Goodbye Irish Medicines Board . . . but hello to Health Products Regulatory Authority

At least 50 per cent of prescription medicines bought over the internet are counterfeit. The figure comes from Pat O'Mahony, chief executive of what was till this week the Irish Medicines Board.

The agency has now rebranded as the Health Products Regulatory Authority (HPRA)*, largely to reflect its rapidly expanding role over the past 18 years.

The HPRA will act as regulator of all products in the health system, acting alongside the professional bodies and the Health Information and Quality Authority, which oversee medical staff and institutions.

Back in 1996 when the Irish Medicines Board was established as a standalone authority, it was responsible for human and veterinary medicines: since then, it has assumed oversight for medical devices, clinical trials, human organs for transplant and even cosmetics.

It’s all a long way from the mid-1960s when the Thalidomide scandal saw Ireland and others establish national drug advisory boards. And it is not just licensing – the agency is charged with enforcement.

Advent of internet

The internet is just one example of how rapidly the regulatory environment is changing and explains the growing role of the EU in setting down the rules for medicines, medical devices, trials and pharmacovigilance, as well as for the growing co-operation between agencies in different countries.

Given the size of the Irish pharmaceuticals and medical device sectors, it is little surprise Ireland punches far above its weight – generally ranking first or second in veterinary medicines and fifth last year for human products in “rapporteurships”, under which local agencies compete for the work of assessing products for pan-EU regulatory approval.

“We’re not an also-ran in any area,” says O’Mahony from the authority’s Earlsfort Terrace base. “We have expertise right across the range, even if we do not have strength in depth everywhere. You couldn’t with the numbers we have.”

The HPRA employs 300 people – compared with the 1,000-plus in similar agencies in the UK, France and Germany – but has managed to grow throughout austerity.

Last year alone, the authority authorised 753 new human medicines as well as 188 veterinary medicines. It was also heavily involved in the Government’s policy to increase the use of generic medicines.

O’Mahony says figures show just 2 per cent of the population buys prescription medicines online, “but there is still no robust legal system that gives people any assurance that any website they look at is legitimate”, he counsels. The most popular medications sought online are therapies for slimming, erectile dysfunction and body building, conditions where patients prefer internet anonymity.

Clinical trials

O’Mahony is a man with seemingly boundless energy and he’ll need it. Alongside the threat of counterfeit product, the authority is implementing new European legislation, and trying to ramp up Ireland’s presence in clinical trials where he considers we should be running about four times our current level of 70 or so trials a year.

And, on top of that, he is looking to implement a new fee-based arrangement for regulation of medical devices bringing it into line with the rest of the authority’s remit.

*This article was amended on July 7th 2014