Proposal for a COUNCIL DIRECTIVE amending Directive 2000/75/EC as regards vaccination against bluetongue
Date: 2010-11-15
Institutions: European Commission
Subjects: animal disease, animal health, infectious disease, regulation of agricultural production, sheep, vaccination, vaccine, veterinary inspection, veterinary legislation

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EUROPEAN COMMISSION 

Brussels, 15.11.2010 
COM(2010) 666 final 

2010/0326 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 2000/75/EC as regards vaccination against bluetongue  

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Bluetongue is a disease affecting ruminants (such as cattle, sheep and goats) and is 
transmitted by insect vectors that spread the virus from one animal to another. This 
means  that  its  occurrence  and  spread  is  largely  influenced  by  environmental 
conditions and that the measures usually applied for the control of contagious animal 
diseases  such  as  Foot-and-mouth  disease  are  not  appropriate  for  the  control  and 
eradication  of  bluetongue.  When  favourable  environmental  and  climatic  conditions 
exist,  epidemic  waves  of  disease  may  occur,  in  fully  receptive  (i.e.  non-immune) 
ruminant populations in late summer-autumn, that are extremely difficult to control. 
In general, bluetongue control is based on a combination of vaccination, protection 
from vectors and restrictions on animal movements.  

This disease was considered exotic to the EU until the late 1990s, as only sporadic 
incursions  in  the  southern  part  of  the  EU  had  been  reported  at  that  time.  However, 
the situation dramatically changed from the early 2000s: several epidemic waves of 
disease  have  occurred  in  many  Member  States,  including  in  central  and  northern 
Europe, causing significant losses in terms of morbidity, mortality and disruption of 
trade in live animals. In the last few years the situation has significantly improved, as 
a  result  of  massive  vaccination  campaigns  largely  co-financed  by  the  Union 
(~150 MEUR  in  2008,  and  allocation  of  ~120  MEUR  in  2009  and  ~100  MEUR  in 
the  years  after),  that  have  been  based  on  new  "inactivated  vaccines",  that  have 
become available as from 2008. However, the disease has also shown a tendency to 
become  endemic  in  some  areas,  and  it  is  possible  that  from  there  further  epidemic 
waves of disease may start in the future. 

Council Directive 2000/75/EC of 20 November 2000 lays down specific provisions 
for the control and eradication of bluetongue, including rules on vaccination. These 
rules are based on experiences with the so-called "modified live vaccines", or "live 
attenuated  vaccines"  that  were  the  only  vaccines  available  when  the  Directive  was 
adopted  a  decade  ago.  Those  vaccines  may  lead  to  undesired  circulation  of  the 
vaccine virus in unvaccinated animals in the areas where the vaccine has been used. 
However,  in  the  last  few  years  inactivated  vaccines  have  been  developed  by  a 
number of companies and largely used in the EU. These inactivated vaccines do not 
pose the risk of undesired vaccine virus circulation.  

It is now widely agreed that vaccination with these vaccines is the preferred tool for 
bluetongue  control  and  prevention  of  clinical  disease  in  the  EU.  Their  use  is, 
however,  limited  by  the  current  rules,  that  in  particular  foresee  the  use  of  vaccines 
only  in  areas  where  the  disease  occurred  and  which  have  therefore  been  subject  to 
animal movement restrictions. 

In  order  to  ensure  better  control  of  bluetongue  and  reduce  the  burden  on  the 
agricultural sector posed by this disease, it is appropriate to update the current rules 
on vaccination to the recent technological developments in vaccine production. This 
proposal  amends  the  rules  on  vaccination  currently  laid  down  in  Directive 
2000/75/EC to make them more flexible, taking into account the fact that inactivated 
vaccines are now available, which can also be successfully used outside areas subject 

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to animal movement restrictions. However, the use of live attenuated vaccines should 
not be excluded provided that appropriate precautionary measures are taken, as their 
use  might  still  be  necessary  under  certain  circumstances,  such  as  following  the 
introduction  of  a  new bluetongue virus serotype against  which inactivated  vaccines 
may not be available. 

2. 

PREFERRED OPTION AND ASSESSMENT OF ITS IMPACTS 

2.1.  Reasons  for  modification  of  EU  legislative  framework  compared  to  other 

options 

Under  the  current  rules,  the  use  of  vaccines  against  bluetongue  is  prohibited 
outside "restricted zones". Consequently, Member States that wish to carry out 
preventive  vaccination  must  either  retain  a  restricted  zone  beyond  the  two 
years  of  absence  of  virus  circulation,  while  other  Member  States  decide  to 
become part of a restriction zone although bluetongue has never occurred. This 
situation  leads  to  unnecessary  restrictions  in  the  concerned  areas  with 
additional burdens for the farmers and the national authorities. 

In  the  past  three  years  modern  inactivated  vaccines  against  bluetongue  have 
become  available  which  could  be  safely  used  outside  restricted  zones.  The 
provisions  on  vaccination  against  bluetongue  should  therefore  be  amended  to 
allow the Member States to develop their national strategies on the prevention 
and control of the disease without the unnecessary intervention of the Union.  

2.2.  Economic and social impacts of the proposal 

The  proposal  is  expected  to  reduce  the  adverse  economic  and  social  impact, 
and the burden related to the implementation of certain veterinary restrictions 
as  a  result  of  bluetongue,  by  increasing  the  number  of  options  available  to 
control the disease. It is, however, difficult to quantify these benefits precisely, 
as they will vary dependent on the largely unpredictable nature of the evolution 
of the disease in Europe. 

2.2.1. Economic impacts 

A. 

Effects on co-financed animal disease control programmes  

The  proposal  does  not  have  an  effect  on  the  control  measures, 
including vaccination programmes that take place within areas that 
are affected by bluetongue disease. Therefore, the proposal will not 
have  a  direct  impact  on  the  EU  annual  and  multi  annual 
programmes  for  the  eradication,  control  and  monitoring  of  certain 
animal diseases.  

B. 

Effects on agricultural sector  

By allowing the wide use of vaccination in the Union, this proposal 
has  the  potential  to  reduce  the  negative  economic  impact  of 
bluetongue caused by both direct and indirect losses (morbidity and 
mortality,  disruption  of  trade  in  live  ruminants)  caused  by  this 

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disease. In addition, a positive effect can be expected on the burden 
on farmers due to disease control measures and restrictions on trade 
currently applied in areas where vaccination is applied and that are 
therefore currently included in restricted zones (see 2.1).  

C.  Effects on other types of operators 

The proposal will allow a wider use of vaccination and therefore a 
potential  increased  market  for  the  pharmaceutical  companies  who 
produce the inactivated vaccines against bluetongue. 

D.  Effects on administrative costs 

It  is  not  expected  that  the  wider  and  more  flexible  use  of 
inactivated vaccines against bluetongue will have any effect on the 
administrative  burden 
for  Member  States.  No  additional 
registration  or  procedures  are  required,  except  for  the  information 
Member States must provide to the Commission of their intention 
to put in place a vaccination programme.  

2.2.2. Social impacts 

Apart  from  a  certain  positive  effect  that  arises  from  the  flexibility  that 
will be allowed for Member States, farmers and other animal keepers in 
the decision making on bluetongue control strategy, it is expected that the 
proposal will have no significant social impact.  

2.3.  Conclusion 

The Commission considers that the amendment of the legislation is necessary 
to  reflect  the  technological  progress  in the  field  of  vaccine  development.  The 
current  obstacles  for  preventive  vaccination  outside  areas  subjected  to  animal 
movement  restrictions  are  not  necessary  when  modern  safe  "inactivated 
vaccines"  are  used.  The  proposed  amendment  will  facilitate  decision  making 
on bluetongue control strategies on the basis of the specific situation within the 
Member States without unnecessary intervention by the Union. 

This  approach  is  expected  to  address  the  demands  of  several  Member  States 
and  receive  the  support  of  stakeholders.  It  is  also  estimated  that  the  potential 
economic and  social benefits of this proposal are likely to outweigh potential 
disadvantages. The expected impacts are not considered significant enough to 
merit a full format impact assessment.  

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

The legal basis of Directive 2000/75/EC is the second indent of Article 15 of Council 
Directive  92/119/EEC  of  17  December  1992  introducing  general  Community 
measures for the control of certain animal diseases and specific measures relating to 
swine vesicular disease (the "basic act"), which provides that the Council may adopt 
specific  provisions  relating  to  the  control  and  eradication  measures  for  any  of  the 
animal diseases listed in Annex I to the Directive, acting on a qualified majority on a 

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proposal from the Commission. Since the  basic act  providing for this  legal  basis is 
still  in  force,  the  legality  of  the  powers  vested  in  the  Council  in  this  act  are  not 
affected by the entry into force of the Lisbon Treaty and these powers remain solely 
with the Council.  

4. 

RELATION TO OTHER EU INITIATIVES 

This proposal is in line with the Animal Health Strategy (2007-2013) "Prevention is 
better  than  cure",  as  it  moves  towards  a  more  flexible  approach  to  vaccination,  as 
well as improving current measures to control major animal diseases.  

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2010/0326 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 2000/75/EC as regards vaccination against bluetongue  

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union,  

Having  regard  to  Council  Directive  92/119/EEC  of  17  December  1992  introducing  general 
Community measures for the control of certain animal diseases and specific measures relating 
to swine vesicular disease1, and in particular the second indent of Article 15 thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions 
for the control and eradication of bluetongue2 lays down control rules and measures to 
combat  and  eradicate  bluetongue,  including  rules  on  the  establishment  of  protection 
and surveillance zones and the use of vaccines against bluetongue. 

In the past, only sporadic incursions of certain serotypes of the bluetongue virus were 
recorded in the Union. Those incursions mainly occurred in the southern parts of the 
Union. However, after the adoption of Directive 2000/75/EC, and particularly after the 
introduction  into  the  Union  of  bluetongue  virus  serotypes  1  and  8  in  the  years  2006 
and  2007,  the  bluetongue  virus  has  become  more  widespread  in  the  Union,  with  the 
potential  of  becoming  endemic  in  certain  areas.  It  has  therefore  become  difficult  to 
control the spread of that virus. 

The  rules  on  vaccination  against  bluetongue  laid  down  in  Directive  2000/75/EC  are 
based  on  experience  of  the  use  of  so-called  "modified  live  vaccines",  or  "live 
attenuated  vaccines"  that  were  the  only  vaccines  available  when  that  Directive  was 
adopted. The use of those vaccines may lead to an  undesired local  circulation of  the 
vaccine virus also in unvaccinated animals.  

In  recent  years,  as  a  result  of  new  technology,  "inactivated  vaccines"  against 
bluetongue  have  become  available,  which  do  not  pose  that  risk  to  unvaccinated 
animals.  The  extensive  use  of  such  vaccines  during  the  vaccination  campaign  in  the 
years 2008 and 2009 has lead to a significant improvement in the disease situation. It 
is now widely accepted that vaccination with inactivated vaccines is the preferred tool 
for bluetongue control and the prevention of clinical disease in the Union.  

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OJ L 62, 15.3.1993, p. 69. 
OJ L 327, 22.12.2000, p. 74. 

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(5) 

(6) 

(7) 

In order to ensure the better control of the spread of the bluetongue virus and reduce 
the burden on the agricultural sector posed by that disease, it is appropriate to amend 
the  current  rules  on  vaccination  laid  down  in  Directive  2000/75/EC  in  order  to  take 
account of the recent technological developments in vaccine production.  

The amendments provided for in this Directive should make the rules on vaccination 
more  flexible  and  also  take  into  account  the  fact  that  inactivated  vaccines  are  now 
available,  which  can  also  be  successfully  used  outside  areas  subjected  to  animal 
movement restrictions. 

In addition, the use of live attenuated vaccines should not be excluded provided that 
appropriate  precautionary  measures  are  taken,  as  their  use  might  still  be  necessary 
under  certain  circumstances,  such  as  following  the  introduction  of  a  new  bluetongue 
virus serotype against which inactivated vaccines may not be available. 

(8) 

Directive 2000/75/EC should therefore be amended accordingly. 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 2000/75/EC is hereby amended as follows: 

(1) 

In Article 2, the following point (j) is added: 

'(j) 

'live attenuated vaccines': vaccines which are produced by adapting bluetongue 
virus field isolates through serial passages in tissue culture or in embryonated 
hens’ eggs.' 

(2) 

Article 5 shall be replaced by the following:  

'Article 5 

1. 

The  competent  authority  of  a  Member  State  may  allow  the  use  of  vaccines 
against bluetongue provided that: 

(a) 

such decision is based on the result of a specific risk assessment carried 
out by the competent authority;  

(b) 

the Commission is informed before such vaccination is carried out.  

2.  Whenever  live  attenuated  vaccines  are  used,  Member  States  shall  ensure  that 

the competent authority demarcates:  

(a) 

a protection zone, consisting of at least the vaccination area;  

(b) 

a  surveillance  zone,  consisting  of  a  part  of  the  Union  territory  with  a 
depth  of  at  least  50  kilometres  extending  beyond  the  limits  of  the 
protection zone.'  

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(3) 

In Article 6(1), point (d) shall be replaced by the following: 

'(d) 

implement  the  measures  adopted  in accordance with  the procedure laid down 
in Article 20(2), in particular with regard to the introduction of any vaccination 
programme or other, alternative measures;' 

(4) 

In Article 8(2), point (b) shall be replaced by the following: 

'(b)  The surveillance zone shall consist of a part of the Union territory with a depth 
of at least 50 kilometres extending beyond the limits of the protection zone and 
in  which  no  vaccination  against  bluetongue  with  live  attenuated  vaccines  has 
been carried out during the previous twelve months.' 

(5) 

In Article 10, paragraph 2 shall be replaced by the following: 

'2. 

any vaccination against bluetongue using live attenuated vaccines is prohibited 
in the surveillance zone.'  

Article 2 

(1) 

Member  States  shall  adopt  and  publish,  by  30  April  2011  at  the  latest,  the  laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

They shall apply those provisions from 1 May 2011. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

(2) 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

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For the Council 
The President 

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