Cavan veterinary supplier challenges import licence for Czech firm

A Co Cavan veterinary medicines supplier has taken a High Court case challenging the decision to grant import licences allowing a Czech pharmaceutical manufacturer to sell its bovine mastitis treatments in Ireland. 

 

Univet Limited, which sells its own mastitis remedy in this State, claims the Minister for Agriculture, Food and the Marine did not follow correct procedures in issuing Special Import Licences (SILs) to Bioveta permitting it to distribute its product, known as Gamaret Intra-mammary suspension, in the Irish market. 

 

Action 

In its action, Univet, which has a registered office in Tullyvin, Cootehill, seeks an order quashing the decisions to grant SILs for Gamaret and prohibiting the Minister from issuing further SILs for the product. The company also seeks declarations that the decision to issue the importation licences was unlawful. 

 

In a sworn statement, Univet’s company director, George Crowe, claims the Minister has “abused his power” by allegedly issuing a series of SILs for Gamaret “virtually on demand”, with the first allegedly granted in late October 2020. 

 

The importation of animal remedies for sale and supply in Ireland is generally prohibited by legislation and can only be sanctioned by way of authorisation by the Health Products Regulation Authority (HPRA), said Mr Crowe. He said the European Communities (Animal Remedies) Regulations, 2007, dictate that an SIL should only be granted by the Minister as an “exceptional measure”. 

 

He claims that there were seven products available in Ireland for treating mastitis in lactating cows prior to January 2020. He said this includes Terrexine, which is manufactured by his own company. All seven products in circulation were authorised for sale in this State by the HPRA, he added. 

 

It is claimed the Minister sanctioned the importation of Bioveta’s Gamaret product following the withdrawal from the market in January 2020 another similar treatment known as Tetra-Delta. 

 

Mr Crowe said this decision, and the subsequent issuing of further licences, was “without legal foundation” as he claimed there was no health situation requiring the immediate importation and there was no shortage of supply of the animal remedy. 

 

Suppliers 

He claims the withdrawal of Tetra-Delta did not cause a shortage and any potential shortfall would have been made up “without delay or difficulty” by the existing suppliers. 

 

Further, he claims Gamaret “never was and is not an appropriate animal remedy” when having regard to European Union policy which he said requires Member States to take steps to limit the amount of antibiotics in such animal products. 

 

Mr Crowe also claims the Minister did not seek independent advice or investigation from the HPRA in determining the import application. 

 

The application to bring the judicial review proceedings was moved before Mr Justice Charles Meenan with only Univet represented in court. The judge gave the company permission to bring its action against the Minister, Ireland and the Attorney General. It was adjourned to next month. 

 

The Irish Times