Making the Difference: Pharmaceutical Access and Value

30 May 2023

Pharmaceutical access and value are currently in the spotlight, as stakeholders review new proposals from the European Commission to update the EU’s regulatory framework for pharmaceuticals.

With this in mind, the European Cancer Organisation brought together policymakers, patient advocates, healthcare professionals, industry representatives and other experts, to analyse the political and regulatory landscape and identify potential consensus recommendations.

Discussions focused on: revisions to EU Pharmaceutical Regulations; further ways to address Europe’s common difficulties with medicines shortages; and the application of the EU’s Health Technology Assessment (HTA) Regulation to cancer medicines.

Headline recommendations from the Report include:

On the new EU Pharmaceutical Regulations:

  1. The application of too narrow a definition of 'unmet medical need' in EU pharmaceutical legislation could have unintended consequences, such as disincentivising development of certain medicines. Examples mentioned during the roundtable include efforts to make treatment more tolerable, reducing side effects, and improving safety.
  1. As a core principle, any application of 'unmet medical need' requires the confidence of patient communities and needs to reflect what is most important to them.

On medicines shortages:

  1. Among the potential solutions to medicines shortages that were discussed at the roundtable were:
    1. A stronger maintenance of buffer stocks by manufacturers for any unforeseen problems in production;
    2. Better support of medicines production within the EU;
    3. Including supply obligations as part of procurement arrangements;
    4. Supporting the ability of pharmacies to compound medicines in scenarios of acute shortage
  1. Improving European coordination on medicines shortages also entails achieving improvements in the interoperability of IT platforms for understanding pan European medicines stocks.
  1. Current requirements that medicines be dispensed with the inclusion of printed patient information leaflets in the language of the country market should be investigated. For example, a universal patient information QR code could bring the patient to the same information, or even more up-to-date information, and in any language they prefer. Such a change could make it simpler and faster to redirect medicines from one country to another country experiencing shortages.

On the new EU Health Technology Assessment Regulations:

  1. There is a risk inherent in the EU HTA Regulation that even after the production of Joint Clinical Assessments there then follows a significant divergence in the way Member States make use of the Assessments.This would set back the attainment of the EU HTA Regulation’s original purpose and should therefore be guarded against via the guidance, Implementing Acts, and other preparatory actions currently under development.

See all 12 key recommendations, and the full Action Report here.