Control of veterinary products: the need for global standards Dr. Jean-Pierre Orand

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 29 6 13 16 24 Americas: 13/29 – Africa: 24/52 – Europe: 29/53 – Middle East: 6/20 – Asia: 16/35

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-9 Veterinary medicines and veterinary biologicals

13. Legislative and regulatory requirements • Public policy • Activities to be covered • Institutional organisation • Penalties and administrative action

14. Legislative and regulatory requirements • 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 • 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 • 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. OIE Strategy for Veterinary Products based on complementaryapproaches: • 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

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