english.prescrire.org > Topics > Advancing healthcare policy > Transparent, independent health authorities > Actions vis-à-vis regulatory agencies > "Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (10/2015)

Advancing healthcare policy

Transparent, independent health authorities

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies
"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (October 2015)

Paris, 19 October 2015

Joint briefing paper.  "Adaptive pathways" raise numerous concerns from a public health perspective. The organisations that endorse this statement have closely monitored developments in EU pharmaceutical regulation for many years and put forward a critique of the "adaptive pathways concept".  Implementing adaptive pathways could lead to a situation where premature marketing authorisations become the rule, even when no genuine public health need exists, therefore putting EU citizens' health unnecessarily at risk.

> Click here to download the Joint Briefing Paper (pdf, 370 Ko)

Executive summary

  • "Adaptive licensing" (AL), also called "adaptive pathways" (AP) or Medicines Adaptive Pathways to Patients (MAPP) aims to allow medicines onto the market faster, based on lower evidence requirements than under a conventional marketing authorisation. The main claimed benefits of AL are that patients will gain "earlier access" to new medicines and that companies will benefit from "an earlier revenue stream (…) and less expensive and shorter clinical trials".
     
  • "Adaptive pathways" raise numerous concerns from a public health perspective. The organisations that endorse this statement have closely monitored developments in EU pharmaceutical regulation for many years and put forward a critique of the "adaptive pathways concept".
     
  • First, we highlight the importance of maintaining the requirement for solid efficacy and safety evidence before a medicine is approved for marketing as the cornerstone of pharmaceutical regulation. We also explore the origins of the "adaptive pathways" concept and debunk the myths supporting this approach.
     
  • Second, we outline the main lessons learnt from current initiatives providing faster patient access to new medicines.  This overview includes a short insight into the new business paradigm of the pharmaceutical industry – the "nichebuster" model.
     
  • Third, our critical assessment of the adaptive licensing/pathways "concept" reveals potential consequences to patients' and society at large by shifting, even more, the burden of evidence from pre-marketing to post-marketing. There is no public health rationale to support such a move. In addition, "adaptive pathways" allows control by industry of other stakeholders, such as health technology assessment bodies, healthcare professionals and patients.
     
  • Finally, faster market access and escalating drug prices are not proper incentives for real drug innovation. On the contrary, to ensure access to medicines for unmet medical needs, we offer pragmatic recommendations to:
    • Demand a robust evaluation of new drugs prior to marketing authorisation (introducing the demonstration of added therapeutic value);
    • Ensure that conditional and expedited approval mechanisms are only used in duly justified circumstances (e.g., when there is a true unmet medical need);
    • Uphold the rights of EU citizens to obtain compensation from drug- or medical device-induced harm;
    • Ensure greater transparency of clinical data, including pharmacovigilance data from regulatory agencies;
    • Reinforce the independence of drug regulatory agencies from corporate influence and funding;
    • Support needs-driven R&D models as an alternative to corporate-driven R&D.

©HAI, ISDB, MiEF October 2015

> Click here to download the Joint Briefing Paper (pdf, 370 Ko)