Interview: Protecting patient safety at Ireland’s medical regulation authority

You might expect the national authority for regulating medicines and medical devices to occupy an imposing historic or modern building in the capital. However, the Health Products Regulatory Authority – formerly the Irish Medicines Board – is housed in a bland, 1980s office block facing the monumental National Concert Hall.

The gravitas may not be prominent, but it is here that decisions are made about whether medicines for illnesses from cancer to cystic fibrosis are safe for use in Ireland or not. The authorisation for clinical drug trials and the safety records of medical devices from diagnostic scanners to breast implants is given by the scientists working here. And it is in this building that illegal websites selling prescription and counterfeit medicines are tackled.

The new chief executive of the authority, Lorraine Nolan, has been in place since January 2016. No stranger to regulation, Nolan worked her way up the corporate-scientific ladder of the authority over the past 14 years, taking over from Pat O'Mahony who moved on to become deputy secretary at the Department of Health.

Nolan’s previous positions include director of human products authorisation. Prior to that, she was in charge of controlled drugs – substances such as morphine used for legitimate medical purposes – at the Department of Health and, earlier still, a forensic scientist with the Department of Justice, Equality and Law Reform. She holds a PhD and degree in chemistry from Trinity College Dublin.

“It’s a good time to start as a new chief executive as we are at the start of a new strategic plan,” she says. The goals for 2016-2020 include appropriate regulation of healthcare products, communicating clearly with health professionals and the public, reducing medicine shortages and supporting innovation.”

Given the pharmaceutical industry’s significant input to the economic recovery, Nolan is keen to talk about the authority’s role in supporting innovation. She cites the major contribution of pharmaceutical exports and notes that, “the medical devices sector is really growing here. We have nine out of the 10 international companies in Ireland.”

However, regulatory authorities across Europe are working hard to keep up with the pace of change. The current European regulatory system for medical devices – which the authority works in tandem with – was developed in the mid-1990s.

“It covers everything from syringes to cardiac implants. The issue now is that there are 500,000 medical devices compared with a few thousand in the 1990s.”

Device monitoring

So, rather than the national regulatory authorities assessing each device for their own market, they now oversee agencies tasked with assessing this equipment throughout Europe. The authority then monitors the safety records of the devices once they come on the market.

“All the clinical data for new medical devices might not be available before it comes to market, which will mean that we will have to watch the clinical performance of the device over its lifetime,” says Nolan.

If you’re anyway squeamish about novel medical products, you might be alarmed at this point. Reports of metal particles released from hip replacements causing inflammatory reactions and toxic materials in breast implants spring to mind.

However, Nolan is keen to reassure the public that new European regulations on medical devices to be published shortly will require measures such as patient registries for high-risk implantable devices.

“This new approach for medical devices will require robust surveillance and engagement with manufacturers and clinicians who are legally bound to report any issues to us,” says Nolan.

Reports of adverse reactions from medical devices and medications can be sent directly to the authority. The organisation works closely with the European Medicines Agency in London and is currently the vice-chair of the agency's safety committee.

Such monitoring work emphasises the authority’s responsibility. “At all times, we have to maintain the appropriate standards of patient safety and public health,” says Nolan. The organisation has the authority to change product information, issue safety notices, and suspend or recall a medicine it has found issue with. It also advises the public on the safety of vaccines with updates on its website.

Investigating the illegal sale of prescription and counterfeit medicines online is a high-profile area of responsibility for the authority. “The internet sale of medicines is a constant focus of our enforcement activities and there is intelligence sharing with the customs service and the gardaí in this work,” says Nolan.

Falsified medicines

One of the most frightening scenarios must be when falsified medicines enter into the legitimate supply chain. “This hasn’t happened in Ireland but counterfeit antipsychotic and cardiovascular medicines have been picked up in other European countries,” says Nolan.

Inspections and spot-checks on medicines at manufacturers and wholesalers aim to prevent any contaminated or falsified medicines reaching the public.

The control and sale of illegal drugs is outside the remit of the authority. And the legal online sale of over-the-counter – non-prescription – medicines by registered pharmacists is overseen by the Pharmaceutical Society of Ireland.

The authority is also responsible for authorising blood products, tissues and organs destined for transplantation as well as animal health products. “We regulate the transfer and handling of all these products and access the quality of the processes,” Nolan says.

In addition, the organisation regulates the ingredients used in cosmetics. Nutritional supplements, which make substantial health claims, are also under its control but most are regulated by the Food Safety Authority of Ireland.

“The majority of dietary products are food but there are borderline cases such as slimming aids and body-building products which are regularly seized.”

A mother of three children under 12, Nolan is conscious of the busy life of a working parent. “My free time is really precious. Saturdays are taken up with dropping children to music and sports but I try to make Sunday as a day out. I like cooking, reading crime novels and watching crime drama television series. I’m also an avid walker. It’s a great way of clearing your head,” she says.

Nolan is also proud to be the first female chief executive of the authority.

“It’s good to see a number of women in this area. I come from a scientific family – my sister is a nurse, one brother is a biologist, another is a biochemist and another is an electronic engineer. I blame my parents who bought us all chemistry sets as children.”

Illegal market Regulatory authority's drug seizures

In 2014, more than 730,000 units of counterfeit and illegal medicines were taken off the market by the Health Products Regulatory Authority.

The majority of these were medicines containing sedatives (407,502 units), medicines for erectile dysfunction (53,963 units) slimming products (53,963 units) and anabolic steroids (16,338 units).

The sedative drugs were mainly ones authorised in another European country and illegally diverted onto the illegal supply market in Ireland. The authority also seized more than 1,000 imported abortion pills in 2014.

Ten district court prosecutions were taken by the authority in 2014. The majority of cases were for the illegal importation and sale of prescription drugs without a prescription. These medicines included Botox and pills for erectile dysfunction.

The Health Products Regulatory Authority welcomes any information that can help reduce the threat to public health from medicines coming into the country illegally.

Members of the public can report suspicious activity to the authority's enforcement section on 01-6343436 or enforecement@hpra.ie.