I propose to take Questions Nos. 260, 261, 263, 264, 268 and 269 together.
On 26 April 2023 the European Commission published a proposal to revise and replace the existing general pharmaceutical legislation. The EU Pharmaceutical legislative package proposes a suite of measures with the purpose of assuring the quality and safety of medicines and ensuring their availability to health services across the EU. As such, the Department of Health is leading on this file in Ireland.
The EU Proposal includes elements in relation to Regulatory Data Protection which is distinct from traditional intellectual property rights as it offers additional protection specifically targeted at the data required for regulatory approval and concerns the timelines regarding generic drug manufacturers accessing the clinical trial data of an original drug manufacturer during which a temporary market exclusivity for the original manufacturer exists.
From an enterprise perspective, industry concerns on this element of the overall package are clearly understood across Government and are taken into account when formulating the Irish contributions to the negotiations at EU level. Government remains very conscious of the importance of retaining a competitive pharmaceutical industry in the EU and in Ireland and the Government’s position on the EU Pharmaceutical Package remains that we are seeking to find the right balance to address three key objectives:
• Retention of a strong, innovative, pharmaceutical sector,
• Access to safe and effective medicines for patients, and
• Sustainability of national health systems.
Specifically, with regards to the Commission’s proposals on regulatory data protection (RDP), Ireland’s position remains that we see merit in the intention underlying these proposals which is to address current inequities in market access to medicines across Europe – an issue we face here in Ireland. However, Government is also clear that any approach to address such inequities must also support the competitiveness of Europe’s pharma ecosystem. In this regard, Ireland’s position in the negotiations on the Package is that pharmaceutical companies who meet the needs of health systems must be rewarded for doing so; with their innovative investments in the EU fully recognised.
The negotiations on the Pharmaceutical Package are complex and are likely to continue for a considerable period of time and the negotiations are continuing to evolve under the Hungarian Presidency. The outcome will be of vital importance to patients, national health systems and to our pharmaceutical industry for many years to come, and, therefore, Ireland will strive towards the best possible outcome that delivers a balanced and predictable approach and is faithful to all three of our key objectives, summarised above.
To date, there has been extensive engagement with stakeholders, including industry representatives and individual companies, as well as between relevant Government Departments and Agencies. This will continue as the negotiations proceed led by the Department of Health in close cooperation with my own Department.
