In a letter to Prime Minister Lawrence Gonzi, the federation explained that the pharmaceutical manufacturing industry has long been concerned with the link that has been established between the remit of the Medicines Authority to become financially self-sufficient, and the level of fees to be paid by the industry to offset the cost of services provided by the authority.

The FOI fully understands that all services rendered by the authority to the industry should be against payment. However, the industry cannot be expected to shoulder the expenses of a regulatory authority. When establishing the size of fees, the government must ensure that the industry is not burdened with fees that render the budding pharmaceutical industry in Malta unattractive to investors, thereby neutralising the competitive advantages that Malta currently enjoys in attracting other pharmaceutical manufacturing companies to set up operations here.

This position was stressed, unfortunately without a positive outcome, to the previous administration in numerous position papers to the director (Medicines Authority), the director-general (Health Division) and the Health Minister and in a consultation meeting with the head of the Core Negotiating Group.

The determining factor in establishing the magnitude of these fees is undoubtedly the fact that, to date, good manufacturing practice inspections and assessments of dossiers for national applications rely on the provision of services by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom.

However, the criteria exercised in determining the corresponding local fees need to be suited to the economic magnitude of the pharmaceutical manufacturing companies operating in Malta. If the Medicines Authority is still unable to totally fulfil its roles without assistance from the MHRA, then in spite of the fact that the MHRA is charging unaltered fees for services rendered to a regulatory authority of a small island nation, the local industry still considers it highly undesirable for the authority to pass on these costs to the industry in order to meet its remit of financial independence.

The FOI believes that these costs are inconsistent with what the local industry and market can bear and represent a high proportion of the overall cost of developing a new medicine, particularly in the case of small to medium-sized enterprises manufacturing generic products.

In view of the above, the federation has requested that the Prime Minister initiate urgent consultations to seek an equitable solution to this matter.