International Harmonisation in the Field of Pharmacovigilance from an OIE perspective

Transcription

1 Anses/ANMV OIE Collaborating Centre on Veterinary medicinal products BP FOUGERES CEDEX, FRANCE International Harmonisation in the Field of Pharmacovigilance from an OIE perspective 3 rd International Symposium on Veterinary Pharmacovigilance, Berlin, 13 th and 14 th December

2 Executive summary Presentation of the OIE Involvement in harmonisation in the field of PhV through the evaluation of performances of Veterinary Services (PVS tool) Involvement in harmonisation in the field of PhV through the VICH 2

3 Presentation of the OIE An intergovernmental Organisation Founded in 1924 by 28 countries Predates the U.N. World Organisation for Animal Health Common name adopted by the International Committee on May

4 177 Members (December 2010) Americas: 29 Africa: 52 Europe: 53 Middle-East: 20 Asia: 35 Some Members belong to more than one Region 4

5 The 6 Objectives of the OIE ANIMAL HEALTH INFORMATION: to ensure transparency in the global animal diseases and zoonosis situation to collect, analyse and disseminate scientific veterinary information ACTIVITIES OF VETERINARY SERVICES: to provide expertise and encourage international solidarity in the control of animal diseases to improve the legal framework and resources of national Veterinary Services INTERNATIONAL STANDARDS: to provide a better guarantee of the safety of food of animal origin, and to promote animal welfare, through a science-based approach within its WTO mandate, to safeguard world trade by publishing health standards for international trade in animals and animal products 5

6 Organisation of the OIE 6

7 Organisation: Specialist Commissions (1) Terrestrial Animal Health Standards Commission "Code Commission" Responsible for updating the Terrestrial Animal Health Code annually Responsible for ensuring it reflects current scientific information 7

8 Organisation: Specialist Commissions (2) Scientific Commission for Animal Diseases "Scientific Commission" Assists in identifying the most appropriate strategies and measures for: - disease surveillance - disease prevention and control methods Examines Members submissions regarding their animal health status for those countries that wish to be included on the OIE official list of free countries and zones for certain diseases 8

9 Organisation: Specialist Commissions (3) Biological Standards Commission "Laboratories Commission" Establishes or approves methods for - diagnosing diseases of mammals, birds and bees - testing biological products, such as vaccines, used for control purposes Oversees production of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Oversees the OIE global network of Reference Laboratories and Collaborating Centres 9

10 Organisation: Specialist Commissions (4) Aquatic Animal Health Standards Commission "Aquatic Animals Commission" Compiles information on diseases of fish, molluscs, crustaceans and amphibians, and on methods used to control these diseases Responsible for updating the Aquatic Animal Health Code and the Manual of Diagnostic Tests for Aquatic Animals 10

11 Organisation: OIE Collaborating centres Centres of expertise in a specific sphere of competence Anses-ANMV: unique collaborating centre for veterinary medicinal products International harmonisation OIE WHO, FAO (JEFCA, CODEX ) VICH Research and expertise antimicrobial resistance Technical assistance Bilateral and multilateral cooperation with OIE member countries (especially developing countries) 11

12 The OIE Fifth Strategic Plan MENTIONS EXPLICITLY THE NEED TO: Develop and update standards, guidelines and recommendations on diagnostic tests, vaccines and veterinary drugs including antimicrobials. Encourage the OIE members to adopt parallel standards proposed by the VICH INTRODUCES the concept of GOOD GOVERNANCE OF VETERINARY SERVICES Need for appropriate legislation and implementation through national animal health systems Quality of Services: use of OIE evaluation and gap analysis tool (PVS) 12

13 International harmonisation/phv: PVS (1) What is OIE PVS Tool? A tool for the evaluation of performance of Veterinary Services A tool for Good Governance of Veterinary services 13

14 International harmonisation/phv: PVS (2) PVS 4 fundamental components Critical competencies (6-14) 5 levels of advancement 14

15 International harmonisation/phv: PVS (3) 4 fundamental components Human, physical and financial resources Technical authority and capability Interaction with stakeholders Access to markets 46 critical competencies 15

16 International harmonisation/phv: PVS (4) 5 levels of advancement (qualitative) for each critical competency A higher level assumes compliance with all preceding levels Level 1 No compliance Level 5 Full compliance with OIE standards 16

17 International harmonisation/phv: PVS (5) Section II-9 Veterinary medicines and veterinary biologicals The authority and capability of the VS to regulate veterinary medicines and veterinary biologicals. Veterinary medicines and veterinary biologicals Levels of advancement 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. 3. The VS exercise quality control (technical standards) over the import, production and distribution of veterinary medicines and veterinary biologicals. 4. The VS exercise complete control over registration, sale and usage of veterinary medicines and veterinary biologicals. Suggested indicators Documented administrative process, including for setting fee-for-service Registration dossiers for import and production Records on performance of these functions Documented quality control procedures and results of controls Information on adverse findings and action taken Dedicated staff and/or equipment 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 17

18 International harmonisation/phv: PVS (6) After OIE/PVS evaluation: next steps OIE-PVS Evaluation = «1st Diagnostic» (qualitative) PVS Gap analysis (basis for strengthening projects) «prescription for treatment» quantitative PVS Follow Up missions Evaluation of «Evolution» Continuous missions (each1-2 years) Upon request of countries OIE-PVS Experts Monitoring and improvement process Assessment of progressive evolution of steps taken Final objective: compliance with OIE standards 18

19 International harmonisation/phv: VICH (1) What is VICH? VICH = Veterinary International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products International cooperation programme US-JAP-EU (+ AUS/NZ + Canada as observers) Created under the auspices of the OIE OIE = associated member ANMV represents OIE at VICH Steering Committees Discussion forum for Regulatory Authorities + Industry 19

20 International harmonisation/phv: VICH (2) VICH objectives: To establish harmonised regulatory requirements for veterinary medicines in the VICH regions 20

21 International harmonisation/phv: VICH (3) VICH work: developing guidelines (9 step-process) VICH Steering Committee VICH Expert Working Group 1: establishment of an EWG 2: elaboration of a draft GL 3: submission to the SC 4: release of the draft GL for consultation 5: preparation of a revised draft GL : submission to the SC 7: circulation of final GL for implementation 8: report of SC members on implementation USA, Japan, EU 9: monitoring, maintenance and review of GL 21

22 International harmonisation/phv: VICH (4) VICH guidelines in Pharmacovigilance Step 7: For implementation Step 7: For implementation Step 7: For implementation Step 4: Under consultation Step 7: For implementation VICH GL24: Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs) VICH GL29: Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Safety Update Reports VICH GL30: Pharmacovigilance of veterinary medicinal products: Controlled list of terms VICH GL35: Electronic standards for transfer of data VICH GL42: Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports 22

23 International harmonisation/phv: VICH (5) OIE/VICH Questionnaire sent in June 2009 to OIE member countries 88 Member countries answered: 26 from VICH countries 62 from non VICH countries 23

24 International harmonisation/phv: VICH (6) Results of the Questionnaire 9 countries have no legislation in place 2 developing countries 5 transitional countries 2 major transitional countries 0 developed countries 24

25 International harmonisation/phv: VICH (7) Amongst countries with legislation in place 98% of developed countries have a pharmacovigilance system in place 40 % of developing countries Pharmacovigilance Major transitional Transitional Developing 25

26 International harmonisation/phv: VICH (8) Needs expressed by developing countries VICH to assist countries with a minimal infrastructure in place OIE to assist countries in developing further regulatory framework The first priority is to assist these countries in implementing the existing GLs. Priority 1 = Quality; Safety; Efficacy Priority 2 = Pharmacovigilance Priority 3 = Ecotox 26

27 Conclusion OIE is involved in harmonisation in the field of pharmacovigilance: By supporting establishment of international standards By assisting countries in the achievement and implementation of these standards Extension of harmonisation to non-vich countries: the VICH global outreach initiative 27

28 Thank you for your attention Organisation mondiale de la santé animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 12 rue de Prony, Paris, France - oie@oie.int 28