Mylan

Lobbying Organisation Mylan

Date published 05 Apr, 2018

Relevant Matter Public policy or programme

Public Policy Area Health

Period 1 Sep, 2017 to 31 Dec, 2017

Specific Details The Department of Health must develop and implement a National Biosimilars Policy, whose objective is to significantly increase the usage of biosimilars in Ireland . This policy must include: • Legislation which reforms the 2013 Act and allows for biosimilars to be included on the list of interchangeable medicines; • The Department of Health must immediately remove the existing biosimilar blocker clause contained within the Medicine Pricing Agreement

Intended results Increased patient access to biosimilar medicines.

Name of person primarily responsible for lobbying on this activity David Delaney

Did any Designated Public Official(DPO) or former Designated Public Official(DPO) carry out lobbying activities on your behalf in relation to this return? You must include yourself, and answer Yes, if you are a current DPO or a DPO at any time in the past. (What is a Designated Public Official?) No

Did you manage or direct a grassroots campaign? No

Was this lobbying done on behalf of a client? No

Lobbying activity

The following activities occurred for this specific Subject Matter Area.

Meeting (2-5)

Low uptake of biosimilars in Ireland – the missed opportunity Ireland lags significantly behind other European countries in its usage of biosimilars with only 11 currently reimbursed by the HSE, out of a to The Department of Health must develop and implement a National Biosimilars Policy, whose objective is to significantly increase the usage of biosimilars in Ireland within 5 years. This policy must include: • Legislation which reforms the 2013 Act and allows for biosimilars to be included on the list of interchangeable medicines; • The Department of Health must immediately remove the existing biosimilar blocker clause contained within the Medicine Pricing Agreement with IPHA to ensure genuine competition between biosimilars and biologics; • The HSE must introduce quotas for the usage of biosimilars in each hospital; and • The Department of Health and HSE, supported by representative bodies such as Medicines for Ireland, must activate an extensive information campaign on biosimilars.

Designated public officials lobbied

The following DPOs were lobbied during this return period on this specific Subject Matter Area. These DPOs were involved in at least one of the Lobbying Activities listed above, but not necessarily all of them. As returns are specific to a Subject Matter Area the above Lobbying Activities may be associated with multiple returns.

Kate O'Connell TD (Dáil Éireann, the Oireachtas)

John Brassil TD (Dáil Éireann, the Oireachtas)

Louise O'Reilly TD (Dáil Éireann, the Oireachtas)

Michael Harty TD (Dáil Éireann, the Oireachtas)

Billy Kelleher TD (Dáil Éireann, the Oireachtas)