Stephen Donnelly (Wicklow, Fianna Fail)
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397. To ask the Minister for Health if Ireland's full participation in the four pillars of the BeNeLuxA collaboration, including information sharing, horizon scanning, joint assessment and joint pricing and reimbursement, will require amendments to existing national legislation or statutory instruments. [8125/19]

Simon Harris (Wicklow, Fine Gael)
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On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg.

The BeNeLuxA collaboration was established in 2015, with a view to taking a collective approach to pharmaceutical procurement and evaluation. Four areas of collaboration has been identified: horizon scanning, health technology assessment, information sharing and policy exchange and joint price negotiations.

Members can determine the scope of their voluntary participation in each of the domain areas. It is envisaged that Ireland will over time become involved in all areas of collaboration.

There is ongoing collaborative work between officials from my Department and national experts from other member countries across the different Domain Task Forces to establish the legislative framework underpinning each administration's pricing and reimbursement system. All member countries have different legislative frameworks and there is an acceptance that cooperation has to conform with the legislation that exists, pending any statutory change that may be brought forward by respective administrations.

Stephen Donnelly (Wicklow, Fianna Fail)
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398. To ask the Minister for Health his plans to undertake a regulatory impact assessment and-or a cost-benefit analysis of Ireland's participation in the BeNeLuxA initiative. [8126/19]

Simon Harris (Wicklow, Fine Gael)
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On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria; Belgium; the Netherlands and Luxembourg. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way.

Successful collaboration with like-minded countries is one policy lever that is being pursued by the Government to enable us improve long-term access to innovative drugs at affordable prices, thereby providing clear benefit to all stakeholders. It is essentially an administrative collaboration whereby Members of Beneluxa will work together to identify pragmatic solutions to the challenges which we all now face with medicines pricing, sustainability and supply. Insofar as a Regulatory Impact Assessment is a tool used for structured exploration of different options to address a particular policy issue, I would not see it as appropriate in this case. The costs involved with our cooperation with other Member countries are minimal and I believe the benefits in the long term have the potential to be significant.

Stephen Donnelly (Wicklow, Fianna Fail)
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399. To ask the Minister for Health if his officials have engaged with officials from other member states on the establishment of the international horizon scanning initiative; the status of progress; and if Ireland will be a participant in the initiative. [8127/19]

Simon Harris (Wicklow, Fine Gael)
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On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria; Belgium; the Netherlands and Luxembourg. The Beneluxa collaboration was established in 2015, with a view to taking a collective approach to pharmaceutical procurement and evaluation. This Initiative seeks to enhance patients' access to high quality and affordable treatments, improve the payers' position in the market through joint negotiations, increase transparency on pricing between the collaborating countries, share policy expertise and focus on knowledge building.

Four areas of collaboration has been identified: horizon scanning, health technology assessment, information sharing and policy exchange and joint price negotiations. Under the domain of horizon scanning, Beneluxa have been developing a shared International Horizon Scanning Initiative (IHSI) where validated information on new medicines entering the market would be available to members. It will provide for national planning and allocation of resources. It will also allow members to explore possible voluntary collaboration on joint price negotiations. Participation in this initiative is open to non Beneluxa countries.

Since 2017, officials from my Department have been engaged with officials from other member states on the technical and procedural preparations for this initiative.

The preparations are now in their final stages and Ireland has signalled its interest in this project.

The next stage of the project will involve a procuring process to select the appropriate company/companies to complete the necessary work and services for an international horizon scan.

Stephen Donnelly (Wicklow, Fianna Fail)
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400. To ask the Minister for Health his views on whether the fiduciary duties of directors of Irish registered legal entities that are wholly owned subsidiaries under the Companies Act 2014 may preclude these companies from engaging in joint pricing and reimbursement negotiations that may occur as part of the BeNeLuxA collaboration; and his views on whether this could be a barrier to Irish registered companies engaging in future pilots joint negotiations. [8128/19]

Simon Harris (Wicklow, Fine Gael)
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On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg.

The BeNeLuxA collaboration was established in 2015, with a view to taking a collective approach to pharmaceutical procurement and evaluation. Four areas of collaboration have been identified:

Horizon Scanning

Beneluxa are developing a shared International Horizon Scanning Initiative (IHSI) where validated information on new medicines entering the market would be available to members. It will provide for national planning and allocation of resources. It will also allow members to explore possible voluntary collaboration on joint price negotiations. Participation in this area is open to non Beneluxa countries.

Health Technology Assessment

Collaboration on Health Technology Assessment would allow for an early exchange of opinions and where relevant, adopt a shared point of view on new innovative medicines.

Information sharing and policy exchange

Collaboration on information and policy exchange has the potential to improve affordability and access to innovative medicines.

Pricing and Reimbursement (to include joint negotiations)

By combining patient volumes with other Member States and collaborating on pricing, the potential exists to secure affordable access to innovative medicine.

Members can determine the scope of their voluntary participation in each of these domain areas. It is envisaged that Ireland will over time become involved in all areas of collaboration.

Ireland joined the collaboration on the understanding that it is an entirely voluntary process and would allow for whatever level of participation in each of the Domain Task Forces that is deemed appropriate. Participation in this collaborative initiative is underpinned by the understanding that collaboration would have to accord to domestic legal frameworks on drug pricing in each country and crucially, respect the fact that pricing and reimbursement decisions would remain a national competency.

It is in this context, that there is ongoing collaborative work between officials from my Department and national experts from the other Member States on the different Domain Task Forces to establish how each country’s assessment and reimbursement processes operate. This work will in due course be broadened to assess any barriers to cooperation, whether legislative or otherwise, and it is in this vein that the matters raised by the Deputy will be considered in due course.