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Report on survey of implementation of legal provisions to improve availability of veterinary medicines

Visegrad, 29 April 2011

J. Gabriel Beechinor

29 April 2011 HMA Visegrad, Hungary Slide 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)

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 4

Results 1

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

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 6

Results 3

• Article 10 (1) [cascade for non food-producing animals]

29 April 2011 HMA Visegrad, Hungary Slide 7

Results 4

• Article 11 (1) [cascade for food-producing animals]

29 April 2011 HMA Visegrad, Hungary Slide 8

Results – impact of data protection 1

• 13 year data protection for fish and bees

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 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)

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 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]

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 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

29 April 2011 HMA Visegrad, Hungary Slide 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

Many of life’s failures are people who did not realise how close they were to

success when they gave upThomas Edison

Thank you

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