Ensuring access to medicines is a major concern for several Member States. Following the Dutch Presidency and other rotating Council Presidencies that came before it, the Finnish Presidency intends to put this issue on the agenda of the meeting of Health ministers on 9 December.
In a briefing paper intended to provide a framework for the discussion between the ministers, the Presidency notes that, despite the efforts that have already been made, “a balanced overall outcome leading to improved access to medicines has so far not been achieved”.
The document recommends taking a holistic approach that includes all the phases of a medicine’s lifecycle, including research and development, the introduction of new drugs, price competition, and maintaining supply of medicines. With regard to the introduction of new medicines, Helsinki warns against accelerated procedures and stresses the importance of a “controlled introduction”. Amongst other ideas, it suggests using empirical data (‘real world evidence’). With regard to maintaining supply, the Presidency notes that the increasing concentration of the manufacturing and logistics chains outside Europe and the fragmentation caused by subcontracting chains has been identified as one of the reasons for shortages of medicines.
The Finnish Presidency stresses that: “Ensuring access requires efficient measures at all phases of the lifecycle of a medicinal product. Mechanisms supporting research and development, controlled introduction, achieving equal access to new medicines, price competition, continuous supply and maintaining old medicines on the market should be sustainable, while taking into account the needs of the national healthcare systems”.
It concludes that there is a need to further strengthen strategic cooperation among Member States as well as to monitor the impacts of the EU measures and to evaluate pharmaceutical policy at EU level and its objectives.
It should also be noted that the European Commission in the process of reviewing the incentives for developing orphan and paediatric medicines. To access the document, click on the following link: http://bit.ly/2qS0PSV (Original version in French by Sophie Petitjean)