The Federation of Industry said yesterday that it failed to see what “new solution” may have been interpreted from the European Commission’s reply to a parliamentary question by MEP Joseph Muscat regarding the effect that registration will have on medicines availability in Malta.
The FOI said it had examined the entire text of the reply given by European Commissioner Günther Verheugen and it was pleased to note that the reply confirmed that small member states, such as Malta and Luxembourg, could apply the simplified registration measures that have already been adopted by government.
“However, the FOI fails to see what ‘new solution’ may have been interpreted from the Commission’s reply. The FOI has, however, recently examined the current simplified registration system in the light of the decrease in availability of medicines in Malta and has concluded that the system has not yet achieved its intended objectives,” the Federation said.
It added: “Thus, in June 2006, the FOI submitted recommendations to the government for the improvement of the system to provide less uncertainty in the risks
associated with marketing medicinal products, in an attempt to improve the incentives to license medicines in this manner and thus address the issue of medicines availability.”
The FOI also warned that while a simplified registration process was desirable, unlike other EU small member states, Malta possessed a thriving pharmaceutical manufacturing industry and care must be taken that the simplification of the medicines registration process would not, in the long term, render the Medicines Authority unable to provide the necessary regulatory support that was crucial to sustain this industry.
“Thus, while the FOI would welcome a solution to the current issue of medicines availability, it is concerned that there are those who would attempt to devise such a ‘new solution’ without consulting the local pharmaceutical manufacturing industry or keeping the local industry informed of their efforts, unlike what has been reportedly done with other stakeholders.”
The FOI said that it was disappointed by such a failure to adequately acknowledge the reality of the existence of a key component of the country’s industry, one that can, moreover, contribute realistically to the public health of the nation.