1 / 10

The Development of a Common European Case Law on Liability for Drugs

The Development of a Common European Case Law on Liability for Drugs. Stefan Lenze, BIICL, Lovells. The Case Law on the Directive. European Court of Justice 5 National Courts about 100 relevant decisions UK 7 France 7 Spain 20 Germany 25 Austria over 50 Supreme Court decisions alone

vida
Download Presentation

The Development of a Common European Case Law on Liability for Drugs

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. The Development of a Common European Case Law on Liability for Drugs Stefan Lenze, BIICL, Lovells

  2. The Case Law on the Directive • European Court of Justice 5 • National Courts about 100 relevant decisions • UK 7 • France 7 • Spain 20 • Germany 25 • Austria over 50 Supreme Court decisions alone • Decisions on pharmaceuticals 3 • 2 on infected blood (A v National Blood Authority; Scholten) • 1 tranquilizer (Halcion)

  3. Roadmap for courts in shaping the law on liability for drugs • Risk-benefit analysis • Regulatory compliance defence • Development risks defence • Warnings: the role of the learned intermediary • Causation

  4. Risk-benefit analysis and PLD • shortcomings of expectations test • legitimate expectations ≠ not actual expectations • pharmaceuticals - a special case • public perception of risk is inadequate • harmonization with regulatory framework • DTI Explanatory Note 1985 • German Drug Act (r/b) seen to be in line with PLD • Halcion case

  5. Risk-benefit analyis and PLD (2) • Directive: “ … all circumstances … including…” • A v National Blood • All “relevant factors” • Important factors are listed: German Directive: “insbesondere”; French Directive: “notamment” • Risk-benefit would be an important factor but is not listed • Why A v National Blood is wrong: • Misinterpretation of German and French Directive • Only unimportant factors could be considered: are they relevant? • Materials from the legislative process  Listed factors are just examples • A v National Blood concerns manufacturing defect (non-standard product)

  6. Risk-benefit analysis in action The regulatory approach Assessment on basis of pre-marketing knowledge (reviews) Suspected harmful effects v prospective benefits Absolute-risk benefit analysis Possible approach of the Directive Knowledge at time of trial ( Art. 7 e) Regulatory environment at the time of circulation ( Art. 6 (1) c)  Alternative therapies Proven harmful effects v benefits “Good for any class of patients” (US Third Restatement)? Limits of judicial decision-making? not as to pharmaceuticals

  7. Regulatory compliance defence • Debate at EU Level • Suggestions by industry groups • Commission and national governments very sceptical about automatic defence • Discussed before adoption Directive • Part of the defect rule • BIICL database (e.g. German case law)

  8. Causation under the Directive • Causation as an element of the PLD • General causation is part of defect rule in Article 6 PLD • Specific causation • Substantive law: Article 1 PLD • Burden of proof: Article 4 PLD • Standard of proof: national law • Material contribution/increased risk: substantive law concept • Loss of chance: substantive law concept • Uncertainty over producer (Fairchild): substantive law concept • Reversal of burden of proof in new German Drug Act contravenes Article 4

  9. Solution for courts (and lawyers)Comparative Law • European Court of Justice does it • National Courts do it • A v National Blood Authority (PLD) • Fairchild (Negligence) • Austrian and German decisions • BIICL Database has it

  10. “There is law elsewhere!” - Lord Bingham -

More Related