Medicines registration fee 'no excuse to raise prices'

Pharmaceutical registration fees should not be used as an excuse for Maltese agents to put up prices, the government said yesterday.

It said the fee to register a product on the local market would be footed by the medicine manufacturers which in most cases were large foreign companies.

The new regulations, which will come into force shortly, establish a Lm50 fee for the registration of pharmaceutical products coming from EU countries, with higher fees for those coming from third countries.

The government said medicine registration aims to ensure that all products on the local market are efficient, of good quality and not harmful to people's health.

"The registration system protects the public from inferior medicines which could be harmful to their health," it said.

The government said there should not be any technical problem for products which were already on the local or European markets to be registered in Malta since the system adopted by the local authority was the same used in other European countries. Registration for medicines that were already on the local market was subsidised by the government and would therefore only cost Lm50.

As from May 1, companies can register products in Malta in the same way as they register them in other European countries, bringing the local market in line with its European counterparts.

Companies might decide not to register some products registered in other European markets. However, if a patient needed medicines which were not registered locally, and there was no alternative on the local market, a doctor could ask for permission for this medicine to be imported for this particular patient, the government said.

The Health Department could import some products considered essential and for which there were no alternatives without the need to register the product locally.

Reacting to accusations of lack of consultation, the government said the Health Division had kept its partners informed about all the developments. It said the department had received comments from the interested parties and the regulations reflected the contribution of all the parties.