Publication of European Commission Proposals Amending EU Pharmaceutical Legislation

26 April 2023

The European Cancer Organisation welcomes today’s publication by the European Commission of a legal proposal to amend the governing legislative framework for pharmaceuticals in the EU.

In the coming weeks, we will be working with our Board of Directors, Member Societies, Patient Advisory Committee and others to scrutinise the details and identify opportunities for improvement. So many important issues for healthcare and cancer care in particular, are at stake, including:

  • How to better address unmet medical needs within the EU pharmaceutical legislation;
  • How to best provide better incentives for new antimicrobials; and
  • How to better prevent medicine shortages and mitigate the impact when they occur.

Opportunities to reduce the environmental impact of pharmaceuticals, including in respect to such matters as reduction of packaging waste, are also helpfully in focus.

In all policy-making of this kind, there will be balances to be struck between advantages and disadvantages of different propositions. To get that balance right it will be crucial that the debate that now follows makes space for all impacted stakeholders to be heard, and their perspectives to be taken into account.

In this context, some key guiding questions for our organisation when reviewing the legislative proposals will include the following checkpoints:

  • To what extent could unmet medical needs associated to poor prognosis tumour types be advanced by changes in the legislative proposal?
  • What are the potential access implications for other disease areas from the exclusivity voucher proposition?
  • To what extent are the real needs of pharmacists, and others involved in the medicine supply chain, being met through the file’s shortages, prevention and management proposals?

The European Cancer Organisation urges wide public scrutiny of these proposals, and an openness to dialogue from all decision-making components of the process.