Patient Safety (HPRA)

Patient Safety

Understanding the Health Products Regulatory Authority:

The Health Products Regulatory Authority (HPRA) is an independent body that regulates medicines and devices for the benefit of people and animals. 

It is responsible for the safety of human and veterinary medicines, clinical trials and medical devices, as well as controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

Previously known as the Irish Medicines Board, the HPRA inspects companies and facilities which test, make or distribute health products to ensure they comply with relevant standards and legislation.

It also grants licences to companies to make, distribute and market medicines after a review of their safety, quality and effectiveness.

It continuously monitors medicines, medical devices and other health products and is obliged to respond quickly to any safety or quality concerns, producing information to ensure the safe use of health products by the public.

In 2022, the HPRA detained some 940,000 dosage units of fake and other illegal medicines.

The agency warned of the serious health dangers posed by sourcing prescription medicines online and from unauthorised sources.

Illegal products detained by the HPRA included sedatives (26%), anabolic steroids (22%), erectile dysfunction medicines (9%), analgesics (7%), and stimulants (5%). 

Since 2022, the HPRA has instructed 135 clinics advertising botulinum toxin online to remove unlawful content; the vast majority acted swiftly.

While last year alone, some 2,350 individual webpages or social media posts promoting prescription-only medicines were removed from social media platforms following intervention by the HPRA.

Many of these sites were involved in promoting medicines used in aesthetic procedures.

Medicines that contain botulinum toxin are prescription-only medicines. It is illegal to supply these without a prescription.

The HPRA also advises that anyone seeking such treatments should engage only with registered medical practitioners or registered dentists, due to the dangers posed by people who are not qualified to administer them.

Over the past 10 years, the work of the HPRA has resulted in 52 convictions, with four arising for breaches of legislation over the administering, distributing, selling or advertising of prescription medicines containing botulinum toxin. Prosecutions are progressed where it is considered that the illegal activity poses significant risk to public health or where there are persistent non-compliances.

Members of the public can report issues to the HPRA about the projects they regulate. Such issues might include side effects, safety issues and quality concerns about a medicine or healthcare products. 

How Whelan Law Can Help 

A Whelan Law, we are committed to achieving the best outcome for each and every one of our clients in cases of medical negligence. If you feel that you have been impacted negatively, our experienced team will be happy to assess your case and determine whether your claim in viable in law. As with all our clients, we aim to ease your concerns and assist you every step of the way.

Whelan Law offers practical advice on the Patient Safety bill and related matters:
Legal advice on the Patient Safety bill

Call us at +353 (0) 62 61110 or visit to arrange a private consultation today.