Malta seeks EU help to ease medicine registration system

The government is asking the European Commission to pile pressure on the pharmaceutical industry so it would start registering in Malta medicinal products approved in other EU member states, the director general of health, Ray Busuttil, said yesterday.

The EU gives member states the possibility of not having to process an application for a medicine to be sold in the country but rather rely on the assessment made by another member state for the same product.

This procedure is used in Luxembourg - a country with a similar population to Malta.

In fact, replying to questions by Labour MEP Joseph Muscat, the European Commissioner for Enterprise and Industry, Gunther Verheugen, said Luxembourg provides a good example of how the EU's present legal framework allows small member states to guarantee the availability of authorised medicines through a procedure called mutual recognition. Although such a procedure can also be used to register medicines in Malta, between January last year and last month it was only invoked in 130 applications although almost 2,000 products were placed on the European market, the Health Ministry said.

Asked why this was happening Dr Busuttil said this was what the health authorities were trying to establish through meetings with the industry.

Labour health spokesman Michael Farrugia said the problem boiled down to the high fees that manufacturing companies were having to pay both to register the product in Malta and also to seek authorisation to make any changes to the literature accompanying medicinals.

He said Malta should facilitate the procedure to register a medicinal product through mutual recognition and lower all fees, which are determined by the Maltese government and not by the EU.

A representative of the Chamber of Commerce's health care trade section, Reginald Fava, warned recently that the number of medicines on the market could go down to just 1,200 as from next year, in contrast with the 9,000 medicines available in 2000 and the 1,700 available today.

In his letter to the commission, Mr Muscat said medicines importers have been blaming the regulatory system for the fall in the number of available medicines and price increases.

Mr Verheugen replied that the Commission was aware of the reduction in the number of available medicines in Malta, and was closely following the situation to try and overcome these problems. He also said the Commission encourages the use of provisions based on the principle of trust between member countries' regulatory bodies in a bid to overcome the availability problems in Malta.

The correspondence between Mr Muscat and Mr Verheugen was forwarded to Health Minister Louis Deguara, the Chamber of Commerce, the Chamber for Small and Medium Enterprise - GRTU and the Chamber of Pharmacists.

The Health Minister said yesterday the fact that the Luxembourg model could also be used in Malta was not "some new discovery" and Mr Verheugen's answer did not come as a surprise to the authorities.

Dr Farrugia argued when contacted that the government had always claimed that the system implemented in Luxembourg could not be applied to Malta because, as a founder member state, Luxembourg had certain conditions that were not applicable to another country.

Government ministers will today meet up with the Chamber of Commerce's health care trade section in a bid to find the way forward in solving the shortage of medicines.

Contacted yesterday, Mr Fava said he believed the proposals made by the section - related to problems of language, registration fees and having to affix a Medicines Authority number on each and every medicinal on the market as from next year - would be accepted by the government.

"If we manage to resolve these issues the rest will be very simple," he said.