OIE Conference on Veterinary Medicinal Products in Africa: Dakar, Senegal 25 -27 March 2008

1. OIE Conference on Veterinary Medicinal Products in Africa: Dakar, Senegal 25 -27 March 2008 International Approach for Veterinary Medicinal Products (VICH) Peter Jones: IFAH

2. Harmonising to Improve the Availability of Medicines in Africa

3. What is IFAH – what is our mission? • The International Federation for Animal Health is the association representing the global animal health industry • The membership comprises 13 international R&D based companies and 26 national/regional animal health associations in many parts of the world • To act as the voice of industry in dialogue with major international bodies that impact on the animal health industry including OIE, WHO, Codex, FAO and others • To encourage and assist the development of predictable, science based regulatory processes and standards • To represent industry with a unified, global voice in dealings with governments, food industry, consumers and other stakeholders • To facilitate international harmonisation of regulatory requirements for veterinary medicines (VICH)

4. Introduction • Regulatory Infrastructure • The need for effective guidelines • Industry regulatory benchmarking survey • Impact on critical success factors • The problem of widely varying requirements globally • The solution and its implementation • Examples of local, regional and global harmonization • Relevance for Africa and this conference in particular

5. Regulatory Infrastructure – a must! • Authorisation of veterinary medicines around the world follows a similar model enshrined in legislation • Proof of quality, safety and efficacy • For vaccines additional requirements to prevent transmission of infectious agents in place (OIE Terrestrial Code underpins such requirements) • Practical implementation of an effective licensing system is based on compliance with reasoned scientifically sound regulatory guidelines • Industry welcomes and supports good regulation of medicines in a framework of scientifically based guidelines

6. The advantages>>>> • Acceptance of medicines by society at large & in the case of those for food animals, consumer confidence in their safety • Assurances on adequate protection of animal health/welfare • Data presented for non-conformity in Senegal and Cameroun in Dr Teko’s paper is clear evidence for this • Inadequacy of controls for antimicrobials is a real concern • Strong legal protection for intellectual property provides incentive to innovate and to compete • Stimulates competitive success in the animal health industry and new product development

7. Facilitating greater provision of medicines is key

8. Industry Benchmarking Survey 2007: The findings • Industry driven by and dependent on Critical Success factors • Time to market • Development Costs • In past 15 years – the world-wide market has grown 20% - but regulatory requirements have resulted in an escalation of development costs by 150% - cost of defensive research has risen by over 30% in some countries • Development time on average has increased by 4.5 years

9. The problem of widely varying requirements across the globe • One overarching problem is that veterinary requirements are often based on testing needs for human medicines • The market for vet medicines is many times smaller than its human counterpart and more complex & fragmented • Examples are many and include: • identical standards being demanded of products being administered intravenously to children as those consumed by pigs form a feeding trough. and • many active ingredients for ecto-parasiticides being subjected to the same GMP requirements as human pharmaceutical products • Widely varying requirements force companies to conduct multiple studies designed to differing protocols to meet the same efficacy and safety thresholds • Hugely demanding on financial and manpower resources • Excessive and unacceptable use of large numbers of animals

10. Recent IFAH publication

11. Possible solutions and their implementation • Regulatory authorities and the animal health industry have been collaborating to identify solutions • Discussions in many countries and regions around the world have focussed on harmonising testing for the 3 major criteria of quality, safety and efficacy • Various examples of the successful outcomes at various levels are reviewed here and their application to African countries considered • Progress has been made on a local, regional and global basis

12. Local Initiatives

13. Wales: 2008 Six Nations (Northern Hemisphere) Rugby Champions!

14. 1. Straightforward bilateral agreements • Harmonisation of Summary of Product Characteristics – SPC’s (Data Sheets) and Product Literature between UK and Ireland A simplified procedure to harmonise the SPC’s and product literature of nationally authorised products (identical in terms of formulation packaging and manufacture in both countries) so that products could be marketed using same labels and leaflets, leading to more efficient and cost effective production of packaging The process id dealt with via a harmonisation variation which is administratively assessed. Clarification paper UK Ref:#170726v1 www.vmd.gov.uk

15. 1. Straightforward bilateral agreements continued: • The Alignment of Immunological Products between the UK and Ireland A harmonisation initiative to align vaccines licensed in one of the two countries with the other especially in the case of older products to facilitate greater availability of immunologicals Clarification paper UK Ref:#167956 www.vmd.gov.uk

16. Regional Initiatives: The European Union

17. 2. Regional Harmonization • Decentralised/Mutual Recognition Systems in the European Union Since 1981 Community legislation in the EU concerning presentation and content of a regulatory application dossier has been harmonised Under this framework, guidelines on testing of medicines have been developed and are common to all 27 member states, to the extent that the criteria of quality safety and efficacy are very similar. In summary there are no fundamental differences in the requirements that have to be met for market access in any of the countries that make up the European Union

18. 2. Regional Harmonization - continued • All yield enhancers and biotech products e.g. recombinant vaccines must be licensed through a centralised agency European Medicines Agency (EMEA) in London; NCE’s & technologically innovative products may also follow this licensing route (Centralised Procedure) www.emea.europa.eu • Benefits are that one dossier is filed in the London agency and once approved allows marketing of the products in all 27 countries in one step • In West Africa there has been an excellent initiative under l’UEMOA whereby a “centralised” system by a harmonisation process of pharma. Legislation is in place • For products not eligible for Centralised Procedure the EU harmonized set of criteria and guidelines provides for a unique system of authorization by the 27 member states called the mutual recognition – decentralised system of authorisation

19. Brief Reminder of how mutual recognition can work. • Where an applicant requests national authorisations for the same product in more than one EU country, the member state to which the original application is submitted, undertakes the assessment and once approved the remaining countries are expected to mutually recognise the first/original assessment report • The only exception is where a country raises serious and justifiable doubts concerning the risk to human and or animal health or the environment • There are significant advantages in reducing the assessment work involved for the countries that agree such a system and in costs for the companies submitting the applications

20. Can it work elsewhere? • It works entirely on the principle of recognition and acceptance of an authorization of one country by another • It illustrates the benefits of countries working together to facilitate the authorisation and availability of veterinary medicines • If countries are geographically and “politically aligned”, it’s possible for the authorities to work together so one country recognises products licensed by the others • Provides for economies of scale and possibly the establishment of centres of excellence in classes of medicines e.g. antimicrobials or parasiticides • Can it work in Africa either nationally and/or regionally? • The benefits can be worthwhile and merits further consideration

21. We can make a difference • Camels and Zebu

22. Canada Europe USA Japan Australia New Zealand The VICH regions

23. “Global” harmonization – VICH – What is it? • International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), established in 1996 at OIE in Paris • It’s a programme of collaboration between the regulatory authorities and animal health industry of the European Union, Japan and the USA, which aims to harmonise the technical requirements for testing veterinary medicines. • Australia New Zealand and Canada are observers, and OIE is an Associate Member with the intention of supporting and disseminating the outcomes at worldwide level • The scope includes biologicals, vaccines and medicated premixes but excludes ecto-parasiticides • VICH is managed by a Steering Committee and when a topic is agreed for harmonization, a working group of experts is established with members made up of all the parties and observers

24. What are its objectives? • To establish and implement harmonized regulatory requirements for veterinary medicinal products in the VICH Regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development. • To provide a basis for wider international harmonization of registration requirements. • To monitor and maintain existing VICH guidelines, and, where necessary, update them. • To ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines. • By means of a constructive dialogue between regulatory authorities and industry provide technical guidance enabling response to significant emerging global issues and science that impact on regulatory requirements within the VICH regions.

25. Step 1 Concept paper to propose issueReview by SCAppointment of Topic Leader/Chairman Step 2 Step 4 Step 5 Step 3 Step 7-8 Step 9 Step 6 9 step procedure SC to review draft Guideline Official consultation in three regions EWG to produce draft Guideline EWG to review comments SC to adopt final Guideline Recommendation for review Implementation of Guideline The VICH Step Procedure

26. Has it worked? • Informed opinion says “yes” • An excellent forum for continuing dialogue and collaboration between the research based animal health industry and the regulatory bodies around the world (3 conferences held since the start),- building confidence into the system • Regular meetings between assessors working towards a consensual approach to assessment and scientific evaluation of regulatory submissions • Over 40 guidelines finalised on a very broad range of topics covering quality, safety & efficacy • Overwhelming agreement that is has helped to streamline the approval of medicines in participating countries

27. Does VICH have relevance for Africa? • YES - very definitely! – to encourage the legal sector • As African countries advance their regulatory systems, the implementation and application of VICH guidelines can align them to global systems for approving veterinary drugs • Adopting pharmacovigilance principles will provide detailed and valuable post authorisation exchange on safety of medicines • Implementing VICH guidelines will provide access for assessors in Africa to the latest scientific thinking on dossier evaluation • Can provide a platform for regional regulatory harmonization for Africa • Need to consider possibilities for involving new regions?

28. Possibility for a VICH Global Coordination Group • Consideration may be given to establishment of a VICH Global Cooperation Group • The purpose if agreed would be to make available to any country or company that requests it, the information on VICH, VICH activities and VICH guidelines. The GCG would respond to regulatory authorities or pharmaceutical companies that request information. • If established the GCG may follow the model of its human equivalent and be made up of one representative from each of the six parties on the VICH Steering Committee, and invite representatives of regional regulatory authority groups to meet with it on an ongoing basis • GCG could then serve as a unique forum for the discussion of harmonization topics and practices, with countries/regions form around the world • VERY EARLY DAYS! – will be discussed at the next meeting of the VICH Steering Committee in June 2008

29. Some closing remarks. • Get correct approved drugs to the right animals at the right time • Many papers at this meeting have reported on the excellent regulatory systems that are in place nationally • Surely this conference has to be an excellent launch pad to progress further harmonisation – regional first • We should not delay further: SEAVDRAC was in 2001! • More information needed on East African countries? • Go home to our hierarchies and get the ball rolling • Updates at OIE General Session each year hereon out might be appropriate to consider

30. Further Information? • www.ifah.org • www.vichsec.org Thank you for your kind attention