News • 31 August 2003

Concern over future prices and availability of medicines

There is concern that new regulations prompted by the EU may mean higher prices for some medicinals with others disappearing from the market.
While all pharmaceutical imports into Malta were always subject to some form of registration, EU membership will mean that all medicines presently imported will have to be registered anew.
The guidelines for registration have as yet not been issued and importers are concerned as more than 6,500 products will have to go through the process prior to the end of 2006.
While the fees payable for registration have not yet been made public there is concern that certain older products that are sold relatively cheaply, will be withdrawn from the market.

Importers claim it will not be commercially viable for the manufacturers to pay the fees in view of the relatively small quantities sold on the islands. If the medicinals are to be imported, the fees would be worked into the price, resulting in an increase.
MaltaToday has learned that there may be a requirement that packs sold in Malta bear a local registration number. In view of the low quantities sold on the islands it may not be feasible for manufacturers to print this on the packs and according to pharmaceutical importers who preferred to remain anonymous, the addition of a sticker or stamp may give rise to abuse.
Registration fees for products originating outside the EU are expected to be substantial. Since the government purchases millions of Liri worth of medicines, all of which fall into this category, these will probably have to be purchased at higher prices from sources within the EU.
If the registration fees are paid, prices quoted would have to reflect the costs of registration.
It will be a requirement that all medicines sold in Malta are to have packs in the English language. However, many packs currently on sale in Malta are not EU packs, but international packs that are suitable to be sold in Maltese and similar humid climatic conditions.
It is of concern that the full documentation required is not usually available for these packs, while on the other hand, the packs for which full documentation is available, are often not prepared to withstand our climatic conditions.
Most EU countries are financially strong enough to manufacture a pack specifically for their requirements. However, most of the times, Maltese importers can only rely on English or international packs since they are the only ones to be described in the English language.
England is, however, in a completely different climatic zone to us. Pharmaceutical importers, who preferred to remain anonymous told MaltaToday they also question government's policy on parallel importation. Parallel important allows a licensed importer to import a product that is essentially the same as another one that has a market authorisation. While this stand is meant to protect the consumer, it is more often the retail outlet that is benefiting, it was claimed.