Harmonisation, Standardisation and approval of diagnostic kits

1
Harmonisation, Standardisation and approval of
diagnostic kits
Manufacturers point of view on validation of
veterinary diagnostics Seeking an efficient
harmonised regulation
EMVD - European Manufacturers of Veterinary
Diagnostics
2
EMVD

• History Who are we?
• Members
• Animal Health diagnostics, Why?
• Achievements
• Existing Regulations.
• Priorities
• Products
• What do we do before marketing a product?
• Objectives

3
A bit of History

• First official meeting in March 2006 in Brussels
• Defend the interests of manufacturers of
  Diagnostics for Animal Health
• Headquarters based in Paris
• Many small or medium sized companies, some large
  companies but with small veterinary activity
• 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)

4
Presence EMVD Members
5
Board members

• Secretary Annita Ginter, BioX Diagnostics,
  Belgium
• Tresurer François Merit, IDEXX, France
• Vice President Liesbeth Jacobs, Prionics,
  Netherlands
• Vice President Jacques Delbecque, Ingenasa,
  Spain
• Vice President Jean-Luc Troch, IDEXX, Europe
• Chair Johanna Koolen, Life Technologies, France
• Secretariat SIMV, France
• Web site www.aefrv.eu

6
Animal Health Diagnostics. Why?

• Human and animal health are closely related and
  should be considered as one
• Some facts
• 75 or more of emerging diseases originate from
  animals
• Neglected zoonosis continue to threat human
  health
• Tuberculosis 1.4 M deaths in 2010 (source WHO)
  Rabies 55 K deaths in 2010 (note 50 are
  children) Brucellosis Anthrax
• Improved Animal Health provides possibilities
  for poverty alleviation (necessary to meet the
  Millennium goals)
• Animals are protein providers through milk or
  meat, and provide work force
• Example Worldwide Rinderpest eradication
  considerably improved welfare
• Economic reasons International Trade of animals
  becomes impossible when some diseases are present
  (Food and Mouth Disease)

7
Achievements

• We became a recognised stakeholder on an
  international level (because of our global
  presence) for international organizations such as
  OIE
• Observer in the OIE ad hoc group on Validation
  of diagnostic assays
• Representation in IAEA/FAO/OIE joint meetings on
  the validation of diagnostics
• We became a recognised stakeholder on an EU
  level towards regulators, committees, veterinary
  health industry
• Animal Health Advisory Committee AHAC (DG Sanco)
• Executive board of the European Technology
  platform for global animal health
• Project Management Board of Discontools
• Request was formulated to DG Sanco for a suitable
  regulatory framework
• Participation to EPRUMA (European Platform for
  the Responsible Use of Medicines in Animals)

8

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

Our know-how

highly innovative products
LEADERS in Biotechnology, key players in the Life
Science market , possibilities to provide
high-tech solutions
SMEs led by veterinarians which prove great
reactivity and flexibility for development of new
products
What can we offer?
Knowledge on technology and regulatory
requirements (veterinary, food safety and human
diagnostics)
Collaborations with animal health vaccine and
pharmaceutical companies as well as important
opinion leaders
9
Regulatory situation in Europe for Animal Health
Diagnostic Products

• Regulation per disease by EU directives, such as
  Aujeszkis Disease, tuberculosis, Brucellosis,
  etc. for which many countries have reached the
  disease free status now
• 28 different ways to interpret an EU directive
• Some countries have registration process
  (Germany, Spain), or apply norms (AFNOR in
  France) Result burdensome situations where
  products need marketing authorisations in some
  countries, or batch liberation in others, or
  both
• OIE published a procedure providing
  harmonisation opportunities. Unfortunately it is
  not considered an alternative procedure by
  countries with registration procedures
• The EMVD supports the harmonization effort
• Mutual recognition is necessary in order to
  lighten the regulatory administrative burden

10
EMVD Priorities
Express need for Harmonization to regulate
veterinary Diagnostics in the EU
Denounce Unfair competition from public
laboratories
Promote mutual recognition of batch control
by EU Member States
11
Our products in a flash

• The following is a non-exhaustive listing of the
  different veterinary diagnostic products we
  offer
• Many different techniques are available to
  demonstrate the presence of antibodies
• ELISA techniques are the most commonly used today
  but other techniques such as Agglutination
  tests Complement Fixation tests Slow
  agglutination test (Wright) are still used and
  available
• The following techniques are used to demonstrate
  the presence of antigens
• Nucleic acid detection methods, mostly PCR
  techniques
• ELISA techniques (capture, or sandwich)
• Classical techniques such as culture and staining
• The above techniques are not exclusive but can
  -and sometimes should be- used in complement
  (antigen and antibody detection)

12
ELISA principles
13
PCR principle
14
PCR principle
Source www.ugent.be
15
What do manufacturers do before marketing a
veterinary diagnostic?

• Emergence of a need (epidemic, eradication
  plan, etc.)
• Partner with disease expert(s) Control of the
  IP (Patents,...) Market and RA overview
• Develop prototype kit Feasibility - Cost of
  Production (Raw Materials)
• Initial validation on limited number of samples
• Design verification /optimisation
• First batches of products, used for Validation
  studies sensitivity, specificity, sample
  treatment if applicable, robustness, external
  validation with collaborators, QC procedure and
  QC panel, etc.
• Results are documented (QA system, validation
  and/or registration dossier)
• Registration where necessary, with registration
  dossier and samples for testing

16
Quality control process

• Quality controls are performed in various stages
  of the production process
• Critical ingredients are submitted for
  acceptation before entering the production
  process
• Quality control standards are used throughout
  the process to guarantee that components fit the
  specifications
• Individual components are tested and compared
  with former batches, and final batch control is
  performed with a control panel for release
  testing
• Our procedures are designed to minimize batch to
  batch variations
• If required, the batch is sent for release to
  the relevant authorities

17
Why are products used for eradication in Europe
interesting for other markets?

• Commercial veterinary diagnostic products have
  been on the market since more than 20 years and
  have proved their effectiveness in disease
  eradication
• They are available for markets outside of Europe
  where the disease prevalence is higher and are
  reasonably priced (ex. Brucellosis ELISA, )
• New techniques are available (PCR) and well
  adapted for Antigen detection, providing rapid
  confirmation ((para)tuberculosis).
• The EU has an interest to stimulate the
  improvement of herd-health status of countries
  close to Europe to prevent reintroduction of
  eradicated diseases

18
Objectives for the future

• Continue to develop kits for emerging diseases
• Continue to propose (new) well validated Kits
  (ELISA, PCR, .) to the final costumers
• Harmonize Validation/Registration processes of
  these tools
• Needs internationally recognised standards
• Could OIE lab network help?
• World wide acceptance of technologies
• ELISA technologies used since decades and
  successfully used for disease eradication
• PCR real time technology provides reliable assays
  for detection of targets in various matrices
  (microorganisms in patient or environmental
  sample material)

19
Thank you