Tuesday, 19 February 2019

Ceisteanna (400)

Stephen Donnelly


400. Deputy Stephen S. Donnelly asked 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 pilot joint negotiations. [8128/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

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.