Control of veterinary products: the need for global standards Dr. Jean-Pierre Orand Collaborating centre for veterinary medicinal products Anses/ANMV BP.

Control of veterinary products: Control of veterinary products: the need for global standardsthe 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

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

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

2950

49

13

26

176 Member Countries (2010) 88 answers

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

24

13

29

6

16

Human Development Index. United Nations

Description English: The United Nations Human Development Index (HDI) rankings for 2008. 0.950 and Over 0.900–0.949 0.850–0.899 0.800–0.849 0.750–0.799 0.700–0.749 0.650–0.699 0.600–0.649 0.550–0.599 0.500–0.549 0.450–0.499 0.400–0.449 0.350–0.399 under 0.350 not available

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

4 Levels of Development

Very High

High

Medium

Low

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

Legislation in Place

Legislation in place

Manufacturing

Legislation in place

Pharmacovigilance

Legislation in place

Inspection

Infrastructure in place

OIE-PVS can Help to establish a diagonostic

Section II-9 Veterinary 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 advancement Suggested 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-serviceRegistration dossiers for import and productionRecords 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 controlsInformation 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 distributionEvidence of the systematic collection of relevant information and decisions in response to findings

Legislative and regulatory requirements

1. Public policy

2. Activities to be covered

3. Institutional organisation

4. Penalties and administrative action

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

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 …

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…

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…

Legislative and regulatory requirements

3. Institutional organisation

Scope of responsibilities and mission statementScience based decision making processHuman resources Fee systemTransparency and communication responsibilities

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

Legislative and regulatory requirements

4. Penalties and administrative actionAdministrative 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

Legislative and regulatory requirements

4. Penalties and administrative actionProsecution 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

Legislative and regulatory requirements

4. Penalties and administrative actionRole 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.

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)

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:

12 rue de Prony, 75017 Paris, France - www.oie.int – oie@oie.int

Organisation mondialede la santé animale

World Organisationfor Animal Health

Organización Mundialde Sanidad Animal

Thank you for your attention