Chief Executive of the Irish Pharmaceutical Healthcare Association (IPHA)
Oliver O’Connor discusses standards that help ensure the healthcare needs of Irish patients are met with valued, innovative medicines.
“In Ireland, pharmaceutical pricing can be an issue,” says O’Connor. “However, the IPHA have entered into a binding Agreement on the Supply and Pricing of Medicines. This is to the Health Services with the Government. The Agreement provides a reliable framework for the process of bringing new medicines into the health services.
Each year 14 EU member states downwardly adjust and set this price. We have provided €12 million per month in savings since the 1st of August last year.”
Timelines are in place for maximum efficiency
As well as having a predictable pricing framework to enable patients access to the medicines best suited to their needs as quickly as possible, O’Connor says it is vital that the reimbursement process is also predictable and administered efficiently.
“An important part of this is ‘horizon scanning’ – reviewing new medicines that are to be offered into Ireland. This means that companies will show the HSE what they are intending to bring forward next year. The HSE will be able to provide adequate budgeting as well as plan the process properly. This will help ensure there is equity among all patients and one type of medicine doesn’t jump in the queue.
However some companies don’t go through a horizon scan. “They may find themselves in a position where this new medicine has come up, patients need it. But the HSE hasn’t budget availability for it.”
Ireland still has some distance to go to get to the level of clinical trials seen in other countries.
Licences require clinical trials
Granting a new medicine licence in Ireland requires several stages of clinical trial. O’Connor says the industry is continuing to invest in new research and development in universities and hospitals. However Ireland still has some distance to go to get to the level of clinical trials seen in other countries.
“Countries like Denmark have good patient registries. This makes it easier to set up a trial because you know the number of patients. Similarly you know their medical history, and so on. We don’t have that across the board in Ireland – in some areas, it is good but in others, it’s not. It’s a broader issue, but building patient registries does require more investment in IT in the health service.”
Ensuring legitimised new medicines in Ireland
Another challenge which may hinder patients’ access to fast and effective treatment by health services is the increasing threat of counterfeit medicines. However, with the upcoming introduction of the Falsified Medicines Directive, O’Connor says patients will feel more reassured.
“This major project, which has been in discussion around Europe for several years, will help to minimise the chances of counterfeit medicines entering into the new medicines supply chain. Pharmacists (the IPU), manufacturers, wholesalers, importers and everyone who supplies new medicines to patients, will put in place a system to verify the authenticity of a product.
Checks are in place for medicines, from Feb 2019 to ensure they are the real thing. This will happen over 100 million times, in less than one third of a second every time”.
“Each pack will be barcoded, which will be authenticated before dispensing, so it’s a huge procedure to coordinate all the data and organise the barcodes on an entire European basis. Very soon, we will have a National Medicine’s Verification Organisation set up here, which will work to ensure this verification system is in place in two years’ time.”
And, with Ireland also in a bid to bring the European Medicines Agency (EMA) from London to Dublin post-Brexit, the protection of human health can only strengthen in Ireland.
“The re-location of EMA to Dublin would highlight Ireland as an area of significance for the pharmaceutical industry in Europe and globally. It would show that we are a highly-regulated country with high-skilled people, both in terms of the regulation of new medicines and life sciences, and we take our standards and regulations very seriously.”