10 MLE

ETPGAH meeting - CG3 Regulatory Issues: 

ETPGAH meeting - CG3 Regulatory Issues Brussels 17.11.06 Meredith Lloyd-Evans MA VetMB MRCVS FTOPRA

TASKS: 

TASKS To address 6.3.1: Undertake an assessment and comparison of the different drivers for regulation of veterinary medicines as compared to human medicines In order to design specific research programmes To better support the specific requirements of the veterinary regulatory environment

DRIVERS for VMP regulation: 

DRIVERS for VMP regulation Programmes for animal health - generally an agfood [and therefore economic] issue Data and performance requirements for animal health products - a compliance and regulatory issue, health & welfare Trade criteria - an economic issue with international implications Feed the regulatory crocodile (expectations and fees)!

COMPARABILITY WITH HUMAN MEDICINES REGULATION: 

COMPARABILITY WITH HUMAN MEDICINES REGULATION Programmes for animal health - MEDIUM Data and performance requirements for animal health products - HIGH Trade criteria - DEPENDS The ‘regulatory crocodile’ - AREA OF CONCERN

Programmes for animal health: 

Programmes for animal health 1 Control of diseases causing loss of productivity including deaths – example rinderpest, pasteurellosis 2 Maintaining safety of food products from animals – example tuberculosis, brucellosis, cysticercosis 3 Reducing or eliminating hazards of zoonoses – example avian influenza, viral encephalitides, West Nile virus

Data and performance requirements for VMPs/bios: 

Data and performance requirements for VMPs/bios is there a difference between developing and established intensive-farming states – quality, safety, efficacy? contextual issues agricultural use of animal health products – human exposure cost-benefit analyses: GDP, value of life, cost of death herd/flock disease management not individual focus – impact on efficacy demands VICH or contextual reference?

Trade criteria - questions & challenges: 

Trade criteria - questions & challenges international trade in VMPs/bios Should those made in developing countries be ‘inferior’ to those in EU/US/Japan? Problem of counterfeiting international trade in foods of animal origin Does it matter what standard of VMP has gone into the animals as long as traded foods do not pose health concerns (residues, contamination, microbiological)?

Context of SRA regulatory projects: 

Context of SRA regulatory projects Species issues: VMPs in general versus human MPs Regional issues: VICH versus others Market issues: Fragmented nature of animal health markets & targets compared with human pharms/bios R&D investment: animal health vs human health Regulatory creep & crocodile-feeding

Suggested gradation of requirements for regulatory rigour of VMPs: 

Suggested gradation of requirements for regulatory rigour of VMPs 1 Control of diseases causing loss of productivity: MODERATE - economic impacts & population dynamics should guide what’s expected 2 Maintaining safety of food products: IMPORTANT AND HIGH - but accurate daily intake/exposure levels needed to decide safety, residues, disease prevention levels needed 3 Reducing or eliminating hazards of zoonoses: ABSOLUTELY IMPORTANT - but incidence of animal disease and actual data on transmissibility are needed to guide regulatory context

6.3.1 - Animal health vs. human - questions & challenges: 

6.3.1 - Animal health vs. human - questions & challenges ‘Nice to know’ or even ‘don’t really need to know’ dressed up as ‘must know’ Degree of scientific confidence of assessors from country-to-country, unit-to-unit Degree of freedom within policy Industry understanding of when policy triggers or science triggers are most important Imperfect understanding by regulators of costs of compliance versus useful impact Balance of ‘de-risking in theory’, at a high cost, versus real-life context Variable state, farm and personal incomes, no general ‘National Health Services’

6.3.1 - Animal health vs. human - potential projects: 

6.3.1 - Animal health vs. human - potential projects Specific study of impact versus cost of following new guidelines - eg ERA, gastrointestinal flora Case study of costs of setting up reference laboratory to qualify new bios strains of rapidly-evolving pathogens eg influenzavirus Case study of electronic data submission - industry-driven output Detailed analysis of cost reductions possible in MUMS initiative (inc. Availability of Medicines Task Force) “Social anthropology” study of how to moderate regulatory demands - powers of persuasion

Impact versus cost of following new guidelines: 

Impact versus cost of following new guidelines Volunteer[s] from AHI to provide specific examples, eg ERA or impact on GI flora Basic question 1: What are the ‘must know’, ‘should know’, ‘nice to know’ and ‘don’t need to know’ aspects? Basic question 2: Do the requirements exist in a vacuum or do they take full enough account of the context of use? Hopeful outcomes What are the costs of deriving the different categories of demanded information? What are the chances that full answering of each demand will de-risk the impact of use? Is the additional de-risking worth the additional cost? A common understanding of data categories

Setting up a reference laboratory: 

Setting up a reference laboratory Relevant for a fast-moving disease of serious animal productivity or health&welfare impact Additional importance if a known or potential zoonosis Requires more than individual companies volunteering Industry needs to collaborate on this concept, which seems a real platform initiative, non-competitive Has much to offer in terms of industry-institute/Government relations Can be internationalised via FAO-WHO-OIE

Electronic data submission: 

Electronic data submission Under study at moment via TIGes group (vet Heads of Agencies sub-committee) Principle of not transposing human requirements seems accepted on paper Industry position set out by IFAH; AVC also involved in TIGes group, but no firm costs yet for worst case scenario Industry can create its own cost models, based on what is doable now and then potentially doable with ICT improvements over next 5 years, and drive the process towards realistic shape Needs of SMEs as well as large companies

Cost reductions possible in MUMS initiative : 

Cost reductions possible in MUMS initiative AVC has already responded to CVMP’s QSE proposals on MUMS and pinpointed very poor savings for industry Scope of problem has not been properly pulled together yet, in context of: Article 79 (D McKay at EMEA) Task Force on Medicines Availability (Gabriel Beechinor and vetHMA) EU-wide and region-to-region needs Role of EU companies in achieving benefits for Africa, Asia, S&C America Paper study in consultation with industry and regional disease authorities is indicated

Moderating regulatory demands: 

Moderating regulatory demands We don’t always know how to moderate regulatory demands - ie ‘starve the crocodile’ Is it: By scientific argument By political and policy negotiation By economic argument By lateral thinking By ensuring large company budgets don’t promote regulatory creep By less defensive sharing of information in industry? Is there room for a psychological or sociological study on this kind of power struggle?