Re­examined proposal for a COUNCIL DIRECTIVE ON THE MINIMUM SAFETY AND HEALTH REQUIREMENTS FOR IMPROVED MEDICAL TREATMENT ON BOARD VESSELS
Date: 1991-12-20
Institutions: European Commission
Subjects: crew, medical device, medicinal product, occupational health, vessel

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

COM(91) 552 final - SYN 278 

Brussels, 2D  December  1991 

Re-examined proposal  for a 

COUNCIL DIRECTIVE 

ON THE MINIMUM  SAFETY AND HEALTH REQUIREMENTS 

FOR  IMPROVED MEDICAL  TREATMENT 

ON BOARD VESSELS 

(presented  by  the Commission  pursuant  to Article  149.2(d) 
of  the EEC  treaty) 

The  initial  proposal  for  this Directive was forwarded  to the Council  by the 
Commission on 20 July  1990( 1). 

Th,is proposal  for a Council  Directive, based on Articje  118a of  the EEC 
Treaty, seeks  to  improve medical  treatment  on board  vessels by  laying down 
minimum  requirements  in respect of  the medical  supplies appropriate  to 
various categories of vessel.  These minimum  requirements apply  particularly 
to the presence of antidotes on vessels carrying  dangerous substances and to 
medical  training  for  the captain  and other  crew members.  The proposal  also 
provides  for  inspection arrangements. 

The European Parliament  (first  reading) and  the Economic  and Social  Committee 
gave  their opinions on 24 January  1991 and 20 September  1990 respectively. 

The Commission  forwarded  an amended  proposal  to the Council  on 
28 February  1991<2>. 

The Council  common position of  1 October  1991 was examined  by  the European 
Parliament  (second  reading) on 20 November  1991  and adopted  subject  to 20 
amendments. 

Of  these 20 amendments, the Commission has agreed  to  incorporate seven, in 
full or  in part,  into  its re-examined  proposal.  As regards amendments No 3 
and No 8, only  the part  corresponding  to the proposal  put  forward  in 
amendment  No 2 has been adopted, with  the rest of  the text  being  rejected. 

It has rejected  13 amendments, namely  Nos  1, 4, 9,  10, 11, 12, 13, 14, 17, 
18,  19, 20 and  21 . 

The Commission's  comments on  the amendments which  it has not  adopted  are as 
fol lows: 

(1) COM(90) 272 final 

(The numbering  corresponds  to that  adopted  for  the plenary  sitting of 

20 November) 

Amendment  No 1 : (Fifth  recital  a) 

This makes provision  for  the Member  States to be asked  to ratify  ILO 
Convent ion No 164. 

Comments: This form of  recital  cannot  be  justified, since  the present 
proposal  for a Directive  is not  a suitable  instrument  for  calling for 
ratification of  an  ILO Convention.  This amendment  had already  been  rejected 
at  the first  reading. 

Amendment  No 3:  (Article  2 (1) (a)) 

The part of  this amendment  embracing  the concept of  "vessels registered  in a 
Member  State" has been accepted  (same purpose as amendment  No 2 ).  This 
amendment  also cat's  for  revision of  the  lists of medical  supplies following 
harmonisation of  various elements, particularly  pharmaceutical  standards. 

Comments : The procedures  for adapting  the annexes of  the Directive are 
covered  in overall  terms and more satisfactorily by  the provisions of 
Art icle 8. 

Amendment  No 4:  (Article  2 (1) (b)) 

This calls  for quantities of medical  supplies  to be determined  on  the basis 
of data supplied  by  the competent  national  authorities. 

Comments: The competent  authorities cannot  possibly  take account  of  the 
various parameters specified  in paragraph  1 (b) of  this Article. 

Amendment  No 8:  (Article  3 (1)) 

The part of  this amendment  embracing  the concept of  "vessels  registered  in a 
Member  State" has been accepted  (same purpose as amendment  No 2 ).  The other 
part of  this amendment  requires  the captain  to be kept  informed of  dangerous 
substances  loaded on board  the vessel. 

Comments: This general  requirement  is excessive  and difficult  to apply, 
particularly  where  ferries are concerned. 

Amendment  No 9:  (Article 3 (2a)) 

This sets out  requirements  in respect of  the transport of  dangerous 

substances. 

Comments: The checks envisaged  by  this provision  are excessive,  largely 

impractical  and entail  too much  red tape. 

Amendment  No  10-, (Art icle 4 (2a) ) 

This gives seafarers  the right  to medical  examination  at ports of  call. 

Comments: This provision would be of  little practical  value and would, in 
many  cases, be unfeasible.  Moreover, the emergency  factor  is already  taken 
into account  in other  provisions of  the Directive, particularly 
Art icle 4 (3). 

Amendment  No  11 : (Article 5 (3)) 

This  relates  to  information  and  training  programmes  for  the captain and other 
persons as regards both  the provision of medical  treatment  and  preventive 
aspects. 

Comments : These elements are already  covered  by  the wording of Article 5 (3) 
of  the common  position, the content of Annex  V and  the principles  laid down 
in Council  Directive 89/391/EEC  (0J No L 183 Of  29 June  1989, p. 1). 

Amendment  No 12: (Article 7  (2)) 

This makes  reference  to  ILO Convention  No  164 and  reinforces  the checks  to be 
carried out on medical  supplies on  life-rafts. 

Comments:  Firstly, the  ILO Convention  in question  does not  cover  life-rafts 
in the terms of  the present  Directive-, secondly, checks of medical  supplies 
on  life-rafts as envisaged  by  the amendment  are  inappropriate. 

Amendment  No 13: (Article 8  (3)) 

This modifies  the procedure  involving  the committee  responsible for 
adaptation of  the annexes of  the Directive. 

Comments: The  regulatory  committee procedure  should  be retained  in accordance 
with established  practice. 

Amendment  No  14:  (Article  8  (3)  new) 

This  provides  for  consultation  of  the  Joint  Committee  on  Maritime  Transport. 

Comments:  Such  consultation  is already  provided  for  in  Commission 
Decision  87/467/EEC  of  31  July  1987  (OJ  L  253 of  4 September  1987, p. 2 0 ). 

Amendment  No  17:  (Annex  II, Section  I (2)  (c)) 

This  extends  the  availability  of  laxatives  to  category  B  vessels. 

Comments : Little  medical  justification  for  this  amendment. 

Amendment  No  18:  (Annex  II,  Section  II  (1)) 

This  extends  the  availability  of  oxygen  to category  C  vessels. 

Comments : There  is  little  medical  justification  for  this  amendment;  moreover, 
many  vessels  in category  C  do  not  have  industrial  oxygen  on  board. 

Amendment  No  19:  (Annex  Ilia) 

This  amendment  introduces  a  list  of  dangerous  wastes. 

Comments : Annex  III  refers  to  a version  of  the  International  Maritime 
Dangerous  Goods  Code  which  contains  all  the  necessary  details. 

Amendments  No  20  and  21 : (Annex  IV) 

These  amend  the  content  of  the  captain's  training  and  make  reference  to  the 
guidance  document  published  by  the  ILO and  IMO. 

Comments:  These  aspects  of  training  are  already  mentioned  in  the  text  of  the 
common  position-, moreover,  it  is  inappropriate  to make  a direct  reference  to 
the  IM0/IL0 guide,  since  the  Community  has  no  control  over  its content. 

DIRECTIVE ON MEDICAL  TREATMENT 

Revised Commission  proposal  in 
accordance with Article  149(2)(d) 

Common  position  adopted  by  the Counc 
1/10/91 

on 

J* 

(Where  there  is no entry  in this 
ppl|i(T)n, the common position 
remains unchanged.) 

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 proposal  from the 
Commission^1),  drawn up after 
consultation  with  the Advisory  Committee 
on Safety, Hygiene  and Health  Protection 
at Work, 

In co-operation  with  the European 
Par I iament^2), 

Having  regard  to the Opinion of  the 
Economic  and  Social  Committee^), 

Whereas  the Commission  communication on 
its programme  concerning  safety,  hygiene 
and  health  at work^4) envisages measures 
to ensure medical  treatment  at sea; 

Whereas  the safety  and  health of workers 
on board  a vessel, which  constitutes a 
workplace  involving  a wide  range of  risks, 
bearing  in mind,  inter  alia,  its 
geographical  isolation, where appropriate, 
require  special  attention; 

Whereas  vessels  should  have  adequate 
medical  supplies, kept  in good order  and 
checked  at  regular  intervals, so that 
workers can obtain  the necessary  medical 
treatment  at sea-, 

Whereas,  in order  to ensure  appropriate 
medical  treatment  at sea, training and 
information of  seafarers  should be 
encouraged  as regards  the use of medical 
suppl ies-, 

Whereas  the use of  long-distance medical-
consultation methods constitutes an 
efficient  way of  contributing  to the 
protection  of  the safety  and  health of 
workers, 

HAS ADOPTED THIS DIRECTIVE: 

(1)  OJ  No C 183, 24.7.1990, p.6 and 0J 

No C 74, 20.3.1991, p.  11. 
(2)  OJ  No C 48, 25.2.1991, p.154 and 

Decision of  (not  yet  published  in 
the Off icial  Journal). 

Art icle 1 

Def ini t ions 

For  the  purposes  of  this  Directive  the 
following  terms  shall  have  the  following 
meanings: 

a)  vessel:  any  vessel  flying  the  flag  of  a  a)  vessel:  any  vessel  flying  the 

flag  of  a  Member  State  or 
registered  in  a  Member  State, 
seagoing  or  estuary-fishing, 
publicly  or  privately  owned, 
excluding: 

Member  State,  seagoing  or  estuary-
fishing,  publicly  or  privately  owned, 
excluding: 

inland  navigation  vessels; 

-  warships; 
-  pleasure  boats  used  for  non 

commercial  purposes  and  not  manned 
by  professional  crews; 

-  tugs  operating  in  harbour  areas. 

Vessels  shall  be  classed  in  three 
categories  in  accordance  with  Annex  I; 

b)  worker:  any  person  carrying  out  an 

occupation  on  board  a  vessel,  including 
trainees  and  apprentices,  but  excluding 
port  pilots  and  shore  personnel 
carrying  out  work  on  board  a  vessel  at 
the  quayside. 

c)  owner:  the  registered  owner  of  a  vessel 
unless  that  vessel  has  been  chartered 
by  demise  or  is managed,  either  wholly 
or  in  part,  by  a  natural  or  legal 
person  other  than  the  registered  owner 
under  the  terms  of  a  management 
agreement;  in  that  case  the  owner  shall 
be  construed  as  the  demise  charterer  or 
natural  or  legal  person  managing  the 
vessel  as  appropriate; 

d)  medical  supplies:  medicines,  medical 

equipment  and  antidotes,  a  non-
exhaustive  list  of  which  is given  in 
Annex  I I . 

e)  antidote:  a  substance  used  to  prevent 
or  treat  a  harmful  effect  or  effects, 
direct  or  indirect,  of  one  or  more 
substances  on  the  list  of  dangerous 
substances  in Annex  M l. 

Art icle  2 

Medicines  and  medical  equipment 
Sick-bay  -  Doctor 

Each  Member  State  shall  take  the  measures 
necessary  to  ensure  that: 

1)(a) every  vessel  flying  its  flag  always 

1)(a) every  vessel  flying  its 

carries  on  board  medical  supplies 
which  meet  at  least,  in  terms  of 
quality,  the  specifications  of  Annex 
II  sections  I and  II  for  the 
category  of  vessel  to which  it 
belongs; 

(b)  the  quantities  of  medicinal  products 

and  medical  equipment  to  be  carried 
depend  on  the  nature  of  the  voyage  -
in particular  ports  of  call, 
destination,  duration  -  the  type  or 
types  of  work  to  be  carried  out 
during  the  voyage,  the  nature  of  the 
cargo  and  the  number  of  workers; 

(c)  th*  content  of  the  medicines  and 

medical  equipment  included  in  the 
medical  supplies  shall  be  detailed 
on  a  checklist  corresponding  at 
least  to  the  general  framework  laid 
down  in Annex  IV,  sections  A,  B  and 
C  II  1 and  II  2; 

2)(a)  for  each  of  its  life-rafts  and  life 
boats,  every  vessel  flying  its  flag 
carries  a watertight  medicine  chest 
at  least  containing  the  medical 
supplies  specified  in Annex  II, 
sections  I and  II,  for  category  C 
vessels; 

(b)  the  content  of  these  chests  is also 

detailed  on  the  checklist  referred 
to  in paragraph  1(c); 

3) every  vessel  flying  its  flag  of  more 

than  500  gross  registered  tonnes,  with 
a  crew  of  15 or  more  workers,  engaged 
on  a  voyage  of  more  than  three  days, 
has  a  sick-bay  in which  medical 

flag  or  registered  under 
its  jurisdiction  always 
carries  on  board  medical 
supplies  which  meet,  at 
least  in  terms  of  quality, 
the  specifications of  Annex 
I I sect ions  I and  I I for 
the  category  of  vessel  to 
which  it  belongs; 

3) every  vessel  flying  its  flag 

or  registered  under  its 
jurisdiction  of  more  than  500 
gross  registered  tonnes,  with 
a  crew  of  15 or  more  workers, 
engaged  on  a  voyage  of  more 
than  three  days, 

treatment  can  be  administered  under 
satisfactory  material  and  hygienic 
cond i t ions-, 

has  a  sick-bay  in  which 
medical  treatment  can  be 
administered  under 
satisfactory  material  and 
hygienic  condi t ions; 

4)  every  vessel  flying  its  flag  with  a 

4)  every  vessel  flying  its  flag 

crew  of  100  or  more  workers,  engaged  on 
an  international  voyage  of  more  than 
three  days,  has  a  doctor  on  board. 

or  registered  under  its 
jurisdiction  with  a  crew  of 
100  or  more  workers,  engaged 
on  an  international  voyage  of 
more  than  three  days,  has  a 
doctor  on  board  responsible 
for  the  medical  care  of  the 
workers; 

5)  when,  in  accordance  with  Annex 

I,  category  B  is extended  to 
cover  longer  trips,  the 
helicopter  rescue  services 
provided  for  are  available  and 
operational  and  the  captains 
of  the  vessels  concerned  are 
informed  regularly  of  their 
ava i lab i I i ty. 

Art icle  3 
Ant idotes 

Each  Member  State  shall  take  the  measures 
necessary  to  ensure  that: 

1)  any  vessel  flying  its  flag  and  carrying  1)  any  vessel  flying  its  flag  or 

any  of  the  dangerous  substances  listed 
in  Annex  III  carries  on  board  medical 
supplies  including  at  least  the 
antidotes  listed  in  Section  I I I of 
Annex  I I ; 

registered  under  its 
jurisdiction  and  carrying  any 
of  the  dangerous  substances 
listed  in  Annex  III  carries  on 
board  medical  supplies 
including  at  least  the 
antidotes  listed  in  Section  II 
of  Annex  I I ; 

2)  any  ferry-type  vessels  flying  its  flag 
whose  conditions  of  operation  do  not 
always  allow  them  to  know  well  enough 
in  advance  the  nature  of  the  dangerous 
substances  being  transported  has  on 
board  medical  supplies  including  at 
least  the  antidotes  listed  in  Section 
I I I of  Annex  I I . 

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  in 
cases  of  extreme  emergency  within  a 
period  of  time  not  exceeding  the  normal 
duration  of  the  crossing; 

3)  the  contents  of  the  medical  supplies, 

as  regards  antidotes,  shall  be  detailed 
on  a  check  list  corresponding  at  least 
to  the  general  framework  laid  down  in 
Annex  IV,  sections  A,  B  and  C,  1 1 3. 

Art icle  4 

Allocation  of  responsibilities 

Each  Member  State  shall  take  the  measures 
necessary  to  ensure  that: 

1)(a)  the  provision  and  replenishment  of 
the  medical  supplies  of  any  vessel 
flying  its  flag  are  undertaken  on 
the  exclusive  responsibility  of  the 
owner,  without  any  expense  to  the 
workers; 

(b)  the  management  of  the  medical 
supplies  is  placed  under  the 
responsibility  of  the  captain  of  the 
vessel;  he  may,  without  prejudice  to 
this  responsibility,  delegate  the 
use  and  maintenance  of  the  medical 
supplies  to  one  or  more  workers 
specially  designated  by  reason  of 
their  competence-, 

2)  the  medical  supplies  are  maintained  in 

good  condition  and  replenished  and/or 
replaced  as  soon  as  possible,  and  in 
every  case  as  a  priority  part  of  normal 
revictualI ing  procedures; 

3)  in  an  emergency  established  by  the 

captain  as  far  as  possible  after  having 
obtained  a  medical  opinion,  the 
required  medicines,  medical  equipment 
and  antidotes  which  are  not  available 
on  board  are  made  available  as  soon  as 
possible. 

Art icle  5 

Information  and  training 

Each  Member  State  shall  take  the  measures 
necessary  to  ensure  that: 

1) medical  supplies  are  accompanied  by  one 

or  more  guides  to  their  use,  including 
instructions  for  use  of  at  least  the 
antidotes  required  in Annex  II  section 
I  I  I ; 

/lo 

2)  all  persons  receiving  professional 

maritime  training  and  intending  to  work 
on  board  ship  have  been  given  basic 
training  in  the  medical  and  emergency 
measures  to  be  taken  immediately  in  the 
event  of  an  accident  or  serious  medical 
emergency; 

3)  the  captain  and  any  worker  or  workers 
to whom  he  delegates  the  use  of  the 
medical  supplies  under  Article  4(1)(b) 
have  received  special  training  updated 
periodically,  at  least  every  five 
years,  taking  into  account  the  specific 
risks  and  needs  connected  with  the 
different  categories  of  vessel  and  in 
accordance  with  the  general  guidelines 
set  out  in Annex  V. 

Art icle  6 

Medical  consultations  by  radio 

1)  To  ensure  better  emergency  treatment 
for  workers,  each  Member  State  shall 
take  the  measures  necessary  to  ensure 
that: 

(a) one  or  more  centres  are  designated 

to  provide  workers  with  free  medical 
advice  by  radio-, 

(b)  some  of  the  doctors  providing  their 
services  for  the  radio  consultation 
centres  have  been  trained  in  the 
special  conditions  prevailing  on 
board  ship. 

2)  In order  to  optimise  the  advice  given, 

the  radio  consultation  centres  may  keep 
personal  medical  records,  with  the 
agreement  of  the  workers  concerned. 

Such  records  shall  remain  confidential. 

Art icle  7 

Inspect ion 

1)  Each  Member  State  shall  take  the 

measures  necessary  to  ensure  that 
competent  person  or  a  competent 
authority  carries  out  an  annual 
inspection  to  check  that  on  board 
vessels  flying  its  flag: 

'"J 

-  the medical  supplies  meet  the 
minimum  requirements of  this 
Di rect ive; 

-  the  checklist  provided  for  in 

Article  2(1)(c)  confirms  that  the 
medical  supplies  comply  with  those 
minimum  requirements; 

-  the  medical  supplies  are  correctly 

stored; 

-  any  expiry  dates  have  been 

respected. 

2)  Inspections  of  the  medical  supplies 

stored  on  life-rafts  shall  be  carried 
out  in  the  course  of  those  life-rafts' 
annual  maintenance. 

Those  inspections may  exceptionally  be 
postponed  for  up  to  five  months. 

Art icle  8 

Commi ttee 

With  a  view  to  the  strictly  technical 
adaptation  of  the  Annexes  to  this 
Directive  in  the  light  of  technical 
progress  or  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  mannner  set  out  in  that  Article. 
The  Chairman  shall  not  vote. 

^ 

3)  The  Commission  shall  adopt  the  measures 
envisaged  if  they  are  in  accordance 
with  the  opinion  of  the  committee. 

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 
quaii f ied  major ity. 

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. 

Art icle  9 

Final  provisions 

1)  Member  States  shall  bring  into  force 

the  laws,  regulations  and 
administrative  provisions  necessary  to 
comply  with  this  Directive  by  31 
December  1995.  They  shall  forthwith 
inform  the  Commission  thereof. 

1) Member  States  shall  bring  into 
force  the  laws,  regulations 
and  administrative  provisions 
necessary  to  comply  with  this 
directive  by  31  December  1992. 
They  shall  forthwith  inform 
the  Commission  thereof. 

When  Member  States  adopt  these 
measures,  such  measures  shall  contain  a 
reference  to  this  Directive  or  shall  be 
accompanied  by  such  reference  on  the 
occasion  of  their  official  publication. 
The  methods  of  making  such  a  reference 
shall  be  laid  down  by  the  Member 
States. 

2) Member  States  shall  communicate  to  the 
Commission  the  texts  of  the  provisions 
of  national  law  which  they  have  already 
adopted  or  which  they  adopt  in  the 
field  governed  by  this  Directive. 

3) Member  States  shall  report  to 
the  Commission  every  four 
years  on  the  implementation  of 
the  provisions  of  this 
Directive,  and  in  particular 
of  Article  2 ( 5 ), giving  the 
views  of  the  two  sides  of 
industry. 

The  Commission  shall  inform 
the  European  Parliament,  the 
Counci I,  the  Economic  and 
Social  Committee  and  the 
Advisory  Committee  for  Safety, 
Hygiene  and  Health  at  Work. 

"fa 

4) The  Commission  shall  report 

periodically  to  the  European 
Parliament,  the  Council  and 
the  Economic  and  Social 
Commi ttee  on  the 
implementation  of  this 
Directive,  taking  into  account 
paragraphs  i,  %  and 3. 

Art icle  10 

This  Directive  is addressed  to  the  Member 
States. 

Done  at  Brussels, 

For  the  Counci 

The  President 

Annexes:  (unchanged) 

IV 

ISSN 0254-1475 

COM(91) 552 final 

DOCUMENTS 

EN 

05  04 

Catalogue number : CB-CO-91-603-EN-C 

ISBN 92-77-79126-8 

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