Deputy Broughan recently submitted a Private Members’ Motion on Spinraza and it is now on the clár of the Dáil.  The motion is supported by Deputies Thomas Pringle, Joan Collins, Clare Daly, Mick Wallace, Catherine Connolly, Maureen O’Sullivan, Gino Kenny, Bríd Smith, and Richard Boyd Barrett and Deputy Broughan hopes for an early opportunity to debate the motion.

There are approximately 70 people, including 26 children, in Ireland with Spinal Muscular Atrophy (SMA), which is a rare and life-limiting muscle-wasting condition.  SMA is the number one genetic cause of death for infants worldwide and will affect around 1 in 11,000 babies born worldwide each year.  Spinraza or Nusinersen, which is produced by Biogen, is the first treatment for Spinal Muscular Atrophy (SMA) and is available in 25 of the 28 countries in the European Union but in February 2019, the HSE did not approve Spinraza for reimbursement in Ireland and negotiations with Biogen are ongoing.

The motion highlights the fact that patients deteriorate when they stop taking Spinraza (Nusinersen) and real life testimony has been given to confirm the efficacy of the drug; that 25 of the 64 Health Technology Assessment reports which were submitted in the period 1st January 2016 to 30th November 2018 related to Orphan Medicines with 12 of these having been approved at the beginning of January 2019 and ongoing deliberations or commercial negotiations continuing for 13; that a 2017 Grant Thornton review of the NCPE indicated that it was understaffed, at 8.5 whole time equivalents, and that an additional 9 staff, including senior pharmacists, HTA assessors and statisticians, would be required to meet the additional workload; and, with revenue and profits often in the billions, pharmaceutical companies also have a moral obligation to enter negotiations with fair pricing, so as to not prolong the reimbursement assessment and deliberation process.

A recent reply to a Parliamentary Question by Deputy Broughan to the Minister for Health on the number of staff in the HSE corporate pharmaceutical unit and the role of each in the organisation showed that in 2016 staff numbers rose from 5.5 for the first time since 2009.  The reply states that “the HSE Corporate Pharmaceutical Unit is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications and is responsible for the day to day operation of the national pricing framework agreements. The unit is responsible for accepting and processing applications for pricing and reimbursement for new generic, biosimilar and branded medicines. The unit acts as the commercial negotiating unit for the HSE in engagements with individual pharmaceutical companies and it provides the Secretariat to the HSE Drugs Group. It is responsible for the HSE’s statutory functions in relation to reference pricing of interchangeable medicines. It provides support to the Primary Care Reimbursement Service across a range of projects. It provides expertise and support to the HSE generally and to the Department of Health on a wide range of projects.”

The reply showed that the number of Chief II Pharmacists and Senior Pharmacists rose in 2018 to 2.5 and 3 respectively but that overall numbers fell from 11.5 in 2018 to 10.5 in 2019 through the loss of a Grade III post.  The full breakdown from 2009 to 2019 is in the following table:

Number of Whole Time Equivalent (WTE) Posts
Year Chief I


Chief II




Grade V Grade IV Grade III Total


2009 1 1.5 0 1 1 1 5.5
2010 1 1.5 0 1 1 1 5.5
2011 1 1.5 0 1 1 1 5.5
2012 1 1.5 0 1 1 1 5.5
2013 1 1.5 0 1 1 1 5.5
2014 1 1.5 0 1 1 1 5.5
2015 1 1.5 0 1 1 1 5.5
2016 1 1.5 2 1 1 1 7.5
2017 1 1.5 2 1 1 2 8.5
2018 1 2.5 3 1 1 3 11.5
2019 1 2.5 3 2 0 2 10.5

Deputy Broughan’s motion calls on the Government to meet with children and adults with SMA and their parents; to urgently direct the HSE to speed up negotiations with Biogen because time is of the essence for these patients; to increase the resources available to the National Centre for Pharmacoeconomics (NCPE) and the HSE Corporate Pharmaceutical Unit (HSE-CPU) to allow for quicker assessment, negotiations and approval of new treatments; to reduce the time allowed under the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, for a decision by the HSE from 180 days of receiving the application down to 90 days, with a maximum of 120 days if further information is needed from the company; to revise the Rare Disease Strategy and include greater input from patient advocacy groups and improve the remit of the Rare Diseases Medicinal Products/Technology Review Committee (RDTRC) to be in line with the Scottish PACE model; to introduce an Orphan Drugs levy on pharmaceutical companies and create an Orphan Drugs fund; to provide a report to the Dáil by the end of Quarter 3 2019, to outline the impact of our membership of the BeNeLuxa initiative; and to ensure that the review of the HSE reimbursement and pricing decision-making process is completed by the end of Quarter 3, 2019.

Deputy Broughan says “I submitted the motion because time is of the essence for the people and children with SMA who need Spinraza.  The negotiations are at a critical stage but people with SMA are continuing to deteriorate while waiting.  Children with SMA could die while these negotiations are taking place.  Another PQ reply that I received from Minister Harris said that already this year the HSE has approved “17 new medicines and 3 new uses of existing medicines […] (at an additional cost of approximately €150m over five years).”  I hope that we will have the opportunity to debate this motion soon and I also hope that Fianna Fáil and Sinn Féin will support the motion, having hosted briefings with families campaigning for Spinraza in recent months.”