About shortages of veterinary medicines

What is a medicines shortage?

The definition of a shortage is when the supply of a medicine does not meet demand at a national level, that is, there is insufficient supply to meet demand in Ireland. Shortages of veterinary medicines are a global problem. Unlike the position of human medicines, shortages of veterinary medicines are often caused by a product being discontinued or not being submitted for authorisation for use in Ireland. However, there has also been an increase in the number of notifications of quality defects and production issues with veterinary vaccines over recent years, leading to shortages.

Why do shortages of veterinary medicines occur?

A shortage can occur for many reasons. Each shortage represents an individual set of circumstances. From industry information received by the HPRA, we know that vaccines are the most common type of shortage, followed by antibiotics.

• Over 60% of shortages relate to delays or breakdowns during manufacturing or a product quality issue.
• Manufacturing can also be delayed when an active substance or other ingredient is in short supply. Shortages in packaging materials can also lead to delays.
• Unexpected demand can cause certain shortages. This could be due, for example, to an unanticipated increase in the prescribing of a particular medicine.

How are shortages of veterinary medicines handled in Ireland?

The regulatory oversight of the market for veterinary medicines in Ireland is carried out by the Department of Agriculture, Food and the Marine (DAFM) and by the HPRA, with each body being responsible for different aspects.

Role of the HPRA

The HPRA:

• publishes a list of shortages and resolved shortages notified by marketing authorisation holders
• collates information on the availability of authorised veterinary medicines and considers the impact of shortages, as well as the availability of alternatives
• takes regulatory actions to help safeguard the long-term availability of medicines in Ireland

The HPRA does not have a role in sourcing alternative products, managing stocks in the supply chain or advising on suitable alternative products.

Role of DAFM

The DAFM:

• coordinates the national response to a shortage among stakeholders to mitigate the impact
• ·operates the cascade system in cases where there is no suitable authority veterinary medicine available in Ireland
• receives reports of shortages from industry, as well as from vets, pharmacists, licensed merchants and others

Can the HPRA take regulatory actions to reduce the impact of a shortage?

Yes, where regulatory flexibility in relation to an existing veterinary medicine can ease a supply issue without impacting patient safety, we will be as practical as possible. In particular, we focus on actions to address acute and urgent patient needs.

For example, we can provide accelerated regulatory approval to supply a veterinary medicine to Ireland initially intended for another market. We can also accelerate the approval of controlled drug licences in a shortage.

However, DAFM is better placed to advise stakeholders in relation to any special imports of veterinary medicines from abroad, as it is the competent authority for licensing such products.

What is outside of the remit of the HPRA?

The HPRA cannot compel companies to supply or manufacture medicines.

Unlike the position for the regulation of human medicines nationally, the legislation does not provide the HPRA with a role in:

• Oversight of wholesalers,
• Managing stocks of veterinary medicines in the supply chain,
• Liaising with pharmacist, licensed retailers or veterinary practitioners regarding stocks.

We also have no role in:

• The purchasing of veterinary medicines.
• Commercial issues.
• The provision of clinical advice and treatment to vets or animal carers.

What can pharmaceutical companies do to minimise shortages?

In European law, pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market.

Companies and wholesalers are expected to develop and maintain resilience in the supply chain by:

• Monitoring their suppliers to detect signals of shortages,
• Regularly monitoring the supply chain,
• Regularly assessing market needs and delivery times,
• Developing shortages prevention and response plans