COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products
Date: 2014-09-10
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, health control, market approval, marketing standard, veterinary drug, veterinary inspection













EUR-Lex - 52014SC0274 - EN











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52014SC0274

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products /* SWD/2014/0274 final */









1.           problem definition
Directive
2001/82/EC and Regulation (EC) No 726/2004 provide the legal environment on the
manufacture, authorisation, marketing, distribution and use of veterinary
medicines. Over the years, this regulatory framework has been amended in
response to scientific advances and the needs of the veterinary sector.
However, stakeholders and Member States have expressed concerns that the
current legislation is no longer fit for purpose and have reported an overall
lack of authorised veterinary medicines for minor species (such as bees), for
rare or emerging diseases and for some diseases in major species. This lack of
veterinary medicines poses significant animal health and welfare problems, increased
risks for human health, and economic and competitive disadvantage for EU
farming.
Veterinary
medicine is private medicine and therefore product development by the industry y
is driven by successful returns to investments. The veterinary pharmaceutical
market is a multi-species and a pluri-national market. Furthermore, the
requirements and procedures for obtaining a marketing authorisation to a
veterinary medicine and for keeping it on the market are complex and generate administrative
burdens to the pharmaceutical industry (estimated to be of 13% of the total
turnover of the sector). These factors, and a legislation which is not suited
to innovation, interfere with returns to investments and are at the
root-problem of the lack of available authorised veterinary medicines. 
2.           need
for eu action and subsidiarity
Legislation
in the area of internal market (Art 114 of the Treaty on the Functioning of the
European Union - TFEU) and regarding standards of quality and safety for
medicinal products (Art 168(4) (b) TFEU) is a shared competence between Union
and Member States. Directive 2001/82/EC and Regulation (EC) No 726/2004 are based
on Articles 95 and 152 (4)(b) of the Treaty establishing the European Community
respectively. Incorrect transposition of the provisions of
the Directive has led to different levels of public and animal health
protection and created obstacles to the functioning of the internal market. Action
at the EU level to draw up a harmonised and proportionate regulatory framework
on veterinary medicines would create an improved, modern legal environment, thus
improving the veterinary sector in general.
3.           objectives of the eu
initiative
The
objective is to improve the functioning of the internal market whilst maintaining
the level of animal, public health and environmental protection and improving
the availability of medicines across the Union. This would require improving
the regulatory environment to:
1)         simplify
the regulatory environment and reduce administrative burden;
2)         stimulate
the development of new veterinary medicines;
3)         facilitate
the circulation of veterinary medicines across the EU.
4.           policy options
Policy options were grouped by specific objectives. “No new EU
action” (options 1, 6, 12, 15, 21, 23, 27) was taken as the baseline
scenario against which the other options were evaluated in this report.
Policy options to expand the market beyond the top four animal
species 
Option 2 - Improve the Cascade – to modify
the Cascade to allow veterinary surgeons to choose the best available treatment
to animals under their care.
Option 3 – Expand the database to cover all veterinary medicines – to create a single, comprehensive EU database. 
Option 4 – Reduced data requirements for medicines for limited
markets - to facilitate the authorisation of some
types of veterinary medicines. 
Option 5 – Reduced data requirements for medicines for bees. 
Policy options to simplify procedures for obtaining a marketing
authorisation in multiple national markets
Option 7 - Automatic recognition of a national marketing
authorisation.
Option 8 - Single marketing authorisation procedure for all products – to ensure that following the assessment of an application a
single decision would be adopted by the Commission or an authorisation issued
by all Member States. 
Option 9 – Wider scope for the centralised procedure – to extend the scope of the procedure to make it available, to all
types of products.
Option 10 – Simpler packaging and labelling – to allow the use of standard pictograms and abbreviations. 
Option 11 – Already nationally approved veterinary medicines allowed
to freely circulate across the Union - to “roll out”
across the EU of “legacy” veterinary medicines which already have a marketing
authorisation in one Member State. 
Policy options to review data requirements in marketing authorisation
procedures
Option 13 – Generic applications may refer to environmental data. 
Option 14 – Harmonisation of clinical trials procedures across the EU.
Policy options to simplify post authorisation requirements)
Option 16 – Risk-based pharmacovigilance

Option 17 – Review procedures to change a marketing authorisation
(variations) – to further simplify variations to a
marketing authorisation. 
Option 18 – Delete the obligation to market a product within 3 years
of approval. 
Option 19 – Delete the automatic requirement for renewals. 
Option 20 – Exempt homeopathic veterinary medicines from
pharmacovigilance requirements.
 
Policy options for breakthrough medicines 
Option 22 - Extend the data protection period for new veterinary
medicines: to extend the overall data protection
period to a maximum of be twenty years and create particular provisions for certain
medicines.
Policy options to clarify rules on internet retailing, on the
authorisation of new treatments, on inspections and on authorisation of medicines
for emerging diseases 
Option 24 – Authorisation to sell veterinary medicines through the
internet in all Member States. 
Option 25 – Establish a framework to authorise new treatments. 
Option 26 – Establish a basis to harmonise the controls on the
veterinary medicine distribution chain. 
Option 4 – Reduced data requirements for veterinary medicines for
limited markets.
 
Additional policy options to strengthen the veterinary medicines
legislation regarding the authorisation and use of veterinary antimicrobials in
veterinary medicine
Option 28 - Introduction of legislative measures to allow
restrictions to be placed on the authorisation and use of veterinary
antimicrobials 
Option 29 - Measures regarding advertising of veterinary medicines,
including antimicrobials Option 30 - Measures
regarding retailing of veterinary antimicrobials - Veterinary surgeons
would not be allowed to supply antimicrobials for animals.
Option 31 - Introduction of a legal basis for the compulsory
collection of data on the use of antimicrobials 
5.           assessment of policy
Options and Comparison of options
Main costs and benefits
of the policy options
The
baseline used was “no new EU action” (no changes to the current provisions) 
Costs and benefits of options to expand market beyond the top four
animal species 
Option 2 - Improve the Cascade – benefits to animal health and welfare; food safety, public health
and the protection of the environment will still remain assured. 
Option 3 – Expand the database to cover all veterinary medicines – more transparency to the sector and benefits to animal and public
health
Option 4 – Reduced data requirements for medicines for limited
markets – more medicines for minor species and
minor uses, and for use in an emergency.
Option 5 – Reduced data requirements for medicines for bees – more medicines for bees 
Costs and benefits of options to simplify the authorisation
procedures
Option 7 -Automatic recognition of a
national marketing authorisation – reduced
administrative burdens on companies (estimated savings of 67.9 million euros
per year); benefits to the free movement of veterinary medicines in the Union. Differences in resources, expertise, policy context and geographical animal health
might affect the focus of the dossier assessment rendering the opinion of a
specific competent authority not acceptable to other countries.
Option 8 - Single marketing authorisation procedure for all products – reduced administrative burden to the industry by ca 67.9 million
euros per year. Regulators concerned that the lack of a peer review stage might
affect the quality of individual marketing authorisation assessments. 
Option 9 – Wider scope for the centralised procedure – more flexibility and choice; savings in administrative burdens to
the pharmaceutical industry of 5.6 million euros per year. 
Option 10 – Simpler packaging and labelling – reduced administrative burden to the pharmaceutical
industry.  
Option 11 – Allow already nationally approved veterinary medicines
to freely circulate across the Union – reduced administrative
burdens to the industry by ca14.2 million euros per year. 
Costs and benefits of options to review data requirements for
marketing authorisation procedures
Option 13 – Generic applications may refer to environmental data – reduced administrative burden to the
industry, leading to an increase in the number of generics, increasing
competition and thus driving down the prices to end-users. No negative impact
on the environment expected. 
Option 14 – Harmonisation of clinical trials procedures across EU – reduced administrative burdens to the pharmaceutical industry and
benefits to SMEs
Costs and benefits of options to simplify post authorisation
requirements
Option 16 – Risk-based pharmacovigilance
– reduced administrative burdens to the industry worth
47.2 million euros per year. 
 Option 17 – Review of procedures to change a marketing
authorisation (variations) –
reduced administrative burdens to the pharmaceutical industry by 10.9 million
euros per year, reduced costs and resources to the competent authorities.  
Option 18 – Delete the obligation to market a product within 3 years
of approval –benefits in particular
to SMEs; improved availability of medicines.
Option 19 – Delete requirements for renewals –reduced administrative burdens to the pharmaceutical
industry of ca 67.5 million euros per year; efficiency measure to the competent
authorities.   
Option 20 – Exempt homeopathic veterinary medicines from
pharmacovigilance requirements simplifies the requirements for homeopathic medicines; potential
increased risk to animal health. 
Costs and benefits of options to review incentives for breakthrough
medicines 
Option 22 - Extend the data protection period for new veterinary
medicines –benefits to innovation and better
availability of veterinary medicines. 
Costs and benefits of options to clarify rules on internet
retailing, on authorisation of new treatments, inspections, authorisation of
medicines for emerging diseases
Option 24 – Authorisation to sell veterinary medicines through the
internet in all Member States – better operation of the internal market; more business
opportunities; increased competition and thus greater accessibility of veterinary
medicines. Benefits animal and human health. Some increased costs to the national
authorities to introduce procedures to regulate the sector. 
Option 25 – Establish a framework to authorise new treatments – harmonisation on the area and improved
animal health across the Union; improved internal market. 
Option 26 – Establish a basis to harmonise the controls on the
veterinary medicine distribution chain – an improved level playing field across the Union regarding control
activities. Some increased costs to national authorities to improve their inspections
programmes.
Costs and benefits of additional options to strengthen the
veterinary legislation regarding authorisation and use of antimicrobials in
veterinary medicines
Option 28 - Introduction of legislative measures to allow
restrictions to be placed on the authorisation and use of veterinary
antimicrobials – Benefits  to
human health. Some savings to the pharmaceutical industry and the national
competent authorities due to reduced referrals. Some loss of income regarding
the sales of some types of antimicrobials. Some negative impact on the
availability of medicines. 
Option 29 - Measures regarding advertising of veterinary medicines
including antimicrobials less
pressure from farmers and pet owners on veterinary surgeons for the
prescription of certain types of “convenient” antimicrobials so benefits to
public health. Less information on veterinary medicines being transmitted to
end users. 
Option 30 - Measures regarding retailing of veterinary
antimicrobials – Significant
negative economic impact on veterinary practices; unclear if there is any
significant positive effect on public health. 
Option 31 - Introduction of a legal basis for the compulsory
collection of data on the use of antimicrobials – some increased costs to the national authorities. Benefits to animal
and public health. 
Preferred choice of options: 
The
preferred options were compiled in a single package, designed to improve the
availability of veterinary medicines without sacrificing standards to public
and animal health and safety to the environment. This package would deliver a
total reduction of administrative burdens to the industry of at least 145.4
million euros per year: 
The
preferred option regarding the authorisation of veterinary medicines extends
the scope of the centralised procedure (option 9), making it optional, whilst
still maintaining the possibility of national authorisations. It introduces
flexibility to the system whilst still allowing the pharmaceutical industry to benefit
more from the centralised procedure. The measures to simplify the packaging and
labelling of veterinary medicines (option 10), renewals (option 19), variations
procedures (option 17) and pharmacovigilance (option 16) should significantly
reduce the administrative burdens to the industry and therefore free resources
for the development of innovative medicines. The preferred package also
introduces measures to extend the period of data protection for new
developments including medicines for bees (options 22 and 5), which should improve
the availability veterinary medicines. 
The
removal of an inconsistency within the legislation to allow the protection
period for safety data to cover environmental data (option 13) could bring
benefits to animal and public health by encouraging applications for generics
and so improve price-competitiveness. It will also be possible for companies to
join efforts to generate data on particular substances (option 11), to cover
any deficiencies regarding information on safety to the environment that might
be detected. 
The
“rolling out” of “legacy products” already authorised in the EU (option 11) could
reduce administrative burdens in the long term and increase the range of
veterinary medicines available across the Union. This could also reduce the
price of medicines through improved competition. In addition, the introduction
of a legislative basis for the regulation of internet retailing (option 24) could
stimulate business growth, improve competition and accessibility of medicines
to end-users. 
The
options to regulate the authorisation of new treatments (option 25), improve
the Cascade (option 2), reduce data requirement for medicines for limited
markets (option 4), and improve the database for products authorised in the Union (option 3) would benefit animal health.
An
improved harmonisation of controls carried out on the distribution of
veterinary medicines (option 26) would further benefit animal and public health. 

The
Union rules apply to all veterinary medicines, and any safety risks to the
animals, users, consumers and the environment are the same irrespective of the
size of the business. Therefore no exemptions could be specifically created for
SMEs. However, their concerns were taken on board and it is proposed to
harmonise the authorisation procedures for clinical trials across the Union (option 14), to remove of the Sunset clause (option 18) and to introduce measures to assist
SMEs at national level (option 9). 
The
package of preferred options tackles the issue of antimicrobial resistance and
introduces provisions to minimise risks to public health arising from the authorisation
and use of antimicrobials (option 28), to harmonise the collection of data
(option 31), to incentivise the development of antimicrobials specific for
veterinary medicine (option 22), and to clarify the rules regarding advertising
of prescription medicines, including antimicrobials (option 29). These measures
take on board the need to promote the continued availability of effective
antimicrobials for use in veterinary medicine whilst at the same time support
their responsible use, to contribute to the management of antimicrobial
resistance in humans.
Regarding
the choice of legal instrument, the analysis of the problems identified with
the current legislation, the objectives of the proposal, and in light of the
Articles 114 and 168 (b) TFEU, led to the conclusion that the proposal should
take the form of a Regulation. This sets out clear and detailed rules which
will become applicable in a uniform manner across the Union. The choice of a
Regulation still allows Member States to retain their competence for granting
of marketing authorisations, enforcement, authorisation of clinical trials,
pharmacovigilance monitoring, and authorisation of wholesalers and retailers of
veterinary medicines.
6.           Conclusions, Monitoring
and Evaluation
The
key indicators to assess whether or not the review has achieved its objectives
will be, for example, the volume of novel veterinary medicines authorised,
applications submitted by SMEs, variations submitted, infringements, internet
retailers authorised across the Union. These data will be evaluated 10 years
after the implementation of the legislation.