Nutzen-Risiko Abwägung in der Zulassung von Tierarzneimitteln

Transcription

1 Nutzen-Risiko Abwägung in der Zulassung von Tierarzneimitteln 6 November 2013 J. Gabriel Beechinor Director of Veterinary Sciences, IMB Slide 1

2 Benefit/risk assessment - overview Theoretical considerations Use of the model Practical considerations Slide 2

3 Reference source Slide 3

4 Requirements for benefit-risk assessment Full applications, well-established use applications, hybrid applications, combination products» standard evaluation Generics» bioequivalence evaluation Exceptional authorisations» specific management measures Periodic safety update reports» ± depending on if new safety issues arise Slide 4

5 Elements of the benefit-risk evaluation Introduction outline of main characteristics of the product The legal basis of the approach The direct therapeutic benefits for each target species and each claim The indirect benefits The risk assessment for all relevant risks The benefit-risk balance taking into account the dose-effect relationship if relevant The conclusion Slide 5

6 Methodology Direct comparison between efficacy and tolerance Level of risk considered acceptable depends on the indication For other risks (consumer, user, environment etc) risks should be considered individually, taking into account risk mitigation measures Consideration of risk-risk scenario Slide 6

7 Examples of benefits Disease prevention, clinical or subclinical treatment Improvement of clinical condition Better quality of life Improvement of physiological status Increase of survival time or life expectancy Reduction of risk of transmission of a disease Diagnostic tool Zootechnical benefit Slide 7

8 Indirect benefits Ease of administration Palatability Longer action Cost-effectiveness Slide 8

9 Perspective of experts to benefits Product may have low-grade indication e.g. For maintenance of normal blood level of vitamins BC etc New disease in EU might not be a threat to a particular country Traditional use or ethical perspective may colour judgement Benefit may be dependent on finding a sub-group of responders Benefits might pose ethical challenges (economic but not animal welfare) Anti-parasitic products must meet certain efficacy goals Vaccines might produce herd rather than individual animal immunity New antibiotics must be restricted to certain types of indications Slide 9

10 Risk assessment Hazard identification Hazard characterisation Exposure assessment Risk characterisation Slide 10

11 General risks Target species User Environment Consumer Slide 11

12 Specific risks Antimicrobial resistance Unintended spread of a vaccine strain Reversion to virulence Slide 12

13 Perspective of experts on risks Familiarity with condition Detection of miniscule residues does not constitute a public health risk Safeguarding the general public or particular target groups New application must meet all requirements versus knowledge from experience with chemical class Do environmental trigger values trump all benefits for veterinary drugs? Are there more acceptable alternatives already authorised? Farm sizes, geographical and meteorological considerations Antibiotic resistance Precautionary principle Slide 13

14 Benefit-risk assessment Slide 14

15 The judgement decision The authorisation should be granted when the benefits have been sufficiently substantiated and when the risks are considered as acceptable, taking into account the proposed risk management measures Slide 15

16 Practical aspects of risk mitigation Irritancy» wear protective goggles Skin sensitivity» wear gloves May be toxic if ingested by children» use child-resistant containers Might be acceptable for anti-cancer drug Unlikely to be acceptable for routine wormer Slide 16

17 Other aspects Method of supply in a Member State Veterinary control versus over-thecounter Concerned Member State might not have the reference product on the market Slide 17

18 Practical suggestions in conducting a BR assessment Know your target audience Know the legal basis of the application and applicable regulatory standards in force Benefit risk is not an exact science it is a judgment call made at a point in time Slide 18

19 Schönen Dank Questions? > veterinary > veterinary medicines Slide 19