1 / 9

REGULATORY COMPLIANCE DEFENCE IN EUROPE

REGULATORY COMPLIANCE DEFENCE IN EUROPE. Mark Mildred Nottingham Trent University. THE EXISTING LAW. PL Directive: article 7(d) defence that “The defect due to compliance of the product with mandatory regulations issued by the public authorities”

audi
Download Presentation

REGULATORY COMPLIANCE DEFENCE IN EUROPE

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. REGULATORY COMPLIANCE DEFENCE IN EUROPE Mark Mildred Nottingham Trent University

  2. THE EXISTING LAW • PL Directive: article 7(d) defence that • “The defect due to compliance of the product with mandatory regulations issued by the public authorities” • CPA s 4(1)(a): “that the defect is attributable to compliance with any requirement imposed by or under an enactment or with any Community obligation”

  3. CASES • No reported cases (?) • Gammagard 1994 • Immunoglobulin used in primary immuno-deficiency • Contaminated with hepatitis C virus • Said to be as a result of manufacturing process mandated by FDA

  4. THIRD REPORT ON PL DIRECTIVE • COM(2006) 496 final, 14 September 2006 • “Some stakeholders, and in particular representatives of the pharmaceutical industry, have argued strongly for the introduction of a defence of regulatory compliance, which would apply to a product whose safety was closely regulated, provided that the product complied fully with the applicable regulations” (page 11).

  5. REASONS FOR A RC DEFENCE • Certainty for all • Avoiding: failed claims • And irrecoverable transaction costs (both sides) • And payment of damages • And waste of management time • And suppression of innovation • Promoting: lower premia so lower prices • And research for new products • Licensing Authority (“LA”) best judge of entitled expectation

  6. PRACTICAL REASONS AGAINST RC DEFENCE • Few successful claims • Discipline of risk-based claimants’ funding • Adequate, stable and affordable insurance cover available • No evidence that innovation is suppressed

  7. PRINCIPLED REASONS AGAINST RC DEFENCE • Potential errors of LA • Inadequate disclosure to LA • Premature disclosure to LA • Continuing disclosure to LA (PMS) • Making those decisions justiciable ? Leads to slower, more conservative licensing process with social costs

  8. PRINCIPLED REASONS AGAINST RC DEFENCE • Satellite litigation over disclosure process • Or raised in main claim where LA has no locus • What would be ambit of defence? • Which products/industries are “closely regulated”? • Necessity (and difficulty) of amending PLD • Undermining fair apportionment of risk

  9. A PLACE FOR PRE-EMPTION? • Would EMEA mandate product information for all member states? • Cumbersome and ?inappropriate • Amend art 7(a) to provide defence where product marketed with mandated info? • In US pre-emption limited to failure to warn • Difficulty over categorisation of defect and ? cause of action

More Related