Irish patients have poor access to new medicines compared to many other European countries, according to the Irish Pharmaceutical Healthcare Association (IPHA). The organisation, which represents research-based pharmaceutical companies, states that Ireland ranks 18th of the 26 European countries for availability of new medicines. Cancer and cardiovascular drugs are the main medicines affected.
“It is not good enough that patients in Ireland should be among the last in western Europe to have access to these new medicines,” says Oliver O’Connor, chief executive of the IPHA. In a comparative analysis, the IPHA found that 57 new medicines authorised by the European Medicines Agency (EMA) in 2014, 2015 and 2016 were reimbursed and available in public health services in Ireland by the end of 2017. While in Denmark, 115 such medicines were available in 2017.
Gaining access to new medicines can be a complex process, particularly if they are expensive and are only used for a very specific group of patients. Before new medicines authorised by the EMA can be made available to patients in public hospitals and general practice, they are assessed by the National Centre for Pharmo-Economics, which then makes recommendations to the Primary Care Reimbursement Service and the Corporate Pharmaceutical Unit in the HSE. This process can take up to three years for some new medicines.
Ireland’s ageing population, the increase of chronic diseases and increased numbers of patients on long-term illness schemes and high-tech drug schemes are all contributing to increased cost and demand for new medicines. Some of the most innovative medicines will also require companion diagnostics, which adds further to the cost.
In his speech to the European Parliament in January 2018, Taoiseach Leo Varadkar called on member states to “work more closely on the cost of medicines”. He said this could save billions for taxpayers, freeing up funding to ensure modern medicines are available to patients at the same time in every country. In February 2018, Minister for Health Simon Harris secured cabinet agreement for Ireland to join the BeNeLuxA initiative, which would enable Ireland to enter into joint negotiations with Belgium, The Netherlands, Luxembourg and Austria to secure affordable access to new medicines from pharmaceutical companies.
The Irish Platform for Patient Organisations, Science and Industry (IPPOSI) has expressed concern that new, innovative and improved drugs will not be available or will be significantly delayed to patients in Ireland because of weaknesses and gaps in the drug therapy approval and reimbursement process.
Many people will remember the public battles fought by cystic fibrosis patients to get access to the drug, Orkambi. Derick Mitchell, chief executive of IPPOSI, says there needs to be much more transparency in the process of assessment for medicines in Ireland. “Patient organisations trying to get access to orphan medicines [for rare diseases] shouldn’t have to march on the streets to get access to medicines,” he says.
Some patient groups, such as MS Ireland, explain clearly the process of public access to new medicines to help people with multiple sclerosis fight for access to new medicines if hospitals refuse or restrict them in an attempt to contain costs. In the MS Ireland campaign handbook on medicines, patients are given a nine-step plan on how to “Get Loud” if they can’t access a licensed treatment that would be beneficial to their health.
Drug therapy strategy
In its recent report on Access to Medicines, IPPOSI called for a new drug therapy strategy for Ireland. The report looked at how some other European countries deal with the introduction of new medicines. Some countries offer early access to medicines which have shown very positive results in phase two of clinical trials. Medicines are usually put on the market after phase three of clinical trials. Other countries such as Germany, for example, offer automatic reimbursement for an initial 12-month period, after which time the new medicine is accessed to see if it has additional benefit to other drugs on the market.
In Sweden, all public health decisions, including access to medicines, are evaluated against three ethical principles – firstly human value: everyone has a right to healthcare, secondly, need and solidarity: patients in the greatest need and vulnerable groups are prioritised and thirdly, cost-effectiveness: resources are used effectively.
In Scotland, which is similar in scale to Ireland, a webpage listing the medicines scheduled for assessment allows patients time to gather relevant information about their condition and treatment options. Patients can then make submissions or presentations to the Scottish Medicines Consortium open meetings when new drugs are discussed for assessment.
The lack of patient registers in Ireland prevents easy monitoring of new medicines across a wide range of patients. Currently, registers only exists for patients with cancer, cystic fibrosis and haemophilia.
The IPPOSI is keen to develop a patient charter for all patients so that patients can follow the progress of new medicines becoming available in Ireland. “We want to see where the drug is at all time in the [reimbursement] process and this could be part of a more transparent process of medicines being made available to Irish patients,” says Mitchell.
And, with more innovative medical treatments such as gene therapy on the horizon, a whole new approach to drug assessment and pricing may well be required, with even clearer guidelines for regulators and patients alike.
