Robert Troy (Longford-Westmeath, Fianna Fail)
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642. To ask the Minister for Health if he can share the submission Ireland made to the EU Commission in relation to the proposed new EU pharmaceutical legislation. [22962/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Thank you, Deputy, for your question on the EU Commission’s proposed revision of the pharmaceutical legislation.

By way of background, in November 2020, the EU Commission published its ‘Pharmaceutical Strategy for Europe’ aiming to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish, and continue to be a global leader.

On 26 April 2023, as one of the actions under the above Pharmaceutical Strategy, the EU Commission published its proposals to revise the general pharmaceutical legislation. This was in the form of one proposed Directive and one proposed Regulation. Notably, this the first full revision of the pharmaceutical legislation in over 20 years and is significant to all stakeholders involved in the medicines’ ecosystem. The Commission’s aim of the pharmaceutical revision is to ensure access to affordable, available medicines, while maintaining the competitiveness of the EU pharma industry sector, combating antimicrobial resistance, and providing for compliance measures which reinforce environmental protections.

The Commission’s proposals are currently undergoing detailed scrutiny by all Member States through the Council Working Party on Pharmaceutical and Medical Devices. The Department of Health (DoH), as the lead Government Department responsible for this file in Ireland, is engaging closely in these deliberations.

To help inform the DoH’s position and ensure a whole-of-government view, the Minister for Health established a cross-Government and cross-Agency group; the Pharmaceutical Strategy Working Group (PSWG) in 2023, on which key stakeholders are represented. The DOH also held targeted consultations on some of the policy topics being discussed at Council, which included policy topics on security of supply / shortages and incentives. Deliberations are still taking place at national and EU level on this file.

Ireland’s current position on the Commission’s proposed legislation is outlined below. It is important to clarify that these positions may change in line with the ongoing deliberative process.

- Opportunities

IE supports the policy objectives of the Commission’s proposal and welcomes the commitment to optimise the EU regulatory framework to improve supply chain resilience and to address the risks of medicine shortages. IE is also supportive of the commitments to enhance environmental protection and counter antimicrobial resistance as well as the measures aimed at addressing unmet need and rare diseases. Proposals relating to adaptive clinical trials and the promotion of real-world evidence are also welcomed, given the importance of the ongoing assessment of the efficacy of new medicines in promoting positive health outcomes.

- Access and Shortages

As a smaller Member State, IE particularly welcomes measures aimed at improving access to medicines. Patients and health systems need access to new, innovative treatments, as well as older (off patent) products, generics, and biosimilars. In particular, IE welcomes proposals in relation to electronic product and patient information and enhancements around multi-country packs. Such measures will directly improve the availability of medicines to all patients across the EU. IE advocates for early and harmonised implementation of these proposals.

IE also supports measures aimed at addressing medicines shortages and the associated work under the wider EU Pharmaceutical Strategy.

- RDP Modulation

IE supports the intention behind this proposal by the Commission and believes that there is a need to address current inequities in market access across the EU which are evident, even for centralised medicines which are approved for use on an EU-wide basis.

IE believes that the proposed reduction of the baseline RDP and its further modulation needs to be critically analysed. We need to support the competitiveness of the EU pharma ecosystem, while achieving and maintaining the critical balance between access and innovation. Delays and uncertainty are detrimental to both innovator and generic manufacturers, as well as health systems. We believe that the Commission’s proposals in this regard need to be revised to mitigate against such delays. Addressing patient need and the sustainability of health systems is a core deliverable of this package, and IE strongly supports these objectives.

- Antimicrobial Resistance (AMR) and ‘Transferable Exclusivity Vouchers’

IE welcomes measures to address AMR, which is a major global health threat. However, we have concerns that the current proposal could pose a financial risk to the EU given that the potential cost for health systems is challenging to quantify. Further consideration is therefore required on this issue.

To conclude, IE fully supports and aligns with the objectives of the EU Commission in proposing this legislative reform and is fully committed to the EU deliberative process to realise these objectives. IE is working to ensure that the correct balance is found between ensuring and enhancing access to and affordability of medicines while also ensuring the competitiveness and innovative attractiveness of the EU is maintained.