1. Control of veterinary products: the need for global standards Dr. Jean-Pierre Orand Collaborating centre for veterinary medicinal products Anses/ANMV BP 90203 - 35302 FOUGERES CEDEX, FRANCE jean-pierre.orand@anses.fr

2. Introduction Veterinary Medicinal Products (VMPs) : Veterinary tools, contributing to the improvement of animal and public health worldwide, and of food security The VMPs policy as part of the animal health policy Need for Efficacy, safety and quality of VMPs Need of a strong legislative and regulatory framework implemented through a strong and comprehensive governance linked to national veterinary services

3. OIE-VICH Mains results Questionnaire sent in June 2009 to OIE Members 2 months consultation 91 answers covering 88 Member countries – 26 from VICH countries – 62 from non VICH countries

4. 176 Member Countries (2010) 88 answers Americas: 13/29 – Africa: 24/52 – Europe: 29/53 – Middle East: 6/20 – Asia: 16/35 24 13 29 6 16

5. Human Development Index. United Nations The Human Development Index (HDI) is a comparative measure of life expectancy, literacy, education and standards of living for countries worldwide. It is a standard means of measuring well-being, especially child welfare. It is used to distinguish whether the country is a developed, a developing or an under-developed country

6. 4 Levels of Development Very High High Medium Low

7. 9 countries have no legislation in place – 2 - Low – 5 - Medium – 2 - High – 0 - Very High Legislation in Place

8. Legislation in place Manufacturing

9. Legislation in place Pharmacovigilance

10. Legislation in place Inspection

11. Infrastructure in place

12. OIE-PVS can Help to establish a diagonostic Section II-9Veterinary medicines and veterinary biologicals Veterinary medicines and veterinary biologicals The authority and capability of the VS to regulate veterinary medicines and veterinary biologicals. Levels of advancementSuggested indicators 1. The VS cannot regulate the usage of veterinary medicines and veterinary biologicals. 2. The VS has only limited capability to exercise administrative control (including registration) over the usage, including import and production, of veterinary medicines and veterinary biologicals. Documented administrative process, including for setting fee-for-service Registration dossiers for import and production Records on performance of these functions 3. The VS exercise quality control (technical standards) over the import, production and distribution of veterinary medicines and veterinary biologicals. Documented quality control procedures and results of controls Information on adverse findings and action taken Dedicated staff and/or equipment 4. The VS exercise complete control over registration, sale and usage of veterinary medicines and veterinary biologicals. Documented procedures for and evidence in regard to the collection of samples, including results, and decision making in response to findings 5. The VS implement systems to monitor the use of veterinary medicines, veterinary biologicals and their side effects (pharmacovigilance). Legislation and procedures for the control of VM and VB distribution Evidence of the systematic collection of relevant information and decisions in response to findings

13. Legislative and regulatory requirements 1.Public policy 2.Activities to be covered 3.Institutional organisation 4.Penalties and administrative action

14. Legislative and regulatory requirements 1.Public policy Written mandate with proportionate objectives and strong commitment to ensure efficiency, competence and impartiality 2. Activities to be covered All activities along the entire life of VMPs from development to usage, including residues aspects

15. Activities to be covered (All, from manufacturing to usage) Manufacturing – Good Manufacturing Practice (GMP) – inspections to assure GMP compliance… Registration – Establish transparent, effective laws and standards for drug registration – Regulate imports, clinical trials – Maximum residue limits setting – Implement market surveillance Pharmacovigilance, advertising – Ensure transparency …

16. Activities to be covered (All, from manufacturing to usage) Control – Of Veterinary medicinal products – Of residues Distribution – Regulate allocation, transport, and storage of drugs – Secure appropriate storage facilities and transport…

17. Activities to be covered (All, from manufacturing to usage) Use – Develop and engage professional associations to improve adherence to professional codes of conduct – Impose penalties for breaches of legal and ethical standards – Regulate industry interaction with prescribers…

18. Legislative and regulatory requirements 3.Institutional organisation Scope of responsibilities and mission statement Science based decision making process Human resources Fee system Transparency and communication responsibilities

19. Inspectorate Body Need for an approach in terms of inspection on the whole chain of VMPs Inspectorate body should be given the necessary ressources : legal and technical – Inspectors : Power Duties Qualifications – Transparence and communication : procedure, accreditation

20. Legislative and regulatory requirements 4. Penalties and administrative action Administrative capacities of national competent authorities The mechanism should be backed (where necessary) by Administrative sanctions as – Recall and destruction of products – Suspension or withdrawal of product, manufacturing or other licences To correct anomalies with a potential impact on health

21. Legislative and regulatory requirements 4. Penalties and administrative action Prosecution capacities : Penal measures for Repeat offending, Counterfeiting, fraudulent intent For most serious situation Fall under the relevant jurisdiction (a judge) Coordination among official services Transparency and communication

22. Legislative and regulatory requirements 4.Penalties and administrative action Role of statutory bodies The system relies also on the involvement of statutory bodies in – Developing guidelines and ethical standards – Improving adherence to professional codes of practices / conduct.

23. OIE Strategy for Veterinary Products based on complementary approaches : Development and updating of international standards and guidelines All aspects detailed about VMP governance will help in developing general or specifics standards Capacity building : legislation, infrastructure and administrative capacities Modernisation or updating of national legislation –OIE Guidelines for Veterinary Legislation are essential elements to be covered in veterinary legislation –Promote regional cooperation Support to Veterinary Services –PVS tool may be developed to VMPs governance (section II-9) Support to laboratories (national/regional)

24. Communication and training Organization of regional conferences (Dakar 2008, Damas 2009) Training of focal points (Serbia, colombia, South Africa) Collaboration and cooperation with international organisations CCRVDF, Task Force of AMR VICH OIE Strategy for Veterinary Products based on complementary approaches:

25. 12 rue de Prony, 75017 Paris, France - www.oie.int – oie@oie.intwww.oie.int Organisation mondiale de la santé animale World Organisation for Animal Health Organización Mundial de Sanidad Animal Thank you for your attention