Visegrad, 29 April 2011

1. Report on survey of implementation of legal provisions to improve availability of veterinary medicines Visegrad, 29 April 2011 J. Gabriel Beechinor

2. Background • Survey conducted in 2006 on impact of specific provisions of 2001/82/EC to address availability (as amended by 2004 directive) • 2006 conclusion was that it was still too early to gauge their effectiveness • February 2011 HMA asked that an update be provided • Survey undertaken in Spring 2011 • Same scoring system used (0-3 scale)

3. Survey details • Responses received up to 8 April 2011 • 26 countries responded (including AU, BE, BU, CY, CZ, DE, DK, EE, ES, EL, FI, FR, IE, IS, IT, HU, LT, LV, NL, NO, PT, RO, SE, SI, SK and UK) • Survey was in two sections • Use of legal provisions in MSs to meet availability needs • Views on situation and whether further measures possible without new legislation

4. Results 1 • Article 4(2) exemptions for medicines intended for aquarium fish, cage birds, homing pigeons, small rodents, rabbits etc

5. Results 2 • Article 6(3) [Horses declared as not for use for human consumption] • 2006: 1.8 • 2011: 1.5 • Article 7 [Health situation so requires..] • 2006: 2.2 • 2011: 2.0 • Article 8 [serious epizootic disease identified ...] • 2006: 2.0 • 2011: 1.8

6. Results 3 • Article 10 (1) [cascade for non food-producing animals]

7. Results 4 • Article 11 (1) [cascade for food-producing animals]

8. Results – impact of data protection 1 • 13 year data protection for fish and bees

9. Results – impact of data protection 2 • Ten year data protection extended by one year in respect of each additional food-producing species authorised within first 5 years

10. Conclusions on survey of legal tools • Are being used to a greater or lesser extent • Apart from market exclusivity provisions, most others are found to be useful (i.e. impact score > 1.5) • Cascade provisions are indispensible in most countries • Scores from current survey are lower than that in 2006 – anticipated benefits might not have materialised

11. Results of section 2 of survey • Availability – improved or disimproved? • Improved or slightly improved – 12 countries (BE,CY, DK, FI, IE, IS, LT, NO, PO, RO, SK and UK) • Mixed or unchanged – 12 countries (BG, CZ, DE, EE, EL, ES, FR, HU, IT, LV, NL, SE) • Disimproved – 1 country (IS)

12. Issues • Impact of company mergers • Only 45% of centrally authorised products are on the market in some MSs • Overall problem of availability continues, especially for MUMS • Extrapolation of MRLs helps but does not often result in marketing authorisations

13. Possible national initiatives which do not need new legislation • Proactive engagement in identifying candidate products being proposed for MRP/DCP • Fee waivers/ fee reduction • Focus only on administrative issues (rather than risking scientific discussions) • Use of Article 7 provision [the Cyprus clause]

14. Possible network initiatives not requiring legislation • Use of multilingual packs • Further commitment to the spirit of MRP/DCP • Harmonisation of SPCs • Worksharing – especially offical batch review of IVMPs • Communication of SME office, free scientific advice and fee waivers • Further support for products for MUMS • Research initiatives • Best practice sharing of experiences

15. Views on impact of Regulation 470/2009 • Does not address core issue • Even if MRLs are available, still need specific PK and/or residue data

16. Overall conclusion • Available tools are a help pending a long-term resolution of availability issue • Final solution must await legislative review • Key driver must be sufficient incentives for industry to develop new products by way of data protection • MSs can do much in the meantime by adopting a proactive but Community-centred approach • Further potential exists for use of multilingual labels

17. Many of life’s failures are people who did not realise how close they were to success when they gave up Thomas Edison Thank you