall  be delivered by the 
majority  laid down  in Article 148(2) of 
the Treaty  in the case of decisions which 
the Council  is required  to adopt on a 
proposal  from  the Commission. 

The votes of  the representatives of  the 
Member  States within the committee shall 
be weighted  in the manner  set out  in that 
Article.  The chairman shall  not vote. 

Tne Commission shall  adopt  the measures 
envisaged  if they ara  in accordance with 
the opinion of  the committee. 

Initial proposal  by the Commission 

Amended proposal  pursuant  to Article  149(3) 
EEC 

- 7 -

If the measures envisaged are not  in 
accordance with  the opinion of the 
committee, or  if no opinion  is delivered, 
the Commission shall, without delay, 
submit  to the Council  a proposal  relating -
to the measures to be taken.  The Council 
shall  act by a qualified majority. 

If, on the expiry of a period of  three 
months from the date of  referral  to the 
Council, the Council  has not acted, the 
proposed measures shall be adopted by the 
Commission. 

Final  provisions 

Article 9 

1. Member  States shall bring  into force 

1.  Member  States shall bring  into force 

the  laws, regulations and 
administrative provisions necessary  for 
compliance with  this Directive by 31 
December  1993.  They shall  immediately 
notify  the Commission  thereof. 

the  laws, regulations and 
administrative provisions necessary for 
compliance with  this Directive by 31 
December  1992.  They shall  immediately 
notify  the Commission  thereof. 

The provisions adopted pursuant  to the 
first subparagraph  shall make express 
reference to this Directive. 

2. Member  States shall  notify  the 

Commission of  the text of the 
regulations under  national  law which 
have already been adopted or will be 
adopted  in the area governed by this 
Direct ive. 

Article 10 

This Directive  is addressed  to the Member 
States. 

ANNEX I 

Categories of vessel  referred  to in 
Article 1 

A. Sea-going or sea-fishing vessel, with 
no  limitation on  length of trips. 

Initial proposal  by the Commission 

Amended  proposal  pursuant  to Article 149(3) 
EEC 

- 8 -

B. Sea-going or sea-fishing vessel, making 
trips of between  100 and 200 nautical 
miles from  the nearest  port. 

C. Sea-going or sea-fishing vessel, making 
trips of  less than  100 nautical  miles 
from  the nearest  port (1). 

D. Harbour  vessels, boats and craft 

staying  very close  to shore or with no 
cabin accommodation other  than a 
wheeI house. 

(1)  This category may be extended  to 

vessels of  less than 50 gross 
register  tons or  to those which 
remain continuously within range of 
helicopter  rescue services. 

ANNEX  II 

Medical  supplies referred  to  in Article 2 

I. Med i cInes 

Categories of vessel  (1) 

1) Cardiovascular 
med i c i nes 

-  Circulatory 
analeptic 
-  Anti-angina 
-  Diuretic 
-  Anti-haemorrhagic 

A  B  C  D 

+  +  + 

+  +  + 

2) Gastrointestinal 

A  B  C  D 

system 

-  Medicines for 
gastric and 
duodenal  disorders 

-  Antiemetic 

-  Laxatives 

-  Anti-diarrhoea I 
-  Intestinal 
ant iseptic 

-  Haemorrhold 

preparations 

+  +  +  + 
+  + 

+  + 

(1)  +  indicates that  this type of 

medicine must be carried on board 
the category of vessel  in question. 

Laxatives 

A BC 
+  +  + 

I n i t i al  proposal  by  the  Commission 

Amended  proposa 
EEC 

pursuant  to  A r t i c le  149(3) 

-  9  -

3) Analgesics 
-  Analgesics, 

antipyretics and 
ant i-infIammatory 

-  Morphine 

analgesics 

4) Nervous system 
-  Anxiolytic 
-  Neuroleptic 
-  Antihistaminic H1 

5)  Hormone  system 
-  Glucocorticoids 

6)  Respiratory  system 
-  Medicines  used  in 

cases of 
bronchospasm 
-  Antitussives 
-  Medicines  used 

for  colds and 
s i nus i t i s 

7) Anti-infection 
-  Antibacterial 

antibiotics and 
sulphamides 

-  Urinary 

ant isept les 
-  Antiparasitics 
-  Vaccines,  a n t i 

tetanus 
gammaglobulins 

8) Compounds 
promoting 
rehydrat ion and 
caloric or mineral 
salt  intake 

9)  Medicines for 
external use 
-  Skin  medicines 
-  Eye medicines 
-  Ear medicines 
-  Medicines for 

oral  and throat 
infections 

LocaI  anaesthetIcs 

A  B  C  D 
+  +  +  + 

A  B  C  D 
+  + 
+  + 
+  +  + 

A  B  C  D 
+  +  + 

A  B  C  D 
+  +  + 

+  +  + 
+  +  + 

A  B  C  D 
+  +  + 

+  +  + 
+  + 

A  B  C  D 

A  B  C  D 

+  +  + 
+  +  + 
+  + 
+  +  + 

8)  Compounds 
promoting 
rehydration and 
calor ic or mineral 
salt  intake 

C  D 

A  B  C  D 
+  + 

Local  anaesthetics  +  +  + 

A  B  C  D 

11. 

Med IcaI  equ i praent 
dressings 

and  A  B  C  D 

1.  Resuscitation 
equipment 
2.  Dressings 

+  +  + 

+  +  +  + 

Initial  proposal  by  the  Commission 

Amended  proposal  pursuant  to Article  149(3) 
EEC 

-  10 -

+  +  +  + 

+  +  + 

+  +  +  + 

+  +  + 

3.  Instruments 
4. General  medical 

equipment 

5.  Immobilization 

equipment 
6. Disinfection  -

dis insectization 
protection 

III. Antidotes 

1) Medicines 
-  General 
-  Anti-infective 
-  Cardiovascular 
-  Respiratory  system 
-Gastrointestinal  system 
-  Nervous  system 
-  For  external  use 

2)  Equipment 

2)  Equipment 

-  Necessary  for 
oxygen 

the administration of 

-  Necessary  for  the administration of 
oxygen  (including  maintenance) 

The substances  listed  in this Annex  are 
covered  irrespective of  their  form  when 
taken on  board,  including  waste. 

ANNEX  111 

DANGEROUS  SUBSTANCES  REFERRED  TO  IN 
ARTICLE  4 

Explosive  substances  and  objects 
Gases: compressed,  liquefied or 
dissolved  under  pressure 
Inflammable  liquids 
Inflammable sol ids 
Inflammable  solids, substances  liable 
to spontaneous  combustion 
Inflammable solids, substances  which, 
on  contact  with  water, give off 
inflammable  gases 
Combust IbIe  substances 
Organic  peroxides 

Initial  proposal  by the Commission 

Amended  proposal 
EEC 

pursuant  to Article  149(3) 

-  11 -

radioactive substances; 

Knowledge of basic health protection, 
particularly personal  and collective 
hygiene, and of basic prophylactic 
measures. 

Toxic substances 
Infectious substances 

-  Corrosive substances; 

-  Various dangerous substances,  i.e. any 

other  substances which experience has 
shown or may show to be dangerous, so 
that  the provisions of Article 3 need 
to be applled. 

ANNEX  IV 

MEDICAL TRAINING OF THE CAPTAIN AND OTHER 
PERSONS, AS REFERRED TO  IN ARTICLE  5(3) 

Basic understanding of  physiology, 
symptomatology  and therapeutics. 

Detailed knowledge of how to use the 
various remote medical  consultation 
facilities. 

Ability  to perform basic  types of 
treatment  and supervise emergency 
disembarkation at sea. 

The abovementioned training should take 
account of  the programmes of  instruction 
detailed  in relevant  recent  international 
documents. 

ANNEX V 

CHECKLIST FOR VESSELS' MEDICAL SUPPLIES AS 
REFERRED TO  IN ARTICLE  7 

1. Details of  the vessel 

Name: 

Initial  proposal  by the Commission 

Amended  proposal  pursuant  to Article  149(3) 

-  12 -

EEC 

Flag: 

Home port: 
2. Medical  supplies 

yes  no 

2.  Medical  supplies 

yes  no  nominal 

remarks 

quant 11 i es 
carried 
0 

o 

o 

o 
o 
o 
o 
o 
o 
o 
o 
o 

o 
o 
o 
o 
o 
o 
o 
o 
o 
oo 

o 
o 
o 
o 
o 
o 
o 
o 

o 
o 
o 
o 
o 
o 
o 
o 

o 

o 

o 
o 
o 
o 
o 

o 
o 

o 
o 
o 
o 
o 

o 
o 

2.1 

Medicines 

-  cardiovascular 
-  gastrointestinal  system 
-  analgesics 
-  nervous system 
-  hormone system 
-  respiratory system 
-  anti-infect ion 
-  rehydration 
-  external  use 
-  other 

2.2 

Antidotes 

-  general 
-  ant I-Infect ion 
-  cardiovascular 
-  respiratory  system 
-  gastrointestinal  system 
-  nervous system 
-  external  use 
-  other 
-  necessary  for the 

administration of oxygen 

2.3 

Equipment 

-  resuscitation equipment 
-  dressings 
-  Instruments 
-  general  medical  equipment 
-  immobiIization equipment 
-  disinfection; 

dis insectization; protection 

-  other equipment 

Date: 
Signature of captain: 
Stamp of  the competent  authority 

ISSN 0254-1475 

COM(91) 65 final 

DOCUMENTS 

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ISBN 92-77-69582-X 

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