With reference to the article by Stephen Calleja entitled “Foreign manufacturers ‘could refuse’ to export products to Malta” (TMIS, 25 July), it is pertinent to make some clarifications. Medicines regulation sets and enforces standards for medicinal products and for pharmaceutical activities for the benefit of the patient, who is the ultimate consumer of medicinal products.

For a medicinal product to be placed on the market in a member state of the European Union, the product needs to be registered in order to ensure that it is safe, is of good quality and has the required therapeutic effects. The authorities are committed to ensure the availability of medicinal products on the local market at affordable prices and the government is in no way trying to get into a dispute with pharmaceutical manufacturers. A good number of manufacturers (both local and foreign) have taken up the commitment to register their medicinal products in Malta. While manufacturers cannot be forced to place medicinal products on the local market, many of them take up their responsibility with due diligence and fulfil their public health obligations. The legislation sets provisions that enable the placing on the market of medicinal products that are not registered in Malta by the manufacturers.

There are different types of registration systems in the European Union with varying costs, depending on the work involved for assessment of the registration dossier. Most new medicines are approved through a centralised European procedure and, once the approval is granted at a European level, the medicinal product can be placed on the market in Malta without delay. For such centrally authorised products one fee is paid to the European Medicines Agency and no additional fees are paid to the local authority. Malta accepts that for such centrally authorised products, the same product as placed on the market in English speaking markets (mainly the UK and Ireland) is placed on the market in Malta, and therefore there are no issues with added costs for regulation and with delays for authorisation for such products to be placed on the local market.

The fees for the registration and maintenance of national authorisations are on the lower side of the EU average and efforts are made not to impose any additional regulatory burdens on the manufacturers to register their products in Malta. Fees for registration of products to be placed on the market in Malta are €116 per product in the majority of cases, both for European and national registration systems (where Malta is not acting as rapporteur or reference member state), and an annual fee of €116. Fees for the same registration procedure in the UK and Italy are €13,323 and €55,680 respectively. Moreover, most post-authorisation procedures are currently processed without payment of any fees. This is a unique situation for Malta, where the government covers part of the costs for this work, therefore indirectly subsidising pharmaceutical companies. Fees for these procedures were removed following pressure exerted by some Maltese representatives of foreign manufacturers. Many of these foreign manufacturers, in fact, are willing to pay fees to receive a good service and timely approvals for their products and have confirmed that prices of medicines are not dependent on registration fees paid in the different countries. In general, prices of medicines in Malta were not lowered when the fees were reduced or, for some procedures, totally removed in 2006.

With respect to standards for the activities required for the supply of medicines, these are intended to protect medicinal products from any deterioration in order to ensure that the products maintain their quality. Standards for maximum and minimum temperatures for storage of medicines are set in line with the recommendations for storage of medicinal products as set by the manufacturer to ensure the integrity of the medicinal products throughout its shelf life until it reaches the consumer. The recommended room temperature in pharmacies is of up to 25°C and fridge temperature between 2 - 8°C. The storage of medicinal products within the temperature as specified on the products’ package is also relevant to storage of medicines by patients in their homes, particularly in the hot summer months.

The authorities are committed to proceed with their endeavours to ensure availability of medicines, which are up to the required standards without compromising medicines availability and affordability, in the interest of all parties.

Dr Patricia Vella Bonanno

CEO

Medicines Authority