Colm Burke (Cork North-Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

1470. To ask the Minister for Health her views on the findings of a report (details supplied) in relation to the development of a system of transferable exclusivity vouchers; whether she is supportive of the introduction of such a system at Irish and EU level; and if she will make a statement on the matter. [29794/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context | Oireachtas source

In April 2023, the European Commission published proposals to revise the general pharmaceutical legislation known as the Pharma Package. The general pharmaceutical legislation encompasses the regulation of the authorisation, manufacturing distribution, marketing, and monitoring of medicines. It essentially creates the framework that imposes controls from “raw material” to a “medicine being placed in a patient’s hand”.

The Pharma Package contains a draft Directive and Regulation which has been the subject of negotiations at EU level for the past 18 months. The Pharma Package reached a very significant milestone in the negotiation of the file on 4th June when the Council of the EU agreed their Mandate for negotiations with Parliament. The Mandate agreed by Council is now publicly available at the below links:

Council Mandate for Directive for Negotiations regulations

and

Council Mandate for Negotiations Directive

.

Ireland welcomes this significant milestone as this is the first revision of the legislation in 20 years and the outcome of these negotiations will be of vital importance to patients, national health systems and to the pharmaceutical industry for many years to come.

The pharma package contains a number of measures aimed at addressing Antimicrobial Resistance (AMR). One novel proposal is the introduction of so-called Transferable Exclusivity Vouchers (TEVs). TEVS are designed to incentivise research and development of priority antimicrobials to help address increasing risk of antimicrobial resistance (AMR). Ireland recognises the threat that is posed by AMR and supports measures as agreed with MS in this regard and set out in Council’s mandate.

The Polish Presidency plan to continue the negotiations of the Pharma package and start trilogues with the European Parliament in the coming weeks.