General Presentation - EMVDEuropean Manufacturers of Veterinary Diagnostics

Johanna Koolen Chair of EMVD - European

Manufacturers of Veterinary Diagnostics

EMVD History – Who are we? Members Engagement Our “Know-How” Regulations on veterinary diagnostics in Europe Priorities Objectives

A bit of History…

First official meeting in March 2006 in Brussels Defend the interests of manufacturers of Animal Health Diagnostics Headquarters based in Paris in SIMV offices Many small or medium sized companies Our members operate under ISO 9001, at least Together we represent the majority of veterinary diagnostics producers in the world:

Most members have global presence

Concentration of this market in EU ( “Diagnosis Approach” vs. “Vaccination Approach”)

We are especially well represented in Western Europe

Pre

sen

ce E

MV

D M

emb

ers

Board members

Secretary: Annita Ginter, BioX Diagnostics, Belgium

Tresurer: François Merit, IDEXX, France

Vice President: Liesbeth Jacobs, Prionics, Netherlands

Vice President: Malik Merza, Svanova, Sweden

Vice President: Serge Leterme, IDEXX, Switzerland

Chair: Johanna Koolen, Life Technologies, France

Secretariat: SIMV, France: Claire Baradat

Web site: www.aefrv.eu

EMVD engagements Be a recognised stakeholder on an international level (because of our global presence) for NGOs such as OIE

Participation as “Observer” in the OIE ad hoc group on Validation of diagnostic assays

Representation of the AH diagnostic sector in IAEA/FAO/OIE joint meetings on the validation of diagnostics

Be a recognised stakeholder on an EU level towards regulators, committees, veterinary health industry

DG Sanco Vaccine task force

Animal Health Advisory Committee AHAC (DG Sanco)

Executive board of the European Technology platform for global animal health

Project Management Board of Discontools

We currently request DG Sanco for a suitable regulatory framework

What can we do for you? We bring highly innovative products on the market:

SMEs w

ith ve

terin

arian

s

leadin

g th

e bu

sines

s

and

which

prov

e gr

eat

reac

tivity

and

flexib

ility

Knowledge on technology

and regulatory requirements

(veterinary, food safety and

human diagnostics)

LEADERS in

Biotechnology, key

players in the Life

Science market , who

provide “high-tech”

solutions

Certai

n mem

bers

are p

art

of an

imal

healt

h vac

cine

and p

harm

aceu

tical

compa

nies

Our know-how

highly innovative products

What can we

offer?

EU Regulatory situation for Diagnostics in Animal Health

Regulation per disease by EU directives (CSF, Aujeszki’s Disease, Rabies, Bluetongue…)

27 different ways to interpret an EU directive

Resulting into burdensome situations where products need marketing authorisations in some countries, or batch liberation in others, or both…

In countries where no regulation exists, public labs are responsible for executing the tests and may decide to use in-house tests

OIE has made an attempt to provide a harmonised procedure, but is however poorly used, because countries do not recognise the OIE procedure next to their national procedure

EMVD Priorities

Dia

log

with

EU

com

mis

sion

: F

ind

supp

ort

for

an

AH

IV

D d

irect

ive

Promote mutual recognition of batch control byEU Member States

Express need for Harmonization

to regulate veterinary Diagnostics in the EU

Denounce Unfair competition from public laboratories

Dialo

g w

ith NG

Os (O

IE, F

AO

, ..): converge interests

support initiatives for harmonisation

Objectives

Support / drive the initiative of a legal framework for AH diagnostics and defend the “Problem definition” we sent to DG Sanco

Partner animal Health initiatives:

OIE, FAO and IAEA

Epizone

Discontools

ETPGAH

EPRUMA

….