Together with our partners in the Irish Pharmaceutical Healthcare Association we believe the Government needs to commit to a continuous and faster flow of new life-enhancing medicines and vaccines. Roche and the industry are ready to establish a new Framework Agreement in 2025. Why? New medicines help patients live longer. They prevent chronic illness and increase survival rates.
We believe there should be three key areas of focus:
Providing a new voice for doctors in the provision of new medicines
Accelerating patient access to research treatments by doubling the clinical trials in Ireland over the next five years.
Create greater equality for rare disease patients access to medicines
Ireland has world class physicians and clinical leaders who want to have the best treatments available for their patients. Their knowledge and advocacy are powerful tools to help introduce new medicines for use across the population. Involving clinicians from the outset would help to speed up this process. How?
The two most important decisions that result in new medicines being introduced in Ireland are the decision a company takes to file and secondly the decision from HSE to agree or not agree to reimburse that medicine.
When it comes to cancer treatment, the National Cancer Control Programme (NCCP), a panel of leading oncologists, would review the medicines currently under assessment of the European Medicines Agency (EMA) and apply an Irish lens to the proposed medicines to assess which would have the most potential impact in Ireland. The ambition is to halve the time it currently takes from two years to one year post EMA authorisation.
This approach can then be applied to other therapy areas including rare diseases. The aim to provide clinicians with an anticipatory role for new medicines that bridges both industry and State authorities and delivers improved patient care.
Clinical trials are vital in developing new treatments as well access to life saving new medicines. Ireland is lagging behind some European countries and we need to attract more clinical trials. For example, Denmark has three times the number of trials in Ireland. The new National Clinical Trials Oversight Group is a positive development but it will require sustained financial and political support in order to achieve its target of doubling the number of clinical trials. Here are five practical steps that can be taken now:
Develop standardrised clincal trial start up requirements
Designate specific clinical trial signatories for each hospital
Appoint a single clinical research nurse post in all teaching hospitals
Ringfence clinical trial funding for multi-disciplinary research
Protect dedicated research time for research staff
Rare diseases are some of the hardest conditions to treat, yet collectively they will impact 1 in 17 people in Ireland. The majority of rare diseases are found in children and carry a high mortality rate. Currently access to treatments for rare diseases is slow and limited in Ireland. Authorisation for the use of orphan medicines in Ireland to treat rare disease should not take longer than one year, subject to clinical approval and clinical need.
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