The benefits of patient involvement in medicines approval and reimbursement has been greatly acknowledged in recent years. Changes have been made at both a European and national level to facilitate meaningful and structured patient involvement. We work to ensure that our members have a voice in these processes and continue to advocate for further improvements in this area.
The Patient Organisation Submission Process in the NCPE allows patient organisations to make a submission as part of a Health Technology Assessment (HTA) of a pharmaceutical product. The process encourages patient organisations to gather information from their members for inclusion in the Patient Organisation Submission of Evidence Template. The template asks questions about the day-to-day experience of living with a particular condition and the impact a new medicine might have on a person’s experience and quality of life. The NCPE include the Patient Organisation Submission of Evidence in an appendix of their report to the HSE and include extracts of the submission within the main body of the report. The HSE Drugs Committee make the final decision on whether or not to fund a medicine.
Fighting Blindness make submissions as part of this process for medicines relevant to our community. To gather information for such a submission we would first consult with individuals who are living with that condition about their lived experience and the impact the new medicine could have on their lives. Calls for contributions to this process are published on the Fighting Blindness website and social media and circulated to Fighting Blindness members and VIP Network participants. If you would like to become a member or join the VIP Network, please contact us on 01 6789 004 or firstname.lastname@example.org.
The European Medicines Agency (EMA) has a number of opportunities for patient involvement. The agency looks for people living with a condition to provide their lived experience of that condition into regulatory discussions. There are two ways in which the EMA identifies people for these roles, one is through contacting patient organisations, such as Fighting Blindness. When we receive a request for patient involvement, we publicise it either through our website and social media or by directly contacting our members or VIP Network participants. In some cases, when dealing with a very rare disease, we will also circulate the involvement opportunity to a number of ophthalmologists who may contact some of their patients directly to provide information to them about the opportunity.
The other way that the EMA identify participants is through contacting individuals who are registered on the EMA expert stakeholder database. If you would like to register as an individual patient expert, you can do so here.
You will find a frequently asked questions document on the EMA individual expert stakeholder database here..