Accessing valued, innovative medicines
Life Sciences Oliver O’Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association (IPHA), discusses the standards that can help to 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 to the Health Services with the Government. The Agreement provides a reliable framework for the process of bringing new medicines into the health services, and the pricing at which new drugs are offered and how this is changed every year.
“Under the Agreement, the pricing of community and hospital prices in Ireland is set to an average of ex-wholesaler price from 14 EU Member States and this is adjusted every year, downwards only. We have provided €12 million per month in savings since the 1st of August last year.”
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, so that the HSE will be able to provide adequate budgeting as well as plan the process properly, to ensure there is equity among all patients and one type of medicine doesn’t jump ahead of the queue.
“If 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.
Before medicines are granted a license in Ireland, they must go through several stages of clinical trials. O’Connor says although the industry is continuing to invest in new research and development in universities and hospitals, 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 which makes it easier to set up a trial because you know the number of patients, 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.”
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.
By February 2019, every medicine will be checked to ensure it’s the real thing.
“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 medicines supply chain. Pharmacists (the IPU), manufacturers, wholesalers, importers and everyone who supplies medicines to patients, will put in place a system to verify the authenticity of a product. By February 2019, every medicine will be checked to ensure it’s 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 medicines and life sciences, and we take our standards and regulations very seriously.”