03 May 2006

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Business Today

Choice of medicines seriously compromised by registration system

As a direct consequence of the implementation of EU directives on Drug Registration Procedures, an alarming proportion of medicines have been removed from the Malta market, limiting choice to the consumer and reducing competitiveness amongst those few products remaining the healthcare section of the Chamber of Commerce said.
The number of medicines available on the island has been steadily and drastically reduced by some 7,000 items such that the country may end up with far less than 2,000 medicinal items available to the Maltese public by January 1st 2007 when new regulations must apply.
After this date patients may be compelled to seek their treatment of choice outside the country.
The Healthcare Trade Section of the Chamber of Commerce said it was excluded from the Government’s EU negotiating team such that recommendations were not lobbied successfully, if at all.
“The complete failure to recognize Malta’s unique status as a small nation with enormous economy of scale anomalies has resulted in an uncontrollable stream of prohibitive regulatory expenses and requirements which immediately proved economically unbearable – as had in fact been readily predicted since 2001,” the trade section said.
Under current circumstances, the number of medicine products available in Malta that can achieve the high level of sales sufficient to ensure the products profitability and viability is exceedingly small. Consequently the vast majority of medicines have already been removed from the Malta market.
Multinational pharmaceutical companies that have had a presence here for several decades are considering total withdrawal from Malta due to the labour-intensive, disproportionate costs and fees demanded for full product registration and their maintenance on this tiny market.
“Meanwhile, the Government talks of price –fixing and cartels,” the Chamber of Commerce said.
The trade section summarized the problems leading to higher medicine costs into four broad categories:
Dossiers – a series of voluminous expensive files containing exhaustive technical details of each individual medicinal product; Maintenance - Once registration has taken place and the initial fees have been paid, variation fees also become applicable and payable on a regular basis if a product is to be maintained on the market; Labeling - Upon registration, a product is allocated a unique Malta Market Authorisation number which must appear on the outer pack of the medicinal product if it is to be sold in Malta. This simple requirement very often can not be met because the required production runs are too small, specialized and too costly. The alternative is to affix appropriate labels locally. Again however, this simple (and laborious) process may only take place if premises have been GMP (Good Manufacturing Practice) certified and the services of a QP (Qualified Person) engaged. There are just 26 registered QPs in Malta; Language - The Malta Government seems to be insisting that patient information leaflets are printed in both of Malta’s official languages even if the EU directive states that any one official language can be used. Whilst information in Maltese would be welcome and desirable, to date the English language has proved more than adequate. Meanwhile translations into Maltese are costly and there is the important issue of who will accept responsibility for an accurate translation. Unique Malta packs are prohibitively expensive to produce and Government intransigence is presenting a barrier that would hinder free trade.
“Local medicinal importers likewise face additional and formidable problems with a reduced turnover of sales (fewer products to sell) and subsequent loss of profits happening at the same time that all other costs are rising. These general expenses include new costs incurred such as engagement of the services of a Responsible Person, warehouse air-conditioning and refurbishment, to maintain new desirable standards as demanded by the Medicines Authority,” the Chamber said.
The Chamber insists that all this flak comes at a time when Government is failing in its duty to pay hospital suppliers within a commercially reasonable time, by-passing it’s own Late Payment legislation and bringing increased bank interest costs and severe cash flow problems into the equation. This situation significantly reduces the goodwill that overseas suppliers show towards their Malta agents.
The Chamber is suggesting that the technical personnel of the Maltese Medicines Authority should cease to duplicate the expensive work being done already by similar EU Regulatory Authorities such that any product already registered in an EU country would automatically be allowed onto the Malta market as long as a CPP (Certificate of Pharmaceutical Product) was produced and the patient information was presented in one of the official languages of Malta.
“Again, it must be stressed that if nothing is done to alter this bleak situation by the end of December 2006, Malta will experience a medical crisis of its own making,” the Chamber warned.

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